Originally Published November 2000
Another device reclassification leads to controversy involving the CDRH division overseeing dental devices.
James G. Dickinson
At first glance, the ingredients are strikingly similar: two small, pioneer medical device companies, each with a successful, old-technology, single-product line, and each facing potential financial ruin by the same CDRH review division— following the reclassification of their preamendment devices.
In 1997, it was Myotronics Inc., a small Tukwila, WA, manufacturer of preamendment orthodontic muscle monitors that ran afoul of CDRH's Division of Dental, Infection Control, and General Hospital Devices. At wrap-up, the fight had involved both Congress and the HHS inspector general's office, and caused two division employees to be disciplined and two Dental Products Advisory Panel members to lose their seats.
In 2000, it is TMJ Implants Inc., a similarly small Denver, CO, manufacturer of preamendment cobalt-chrome ASTM temporo-mandibular joints (or TMJs, the joints that connect the lower jaw to the skull). As described by its president, Robert W. Christensen, the company has run afoul of two other employees in the same division, in a way that not only virtually removed his product from the market but also, he alleges, delivered market share to a competitor.
In each case, the companies claim to have lost more than $1.5 million and to have been forced from the market for longer than a year while battling FDA. Christensen has been awaiting final approval of one premarket approval (PMA) application (an "approvable" letter pending GMP inspection had been issued on September 1) and a panel hearing was scheduled for October 6 on a second PMA for a partial version of the same device.
As in the Myotronics precedent, a central issue in the current case is CDRH's decision to reclassify preamendment devices that had long marketing histories and records of clinical use, but lacked the finely disciplined scientific documentation that FDA expects for a Class III PMA application.
FDA classified Myotronics' device into PMA-required Class III in response to criticisms from the clinical community orchestrated by adherents of a newer, rival technology who had infiltrated the Dental Products Advisory Panel and won over key employees in the CDRH division.
FDA reclassified all TMJ devices into Class III in response to the national controversy over unnecessary surgeries and adverse reactions to a TMJ device manufactured by Vitek Corp. in the early 1990s.
In both the Myotronics and TMJ Implants cases, the companies alleged that division employees presented biased information to the advisory panel in a way that brought unfair advantage to marketplace rivals and failed to investigate each company's complaints.
In the current case, the competitor, TMJ Concepts (Camarillo, CA), won approval of its PMA within two months of presenting it to the advisory panel, in the same session in which TMJ Implants' PMA was presented. Both devices were recommended for approval unanimously, but the older, all-metal device was subject to more restrictions than the newer device, which uses a high-molecular-weight polyethylene head (the upper-jaw cup in which the lower jaw's metal prosthesis pivots) and came to FDA with the level of documentation typical of modern orthopedic design and development technology.
The newness of the TMJ Concepts device seems to have impressed FDA's staff reviewing the long, mixed documentation of the older product, Christensen says. He recalls CDRH's lead reviewer, branch chief Susan Runner, commenting in a meeting that the Christensen technology was dated and questioning why it hadn't been redesigned. According to Christensen, there is no need to fix what isn't broken. "This thing works better than anything they've got out there," he asserts.
Christensen argues that Runner should have recused herself from reviewing the rival devices in 1999 because, he alleges, she received oral surgery training under a surgeon who subsequently became a lead technical consultant for TMJ Concepts. However, Runner states that she only performed one or two procedures under the direction of the surgeon, approximately 10 years ago. Runner contends that she had no further contact with him until the advisory committee meeting that reviewed the TMJ Concepts device in May 1999.
Last April, Runner prepared a critical memorandum on the Christensen device for the October 6 advisory committee meeting, faulting the quality of the clinical data presented and concluding that it was "insufficient to support safe and effective use of this device."
Runner wrote that her review branch had "many concerns," among them the "varied group of individuals with a range of diagnostic characteristics" that TMJ Implants had identified as the target patient population. "The indications that are proposed are vague," she wrote. "Internal derangement is not a specific diagnosis and the treatment information does not demonstrate that confounding conditions were eliminated from the patient set."
Christensen asked a consultant, dental surgeon James T. Curry of Colorado's Highlands Ranch Center for Aesthetic and Maxillofacial Surgery, to critique Runner's memorandum, which he did in a three-page letter to FDA. In the letter, he said Runner's conclusion that the data were insufficient to support safe and effective use of Christensen's device "is puzzling to me, because it does not accurately reflect the contents of the data presented throughout the PMA documents as well as recent communications to
Curry scorned Runner's criticism of "internal derangement" as a specific diagnosis, saying it has long been recognized by the Society of TMJ Surgeons, among others. He also wrote that Runner had mistakenly characterized one of his own studies on the Christensen device: "What on earth could Dr. Runner hope to accomplish with the FDA panel by stating only half-truths in much of her memorandum?"
Four years ago, an analogous complaint was leveled at another Division of Dental, Infection Control, and General Hospital Devices employee during the Myotronics turmoil. That employee was disciplined and left the agency. This time, however, CDRH director David W. Feigal says he is satisfied that Runner has no agenda against Christensen's device.
Another TMJ Implants consultant, oral surgeon Rick Alexander, director of the division of oral and maxillofacial surgery at St. Lukes–Roosevelt Hospital Center, New York City, is also critical of Runner and the way her branch has handled the two competing devices. He cites scientific reports linking the polyethylene material used in the TMJ Concepts implant to osteolysis. Alexander states that he and about 100 other oral surgeons he knows are telling patients to wait until FDA approves the TMJ Implants all-metal device.
TMJ Concepts president and founder David Samson strongly defends the material used in his device, contending that the literature cites osteolysis only in connection with some heavy-load-bearing hip implants. It's a long-known problem that arises from polyethylene particles "of a particular morphology or a particular size" that wear away from the material after prolonged and heavy use, and provoke an adverse reaction in the surrounding tissue.
Alexander lauds the amount of research and testing that Christensen has done on his device, saying it has been more than that done on any other type of joint replacement device. "There's not one hip or knee manufacturer that's done the volume of testing that he's done. Runner just keeps ignoring all this. They're getting ready to have a panel meeting on the partial joint replacement, and she just absolutely took all the facts and totally distorted them. We've got three or four doctors writing letters to try to introduce this distortion of the truth at the panel meeting," says Alexander.
Alexander charges that Runner and her superior, division director Tim Ulatowski, singled Christensen out because "they want to get him off the market." According to Alexander, potentially damaging confidential FDA information was leaked at the October 1999 New York Society of Oral-maxillofacial Surgeons meeting that suggested that the Christensen device would soon be removed from the market.
Alexander says that "Runner has told everybody that published data in our specialty is no good because it's anecdotal. It's not anecdotal." According to Alexander, the studies were published in several peer-reviewed scientific journals, including Oral Surgery, Oral Medicine, Oral Pathology, Oral and Maxillofacial Clinics of North America, and the British Journal of Oral and Maxillofacial Surgery.
Alexander was so concerned about Runner's alleged bias and association with TMJ Concepts' consultant that he sent Feigal four complaints about her over a seven-month period. However, FDA's press office told this reporter that an investigation was not opened "because we never got enough information to warrant one." Alexander says he was never told his information was weak, nor was he asked to elaborate on it.
In a rejection of Alexander's charges, a May 25 letter from CDRH Office of Device Evaluation integrity officer Carl DeMarco said the charges related to "statements by third parties, rumors, and past professional training that occurred a long time ago." Despite these weaknesses, DeMarco said, the allegations had been referred six months previously to FDA's Office of Internal Affairs.
Feigal states that there is no FDA effort to keep the Christensen device out of the market and that CDRH "recognizes that there is a following for this device."
Note: As MD&DI was going to press, FDA conducted a week-long preapproval inspection of TMJ Implants—just as the panel meeting on Christensen's second PMA was opening. However, after a session that dwelt heavily on data issues, the panel voted unanimously to reverse its 1999 decision and find the devices not safe and effective at this time. Alexander and Curry have challenged the panel members' qualifications in written complaints, and DeMarco has agreed to investigate.
James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.