FDA, You Were WRONG! Stopping Innovation Stops America!
DR. ROBERT W. CHRISTENSEN with LYNN M. WATWOOD, JR. ESQ, LARRY R. PILOT, ESQ, and DR. CHARLES A. HOMSY
FDA You Were Wrong! Copyright © 2012 by Dr. Robert W. Christensen. All rights reserved.
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Published in the United States of America ISBN: 978-1-62147-258-2 1. Medical / Surgery / Transplant 2. Medical / Prosthesis 12.10.11
“To Know Him and To Make Him Known”
THE PURPOSE FOR WRITING THIS BOOK
It is with a degree of sadness that we attempt to write this book in a way that doesn’t condemn all of what the FDA does in the regulation of our medical devices and drugs, all of which are so needed in our present day practice of medicine and surgery. We know there are many dedicated individuals who work in all of the government agencies, and certainly HHS and FDA and the branches are no exception. It is apparent from the process which this small medical device company had to endure; there are many individuals, working in the FDA, who should be released from service in this regulatory body. These implants were grandfathered, pre-amendment devices to replace and reconstruct the degenerated or deficient temporomandibular joints. In this particular case, the entire process of innovation and entrepreneurship was accomplished by one individual in his attempt to help his surgical patients and all of humanity, without ever asking for, nor receiving any government subsidy, grant or outside investments. The true entrepreneurs of these United States, for the most part, allowed their own God-given talents of innovation to bring forth very excellent devices, without requiring any special government control or oversight. In the case of Dr. Christensen’s bringing forth the most successful treatment for TMJ anomalies and degenerative disease ever thus far accomplished, without oversight by the Government, nor contribution by the Government in any way, and with ever causing harm to any patient. After the Medical Device Act was established in 1976, some 16 years after Christensen innovated and implanted his TMJ devices, the government got involved in ways which to say the least were most remarkable and restrictive. The unusual requests of the Center for Devices and Radiologic Health, the branch of the FDA which approves and oversees medical devices and drugs, were so outlandish for a pre-amendment device, that the cost factors eventually forced Christensen’s company, owner and innovating surgeon into bankruptcy, and off of the market, depriving patients of the care which they so needed. We will attempt to tell this story with as much accuracy and objectivity as possible. It is a story which covered a 10 year battle between the small medical device company and the Food and Drug Administration and cost the small company upwards of 8 million dollars in actual costs and loss of revenue. To begin with, Dr. Christensen, as an oral and maxillofacial surgeon in Pasadena California, in 1960 developed the first successful implants for the reconstruction and replacement of the human temporomandibular joint. These devices had been implanted in patients during the period, before and after, the Medical Device Act of May 28, 1976, was established. The implants as Total and Partial temporomandibular joint implants were implanted with great success over the next 50 years since their innovation. It is the authors’ belief that today in so much of our lives the spirit of innovation and entrepreneurship is being severely damaged by thoughtless, over control by Government bureaucracy, regulation and loss of commonsense, to where our healthcare system and the patients, which they serve, are being severely damaged. Patients, truly are being denied proper and successful treatment modalities by the over regulation which is so prevalent today. In fact, the only Partial Joint TMJ implant available today, (the Christensen FEP), has been kept off the market for several of the last few years, putting needy patients in harm’s way and causing them to either get no treatment or worse having to endure a Total TMJ replacement which is much more harmful. Much of this delay is caused by FDA bureaucratic inefficiency or outright stalling, causing many patients to be harmed.
In thinking back over all my years of being involved in surgery of the temporomandibular joint there are many other surgeons and individuals I am indebted to. One of the earliest general surgeons who befriended me and took me under his wing was Douglas Donath, MD of Pasadena California. At a time when I came out of the military service as a Navy surgeon, stationed with the Marines, I was a proficient and capable surgeon, but as I began to get involved in more serious trauma and tumor surgery, it was nice having Doug run a bit of interference when some Plastic Surgeon would feel I was overstepping my boundaries. Doug worked with me on many surgical cases and especially the early TMJ surgeries in the 1950’s where I was pushing forward into somewhat unproven ground. It seemed there was always some jealous colleague out there to raise some interesting questions, but Dr. Donath was steadfast in his loyalty and support for me and my ability. He has since passed on some 10-15 years ago, but I will always hold the memory of our times together in high regard. Dr. Donath had earlier been President of the Pasadena Medical Society and I certainly considered him a friend and a mentor. In those early years after my military service during the Korean War, I developed another interesting and useful friendship with a cinematographer named Bob Chapin, also of Pasadena. Ours was an unusual relationship which started back in 1952, the first year after the Korean War, as I began to do some unusual surgeries in my private practice. One was a 57 year old female patient in whom I had to remove about 50% of her lower jaw due to cancer of the floor of her mouth. I would be placing a metal jaw implant, to replace her resected mandible. The replacement implant I had designed and constructed in my own garage, at night, out of 316L surgical stainless steel. I would add one of her ribs to this implant and at surgery I would remove her half mandible and place the implant and rib in to replace the removed section of bone. I had decided to make a motion picture film recording of the actual surgery and it was then that I came across Bob Chapin who was filming science type films for the National Science Foundation, Jet Propulsion Laboratory and the California Institute of Technology there in Pasadena. Working together, I was able to help Bob become an excellent surgical cinematographer over the next 15 years to where he produced some 25 excellent surgical films for me. We won a Golden Eagle Award in about 1967 for a film titled, “The Endosseous Dental Implant” which depicted one of my early innovations in the dental implant field. Bob and I spent many a night, well past midnight, talking about some surgical procedure we were going to film or editing some footage we had already taken. Then we both would go back to work early that morning, being somewhat exhausted. I am indebted to his ability, dedication and loyalty in capturing on film, very well, the surgical point I would be making. He was a dear friend. As I began TMJ Implants, Inc. there were a number of others who came alongside of us to give their support. One of those people was a renowned and outspoken surgeon named, Dr. Donald Chase. He was chairman of the oral and maxillofacial department at the medical school of the University of Tennessee. Don stood up with me and for the value of our implants when others in high places were condemning the practice. He was a skilled surgeon, a dear friend and a stalwart defender of the innovation and work I had undertaken. His career was shortened by his requiring brain surgery because of an intracranial tumor. He is doing well and we all sing our praise for all that he accomplished in his life. Another stalwart is Dr. James Curry of the Denver Colorado area. Back in 1988 he and his office partner, Dr. Jim Latta, grasped onto the idea of implanting the Christensen Partial Joint implant as a hemiarthroplasty in their early and late degenerative joint disease patients. Their success with this technique and implant procedure was so phenomenal that, over the following 22 years, they were able to lecture their results across America and around the world. They were very bold when in 1988 they first heard the description of the use of these implants. In the following 7 days they had placed five of these Partial joint implants in five of their patients with great, long term success. Dr. Curry accompanied me on many teaching presentations around the world as well as making a number of presentations before the FDA and other regulatory and judicial bodies. He is a great friend and one whose loyalty and support has been most appreciated and most valuable. Roland Jankelson, of Lakewood, Washington is a former CEO of a medical device company, Myotronics, and one who fought a similar battle with the FDA and won. When he heard of what the FDA was doing with TMJ Implants, Inc. of Golden Colorado, he became incensed and joined the battle with me. He was a remarkable and steady colleague and counsel in this protracted battle with the various levels of the FDA, HHS and the Judicial Branches which became involved. Without his help and friendship, we would never have been able to sustain the battle for justice, which is yet to come. Another individual who afforded me much wisdom and counsel was Kevin Cornwell, CEO of Utah Medical. He like Jankelson had courageously stood up to the corrupt and abusive behavior of CDRH and the FDA and won his battle in court. I will be forever grateful to Jankelson and Cornwell for the support they afforded me during our battles with the FDA.
Dr. Ricardo Alexander of Huntington, LI, NY, became a user of the TMJ Implants over 20 years ago and became a spokesman in a variety of ways. He lectured this surgical technique in various parts of America and the world and was a staunch defender of these implants before a number of meetings with CDRH, FDA and the various judicial systems. As a noted surgeon with the Navy in Vietnam at their trauma center, and then later as the Director of Oral and maxillofacial surgery at St. Luke-Roosevelt Hospital in Manhattan as well as a second major training center in Manhattan, his voice carried with authority in those various settings where he presented information. I will be eternally grateful to Ric as a friend, a colleague and as a teacher and skilled surgeon. His phrase, “This Is America- How Can This Happen?” will resound in not only my ears but should in the halls of the Food and Drug Administration as well. Mr. Jim Dickinson, who owns and publishes the Dickinson FDAWebview publication has been a constant reminder of what a travesty much of our journey in the battles with the FDA, has been. He has chronicled much of this journey, sometimes putting himself in harms-way by his Commentaries about the areas where the FDA attacks against TMJ Implants or I may have been over the top. I certainly owe Jim a note of respect and gratitude for his truthfulness and fortitude in reporting parts of this story. I also wish to acknowledge several individuals who were serving in the U.S. House of Representatives or U.S. Senate who also went to bat for TMJ Implants, Inc. and me, personally, before the Food and Drug Administration. Congressman Tom Tancredo was a particularly vocal force against the FDA in the TMJ Implants, Inc.’s battle with the FDA. He read the TMJ Implants’ Story into the Congressional Record twice. The same assistance was later offered by Congressman Bob Beauprez, followed by Congresswoman Diana DeGette and Senator Wayne Allard. They all tried to move the FDA to approve our pre-amendment, grandfathered devices through the approval process at the FDA, but all met with
fierce resistance and outright lies and distortions by those in command at the FDA. Their efforts even brought forth an Op-Ed in our favor in the WSJ, but it all had little effect, but cover-up. Another interesting individual who happens to be a physician and who happened to be in Administration at CDRH and the FDA was a remarkable help in seeing TMJ Implants, Inc. finally getting through the logjam in its PMA approval process. His name was Dr. Bernard Statland and he had informed Christensen on the phone one evening during the latter period of the approval process in 2000 that he was unable to sleep for 2 nights because of the treatment he perceived we were faced with and receiving at the hands of several key people at CDRH on our approval. He took a courageous stand for approval of these pre-amendment implants, over the objection of other key figures, such as Tim Ulatowski and Dr. Susan Runner, in the oversight at CDRH. He decided to retire from the FDA and within a month, he had passed on. I believe he was only in his mid-fifties. I will always hold him in high esteem for his stand and courage which resulted in our devices being approved. At the very end of my career as President and owner of TMJ Implants, Inc., I received two very kind letters from surgeon colleagues complimenting me on all that I had accomplished in the realm of surgical implant innovation. One was Dr. Eugene Keller who is director of the Oral and Maxillofacial section at Mayo Clinic in Rochester, where they use these implants on a regular basis. The other was from another excellent surgeon, of Nashville, Tennessee, who had successfully used these implants in his TMJ surgeries for over 20 years. Both of these colleagues and friends were most complimentary and their words were very welcome as I departed the very field that I had spent some 60 plus years in. I definitely wish to express my appreciation to Lynne, my wife of nearly 40 years, for all of her support. Also to my daughter, Joan, and my sons Bob Jr. and Matthew, all of whom offered support to Lynne and me as we founded the company and worked our way through some interesting years as the company grew. I also want to express my sincere appreciation to Lisa Deckard and Lenaya Casados who helped me tremendously in editing, proofreading and preparing this manuscript for printing. Both of these very lovely young women were not only very helpful, but were always there to help this author complete some computer task, and they always did so with a smile on their faces and were most gracious. I am most grateful.
It is in writing this book that the authors wish to shed some light on the actions of certain individuals involved in the regulatory process and oversight of the small and large medical device companies, which are hampering the innovation and entrepreneurship so needed in today’s market and economy. At a time when the United States is going through a significant downturn in the economy, we find a bureaucratic stifling of entrepreneurship and innovation. It is in telling this story of conflicts of interest, lying, cover-up and other possibly criminal behavior of persons within the Food and Drug Administration in the hopes that others might come forth to give their similar accounts of outright persecution and over regulation, so that future companies will not have to endure the same destructive and costly practices by our government agencies. I am a retired oral and maxillofacial surgeon who founded, in 1989, a small medical device company in Golden Colorado. I was the innovator of the first successful implantable devices for the temporomandibular joint starting in 1960. These devices were successfully placed in my patients going back to 1961. I am known as the pioneer in this type of surgery for degenerative joint disease, traumatically or congenitally missing portions of the associated bony anatomy and for certain tumor surgeries where resection of the actual TMJ may be required. The story to be told in this book will be about the rigorous path this small medical device company was forced to undertake after being considered a “grandfathered medical device’ with some 40 years of successful medical history. It was a story of persecution, abuse, conflicts of interest, corruption and distortion causing a serious financial burden for this small company. We will also show there is a pattern of similar, unreported tales by other medical device companies which need to be presented. If America is going to lead the world in innovation, entrepremiership and increasing market share, it is imperative we develop a sound, common sense, free of fraud and criminal activity regulatory process, which is friendly and fair to business. We have had enough of the delays, petty actions and favoritism which we have seen in this government for some years. Those personnel in the FDA and HHS who have been there wielding their unscrupulous power need to be gotten rid of, fired, terminated and held accountable. As a Christian, who is also ordained in ministry, I will likely disperse some biblical truth through this story. To some, it may seem out of place, but to me there is no separation a man’s profession and life from the Christian walk he is taking. This is truly who he is. It is my personal belief that much of the attack on me and my company came because I was a committed Christian.
IN THE BEGINNING
The following pages unfold a story of the Food and Drug Administration’s CDRH abuse of a small medical device company in its pursuit of an approval for their implants for reconstructing the temporomandibular joint. These devices are presently in their Jubilee Year (50) since their innovation, and have had a spectacular history of safety and effectiveness and have gained in acceptance and popularity as the state of the art of surgery for correcting the simple and the more complicated surgical problems within this human joint have evolved. The recent story starts in 1987 when I, Dr. Robert W. Christensen, the innovator of this surgical technique and implants, first started his medical device company, TMJ Implants, Inc. in California and later in Golden, Colorado. I was recognized as the pioneer and father of this surgical technique around the world and has sought to not only bring these implants forward for the patients who need them, but give life to teaching this surgical technique to hundreds of oral and maxillofacial surgeons around the world. The actual conception and innovation of these devices started in the late 1950s. Some of the earliest patients in which I surgically placed these TMJ implants, as far back as 1961, still remain pain free and functioning. Others have passed on never needing another surgery, and remained well through their remaining lives. I, as an
Assistant Clinical Professor of Surgery in the Medical School of the University of California, Irvine Campus, taught this surgical technique to the residents and staff in the 1960-1970s. I have also been available to teach this surgical technique to surgeons in and out of university settings around much of the world over basically the last 50 years. In 1987, Mrs. Christensen and I founded TMJ Implants, Inc. originally as a corporation in California and the following year moved it to Colorado and formed it as a Colorado corporation. It was shortly after moving to Colorado that the Christensen’s sought legal advice as to what needed to be accomplished to comply with any FDA regulation. The implants were actually considered as pre-amendment devices meaning they had been in commercial distribution during those years after 1961 and before the enactment of the Medical Device Act of 1976. In 1976 the U.S. Food and Drug Administration sought to classify all medical devices into one of three classifications. In so doing, they failed to recognize the availability of the Christensen implants for the temporomandibular joint and thus they were not classified into any of the three classifications. Our legal contributor, Larry Pilot, Esq. will speak more fully to these issues since he was in the Legal Counsels office of the FDA, in the 1995-96 timeframe, and helped write the Medical Device Act of 1976. In the original enactment, most of the pre-amendment orthopedic devices were classified as either Class II or Class III. Somehow the Christensen TMJ implants never got classified until about 1993-4. That was the beginning of a saga which has gone forth for the next 16 years for the small medical device company of Golden Colorado, known as TMJ Implants, Inc. During the early 1980s there was a Houston-based medical device company named Vitek, which came up with a new implantable device for replacement of the meniscus of the temporomandibular joint. This was called the Proplast Interpositional Implant (IPI). It was a thin lamination of Proplast implant material to Teflon FEP polymer. In the late 1980s a two-part implant to replace the entire TMJ joint was added to the Vitek line. This matched a metallic condyle replacement with a fossa implant that exhibited an ultrahigh molecular weight polyethylene articular surface bonded to Proplast implant material for tissue ingrowth fixation to the natural fossa. The FDA proposed approval of Proplast as a Class II material, subject to certain regulations, for use as a dental device in 1980 and as an ear, nose, and throat device and a general plastic surgery device in 1982. Final approval for dental applications was granted in 1987 and for ear, nose, and throat and general, facial, plastic surgery applications in 1988. In making those approvals, the FDA concluded that “the safety and effectiveness of Proplast has been established through long-term clinical trials” (Reference: Federal Register 47, no 12 (January 19. 1982), p 2818.). Successful use of the products is documented in more than 125 peer-reviewed publications. Some of these include:
F. B. Kessler et al., “Proplast Stabilized Stemless Trapezium Implant,” Journal of Hand Surgery 9A (1984): 227–31
G. G. M. Keet and W. C. Runne, “The Anaform Femoral Endprosthesis: A Proplast Coated Femoral Endoprosthesis,” Orthopedics 12 (1989): 1185–90
H. W. Hörl, M. Klöppel, and E. Biemer, “Prefabricated Free Flaps with Vascularized Polytetrafluoroeth-ylene (Proplast II),” European Journal of Plastic Surgery 17 (1994); 144–50
J. N. Kent, R. L. Westfall, and D. M. Carlton, “Chin and Zygomaticomaxillary Augmentation with Proplast, Longterm follow-up,” Journal of Oral Surgery 39 (1981): 912–19 L. A. Whitaker, “Aesthetic Augmentation of the MalarMidface Structures,” Plastic and Reconstructive Surgery 80 (1987): 377–46
R. P. Clark et al., “Closure of Dural Defects with Proplast,” Annals of Otology 5 (1984): 179–82
R. W. Neuhaus, B. Greider, and H. I. Baylis, “Enucleation with Implantation of a Proplast Sphere,” Ophthamology 91 (1984): 494–96.)
The IPI was designed in 1982 by Dr. John Kent, an oral surgeon at the Louisiana State University School of Dentistry, on the basis of seven years’ prior clinical experience with a similar lamination sold for plastic surgery uses. The FDA approved the IPI for marketing in early 1983. “You may market your device subject to the general controls provisions of the Federal Food, Drug and Cosmetics Act…until such time as your device has been classified under section 513 (Reference: Federal Register 21 (April 1, 1992): 317.) Dr. Kent designed the implant for patients whose TMJ discs had been destroyed by injury, malocclusion or jaw misalignment, bruxism (the grinding of teeth), and sometimes all three. The disc acts as a cushion for the jaw bone to slide over as the mouth is opened and closed. The product had the best success rate of the various products designed to deal with this very difficult problem. (Reference: L. N. Estabrooks et al., “A Retrospective Evaluation of 301 TMJ Proplast-Teflon Implants,” Oral Surgery, Oral Medicine, and Oral Pathology 70 (1990): 381–86.) However, if underlying clinical problems such as bruxism and malocclusion were not fixed, the implant would wear out, just as had the natural tissue. The FDA delayed classifying the IPI and all other TMJ implants until 1992, four years after Vitek stopped selling their implants. Under the Device Amendments of 1976 to the Food, Drug and Cosmetic Act.2 Count 9 the FDA should have classified those products in a timely manner as either Class I, de facto safe; Class II, safe and effective after review of data and sellable; or Class III, in need of data to show safety and effectiveness before sales could commence. Such a delay in timely classification underscores the ineptitude of the FDA. The FDA could have stopped sales at any time between 1976 and 1992 and asked for more data. But it waited for years after the devices were no longer being made or sold to decide that more tests were necessary. Why? One conclusion is that personal injury lawsuits against the IPI were driving force behind FDA’s behavior instead of the health and welfare of patients. (General reference: Cato Institute Policy Analysis No 412, August 28, 2001, http://www.cato.org/pubs/ pas/pa412.pdf) According to the testimony, personally given by their own patent attorney to me in 1987, the Vitek Total TMJ Replacement implant was in the line of the Christensen family of U.S. Patents for implants for the temporomandibular joint. Because of the FDA fiasco with the Vitek TMJ implants, the CDRH of the FDA stormed into action, blaming any and all TMJ implants with the same destructive brush. The predicate for this type of implantable device was the Christensen implants, which were in commercial distribution and allowed to go forth until CDRH got their act together and then called for a Premarket Approval, after now classifying all TMJ implants as Class III medical devices requiring the most vigorous scrutiny and regulation. It was this overreaction that caused the unprecedented regulatory testing and scrutiny for Christensen’s pre-amendment device, which should have been grandfathered through the approval process, with ease. In the following pages, we will tell a story of FDA deception, ignorance, and conflict of interests, inefficiency, corruption, and intrigue—all of which made these very effective implants unavailable to many patients who desperately needed them.
TYPES OF TMJ SURGERY PRIOR TO 1960
Without getting necessarily into the intricacies of the various surgical techniques, let me just state there were no surgical treatment modalities for the temporomandibular joint, which had a significant rate of success going out over 5 years post-surgically. There were few studies accomplished on any surgical treatments prior to the retrospective study on the Christensen TMJ implants starting in the 1993-4 era and beyond. That study has brought forward a real story showing the successful use of these implants for a variety of TMJ surgical problems. In 1971, I published an article depicting success for the partial TMJ implant over a 10 year period. The testimony of hundreds of surgeons to the effectiveness and safety of these devices over many years of use will also give a clear cut and very positive picture. With as much positive history behind these implants, and being also there position as grandfathered, pre-amendment devices one would have thought their transition through the approval process would have been similar to the pre-amendment orthopedic devices. The earlier surgeries which were available and in which I was involved fell into one or more of the following categories: • Menisectomy • Plication
• Condylectomy • Gap arthroplasty • Condylar shave • Sub-condylar osteotomy • Placement of a silicone spacer Many of these treatment modalities have persisted over all of these ensuing years, but most with very limited success or outright failure. There certainly were little or no long term studies with any of these surgical techniques. When compared to the TMJ Implants, Inc.’s Retrospective and Prospective Studies on the Total and Partial TMJ implants, there is no comparison for effectiveness and safety and longevity.
THE ORTHOPEDIC EXPERIENCE
In my early years of practice as an oral and maxillofacial surgeon, I became very interested in surgery of the temporomandibular joint. That led to my seeking information from my orthopedic friends as to what they were doing to improve the joints which they would be operating. Early on I purchased a book by Dr. Otto Aufranc, titled “Arthroplasty of the Hip”, which dealt with Dr. Smith-Peterson’s work with the mold arthroplasty of the hip. Dr. Smith-Peterson was a Norwegian orthopedic surgeon who was born in 1886 and died in 1953. His major pioneering effort was in the 1930-1940 period. Dr. Otto Aufranc was Professor of Orthopedic Surgery at Massachusetts General Hospital and Harvard University School of Medicine. Dr. Smith-Peterson was the innovator of the hemiarthroplasty implant for hip reconstructive surgery known as the mold arthroplasty of the hip. Dr. Smith-Peterson developed a hemispherical, acetabular-shaped implant to be placed within the hip joint in cases of early joint degeneration. He started with this project in 1925 by using glass as the material of choice for those first implants. He soon found those would fracture so went to a variety of materials until about 1938 when he learned of the Vitallium Cobalt-chrome metal, as a casting which he then used for these implants.
The original implants were placed in the freshened acetabular cup of the natural iliac bone. It was allowed to be unattached and thus was able to rotate or move as the head of the femur was taken through its normal rotation. This technique had a lot of success and some failures. This implant was state of art until the more radical total hip joint implant was developed. Others came along like Dr. Marshall Urist who felt the hemispheric implant should be solidly fixed to the acetabular portion of the ilium, and thus had three small foot-like retaining spikes on the proximal surface which allowed for fixation of the implant to the iliac bone thus immobilizing the implant. Dr. Urist became chairman of the Orthopedic Surgery Department at the UCLA Medical School in 1969 and later became an adjunct professor until the time of his death, in Los Angeles in 2001, at 86 years of age. He had been born in Chicago in 1914 and graduated in medicine at Johns-Hopkins University in 1941. He placed some of the earliest total joint implants in the United States and wrote several books and about 400 scientific articles on orthopedic surgery. He trained hundreds of surgeons and became most well-known for his research on the value of bone morphogenetic protein (BMP), in the restoration of normal bone within tissue and joints. His legacy, like those pioneers before him, is
well established. A Dr. Stephen S. Hudack, a New York orthopedic surgeon began experimenting with total hip replacement as early as 1939. It was at New York Orthopedic Hospital in 1948 that he began replacing the hip joint with the total hip replacement (THR) with some success. The previously popular forms of hip surgery for degenerative disease were the interpositional arthroplasty, where skin, muscle or tendon tissues were placed within the joint to prevent the bone surfaces from contacting each other, and the excisional arthroplasty, where the surface of bone was removed allowing for scar tissue to resurface the bone in hopes of reducing the pain.
There certainly were other forms of arthroplasty developed over the years, such as: • Resectional arthroplasty • Resurfacing arthroplasty • Mold and cup arthroplasty • Silicone replacement arthroplasty • Total joint replacement arthroplasty Much like we have seen in the surgeries on the temporomandibular joint, most of these earlier types of hip or knee arthroplasty have been replaced by either the total joint reconstructive surgery or in some cases a more minimal resurfacing type of implant reconstructive surgery, getting totally away from the use of autogenous materials. Many of the earlier implants used for joint replacement of the hip and knee were passed through the FDA regulatory process as pre-amendment, grandfathered devices with little if any further testing. The written articles attesting to the effectiveness of the implants was considered sufficient for the approval of them by the FDA.
DR. CHRISTENSEN’S EXPERIENCE
After leaving active duty during the Korean War as a Navy surgeon stationed with the U.S. Marines at the Marine Recruit Depot in San Diego, I moved in 1952 with my wife and three children to Pasadena California to begin a private oral and maxillofacial surgery practice. It was in that setting and during those post war years that I began to see many patients in need of some temporomandibular joint surgical correction. Some were for trauma where fractures had occurred, but others were for degenerative joint disease. As a successful oral and maxillofacial surgeon practicing alone in Pasadena, California, I was being asked to treat many difficult and complex patient issues. For some of the problems, there had been no effective treatment and I was attempting to think out of the box to be helpful to those patients. One area of surgical treatment in which there was no consensus and certainly no satisfactory treatment modality, had to do with the surgical TMJ problem. The problem could manifest itself in a host of ways from fractures of the joint all the way to agenesis or even tumors of the particular structures. I had examined many patients during my training at the Los Angeles County General Hospital, prior to my Korean War years, who had suffered trauma to the mandible and who then suffered fractures of the condylar neck, unilaterally or bilaterally. The usual
treatment being recommended at that institution was the closed reduction with immobilization of the mandible, in occlusion, to allow the fractured condylar portions to heal in whatever position they found themselves in after the trauma. As I started my own specialty practice, after the Korean War period, I began to see a pretty significant number of similar patients. I wasn’t comfortable with not attempting to do what we now call an open reduction and skeletal fixation of the fragments. As time went on I found I had a great deal of success. Was it a more risky procedure than the closed reduction? Yes, definitely. But I really did master that operation and in the next 8- 10 years I had probably operated some 50-75 such patients with measurable success. With this background, it is easier to see why I began to operate on the degenerated TMJ, that didn’t have any fractures, but was deteriorating much like the degenerated hip or knee joint. The problem was there were no excellent surgical techniques which would give any long term satisfactory results. We might do a disc removal procedure, but overtime that would cause more serious problems within the joint. Or, we might do what is called plication of the disc. In that instance, the displaced and somewhat degenerated disc was repositioned back over the condylar head, in hopes that it would stay in that position, and secondly that it wouldn’t repeat the dislocation or just plain wear out. There were other procedures, and to be truthful the success rate was usually less than 30% in the first 5 years. Not a compelling reason for doing that procedure. Now came 1960 and Sister Lucille. Here was a young Catholic nun in her mid-thirties, who has had a prior discectomy seven years earlier, followed by a high condylectomy some 3-4 years later. Her condyle is now anchored (ankylosed) to the skull base with almost no jaw function. Now what, Lord? “Physician, do no harm.” Both of the prior procedures accomplished on this young sister were accomplished by a very knowledgeable surgeon, who happened to be an orthopedic surgeon in the Central Valley of California. Was he negligent? No. He was doing the only treatment considered effective at that period of time. But, how could I help this young Sister have proper, pain free joint function? This was the challenge I was faced with that winter day in 1960. Was I capable of improving the situation? I certainly had been recommended very highly by the surgeons at St. Luke Hospital as well as Huntington Memorial Hospital. But, would that be good enough? I certainly could operate on Sister Lucille and get an immediate relief from pain and a greater amount of jaw function, but I could not guarantee that this good effect would last more than a few weeks to a few months. The problem which would occur after any surgery, normally accepted, at that time, by the medical community, would be that the bones would grow together and she would be worse off after another surgery than if we had performed no surgery at all. Only God could really make a difference. Either He would miraculously heal Sister Lucille, or He would show me how to operate on her TMJ and make it well. In 1960, as I was driving from Pasadena toward Santa Barbara, God placed an idea in my head which was so simple, so perfect and so just as easily condemned by the naysayers. He showed me that I could take the ten human skulls which I possessed and could fabricate a metal, S shaped implant to cover the bone at the base of the skull, which was the superior joint surface, and the one the degenerating condyle would normally attempt to function against in degenerative joint disease. It would, also, prevent the roughened surface the adjacent condyle from attempting to attach to the superior bone surface. So, it was December 1960 when I began to work on my new project. It meant I would need to place all ten of my skulls on a laboratory table, unhinge the lower jaw (mandible) and make wax patterns to duplicate the base of the skull in the area of the TMJ. The implant would need to extend laterally over the rim of the
zygomatic process and have 3-5 holes placed for the screws which would be required to hold the implant in place. This was getting exciting, but could I pull it all together? If when I got the first wax patterns developed, what metal should I use to cast the final implants? What made me think that I could make any of the ten implants which I would be fashioning fit Sister Lucille’s skull base accurately enough? That was the biggest challenge. If, at surgery, I had her left TMJ fully exposed, and the new implant didn’t fit, what then? I would be no better off than the earlier surgeon and she would have trusted me and we both failed. Well it took me the next couple of months to fashion 15 implants for Sister’s left TMJ. I then had to do some corrective bone surgery to go with the implant, if I was going to give Sister a chance for proper jaw function. I decided to do all of this surgery on a skull, including the bone corrective surgery which would have the effect of lengthening that part of her left mandible and putting the articular portion back into the cup configuration of the new TMJ implant. It was all getting more complicated, but more exciting. I decided, with Sister’s permission, to make a surgical film of the entire surgery. I had fully explained the surgery to Sister Lucille and she and I explained it to the Mother Superior of her order of Dominican Sisters. We were now just three days before the surgery, when I made a costly mistake. There was an excellent general dentist, whose office was near mine, that I made the mistake of telling him about what I was contemplating. He taught at USC and of course had many colleagues there. It turns out they were having an office party that very evening, and my friend Dr. Ray Contino let his comrades know about what I was doing the next Tuesday on a young Catholic nun named Sister Lucille. There was a couple there that probably was not too friendly with anything I might be doing. Thus, on Monday early afternoon, one of those darling doctors took it upon himself to phone the sister administrator of St. Luke Hospital to ask “if they allowed experimental surgery to be done in their hospital?” The custard hit the fan. Sister had been admitted in the hospital and was awaiting surgery at 7:30 AM on Tuesday. She was unaware of what had transpired over the weekend and on Monday noon. Now, sister administrator found herself in a pickle. After all, I had been on staff for about 8 years, had taken my rotation as head of the OMS department of the surgical staff, and was very well respected for doing a great deal of excellent surgery, and sometimes on the sisters, at no charge of course, but even for the Catholic priest at the hospital. She had to call me and explain I would not be allowed to do that “experimental” surgery in St. Luke Hospital and especially on a Catholic nun. That last part added by me. Won’t the devil attempt to stop God’s plan at every turn? After all it was God who showed me how we might effectively treat this type of problem. And now what? Only God could have orchestrated the next words out of my mouth. I said calmly to Sister, “I would like to go before the Executive Committee.” It just happens that they were meeting that very night. Well, PTL. So they listened to me as I explained what I have just written, and long story short, they allowed me to operate Sister Lucille the next morning, and all went perfectly. The implant fit well and then it was secured with four screws. My assisting surgeon, Dr. Douglas Donath, and I accomplished the other bone corrective surgery and the patient was returned first to ICU then to her room on the surgery floor of St. Luke’s Hospital of Pasadena, California where the first Christensen TMJ arthroplasty was accomplished in 1961. That was a momentous moment for future TMJ sufferers. Over the next 15 years I had the opportunity of operating on hundreds of patients with a variety of TMJ problems. The surgery was proving to be more successful than I might have first imagined. I was on about 17 major hospital staffs in the greater Los Angeles area and in 1964 we put on a teaching symposium
on TMJ arthroplasty at Hollywood Presbyterian Hospital where I performed a live surgery which was televised to about 200 surgeons from across America who were present for the symposium. That TV program on TV 13 in Los Angeles brought a lot of attention to the work that I was doing and was featured as a news story in a number of papers across America. TV Channel 13 in Los Angeles recorded the live surgery and it was shown a couple weeks later on a prime time, one hour program called, “Surgery 64”. It was seen by likely tens of thousands in the Southern California region. The patients continued to be referred to me from across the country and many of them had severely arthritic TMJs to where they had not had any jaw function or mobility for over 20 years. The successes were phenomenal and I give all of the glory to God. It was God who showed me very simply how to correct these problems. There were always the naysayers somewhere in the crowd of professional people, but the successes were so spectacular anybody really reviewing them couldn’t help but be impressed. I started a company called Implants Inc. back in the 1960s but I was just too far ahead of the curve. The accomplished professionals just never caught on. The public was much more attuned to why this technique would work, but the profession was cautious, if not outright skeptical. A number of attacks seem to come my way from jealous professionals.
THE CHRISTENSEN INNOVATIVE YEARS (1960-1969)
Some of the innovations we depict in this chapter will have no direct relationship to the FDA approval process which is the center of this book, but the ones dealing with the temporomandibular joint reconstructive surgery and TMJ implants are the subject of this book. The purpose for showing these implants is to make the point that each one of these innovations were for a particular implant and were the predicate or original devices for all later implants in those categories. None of these innovations required any Government funding but were paid for by the Christensen’s out of their earnings from the oral and maxillofacial surgical practice. These innovations all received U.S. Patents for being the first in their class, and were the basis for a large entrepreneurial effort by many other companies whose sales eventually went into the billions of dollars annually. The Circumferential Dental Implant It was in those years between 1950 and 1960, when I was age 35 and 40 years that seem to be my more innovative years. These were years before the advent of the Medical Device Act, so that any innovator could develop a fine medical product and even bring it to market with minimal cost and effort, allowing the free market to approve it or disprove it. It didn’t require millions of dollars be spent to overly test the product, but brought the product forward in an efficient, economical and commonsense manner. In my first innovation in the late 1950’s, I sought a simple, single or multiple tooth replacement type of dental implant. At that time there were no other individual tooth implants in existence. The Circumferential Dental Implant received a U.S. Patent in 1962 and was the first individual, single or multiple, tooth implant in the U.S.
The Circumferential Dental Implant
One area of surgical treatment in which there was no consensus and certainly no satisfactory treatment modality, had to do with the surgical TMJ problem. The problem could manifest itself in a host of ways from fractures of the joint all the way to agenesis or even tumors of the particular structures. But the most frequent was degenerative joint disease, just like we see in the hip or knee in patients. In 1959-60 I innovated and patented the first successful Partial implant for the temporomandibular joint. It is used to create a new bearing surface at the base of the skull for the mandibular condyle to function against in cases where there is loss of a healthy meniscus, degeneration of the natural condyle or some anomaly of the structures involved.
The TMJ Partial Joint Implant
The Transosseous Dental Implant My next innovation occurred about 1964 and was what I called the Transosseous Dental Implant. It was an implant which I held the U.S. Patent for which was a dental implant which traversed the mandible in the chin area.
The Transosseous Dental Implant
The Endosseous Dental Implant This was my most recent dental implant innovation in the middle 1960s which would allow for a single or multiple tooth replacements. This implant literally brought forth a multi-billion dollar industry which we have today in the dental implant arena.
The Endosseous Dental Implant
The Modular Mandibular Implant This was my final implant to be developed by me in the 1960s. The cost of innovation and gaining U.S Patents was beginning to overcome my resources and so I decided to not attempt to patent anything after that.
The Modular Mandible
The reason for showing these innovations of Dr. Christensen is to show that without the oversight of the regulatory process seen later by the FDA, it was possible for a person to bring forth innovations to help many people around the world. Once the overbearing and flawed regulatory process came into being, it prevented patients from getting successful innovations in a timely manner.
STARTING TMJ IMPLANTS, INC.
In 1988, I knew we were to close my surgery practice in Northern California, which we did. We knew we were to move to the Denver area and to start the medical device company. Alongside of the medical device company we started a ministry to marriages with its own TV show daily across the Nation. A number of interesting things occurred surrounding that transitional time in our lives. Some 30 years earlier I had started a medical device company, while practicing as an oral and maxillofacial surgeon in Pasadena, California. I selected and received the name of Implants, Inc. A California corporation. I held the earliest three dental implant U.S. Patents as well as the earliest U.S. Patents for any implants for the temporomandibular joint. I felt I could get a start on the manufacturing and sale of these implants, but without any outside funding for manufacturing and PR, it seemed impossible to get off the ground. Also, I realized the profession was not quite ready. Thirty years later when I started the ministry and medical device company side by side, a couple of interesting things happened. I had attempted again to get the name, Implants, Inc. and was originally told it was available, but within a week or two I was told it was not available, so I then chose TMJ Implants, Inc. and that was available, which turned out to be fortuitous. As I prepared to close down my practice, which by itself was a weird thing to be doing as we had no other income to sustain my wife and two young boys, a friend in ministry from the Denver area came to visit us in Ukiah. We talked about the vision for the ministry and the medical device company the Lord had given us some years before. Our friends suggested we come to visit them in Lakewood, Colorado and we did so over the Christmas holiday in 1988. I had decided to bring along a box full of the various sized TMJ implants, just in case I met some Colorado surgeon who might like to see what they were all about. We enjoyed out visit with our friends in Lakewood, Colorado, but then I looked in the phone book for some local, Colorado surgeons who might wish to hear of the type of TMJ surgery I had innovated, I found a couple of surgeons whom only the Lord could have arranged for me to contact. To make a long story short, the two surgeons who I had chosen to visit and to teach about these implants, they themselves, at my direction, accomplished five such surgeries in the next 7 days while we were in the Denver area. I was able to come into the surgeries and instruct them in the technique and provide the implants. It was a sign to Lynne and me that we were to sell our home and move from Ukiah to Lakewood, Colorado to start the medical device company alongside of the marriage ministry. And thus we did. In looking back over this move and how preposterous it would seem, it seems unlikely we would ever get such a venture off of the ground. We certainly never knew the enormity of the challenge, and especially what we would face in bringing such implantable devices through the regulatory process. Our total wealth as we closed the office in California and sold our little home in the wine country of Calpella and Ukiah was $10,000. We had two cars, a dog, a cat and two young sons. We sold our home in about 20 days after returning from our visit to Lakewood Colorado and we started our trip pulling a trailer behind one of the cars. On the trip across Wyoming one of our cars broke down so we left it in that town and never saw it again. What an adventure. When we arrived in Lakewood, we stayed with our Christian ministry friends Mike and Marilyn Phillips. They were gracious enough to not only house us but to give us a place to start our ministry and medical device company in their basement. I think we probably had about 400-500 square feet of space to use as a total for both ventures. Everything we did to start TMJ Implants, Inc. started in that spot. This was a time before we even had one computer, nor knew much about a computer. This was going to be some adventure. We had inquired of an attorney in Santa Rosa, California about what was needed to get through any FDA regulatory process and she told us that since my implants were pre-amendment implants there would be no process to even go through. Wrong. Sometime after arriving here in Colorado and getting started with the new company and ministry, I came down with an acute attack of asthma and ended up in the hospital for a week, using up our life’s savings. Lynne was anxious to return from where we had come but I just knew we were called to start the company in Colorado and we should persist and hopefully persevere. Within another month we rented our first home and used our basement as the headquarters for TMJ Implants, Inc. and Covenant Marriages Ministry, just as the Lord had directed me some 6 years earlier. It was a surrealistic appearing venture. I hadn’t even gotten a computer for about another 30 days and on one particular weekday morning I typed my first one page history of the implants and the new company, TMJ Implants, Inc. It was sitting on my computer when upstairs there was a knock on the door and my teenage son, Matthew, answered and came down to tell me there was a man at the door who said he was from the FDA. This was my initial contact with the FDA other than filing a notice that we were beginning as a company selling TMJ implants.
I came upstairs and courteously introduced myself and walked down into our basement with this gentleman. After some hour or more discussion, he was ready to leave and all he wanted to take with him was my one page history of these implants and this
new company. Over the years many things happened as we grew from a small medical device company, with two employees, to a company functioning in at times 27,000 square feet of space and with up to some 38 employees. We’ll tell more of this story as we go along.
THE MEDICAL DEVICE AMENDMENT OF 1976
To the U.S. Food and Drug and Cosmetic Act
(Paraphrased from Larry Pilot’s “Stifling Medical Device Innovation” Article) The United States has long been the home to cutting-edge innovations in the medical device industry, a remarkable private enterprise success that has improved or extended the lives of millions of people. However, increasingly burdensome regulatory policy is driving pioneering research and development to Europe and to the rest of the world. Nevertheless, the U.S. Food and Drug Administration (FDA) and self-styled public health advocates are engaged in an assault on the primary regulatory pathway through which new products reach the market. This could lead to further erosion of U.S. leadership in this important field and be most hurtful to patients requiring a specific implant, technology or treatment. The primary law governing medical devices was enacted in 1976, and it established a flexible review process intended to tailor FDA oversight of new and improved devices to a level of regulatory control sufficient to provide a reasonable assurance of safety and effectiveness. In the TMJ Implants approval process, Dr. Bernard Statland, newly appointed Director of the Office of Device evaluation, rebuked the leaders at CDRH, Ulatowski and Runner and others, for requiring an absolute evidence of safety and effectiveness, which he knew as a physician was an unreachable goal. Most new devices incorporate fairly modest changes or improvements on previously marketed ones. For that reason, an estimated 90 percent or more of the devices now on the market have been authorized for commercial sales through what is known as the 510(k) process, which is a less stringent approval process than the pre-market approval process, known as a PMA, which will require a far more stringent review on items like heart valves, etc. The grandfathered devices such as some hip and knee implants were never required to go through such expensive and time consuming reviews since they, like Dr. Christensen’s TMJ implants, had been in commercial distribution for many years before the Medical Device Amendments were even instituted. Most of the more recent innovations, as iterations of earlier products, do not go through a full premarket approval. (PMA) But they are nevertheless subject to numerous and burdensome legal requirements to ensure their safety and effectiveness. While there have been a few examples of FDA mishandling the 510(k) process by inappropriately clearing devices that should have been subject to full premarket approval, there is no evidence that the 510(k) process itself systematically allows unsafe devices on the market. Nevertheless, the process has been made stricter and more comprehensive over the years through legislative changes and bureaucratic excess. Consequently, many 510(k)cleared devices must now meet requirements similar to those for devices that go through the full premarket approval process. This has resulted in a lengthier and less predictable review process that hinders innovation. The FDA recently proposed additional changes that would make the 510(k) review even more onerous, and a report from the Institute of Medicine (IOM) has called for scrapping the 510(k) process altogether. However, most criticisms of the 510(k) process
are based on a misunderstanding of how it works and why it was designed the way it was. The Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act created a classification system for devices based largely on the nature of their intended use, the importance of those uses in sustaining or supporting the life or health of patients, and the sufficiency of various regulatory standards in providing a reasonable assurance of safety and effectiveness. • Class I includes fairly simple products, such as tongue depressors. • Class II includes somewhat more important devices, such as most artificial hip and knee joints. • Class III includes devices most important in supporting the life or health of patients, such as heart valves.
The 1976 Amendments also recognized that most devices would not need to surmount a comprehensive clinical testing and approval process to ensure their reasonable safety and effectiveness. Nearly all Class III devices would have to be rigorously tested and pass through the FDA’s stringent premarket approval (PMA) process. All genuinely novel devices that are not substantially equivalent to other devices already on the market are automatically placed into Class III. Devices that contain only minor improvements to a previously marketed Class I or II device must comply with rigorous performance standards and other regulatory controls, but generally do not have to be reviewed through the comprehensive PMA process. It was because of the inexperience of the CDRH’s Dental Division, which was selected to oversee the approval of all TMJ implants, which caused much of the problem, in the approval process for the Christensen, predicate or grandfathered implants. Most all of the other joint replacement implants had automatically been placed in a specific classification, at the time of the 1976 Medical Device Amendments. No TMJ implant had been classified until approximately, 1994, and then they were classified as a Class III device. The Christensen TMJ implants had been in commercial distribution since 1961 and sold by Implants, Inc. first and then later by HOWMEDICA, Inc. and consequently they had been overlooked by the FDA in the classification process. Ideally, they should have been classified and placed with the other joint implants under the supervision of the Orthopedic Division of CDRH. The Orthopedic Division had the knowledge to have brought them into compliance with ease and a lot less heartache to the innovator and more timely for the patients. In comparison, there was a total lack of understanding what the Christensen Partial TMJ implant was used for and then there was bias, conflicts of interest and corruption with the approval process for devices which had been on the market and implanted in patients with total success for some 38 years. The FDA had later problems with another substantially equivalent TMJ implant known as the Vitek implant, in the late 1980s and early 1990s, and thus they attacked the approval of the Christensen TMJ implants, which had been functioning very well over the preceding 38 years. It truly was a travesty, but no amount of arguing by Christensen, other surgeons or the Congressional Representatives, who also got involved, could sway the minds of the CDRH hierarchy. Another interesting thing happened in the approval process for both Christensen’s predicate device, known also as the TMJ Implants, Inc.’s device was when it came time for the Dental products Panel hearing, the more recent TMJ Concept’s devices were passed though the approval process in about 2 months, whereas the predicate, grandfathered TMJ Implants, Inc.’s devices were withdrawn from the market, and placed in an IDE for some 21 months and they only got through the process by Dr. Statland overriding the wishes of Runner and Ulatowski. It was an unbelievable event, especially since the Christensen Partial TMJ was the only procedure which had such a long track record of correcting the earlier TMJ problems such as internal derangement. This was especially remarkable since the original May 10, 1999 Panel voted 9-0 in favor of passing the Christensen implants through the approval process. With the previously mentioned classification system in mind, the 510(k) review was designed to ensure that new products were assigned to the correct class. It was not intended to establish an independent safety or efficacy review process akin to premarket approval because the regulatory controls associated with the classification system itself are sufficient to provide a reasonable assurance of safety and effectiveness. Certainly, most all of the pre 1976, or pre-amendment devices were grandfathered into actual approval, just using whatever articles or studies or other evidence which was available because of their being in commercial usage prior to the amendment. Many observers mistakenly equate the device classes with a measure of risk. However, the classification system is not based on the inherent riskiness posed by the devices, but on their complexity and function. Even for a Class III device, the FDA confirms by approving the PMA application that the product does not pose a “high risk,” but in fact is reasonably safe and effective for its intended use. Although most Class I devices are exempt from the 510(k) clearance requirement, essentially all post-amendment Class II devices may not be marketed until the manufacturer submits a 510(k) notification providing a substantial amount of data from laboratory testing, bench trials, and comparative studies demonstrating substantial equivalence to a predicate device before they may be marketed. Clinical testing is not explicitly required by the statute, but the FDA has broad authority to demand clinical data before clearing a Class II device. During the past 20 years, the FDA has become more aggressive in using this authority, and it has required more and more devices to go through the full PMA process. This has drawn out both 510(k) and PMA review times and has created an atmosphere of unpredictability and uncertainty about what will be necessary to get products to market. Yet, critics have increasingly called for even more legislative and regulatory burdens. Much of the criticism has focused on a seemingly high number of medical device recalls. From 2005 through 2009, device manufacturers initiated a total of 3,510 recalls for products in all three classes. Without any further context, that number may seem to suggest deep flaws in the regulatory process. But it is essential to examine the data more closely and place those figures in the appropriate context. In most cases, recalls involve manufacturing or packaging problems that occur after the FDA cleared or approved the device. And, in any event, many recalls involve technical violations of statutory or regulatory requirements that do not affect the safety or effectiveness of the devices in question. Of the recalls issued from 2005 to 2009, the FDA concluded that approximately 96 percent involved little or no risk of harm to patients. Only 131 recalls were considered “high-risk.” Yet even among these, more than half involved infractions such as labeling errors, inadequate instructions, or manufacturing glitches that could not have been prevented by a more thorough FDA review. Roughly 87 percent of those high-risk recalls were of devices cleared through the 510(k) process. But the FDA cleared approximately 18,500 devices through the 510(k) process during the five-year study period, and approved just 150 through the PMA process. That means that fully approved devices, by the PMA process, were more than 30 times more likely to be recalled than those whose approval was through the less stringent 510 (k) process. Arguably the most stinging safety criticism that can be made against the FDA is not that the 510(k) clearance process is flawed per se, but that the agency has mismanaged it by occasionally clearing devices that were not in fact substantially equivalent to predicate devices. Over the past decade, the FDA’s response to the increased public scrutiny over such mishaps has been to add new and more burdensome laboratory and clinical data requirements, and to repeatedly request additional information from manufacturers during the 510(k) review. That response represents yet another form of FDA mismanagement. The medical device industry is a remarkable example of private enterprise success that has improved or extended the lives of millions of people. The United States has long been the home to the majority of cutting-edge innovations in the medical device industry. However, increasingly burdensome U.S. regulatory policy is driving pioneering research and development to Europe and to the rest of the world. The U.S. Food and Drug Administration (FDA) and many self-styled public health advocates are now engaged in an all-out assault on the primary regulatory pathway through which new products reach the market. This could lead to further erosion of U.S. leadership in this important field. The FDA regulates not only sophisticated and cutting-edge medical technologies such as artificial heart valves and MRI machines, but simple devices as well—from tongue depressors and surgical drapes to IV fluid bags and contact lens solutions. The primary law governing medical devices is the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act. The Amendments established a flexible review process intended to tailor the level of FDA oversight of new and improved devices to a level of regulatory control sufficient to provide reasonable assurance of safety and effectiveness. The 1976 Amendments also recognized that many new devices incorporate fairly modest changes or improvements on previously marketed versions. If a new device had the same or similar technological characteristics as a device already on the market, and had the same intended use as that predicate device, the new one would be considered “substantially equivalent” and subject to less comprehensive premarket review. Most of these
products do not go through a full premarket approval process that may require substantial clinical testing, but they are still subject to numerous and burdensome legal requirements to ensure their safety and effectiveness.
When the original Medical Device Act was enacted on May 28, 1976, there was an understanding and a provision that those medical devices which had been in commercial distribution prior to that date would be exempt from the rigors of the approval process. There was also a delineation of those devices by various categories and although they would be required to register the device, they would be exempt from the scrutiny to be placed on subsequent entries into this market field. They would be termed a “predicate device,” or a “grandfathered device.” There was also a provision for devices entering the market that could prove substantial equivalency to pre-amendment devices that then would be allowed to enter the market with possibly a 510(k) evaluation. For the various orthopedic type implants which had been on the market prior to the Act, they were given the opportunity of presenting information from earlier written and published articles that gave a picture of the usefulness and safety of these devices. The process was quite simple and seemed to accomplish what was necessary to show the safety and efficacy of the various devices. They were never asked to go through either a 510(k) or Class III PMA approval process. The latter being the most rigorous, time consuming and extremely expensive evaluation of the safety and effectiveness of a device. The cost for that type of evaluation of safety and effectiveness can easily go into the millions of dollars even for a small company. In that original process, though the Christensen TMJ devices were in commercial distribution and should have been so included, they weren’t, and Christensen personally was never made aware of the need to bring these forth for some type of registering
or evaluation. Consequently, implants for the temporomandibular joint never even got classified as Class I, II, or III, even up until about 1993. This oversight by the FDA created all sorts of
THE FDA FIASCO WITH THE VITEK TMJ IMPLANTS
This story starts way back even in the late 1950s when Christensen was first attempting to place a Silastic block into an area of ankylosis of the TMJ where a gap arthroplasty had been done in order to prevent bone fusion from recurring. The Dow Corning Company had later come out with a thin sheet of Silastic for use for this purpose and called it the Dow Corning Disc Implant. This implant was undoubtedly “grandfathered” through the FDA as a pre-amendment device with little or no evaluation or testing. As discussed on pages 22 and 23, it was in about 1981 that the Vitek Company and its president, Charles Homsy—a bioengineer by profession—joined with a Dr. John Kent of LSU to bring forth an implant for the replacement of the interpositional disc of the temporomandibular joint in which a product known as Proplast was part of the design. It was in 1987 that Christensen was invited to give a presentation to the oral and maxillofacial surgery department at the University of Texas Dental Branch in Houston. After the presentation Christensen was invited to meet with Dr. Homsy and the patent attorney for Vitek. It was during that meeting in which the patent attorney said to me that his patent for the Christensen TMJ implants had started the Christensen family of patents for the TMJ—a rather interesting admission by the Vitek patent attorney.
It is interesting that Christensen had used a film-like surface of Teflon placed on his Cobalt-chrome, Fossa-Eminence Prosthesis, as early as 1961, and there appeared to be no downside from that use of that material. He had shown those implants in his 1963 film on the subject of “TMJ Arthroplasty Using the Christensen TMJ Implant.” Whereas Teflon PTFE had been used as a bearing surface in the hip implant in the early 1960s, a Dr. Charnley in London reported on failures a bit later, and it was abandoned by him. But in a letter to the London Review of Books on October 15, 2011, Dr. Homsy lends perspective to the use of “Teflon” as the acetabular cup of total hip joint replacement implants in the United Kingdom as reported by Sir John Charnley. “In 1966 I established the first biomedical engineering facility in a major US hospital in Houston, Texas. My background had included work in Teflon polymer at the Dupont Company Research Center in Delaware. I wrote Sir John and inquired about his poor results with “Teflon” for the cup component of his total hip replacement. He immediately replied at length to explain that the polymer he used was not Teflon PTFE but “Fluon G1 or G2 PTFE” (a product of ICI Ltd.), and this had been processed for him into block shapes by “Messrs. Crossley (Packings) Ltd of Astley Bridge, Near Bolton, Lancashire, England.” Sir John had machined cups for his hip implants from a PTFE, which was not Teflon and further had been made for gaskets and such for chemical manufacturing. Thus, the cups were potentially contaminated because of the non-medical grade conditions under which they were made. Nevertheless, being PTFE, the cups wore under the conditions in the hip joint, thus potentially releasing PTFE particles and random contamination derivative of the industrial manufacturing conditions employed. Serious tissue reactions were seen around failed hips likely involving the contamination debris.” Christensen had placed about six Cobalt-chrome, Christensen Fossa-Eminence Prosthesis (FEP) with a Teflon coating in patient’s temporomandibular joints during 1961 to 1962 with no apparent failure problem. He, at that time, attempted to get a U.S. Patent on that use as a film on the metal implants, as well as on dozens of his surgical instruments, but he abandoned the idea since the frying pan surfaces were already being patented. He also abandoned using Teflon as a coating surface for his implants as it seemed no improvement over the highly polished Cobalt-chrome surface for which he had already filed for a U.S. Patent. In the case of the Vitek Interpositional (IPI) implants, it was becoming very apparent by 1988 that the procedures were failing and at revision surgery there appeared to be severe bone destruction and tumor-like formations of foreign body inflammatory masses in the region of the joint. In some cases the cranial base was being penetrated by the foreign body tissue masses. The pain factor was becoming very severe in many of these patients. The FDA delayed classifying the IPI and all other TMJ implants until 1992, four years after Vitek stopped selling their implants. Vitek made that decision when conflicting reports appeared concerning the use of the IPI implant by oral surgeons. Under the Device Amendments of 1976 to the Food, Drug and Cosmetic Act.2 Count 9, the FDA should have classified those products in a timely manner as either Class I, de facto safe; Class II, safe and effective after review of data and sellable; or Class III, in need of data to show safety and effectiveness before sales could commence. Such a delay in timely classification underscores the ineptitude of the FDA. The FDA could have stopped sales at any time between 1976 and 1992 and asked for more data. But it waited for years after the devices were no longer being made or sold to decide that more tests were necessary. Why? One conclusion is that personal injury lawsuits against the IPI were driving force behind FDA’s behavior instead of the health and welfare of patients. The Dupont Company had been targeted in multi-plaintiff lawsuits because Vitek had used Teflon, its product, in making the
IPI. Most of these suits ended in summary judgment or victory by Dupont at trial. Appeals were made by plaintiffs to various Federal Circuit Courts of Appeal. An analysis of several cases by the judges of the Sixth Circuit Court of Appeals not only cleared Dupont but showed that Vitek was not negligent in developing its devices. “Dr. Homsy was also aware of the Leidholdt study as evidenced by a chapter he wrote in Biocompatibility of Clinical Implant Materials entitled ‘Biocompatibility of fluorinated polymers and composites of these polymers.’ In this chapter, Dr. Homsy questioned the experimental methods of Dr. Leidholdt by noting that [Teflon] PTFE [one of the materials used in the devices] was used in conjunction with dissimilar metals, thus potentially contributing to the inflammation observed.” The court found further: “The record…demonstrates that Dr. Homsy’s writings were an effort to distinguish the [Charnley and Leidholdt] studies, not to disregard them. His correspondence to Dupont and professional writings explicitly noted the experimental contrasts between his work and that of Drs. Charnley and Leidholdt. Furthermore, Dr. Homsy carefully developed means and methods to address the concerns raised in those studies in creating Vitek’s prostheses. We [the court] also believe that the District Court wrote properly that [Teflon] PTFE and FEP were not defective in and of themselves.” For more information:
D. Jacobs et al. v. E.I. du Pont de Nemours & Co., U.S. Court of Appeals for the Sixth Circuit (file 1895a0312p.06), October 19, 1995, http://www.law.emory.edu/6circuit/ oct95/95a0312p.06.html.
The Fifth, Seventh, and Ninth Circuit Courts of Appeal found analogously for Vitek and Dupont.
The opinion of the U.S. Court of Appeals for the Ninth Circuit in Kealoha v. Du Pont et al. and Wolfe v.Vitek et al., May 3, 1996, http://www.vclip.org/ Fed-Ct/9th/opinions/9415688. htm; and the opinion of the U.S. Court of Appeals for the Seventh Circuit in Styke v. Du Pont, November 18, 1994, http://www.kentlaw.edu/7circuit/1994/93-3947.html.
(General reference: Cato Institute Policy Analysis No 412, August 28, 2001, http://www.cato.org/pubs/pas/pa412.pdf)
Despite the nearly thirty-two years of successful use of the Christensen Partial and Total TMJ implants, the FDA overreacted and classified all TMJ implants as Class III medical devices, thus pushing eventually for a PMA type of approval, even of the definitely pre-amendment Christensen implants. This started a string of FDA abuses of the Christensen devices, and TMJ Implants, Inc..
THE BEGINNING REGULATORY PROCESS
A little history of the FDA’s action to regulate medical devices and specifically, implants for the temporomandibular joint is required. To begin with, the Medical Device Act came into being on May 28, 1976. Any TMJ implant or orthopedic implant which was in the market prior to 1976 was considered a pre-amendment device, thus allowing marketability of such devices without requiring any further demonstration of safety and effectiveness. Any TMJ device on the market prior to the establishment of the Medical Device Act was exempt from any specific regulatory action in which an investigation of S & E (safety and efficacy) was required. Christensen’s TMJ implants had been in use and distribution since the middle of 1961 and thus were grandfathered under the MDA of 1976. Devices introduced after the May 28, 1976 date would require some further FDA clearance, depending on whether they were or were not “substantially equivalent” to a predicate device on the market. In 1993, after the Vitek fiasco and recall, the FDA Dental Products Advisory Panel first classified TMJ implants into Class III, highest risk category. It wasn’t until December 1994 when the FDA issued its Final Rule which would require some time in the future a PMA application to commercially distribute these devices. Despite FDA’s proclaiming the TMJ products were
re-classified, that is an untrue statement as the implants had never been classified any time earlier. By placing them in such a category it would mean that all manufacturers of TMJ devices would be required to submit a Pre-Market Approval Application (PMA) to demonstrate safety and effectiveness, at such a time it would be called for by the FDA and within a certain period of time. This is where the FDA began to show their colors of deception because no pre -amendment implants had ever been required to go through such a rigorous, timely and expensive approval process. They were all grandfathered, mostly by the Orthopedic Division, not the Dental Division, which lacked expertise in the subject of joint implants, but who also was showing tremendous bias toward a more recent implant company. At that moment there were only two U.S. manufacturers of temporomandibular joint implants in the United States. One was the TMJ Implants, Inc. who manufactured the pre-amendment, Christensen Partial and Total TMJ implants which had been on the market since 1961, and the other was Techmedica, based in Florida, which later was purchased by a start-up group with the name of TMJ Concepts. The Techmedica implants had been allowed to be marketed in 1995, as substantially equivalent to Christensen’s legally marketed product even though their entrance into the market place was almost a quarter of a century after the Christensen devices had been developed. No other orthopedic implant, which was a pre-amendment device, was ever required to go through a rigorous PMA application for marketing by the FDA. It would be December, 1998 when the FDA finally called for the PMAs for all TMJ implants. This would be some 38 years after the Christensen TMJ implants were first placed in patients here in the United States with no history of either a safety or effectiveness problem in all of those years. The date for the applications to be submitted for a PMA process was by February, 1999. TMJ Implants, Inc. got their application into the FDA by January 21, 1999. The Dental Products
Advisory Panel was scheduled to be held on May 10, 11 1999 with the TMJ Concepts company being reviewed first on May 10, 1999. It would seem that this sequence of which devices might be brought forth earliest was a bit unusual since the Concept’s devices were allowed originally because they were substantially equivalent to the Christensen TMJ Implant’s devices. Some statements found in the compilation known as “A History and Evidence of FDA Abuses of TMJ Implants, Inc. 19992001” the FDA documents referred to, brings forth some interesting information and observations. In describing the Agency’s consideration of any “pre-amendment device,” the following statements are important; “The Agency understands and expects that such devices, lawfully marketed and in clinical use for many years prior to the Medical Device Amendments, lack the prospective data required of new devices, but offer sufficient clinical evidence (significant human experience) as a reasonable assurance of safety and efficacy. In fact several Class III pre-amendment joint prostheses (orthopedic devices) have been down-classified as Class II devices based solely on Medical Device Reports (MDRs) and available clinical experience.(who’s quote) A review of the Panel meetings for such devices reveals the concerns raised at each Panel hearing are identical to the concerns raised by the Panel reviewing TMJ Implant’s implants. However, in all the other Panel Hearings these concerns did not prevent approval.” It will be clear to the reader that the Agency held TMJ Implants, Inc. to different standards than other pre-amendment devices.”
THE DR. SUSAN RUNNER COVER-UP SCANDAL
The following email was uncovered during an FOI request by Dr. Christensen and Lynn Watwood, Esq. during a later legal action by TMJ Implants, Inc. and the FDA.
Date: Fri, 22 Jun 2001 10:03:06 -04C From: “Runner, Mary S.” <MSR@CDRH.FDA.GOV To: firstname.lastname@example.org <email@example.com>, Dr. Steve Milam <firstname.lastname@example.org>, Dr. Leslie B. Heffez <email@example.com>, Dr. Bertrand <firstname.lastname@example.org. navy.mil> Subject: Women’s Health Grant FDA/TMD Implant Patients
As many of you may know I have for several years been interested in applying for an FDA Office of Women’s Health (OWH) Grant related to TMD implant patients. My first attempt dealt with testing procedures for total joint implants, my second attempt dealt with a registry type program. Neither of these were successful but I never give up!
This is the eighth year of funding of projects by the OWH. The OWH seeks submission, which, contribute substantially to one or more of the following topic areas:
a. To apply new technology and novel approaches to improving the -health of women. b. Developing risk assessment, risk management and risk communication algorithms for evaluating gender differences in product safety. c. Identify of risk factors associated with adverse events of regulated products observed in women.
The OWH also will consider projects outside of the defined area for certain cases.
The OWH looks for partnering with other groups etc.
I have been working the past several years with the interagency TMD group at NIDCR and their focus has been appropriately research related to the general area of TMD with some emphasis on registry development. I however am constantly struck with the number of patients that are failed Proplast patients who seem to have increasing difficulty in getting answers, treatment etc. from the medical/dental community. I must get several calls a week in a good week from these patients, desperate for knowledge, information and help. I know you all know this from your experience in the field.
My new idea for a funding proposal would look at implant patients (Proplast in particular) who have had failures and successes. My idea is to find as much about these patients as possible in a registry type setting. (i.e. background information, reason for original surgery, medical information on patients, blood work etc.) A possible adjunct to this would be to attempt to look at treatment for these failed patients.
I know that this sounds like a large project and maybe I am expanding it too much beyond what could be obtained in a registry for these patients alone to gather information on what is happening to them. There are so many that get refused
treatment or cannot find a place to go. If we could gather data in an organized way in a database maybe this would be helpful to other researchers, medical and dental practitioners etc.
Anyway, what I am asking for is twofold, one I would like any ideas, thoughts etc. that you have on this idea, second I would love to have your participation in any way that you think might be possible. These patients are all over the country and any evaluation etc. of these patients would require travel to various points around the country.
I need to develop a 1-2 page concept paper to be turned in by July 15, 2001 following a decision about selection in August of 2001 the complete proposal would be due Oct. 1, 2001, with anticipated award announcements in January 2002.
I know that you are all desperately busy and summer is a bad time, but if you have interest or time please respond to this and let me know what you think.
Thanks so much. Susan
Comments on the Runner E-Mail
Why didn’t FDA’s Office of Internal Affairs know Runner was involved with the Office of Women’s Health, which was involved with seminars involving NIH to do research in TMJD field that could potentially conflict with approval of this company’s medical devices contained in its PMA? These seminars purposely excluded oral surgeons that had successfully treated this TMJ Disorder. The Christensen implants had salvaged harm done by Vitek’s implants, but was not asked to participate.
Most importantly—and known by Runner, from data in our PMAs—the partial joint prosthesis took care of treating severe internal derangement (when other therapy failed) in over 95% of the cases. This included registry and clinical studies whose grafts were identical. Why did Runner not want to accept our Registry as valid scientific evidence and say it lacked numbers? Why, with the presence of our exhaustive TMJ Implants, Inc. Registry and clinical data, does Runner in this e-mail discuss need for developing a Registry and have clinical studies, which obviously would only duplicate much of our work? Why now does Runner think a registry would be valid scientific evidence when for two years she said registry evidence is merely anecdotal?
This e-mail confirms Dr. Runner’s bias in her involvement in the finalization of FDA’s Summary of Safety and Effectiveness for the company’s Fossa-Eminence partial joint prosthesis. Dr. Runner and her staff continue to dispute the effectiveness of this product in spite of the overwhelming evidence to the contrary. The finalization of this public document without fair analyses of this device has the potential to harm the future health of the company, and possibly discourage patients from having this implant.
This e-mail confirms that Runner has been working closely with the TMJ Association as part of the OWH for some time and obviously was the “mole” providing the Association with leaked information on our PMAs etc. Allowing the TMJ Association to testify on matters “unrelated” to the hearing on the partial showed Runner’s bias to assist having unrelated but damaging testimony as part of the record for this hearing.
This e-mail confirms our suspicion that the goal of OWH is to get grants to study TMJD. This goal needs justification that there is no present successful treatment for TMJD when it reaches the internal derangement phase recognized by AAOMS. Obviously to reach this goal there is a need to demonstrate that all past and present TMJ devices, except custom last resort totals, are a complete failure not only for effectiveness but also for safety (i.e. that they cause auto-immune, giant cell reaction, etc.) For this purpose to have the Christensen devices, partial joint and stock total joints, in distribution and proving effective conflicts with the goals of OWH. Runner’s position with the Dental Branch and OWH directly and indirectly assists the selfish aim of Terrie Cowley and Kevin Clark of the TMJ Association in that assisting in refusing to recognize any successful implant treatments, especially that of the Christensen partial, the Association can garner grant funds form NIH etc. for research and fuel the flames of the TMD controversy to solicit and obtain a greater contributing membership for the Association as part of Cowley’s empire building strategy.
Dr. Runner’s direct involvement in promoting a second and rigged advisory panel to review the Partial Joint PMA—which had been used successfully for nearly 40 years, and which the FDA had declared a medical necessity most of the previous year—best shows her brazen bias, contrary agenda, if not corruption of the process. The panel was “stacked” with persons willing to vote against the Christensen device with little background in the TMJ field. If there were no such new panel, the continued distribution and use of the partial joint, while reviewing the PMA, would have made it almost impossible for the Dental Branch of FDA to deny the application. This is true because from the time of the finding of “Public Health Necessity” on August 10, 1999, until its removal from distribution on April 28, 2000, TMJ Implants,
Inc. had provided FDA with additional evidence of a scientific as well as clinical nature, which further substantiated its safety and effectiveness. To let the partial joint continue in distribution while reviewing its PMA ‘til the review period would terminate later in the year 2000 and then attempt to justify denying approval would prove to be very embarrassing.
This factual situation and implications show that there was collusion within FDA to support Runner’s agenda. FDA refused to remove Dr. Runner from the review process after TMJ Implants, Inc.’s objection to her continued involvement based on knowledge: • that Runner was trained by Dr. Mercuri—the main advocate of the sole competitor of TMJ Implants, Inc.’s devices—and would gain greatly from removal of its devices from competition. • that Runner trained under Dr Heffez who voted no at the October 2000 Panel. • that Runner worked 4 years under Dr. Burton who initiated the NO vote on the second Panel Hearing. • that Dr. Runner (unbeknownst to us but known obviously within FDA) was involved with OWH that, as stated above, had its own agenda in conflict with our PMA approval. How could FDA’s internal investigation state they found no basis for conflict of interest by Dr. Runner? How could the office tell Dr. Alexander it had investigated these allegations? Based on their knowledge from this office that Dr. Runner had told this company not to come to the May 10-11, 1999 Panel Hearing because our PMA was going to be denied—yet the Panel voted 9-0 to approve all our devices, along with voting 8-0 for approval to TMJ Concepts, Inc.’s devices—how could the office not ask her hard questions?
Why did Tim Ulatowski allow himself to participate in Dr. Runner’s scheme? He and Dr. Runner had participated in like action to deny Myotronics’ PMA approval, which backfired; as a result, both were disciplined with warnings because of their behavior, 4 other employees were fired, and the FDA paid the legal fees of Myotronics.
Why did Feigal allow himself to be used or to participate willingly in this matter? Feigal went to one or possibly two of the NIH, OWH conference for the TMD and stated, “That a device for approval need only be as good as the poorest devices approved by the FDA.” At the same conference he said, “Most medical devices have no or little clinical experience.” Why didn’t Feigal assert himself in the Runner OWH strategy and demand inclusion of evidence from oral surgeons who were successful
with devices? Why didn’t he question Runner in this matter? If he did, what was Runner’s response, and why did he go along? Didn’t this willingness to justify to congressional inquiry the delay in approving our PMA, because of the alleged lack of the presence of valid scientific evidence at the time, show his
active involvement? What was Feigal’s role in stonewalling any real investigation of Dr. Runner?
Doesn’t the e-mail of Dr. Runner support the feeling here in TMJ Implants, Inc. that Dr. Runner had input in the FDA denial letters of August 10, 1999, rationalizing their position that the PMA lacked certain critical evidence and giving alleged examples of such, when in actuality much of this material was present as part of the PMA? Didn’t this demonstrate FDA’s position not to approve our PMA from the beginning without attempting a bona fide review of our PMA, and doesn’t this show this letter
was probably drafted moths before possibly even before the May Panel Hearing 1999?
Interesting that Dr. Runner emails Milam, Baier, Heffez and Bertrand, all of whom were placed on our Dental Panel Hearings and one of whom (Dr. Stephen Milam and his university) was the recipient of a $10,000,000 NIH Grant to set up a TMJ Registry.
The apparent collusion between CDRH, Runner, OWH, NIH and the Panel consultants was much more than just coincidental, yet we could never get CDRH or FDA or HHS to ever move on the request for an investigation.
DENTAL PRODUCTS PANEL HEARING OF MAY 10, 1999
The TMJ Concepts Panel
The following information was taken from the actual HHS, FDA CDRH transcript of the actual Panel Hearing, Volume I, in the Holiday Inn in Gaithersburg, Maryland. The makeup of the Panel and observers was quite telling and remarkable. There was a TMJ Association present, which is a woman’s so-called advocacy group started by a Ms. Theresa Cowley and whose husband was a consultant for NIH. She was a patient representative to the Hearings. The TMJ Association is an organization centered in Milwaukee, Wisconsin. A Dr. Diana Zuckerman was a representative of the National Women’s
Health Network. The exact make-up of the May 10th Panel was listed as follows: • Janine Janosky, PhD Acting Chairperson • Pamela Scott, Executive Secretary • Mark Patters, DDS, PhD • Donald Altman, DDS • Alton Floyd, PhD • Theresa Cowley • Peter Bertrand, DDS • Richard Burton, DDS
• Gilbert Gonzales, MD • Leslie Heffez, DMD, MS • Stephen Li, PhD • E. Diane Rekow, DDS • Willie Stephens, DDS FDA Representatives or Observers • Timothy Ulatowski • Susan Runner, DDS • Angela Blackwell, engineer • D. R. Murty Ponnapalli So many interesting and questionable things occurred through these two days of Panel Hearings. One early statement in the May 10th TMJ Concepts hearing, made by Dr. Zuckerman, “When FDA determines that a medical device is safe and effective, patients are, of course, much more likely to use it. Since these TMJ implants have already been available for many years due to grandfathering and due to the lax regulation, the standard for approval should be even higher than is usually the case in a PMA.” That statement is contrary to what has been used before as the method of bringing the orthopedic implants to market as an approved device. In those cases the availability of testimonies from patients and the articles written by surgeons was more than enough to bring these devices to approval. In the early stage of the hearing the Executive Secretary stated in regards to any conflict of interests that the following statement is made a part of this hearing “and should preclude even the appearance of impropriety.” “The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employer’s financial interest.” As we shall point out there were several instances where these types of conflicts were patently present and where no correction occurred by the Agency. In the case of Terrie Cowley who was listed as a Patient
Representative she has a close alliance with NIH which she can likely secure possible grants at tax payer’s expense. She has had a very negative and antagonistic relationship with TMJ Implants, Inc. She later spoke against our Partial TMJ implants and even submitted a restraint against TMJI being approved. She clearly has other interests and conflicts of interest. In the case of Dr. Susan Runner she has several conflicts going back to the days when she received part of her oral surgery training under Dr. Louis Mercury, consultant and later part owner of TMJ Concepts as well as Dr. Burton who is also on
this committee. During the Hearing Record, as they were getting ready to introduce the presenters during the public hearing portion, the point was again made that each speaker, “was to state whether they had any involvement included but not limited to, financial involvement with manufacturers of the products being discussed today or with their competitors.” Dr. Zuckerman makes a comment certainly contrary to FDA statements regarding “grandfathered devices, that “if there are no long term data or history available the devices should not be approved for sale.” Dr. Mercuri, one of the two participants in the TMJ Concept study made the following statement. “I have no financial interest in the Company at this present time.” There was no question about the fact that he was, or was about to be, a financial owner of TMJ Concepts, Inc. It was a most interesting fact that only he and Dr. Larry Wolford were the only two investigators whose patients were finally used for data in their Prospective Study, when another 5 or 6 investigators were conveniently dropped from the study. Not so for the TMJ Implants, Inc.’s Prospective Study, where I, Dr. Christensen, the sole owner, was never a participant, and where another 8-10 surgeons were listed in the Study, and where all of their patient’s results were used for the Prospective Study. It is most interesting that in the Concept’s Study, the patients operated by 4 or 5 surgeons, were just dropped from the Study when there was an inconvenience about them being in other States but Illinois and Texas. It is an interesting thing to point out that less than a week before the Panel Hearings were to occur, Dr. Susan Runner, Chief of Dental Division at CDRH and formerly a trainee under Dr. Mercuri and also Dr. Burton, called Dr. Christensen and informed him that he and TMJ Implants, Inc.’s people should not come to the May 11 Panel Hearing because his PMA would be disapproved and advised him to withdraw it. Dr. Christensen advised Dr. Susan Runner he would consider her suggestion and get back to her shortly. Within 24 hours he contacted her and said he and the company were coming to the Panel Hearing. Since the May 10th, 1999 Dental Products Panel hearing was devoted to the TMJ Concepts devices, I will limit most of my comments at this moment to a few of the things which transpired during that portion of the Panel Hearing. It will have a bearing on some of the remaining part of this story. The Company presentation was made by only two individuals, Dr. Louis Mercuri, professor of oral and maxillofacial surgery at Loyola University College of Dentistry, and the principal investigator for TMJ Concept’s Prospective Study. The other individual was Mr. Greg Rose, and engineer, and acting president of TMJ Concepts. In discussing the results of their Study, Dr. Mercuri makes the following statements. He first states he has no financial interest in TMJ Concepts, but there has always been some question about that statement as he later becomes an owner, with others, in
the company. In the transcript of the meeting, he makes the following comments relating to the VAS using a 55mm line. “We looked at the pre-operative level (of pain) on the 215 patients with a mean score of 42.” This would indicate a pain level in the range of 8 on a 10 cm VAS scale. He goes on to say that at 13 months the pain level went from 42 to 19.5. He relates that the pain score goes down significantly from the 2nd month to out 48 month. At this point in the testimony Mercuri comments on Dr. Runner’s statement, given earlier, “Patients with one year followup are very similar to these patients without follow-up with not statistically different variable between the two groups.” He goes on to say, “so this has been subjected to statistical analysis as well as the FDA’s analysis as well.” Isn’t that just a statement which warms your heart? Here is a statement by the lead FDA reviewer, who has told Christensen to not attend the Panel Hearings, and who trained under Mercuri and Burton, that everything is the same between the patients they followed and ones they did not. Mercuri goes on to say the pain remains the same between 12 and 36 months. Mercuri talks about the study of 128 patients and where at the end of 12 months there were only 10 patients with data. He goes on to say there were 13 devices removed out of the 111 placed which means that 10% failed for one reason or another. Mercuri also makes the statement that there is a 90% life expectancy for the Concept devices for a 10 year period. Is that right? Again on the transcribed FDA report of the May 10, 1999 meeting, Mercuri quotes an FDA report to Concepts. “That TMJ Concepts Inc.’s documentation answers most of the essential questions that should be asked in relation to Total Temporomandibular Joint Reconstruction. They have presented evidence that the characteristics of the patients that did complete the extended period of follow-up are very similar to those who were lost. The company has also started a post market study to prospectively follow additional patients. In addition, the engineering review of this implant has demonstrated that its principles are very similar to other, more fully characterized joint reconstruction i.e.: total hips, in terms of materials and the mechanical characteristics.” That is a quote of an FDA report to Concepts as read by Mercuri. This is a most unusual statement by likely, Dr. Susan Runner at this moment in the Study and presentation when by Dr. Mercuri’s own admission they had only been able to follow 10 of the 111 patients for 12 months. Yet later, Mercuri states that Concept had 8% adverse reactions, with 13 patients having had implants removed. He acknowledges that to be 12% of the implants were removed in their three year Study. Where in the world does he get that there is a 90% chance of survivability at the 10 year mark? Is that correct? Later, Mercuri elaborates again on the fact that 6 of the original 8 surgeons were taken out of the Study because, “it was difficult to get the proper follow-up. It was impossible to get the data.” Yet TMJI was required to show all of the data accumulated from the 8 surgeons involved in the Study. Why? Again Dr. Runner comes to the aid of TMJ Concepts by making the following statements, which I might say you will see later, are in distinct conflict with her statements about the 38 year old Christensen implants. She states, “These devices have a very long history with the Agency, with the patient population and with the researchers and surgeons.” Runner in her statement, states that the earlier Panel meeting regarding the classification of all TMJ devices, as of December 20, 1994 believed that these devices presented a potential unreasonable risk to health and that insufficient data and information existed to determine that general controls were adequate to provide safety and effectiveness information for these devices. She went on to say, “This classification came after several very well-known implant disasters related to TMJ implants.” In that instance we believe she is referring to the Vitek implants. It is interesting that there were zero known, confirmed difficulties with the Christensen implants over the preceding 38 years, yet they were put in with the Vitek implants which had not been adequately screened by the FDA. The problem was the FDA had no known consultants who were really knowledgeable in this type of surgery and the true indications for that surgery. The Dental Division was over its head.
Runner went on to say, “That concepts documentation answers most of the essential pre-clinical questions that should be asked in relationship with total TMJ reconstruction.” She goes on to say, “Concepts pre-clinical data indicates that the characteristics of this TM joint are similar to other successful joints that are reconstructed in other parts of the body, i.e. total hips.” The FDA engineer, Blackwell, was asked what did any retrievals look like and she answered they didn’t have any.” What happened to the 12% of removed devices? Dr. Li asks the question about retrievals and wear areas versus wear simulators? Blackwell goes on to say in answer to Dr. Li, “Even in orthopedics they do not have a good way to generate the same type of particles in the lab, so that is not really expected for pre-clinical testing.” Is that so? Then why was TMJ Implants required to generate particles, measure them and put them in live rabbits TMJ joint tissues and inspect that after one year, and then look at that tissue for any wear debris particles and describe and measure the wear patterns?” Dr. Heffez asks Blackwell for pound force in TM Joints or actual patients with implants. Blackwell gives an estimate from an article. But then Runner comes to her rescue and anecdotally says “the lateral pterygoids and temporalis muscles make up 50%, or 150 pounds.” Heffez asks if there have been any pre-surgical attempts to measure the bite force. Mercuri, answers there is no way to do it. Yet TMJ Implants, Inc. did do it with a kinematic study performed by Rose Muscular Studies, and at a rather large cost. Since that time Dr. Christensen and TMJ Implants, Inc. have been involved in many studies of the forces on the jaws and implants in cooperation with Dr. Subrata Saha and staff at SUNY Downstate Medical in Brooklyn, New York, and even earlier Clemson University and Alfred University. In discussing the Concept’s Study, FDA’s Pannapoli suggests
the survivability of the Concept’s implants quite likely unreliable due to the lack of accurate data. At one point Dr. Mercuri states he has complete data on 34 patients to 36 months, but he could not tell what the repeat surgery was for those 34 patients. Dr. E. Diane Rekow states about static wear and strength tests done by Concepts had no data available for review. That would seem to be very unacceptable. Mercuri on page 129 states that when a patient wants an implant removed, that is not a failure? He states there were no MDRs filed in the last 5 years and they have no explants to review. Cowley makes the statement she would like to get funding from FDA and NIH to set up Registries and studies. Is this not a conflict with a Patient Representative on the Dental Products Panel wanting a government grant for her TMJ Association? Dr. Janoski asks a question of the FDA Panel members which the FDA wishes answered. “Based on the engineering data for an implant the lifetime should be greater than 10 years for Concepts device.” Does the fatigue and wear testing presented in the PMA support this prediction? Dr. Li goes on to say that the company’s evaluation is nonsensical as to the life of the implant. He goes on to say the strength and yield tests should be on same specimen and that there were no retrieved samples to compare, so consequently we don’t know what the wear is of these devices. He goes on to say the fact you don’t find wear particles in the tissues makes this a non-valid test. Dr. Patters says that most of the data looks anecdotal, and there is no long term data regarding effectiveness of Concept’s devices. It should be a treatment of last resort with a high failure rate. Dr. Gonzales says the pain data should be thrown out and that it certainly is not helpful to patients who had more than 10 prior surgeries. Dr. Rekow says that patients who are between 35 and 45 years old cannot look forward to a lifetime without pain with these devices. Isn’t that something since the average patient requiring this type of joint reconstruction falls between 35 and 45 years
of age. Dr. Heffez says we should look at device as a temporary device of 5-10 years. Isn’t that just something? It all goes to show some of this Panel had no idea of the usefulness of TMJ reconstructive surgery. The same is true of hips and knees, providing the correct surgery is accomplished early or the first time. Dr. Li states that osteolysis takes 4-5 years to even show up and that long term consequences for this device are unknown. Some interesting comments occur by Mr. Tim Ulotowski. He reminds the Panel that valid scientific evidence may be flexible under the regulations. Actually, he is attempting to bring to their attention that one doesn’t always have all of the well-formed, compact, orderly evidence of scientific evidence you might wish for. This is especially important as the FDA later considers the Christensen devices which had been in successful existence for some 38 years. Floyd reminds the Panel of the availability of tracking devices which have been implanted. Then Dr. Li asks, what happens if osteolysis does occur as it has in hip and knee reconstructions? Mercuri then says he’s never had to take one of his implants out of a patient. What? Dr. Willie Stephens says he has been using the Christensen devices for some long time and he says they have a greater than 90% success rate. Miss Scott then read from the Panel PMA document and she is describing Safety and Effectiveness. For safety she states, “Safety is defined in the Act as reasonable assurance based on valid scientific evidence that the probable benefit to health under conditions of use outweighs any probable risk.” For, “effectiveness it is defined as reasonable assurance that in a significant portion of the population, the use of the device for its intended use and conditions of use when labeled will provide clinically significant results.”
Dr. Li calls for a study of retrievals. Before that, he had inquired about crevice corrosion. Runner makes a summary of conditions for approval as follows: • 1. Study pain out 5 years. • 2. Studies not completed depicting long-term relief of pain. • 3. Particulate debris study. • 4. State of art Wear testing, weight loss, analysis of particles. • 5. Tighter material sourcing. • 6. Study effect of diverse metals. • 7. Develop registry. • 8. Study life interferences. • 9. Pay participants in study.
The vote follows and is 8-0 for approval, with no recommendation to return to panel.
DENTAL PRODUCTS PANEL HEARING OF MAY 11, 1999
The TMJ Implants, Inc. Panel Hearing
The following information was taken from the actual HHS, FDA CDRH transcript of the actual Panel Hearing, Volume I, in the Holiday Inn in Gaithersburg, Maryland. At the very beginning of the hearing the FDA read into the record the letters of support from two surgeons for the Christensen devices. Let me start off by incorporating Dr. Guy Catone’s letter read into the Hearing by Pamela Scott, executive secretary in the CDRH.
This brief document is in reference to the open public hearing testimony on temporomandibular joint prostheses. As a surgeon who has devoted a significant percentage of my practice to the surgical management of organic temporomandibular joint disorders/diseases, I can offer my humble opinion that one of the most successful and well researched contributions to the surgical practice of rebuilding the severely diseased jaw joint has been the CAD-CAM technology to use the (Christensen) cobalt-chrome implant to replace vital portions of the temporomandibular articulation.
In my experience the metal/metal custom TMJ prosthesis has been uniformly well tolerated by patients who have had multiple surgeries or arthroplasty with or without autogenous or other alloplastic devices to attempt to recreate a functioning jaw joint.
The very nature of the custom joint eliminates attempting to modify autogenous or alloplastic devices to fit a given patient. These implants simply are designed for the individual patient and must remain available to salvage lives of patients who had lost jaw joint function for reasons of arthritis, ankylosis, trauma or neoplastic disease.
With the notable exception of the Christensen and custom made total joint prosthetic devices, there simply is nothing available in the technical surgical marketplace to offer the patient who has an end-stage disease of the jaw articulation. Patients who have lost function and have severe pain syndromes can have a significant restoration of function and an amelioration of their pain by reconstructing their diseased jaw joints with the Christensen prostheses.
I am aware the above information is anecdotal and my conclusions do not represent the results of a formal scientific study. However, any hearing regarding the efficacy of a surgical device should at least reflect opinions of surgeons with some experience (in this case 30 years) who must deal with the suffering of individual patients, not groups or populations in a laboratory environment. Both of these kinds of inquiry are necessarily important and each should have appropriate weight in any decision, which would change the availability of a surgical device.
Kindest regards, Dr.Guy Catone, Associate Professor, Department of Surgery Division of Oral and Maxillofacial Surgery
Allegheny University of the Health Sciences The Second Letter read into the Hearing was from Dr. William Buck and is as follows:
This letter is for open public hearing testimony on temporomandibular joint prostheses. I have been exposed to the Christensen total and partial joint system for approximately 11 years. The Christensen joint has had an excellent track record in a field of other joints that have fallen out of favor because of chronic failure.
I have used the Christensen partial and total joint implants, both stock and custom with success. This procedure is always preserved to a last ditch effort to give the patient function of her jaw when all else has failed. It is used when a bone graft has failed and has no hope of future success. In my patients, there was no other alternative for them to have normal life function.
The evidence is clear that the Christensen Joint has proven successful over a period of greater than 25 years. Newer joints have come and gone, but the Christensen (joint) is a proven device that is absolutely needed for severely damaged temporomandibular joint patients. There is no other reasonable alternative. Please let me know if I can answer any other questions.”
Signed Dr. William Buck
As was stated right after the reading of those two letters by Pamela Scott, “I would also like to note that the Center did receive numerous other letters regarding this particular meeting, and if any of the Panel members would like to see them, they are available for review.” At this point, in this text, I would like to include some of those many statements made by surgeons who had placed these implants in many, many patients, some for over a dozen years or more. Then was my testimony in which I gave briefly his history of surgical intervention in the temporomandibular joint. My testimony follows:
My beginning in oral surgery started about 50 years ago, and that first 10 years was a kind of an interesting time to do all sorts of surgery on that joint, from fracture repair, but also condylectomy, menisectomy, and you name it.
During that time, I wrote several articles regarding arthroplasty of this joint, but about 1960, I realized that something better needed to happen, and I came up with the idea of replacing this joint, both in a partial way and in a total way, and began to see my patients do very well. As a matter of fact, a chapter written in a book titled Oral Implantology, which I wrote in 1967, I talk about the first five or six years of arthroplasty of this joint using this alloplast.
In that time, I had done about 60 partial joints and a number of total joints, and I talked about the 60 partial joints as that I had not had to re-operate even one of those during that period of time with the exception of one joint where it overgrew more bone.
I am not going to give you much of a story this morning because I have a panel of experts here that can do a better job than I can do presenting this material. I would like to read to you part of a letter I received from Dr. Otto Aufranc who is an orthopedic surgeon that co-founded the first metal hip joint implant. In that letter, Dr. Aufranc commented that he had read Christensen’s first article on this method of TMJ arthroplasty in the January 1963 Journal of Arthroplasty. He went on to say, “This is a real contribution to the art of surgery and the correction of disabled joints, I have no suggestion to add to this except to compliment you on your good work.”
The second letter was from Dr. J. Vernon Luck, of Los Angeles Orthopedic Hospital also complimented me on my pioneering work of TMJ arthroplasty. He was in a conference I sponsored in 1964 on Arthroplasty of the TMJ. He wrote to me later and said, “I learned a great deal about temporomandibular joint arthroplasty that I did not know before. This subject is dramatically presented in your film.”
I feel as do the suffering patients and have been so involved in the last 50 years to see them get healed. That is why I started to develop a technique that works. I think as you, the Panel members see that we have brought today, you will agree it is some very good information on this subject and this device.
Mr. Jim Morgan, Director of Quality Assurance and Regulatory Affairs for TMJ Implants, Inc. went on to talk about the company and the devices and to introduce the remainder of TMJ Implant’s presenting staff. • Dr. James Curry, Surgeon and user from Denver area • Al Lippincott, Consulting Biomaterials Engineer • Doug Albrecht, Mgr. Clinical Affairs • John Durnell, Operations Mgr. • Candace Cederman, Regulatory Consultant • Dr. James Murphy, Professor of Biostatistics U. of CO Health Science Ctr. • Dr. Subrata Saha, Prof. Dept. of Bioengineering, Clemson Univ. • Dr. David Gerard, cell biologist and Dir. of Research, Dept. of OMS, U of TN One can certainly see that TMJ Implants came very well prepared especially in comparison to the two presenters for TMJ Concepts. The slide story which was given in the earliest part of TMJ Implants, Inc.’s testimony more than depicted the success of these implants over a 38 year period. At the time I was very comfortable with the presentation we were about to make using some 9 or 10 consultants to present the full story of the research
and science behind the devices and story we were to present. It would certainly be a much more thorough presentation on the subject than we got from Dr. Mercuri and Mr. Rose with their poorly shown overhead presentation of the day before. In the early part of the presentation for the Company, Mr. Jim Morgan describes the indications for the use of the Christensen Partial TMJ implant as internal derangement, meniscal perforation, adhesions, and ankylosis of the TMJ. He goes ahead and then describes the use of the Christensen Total TMJ implants as adhesions, condylar pathology or destruction, ankylosis, AVN, intrinsic bone disease, such as rheumatoid arthritis, osteoarthritis, foreign body giant cell reaction, failed implants or other pathology with or without resultant occlusal or functional deficiency. He then talks about the over 14,000 TMJ Implant devices implanted in over 6,700 patients over the 38 year period. What a contrast to the small number of TMJ Concept devices implanted over at most 8-10 year period. Mr. Morgan went on to reiterate what Mr. Ulatowski had said regarding valid scientific evidence. “Valid scientific evidence includes evidence from well controlled investigations, partially controlled studies, studies and objective trials without, matched controls, well documented case histories conducted by qualified experts, and reports of significant human clinical experience with the marketed device. Our sources to be presented qualify as valid scientific evidence.”
Mr. Al Lippincott of Engineering Consulting Services of Minneapolis starts his detailed description of all the tests which TMJ Implants, Inc. went through to show the safety and effectiveness of these pre-amendment devices. He discusses things in five categories: materials, device designs, mechanical testing, retrievals, and other subtopics. To say the least, the amount of testing of these devices was almost staggering, especially compared to some of the paucity of scientific evidence shown in the earlier TMJ Concepts presentation. Mr. Lippincott went on to describe the following points:
• Regarding materials: • All materials met the ASTM standards, or medical standards, study microstructure and polish. He brought up the fact that the materials used in the Christensen TMJ implants have been in use medically for well over 50 years very successfully. • Animal tests were developed and showed no tissue reaction to these materials. They are very biocompatible not only to tissue but also to blood. • There was no evidence of foreign body reaction to these materials. • Testing evaluated the metal microstructure and polish, which was the same as other orthopedic type implants. • The Finite Element Analysis (FEA), which was to show stress distribution within condyle and fossa, showed they were within proper allowances. • Regarding the in vivo kinematics and kinetics of the TMJ with and without Christensen TMJ implants: • The study used fluoroscopic and computer analysis of bite forces in 15 patients with and without implants. This study confirmed the lower bite forces in patients with a Partial TMJ arthroplasty and a Total TMJ arthroplasty as compared to the unoperated patient’s joint. Going from 78lbs to 45lbs to 20lbs respectively. • The final design study showed the stress values at the point of contact of the implants were well within mating surface yield strengths. In the m/m joint an average failure load was 465 pounds which then resulted in screw pull-out and bending of condylar attachment arm. • Dynamic fatigue testing for 5 million cycles at a variable of 2-35 pounds showed no test fracture or signs of fatigue failure. It proved that the loading conditions are comparable to various mathematical calculations as determined from the literature.
• The results of the dynamic fatigue test showed that no test units fractured or showed signs of fatigue failure. • The final mechanical test was the cyclic wear test performed under physiology conditions as described in an FDA document. • Particulate wear volume was also measured. • The metal/metal joint had a very small wear potential which was anywhere from 24 to 80 times less that the wear of metal/metal hip implants. • The wear pattern from retrieved m/m Christensen implants in place for at least 5 years showed a highly burnished surface with very minimal, multidirectional wear pattern. • In summary, the materials used for the manufacturing of Christensen implants conform to all medical standards of biocompatibility. Animal tests show there is no foreign body reaction to these implants.
Mr. Doug Albrecht, Manager of Clinical Affairs for TMJ Implants will now present valid scientific evidence supporting the reasonable assurance of safety and efficacy of the Christensen TMJ implants. Mr. Albrecht informs the Panel that: • The Christensen implants have been available for over 35 years with no history of failure or patient adverse reaction. • The information to be presented comes from significant human experience, marketing and MDR history obtained from the Company over an 11 year period, plus data from a partially controlled retrospective study and an ongoing prospectively-controlled clinical trial. • This information is being presented to show that the Christensen TMJ implants are safe and effective in the majority of patients through the evaluation of pain reduction, improvement in interincisal opening and the evaluation of adverse events.
• The TMJI Registry study was started in 1993 and includes all patients who receive the Christensen TMJ implants from that day forward. The data from other studies is incorporated in the Registry, but that data will have other given parameters. • Even from this study we see that the baseline data of age, gender, and pre-op pain and opening values are consistent across all studies. The patients, who are listed in the Registry but also in other studies, will have their data analyzed separately in and for the other studies. • For the Registry, every month a request was sent to either the operating surgeon or the following physician for information on the progress of that particular patient. The information when returned was recorded in the study. The system was a voluntary system and physicians were not required to respond. Since the same patients were not recorded at each time period, we conducted a cohort analysis of patients who reported progress at the same time period. All of this material was handled in a very scientific manned to be able to gain statistical analyses. This cohort data is now being shown with overlying cross-section data, showing identical responses and curves.
After this slide presentation, the presenter gave a summary of the safety and effectiveness of the Christensen TMJ Implants over a 35 year period, with basically no unanticipated adverse events. He related that even, in a couple of cases where fracture of the Condylar prosthesis had been reported and filed as an MDR, upon further investigation and inspection one was not even our brand of implant and another was not fractured at all. The overall picture was that of a reconstructive device for replacing part or all of the TMJ that has functioned admirably over the many years of use, in the hands of hundreds of surgeon and in likely well over 10,000 patients over a 35 year period. It was a remarkable summary of a remarkable device showing the benefit of using this device far outweigh the risks of so using.
At this point Dr. James Curry was introduced. He is an OMS with 29 years of TMJ surgical experience and with at that moment in time some 11 years of experience with the Christensen TMJ implants on probably more than a hundred and fifty patients. He explained that he and his partner, Dr. Jim Latta, were at the point of possibly stop doing open surgery on the patients with TMJ problems as nothing they were doing was having any lasting results. He went on to say that “the outcomes we have seen in our practice have been so dramatic that we continue to use these devices for treatment of simple and severe TMJ disease” Dr. Curry went on to say that he and his partner were vitally interested in safety and effectiveness of any procedure they would use to treat this group of patients because we all know of the harm done by other treatment types. Curry went on to say he was able to examine a patient that had Christensen TMJ implants for some 25 years, and the way she had progressed more than convinced him the Christensen implants were the way to go. He went on to say his treatment is based on science, much of what has already been presented at this Hearing, but also his close relationship with Dr. Christensen, the company and the
observation of thousands of successful surgeries by literally hundreds of surgeons over these past 11 years and even earlier. He again re-stated the fact that these implants have been successfully placed in diseased TMJs for now some 35 years and that no one else has shown such a pattern of successful treatments over such a long time span. He went on to say that his treatment philosophy is based also on common sense and the fact that the materials used in these devices has been used in orthopedic surgery for almost 62 years, very successfully. He went on to praise the concept of a hemiarthroplasty for several reasons: • It is anatomic • It protects the skull base from pathologic changes • It retains a normal joint anatomy • It limits joint degenerative disease • It greatly reduces pain • It generally improves of maintains function • It maintains a normal dental occlusion when present • I t can be placed rather easily • It cuts down on surgical time • It causes no joint mutilation as does a total joint • It can be available for any open surgery at any time • It allows almost normal joint function • It doesn’t remove needed muscle attachments • It requires only one point of incision • It allows performance of normal nerve-muscle function • It allows for speedier healing • It generally prevents bony ankylosis • It can be accomplished without jaw immobilization • It is less expensive for the device and for the surgical time, and possibly even hospital confinement • Perhaps, lastly, it can be done as the first open joint surgical procedure and will likely limit any further surgeries.
Dr. Curry then told the Panel that he wanted them to see some of the types of patient problems he was seeing and how he taught around the country the proper surgical correction of the problem. He mentioned the following types of situations confronting him in which he would wish to do a Christensen hemi-arthroplasty: relatively young patients, over 90% in female patients, and those who had experienced failures of other autogenous or alloplastic techniques. He also discussed what a patient’s TMJ and condyle look like after a Christensen hemi-arthroplasty, noting that the condyle is maintained in form and function and pain is greatly reduced. He went on to say in reviewing hundreds of x-rays of hemi-arthroplasty patients, they all showed condyle health, in contrast to the unbelieving naysayers. The procedure can be done unilaterally with no harmful effect on the contra-lateral joint. He then showed a 10 year follow-up x-ray of one of his hemi-arthroplasty patients and how the condyle articulating with the Christensen TMJ implant appeared normal as did the contra-lateral TMJ, and the occlusion was maintained. After briefly discussing some of the patient-types that would require a TMJ Implants, Inc.’s Partial joint implant, he went on to talk about the need for Total TMJ reconstructive surgery with a Total joint implant. Dr. Curry discussed patients who have had multiple failed surgical and treatment procedures to curtail pain and dysfunction and to improve esthetics. He showed cases where he had only to place Christensen “Stock” total joint implants to correct all of the resulting problems from earlier surgeries. He showed trauma cases where condylar fractures had occurred and how successful it had been to place a Christensen total TMJ implant to increase function and reduce pain. He described where the mandible had (either congenitally, traumatically and due to tumor) been greatly altered and where the jaw and joint reconstructive surgery was most valuable and
successful. He showed seriously ankylosed cases and described how these could be helped by using the SLA model to produce a PatientSpecific implant that would accomplish not only freeing the ankylosis, restoring motion but frequently replacing any need for orthognathic surgery. He brought up the advantage of the Sizers for the placement and selection of the FEP and how this shortens the time needed for surgery in placing the upper joint implant. Dr. Curry showed slides of a Total TMJ implant with the PMMA head which had been in place some 11 years and when removed and replaced all of the adjacent bone was intact and looked very healthy as it should. Dr. Curry concluded that certainly alloplastic devices are needed to properly reconstruct the variety of TMJs that require surgery and that no other system of implants meets his requirement for safety, efficacy and ease of use with such a long history of success as the Christensen TMJ implants.
Following Dr. Curry’s clinical presentation there were quite a number of questions from the Panel members. Some were from Dr. Li regarding fracturabilty of the PMMA headed Condylar Prosthesis. We discussed the fact that although we did do load to failure tests, a Static Load Test, which showed that it required some 900 pound force to cause fracture, we did not do it on PMMA alone. That discussion becomes very academic for two reasons.
1. We have only seen one PMMA headed CP fail and that was when one side of it contacted a screw head when functioning in a patient over some protracted time period, and that was after hundreds or thousands of PMMA head CP had been implanted over many years.
2. We are discontinuing fabrication of the CP as of now in favor of the all metal implants. Dr. Skinner asked about any tests of the devices under fluoroscopy and Dr. Christensen mentioned the kinematic testing which showed the Partial Christensen TMJ implants in function as well as the Total Christensen TMJ implants, also in function. Then Dr. Curry addressed the fact that he had reviewed a few under fluoroscopy in his IRB study with no problems noted. The question arose about the PMMA head TMJ implant compared to the Judet Hip implant which also embodied a degree of PMMA and Lippincott answered that very satisfactorily. Dr. Li questioned about any foreign body type reaction in surrounding tissues to either M/M or PMMA/M TMJ implants and Dr. Gerard answered that he had seen tissues from some 400 surgeries where implants had been placed, as well as the New Zealand rabbit studies and saw no foreign body reaction in any of
the specimens. Dr. Li asked a question about the relative stability of these implants and Lippincott answered we have seen no evidence of either micro-motion or outright loosening of these implants. On occasion we will see a bone screw loosened. The MDR reports show the less than .03% of screw loosening and a collectively less than .92% for all MDR events over a 7-year period in 8,500 implants placed. We also point to the blood studies accomplished in our rabbit studies to show no raised level of metals within the blood,
tissues or organs. This was not accomplished by the competing implant company.
Now for the actual comments by the FDA staff and associates. Dr. Runner starts off with a statement, “that it is difficult, in their review of data to separate out the various endpoints of pain, diet, opening and get a clear picture of the relative success or failure of all one complaint in the sponsor’s study. That is a most interesting fact when Concepts said all of their devices
are different? She carries this argument out further by saying, ”In our opinion the sponsor (TMJI) has not adequately separated the various implant types, i.e.: partial from total. Metal vs. PMMA vs. Patient-Specific in terms of results that were achieved in the clinical studies.” Then she goes on to downgrade our clinical and pre-clinical testing. She goes on to speak about the inappropriate nature of engineering data and the equivocal nature of clinical data and her questions about failures and safety of our devices. She goes on to say we have not provided adequate separation of the data regarding S&E of these different configurations. We did all of that in our February 11, 1999 submission as they requested. Runner went on to say we had not presented S&E data on a sufficient number of patients over a 3 year period. We certainly had plus the fact that this device has been in use some 38 years. It was becoming very obvious that FDA’s CDRH had another agenda and that was to block approval of the Christensen, TMJ Implants, Inc.’s devices. Blackwell, one of their engineers, states that our fatigue and wear testing are deficient. She goes on to say that the literature talks about the forces on the human bite can be 300 pounds. She totally ignores the fact that we had done likely the only kinematic study of the actual forces exerted on the TMJ with a natural joint, a hemiarthroplasty with the Christensen implant and a Total TMJ reconstruction using the Christensen implants. In that study the forces recorded using fluoroscopic evaluation on five subjects in each category showed that the average force in the natural TMJ was 78 pounds, and in the hemi-arthroplasty patient was 45 pounds whereas the Total TMJ patient was less than 20 pounds. You would think that would have settled the argument as we had researchers at the Colorado School of Mines do the study, but as I mentioned earlier, the CDRH people had an agenda.
We had tested the bite force in a sinusoidal manner from 2-35 pounds, which is what the University Musculoskeletal Engineers had suggested. She continued to degrade every test we had performed and yet they gave us no guidance on what they wanted prior to the testing so we went with the experts who knew these tests and performed them for the orthopedic community. Then Blackwell complains about not doing some of these tests on Patient-Specific implants, but she does not even understand that the Patient-Specific implants are sturdier than the “stock” implants which we tested. There was no logic or pleasing the CDRH examiners in this case. They certainly never held Concepts to such a standard. She went on that the partial TMJ implants need to be tested in fatigue against natural bone. That is absurd because against the rigid and very hard surfaced Condylar Prosthesis would be by far the more likely for fatigue. This is ignorance and bias on their part, especially since these have been in thousands of patients for up to 38 years with no history of fatigue fractures at all. Then she complained about not doing the fatigue testing on the PatientSpecific Partial joint implant which is always made thicker than the “stock.” She then complains that our Partial TMJ implant when mated against the Condylar prosthesis as a Total TMJ implant are not perfectly matched to each other. McKellop, an MD at Orthopedic Hospital in Los Angeles, who has done tons of tests on the mating and function of total joint orthopedic implants, totally disagrees with her and so do we. He was also involved in much of our testing. It seemed that no tests we had performed or evaluations and history given would ever satisfy their insatiable appetite for more. When we had 4,000 patients operated with data on 2000 and cohort values on 284 out 24-36 months it was never enough. As I mentioned earlier in the TMJ Concepts Study with pain as the main goal, there was a total of 128 patients at the beginning with only 10 at 12 months, with 13 devices removed and yet Mercuri and also Runner had said that was a sufficient number to represent the entire body out 36 months. Give me a break. What an obvious bias. Mercuri states that it was difficult to get the proper follow-up and impossible to get the data. Runner’s comment was classic, “That Concepts documentation answers most of the essential, pre-clinical questions that should be asked in relationship with total TMJ reconstruction.” What a difference in the CDRH attitude toward the predicate device company who’s product had been in service some 38 years with no evidence of problems and another company where only a few hundred devices had even been implanted probably less than 5-6 years. In the Concepts Panel Hearing, Blackwell was asked, “What did the Concepts retrievals look like?” Her answer was, “They didn’t have any.” Yet they had a 13% failure rate in 3 years and yet they never submitted a retrieved device for examination? Mighty interesting that Blackwell and Runner seemed to not be disturbed by that act. When, Pannapoli, states TMJ Implants list 4,000 patients which had implants and we only have data on 2,000 patients and cohort data on 284 patients out 3 years. Give me a break. There is no comparison to these two studies for giving some valuable information on S&E. He complained about it, and yet a cohort was never needed in the Concepts study which had only 10 patients out 12 months. Pannapoli had to admit in all of the TMJI Studies performed pain always went down and opening increased. He never could say anything against what we were giving as data he just always wanted something more. Mr. Floyd was an industry representative who stated that he sees no problem with the Fossa-Eminence Prosthesis against the natural condyle a hemiarthroplasty, to be exact. Now enters Blackwell who says CDRH has telephone reports of the natural condyle
being destroyed by the FEP. Dr. Curry and I examined hundreds of x-rays on patients who had hemiarthroplasty for up to 25 years and never saw one case where the condyle was destroyed by the FEP. That former statement by Blackwell shows their bias and should never have been allowed in this Hearing. Then Blackwell makes the gaff of the day when she states, “about design, the comment was about the fact they (TMJI) haven’t used any modern technology at all.” Followed by her statement, “They (TMJI/Christensen) are using 1960s technology.” Morgan answers her by saying, “We have not heard or seen any evidence of the condyle being destroyed by these implants as a hemiarthroplasty.” I followed up with, “He has seen the natural condyle 38 years later still functioning against the FEP.” Heffez says the CDRH can accept certain anecdotal information from other sources then he goes on to say that the TMJ Association has received greater number of MDR reports than the company describes. Let me say there was no information about any of those so-called MDR reports ever described, yet we gave an accurate account of what we had seen in 8,500 implants placed over an 8 year period. Heffez goes on to belabor our testing. He doesn’t understand most of it. Then Heffez makes a really ridiculous statement that he didn’t feel we addressed the subject of osteolysis. We had shown rabbit studies and Dr. Gerard’s looking at many tissue samples and never found any foreign-body reaction or osteolysis. They did not question Concepts about the very material that orthopedics have found causes osteolysis and that is the UHMWPE. Heffez shows his true colors by stating he doesn’t want to see the Christensen partial TMJ implant used as a primary surgery. On page 136 he makes another great statement that says it is OK to attribute failure to the device but not success. Zuckerman makes the point you need reports from lots of surgeons to attest to S&E not just one or two. Yet it was only two individuals in the Concept’s study where as we had 14 plus
the years of hundreds of surgeons having placed the Christensen devices and probably 50 or more surgeon had reported on their success with the products. She reiterates the fact of the more people you have in your study the more likely you are to get accurate results on safety and efficacy. Yes, that is correct. Dr. Li comments that the wear testing was not validated from two centers. Why is one expensive test, for a 38 year old device, not adequate? He does go on to say that, “History is on your side, because you don’t get osteolysis from M/M vs. UHMWPE/M.” He relates that to the hip research; that is correct. Pamela Scott defines effectiveness. We proved our point. She states the PMA needs to be voted on its entirety. At that point Dr. Skinner, the only orthopedic surgeon on the Panel voted for approval, with conditions. At the end of the day’s hearing Dr. Skinner approached me and said, “That was a nice presentation,” referring to our entire presentation for the Company. We agreed. After the vote statement by Skinner for approval, Dr. Burton seconded the motion. Dr. Skinner says he has a good statistician who can gain much information from small, heterogeneous samples. It is interesting that Dr. Skinner is the current Professor of Orthopedic Surgery at UCI, exactly where I was Assoc. Professor of Surgery, Head and Neck Surgery at UCI some 32 years earlier. Dr. Bertrand shows his colors when he states, “I do not think that these implants should be approved as a primary surgical intervention for internal derangements. I am suspicious of whether they should be approved as a primary intervention for meniscal tears or perforations and also adhesions. I have real concerns about approving the delivery of these implants unless those things are excluded from primary interventions.” That statement about sums up the lack of knowledge the CDRH has about the use of the Christensen Partial TMJ implants in cases of hemi-arthroplasty. Everything he has mentioned he is dead wrong. Those are the very reasons why these devices should be used as primary surgery as all
other treatment options for those very problems show almost zero good results. Ulatowski makes the statement that the older 515(b) applications are the older devices that have been around for some time and they have a mixed set of data and sometimes it is more difficult for the Panel to come to grips with it. He went on to say the threshold is not an absolute assurance of S&E but a reasonable assurance, which gives the Panel a lot of leeway. The vote occurred and all 9 of the Panel Members voted for approval of the TMJ Implants, Inc. (Christensen) devices.
THE FDA DETERMINATION
By the middle of July, 1999, TMJ Concepts had been given the green light of approval to openly sell their implants without restriction and TMJ Implants would wait another period to be told they were basically being taken off of the market for the first time in 39 years, and would be forced to go through a 510(k) evaluation for Safety and Effectiveness. This process would put them in the category of being a new device undergoing trials with limited sales. What a blow to the individual who had introduced these devices in the first place and whose devices were the predicate devices allowing other TMJ implants to enter the market. This also took the world’s only Partial TMJ implant off of the market, thus not allowing any proven method for early TMJ sufferers to be helped surgically. What a travesty. It might at this point be interesting to read some of the reports from others about this whole debacle of FDA approval for the TMJ Implants, Inc.’s devices. In some of the FDAWebview articles in that time period we find the following statements. Dr. Ric Alexander, Director of Oral and Maxillofacial Surgery at St. Luke-Roosevelt Hospital in New York City, was brought into the panel Hearings by TMJI as a consultant and made the following statements. He lauded the amount of research and testing that I had done on his device, saying, “It has been more than on any other joint replacement device. There is not one hip or knee that has done the volume of testing TMJ Implants, Inc. has done. Runner just keeps ignoring all this. They’re getting ready to have another panel meeting on the partial joint replacement, and she just absolutely took all of the facts and totally distorted them.” He went on to say, that Runner and her superior, Division director, Tim Ulatowski, singled out Christensen because they want to get him off the market.” Alexander was correct as Dr. Peter Quinn, who later came out with his own TMJ device, came out with the statement at an N.Y. Society of OMS Fall meeting that, “If the Christensen device isn’t off the market as we speak, it will be shortly.” Ric went on to say, that is confidential information at the FDA. He should not have that. Alexander went on to say that Runner has told everybody that published data in our specialty is no good because it is anecdotal. He went on to say, it is not anecdotal. These were studies published in respective journals in our specialty. He listed the following journals where the reports of Christensen devices have been published: Oral Surgery, Oral Medicine and Oral Pathology, Clinics of North America, The British Journal of Oral and Maxillofacial Surgery, The American Journal of Orthopedics, the text book Oral Implantology, and Current Concepts in Oral and
Maxillofacial Surgery. He went on to say he had personally sent four separate letters to Commissioner Feigal about Runner’s bias and association with TMJ Concepts investigator and later owner, Dr. Lou Mercuri, but the FDA Press office said they never got enough information to warrant an investigation. FDA’s Carl De Marco said the allegations had been referred to the Office of Internal Affairs. When Jim Dickinson of FDAWebview attempted to contact Ulatowski, Runner’s boss, he never returned the call. Commissioner Feigal told Jim Dickinson that there is no FDA effort to keep the Christensen device out of the market. In a 9-19-2000 FDAWebview article, the writers talk about the similarity of the approval process for two small,
pioneer medical device companies, each with successful, old technology single product line, and driven by the same CDRH review division to the point of financial ruin over reclassification of their devices. One was Myotronics Inc., a small Tukwila, Washington orthodontic muscle-monitoring device. In their battle with CDRH same Dental Division, they finally elicited the help of Congress who were able to take it before the HHS IG’s Office. In their case two employees were discharged. In the TMJI battle they ran afoul of two other employees in the same Division, in a way that not only removed their product from the market but gave their market share to the
competing company. The article goes on to say that both companies have lost well over $1.5M and were forced from the market over a year while they battled FDA. In a 9-29-2000 FDAWebview article, they mention an article written by Florida surgeon, William Garrett to the FDA supporting the approval of the Christensen Partial TMJ implants saying, “The FDA has been irresponsible in keeping these devices off the market for over a year.” He goes on to say he has used the device several hundred times in the past 10 years, “With immediate and dramatic decrease in pain, increase in range of motion and increased function.” Garrett went on to say that Runner’s comment about the TMJ Implants device as “insulting” and “inappropriate.” In comments for the advisory panel, Runner addressed the need for muscular examination and neurological examination prior to surgery, advice Garrett calls. “Obvious.” Garrett in his 9-26-2000 letter to the FDA made the following statement, “There is no question in my mind and in my practice that I would use this prosthesis by appropriate protocol with its 30 years of experience without hesitation before I would use the prosthesis created by TMJ Concepts.” The controversy over the FDA pulling the TMJ Implants, Inc.’s prostheses off of the market and putting them not only through many other rigorous engineering type exams was not only an abuse of power, but most likely driven by bias and outright conflict of interests by those in authority in the regulatory body. There is so much more that can be said in support of the TMJI devices in contrast to what the FDA was proposing, but perhaps this is enough to show the difficulty with the regulatory process for these pre-amendment implants.
A Second Panel Hearing was called for and occurred on October 6, 2000 for a review of the Christensen Partial TMJ implant. Christensen inquired of Ulatowski as to whether the Company could make recommendations regarding the makeup of the Panel. The answer was, “Yes” and so we made three recommendations, but none were taken. The FDA loaded the panel with nonsurgeons and other professionals who had no basic knowledge of TMJ arthroplasty. It really was a joke, except it was about to destroy the ability of TMJ Implants, Inc. to survive. They didn’t care that the Company had to downsize from nearly 40 employees to about 16 and the sales went from about 185 implants a month to about 25 implants per month, thus causing me to subsidize all of the operations. Two of the surgeons who used the devices wrote letters to the FDA criticizing the Panel members selected for their lack of competence. Congressman Tom Tancredo even offered a comment in support of me and the Company. Perhaps, Dr. James Curry, who was one of two surgeons presenting at the Hearing summarized it best in a letter to Commissioner Feigal when he said, “He was embarrassed by the Panel proceedings. The Panel was overloaded with dentists who have almost no experience in the area of jaw joint disease and joint surgery.” Later Alexander complained to Rep. Tom Tancredo about “the poor make-up of the panel for expertise in which,” he said, “the public credentials of each of the six panel members and seven consultants who voted the Partial TMJ un-approvable in this Second Panel Hearing, found that all but two of them unqualified to review this device.” By the time that Panel was done they all voted against approval, when at least two of them who had been on the May 11, 1999 Panel had voted for approval of all of the Christensen devices. I smell a rat. Terry Cowley, President of the TMJ Association stated that injury to the natural condyle occurs from implanting the Christensen Partial joint implant, which is an outright lie. It was apparent the deck had been severely stacked against the Company and the product. Dr. Anthony Urbanek, a very qualified surgeon from Nashville, TN offered his testimony of implanting well over 345 implants with virtually no adverse events said that over 95% of his patients with those implants placed in their TMJs are out of pain and thankful for this “life-saving” procedure. (I might add that since those days, Dr. Urbanek’s wife had these very same implants placed in her TMJs with complete success.) So now the Christensen TMJ implants are placed in an IDE (Investigational Device Exemption) after some 39 years of successful use in humans and basically no adverse events of any merit. Somehow, this seems like over regulation, abuse of power, bias, corruption and certainly lack of commonsense and efficiency. But the story doesn’t end there.
A GATHERING OF EAGLES AGAINST THE FDA ACTION
After the disapproval of the Company’s 2 PMAs, we put together a document to more fully show the information that more fully tells the story of FDA abuse. It shows my and TMJ Implant’s desire to gain Congressional Review. The following pages unfold a story of the Food and Drug Administration’s Center for Devices and Radiological Health (FDA, CDRH) abuse of a small medical device company in
its pursuit of an approval for their Pre-Market Approval
(PMA) application. I, Dr. Robert W. Christensen am the inventor of the FossaEminence and Condylar prostheses, and founder and CEO of TMJ Implants, Inc. of Golden, Colorado. This company manufactures these prostheses for reconstruction of the temporomandibular joint (TMJ), for partial joint replacement, and for total joint replacement, respectively. I developed and first implanted these devices nearly 40 years ago, and my initial patients continue to benefit from this surgery. TMJ Implants, Inc. is the only company that provides a partial joint device, medically critical because the majority of TMJ patients do not require the more significant surgical intervention of a total joint replacement. You will see in this document evidence that demonstrates CDRH actions caused not only severe financial and competitive damage to the company, but denied patients access to a critical medical alternative to a higher risk surgery. These implants are pre-amendment devices, lawfully marketed and successfully used for 30 years prior to regulation by FDA. These devices were also considered “Predicate Devices”, meaning any new TMJ implant device seeking market clearance from the FDA must prove substantial equivalence to these devices. Then, in response to the Vitek disaster from the 1980s and early 1990s, the FDA classified all TMJ implants as Class III, significant risk medical devices in 1994. Subsequently, in December 1998, the Agency implemented new regulations requiring all TMJ implant devices to submit Pre-Market Approval applications (PMAs) to the Agency for review and approval. The Company’s PMA was first submitted on January 21, 1999. The pre-clinical and clinical data was presented to an FDA Advisory Panel on May 11, 1999, who recommended unanimously, approve their PMA. This recommendation for approval came in spite of the fact that CDRH had advised the Company not to attend the Advisory Panel hearing because they felt the PMA was not approvable. But as you read through this report, you will find that they (CDRH) appeared unprepared for the Panel Hearing, thus hoping to delay the review of our application. You will find that the conditions for final approval recommended by the Advisory Panel were substantially similar to those recommended for the Company’s competitor. However, CDRH then imposed additional regulatory requirements on the Company that could not be completed within the statutory review period, thereby forcing the Company off the commercial market and limiting the Company’s devices to research use only for nearly 18 months. This without any public disclosure by the Agency of unreasonable risk associated with the use of these devices. In contrast, CDRH failed to apply these additional standards to the competitor, granting approval for their device within 2 months of the Advisory Panel recommendation with similar conditions. The following report depicts the Agency’s:
• Lack of expertise among CDRH reviewers and unwillingness to obtain appropriate expertise; • Anger and retaliation towards the Company for its efforts to obtain a fair and adequate review of their PMA; • Application of excessive statutory standards and regulatory requirements; • Failure to apply consistent standards and review to two competing companies in an even-handed and unbiased manner; apparent conflict of interest by the lead reviewer, and others; Unwillingness for the agency to seriously investigate allegations of abuse and bias.
This is a story that cries out for Congressional oversight, justice and retribution for regulatory wrongdoing. The Agency’s actions were arbitrary and capricious, outside the statutory and regulatory boundaries, and in some cases, were illegal. The Company is now seeking Congressional, Inspector General, and Department of Health and Human Services reviews of the many and serious allegations. This story and the justification for seeking such investigations, is set forth in the following report. The Purpose of This Presentation This material has been assembled to provide a review of the handling by the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of two Premarket Approval Applications (PMAs) submitted by TMJ Implants, Inc. and to provide evidence that CDRH’s processing of these applications involved acts that were: 1) without scientific rationale and justification and were arbitrary and capricious, 2) outside of FDA’s/CDRH’s normal practices, rules, procedures, and established regulatory and scientific standards of review, 3) illegal, and 4) intended by certain senior CDRH employees as retaliation against the Company.
The Company and Its Medical Product(s) TMJ Implants, Inc. is a medical device manufacturer located in Golden, Colorado. It is one of only two companies that manufacture and sell a temporomandibular joint prosthesis for implanting in human patients. As the Company’s president and owner, I, Dr. Robert W. Christensen am internationally recognized as the pioneer of this very specialized surgical procedure. TMJ Implants, Inc.’s competition is TMJ Concepts, Inc. located in Camarillo, California. Although the two companies compete for the TMJ prosthesis market, there are several significant differences in the product choices provided by of the
two companies. TMJ Implants, Inc. manufactures the only metal-on-metal TMJ Prostheses System. TMJ Implants, Inc. manufactures the only partial joint system (known as the TMJ Fossa-Eminence Prosthesis), as well as a total joint system. TMJ Concepts Inc., on the other hand, provides only a total joint system. The TMJ Fossa-Eminence Prosthesis (partial joint) was invented by me, Dr. Christensen in 1960 and first implanted into a human patient by me in 1961. The TMJ condylar prosthesis (total joint) was invented by me, Dr. Christensen in the early 1960s and first implanted into a human patient in 1965. The original Total Joint Prosthesis was manufactured from polymethylmethacrylate and cast cobalt-chrome-molybdenum alloy, and was also available in an all-metal version. The Fossa-Eminence and Condylar Prostheses have been manufactured and sold in commercial distribution since 1961 and 1965, respectively, (through various distribution entities.) For approximately 3,800 metal-on-metal total joint devices registered, fewer than 5% have been explanted. Device related failures are less than 0.1%. For approximately 6150 partial devices placed over an 11-year period fewer than 5% have been explanted. Device related failures
are less than 0.17%. The history of safety is extraordinary for both the total and partial joint systems. Throughout almost two years of withholding the Company’s products from the market place, the FDA never provided any evidence of unreasonable risk of illness or unjust injury associated with the Company’s devices. History of Pre-Amendments Devices The TMJ Fossa-Eminence Prosthesis and TMJ Condylar Prosthesis systems are pre-amendment devices meaning they have been commercially marketed in the United States for treatment and repair of temporomandibular joint disease for many years prior to the Medical Device Amendments of 1976 (amendments to the Food, Drug, and Cosmetic Act, which specifically addressed the regulation of medical devices). These devices were classified to Class III (significant risk devices) in December 1994, when FDA issued its Final Rule 4, thereby requiring sometime in the future an approved PMA application to continue to commercially distribute the devices. This classification was in part due to the devastating effects of the Proplast-Teflon interpositional TMJ devices manufactured by Vitek Corporation that caused irreparable harm to thousands of patients. The Agency understands and expects that such devices, lawfully marketed and in clinical use for many years prior to the Medical Device Amendments, lack the prospective data required of new devices, but offer sufficient clinical evidence (significant human experience) to support a reasonable assurance of safety and efficacy. In fact, several class III pre-amendment joint prostheses have been reclassified as Class II devices based solely on Medical Device Reports (MDRs) and available clinical evidence, both from peer reviewed journals and from relevant clinical experience. A review of the Panel meetings from such devices reveals the concerns raised at each panel hearing are identical to the concerns raised by the panel reviewing the Company’s TMJ prostheses.
However, in all the other panel hearings these concerns did not prevent approval. It is clear that the Agency has held the Company to different standards than other pre-amendment devices.1 2 3 The FDA Regulatory Process Imposed on TMJ Implants, Inc. Prior to 1999, the Company’s products were legally marketed as pre-amendment devices. In December 1994 the FDA issued a final rule classifying all TMJ prostheses as Class III medical devices.4 A 510(k) was submitted for the Christensen/Chase condylar prosthesis (k935432) and approved in March 1995 based on substantial equivalence to the Christensen Condylar prostheses. On July 17, 1997 the FDA issued a proposed rule to require a PMA for all TMJ prostheses.5 On January 21, 1999, the Company submitted a PMA (P990003) for the Fossa-Eminence Prosthesis (Partial Joint) and the Condylar Prostheses (Total Joint.) In May 1999 a Dental Products Panel voted unanimously to recommend approval of the Company’s PMA and its Competitor’s PMA, with certain post-approval conditions. 6 On August 10, 1999, at the request of the Agency, all components included with PMA P990003 were withdrawn, except those for the Fossa Eminence Prostheses. All devices that were withdrawn from the PMA were now the subject of an Investigational Device Exemption (IDE) application. On November 9, 1999, the PMA was resubmitted, PMA (P990070). On April 28, 2000, in what the Company perceived as a threat, the Agency “advised” the Company to withdraw both P990003 and P990070, or the Agency would post a denial of its PMA applications on the Agency’s website. Under fear of the Agency’s threat, the Company withdrew both P990003 and P990070. (Note that this threat and the Company’s withdrawal occurred
with 71 days remaining in the mandatory 180-day review period.) On June 20, 2000, a single PMA for both the Partial Joint System and the Total Joint System was resubmitted to the Agency. However, upon receipt of the application the Agency split the Company’s PMA into two separate PMAs, one for the Total Joint (P00023) and one for the Partial Joint (P00035). The Company was not notified of this change. In October 2000, CDRH assembled a second Dental Products Panel to review the Partial Joint PMA resulting in what TMJ Implants, Inc. and others who have followed CDRH’s review process for the Company’s PMAs believe was a deliberate effort by Ulatowski’s (Tim Ulatowski, Division Director, Division of Dental, Infection Control and General Hospital Devices) group to stack the panel with biased and unqualified members to insure a negative recommendation. This Panel voted unanimously, recommend the Partial Joint PMA non-approvable. On January 5, 2001, and February 27, 2001, respectively, the Total Joint PMA and Partial Joint PMA were approved by the Agency. It is clear from the evidence that these approvals were granted only after Bernard Statland, CDRH Office of Device Evaluation Director intervened in the process and overruled Ulatowski, Runner (Susan Runner, DDS, Branch Chief, Division of Dental, Infection Control and General Hospital Devices) and their colleagues. It is clear that Dr. Statland recognized the irregularities, the injustice, and personal retaliation directed at TMJ Implants, Inc. by Ulatowski, Runner, and colleagues. Excerpts from a 2/18/2001 FDAWebview article are insightful:
“Assuming the mainstay device’s return to the market is not further delayed by FDA nit-picking of the five conditions, final approval will close a 20-month hiatus in the products’ marketing, a timeframe that TMJ Implants, Inc. CEO Robert Christensen says gave much of his long-established
“total” market to a recent competitor, TMJ Concepts of Camarillo, CA.
Before FDA decided to classify temporomandibular joint prostheses into Class III, the two companies competed headto-head in total-joint prostheses, but TMJ Implants has the only partial joint prosthesis, which was by far the largest part of my market.
FDA approved his competitor’s total device within two months of its advisory panel meeting in 1999, but held me off for a total 19 months, approving it only last month and earning strong complaints of favoritism and bias, especially after Christensen discovered that the clinical consultant for his competitor had once taught the lead FDA reviewer of both devices.
His products’ long absence from the market and associated legal expenses to reinstate them cost his company over $6 million and forced plant closure, Christensen said.
FDA has refused to answer questions about its conduct of the review of both Christensen devices, or my complaints of favoritism, which included CDRH “stacking” of the Dental Products Panel to produce its negative vote on the partial joint last October.
Two external investigations were opened -- one by the House Energy and Commerce Subcommittee on Oversight and Investigations, and the other by HHS Office of the Inspector General. The Latter tentatively reported no finding of wrongdoing against CDRH, but the former was still open at press time; a subcommittee source said CDRH’s belated efforts to override the Dental Products Panel’s negative vote last October showed that the external criticism had embarrassed the Center.
The case has many similarities to a similar scandal involving the same panel and CDRH review division in 1997, when a jaw muscle monitor manufacturer, Myotronics Inc. of Tukwila, WA protested similar review-staff and panel irregularities and succeeded in getting the advisory panel proceedings nullified.
In the approvable letter to Christensen 2/13, CDRH Office of Device Evaluation director Bernard Statland labored to achieve a positive resolution of the dispute between Christensen and his Division of Dental, Infection Control and General Hospital Devices in a way that could be facesaving for the Center.
It may be significant that it was Statland, a recent (last August) arrival at CDRH, who issued the approvable letter; normally it would have been issued directly from the division most probably over the signature of its director, Timothy A. Ulatowski.
In the close-quarters bureaucracy in which most FDA employers work, interpersonal chemistries can loom large in an atmosphere that demands collegiality. Loyalty becomes a major factor when decisions and behaviors are challenged, as they have been in this case—the officials who would normally communicate review decisions to TMJ Implants had staked out positions hostile to these devices and therefore became polarizing forces in their approval, especially when the advisory committee they had convened has to be contradicted by their supervisors. Statlands newness apparently isolated him from this history, which had even Longer roots than the TMJ case when the 1997 Myotronics affair involving the same review division is considered.”
Harm to TMJ Implants, Inc. From FDA Abuses
The financial harm inflicted on TMJ Implants, Inc. has driven the Company and its owner/founder, Dr. Christensen to the brink of financial ruin. The financial damage inflicted results from: • Extraordinary legal fees incurred to respond to the Agency’s PMA process. These fees reached greater than $1 million. • Loss of revenue as a result of FDA’s removal of the Company’s product from the market for nineteen months. • Competitive advantage gained by its competitor, TMJ Concepts, Inc., whose PMA was quickly approved giving it the entire TMJ prostheses market for more than a year and one-half that TMJ Implants, Inc.’s products were removed by the Agency from the marketplace. • Harm to its commercial reputation from the adverse publicity resulting from removal of its products from the market place. The Company has estimated that the FDA’s abuses have cost it in excess of 6 million dollars. The impact on the Company and its owner are substantial: • In 1999 the Company employed 35 people. Many of these employees were “laid off” in 2000, and currently (April 2001), the Company consists of 15 employees. • Company revenue in 1998 was $4,559,000. Revenue in 1999 was $3,337,000, and in 2000 was $1,900,000. Note: from August 11, 1999 through 2000 the revenue was primarily from those cases performed under IDE G990191. Dr. Robert Christensen, President and owner of TMJ Implants, Inc. has secured a second mortgage on his personal residence and
mortgage on a second home/investment property in order to provide funds to his company to continue operations. Legal fees of greater than $1 million were incurred during the period of PMA reviews to attorneys to process PMAs, and related materials. In contrast it can be assumed that the legal costs to TMJ Concepts, Inc. the competitor, were negligible by comparison. Harm to Patients from FDA’s Wrongful Review Process The health impact on patients of the FDA abuse was equally egregious. The FDA itself recognized the need for the partial joint device (which CDRH was threatening to permanently remove from the market) on August 10, 1999; the Agency issued the Company notification that the Fossa-Eminence prosthesis as a partial joint replacement met the Agency’s requirements of “necessary for the Public Health.” Countless physicians notified the FDA of the need for the TMJ Implants, Inc.’s prostheses, especially the partial joint. (See excerpts from Physician letters, Section 11, and copies of entire letters in the Exhibits). The Agency knew that its removal of the Fossa-Eminence (Partial Joint) deprived physicians and their patients of access to preferred medical care in those cases requiring only a partial joint replacement, leaving physicians to choose between denying the patient a needed surgical procedure or implanting a total joint prosthesis that unnecessarily replaced healthy condyle anatomy. The Agency has History of Retaliation Against Private Companies As the evidence presented in this report shows, the Agency’s failure to approve the Company’s PMAs until after almost two years following the May 1999 Dental Products Panel’s unanimous 9-0
recommendation for approval, with conditions, was the consequence of a combination of factors: incompetence, favoritism of one company over another, and retaliation against the Company, TMJ Implants, Inc., was deemed by Ulatowski, Runner, and colleagues to be insufficiently compliant in the face of the reviewers’ decisions and the exercise of their authority. The evidence shows that TMJ Implants, Inc.’s PMA problems were rooted in Dr. Runner and Angela Blackwell’s negative bias toward its products and were exacerbated by its complaints about Susan Runner’s conflict of interest. The Partial Joint reconstruction uses only the Fossa-Eminence Prosthesis and is used when the disease or degeneration affects mainly the meniscus (disc) and may to a lesser degree affect the articulating surface of the temporal bone. In these patients the normal condyle is healthy or has the capacity to repair itself. In these cases it would be potentially harmful to the patient to suggest a total joint reconstruction, when a partial joint reconstruction would suffice. The Total Joint reconstruction employs the Fossa-Eminence Prosthesis and the Condylar Prosthesis as a unit and is used when the disease or degeneration of the joint is advanced to where the normal condyte and meniscus (disc) need to be removed and reconstructed. This pattern of retaliation by FDA is not new. Congressional hearings24 and extensive investigation by the Office of the Inspector General (1G), Health and Human Services (HHS) in 1995 established a clear pattern of retaliation by the Agency against private companies. The focus of these hearings, ironically, involved a private company, Myotronics Inc., which protested abuse by the same CDRH group headed by the same Tim Ulatowski, in charge of the TMJ Implants, Inc.’s PMAs. As a result of the 1995 Congressional and 1G investigations, Senior FDA employees were fired or separated from FDA service, the affected company received reimbursement of it legal fees, product claims were restored, and other remedies were provided the affected
company. A reading of the transcript of the 1995 Congressional Hearings reveals the deep-seated culture of retaliation and pursuit of personal vendettas by FDA employees against selected companies. Congressman Joe Barton, then Chairman of the House Subcommittee on Oversight and Investigations set forth in a 1995 hearing on FDA abuses the following statement: “Rather than preview today’s testimony, I would like to point out that these stories are not rare exceptions. One only needs to look at the history of the FDA. A former Chief Counsel for the FDA recently explained how the FDA never forgets who its enemies are. “If you lose a lawsuit against them, you have an angry FDA which is willing to slit your throat,” and I’m quoting. ‘When the FDA loses a case, it has a mind like an elephant. It’s just something you’ve got to understand about the FDA. Once the Agency makes a collective decision, trying to make it let go is almost impossible. These are ‘FDA crusades.’ In a real sense, they’re vendettas. They started a war in 1920 with the diet supplement industry, and it’s not over yet.” A notable case of retaliation involved RS Medical, a medical device manufacturer that appeared to have raised the ire of the FDA. Aware of the bias against the firm, RS Medical undertook the cost of an experiment that ultimately convinced a Federal District Court of the retaliation practiced by FDA. The firm had a muscle stimulator that required 510(k) approval. They prepared 2 identical applications and submitted them to the FDA simultaneously. One submission was in their name and the other was presented as the work of a consultant. The latter application was approved in less than 3 months. Their application with their name on it took almost one year for review and was found not to be approvable. The District Court found the FDA determination to be ‘unreasonable and arbitrary’ and that the Agency had engaged in “bad faith conduct.” RS
Medical won nearly $400,000 in attorney fees. As we will see, FDA has investigated allegations of abuse before, but without much effect. The climate of fear and the perception of the FDA unfairness and retaliation remain. Strong words against retaliation are not enough. The Agency has been unable to investigate itself seriously or punish the wrongdoers within its
Agency appropriately. When evaluating the Agency’s history of personal retaliation, it should not go unrecognized that the same review group (Tim Ulatowski’s) implicated in the CDRH employee abuses in the Myotronics case was in charge of the TMJ Implants, Inc.
PMA reviews. In an article about the TMJ Implants Inc. case a February 18, 2001, FDA Webview article states: “The case has many similarities to a similar scandal involving the same panel and CDRH review division in 1997, when a jaw muscle monitor manufacturer, Myotronics Inc. of Tukwila, WA protested similar review staff and panel irregularities and succeeded in getting the advisory panel proceedings nullified. In the Myotronics case, that company alleged that the Agency engaged in retaliation and cover-up as well as purposeful acts intended to inflict fatal commercial damage on the company. Evidence uncovered in Congressional Hearings and Office of Internal Affairs and IG, HHS investigations supported the
company’s allegations.” Although states of mind and individual’s motivations are difficult to ascertain, the evidence seems compelling: TMJ Implants, Inc. and physicians angered Tim Ulatowski, Dr. Runner, and the review group by complaining to the CDRH Director and other Agency officials, alleging improper handling of its PMAs. The subsequent acts of the reviewers leave little doubt that the culture of retaliation and personal vendettas identified in the 1995 Congressional Hearings and Myotronics case investigations were
“alive and well” in the TMJ Implants, Inc. case, five years later. The propensity of the Agency to cover up employee misconduct became the dominant force as Agency officials rushed to close ranks by summarily dismissing allegations of irregularities as having no basis. In the Myotronics case, advisory panel proceedings were invalidated, two FDA employees including the senior reviewer and Dental Products Panel Consultant were fired by the Agency, and others reprimanded. In the TMJ Implants, Inc. case nothing has been done to address the many serious allegations of
Agency irregularities. As a consequence of the Myotronics investigations, then director of device evaluation, Susan Alpert, issued a statement that said, she would use the Myotronics experience as a staff-training case study in how not to review a device.” It is ironic that five years later, on March 1, 2001, Mr. George F. Grob, Deputy Inspector General, Department of Health and Human Services in a letter to James Bergeron, Chief of Staff for Representative Tom Tancredo stated: We may use the review of the TMJ Implants, Inc.’s device as a case study of the FDA’s approval process”. In response to Grob’s letter to Bergeron, Dr. Christensen expressed his outrage at the IG’s failure to open a full investigation stating as follows: I am incensed by the response of Mr. Grob to our various allegations of mishandling, bias, conflict of interest, and possible more serious accusations. In his letter, Mr. Grob states, “We believe it would be inappropriate to open a full investigation of the FDA’s review of your product.”
I would like to demand of him an answer as to why it would seem inappropriate with all the allegations mentioned in my letters and Mr. Roland Jankelson’s letters, as well as Congressman Tom Tancredo’s letters. Is this a body that doesn’t get involved
in oversight and wrongdoing and hear the complaints of the tax paying public? Later in his letter he states, “We may use the review of the TMJ Implants, Inc.’s device as a case study of the FDA’s approval process.” Well that’s just wonderful if they use this as a teaching case and I am sure into areas of wrongdoing, but they haven’t got the integrity to require an open investigation of the process that drained all of the corporate assets of TMJ Implants, Inc., plus the personal assets of its President, Dr. Robert W. Christensen and family. They think this is all normal conduct of business. I say, I hope not. This company, unless it can find somebody to produce financial backing, has no way of keeping in business. I well remember, in I believe the 1993 Federal Register, where the same FDA body stated there would be no financial impact on a company in their making these devices Class III devices. What an outrageous lie that has become. CDRH Misunderstood, Misrepresented, Misstated and Mislead Others From the early beginning of the Agency’s review, CDRH staff, misunderstood, misrepresented, misstated and mislead others, including the second Dental Products Panel. The record of the Agency’s review and efforts by the Company to correct staff’s mischaracterization of the data before it and to bring staff back to the appropriate regulatory standards provides evidence of: • Staff’s lack of expertise to properly interpret data before it. • Staff’s insistence on standards that exceeded the statutory requirements for reasonable safety and efficacy. • Staff biases that predated the PMA application and effected its treatment of the Company’s review throughout a “tortuous” review that took almost two years.
• Staff’s unethical practices regarding breaches of confidentiality, medical opinions by non-medically trained staff members, unwillingness to grant “compassionate use” for specific cases, thereby “tying the hands” of surgeons wishing to provide the best care possible for their patients. • An unwillingness of CDRH to correct its mistaken interpretation of data and information when the Company, other experts, and effected physicians brought evidence of its mistakes to the attention of the Agency. • Staff’s stacking of the second panel with members whose biases and/or • lack of expertise could be expected to result in is being led by the • staff’s misinformation to CDRH’s desired “non-approval.” There was no lack of effort by the Company, its consultants, concerned physicians, and Congressmen to bring to the staff’s and to other Agency officials’ attention the staff’s mistakes and misinterpretations of data and information. For example, Dr. Ric Alexander, who closely followed the TMJ Implants, Inc.’s reviews and has written numerous letters to various Agency officials protesting the CDRH’s treatment of these PMAs, highlighted in several letters CDRH’s mishandling of its review of TMJ Implants, Inc.’s PMAs. In an October 11, 2000 letter from Dr. Alexander to Congressman Tancredo, Dr. Alexander states:
“The case reeks with favoritism, incompetence, and abuse of power by the people at the dental services division of CDRH.”
In another letter dated September 18, 2000, Dr. Alexander writes to Pamela Scott, Advisory Panel secretary:
“I recently reviewed Dr. Susan Runner’s memorandum to the Panel regarding the FDA’s dental branch concerns regarding TMJ Implants, Inc.’s PMA application for the Fossa Eminence Prosthesis. I was absolutely appalled by some of her comments referencing information submitted in the PMA. Dr. Runner’s statement that, “The data is insufficient to support safe and effective use of this device.” is false, misleading, and a distortion of the truth. Dr. Runner’s critique of Dr. Curry’s data is inaccurate, distorted, and untruthful.”
Again on April 26, 2000, Dr. Alexander writes to Dr. David Feigal, Director, CDRH:
“I have been informed on several occasions that I should refrain from writing letters to the FDA because they may make Dr. Runner or Mr. Ulatowski “angry” and then no device approval will be forthcoming. Imagine that, a device or devices being given a not approvable or a denial because the people at the FDA looking at the PMA get angry at being sent factual data and scientific information by doctors concerned about the safety and wellbeing of their patients.”
In a response to a letter from Dr. Feigal on December 9, 1999, on December 17, 1999, Dr. Alexander states:
“Unfortunately, I must report to you that it [Feigal’s letter] contains a number of inaccuracies. It appears that misinformation is being passed to you from below.”
On November 8, 1999, in a letter to Dr. David Feigal, Dr. Alexander states:
“The scientific data on these devices overwhelmingly shows they are safe and effective. The problem appears to be that
the individual(s) interpreting the data are unable to do so in an objective and unbiased manner.”
On October 4, 1999, Dr. Alexander writes to Dr. Susan Alpert, Director ODE, CDRH:
“The scientific data available is sufficient to grant PMA status to these prostheses. Failure to do so suggests that something other than science is at work.”
Similar communications of allegations of irregularities were communicated by the Company and others in writing to senior Agency personnel including to CDRH Director Feigal; to Susan Alpert, Director Office of Device Evaluation, CDRH; to Cart DeMarco, ODE Integrity Officer; to Les Weinstein, FDA Ombudsman; and to Michael Mangano, Acting Inspector General, HHS. In a September 12, 2000, letter Dr. James Curry, a TMJ Implants, Inc. consultant, wrote to Pamela Scott:
“I have reviewed Dr. Susan Runner’s memorandum to Panel members stating FDA’s analysis. In that document, Dr. Runner makes several statements that are inaccurate and misleading. What on earth could Dr. Runner hope to accomplish with the FDA Panel by stating only half-truths in much of her memorandum?”
Other communications between the Company’s attorneys and the Agency reflect the Agency’s “internal gridlock”, biases, and inability to resolve simple labeling issues that historically have been post approval issues. In a January 3, 2001 letter to Tim Ulatowski, Mr. Michael Cole voiced his disagreement with Ulatowski’s assessment of our indications, stating:
“...we believe the [Agency’s] concerns about the adequacy of the efficacy data are baseless. First the idea that the submitted data and testimony on the pre-implant work-up is inconsistent, is an overgeneralization, and misses the point.”
Mr. Cole goes on to say:
“This is an integral part of the practice of medicine and is not something FDA should seek to manage beyond stating the goal that surgery not be contemplated until all other avenues of treatment have been eliminated as meaningful possibilities.”
In a January 22, 2001 e-mail from Mike Cole to Dan Schultz, CDRH Deputy Directory for Clinical Review and Policy, expressing his dismay over further delay of the partial joint application until a formal letter is prepared, this after Tim Ulatowski had told Mr. Cole on January 9th they would have a decision on the partial joint application that week (the end of the week being January 12, 2001). Another e-mail on January 23, 2001 from Mike Cole to Dan Schultz, responded
to Dr. Schultz’s response that a formal letter is required by law. Mr. Cole states the Company’s 180 day review period ends on April 13th, questions why a formal letter is necessary at this early date, and asks why their concerns cannot be provided by e-mail to enable a prompt response. Mr. Cole complains about a lack of action from the Agency and further delays by Ulatowski. (Note this discussion is focused on labeling issues, not safety or effectiveness).
Over the next week a number of e-mails and phone calls were exchanged between the Company’s attorneys and Dan Schultz trying to resolve this gridlock. On January 29, 2001, an e-mail from Mike Cole to Dan
Schultz states he is still confused about this whole process, and repeats to Schultz that our submission on 10/13/00 was a major amendment and the review period is extended until 4/13/01, and that another deficiency letter now would probably delay the review for another 6 months. January 30, 2001, Bernard Statland, Director CDRH, feels the Agency and the Company can come to a mutual agreement and wrap this up rather quickly, even if it takes overruling his staff. After approximately one month, final details are resolved and the Company finally receives approval of the partial joint PMA, amazingly with the same indications submitted in the original PMA two years previously. Was the staff’s failure to assimilate the data and information that supported the PMAs a function of its lack of competence in this very specialized area of medical care? The record supports the conclusion that CDRH, including its second Dental Products Panel, did not meet reasonable standards for expertise. However, the record leaves little choice but to conclude that even more sinister dynamics were at work. Biases toward the Company’s products previously held and publicly stated by Dr. Runner, personal relationships with persons outside the Agency associated with a competing company, regulatory standards applied to these PMAs and not to others that was outside and far exceeded the statutory standard of reasonable assurance of safety and efficacy, a mindset by Dr. Runner and her staff that resulted in overzealous “micromanagement” of product labeling and indications, and the Agency’s long standing culture of punishing companies that complained about the treatment being rendered. The Agency and the Inspector General Failed to Act
In spite of repeated requests by the Company and other interested persons for investigation, the Agency and the 1G, HHS failed to act to investigate any of the serious allegations. Did the several layers of institutional mechanisms within the Agency designed to police and investigate employee misbehavior fail in the TMJ Implants, Inc. case? The record makes it clear that the answer to this question is a resounding, yes. Complaints about Susan Runner’s conflict of interest were directed to CDRH Director, David Feigal and the Office of Integrity Director, Carl T. DeMarco. The disposition of this complaint is subject to varying and contradictory explanations provided in the written statements of Feigal and DeMarco: On December 9, 2000, David Feigal, CDRH Director wrote to Dr. Alexander stating:
“Concerning your allegations that Susan Runner has a conflict of interest in relation to devices manufactured by TMJ Implants, Inc., the ODE Integrity Officer has referred this matter to the FDA Office of Internal Affairs for investigation.”
On September 27, 2000, letter to Dr. Christensen from Carl T. DeMarco, Integrity Officer, Office of Device Evaluation:
As you probably know, allegations and evidence concerning Dr. Runner had been submitted to FDA by your consultant, Dr. Ric Alexander. The evidence presented by Dr. Runner related to statements by third parties, rumors, and past professional training that occurred a long time ago. I referred the matter on November 18, 1999, to our Office of Internal Affairs, (OIA). After consideration of the allegations and evidence presented by Dr. Alexander, the OIA did not find sufficient justification to open an investigation into the allegations related to Dr. Runner.”
In a letter dated January 22, 2001, Dr. Christensen wrote to Michael Mangano, Acting Inspector General, HHS:
“Let me briefly say to you that the information you received from the FDA regarding their in-house investigation of our claims of bias, conflicts of interest, and preconceived agendas by agents of CDRH in their treatment of TMJ Implant’s PMA is an outright lie.”
Read the enclosed Dickinson’s FDAWebview of November, 2000 in which Feigal says, “I am satisfied Runner has no agenda against the Christensen Devices.” It also states, the “FDA’s press office told me (Dickinson) that an investigation was not opened because we never got enough information to warrant one.” “Yet in your letter to the Congressman they apparently stated they had performed an investigation. In Dickinson’s same report the reporter states, “In a rejection of (Dr. Ric) Alexander’s charges a May 25th letter from CDRH Office of Device Evaluation integrity officer, Carl De Marco said the charges related to statements made by third parties, rumors, and past professional training that occurred a long time ago...” Despite these weaknesses, De Marco said, the allegations had been referred six months earlier to FDA’s Office of Internal Affairs. “No one from FDA ever asked Dr. Alexander for any information he had on the charges he was making, nor has anyone contacted me for any information I might be able to supply regarding bias, favoring a competing company or the fact that they chose a very inappropriate, biased and ill-informed Panel Of Experts for the October 6, 2000, Panel Hearing on our Partial Joint Prosthesis.” On February 16, 2001, Roland Jankelson who had been contacted by Dr. Christensen about TMJ Implants, Inc.’s problems with the Agency wrote to Melinda Plaiser, Associate Commissioner for Legislation, FDA, HHS. In his letter Mr. Jankelson recalled the words of Congressman Joe Barton from the 1995 FDA “Abuse Hearings”:
“As we will see, FDA has investigated allegations of abuse before, but without much effect. The climate of fear and the perception of the FDA unfairness and retaliation remain. Strong words against retaliation are not enough. The Agency has been unable to investigate itself seriously or punish the wrongdoers within the Agency.”
It needs to be noted that following the 1995 Hearing and IG investigation of the Myotronics case, the Agency terminated the services of a senior dental products reviewer and the consultant to a Dental Products Panel, and reprimanded the Panel’s secretary, but did not discipline Tim Ulatowski. The evidence and record of its handling of TMJ Implants, Inc. PMA shows that the 1995 Hearings, IG investigation and the Agency’s actions to respond to the public disclosure of wrongdoing did not change the retaliatory culture at the level of Utatowski’s review group and did not make the Agency any more willing or capable of selfinvestigation or acknowledgment of wrongdoing. Mr. Jankelson further summed up his feelings in the letter to Melinda Plaiser. He wrote:
“About four months ago, Dr. Christensen, President of TMJ Implants, Inc. called me about his FDA problems because he had heard of our experiences and success in getting the truth revealed. I was appropriately skeptical since I believed that the Myotronics case had made a difference in the way the FDA “policed” its review process. Since his initial phone call to me, I have reviewed the considerable materials on this case available to me and have followed the day-to-day activities on the TMJ Implants case.
As a result, I sent to Mr. Les Weinstein the letter dated December 28, 2000, and also the letter of January 19, 2001, to Mr. Michael Mangano, Acting Director, Office of Inspector General, Health and Human Services, (see copies enclosed) I have set forth over twenty individual allegations of miscon
duct, irregularities, issues of competence and violations of statute and regulations.
Contrary to your statements to Congressman Tancredo, there never has been a legitimate investigation of any of these allegations. If you have evidence of serious investigations by OIA of these allegations (which you do not have because they never took place), please make these available to Dr. Christensen. The shuffling of “uncomfortable” allegations from one person or area of the agency to another without any serious purpose except the Agency’s denial of any wrong doing is not an investigation, regardless of how many letters are written by FDA officials claiming to assure outsiders that these matters were investigated. These matters have never been investigated. You know it, or the persons misleading you know it. The record will show it. The efforts of the FDA at the highest levels to cover up wrong doing on the Myotronics matter were the reason the Subcommittee ordered Dr. Kessler to refer the Myotronics investigation out of OIA up to the Inspector General, HHS.
(See portion of the hearing transcript enclosed)
The historical record of the FDA’s claims for self-investigation make it clear that your response to Congressman Tancredo is predictable, i.e. your statement that, “The allegations made regarding the competence and objectivity of certain FDA employees with respect to these two PMAs were investigated by FDA’s Office of Internal Affairs (OIA). The OIA review did not substantiate the allegations, predictable, predictable, predictable. But not true.
The question for the FDA to address as regards the TMJ Implants matter is whether it is the same old FDA: retaliation, vendettas, incompetence, flawed processes, cover up and denial. Has it not changed? Or is the FDA capable of acknowledging wrongdoing, removing incompetent and
misbehaving employees, acknowledging error, and fixing flawed reviews when the evidence indicates problems? Unfortunately, your letter to Congressman Tancredo and the unwillingness of the Agency to treat seriously the allegations of corruption, retaliation, incompetence and flawed processes on the TMJ Implants, Inc. PMAs seems to allow no conclusion except that it is the same old FDA, at least as regards to CDRH. I do want to acknowledge the contributions of Dr. Bernard Statland in taking this case into his own hands, and removing it from the hands of Susan Runner and Tim Ulatowski. Without his intervention, the PMAs (although two years late) would still be held hostage in the hands of these two FDA employees (as were Myotronics’ 510(k)’s being held hostage to the subsequently dismissed reviewer, Dr. Singleton.).
The willingness or lack of willingness, of the FDA to reassess its position on investigating these allegations and referring them to the IG, HHS will speak loudly about whether the public and industry can have confidence in the Agency’s fairness and competence. A continuation of the “stonewalling” reflected in your response to Congressman Tancredo will stamp the Agency, or at least CDRH, as untrustworthy, unaccountable and unchanged. It will demonstrate to Congress that the changes promised following the 1995 Hearings and IG investigations did not occur. If that is the result, all officials responsible for policing this review and responding to allegations of impropriety can be assured that this matter will proceed to other forums. The real truth of the FDA’s mishandling of the TMJ Implants PMAs will be told. It will serve the FDA and the public well if the Agency becomes a participant in uncovering the truth concerning the TMJ Implants PMAs. It will demonstrate to industry, the public and Congress that the FDA truly did learn some lessons from the experience in 1995, and has moved forward to become a more trustworthy organization. So far, the indicators are that it has not.”
From the beginning of the review process, the Company’s concerns and its allegations of multiple wrongdoings were delivered to the Director, to the Integrity Office (ODE), to the FDA Ombudsman, and to others in the Agency. These concerns and allegations of mishandling of this review were clearly and forcefully articulated by the Company, its consultants, physicians concerned about the harm caused their patients by the Agency’s action, by Roland Jankelson who followed the case at Dr. Christensen’s request, and by others. On December 28, 2000, Roland Jankelson wrote to Les Weinstein, FDA Ombudsman, and copied David Feigal, Director CDRH. In that letter Mr. Jankelson stated:
“The record cries out for intervention by you and other responsible FDA officials. Neither Susan Runner nor Tim Ulatowski has credibility in this matter. In reviewing this matter, you and senior FDA and OIA officials should look at a number of issues: • A phone call, from Dr. Susan Runner to Dr. Christensen days before the May 1999 Panel meeting informing Dr. Christensen that his PMA would be disapproved, and advising him to withdraw it. • Information leaked by the FDA prior to the 1999 Panel that TMJ Implants, Inc. devices “were either withdrawn by FDA or would soon be.” Remember the FDA leaking in the Myotronics case. • Treatment of TMJ Implants, Inc. PMAs with standards different than used for its competitor, TMJ Concepts, Inc.’s PMA: TMJ Concepts, Inc. was approved without delay in spite of a device history covering only a few years and limited data, compared to a device history of more than thirty years for the Christensen devices, and much more data.
• Removal of the partial and total joint from the market in spite of a 9-0 Panel approval, and a need acknowledged by the FDA Panel. • Allegations that Dr. Susan Runner had a conflict of interest stemming from her past relationship with Dr. Mercuri, TMJ Concepts, Inc.’s chief technical consultant—allegations rejected by OIA without any apparent serious inquiry. • Data and evidence covering over thirty years of use that demonstrates a remarkable safety record. Why has this device been held hostage? • Staffs dismissal of TMJ Implants, Inc.’s request for the addition of qualified experts for the October 2000 Panel. • The assembly of a Panel for the October 2000 meeting, which lacked balance and qualifications. Only one certified Oral Maxillo facial surgeon among five consultants. Why? • Concerns about the independence of a number of October, 2000 Panel members and consultants. • Acknowledgement by one of the October 2000 Panel members to Dr. Christensen prior to the Panel meeting that he believed (knew) the Panel would recommend disapproval. • Acknowledgement by the same Panel member that he knew by the noon break in the October 2000 Panel meeting, members intended to vote for disapproval. • Acknowledgement by the same Panel member that he believed the PMA (the TMJ Implants, Inc. partial joint) should be approved, but that he voted for disapproval (with the majority) because he believed he would not otherwise be invited to another Panel. So much for the idea of independence! Questions concerning why the partial joint PMA was subjected to a second Panel (the October 2000 Panel) after a May 1999 Panel recommended approval 9-0 (with conditions).
Question regarding the appropriate level of micro-management, of diagnostic protocols, pathology indications, and why Labeling provided by the Company was deemed unacceptable. On the issue of concern about improper staff micromanagement, see December 31, 2000, letter from Roland Jankelson to Les Weinstein. Did the Ulatowski group, particularly Susan Runner, ignore information and misrepresent data and information provided by the Company? Incompetence? Deliberate?
Did the Ulatowski group ignore for two months the Company’s responses following the October 2000 Panel meeting when it knew the delay threatened the financial viability of the Company? See 1) Mike Cole’s notes, and 2) Mike Cole’s letter to Ulatowski dated December 27, 2000.
There are questions about Susan Runner’s independence and objectivity, and the appearance of a personal agenda to favor TMJ Implants, Inc.’s competitor. Difference of standards and treatments applied to each are indisputable. Why did it happen?
There are concerns about the extraordinary delay in the review process, continuing to this date, and whether it is intended to deliberately punish TMJ Implants, Inc. There are similarities between this case, and a history of retaliation by FDA employees revealed by 1995- 1996 hearings of the House Subcommittee on Oversight and Investigations.
Also, concerns about Susan Runner’s competence (qualifications, training, and experience) to review these particular devices.
Questions about why the Ulatowski group has ignored the physicians’ claims of patient harm from the removal of these devices from the market. See samples of physicians’ letters. See samples of patients’ letters.
The Agency has never responded to Mr. Jankelson’s allegations or those of the Company or others with any indication that they have been addressed. In fact, its explanation of what it has done to address any of the many, many issues of wrongful conduct in the reviews is contradictory. Les Weinstein, Ombudsman wrote to Dr. Christensen on June 28, 2000, stating:
“Regarding your comments about Dr. Susan Runner, Carl T. DeMarco, ODE Integrity Officer, stated to you in a letter dated May 25, 2000, that he had previously referred your complaint about Dr. Runner to FDA’s Office of Internal Affairs (OIA). As I do not investigate allegations of employee misconduct, I agree with him that, if you would like further information regarding your complaint, please contact OIA at 301-827-0243, and speak to Mr. Don Briggs, Special Agent in Charge. You may also wish to speak to Mr. Briggs if you have any additional information about the allegations you previously made or have any new allegations that were not included in the November 18, 1999, referral to OIA.
Carl DeMarco in his September 27, 2000 letter to Dr. Christensen stated:
“As you probably know, allegations concerning Dr. Runner had been submitted to FDA by your consultant, Dr. Ric Alexander. The evidence presented by Dr. Alexander related to statements by third parties, rumors, and past professional training that occurred a long time ago. I referred the matter on November 18, 1999, to our Office of Internal Affairs (01A). After consideration of the allegations and evidence presented by Dr. Alexander, OIA did not find sufficient justification to open an investigation into the allegations related to Dr. Runner.”
Dr. Feigal was aware of some of the Company’s complaints as early as December 1999 when he wrote to Dr. Alexander:
“Concerning your allegations that Dr. Runner has a conflict of interest in relationship to devices manufactured by TMJ Implants, Inc. the ODE Integrity Officer has referred this matter to the FDA Office of Internal Affairs for investigation.”
In short, the Director, the Integrity Office (ODE), the FDA Ombudsman, and the OIA did no investigation. Bottom line no evidence exists that any of the voluminous allegations of irregularities, tack of expertise among reviewers, conflict of interest, disparate treatment of competing companies, reviewer bias, and retaliation have been investigated. It is evident that the improvements in Agency ethics and willingness for self-policing which it promised Congress, industry and the public following the 1995 Hearings and IG Investigation did not occur, at least not in the TMJ Implant Inc.’s case. Added to the list of allegations surrounding this case for which the Company seeks investigation must now be added the following: failure to investigate allegations or irregularities. Is this another case of agency cover-up or wrongdoing? The evidence leaves no choice but to believe that the Agency’s failure to investigate is another example of institutionalized cover up, and that the policy of cover-up by senior FDA officials encouraged staff to continue the abuses to which TMJ Implants, Inc. was subjected. The CDRH Director failed to investigate. The Integrity Office failed to investigate. The Ombudsman Office, claiming it had no investigative authority, failed to investigate. THERE WAS NO INVESTIGATION. The words of Congressman Barton spoken during the 1995 FDA Abuses Hearings were as true five years later as when he made this statement. In the 1995 Hearings he said, “The Agency
has been unable to investigate itself seriously or punish the wrongdoers within its Agency appropriately.”
A Thorough Investigation of All Allegations Must Be Undertaken The Office of Inspector General, Health and Human Services and by Congress through the appropriate committee or subcommittee with Oversight responsibility over the FDA must investigate all allegations brought by the Company and others regarding the wrongful and abusive TMJ Implants, Inc.’s review. The Agencies (FDA and CDRH) have failed for almost two years to investigate serious allegations of wrongful conduct in the review of TMJ Implant, Inc.’s PMAs. The House Subcommittee on Oversight and Investigation of the Commerce Committee in 1995 concluded that the Agency was infected with a culture of cover-up and incapacity to investigate itself. In the case of FDA abuses of Myotronics in 1995, the Agency denied wrongdoing in spite of substantial allegations of misconduct until testimony before the House Subcommittee on Oversight and Investigations forced the FDA Office of Internal Affairs to initiate serious investigation through and by the Office of Inspector General, Health and Human Services. On a conflict of interest allegation regarding the Chairman of a 1994 Dental Products Panel, Congressman Joe Barton in Hearings before the House Subcommittee on Oversight and Investigations responded to the witness, then FDA Commissioner, Kessler by stating:
“We have documents that we will put into the record that build the case that it was not referred, at least on appearance’s sake, as part of some effort to cover-up impropriety.”
Again in these Hearings, Congressman Barton in an exchange with Dr. Kessler:
“I would like for you to refer this Myotronics case and the way it has been handled to the Inspector General and refer all substantive materials that deal with this case to the Inspector General so the body who has statutory authority to investigate these types of situations can perform a real and thorough investigation and a prompt response. Will you do that?”
Chairman Barton continued:
“I want to be perfectly clear. If you do not believe that it should be referred immediately to the Inspector General and all relevant materials transferred so they can conduct this investigation, I will in my capacity as Chairman of the Subcommittee write a letter, that, that be done immediately.”
Chairman Barton continued to make it clear to the FDA Commissioner that the IG, HHS in the view of Congress was the appropriate authority to investigate allegations of FDA wrongdoing and that the Office of Internal Affairs was unreliable for the self-policing function claimed by the Agency. Chairman Barton to Kessler stated:
“I want the statutory authority, in this case to Inspector General of Health and Human Services to conduct the investigation on Myotronics, to get the material, and to do it thoroughly and to report to you and to this subcommittee as soon as possible.”
The Subcommittee in 1995 concluded that the Inspector General, HHS, was the proper authority for such investigations in view of the Agency’s history of failing to police its own misbehavior and its history of attempting to cover-up wrongdoing. The record of the TMJ Implants, Inc. case is a history of
employee misbehavior, inept review, conflicts of interest and retaliation by the Agency, and a conspicuous effort by the Agency to avoid public disclosure of these irregularities. For TMJ Implants, Inc., the very same circumstances exist that caused the Congress in 1995 to demand investigation by the IG, HHS. TMJ Implants, Inc. is entitled to equal access to justice. Failure to investigate leaves TMJ Implants, Inc. without access to public disclosure concerning the Agency abuses to which it was subjected. The substantial record of misinformation generated by staff and by the Second Dental Products Panel should not go uncorrected. The Company is entitled to an investigation that could result in disclosure of how bias, conflicts of interest, lack of staff and Panel expertise, and imposition of regulatory standards exceeding statutory standards resulted in the Agency’s negative characterization of the Company’s products for almost two years of “tortured” review. Failure to investigate potential employee misbehavior sends a message that misconduct will go unpunished, and will lead to more abuses in the future. The Agency, as a result of the disclosure in 1995 of widespread FDA abuses of private companies promised Congress, the public, and industry that it would institute reforms to prevent future abuses. The efforts of Congress to make the Agency more accountable are as important in 2001 as in 1995. Congress, through the Commerce Committee’s Subcommittee on Oversight and Investigations afforded affected companies in 1995 access to thorough investigation and a means to achieve disclosure of their mistreatment. Congress should provide no less justice to TMJ Implants, Inc. six years later. The TMJ Implants, Inc. case if properly investigated provides an opportunity for continuing study by Congress of systemic problems with the Agency and need for further legislative action.
Excerpts of Letters to the FDA from Oral and Maxillofacial Surgeons Ronald Crane, DDS: “I have used only Christensen Condyles and Fossas. These patients have all done very well with cessation of their problems and return to normal function. O remove all replacement systems would be a travesty for our patients, keep one that works!”
D. Lamar Byrd- DDS, MSD: “This is the only predictable prosthesis for the TMJ. Any act to remove these implants from patient care will seriously impair function and quality of life for the patients I serve.”
Richard Delo, DDS, MS: “The beauty of this implant is that it provides a metal lining for the fossa which is highly polished and prevents degenerative changes of the fossa.”
Rocklin Alling, DDS: “By far the most successful and most tolerated system is Dr. Christensen’s Fossa-Eminence. We believe these metallic implants are a necessary option in today’s practice of oral and maxillofacial surgery.”
Richard Haug: “I have used the Christensen TMJ prosthesis and have found 100% success, with no clinical problems.”
Nicholas Prusak, DDS: “Removing these implantable devices from the market or limiting their usage, would severely impact my patients.”
Donald Chase, DDS: “Success rate of the Fossa-Eminence is highly predictable.”
Anthony Urbanek, DDS, MD: “This technology allows patients to chew and function who otherwise would have been relegated to a life of pain and inability to masticate. There is no other treatment procedure or technology which even approaches the efficacy of pain relief for those selected surgical patients who need TMJ surgery.”
Joseph Niamtu,III, DDS: “There have been absolutely no problems in my experience with the TMJ Implants, Inc.’s implant system. It would be a great mistake to reduce the availability of this implant. However, it would be an extreme disability to patients.”
R. Dean White, DDS, MS: “If these devices are removed from the market the patient population I serve will be severely hindered.”
Scott Thatcher, DDS: “From the patient’s perspective, this device is very much needed. For many TMJ anomalies this is the most predictable treatment for the pain-free normalization for function.”
James Curry, DDS: “I do not know what we would do if this system (Christensen) were not available. Many patients would suffer through increased morbidity, possibly never experiencing smooth, relatively pain-free jaw function. My patients need access to a Partial joint replacement, just like the orthopedic surgeons have at their disposal.”
Kevin McBride, DDS: “If the total prosthesis was removed from the marketplace or severely restricted in availability, patients will have virtually no consistently effective treatment available.”
Manuel Davila, DMD: “All agree, that this is an excellent system and should be kept on the market.” Martin Turk, DMD: “I urge your assistance in support against any action by the FDA limiting TMJ Implants, Inc.’s devices: any embargo will have a severe adverse health impact on denying patients’ treatment.”
L. Vaun Mikesell, DDS: “To lose this system would create a void in the treatment of TMJ. I can endorse this procedure and product without reservation.”
R.M.Phillips, DMD: “The removal of the Fossa-Eminence and Condylar Prostheses from the market would be a severe disservice to many existing patients and many patients who may develop TMJ dysfunctions in the future.”
Norman Cranin, DDS: “We need these good TMJ Implants, Inc.’s devices for today’s patients and I urge you to keep them readily available.”
Charles Witkowski, Sr. DDS: “Administrator of our medical center asks why I have stopped doing so much TMJ surgery. The answer is that there is a reduced need to have additional surgery since I have started using the Christensen Fossa-Eminence implants. In addition, third party carriers like this as well.”
William Garrett, DDS: “This prosthesis has proven itself over the past thirty years and has been invaluable in my hands and practice. It should be approved without further delay. My hope is that you will base your decision on the expertise of the surgeons who have
the most experience in total joint replacement of the TMJ and specifically with these implants.”
R. Alexander, DDS: “I find it impossible to believe that a prosthesis with the track record of TMJ Implants, Inc. has been removed from the market. This decision drastically reduces the quality of care which can be rendered by those of us experienced in TMJ surgery.”
Patrick Collins, DDS: “It is an absolute medical necessity that the Christensen stock and total TMJ prostheses remain in service for those patients suffering severe pain and dysfunction in their TMJs. I am writing on behalf of my many patients who are suffering irreparable harm due to the irresponsible and corrupt actions of the FDA/CDRH in delaying action on the Christensen implants. The Christensen Fossa is the most reliable method to prevent adverse changes in the joint such as ankylosis or condylar resorption.”
David Leever, DDS: “The Christensen Fossa-Eminence Prosthesis when appropriately placed with respect to a surgical procedure and to a disease process timing, is a conservative and predictable treatment adjunct.”
Joseph McCain: “Taking this implant off of the market is a travesty to patients. As a surgeon it completely ties my hands in a reasonable surgical protocol in taking care of TMJ patients. I urge you to put it back onto the market place so we can use it.”
Crayton Walker, DDS, MD:
“This lack of FDA approval for the Christensen devices is seriously affecting my ability to provide appropriate patient care.”
Barry Levine, DMD: ”I would emphasize the great success that the TMJ Implants prostheses have given to our patients. The success both they and we have enjoyed has changed our practice dramatically.”
Ric Alexander, DDS: “Once again I am pleading with you to restore the availability of this marvelous system which has proven over many years and much use by hundreds, as the very best for our hemiarthroplasty and total joint patients.”
TMJ IMPLANTS, INC. SECOND PANEL HEARING
October 6, 2000
Everything about the calling for a Second Panel Hearing was a sham, but there was no way TMJ Implants, Inc. could avoid the spectacle. We had asked Tim Ulatowski if we might recommend three professional representatives to be able to sit on the actual Panel. He said we could, so we made three recommendations. None
were accepted. The date was set as Friday October 6, 2000 and the meeting place would be Room 020B, 9200 Corporate Blvd. Rockville, Maryland.
Department of Health And Human Services Food And Drug Administration Dental Products Panel of the Medical Device Advisory Committee Open Session 9 o’clock October 6, 2000
Panel Meeting (Summary Notes of TMJ Implants, Inc.)
1. Opening Remarks by Pamela Scott of FDA. Conflict of Interest determination made in regard to financial interest only.
2. Willie Stephens stated other interest but none financial. Found to be no problem and granted full participation. No explanation of this interest and no apparent determination of scientific or professional interests through FDA’s published process of clinical review.
3. Dr. Alexander- Conflict of Interest determination made in regard to financial interest only. Willie Stephens stated other interest but none financial. Found to be no problem and granted full participation. No explanation of this interest and no apparent determination of scientific or professional interests through FDA’s published process of clinical review.
4. Dr. Urbanek- Recounts conversation with Dr. Runner from February 2000, She asks “Dr. Urbanek what would you think if in the next couple of months we took this product off the market for a period of time while we reviewed it.” *FDA decision preordained and withdrawal not related to specific concerns.
5. Dr. Curry- Shows data to address concerns of condylar/ bone response to metal partial joint. Panel concerns based on anecdotal information for other devices and surgeries.
6. Dr. Curry- Data presented citing clinical evidence supporting need/use of partial joint. Asks CDRH not to substitute its judgment in place of evidence.
7. Clinical Presentation-Data shows metal bone degeneration not seen.
8. Preclinical Presentation- Cole state FDA comment in material to Panel that “no engineering data” had been submitted. John then presents the data submitted in the PMA *False statement by FDA may introduce pre-meeting bias for panel members.
9. Ulatkowski- States the panel requested the 2nd hearing.
10. Ulatkowski- States FDA considered information presented in May panel hearing but felt the “vote did not reach the threshold FDA considers appropriate for approval.” Vote was unanimous for approval.
11. Ulatkowski- “Today’s a new day...” There is more extensive engineering data and clinical data. SAME DATA PRESENTED!
12. Blackwell- FDA concludes additional wear testing was not required for total joint. Partial joint had no preclinical info (did not say it was a problem.)
13. Dr. Runner- For pre-enactment device, available clinical experience should be sufficient without preclinical data (which is normally part of testing done prior to enforcing clinical area). Runner summarizes clinical data, then states “Preliminary data from the study indicated the Fossa may result in decrease in pain and dietary restrictions in certain patients.” And then, states concern that group studied is not sufficiently precise to identify target population. Data summary more conclusive than stated above, diagnostic criteria is well established in presentations and literature.
14. Dr. Urbanek- Upon questioning, Dr Urbanek emphasizes repeatedly lack of bone degeneration with device.
15. Dr. Curry- Same as above. And compare lack of fossa bone degeneration to bone degeneration commonly seen with many standard surgical procedures.
16. Dr. Burton — Blackwell- Engineering concerns shall being discussed. Previous panel referenced. Save questions on previous panel, yet they unanimously voted to recommend approval. Why is this still an issue?
17. Burton -States device is apparently safe, given appropriate label conditions and that efficacy is related to training and experience... perhaps solved by labeling. Later Burton votes, “not approvable” due to lack of safety and efficacy data. Reminds panel that 515(b) devices often do not have the prospective data sought in new device reviews. That the data and experience should be considered a whole to determine scientific validity.
18. Hewlett- Comments that this device lacks sufficient prospective data. (Apparently didn’t listen to Ulatkowski, above.)
19. Burton- Does not understand and misrepresents available literature and current experience, despite repeated clarifications by TMJ and independent surgeons.
20. Dr. Besser- Worried about joint leads despite repeat clarifications and presentations. *”Clinical evidence” apparently not began considered in lieu of desire for prospective data.
21. Ms. Scott- Again reminds panel to consider all data available to them, including publicly available data, or PMA data.
Dr. Burton-Initial “move” to declare, “Not approved” based on inconclusive S&E and that completion of study would warrant return for approval. *”Inconclusive” does not meet
established criteria for a “not approvable” determination, should be part of “Approved with conditions and those conditions related to study completion.”
22. Dr. Besser- Wants additional preclinical (ignores clinical experience,) Not a criteria; for “not approved” — again, normally an “approvable” condition.
23. Dr. Burton- Clarifies his motion stating, other treatments are available as salvage and this is for first line.
24. Our label proposal is clearly not primary treatment and is salvage.
25. Panel-Panel ignores clarification that our proposed indication is for salvage treatment.
26. Heffez- Not approvable with currant indications.
27. Proposed labeling clearly shows salvage indications which is exactly what panel says is lacking.
From October 6, 2000 FDA Panel Data 1. Cohort in 88- Pain 8.2-2.1 @ 36 months- Registry data. Why wasn’t that quoted?
2. Cross section in 1270 pts = approximately 1900 partial preop pain 7.6 + cohort + prospective study pain @ 24 months = VAS 2.0 & at 36 months = VAS 2.0
3. Urbanek presented his partial patients-217pts =351 joints a. 83 unilateral partial b. 134 bilateral partial c. 11 total = 15 joints d. Overalls - 228 patients = 366 joints
4. Two patients, Jasperson and Hosford both testified they had no more pain after Christensen implants placed years before.
5. Billingsley described 80 joints in 50 patients since 1991 with partial a. + 5 total — success rate over 90% of pain reduction or VAS 8 to less than 2 b. No major complications c. No condylar resorption noted
6. Tancredo (Bergeron)- “The constant moving of the goalposts” a. “Why was a new panel needed?” b. “The May 1999 Panel knew exactly what it was voting for.” c. “The agency has raised the bar to a new level significantly out of the ordinary, well beyond the statutory stand and of reasonable safety and efficiency.” — “The agency has done nothing more than cause harm to patients.” d. “The device should not have been removed from the market.” e. “The safety concerns are suspect.” f. “A health hazard has been created by the removal of the partial from the market.” g. “All this calls into question the integrity of the agency, something the congressman finds disturbing.” h. “The congressman is convinced that the work of TMJI is based on solid scientific principles, and removal of the implant from the market has been, and continues to be, erroneous, contrary to the agency’s earlier findings and the standard should be applied.” i. “This disaster must be remedied as soon as possible.”
7. Urbanek — Placed 351 partial joints in 217 patients
a. Next page Runner asked “What would he (Urbanek) think if FDA took partials off market in a couple of months?” b. “I have been into approximately 5 joints 2 years or more after I placed them, because of trauma.” c. “I have never seen any evidence of condylar degenerations — between a year and five years.” d. “I have reports of success (written by patients) in 10 of those patients in my hands out over last 10 years and I have a 100 more back in the office.” e. “I have found over the last 10 years that there is a prosthesis (TMJI Partial Joint) that in my hands - consistently works to the betterments of my patients.”
8. Curry — “I looked at patient I had operated between 1988 — 1992, a study which was subjected to statistical scrutiny and there is a significant decrease in pain in this group of 50 patients.” a. “Curry did CT scan to show no bone loss in condyle.” b. “There is an abundance of clinical evidence to support the use of partial joint replacement systems in these joints.” c. “CDRH should not substitute its judgment for the years of clinical experience with this device.”
9. Albrecht a. 88pts cohort with partial b. 46pts had Wilkes III or more c. 1300 also had partial joints d. 800 doctors reported Wilkes classification e. No unanticipated adverse events in cohort group
10. Cole — FDA submitted to Panel — No engineering data submitted — That is a lie!
11. Durnell — Material submitted on engineering tests was for partial joint & some for total — many, many tests performed — read his numbers.
12. Ulatowski — He states erroneously “to respond to the panels’ request to revisit data for TMJI in regard to the FE device.”
13. Talking about May 11 Panel — “The vote did not reach the threshold that FDA considered to be appropriate for approval at that time.”
14. WHOA!— That panel voted for the entirety of TMJI’s devices — FDA says the 9 —0 vote for approval did not meet the threshold??
15. “Blackwell’s the lead reviewer for TMJI’s PMA”
16. “There wasn’t testing on the Fossa alone” — Wrong
17. “No wear test of Fossa against natural condyle was provided” —There was no wear, period, for a Christensen Partial Joint hemi-arthroplasty. What are they talking about???
18. Runner — Makes the following statement, which is absolutely wrong —“This particular retrospective study does not elaborate on the diagnostic criteria for the selection of patients in this cohort.” They are part of the 1300 patients with a large percentage having Wilkes data.
19. Urbanek on Cross a. “I have seen no problems associated directly with the device.” (Out of 345 joints) b. “I have seen no adverse events related to the prosthesis itself.”
c. “Of the patients I have done in this series, 95% report back to me that they are happy, doing well, their life has changed, they are comfortable.” d. “Menisectomy alone does not work.” e. “I see no reaction of soft tissue, hard tissue, no bone resorption whatever 20. Curry on Cross: “I have not seen a single case of severe condylar degeneration...”
21. Urbanek on Cross a. “Christensen partial patients don’t come back for opera tion 2,3,4” b. “I would say 90% of my patients do not require any kind of further operations.”
22. Christensen on Cross a. “We have seen 600 to 700 surgeons do this surgery and their results are routinely good with VAS pain scores drop ping from 8.0 to 2.”
PARTICIPANTS Leslie Heffez, D.M.D., M.S. (Chairperson) Pamela D. Scott (Executive Secretary)
Kristi Anseth, Ph.D.
Edmond Hewlett, D.D.S.
Janine E. Janosky, Ph.D.
Mark R. Patters D.D.S., Ph.D.
CONSUMER REPRESENTATIVE Lynn Morris
INDUSTRY REPRESENTATIVE Floyd Larson
PATIENT REPRESENTATIVE Sue Warman
Peter Bertrand, D.D.S.
Marcus Besser, Ph.D.
Richard Burton, D.D.S.
David Cochran, D.D.S., Ph.D.
Willie Stephens, D.D.S.
FDA, Timothy Ulatowski
Dr. Christensen Receives a Late Night Phone Call from Dr. Willie Stevens
Congress of the United States
House of Representatives Washington, DC 20515-0606
November 9, 2000
Thomas Tancredo Washington Office 1123 Longworth Building Washington, DC 22515 12021225-7882 Fa..)C 1202) 225-4823
COMMITTEE ON EDUCATION AND THE WORKFORCE
District 5601 S. Broadway, Suite 370 Lakewood, CO 80121-6079 Main (720) 283-9772 Fax (720) 283-9776
COMMITTEE ON RESOURCES
Senor Resource: 17201 283-90213 Co Schogl Safe1-Y Fiotlint 18771 542—Safe
COMMITTEE ON INTERNATIONAL RELATIONS
The Honorable June Gibbs Brown
I Inspector General
Department of Health and Human Services 5250 Wilbur J. Cohen Bldg. 330 Independence Avenue, S.W.
Washington, DC 20201
Dear Ms. Brown:
I am writing to you to urge you to conduct a thorough investigation into the Food and Drug Administration’s (FDA) review
COMMITTEE ON EDUCATION AND THE WORKFORCE
COMMITTEE ON RESOURCES
COMMITTEE ON INTERNATIONAL RELATIONS
of the Premarket Approval Application of the TMJ Fossa-Eminence Prosthesis manufactured by TMJ Implants Incorporated. TMJ Implants is headquartered in Golden, Colorado, which lies within my congressional district, and up until last year was the premier market supplier of temporomandibular joint prosthesis. Over the last two years, I have taken an active interest and an active role in monitoring the progress of TMJ Implants’ application. On numerous occasions, I have met with Dr. Bob Christensen, President of TMJ Implants, to find out information about how the approval of the Partial and Total Joint, and have personally talked to FDA Commissioner Jane Heaney and to members of the Agency about the status of the company’s applications. I have also been in contact with the House Commerce Subcommittee on Oversight, which has sole jurisdiction over the FDA and issues relating to abuse and the internal operations of the agency. Specifically, I have been closely following this case since my office’s first contact with Dr. Christensen and TMJ Implants in early May 1999, after a meeting of the FDA’s Dental Products Panel of the Medical Devices Advisory Committee was held to review the company’s PMA and recommended approval of the PMA by a 9-0 vote. From this point onward, the FDA has engaged in an obvious pattern of delay and deception and even went as far as to remove TMJ Implants’ Fossa-Eminence Prosthesis from the market, which had been available for almost 40 years. This has done nothing more than to cause harm to patients and has cost the company more than $6 million in lost profits. This was done at the same time that the application for TMJ Concepts, a competitor of TMJ Implants, sailed through the process. Several allegations have come to light over the last year detailing the fact that several Agency employees have worked under the direction of TMJ Concepts’ associates. Recently, the agency went so far as to reconvene a new Medical Devices Advisory Committee; a clear majority of its members lacking the required expertise, which denied the company’s
application. While I was hopeful that the Committee would keep an open mind, it seems to me that the case can be made that the panel was extremely biased against the company. As the above demonstrates, I have extreme concerns about the process that has taken place over the last two years. There is no secret from all involved in this case that there have been significant questions raised about the process—the sluggish pace of the review of the engineering data for both the total and partial joint and, more importantly, the constant “moving of the goal posts” during the review of both PMAs. I sincerely believe that most of the frustration that has been expressed here could have been avoided had everyone sat down and laid everything out on the table in the spirit of what called for under the FDA Modernization Act . Unfortunately, the agency has been unwilling to do so—and it seems like these problems will continue into the
foreseeable future. Over the last year and a half, my office has received numerous letters from physicians all across the country—from the Mayo Clinic to the University of Maryland—each relaying the benefit of the partial joint and the fact that the partial and total joint results in immediate and dramatic decrease in pain, an increase in range of motion and increased function. I am concerned about what has happened here—for this device is not available to clinicians that have made it clear that it is helpful. All of this calls into question the integrity of the agency—something that I find
very disturbing. Dr. Christensen is a true professional and a pioneer in his field and holder of the first patents. His implants are widely accepted as effective and safe throughout the dental and surgery community—indeed, several of my constituents have literally had their lives changed by the procedure. I am convinced that the work of TMJ is based on solid, scientific principles and the removal of the implants from the market has been and continues to be erroneous, contrary to the Agency’s earlier findings and the statutory
standard that should be applied. This has been devastating to thousands in the general public. I believe that this situation should be remedied as soon as possible and urge you to conduct a full investigation into the matter. I have included a number of supporting documents that may be helpful in determining the extent of this disaster. I thank you in advance for your consideration of this request. If you need further information, please do not hesitate to contact me or James Bergeron, my Legislative Director, at (202) 225-7882.
Sincerely, Tom Tancredo Member of Congress
North Shore Oral & Maxillofacial Surgery
Doctor R. Alexander Diplomas.
American Board of Oral & Maxillofacial Surgery
7 Nigh Stoat, Suite #308
Huntington, NY 11743
(531) 5474324 (631) 271-1148 Fax
Orthognathic Surgery, TMJ Surgery, Implant Surgery, Ulmer Surgery Trauma & Reconstructive Surgery
Via Fax and Overnight Mail April 26, 2000
HIGHLANDS RANCH CENTER
For Aesthetic and Maxillofacial Surgery
James T. Curry, D.D.S. James E. Latta. M.A.
October 10, 2000
David W. Feigal, M.D., M.P.H., CDRH, FDA
Office of the Center Director (HFZ-1)
9200 Corporate Boulevard Rockville, MD
Supervisory Review 1/29/01
North Shore Oral & Maxillofacial Surgery
Doctor R. Alexander
Diplomat. American Bowl of Oral d Maxillofacial Surgery
7 High Street, Suite 308 Huntington, NY 11743
(e31) 547-8324 (831) 271-1148 Fix Email dransornseearthlink net
Via Fax and Regular Mail October 9, 2000
The Honorable Thomas Tancredo
United States House of Representatives
1123 Longworth HOB Washington, D.C. 20515-0606
Re: FDA Panel Meeting 10/06/00 - TMJ Implants, Inc. Devices
Attn: Mr. James Bergeron
Dear Congressman Tancredo:
TMJ ASSOCIATION PETITIONS THE FDA
Only a few months after the FDA approval of the Christensen Partial TMJ implant to be used as a hemi-arthroplasty, the patient advocacy group known as the TMJ Association gets back in the picture by petitioning the FDA to rescind the approval of our implant. As Jim Dickinson reported in FDAWebview on May 22, 2001, “they petitioned the FDA to hold a public hearing on the Agency’s 2-27-2001 approval of TMJ Implants partial joint prosthesis, known as the TMJ Fossa-Eminence. In a press release, the association called the approval, which took 20 months of acrimonious review, “unconscionable and cowardly” because it doesn’t just put patients painfully suffering from TMJ at risk, it asks the patient to share the risk. The association said the approval contradicted the scientific and medical conclusions of two dental products Panels and FDA’s own internal scientific staff.” In that particular article of Dickinson’s he went on to say, that “Terrie Cowley is incorrect in that statement because the May 11, 1999 Dental Panel voted 9-0 in favor of approval of our TMJ implants. Christensen said the Association’s petition ignored 40 years of successful surgeries with this device in over 10,000 patients. Over 90%, perhaps even 95%, never progress to a total joint replacement after receiving the Fossa-Eminence Prosthesis as a hemi-arthroplasty”. All the way through the approval process for the Christensen
Partial and Total TMJ implants, we were faced with the ignorant statements of members of that particular Association. It was obvious that Terrie Cowley the president of that Association and Susan Runner of CDRH had an unusually tight relationship. Fortunately the petition was turned down by the FDA as I suspect they had experienced enough battles with Christensen, TMJ Implants, Inc. and their attorneys and the FDA, and wanted no more. The success of these implants as a first line of surgical intervention in serious TMJ maladies has been proven again over the next ten years, giving a total of 50 years of very successful service to humanity. But what a battle it has been to bring these implants through an acceptance by the Food and Drug Administration and the professional arena. As Christensen has frequently stated it has been a spiritual battle that just didn’t want to stop. Dr. Eugene Keller, Director of Oral and Maxillofacial Surgery Department at Mayo Clinic in Rochester made the following statement to FDAWebview: that during the 20 months that FDA held the Fossa-Eminence off the market. He became very worried that the new patients would have no therapy. He went on to say that those patients, who have been operated on using this technique, get excellent and highly predictable results. After 10 years and over 100 such surgeries, Keller said fewer than 5% of his patients required explanation.
THE DENVER DISTRICT INSPECTION OF TMJI
This next part of the story of FDA retaliation and strangling of free enterprise and the medical device industry is perhaps even more telling. I will begin with just the preamble of the problem and have Lynn Watwood, our legal expert who handled the matter, give you a broader picture. Let me start with the following. In 2004 TMJI had a scheduled site inspection by the Denver District Office of the FDA. We had always attempted to have a friendly relationship with the District Office, but we were always very aware of the fact they were walking in lockstep with the Center. Their lead investigator was Nick Nance, who I always figured I had a good working relationship with, but in essence I found I was wrong. That last visit of his was probably in 2005 and it was quite interesting what happened. At one time during the inspection it was just me and Nick together in a hallway and he gestured to me for a “pay off.” In essence he was saying if you will pay me under the table, I can fix things. I was so flabbergasted at what I was seeing that I didn’t answer or even show that I recognized what he was doing. To me, it was scary as I knew if I in anyway acknowledge his gesture I could end up in jail. It could well have been a real set up, and I wasn’t interested. I let my V.P. know at that very moment about what Nick Nance had suggested by his gesture. Several things happened after that inspection, which were especially weird. Probably the most important was his claiming
we had not filed 17 events as MDRs. Actually, it may well have been 28 events he was claiming. What does this mean in lay terms? When a medical device company learns of some event occurring in a patient that may have an implant placed in her/ him, an evaluation needs to be made by the company to determine if the implant contributed to a serious, permanent injury or death. If a reasonable person can surmise that this was the situation, then the company is required, by FDA, to file what is called an MDR (medical device report). These reports are then posted on the FDA website for any attorney or disgruntled patient to review. The company, TMJ Implants, Inc., is required to prepare a decision tree in their SOP’s acceptable to FDA, to use as a tool in making such an evaluation of any such event that it receives. These events are logged in the company files and can be reviewed by the District Office during any such site inspection. That was the case for TMJI. Since I, personally, was not only the innovator of these implants and this type of surgery, who could better evaluate such events as to whether they might be caused by the event? Well, Nick Nance determined he was the arbiter of such events and he chose to say 19 of them required filing as MDRs. In my review of these events I would take into account years of laboratory test results, years of clinical trial data, and the large group of devices being tracked by our company over a 10-12 year period. It all would play a part in my review of any event. That was not the end, but what did I know about TMJ degenerative disease and other entities and their propensity for wanting to progress, like any other arthritic disease in any other joint of the body. It all plays a part in reviewing any of these events. Did I think Nick knew more than I did? No, he did not. No questions asked, according to FDA these events needed to be filed as MDRs. I of course reviewed these events again and found them not to be reportable according to the CFR (Code of Federal Regulation), in my humble, but educated opinion. Nine
of the events could not be determined from the original event filings, by some unknown individual or entity, as to whether any implant had ever even been placed in the individual patient, and if so, whose implant, when and by whom? The whole MDR system was broken, and needed to be scrapped. My reviewing of the additional 8 events depicted several things, but mostly that these several patients had a long history of frequently questionable surgical care, before any of our implants were ever placed, which would be the most likely contributor to why the patient was either having some ongoing pain or problem or might require some additional surgery. If the person had a Vitek implant placed before and subsequently removed before TMJI’s implant was placed, this might influence the post-operative course of that patient. Recurring ankylosis of a joint might mean that a single arthroplasty would not be the final solution, but the patient might require more surgeries in the future. There are a lot of different scenarios which must be considered by whom would be evaluating the decision tree for MDR reportability. None of these events were just some simple thing, but frequently were a bit more complex, and most of them did not represent any permanent, serious injury or death caused by the device. Thus, my decision of filing of an MDR was not a requirement according to the CFR. Well, the debate went back and forth for a few months between me and the Center. Finally, on about November 12th, 2004 I received a letter from the top person at CDRH, written on the 4th, who told me, when I asked the question who at FDA was making the determination that I was wrong in my assessment? I was never told who was making the FDA’s final decision. I was told that I could appeal my decision to the Commissioner. I did that by letter as they requested on November 16th, 2004. For 8 months I received nothing from CDRH or FDA regarding the subject, but on about July 21, 2005 I received a notice of a CMP (civil money penalty) having been levied against
TMJ Implants, Inc., Robert W. Christensen as CEO and Maureen Mooney as regulatory director at TMJI. I had never before heard the word CMP, nor was I ever familiar with FDA having ever filed such a punitive action against any medical device company for an MDR issue. The total amount of the CMP was $630,000 (divided in three equal parts between the three entities mentioned above) Well, this started a long and hurtful slope of legally attempting to fight this issue. I, early on asked FDA that if I went ahead and just filed the 17 events as MDRs would that nullify the CMP? I was informed by the lead FDA attorney that I would have to pay a six figure penalty. That didn’t help, as we didn’t have such funds available, and where was Christensen’s interpretation of the MDR issue incorrect? That question has never been answered. The FDA just quotes the CFR, period! No explanation of how, who or what they did to come up with their interpretation? They just insist their way, or the highway. An interesting thing occurred back in that 2005 time period. There was a gentleman in an executive position of another very sizable medical device company, Synthes, who came by to discuss an issue with me. He had a female neighbor who had worked at the Denver District. She knew Nick Nance, Denver District’s most senior investigator, and had been personally told by Nick Nance that there were two companies he was out to get. They were the other gentleman’s company and TMJ Implants, Inc. I was very surprised and shocked. I really had felt Nance and I had a good working relationship, up until the time he gestured for a “pay off”. Interestingly, too, was the fact Nance was scheduled to retire within just a few months after his last visit with me. Within a month of leaving FDA, he died of a sudden and unexpected heart attack. He was only about 54 years of age. Nothing we attempted could take the CMP issue off of the table. So, according to the CFR, we were permitted to seek a hearing for correction in several legal ways. At this point, and
earlier, Lynn Watwood, our in-house legal attorney began to petition the Administrative Law Judge (ALJ) for a hearing. He is a single Judge appointed by the FDA commissioner. We can bring witnesses and compel FDA to bring their witnesses who made
their decision. The only witness FDA brought was a financial consultant, out of their organization, who had no absolutely no ability to evaluate whether any medical event might be classified as an MDR. We of course, travelled to Rockville, MD and brought Dr. James Curry of Highlands Ranch, Colorado who had placed some 500-600 of the Christensen TMJ implants, with tremendous success. Dr. Ric Alexander of Huntington, IL, NY was a second maxillofacial surgeon with, also, a great deal of experience. Both of these surgeons, along with my input, should have been more than enough to match any economic specialist from FDA about the sense of Christensen’s decision on the MDR issue. The message was clear, but totally unmatched, so now it would be up to the decision of the ALJ (administrative law judge), named Davidson. Davidson returned a decision some months later and it was a complete sell out to the FDA’s prior decision. The CMP for $340,000 was due and payable. What a sham. None of us nor our consultants and attorneys could fathom that Judge making that decision unless, as we have just said, it was a sham. The next level of hearing allowed in such cases would be to place a petition before the Departmental Appeals Board (DAB) of HHS, for another review. One must remember that HHS is the parent organization over FDA, and since they appoint the three Judges to the Departmental Appeals Board, we likely will not get justice here either. So, some months or year later we were heard on paper before this three man board and to no surprise, we were again overruled, without any “fact” witness having ever testified before either legal entity. There seemed to be no way we would ever get an answer to my original question, “who at FDA was making a decision at the
FDA that countered my experience and decision to not file these events as MDRs”? The next level of hearing would be at the 10th Circuit Court of Appeals, here in Denver. It again would be handled by briefs and words already filed in our case by our attorney, Lynn Watwood. Remember, TMJ Implants, Inc. was being asked to pay for whatever it was seeking without any help from the government, plus we were being asked to pay the government’s legal fees. What might we expect from our Federal Court? The big problem was that there was no way we can have a hearing before peers, as in a jury trial. In that scenario, we felt we would win this argument, “hands down,” but the setup of this sort of hearing had thoughtfully been precluded by the bureaucracy from the time it had been organized, so that it would work against the person attempting to get a resolution of differences. We were hoping for a fair hearing from this Federal Court, but again, what a sham. We had listed all sorts of mitigating circumstances that should have been judged fairly. They weren’t, and the same decision rendered by the ALJ, the DAB and now the Tenth Circuit Court of Appeals was forth coming. What a disappointment, to put it mildly. The only point we won was to get our Regulatory person removed from the CMP. Christensen, personally, should also have been removed, but wasn’t, even when it was shown he had expended all of his finances to keep these implants on the market.
AGRICULTURE, RURAL DEVELOP MENT, FOOD AND DRUG ADMIN ISTRATION, AND RELATED AGENCIES APPROPRIATIONS ACT, 2002
Speech Of Hon. Thomas Tancredo Of Colorado
IN THE HOUSE OF REPRESENTATIVES Wednesday, July 11, 2001
The House in Committee of the Whole House on the State of the Union had under consideration the bill (HIR. 2330) making ap propriations for Agriculture, Rural Develop ment, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 2002, and for other purposes.
Mr. Tancredo: Mr. Chairman, I rise in op position to H.R. 2330, the Agriculture Appro priations Act, a bill considered on the floor today which makes appropriations for the De partment of Agriculture and related agencies. But more specifically, I rise in strong opposi tion to the increase provided in the bill for the Food and Drug Administration (FDA) and would like to call the House’s attention to a problem that one of my constituents has been having with the agency and one that I believe deserves careful consideration by the over sight committees in this chamber. Recently, the FDA gave final approval of my constituent’s Pre-Market Application for both total and partial joint implants after an exhaus tive and blatantly biased two year review, but not before costing his company over $8 million in legal fees, lost wages and profits. In April 1999, I received a phone call and letter from TMJ Implants, a company located in Golden, Colorado, in my district, which had been having problems with the review of its Premarket Approval Application of the TMJ Total and Fossa-Eminence Prosthesis. Up until last year, the company was the premier market supplier of temporomandibular joint prosthesis. Over the last two years, I have taken an ac tive interest and an active role in monitoring the progress of TMJ Implants’ application, which was finally approved in February. On numerous occasions, I met with Dr. Bob Christensen, President of TMJ Implants, to find out information about the approval of the Partial and Total Joint, and personally talked to FDA Commissioner Jane Henney and to members of the Agency about the status of the company’s applications. I was also, and continue to be, in contact with the House Commerce Subcommittee on Oversight, which has sole jurisdiction over the FDA and issues relating to abuse and the internal operations of the agency. Specifically, I closely followed this case since my office’s first contact with Dr. Christensen and TMJ Implants in early May 1999, after a meeting of the FDA’s Dental Products Panel of the Medical Devices Advi sory Committee was held to review the com pany’s PMA and recommended approval of the PMA by a 9-0 vote. From this point on ward, the FDA engaged in an obvious pattern of delay and deception and even went as far as to remove TMJ Implants’ Fossa-Eminence Prosthesis from the market, which had been available for almost 40 years. This had done nothing more than to cause harm to patients and cost the company millions of dollars. This was done at the same time that the ap plication for TMJ Concepts, a competitor of TMJ Implants, sailed through the process. Several allegations have come to light over the last two years detailing the fact that sev eral Agency employees have worked under the direction of TMJ Concepts’ associates.
The agency went so far as to reconvene a new Medical Devices Advisory Committee late last year, with a clear majority of its members lacking the required expertise, which denied the company’s application. It was not until Mr. Bernard Statland, the new Director of the Office of Device Evalua tion (ODE) was brought in that the logjam was broken the PMA was quickly approved. As the above demonstrates, several con cerns remain about the process that has taken place over the last two years. It is no secret that everyone involved in this case believes that there have been significant questions raised about the process—the sluggish pace of the review of the engineering data for both the total and partial joint and, more impor tantly, the constant “moving of the goal posts” during the review of both PMAs. Over the last two years, my office has re ceived numerous letters from physicians all across the country—from the Mayo Clinic to the University of Maryland—each describing the benefit of the partial joint and the fact that the partial and total joint results in immediate and dramatic decrease in pain, an increase in range of motion and increased function. While I am, of course, pleased that the ap plication has been approved by the FDA after much delay, the circumstances of the last two years calls into question the integrity of the agency and, it is for this reason that I bring it to the House’s attention. Dr. Christensen is a true professional and a pioneer in his field and holder of the first pat ents. His implants are widely accepted as eff ective and safe throughout the dental and surgery community—indeed, several of my constituents have literally had their lives changed by the procedure. I am convinced that the work of TMJ is and always has been based on solid, scientific principles and the re moval of the implants from the market had been erroneous, contrary to the Agency’s ear lier findings and the statutory standard that should be applied. This was devastating to thousands in the general public and dev astating to the financial status
of the company. Later this year, the House of Representa tives will consider legislation reauthorizing the Food and Drug Administration and I would like to urge the House Commerce Committee to hold hearings on the TMJ Implant case and to conduct a thorough investigation into the FDA’s review of the Premarket Approval Appli cation of the TMJ Fossa-Eminence Prosthesis. I would like to take this opportunity to sub mit into the record two articles from FDAWebview which shed light on the TM] Im plant case.
From FDAWebview, Feb. 28, 2001 “‘Full Disclosure’: Standard in TMJ Approval Opens New FDA Era”
Instead of FDA tying itself in knots trying to guarantee no inappropriate patient expo sures to implanted devices—and stalling a product in mid-review as a result—yester day’s approval of the TMJ Implants Fossa -Eminence Prosthesis set a new “full disclo sure” labeling standard that lifts that self-imposed burden from the agency and should expedite other product reviews. TMJ Im plants’ pre-1976 jaw joint devices was stalled for 20 months in a classification PMA review until new Office of Device Evaluation (ODE) director Bernard Statland broke the logjam. In doing this, he was implementing one stage of a bold new Center policy on innovative public use of clinical device information ar ticulated last year by Center director David Feigal—placing such FDAheld information in the hands of physicians and patients. According to one of the two attorneys who steered the TMJ Implants submission through its FDA ordeal, Mike Cole (Bergeson 8G Campbell), yesterday’s approval is the first he’s seen in 25 years of dealing with ODE where the agency stepped back from its “ap propriate use” worries and left them to phy sicians and patients to decide, based on full disclosure
in labeling of the device’s real-world limitations—including the availability of no-device alternative therapies.
Under the Fossa-Eminence labeling’s Warnings Section is a boxed statement head ed, “The medical literature reports,” with four bulleted statements:
That many cases of Internal Derangement resolve after nonsurgical treatment, or, in some cases, with no treatment at all. That the complexity of contributing fac tors in this patient population must be con sidered in the diagnosis and decision to sur gically treat patients.
That replacement surgery, therefore, should be utilized only as a last resort after other treatment options are exhausted or de termined not to be warranted in the medical judgment of the physician/dentist in con sultation with the patient.
The Wilkes classification is a guide in determining the severity of the disease. This classification should not be relied on as a sole criterion for surgical treatment.
“It really is a striking difference in philos ophy,” Cole told FDAWebview. “It discloses that a lot of patients have responded without surgery . . . It describes situations where the doctor arrives at the diagnosis that surgery may be appropriate, but it doesn’t prejudge it. Over the years, there have been all these notable instances of concern about off-label use of products and misuse of products, and part of it comes, I think, from a mentality that we have to be 100% sure that it will be used appropriately. As a result, manufacturers have started submitting applications with more and more restricted indications statements in them because that can get through system.”
Cole and colleague David Rosen (McDermott, Will and Emery) believe the TM) Implants devices had been log
jammed at FDA for so long simply because reviewers were afraid the products would be used inap propriately—an FDA syndrome that has ef fected many other products over the years. “A lot of times, what it really comes down to is demands for more data, more data, more data,” Cole explained, “because the re viewers are not comfortable with the idea that the device ought to be on the market, or available. The way out of that is to keep asking for more information.”
In TMJ Implants’ case, he said, review leader Susan Runner “held what I think was a very honest and sincere concern about the device being used in cases where patients might respond without surgical treatment. Because the studies hadn’t been set up to prove exactly what I think we had demonstrated, she had this really deep-seated concern about the product being used, and it just went round and round in circles. We had no apparent instances of misuse of the de vice, but we were getting nowhere.
“When we had this meeting with Dr. Statland, he got up with a whiteboard and started talking about the data, and he said to his people, ‘You know, we’ve got a lot of in formation here; what we need to do is figure out how we’re going to present this informa tion to the doctor so that the doctor and the patient understand exactly where surgery fits in this and make sure we discuss the lim itations of the data.’ For the first time that I’ve heard this in 25 years dealing with Cen ter, he said: ‘We’ll discuss this information in the labeling and we’ll let the doctors and the patients decide whether they want to use the device—we won’t decide for them.”
Statland, Cole said, stopped the reviewers’ agonizing at the point where reasonable as surance of safety and efficacy had been dem onstrated, thus preventing the agency from continuing to stray into attempts to secure an absolute guarantee that the product would not be used improperly. “In a way it’s a kind of subtle point, but in a way it’s also a sledgehammer point. When Dr. Statland said ‘This is what we’re going to do,’ it was over.”
“TMJI’S CEO GAGGED FROM SPEAKING AT BIOMED MEETING.”
My Scheduled Talk at AIMBE
This short episode was one of the more bizarre things to tell. In 2003 I had been nominated for membership in a very prestigious bioengineering society by a friend of mine, Professor Subrata Saha, who earlier had been in charge of research and development in the department of orthopedic surgery at Loma Linda University, school of medicine. He asked me to be on the research board of that department. Later professor Saha had held professor positions at Clemson University and Alfred University, but now is a professor at SUNY, College of Medicine, department of orthopedic surgery. The particular society which Dr. Saha had recommended and sponsored my membership was as a fellow in the American Institute of Medical and Biological Engineering. This was made up of about the top 2% of professors of bioengineering in the engineering colleges of America. Almost all of the 500 members were PhDs, some 40 had also there MD degrees and I would be one of two members who held DDS degrees, the other person had also a PhD. So, to say the least it was an honor to have been included. I believe the rationale for Dr. Saha recommending me for membership was the fact that I had innovated the earliest individual dental implants in the U.S. as well as the first TMJ implants in the U.S., with U.S. Patents in all. I was deeply honored to have been included with such noteworthy individuals, many of whom had invented many major breakthroughs in medicine. About two or three years later, I was asked to be a moderator on the opening session for the 2006 meeting in Rockville, MD. I would be also giving a presentation which I titled, “Innovation, Regulation and Entrepreneurship”. It would give me the opportunity of not only speaking on the balance between those three subjects, but also leading some discussion about how fragile they are to the innovation which so necessary in a free society. I had submitted my presentation slides about three weeks earlier to the program chairman. I had planned the whole presentation to be sensitive to the fact that there would be FDA higher-ups as members and participants, thus I would make my talk very constructive and not overly accusatory. The three weeks had gone by and Lynne and I spent all day at airports getting to the hotel where we would be lodged and where the following morning I would be presenting. As we approached the hotel desk with a degree of anticipation, we let the attendant on the desk know our names. He then handed me an envelope, which had my name on the outside. When I opened it and read it to Lynne, our jaws dropped in disbelief. The letter from the program chair just stated my position on the program had been cancelled. What? We were terribly disappointed. I asked the attendant on the desk if he knew how I might find the chair who had written or at least signed the letter. He pointed to a gentleman in the lobby. We approached him and asked what was happening. He just let me know my presentation and leading of the following morning’s session had been cancelled. Lynne and I spoke briefly and then decided we should not stay and attend the meeting, but should now turn around and travel home. Before doing so, I called our regulatory attorney, Larry Pilot and let him know what was happening. He said just wait for him and he would give us a ride to the airport, which he did, giving us the opportunity of discussing this distasteful event with him. Larry had helped write the Medical Device act of 1976
when he was an attorney at FDA. He was fully aware of all of the politics surrounding the FDA and people in medical device manufacturing, such as me. We were all bummed out by what had just happened. It was showing the effect of the FDA on this Institute. It was showing that free speech was not fully tolerated here in the United States. We were very discouraged about that episode as I feel sure some good would have come out of that presentation and discussion, but as we have found over and over again, the FDA will do everything possible to prevent an open and free discussion of any item they want to control or where the discussions might show the errors of their ways. I can only lift this situation up to the Lord and ask for
any vindication which he feels is necessary. Certainly, I need to forgive those in charge, but I must say that was a long trip home
The FDAWebview Article Hurt FDA TMJI Chief Gagged at Biomed Meeting 02/27/2007
Invited several months ago to make a presentation at a biomed annual meeting in Washington 2/28, TMJ Implants president Robert W. Christensen was summarily disinvited as he was registering at the Westin Grand Hotel the evening before his scheduled appearance. Christensen said the desk clerk handed him a note which said his talk tomorrow had been canceled. When he asked who had left the note, the clerk pointed to a man standing nearby, who identified himself as Joe Salamone, chairman of the Industry Council of meeting host American Institute of Medical and Biological Engineering (AIMBE). The AIMBE Web site bears a photo of Salamone and identifies him as a vice president of Bausch & Lomb; another page says he is now chief technology officer at Roche Industries LLB.
According to Christensen, who is an AIMBE Fellow and intended to talk about his invention and development of temporomandibular joint prostheses and his six-year battle with FDA, Salamone told him his presentation could “be very hurtful to the FDA,” and he would therefore not be allowed to speak. Christensen asked if his expenses would be paid, and Salamone said they would not, Christensen told us. Christensen immediately left the hotel with his wife and returned ‘to the airport. He said he intends to deliver the same presentation in April at a Southern University of New York meeting.
Christensen said he had prepared the power point presentation in close consultation with AIMBE conference program officials and provided it to them in CD form a week before. Several hours after he was summarily disinvited, AIMBE’s Web page for the conference still listed Christensen’s presentation under an AIMBE Industry Council session entitled: “Impacts on Innovation: How Can Industry Influence Change?” It described the session’s content as being intended to “allow attendees the opportunity to hear examples of how government policy may impact innovation, and allow representatives the opportunity to voice their concerns. Attendees are expected to participate in a free flowing discussion on how government policy can enhance the entrepreneurial spirit, and allow for innovation and research to improve the health and welfare. The Industry Council will use this information to shape their goals and purpose and encourage all members of AIMBE to attend to share their ideas and strategies.”
Christensen’s presentation was promoted on the AIMBE site as speaking “to these matters from the perspective of his more than 55 years as a leading clinician, surgeon, scientist, pioneering innovator of medical devices in the cranio-maxillofacial realm, entrepreneur and his recent experience with FDA regulators.”
Meanwhile, the American Institute for Medical and Biological Engineering (AIMBE) is investigating a complaint by Christensen that he was prevented from delivering a scheduled presentation on his FDA travails at the institute’s annual meeting, according to executive director Jennifer Ayers. A letter from Christensen to outgoing president Herbert I Voigt had been “sent up the line,” she told FDAWebview. Asked if FDA had complained about the forum being provided Christensen, she said not to her knowledge.
Voigt told us he had not yet seen Christensen’s letter, but his understanding was that when AIMBE Industry Institute chairman Joe Salamone canceled Christensen’s presentation at the last minute, it had been “based on a document he wanted to pass out” which Salamone judged to be “too adversarial” to FDA. According to Voigt, Salamone said Christensen would have been free to stay for the session and to participate in the panel discussion afterward, even though his presentation would not have been heard. Christensen and his wife left the meeting immediately on being told of the cancelation. Voigt said he was present throughout, and no mention was made of Christensen’s presentation or its cancelation.
THE MDR ISSUE
This issue became a real stumbling block for the Company and for Dr. Christensen. In the Standard Operating Procedures for the operation of TMJ Implants, Inc. it had been necessary to formulate an SOP (standard operating procedure) as to how to handle any report of an “event” which the Company might receive after the implantation of one of its implants. This SOP had been reviewed by the FDA in an earlier Inspection and had been acceptable for some fairly long period of time. The Code of Federal Regulations had prescribed an MDR as a reportable event to be one that was likely related to the device implanted as the cause, to be of a “permanent injury” or had caused a fatality to the patient. The run of the mill of events would be recorded by the company, made an open record for any FDA inspection and then to have been evaluated by some appointed (medically experienced) individual within the Company as to whether it had risen to such a level that it would be handled as a Medical Device Report to the Agency. Since Dr. Christensen was the person within the Company who had not only innovated this technology and these implants, and since he alone had an exceptional grasp of not only what testing had been done on the product, but what the history of these devices was and what events had occurred over the 40-50 years of these devices being used in surgery and patients, he was the logical
person to make the final call, for the Company, as to whether an MDR was required. Sometimes the incidence or event would be reported directly to the Company by the operating surgeon or the hospital where the surgery was accomplished, or by some explanting surgeon or even by the patient, on occasion. Other times the FDA’s CDRH would be the one submitting, frequently, a one or two page, handwritten and heavily redacted memo purportedly describing some event. By the time the Company received the report from the CDRH, usually, the Report had been placed on the CDRH or FDA webpage for all to review. This tactic was extremely unfair as the Company had no input in what was being placed on the webpage, nor any ability to refute the information so posted. Most often the report received from the FDA to the Company, was some handwritten page from some patient or other individual who had no ability, knowledge or understanding as to what event might or might not be caused or contributed to by an implant, (a metal plate essentially) being placed in a person’s body. For the Company, a thorough review of the circumstances and whether or not any implant was implanted and if so which Company’s implant? Almost without exception, the CDRH had so redacted the page with black ink that we had little chance of ascertaining whether any implant had been placed or whose. There would be no identifying information as to the surgeon, the patient, the hospital, the dates of surgery or explanation or the patient. It was a fool’s guessing game as to what really happened and what might have contributed to whatever. We at the company did all things possible to take these reports seriously and to research every aspect of what was or not being reported. To put it mildly, the MDR reporting requirement is a nightmare for any serious Company representative who might wish to take it seriously. Worse yet, it becomes a serious and unequal force against a Company attempting to follow
proper rules, and a force which is used by the competing Company spokespersons as they attempt to create leverage against the Company who has received such a notice from CDRH. It is interesting that CDRH receives 80,000 or more MDRs filed every year. And by their own admission, only a portion of those reports ever get reviewed by anyone at CDRH. So, if a company and its medically savvy person is supposed to review each “event” submitted to them, and if as in TMJ Implants case, no one came forth from the FDA to give medical testimony why TMJI’s decision was incorrect, why should the company change its policy? But even as we got into a prolonged discussion, maybe better termed as a battle, we always sought the FDA’s justification for their insistence that these 17 events in question should be filed as MDRs, but that never was forthcoming. When Dr. Shultz told us we could appeal to the Commissioner to resolve the dispute, we did so that week by letter. We waited 8 months for a reply, and none was forthcoming. Then after 8 months we receive a Civil Money penalty from the FDA. Our attorney, Lynn Watwood will discuss what happened next in the following chapter.
A CMP ISSUED AGAINST TMJ IMPLANTS, INC.
In July 2005 TMJI was served with a Complaint for Civil Money Penalties (the CMP) by the FDA, seeking a total of $630,000 for failure of the company and two of its employees to file 21 events as Medical Device Reports (MDRs) with the agency. This was done without any prior indication of the disposition of TMJI’s earlier appeal it had filed with the Commissioner to resolve the subject dispute. The CMP named the company and personally two of its employees, Dr. Christensen as CEO, and Mrs. Maureen Mooney, the company’s compliance director, as defendants. In the CMP FDA sought damages from each defendant in the amount of $210,000, which accounted for the total of the $630,000 damages being sought. Prior to the filing of the CMP, TMJI, over a period of almost two years, had disagreed with FDA’s Center for Device and Radiological Health (CDRH) that the events had to be filed as MDR’s. In his letter to TMJI dated November 10, 2004. Dr. Schultz, Director of CDRH stated that he would consider any further communication he received from the company on this subject in writing as its request for appeal to the Commissioner. He also stated that he would personally forward such written request to the Commissioner for disposition. By reply in its letter dated November 16, 2004 to Dr. Schultz, TMJI requested appeal of the matter to the Commissioner through Dr. Schultz as he had promised.
From that time to the service of the CMP on July 5, 2005, a period of approximately eight months, there was utter silence from the FDA on the status to the appeal. Never having been involved in this type of dispute and process TMJI waited in good faith to hear from the Commissioner as to whether there would be a hearing on the matter or whether he would summarily decide the matter on the existing written record. At worst this could mean that the company would have first been ordered to file the events as MDR’s before facing formal legal proceedings under FDA’s CMP regulations to solve the matter. Therefore one can see that the service of the CMP without any disposition of TMJI’s appeal request by the Commissioner came as quite a shock to the company, and of course to the two named employees. It should be noted here that under the MDR regulations a company is solely responsible for compliance with the terms of the MDR regulations, not its employees. Under the regulations the actions of the employees in this regard are imputed to the company. Thus, Dr. Christensen and Mrs. Mooney were
added to the CMP clearly sole for purposes of intimidation, to force a quick settlement of the matter at the mercy of FDA instead of having to spend hundreds of thousands, if not millions of dollars in its defense in a protracted legal appeal process. This appeal process set up in FDA’s CMP regulations is rigged so that a company has all the cards stacked against it if it decides to defend itself. In the case of a small company such a defense, if lost, could end up bankrupting it. This is what ultimately contributed to just
such an ending to TMJI as you will see as the story continues
to unfold. Outrageously, only weeks after having been served with the CMP, Ms. Sheila Walcoff, FDA”s Deputy Commissioner for External Affairs(?) in late July of 2005 wrote to the company apologizing for the Commissioner’s Office waiting so long to reply to the company’s appeal request. In this letter Ms. Walcoff acknowledged that, although she only learned after the fact that
the CMP had already been served. She stated that for the Commissioner, under the circumstances, to then entertain a review of the matter (clearly implying that the CMP process would have to be held in abeyance) would be “ineffective and duplicative”. Her rationale was that the defendants had available the legal process contained in the CMP regulations to defend themselves. However such a process could bankrupt a small company in legal costs. In our CMP the administrative process alone lasted for over 3 years before appeal could be made to the federal circuit court of appeals. Not only was this letter of Ms. Walcoff completely disingenuous, and outrageous, demonstrating a complete lack of good faith by the Commissioner’s Office, but later TMJI’s Washington legal counsel obtained through Discovery certain FDA Privilege Logs (Logs) pertaining to internal communications within FDA and CDRH involving the MDR dispute. The company learned from review of these Logs that within days after the appeal request was made to Dr. Schultz in November 2004, FDA’s legal department was drafting a proposed CMP for filing against the company, showing that FDA never intended to give a proper consideration of the company’s appeal request. As a further insult and demonstration of lack of good faith in the appeal process by both Walcoff and FDA, these Logs showed that in May 2005, just 2 months prior to service of the CMP, she was in part of the loop reviewing the proposed CMP for comment. This proved conclusively that Walcoff had a direct hand in the “blindsiding” of the company with
the CMP. Shortly thereafter, FDA refused to settle the matter with the filing of the disputed events as MDR’s without the defendants agreeing to a settlement in the amount of at least six figures in total, for the three defendants. Thus TMJI had no other recourse but to defend itself against the CMP. After approximately 14 months of representation by its Washington legal counsel, because of cost restraints, the company’s in–house counsel Mr. Lynn Watwood took over the case, and
proceeded to represent the company in all its hearings and appeals through the final hearing before the U.S. Tenth Circuit court of Appeals, located in Denver, Colorado. This would have been impossible without the help of Mrs. Bonnie Ray, one of the company’s employees, working in Compliance under Mrs. Mooney. Mrs. Ray had gone to but not finished paralegal school. Thus Mr. Watwood and Mrs. Ray ended up taking on not only the FDA, but also its parent agency HHS in a process that lasted for the next three and a half years, culminating with the hearing before the U.S. Tenth Circuit Court of Appeals. On April 16, 2009, the initial hearing was held before the administrative law judge (ALJ) assigned to FDA, and whose office was in FDA’s complex located in Rockville, Maryland. This fact did not give TMJI a feeling of confidence in an impartial hearing. The Hearing lasted only one day. FDA’s only employee witness had no background in medical matters, merely in statistics. He was not a lawyer either but was offered as the agency’s interpreter of its MDR regulations which should have proved to have been a disaster for him and the agency. Under cross-examination concerning application of the agency’s Freedom of Information restrictions on companies it regulates, he testified that regulated companies are subject to the same restrictions on the release of certain information that constrain the public at-large. However, under these regulations such companies, including those subject to the agency’s MDR requirements, are not considered the public at-large seeking agency information that has certain privilege restrictions. They are, because of the MDR requirement to investigate complaints against their products, to be given unrestricted access to all necessary information available in the agency. One of the agency’s two expert medical experts admitted under oath that, since the overwhelming number of potential MDR reports were redacted (blacked out) to such an extreme extent prior to having been forwarded to the company for review, any actual review by the company to ascertain if its devices were involved and defective in any way was impossible.
The agency’s other expert medical expert stated that FDA Devices
were “excellent.” A significant defense of the defendants which, if accepted by the ALJ would have caused the dismissal of the CMP, was the assertion that FDA did not provide TMJI proper due process through prior disposition by the Commissioner. It should be interesting to note that in the record before the ALJ was an affidavit made by an FDA employee, under penalty of fines for perjury, which contained the statement that after review of the appeal request by the Commissioner the CMP was filed. Of course factually this time frame was not true. However, the ALJ, in his Opinion ruling, against the defendants, cited this incorrect time frame in support of his decision, only referencing in a footnote that this time frame was somewhat incorrect. Since this misrepresentation was at the heart of the due process issue being advanced by the defendants it was inexcusable for the ALJ to just summarily disregard its significance. Thus, in spite of all the clear evidence submitted in their defense justifying dismissal of the CMP, the ALJ ruled in favor of FDA on all counts, for failure of the Defendants to file MDR’s for all the events at issue. In addition, in evaluating the ability of each defendant to pay its proposed fine, the ALJ refused to postpone his decision on the ability of Dr. Christensen to pay for a few days until he received an updated copy of Dr. Christensen’s current tax return. He also improperly considered the separate income and assets of Mrs. Mooney’s husband who did not work for the company to justify upholding the proposed $210,000 fine against her. Mr. Watwood appealed the decision of the ALJ, as provided under the CMP regulations, to the Departmental Appeals Board (DAB) of HHS, FDA parent agency, The Department of Health and Human Services. Under these regulations appeals to the Board do not allow for an oral hearing, but only a review of the written record of documents involved in the dispute, including briefs of the parties, and the transcripts of the hearings before the ALJ. In addition the parties are only allowed to submit briefs in support of
their respective positions regarding the decision of the ALJ. The DAB upheld the decision of the ALJ in all respects except for the dismissal of Mrs. Mooney from the CMP as a defendant. This supported Defendants’ contention that her inclusion really was solely for purposes of intimidation, although the DAB did not couch its rationale for her dismissal in those terms. In reality Dr. Christensen should have also been dismissed from the CMP since, as stated earlier, it is the company and not its employees under the MDR regulations that solely legally responsible for filing of MDR’s. In arguing for Dr. Christensen’s dismissal along with Mrs. Mooney, the DAB ignored the fact that historically, in matters involving companies it regulates, FDA has only named key employees personally as defendants in criminal cases, never in disputes of merely a civil nature. Under the CMP regulations defendants, after an adverse ruling by the DAB, can either ask for a re-hearing/review by the Commissioner of FDA, or, file a timely appeal directly to the appropriate U.S. Circuit Court of Appeals. But, these regulations do not provide for an appeal first to a lower federal district court where a full blown trial with additional witnesses, new evidence and a potential jury would be available. Obviously, one can see that if this latter avenue were available defendants would have a better chance of receiving true neutral due process. Appeals to federal circuit courts are solely on the existing record. No new evidence can be introduced and the oral argument provided is only for a total of 30 minutes, with each party only having 15 minutes to present its side. In addition under the circuit court’s procedural requirements the parties have to meet with the court’s designated mediator shortly after as appeal is accepted by the court. In this case this was done. However in a separate telephone conversation between the mediator, Mr. Watwood and Dr. Christensen, the mediator told them that historically appeals from adverse administrative rulings have less than a twelve percent chance of being overturned in that court. He stated that under the circumstances TMJI
would stand a better chance of at least getting the money penalties reduced by negotiating settlement with FDA even at that late date instead of going to hearing. If one were betting Las Vegas odds what would one bet that a company would get a fair initial hearing within the agency that regulates it and a fair neutral consideration of its appeal by its parent agency’s DAB? Magnify this with the fact that FDA’s whole MDR program was at issue and the circuit court’s history in favoring rulings of administrative agencies and one can readily see that odds of surviving the CMP’s allegations were almost impossible. Before going any further we would like to comment on the matter of whether the process contained in the CMP regulations actually reflect true due process as protected by the U.S. Constitution. The U.S. Supreme Court in Matthews v. Eldridge, 424 U.S. 319 (1976), set forth the criteria for review where the issue of due process is involved. In Matthews, The Supreme Court stated: “Due Process is flexible and calls for such protection as the particular situation demands ... Accordingly, resolution of the issue whether the administrative procedures provided are constitutionally sufficient require analysis of the governmental and private issues that are affected…More precisely our prior decisions indicate that the identification of the specific details of due process generally requires consideration of three distinct factors: first, the private interest will be affected by the official action; second, the risk of erroneous depravation of such interest through the procedures used, and the probable value, and finally, the Governments’ interest, including the function involved and the fiscal and administrative burdens that the additional substitute procedural requirement would entail.” The facts present in the CMP demonstrated that in applying the test in Matthews, TMJI had been denied real due process. First, the private interest of TMJI was huge, including irreparable harm that the CMP had on the company’s reputation. Secondly,
the CMP obviously presented a much higher risk of erroneous depravation of the interest of the company and a much higher probable value than the alternative due process avenue of direct appeal to and disposition by the Commissioner that was disregarded in favor of the CMP; and finally, there was no question that the CMP avenue for disposition of the MDR matter, instead of resolution first by the Commissioner resulted in a huge unjustified fiscal and financial burden on the parties, and especially on the company. In fact in its decision on the company’s appeal from the ALJ’s decision the DAB admitted that that the CMP entailed great costs and time. It is undeniable that, if the FDA’s Commissioner had acted in good faith in acknowledging TMJI’s written appeal request, the dispute could have literally been resolved in a matter of days. Instead, this punitive CMP avenue caused the dispute to be dragged out for over 4 years, (3 ½ years even before appeal could be made to federal court). Thus the company was needlessly placed by FDA in great financial jeopardy with grave implications to is reputation. Finally, to add further insult and injury in this matter, in the interim time between the filing of its Petition to the Commissioner for reconsideration to the ruling of the DAB and the filing of its Appeal to the 10th U/S. Circuit Court of Appeals, Dr. von Eschenbach, FDA’s Commissioner, in his written response to the inquiry by the two ranking Republican members of the U, S. House of Representative’s Committee of Commerce and Industry, the congressional over-site authority over FDA, admitted that there had been a “process failure” in how the dispute had been handled within FDA. To compound this, the record showed that he even had one of his deputy commissioners contact Dr. Christensen by e-mail, seeking his advice on how the review process could be improved in the future. But in spite of his admissions, Commissioner von Eschenbach had the gall to refuse to accept the company’s Petition for reconsideration. Thus the company had no alternative, having gone this
far to protect itself. But to proceed with its defense by its appeal to the U.S 10th Circuit Court of Appeals. Ultimately the Circuit Court sustained the decision of the DAB, ignoring the company’s arguments concerning the due process issue and the interpretation of the MDR regulations. In so doing the Court ignored the precedent the ruling of the federal district court judge against FDA in the 10th Circuit federal district court case of the U.S. v. Utah Medical Products, Inc., 404 Fed Supp. Second, 1315, decided only 3 years earlier in 2005. This case, like this CMP involved FDA’s assertion that it should be given preference in the interpretation of its own regulations that were at issue. However, the judge dismissed this argument of FDA stating that FDA’s position contained the “virtue of generality and the vice of imprecision.” To our knowledge no other company, after having been served with a CMP by FDA has ever proceeded to defend itself through the internal administrative appeal steps and ultimate appeal process to a federal circuit court of appeals. We have not been able to obtain from FDA the number of CMPs it had filed against other companies. However, we do know that the big national or international companies just cave in to the demands of FDA. Whereas, ironically, the smaller companies that survive or fail on the public reputation of their limited products, are almost compelled to stand up and defend themselves, even at the risk of overwhelming costs of litigation. FDA knows this and uses this threat of power to intimidate the small companies that stand up for their rights. The MDR and CMP matters that FDA has used to intimidate companies large and small that it regulates and which are reflected in this CMP are so huge, with implications for the constitutionality of the agency’s whole administrative regulatory process, that it is quite obvious that the courts are hesitant to tackle their legality. Unfortunately, this results in small companies like TMJI having no real neutral legal recourse to defend themselves in disputes with the FDA.
THE RECESSION OF 2010
TMJ Implants, Inc. over the previous 5-7 years had taken on more obligations in manufacturing equipment which was very expensive and large and requiring more manpower skills and manufacturing space. It had become apparent to Christensen that a broader base of highly technical product line was going to become necessary to meet the future economy and growth situation. There was no doubt we were pressing the limits, but that had been so since day one. When the stereo-lithographic technology became available in the early 1990s, Christensen felt it had a particular value in the medical device area for the manufacturing of specialized, custom implants and other items yet unknown. The cost of the equipment was very expensive, but in time the Company was not only able to acquire its first such equipment, but in time set up a whole other company devoted entirely to the manufacturing of specialized medical models as replicas of a patient’s special pathologic or implant need. Such things as conjoined twins could now be visualized from stereo-lithographic models of their body parts taken from CT scan data and then used to actually separate the twins. This was a marvelous innovation and one that placed this new medical device company in the forefront of this technology. This company was later given to Dr. Christensen’s son, Andrew. Other specialized equipment became available for the actual manufacture of metal implants right from the CT scan data,
through a conversion of actual metal powder into an actual device or implant. This technology had first been used in aerospace to bring prototypes to market overnight. What a breakthrough it was, but the equipment got into the many hundreds of thousands of dollars, and again required more space and technical help. TMJ Implants, Inc. purchased a single machine which was used for the manufacturing of missile parts being ordered by large aerospace engineering companies. It was an interesting synergistic relationship which held much promise in the future, as well as in the future of overnight manufacturing of specialized medical implants. As we travelled through the early 2000s things were progressing quite well for the company, but financially the owner was always living on the edge, pushing the boundaries of science and of needed finances, nothing new there, just a matter of fact. Then comes the additional legal fees and personnel needed to come against the attacks of the FDA, but we were still doing well, except for losing the court battles with the FDA and the owing of $340,000 to the government. That carried the Company to the edge of the waterfall and when in January, 2010 the sales of the TMJ implants dropped by about 50%, and remained so for six months in a row, that pushed the company over the cliff.
THE INEVITABLE HAPPENED
As of June, 2010, the Company was forced to accept a Chapter 7 Bankruptcy and basically close shop. It was Dr. Christensen’s wish that the actual implants for the temporomandibular joint, which he had innovated some 50 years earlier, would remain on the market for those patients and surgeons who would require them, but he also desired that each member of the Company Staff would continue to be employed by a new Company which would acquire all implants, technology and staff through the bankruptcy. That desire was accomplished. So as of this moment of writing these chapters, we have taken the company, TMJ Implants, Inc. and Christensen, personally, through the chapter 7 bankruptcy. We gave it all to accomplish what we knew God had asked him to do. It reminds me of something which happened in the last 3 years. I was having a pulmonary function test as part of general health exam prior to an upcoming review regarding the need for a cardiac valve surgery. In that test you are asked to breathe in fully and then blow out all of the air in your lungs. When I had done so for the third time, I all of a sudden passed out and when I awoke, there were three EMT type persons surrounding me to be sure I hadn’t died or that I wouldn’t possibly fall out of the chair. A little later when I visited with Dr. Daniel Smith, he made the comment “that I sure had given it my all.” I asked if this happened often and his answer was possibly a time or two in any given year. This was at National
Jewish Hospital here in Denver where they see hundreds of thousands of pulmonary patients each year. So I guess I was one in a very large number. Yes, he was right, that had always been my level of involvement in any of life’s experiences or tests. And certainly in bringing these implants forward all these years for the patients who required them, it would be my highest goal. Did I make it? Yes, I did, but it caused my wife and me to lose all. Was it worth it? Yes, anytime you are fulfilling God’s plan for your life, it is absolutely necessary and expected that we as Christians are asked and compelled to give it our utmost. That is what this book is all about.
A FINAL INSULT
It is with a great deal of sadness that I write this book about the demise of the Company which I had given my life and love to build. I feel I can stand proudly with others who had to fight some rather unusual battles and at times perpetrated by their own Government. I well realize medical device companies like Myotronics and Utah Medical, under the leadership of their talented CEOs were able to withstand the attacks. Sometimes a person may not have the resources to fight indefinitely the forces which they may find come against them. Do I feel we did well bringing this surgical technique this far? Absolutely, we truly gave it our all. Am I disappointed that in my 87 years I find myself totally broke? Yes, certainly. But I still have the $170,000 CMP hanging over my head since it was not discharged in the personal bankruptcy. Do I feel there are many changes which should have occurred in our progress toward full approval and in resolving the MDR situation? Yes. I, in no way feel the FDA or HHS handled that in a user friendly, equitable or wise manner. I hope by writing this book that there will be some inevitably proper changes occurring in the whole Regulatory Process. There needs to be some common sense approaches to many of the things which are being done and which can have such dire effects on the patients we in Medicine attempt to serve. Certainly the innovators of the future and the entrepreneurs who attempt to bring excellent products to the market are going to be unable to do so, and then we all lose. As my dear friend Dr. Ric Alexander so aptly said, “This is America; how can this happen?”
THE MORAL OF THIS STORY
Over the past dozen years I had been saving information which pertained to the regulatory path which TMJ Implants, Inc. had been on. I kept filing the information in ongoing files titled, “The Back of the Book” files. As time had gone on, I contemplated whether I should tackle such a monumental task as the writing of this book. I sought out guidance from God as to what wisdom he would wish to give me for this occasion. His answer was swift and very precise. Review what happened in Luke 9:13-14. When I did, I was convinced He was telling me, “With Me, all things are possible.” In that particular story, Jesus had been ministering to the 12 disciples when He gave them power and authority over all devils and to cure diseases. He had sent them forward to minister to the people but to take nothing with them. In other words God would supply all of their needs. So they departed and went through the towns preaching the Gospel and healing everywhere. When they returned from their adventure they told Him of all of the miracles that had occurred. Now, Jesus departs with them to the city called Bethsaida. After a day with Him the townspeople began to throng around Him, so the disciples told Jesus to send the throng away, since there was no food, before they all were famished. But the words of Jesus to them was, “Give you them to eat.” They informed Jesus they only
had five loaves of bread and two fishes. The Bible tells us there were about 5,000 men to feed, and likely another few thousand women and children. Just as I was thinking before starting this book, how can I do it? But just as Jesus told His disciples, just start by putting things in order and I’ll do the rest. In the disciples case they ended up with way more food than they needed to take care of the need of that day. Basically, Jesus was telling me the same, “Just start.” So that is what I have done and at the end, I had much more material which could be added to this story, but I suspect there is ample within this book to show that the FDA causes much harm by their nonlogical, inefficient and abusive enforcement of regulations which has and will cause a slowdown in our economy, but even worse, a stifling of innovation and entrepreneurship in America! What can we do? First, if I were President or a member of Congress, I would immediately reduce the overall budget of HHS and the FDA, including CDRH by 15% the first year, followed by a 5% decrease in budget, yearly, over the following 5 years, allowing the Agencies to determine how best to accomplish that change. Then, I would look at every possible way to reduce the regulatory process for approval of drugs and devices to make it much more common-sense and uniform so that anyone starting into the approval process would know exactly what needed to be accomplished and then give the FDA a set time of 30 days to make their decisions on the more routine items. In the case of TMJ Implants, Inc. it was the inefficiency, lack of proper knowledge, biases, conflicts of interest and outright criminal behavior which made every part of the approval process an absolute nightmare. Then the foolishness of the CMP was to be the nail in the coffin. In that situation there should have been proper dialogue between knowledgeable professionals and if that couldn’t resolve the problem it could have been appealed to the
Commissioner, as they had promised, and he would have accepted the appeal, in short order. That did not happen, and consequently much suffering occurred not only for the medical device company, but possibly even more importantly to the hurting patients who needed these implants.
THE MAYO CLINIC LETTER
It was a pleasant surprise getting the following letter from Dr. Eugene Keller, who is chief of the Oral and Maxillofacial Surgery Section, Department of Surgery, at Mayo Clinic in Rochester, MN. Back in 1972, when Dr. Bruce Lund was chief of the same oral and maxillofacial surgery section, I had presented a surgical film presentation on my 1960 innovation of the partial TMJ implant. It had gone over well before the OMS and ENT staff and residents. It was some 15 years later that Dr. Turlington started using TMJ Implants, Inc.’s implants for their patients with a great deal of success. He had done many partial and total TMJ implant surgeries using our devices. When in about 1989 Dr. Turlington retired, Dr. Keller began using our partial TMJ implant as the main surgical treatment for the TMJ surgical patients they were seeing at Mayo Clinic. Over the years, they had placed some implants almost every week and had written up some four or more articles showing their retrospective studies on hundreds of patients over an 8 to 10 year period with phenomenal success. When TMJ Implants, Inc. had suffered an economic loss in the recession of 2009, and in June 2010 we had to take the company through bankruptcy, it meant the implants would not be available until the new owners could resurrect the new company from the first company. I knew that Mayo Clinic and a lot of other surgeons and hospitals around the world would suffer, but I could do nothing about it. It was in that period that Dr. Keller sent me this very kind letter, extolling my courage and pioneering spirit in innovating and proving the value of these fine implants. It was a welcome endorsement, when it seemed no one remembered much about my contribution to this surgical field. I wanted you to see Dr. Keller’s fine letter as an encouragement to you in your efforts to accomplish what God has called you to do. Almost no one ever took the time to do what Dr. Keller did, even after some 62 years of my life just giving back whatever God showed me to do, and usually with heckling, seldom with bouquets, and almost never with awards or banners. It is OK to give one’s life just doing what he or she can do to help spread God’s word somewhere in the other most parts of the world and at the same time doing what you can to relieve some of the heartache or suffering around this world. The following two letters were sent to me at the time of my retiring from the CEO of TMJ Implants, Inc., and were the only letters that I received, at the end of my career, and to say the least, were greatly appreciated by this 85 year old surgeon. Sometimes the smallest gestures of kindness mean the most.
February 13, 2012
Dr. Eugene E. Keller
Thank you for your knowledge and insight contained in you recent book “FDA, You were WRONG”, regarding the cumbersome bureaucracy faced by the innovation and research community.
I cannot imagine a more meaningful career you have lived and shared with others. Our profession has greatly benefitted from your past innovation and brilliance in dental and craniofacial reconstruction.
I often wonder where our TMJ surgical practice would be without the Christensen metal Fossa-eminence Prosthesis, which helps patients with the greatest disability and pain.
I hope you can now take some time for yourself and your wonderful spouse to explore more leisurely activity in your upcoming retirement years. If I know you, you will continue to give back to your community, professional colleagues, and patients.
Best personal regards.
E.E. Keller, D.D.S., M.S.D. Dir. Dept. of OMS Mayo Clinic
This 2nd letter from a surgeon in a Southern State came as a surprise and was greatly appreciated. In it the surgeon said the following:
I received your beautiful card and the sentiments expressed in your letter extolling the virtues of a life of 85 years with some 60 years designing and implanting surgical devices which greatly help mankind.
When I was introduced to your TMJ implants some 20 years ago, I was unaware that I would 20 years later be so involved
in convincing people that this was the best prosthesis I Have encountered in my 30 years of surgery practice.
You have been a blessing to so many people in the realm of temporomandibular joint disease that I firmly believe your legacy is indelibly stamped on the lives of the surgeons who have placed them and the patients who have benefitted from their existence.
I wish you all the best in your next 20 years of increased leisure time, but I know that you will be there when anyone of us needs the expert advice from the master himself. Enjoy. But stay close, stay connected and stay healthy.
Your surgeon friend”
In this next unsolicited letter from a surgeon in Nevada, we see his biannual progress report on one of his patients whom he placed a Christensen Partial TMJ implant as a hemi-arthroplasty procedure, in her right TMJ, some 10 years earlier. This patient had an early degenerative joint problem with marked pain, who, had been treated earlier by non-surgical means, and without any relief of her symptoms. Without this hemi-arthroplasty procedure being available she would either have never found relief of symptoms and regression of disease, or she would have been compelled to have had a total TMJ reconstructive surgery with amputation of an otherwise useful and somewhat healthy natural condyle. What a travesty that would have been for this patient. In this 10 year report, the patient is totally free of any ongoing TMJ destruction or pain or other symptoms of disease. What a blessing for this patient. From experience along with the data seen in the studies which have been accomplished, there is a 95% chance this patient will never have another episode of painful symptoms and ongoing disease in her lifetime.
A Doctor’s Progress Notes
PATIENT: XXXX DOB: 11/20/1971 DATE: 08/30/2011
S: Patient presents for yearly recall for right TM joint. The patient received a patient specific fossa eminence prosthesis right TM joint 1/8/2001. She is now 10.6 years following surgery.
Patient reports no problems. She states that she is doing great, with no pain or any issues. She has no headaches. She eats everything. She reports she is taking Aleve at this time for a knee injury that she suffered when she fell off her horse. Otherwise, her VAS pain scale for her TM joint is 0/10.
0: No Panorex was taken today since the patient is asymptomatic and has been now for two years. The Panorex taken last year was normal for any TMJ prosthesis problems. The patient has no tenderness to muscle palpation and no tenderness over the right TM joint. The patient opens to 40mm which is unchanged since last year. The patient deviates to the right with opening. Mild crepitus right TM joint. A: Stable following partial joint prosthesis placement right TM joint 10.6 years.
Observe in one year with new Panorex.
PATIENT: XXX DATE: 09/2112011
Patient is now over seven years following left TMjoint reconstruction with arthroplasty and fossa eminence prosthesis (partial joint) reconstruction. Surgery was in August of 2004. Patient reports-no problem and he is doing great. He has no headaches. He has no problems chewing and is in fact is now eating hard things such as carrots without any pain whatsoever. He also reports that his TMJ is no longer a weather vane for storms that come into the area.
The patient states that his bite feels good and he has good mobility. • Opening to 42mm. Right lateral 5-6mm. • Left lateral 10+mm. • Protrusion, patient is way past end to end and I would estimate 8-10mm. • Patient has no muscle tenderness except for the left masseter muscle which he describes as a very mild discomfort to palpation. • Auscultation reveals 1/3crepitus left TMJ as expected.
Very stable left TMjoint following partial joint replacement. No symptoms. No pain. Good opening to 42mm. He is even better than he was last year as far as his ability to chew foods such as raw carrots.
Observe one year with new Panorex.
A TMJ Patient’s Testimony
My TMJ Journey
This is my testimony of my TMJ story, it begins several years ago, I was suffering with TMJ and had no hopes of ever finding help or a cure. I was living on a diet of baby food, malts, mashed potatoes, basically a NO CHEW diet to prevent pain. I did all of the conservative treatments, pain medications, muscle relaxers, tranquilizers, I had 4 arthroscopy surgeries, I tried wearing splints. To no avail none of these theories relieved my pain and suffering from this debilitating disease.
It’s hard to describe to others just what a TMJ patient goes through, when you have TMJ you cannot eat, smile, talk for any length of time, laugh or even have your teeth worked on, I had lost a lot of weight that I looked like skin and bones. And kissing my husband was out of the question, as it brought on so much pain for me, that I would just cry. I was ready to give up on life, my friends and family had enough and was tired of all this pain and suffering that I was going through, that they began to pull away from me with their support.
I knew then that it was time to find some answers for my pain. I heard about Dr. Christensen from a friend and neighbor of mine who also suffered with TMJ. I called Dr. Christensen and he invited me and my husband over to his house to meet with him to discuss the possibility of having his TMJ Implants. Dr. Christensen referred me to Dr. James Curry who then order some X-rays on me to see what the problem was, and if I was a good candidate for the surgery. I knew in my heart that this was the answer for me, and that all of my pain and suffering from TMJ would finally be over.
We scheduled the surgery for Dec of 1990, as my discs were badly deteriorated and causing all of my pain. I had the TMJ surgery done replacing my discs with the Fossa-Eminence
Prosthesis, and I am now pain free 21 years later, I’m eating everything with no problem or pain, I’m doing what I have not been able to do all of those years ago, even kissing my husband is such a joy now..
I still have my own condyles as with the deterioration of my discs the fossa eminence prosthesis have prevented my condyles from deteriorating! I truly believe in this product the fossa eminence prosthesis that I began to run a support group helping others who suffer from TMJ. I have dedicated my life in a personal crusade of helping others. I even hosted patients in my home who, would come from out of state to have this surgery, and needed a place to stay for their recovery.
It has been a long hard fight all these years of finding a cure/ help, that I can safely say I’m TMJ Free!
HOW DOES THE FDA REALLY FEEL ABOUT DR. CHRISTENSEN?
Perhaps the best summation of how the FDA thinks about Dr. Christensen occurred at the end of an FDA sponsored, two day teaching conference at the Exactech Company in Gainesville, Florida. Dr. Christensen’s son, Matthew is Director of Clinical Monitoring at Exactech and was in attendance as the FDA’s Orthopedic Division’s Dr. Stan Brown was presenting. Dr. Christensen had told his son, Matthew, that he might introduce himself to Dr. Brown at the end of the two day teaching conference. Matt asked his Dad if he knew Dr. Brown and his Dad said he had met him at the FDA headquarters in Rockville, Maryland on at least one occasion. So, at the end of the two day presentation, Matt introduced himself to Dr. Brown, “I think you know my father, Dr. Bob Christensen?” and Dr. Brown came back quickly with the statement, “Oh you poor bastard.” I guess that says it all. Dr. Christensen is well known at CDRH, even in the Orthopedic Department. Now that I have uncovered my dear son, Matthew, maybe he will take over the enviable spot in the hearts of the FDA leadership that his father has enjoyed for so many years. Go Matt!
OUR JUBILEE YEAR OF TMJ IMPLANTS
I had always felt that when fifty years have gone by since the time that I first innovated and implanted these temporomandibular joint implants, that we would undoubtedly have a grand or stupendous celebration of the Jubilee Year. I was wrong. Nobody even said thank you for inventing these implants. There was no celebration, but you know, that’s just life. Sometimes you just do your part and nobody much cares about recognizing the effort and sacrifice you made. I have come to realize that it doesn’t make much difference in the Lord’s scheme of things. As Solomon once said, it is all vanity. Just be thankful our good Lord showed us what He wanted us to do, and then do it and be glad. I would like some government investigative body to review what has been written and then search out the truth to what and why this approval process became so tortuous and expensive, costing many of the early employees to lose their jobs and for the owner to finally lose all of his worldly possessions. This type of government process certainly attacks the innovation and entrepreneurial spirit of any person in this country. At a time when we are losing many jobs and businesses to foreign lands, something better than this particular approval process
must occur. In this particular situation there appeared to be a vengeance to go after not only the particular medical device company but also
the innovator, of the implants and the founder of the company who had never sought any financing from any government entity or from any other person, but then when the attack occurred it took away all of the financial reserve of this 86 year old surgeon, and his wife, and if that weren’t enough they levied a $170,000 Civil Money Penalty against the owner.
TITLES OF FDAWebview ARTICLES
The Chronological History Of TMJI’s Battle with the FDA
3. TMJ Prosthesis Still Available 8-16-1999
4. FDA Wrong Doing Alleged in TMJ Device Controversy 9-19-2000
5. Surgeon Challenges FDA on Non-Approval of TMJ Implant’s Device 9-29-2000
6. Hatch Urged to Intervene in FDA Action on “Compassionate” TMJ Device Use. 10-5- 2000
7. FDA Advisors Vote TMJ Implant is Not Approvable 10-09-2000
8. Case Study in FDA Staff Bias. 11-08-2000
9. FDA Says Stalled TMJ Partial Implant is Now Approvable 2-14-2001
10. Congress Eyes FDA’s reversal on TMJ Implants Device 2-16-2001
11. Toughest Device Approval Clears last of Embattled Firm’s Implants 2-27-01
12. “Full Disclosure” Standard in TMJ Approval Opens New FDA Era 2-28-2001
13. TMJ Patient’s Group Protests FDA Implant Approval 5-22-2001
14. Congressman Demands probe of CDRH’s handling of TMJ Implants, 7-18-2001
15. CDRH Agrees To Change SSE on TMJ Implants 7-24-2001 16. CDRH Revises Its Summary for TMJ Device 7-25-2001
17. TMJ Firm’s Charges About CDRH Goes to Internal Affairs 7-27-2001
18. FDA Rejects TMJ Implants’ Conflict of Interest Charges 7-30-2001
19. TMJ Implants Petition Nears FDA Answer 4-26-02
20. ODE Director Statland leaving FDA 8-2-2002
21. FDA Denies Petition to Undo TMJ Approval 8-21-2002
22. TMJ Implants Still Troubled on MDR reports 3-10-2004
23. TMJ Implants Rebuts 17 MDR No-report Citations 4-2-2004
24. FDA-Targeted Device Maker Joins Journal’s Editorial Board 4-15-2004
25. TMJ Escalates Case Against FDA 4-21-2004
26. Political Interference Seen in “Criminal” IG Probe at FDA 4-29-2004
27. Rumsfeld Not Alone: FDA Covers Up Its Deeds Too 5-6-2004
28. Committed to Compliance, But FDA Silent: TMJ Implants 5-17-2004
29. Has FDA Ever reversed itself? 11-1-2005
30. FDA Ambush? Device Maker Faces Up to $630,000 MDR Penalties 9-5-2006
31. From FDA’s Dept. of “Dirty Tricks”: TMJ Implants Case 9-26-2006
32. More “Dirty Tricks Dept.” Investigation That never Was 9-27-2006
33. 12 Years Later, “Corrupted CDRH Practices Continue.” 10-30-2006
34. Device makers Warned on Costs of Non-compliance 11-3-2006
35. FDA Warns TMJ Implants on Promoting Unapproved Devices 1-3-2007
36. TMJ Implants CEO to Speak on FDA Issues at Conference 1-10-2007
37. TMJ Implants Says It satisfies FDA on Web Changes 1-25-2007
38. Few Warning letter recipients Get “Public” Justice 1-17-2007
39. TMJ Implants, Inc. Challenges FDA on Warning Letters Policy 1-26-2007
40. TMJ CEO to Speak on FDA Issues at Conference 1-10-2007
41. FDA Posts TMJ Implants Warning Letter Response 2-15-2007
42. Von E Urged to Probe TMJI Case, Stop Web Postings 2-26-2007
43. TMJI Challenges FDA on Warning Letters policy 1-26-2007
44. Von E Urged to Probe TMJ Case, Stop Web Postings 2-26-2007
45. AIMBE “gag” Investigation
46. Hurt FDA? TMJI Chief Gagged At Biomed Meeting 2-27-2007
47. TMJI Seeks to Revive Appeal Before Penalties Hearing 3-7-2007
48. TMJI’s “Day in Court”’ Both sides Should Settle 4-17-2007
49. Device Maker Threatens Lawsuit Over FDA Seizures 4-18-2007
50. Republicans challenge FDA Tactics in TMJ Implants’ Case 5-1-2007
51. FDA Insists on Money from TMJ Implants 5-7-2007
52. It’s Personal, FDA Judge Tells TMJ Respondents Company Says 5-12-2007
53. TMJ Case “Hangs on Opinion, Not Law” Company says 6-14-2007
54. FDA’s Judge Rubber stamps Agency on TMJ Implants 7-9-2007
55. FDA Judge Insists on $510.000 Penalty9-26-2007
56. Deep FDA Distrust shown in Civil Monies Penalty Cases 10-2-2007 57. GAO Finds Continuing FDA Dissent on TMJ Implants 10-18-2007 58. FDA’s Office of Internal Affairs Removed from Investigations 11-12-2007
59. TMJ Implants Alleges 94 Errors in GAO Report. 11-29-2007
60. HHS Upholds TMJ Implants Civil money [penalties 3-28-2008
61. GOPers Seek Pre-Budget Meeting with Von E on TMJI Issue 4-3-2008
62. TMJI Urges Barton to “Confront” von E on Waylaid Appeal. 4-10-2008
63. Von E to Meet Republicans on “Lost” TMJ Implants Appeal 4-17-2008
64. Von E Sees “Process Failure” in TMJ Implants: Barton 4-30-2008
65. FDA Loses Another Medical Device Case 5-6-2008
66. CDRH Court Losses Shows Need for Policy Change 5-7-2008
67. TMJ Implants Appeals FDA Civil Monies Penalties 5-19-2008
68. After 4 Years, TMJ Case Offers “A Way Out” 5-28-2008
69. “Too Late”: CDRH Urges Rejection of TMJI Petition 5-30-2008
70. FDA vs. TMJI: Dancing with Time Frames. 6-6-2008
71. FDA Has No Records on Its Litigation Costs 7-8-2008
72. FDA orders Device Tracking for Certain Devices and Implantables 8-14-2008
73. FDA Doesn’t Track Resources in Enforcement actions 8-15-2008
74. FDA “Must Explain” MDR Decisions, TMJI Says In Appeal. 8-15-2008
75. FDA-TMJI Case Depends on Definition of “Serious Injury” 9-22-2008
76. CDRH Warnings “Didn’t Speak” for FDA-TMJ Implants 10-3-2008
Not to mention an Op-Ed Page article in the Wall Street Journal.
TMJ IMPLANTS, INC
The Facility (A View of the Past)
In these views of the atrium we can easily see the tranquil nature of the setting for all who would visit TMJ Implants, Inc. as well as the peaceful surroundings for the staff.
The initial entrance to TMJ Implants, Inc.’s facility gave a friendly and reassuring atmosphere.
In these views we see several of the spacious and useful offices within the company.
The larger of the two conference rooms was used as a meeting room for outside guests, for inside meetings and as a study and library for the company use.
This is the room where TMJ Implants’ orders from the doctor’s offices and hospitals were taken
This is the Record Room and Labeling Room
This is the Copy Room and the Stamp Room
The Finishing Laboratory
The Waxing and Casting Room
The Packaging Room
The Larger Lunch Room and kitchen
The Stereo-lithographic Room for making plastic replicas of a patient’s CT scan data
The TV Studio and Editing Room
The Smaller Conference Room
The Implant Shipping Room
This is the story of a 17 month old boy we called “Baby T”. Over a few days to a very few weeks, Baby T developed a tumor of his left mandible. Resection is required. This was in the very early 1960s and Dr. Christensen elected to have an immediate replacement of the portion to be resected, which was unusual at that period of time.
A custom, metal implant was cast in Co-Cr in a manner that an iliac bone graft might be incorporated. The bone graft was removed a week earlier from a patient who died.
Baby T is seen just 3 weeks after the malignant bone tumor and the better part of half of his mandible was removed.
“The Team” These are the Skulls used to replicate the actual glenoid fossa in the natural human anatomy for the design and manufacture of the “stock” implants
Metal molds made from patterns taken from the actual skull base of the many skulls found in skull of “The team”
These views show the Fossa-Eminence Prosthesis, first on the skull, then surgically in a patient Dr. Christensen operated in 1965. It never needed to be removed and the patient was healed with one surgery for the remaining 46 years of her life.
X-ray showing TMJ after hemi-arthroplasty in 1965, in open and closed jaw positions
This x-ray of the same patient’s TMJ is seen some 35 years later.
The same TMJ in x-ray some 35 years later. The lower picture shows the correct placement of the Christensen Fossa-Eminence Prosthesis against the skull base.
These two views show the Fossa-Eminence Prosthesis, innovated by Christensen in 1960
These two SLA models show the disparity of condylar growth between the Right and Left Condyles due to a birth injury, during forcep delivery to the left TMJ and ear.
The disparity of Condylar growth is more visible on these two models
The distraction device and Left TMJ hemi-arthroplasty are seen both on the SLA model (reversed) and on the patient’s post-surgical x-ray. The patient is seen 3 weeks post-surgery eating a hamburge
The placement of the FEP is seen during surgery. The patient is also seen eating a hamburger 3 weeks following his TMJ surgery.
These are SLA models of a young male who was injured by gunshot wound to the left ear-temple region
A “gunshot” wound to base of skull and zygoma and being TMJ being reconstructed with a custom Christensen FEP
The “Stock,” off the shelf, Christensen FEP
The “Custom” Christensen FEP
A massive ameloblastoma involving the right mandible in a 24 year old patient
The “custom” TMJ-mandible implant to replace the massive ameloblastoma
Placing the FEP during surgery
Frontal and inferior views of the implant on the patient’s SLA model
Showing the “Total” Christensen TMJ implants in place during surgery
Bi-lateral Christensen hemi-arthroplasty in a severe ankylosis patient following childhood TMJ infections
Bi-lateral Christensen hemi-arthroplasty to free mandible in ankylosis patien
Mandible ankylosed in open position in a Treacher-Collins patient
This SLA model is of a Treacher-Collins Syndrome patient who shows congenitally missing zygomas and mandibular rami which have been partially constructed earlier with rib grafts
Models showing implants for jaw reconstructive surgery
The Patient is seen 6 months following jaw reconstructive surgery
The SLA model of the patient with left Golden-Har Syndrome
Click here to edit textModels depicting wax-up and cast of implants
Implants shown in place at surgery
Patient is seen three weeks post-surgery
This last surgical case I will mention in this book had to do with a 15 year old young woman who had been born with what is termed bilateral Golden-Har Syndrome. It is a congenitally acquired situation where a person may be born missing ear(s) and parts of the mandible (lower jaw) and sometimes with large clefts in the cheek region. In her case she was born with all of those deficiencies in anatomical structures and most unusual, but, for her it was bilateral. The pictures which will follow will give you an idea of what TMJ Implants, Inc. was all about in figuring out how to best reconstruct her temporomandibular joints, but at the same time reconstruct much of her lower jaw so that she could have a more normal appearance and jaw function. She had earlier reconstruction of parts of her lower jaw using rib grafts, but they were basically ineffective. It now would require resecting the earlier rib grafts, removing a segment of bone in her chin region and then reconstructing her TMJs at the same time as rebuilding the rest of her lower jaw. This procedure had not been accomplished in the same fashion as far as we could determine. The surgery went very well and the patient recovered and was now able to use her lower jaw and teeth in a more normal fashion and her appearance also became normal. Over the following number of years she did very well and at age about 21 she was seen on both the Ripley’s Believe It or Not, television program as well as the Montel Williams television program.
We can see the pre-operative, SLA models of the patient’s lower jaw with the remnant of rib grafts still present from the earlier reconstructive surgery.
At surgery, it was first necessary to reconstruct and re-contour the areas at the skull base so that the TMJ implants could be placed.
The entire mandible is necessarily de-gloved to allow the positioning of the mandibular implant after resecting a 3/8th inch portion in the symphysis region of the mandible.
The one piece implant is seen replacing both temporomandibular joints as well as much of the missing mandible
The implants are seen on these three models
An Interesting FDA Attack Regarding This Patient’s Treatment and Implants
In the latter part of 2006 TMJ implants and Dr. Christensen received a Warning Letter from the FDA saying “the company is misbranding and adulterating their claims on their Website” when they state they can design and deliver hemi and full mandibles to meet the most unique and unusual patient needs.” It goes on to say that the Company stated: “the company has created solutions for such unusual conditions as Golden-Har Syndrome and Treacher-Collins Syndrome patients.” The FDA went ahead in their published Warning Letter to say: “that the firm does not have an approved application or premarket approval for these claims”. Christensen and the Company reiterated that the FDA was incorrect in their assumption, because these Syndrome patients routinely are congenitally missing the actual temporomandibular joints, either unilaterally or bilaterally, and the only way to restore the anatomy and function is to rebuild the missing part of the mandible at the same time. Fortunately, the FDA had to back down and retract their Warning Letter accusations, which allowed the Company to continue to advertise and market their implants in the same manner in which they had done previously in the Website.
A monthly Journal published by TMJ Implants, Inc. as an educational journal for surgeons.
Sometimes it is necessary to keep your eye on the road when all about you seems to be spinning out of control. As a person who enjoyed flying jets and racing gas-comp racers, I am used to keeping focused. I hope that this book will be useful in bringing some changes to a government bureaucracy, which has been divisive and overly cumbersome, to the point it truly has hurt some patient’s ability to get excellent care in a timely fashion, sometimes having to accept a standard of car which is not ideal and frequently harmful. It is in that spirit that this 87 year old surgeon and innovator brings forth this message in the hopes that somehow commonsense and wisdom will re-enter the U.S. Food and Drug Administration. I really feel like I received a loaf and a fish and I then chose to give them to others so they might enjoy being able to eat.
Dr. Christensen at age 72
Matthew at age 21
THE COLORADO SOCIETY OF ORAL AND MAXILLOFACIAL SURGEONS
Special Recognition Award
At the 41st Annual Meeting of the Colorado Society of Oral and Maxillofacial Surgeons meeting in the Broadmoor Hotel, Colorado Springs, On July 28th the first ever Special Recognition Award was presented to Dr. Robert W. Christensen for his 64 years of service to humanity, innovation and contributions to the field of oral and maxillofacial surgery. The presentation was awarded by Doctors Randolph Robinson, James Curry, Crayton Walker and Ricardo Alexander (in absentia). The three day meeting had as the only presenter, Dr. Eugene Keller, Director of the Oral and Maxillofacial Surgery department at Mayo Clinic; who had spoken that very morning on the 25 year history of using the Christensen TMJ implants as their mainstay in surgery of the temporomandibular joint. Dr. Keller had made the statement that the Christensen Partial TMJ implant was useful in correcting the problem in 95% of the arthritic TMJs seen at the Mayo Clinic. No other treatment had the long, 52 year, history of success that the Christensen Partial Joint implant had shown for this joint. Dr. Robinson led off the presentation by saying,
Drs. Walker, Curry, Roinson, and Christensen
Bob and Lynne Christensen
Robinson, Walker, Jenson, Christensen, Curry, and Matt Christensen
Joan Johnson, Lynne Christensen and Sherilyn Curry