In the TMJI approval battles and other issues there was a deliberate attempt to cause the TMJ Implants, Inc. much harm. In so doing they would also be harming thousands of patients.
- Dr. Runner, of FDA asking Dr. C to not come to the May 10-11, 1999 Panel
- Dr. C brings full contingent of scientific experts. Vote 9-0 for approval
- Orthopedic surgeon professor on Panel tells Dr. C that was excellent presentation
- In July FDA approves TMJ Concepts devices with 34 patients out 24 months
- July-August Runner tells Dr. C TMJI devices unapproved. TMJI has some 16,000 devices out a total of 38 years
- FDA takes TMJI devices off market for 21 months
- TMJI downsizes 39-15 staff
- Approx. 50 surgeons complain to FDA about no availability of a Partial TMJ device for hemiarthroplasty. Surgeons can only do total TMJ arthroplasty. This harmful to patients and not medically correct.
- Dr. Ric Alexander in his 4-26-2000 letter to Dr. Fergal has complained about the treatment of TMJI in the approval process and relates earlier CDRH/FDA correspondence where he is told don’t write to CDRH/FDA as Runner and Ulatowski will get “angry”. He is also said Runner’s statement “the surgeons performing the Christensen hemiarthroplasty are in violation of the standard of care”, is outrageous.
- Dr. Alexander goes on to say, “you are advised that if fairness, scientific data, objective evaluation, attn. to publications and to the AAOMS Parameters of Care are not returned to the decision making process regarding the TMJI devices, the aforementioned surgeons are resolved to do whatever is necessary to resolve this travesty of science and justice.”
- FDA calls for 2nd Panel Hearing Oct 6, 2000. Vote is rigged 8-0 disapproval.
- In his October 10, 2000 letter to Feigal, Dr. James Curry lists a long list of grievances regarding the October 6, 2000 Panel. He was a surgical witness for TMJI. He makes the statement about the Panel Hearing, “I quite frankly was embarrassed for the FDA and my profession witnessing the events that took place last week.” In another letter Dr. Curry asks what possibly gives Runner the permission to lie?
- U.S. Congressman Tancredo in a Nov. 9, 2000 letter to J.G.Brown, HHS, IG in referencing the TMJI situation states “he has extreme concerns about the process.”
- Dr. Stephens, an October 6th Panel member calls Dr. Christensen afterwards. He voted against approval of the TMJI devices, when before, in the May 11, 1999 Panel he voted for approval. He tells Christensen on the phone why he now voted against, because, “If I vote for the device and no one else does so, and then, as a consultant, I will not be asked to return.”
- Dr. Alexander’s October 9, 2000 letter to Congressman Tancredo, he states, “This Panel meeting was a total and complete farce.” He went on to say that the chairman Heffex allowed Dr. Doran Ryan to blatantly lie to Panel members regarding hemiarthroplasty of other joints. He also mentioned that one of the lay Panel members, Mr. Larson, “smelled a rat.” Alexander goes on to say that Runner, Ulatowski and Angela Blackwell must be removed from their positions of power and authority before another company is subjected to their outrageous behavior and abuse.”
- In January, 2001, Dr. Statland overrides Runner and Ulatowski and asks for approval of TMJI devices. Ulatowski says Statland will regret that action. Statland’s words to Ulatowski and Runner were, “This is what we are going to do.” Ulatowski gets mad.
- Bernie Statland, MD, JD, brought in as the new Dir. of the ODE to help with dispute tells Dr. C he was so upset with how Dr. Christensen and TMJI have been treated. He stated he could not sleep for two nights thinking about it. This was before the final approvals. He had 6 months earlier told Christensen how pleased he was to be working for the FDA, but within 6 months after pushing TMJI’s implants through the approval process he resigned his position with FDA and a few months later he dies at a very early age.
- May 22, 2001 the TMJ Association, a lay group headed by Terrie Cowley, a friend or Runners, petitions to get the FDA approvals of TMJIs devices rescinded. The FDA turns that suggestion down.
- FDA/CDRH aren’t through with their attacks on Dr. Christensen and TMJI. Now comes Nick Nance and the 7-29-2003 to 8-11-2003 FDA Denver District inspections of TMJI. TMJI receives Warning Letter dated 2-24, 2004 stating TMJI must file 22 events as MDRs (Medical Device Reports)
- Dr. Christensen meets with Warwick and others at the Denver District with Dr. Curry, Watwood, Maureen Mooney, the TMJI Regulatory person, to discuss the now 17 events listed. Warwick states all decisions are being made by FDA Center in D.C. and that Dr. C needs to take further discussions to the FDA Center.
- Dr. Christensen’s letter to Tom Warwick Compliance Officer Denver Dist. re TMJI- FDA Denver District meeting re MDR events. TMJI attempts to find who at FDA was responsible for making decision the 17 events should be reported as MDRs. No answer, ever.
- We finally took the discussion to FDA Center with Schultz and team. We are informed by Schultz, that we need to make an “appeal” to the Commissioner. On November 16, 2004 Dr. Christensen sends a letter to Schultz for delivery to the FDA Commissioner. No reply for the next 8 months.
- July 14, 2005 CDRH/FDA files a CMP (Civil Money Penalty) against TMJI, Dr. Christensen and Mrs. Mooney.
- July 21, 2005, Dr. Christensen receives a letter from Sheila Wycoff, Assistant Commissioner, FDA stating she was unaware of CMP and now an “Appeal to the Commissioner would be ineffectual and duplicative.”
- In later discovery it is shown CDRH had been discussing a CMP action against TMJI for some 4-5 months before the suggestion to Dr. Christensen of the fact he might ask for an appeal to the Commissioner.
- Also in discovery it is shown that Sheila Wycoff had been involved in making the CMP decision as early as 4 months before the CMP was filed. Making her comment about not knowing about it to Dr.Christensen, an apparent fabrication..
This approval process and later MDR/CMP actions for the TMJ Implants, Inc. was not just a discussion about a normal approval process for a commercially viable, very successful medical device for correcting early and late TMJ degenerative joint disease, but also for the reconstruction of serious body parts in cases of congenitally missing TMJ and associated anatomical structures, such as mandible, skull base, cheek bones and even orbital rims when these structure were involved in the deficient or diseased temporomandibular joints. The approval process was anything but routine or normal for these pre-amendment, grandfathered, predicate devices
The later attack regarding which patient events should be included in MDR reportable events was anything but a real discussion. As Lynn Watwood Jr., Esq. pointed out, of the 17 events in question neither we at TMJI nor FDA’s surgeon witness at the ALJ hearing could see where anyone might think 9 of those 17 events were in anyway reportable since there was no real evidence implants had been placed, and if so, who’s? Of the balance, one would have to stretch one’s imagination to consider 3 events as reportable. Dr. Christensen as the innovator of these implants and even this form of surgery was certainly an authority on the use and history and testing of these TMJ implants in thousands of patients. Consequently he would have a pretty reliable and accurate feeling about which events, if any, would fit the Code of Federal Regulations definition of which events might be MDR reportable.
Should there have been one in those 3 events that might have been so reportable, Dr. Christensen would have it as an MDR. Should I somehow been wrong, would it warrant filing a $630,000 penalty against me, my company and the regulatory person? Has FDA ever done exactly that to any other medical device company since the MDA was brought into existence in 1976? If so, to whom? As Lynn Watwood, Esq. has stated, there was no due process in any of these actions
Was the process of the Approval and later the CMP just a corrupt process, or was it criminal? You decide.