Opinion ID: 172805
Heading Depth: 2
Heading Rank: 2

Heading: The Events Giving Rise to the Imposition of Money Penalties Against Petitioners

Text: FDA employees conducted an inspection of TMJI's facility and MDR files from July 29, 2003 to August 11, 2003. As a result of that inspection, FDA determined that TMJI should have submitted MDRs for twenty-two events, each of which involved either a device explant (the device was surgically removed) or antibiotic treatment. According to information received by petitioners, these surgical and medical interventions were performed due to, among other things, apparent infections, loose screws, swelling, pain, bone growth, decreased mobility of the jaw, headaches, seizures, inflamed tissue, vertigo, and foreign body reaction occurring after a TMJ had been implanted in the patient. FDA informed petitioners in a February 24, 2004 Warning Letter to Dr. Christensen that written MDRs must be submitted for the twenty-two events within fifteen days. The Warning Letter further notified petitioners that [y]ou should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties. Petitioners did not submit MDRs for these events. Instead, on March 4, Dr. Christensen wrote to FDA to express petitioners' substantial disagreement with the FDA's position. Christensen requested a meeting with FDA personnel to arrive at a proper decision with respect to what, if any, actions are required of the company in this matter. Dr. Christensen further expressed his view that FDA may be using Warning Letters to retaliate against TMJI. Dr. Christensen and three colleagues met with FDA representatives at FDA's District Office in Lakewood, Colorado on March 10, 2004. The meeting can be summarized as follows: Dr. Christensen contended that in each of the disputed events TMJI's devices were not explanted because of any inherent problem with the device itself; rather, natural progression of the TMJ disease necessitated removal of the device. For example, Dr. Christensen explained that bone growth may occur after a TMJI device is implanted, but that in such a case, [t]he device didn't go bad[,] it just meant that the disease continued despite what we did and now we've got to go in and maybe build a bigger one or take out more bone or get rid of adhesions or something else. Petitioners' position was that pain, swelling, and loose screws are not serious injuries because they are temporary and are not unexpected following placement of the device; infections did not need to be reported because the devices are sterile when they leave the manufacturer's facility and therefore could not have caused any infection. Dr. Christensen explained that his thirty years of experience with the devices made it reasonable to conclude that the devices themselves did not cause the symptoms that necessitated the explant. Dr. Christensen and his colleagues also expressed concern that filing MDRs would expose TMJI to civil lawsuits and provide their competitors with an unfair advantage. They further contended that they could not conclusively determine that their devices were even associated with certain events, since the only information they had about those events came from voluntary MedWatch forms that did not contain sufficient information to conduct an investigation of the events. FDA personnel disagreed with petitioners' position. The agency explained that the definition of serious injury is one that requires medical intervention to prevent a permanent impairment. Thus, while pain and loose screws may not be serious injuries in and of themselves, the failure to medically intervene to treat those conditions could lead to permanent impairment of the TMJ or jaw function. According to FDA, the relevant regulations require TMJI to report all explants and medical interventions when TMJI's devices may have been a contributing factor in the need for such interventions, and that if TMJI did not have sufficient information to rule out its device as a potential cause of the interventions then it must report them. FDA made clear that submitting an MDR did not constitute an admission from TMJI that its devices contributed to any injury, and the agency suggested that TMJI articulate a response to the warning letter that addressed each one of the events and why petitioners did not consider them to be reportable. Thereafter, petitioners initiated a series of phone calls and letters to FDA. The communications, which included petitioners' written position on each of the twenty-two events, continued to express petitioners' views that filing MDRs would subject them to liability; disease progression was the reason for each device explant or medical treatment; FDA's interpretation of § 360i was overly broad; petitioners could not determine whether TMJI's devices were involved in many events; and FDA was not as experienced as Dr. Christensen and thus incorrectly determined that TMJI devices may have caused or contributed to the reported events. Petitioners sought another face-to-face meeting with FDA. In its letters in response, FDA adhered to its position as articulated during the March meeting. On July 14, the agency emphasized the statutory and regulatory language requiring MDRs whenever a manufacturer has information reasonably suggesting that its device may have caused or contributed [to] a serious injury. FDA concluded: For the reasons discussed in this letter, the events identified in the Warning Letter are reportable under the MDR regulation. Because these reports are already past due under the MDR regulation, we expect these reports within thirty days of the date of your receipt of this letter. Petitioners did not submit the twenty-two MDRs. Instead, they continued to send letters to FDA, pressing for a more comprehensive definition of serious injury and noting that petitioners were undertaking another review of the twenty-two events identified in the Warning Letter. Petitioners also continued to request another meeting with FDA to further discuss their concerns. On August 12, petitioners determined that user error was involved in five of the twenty-two events and filed MDRs for those five events. In a September 7 letter, the director of FDA's Center for Devices and Radiological Health (CDRH) reiterated FDA's position that petitioners' construction of the MDR reporting requirements was too constrained. The letter explained that [b]ecause of their unique knowledge about their devices, manufacturers often look for a direct causal link between the device and the adverse event, overlooking the possibility that the device `may have contributed' to a reportable event [as articulated in 21 U.S.C. § 360i(a)(1)(A)]. FDA reminded petitioners that the remaining . . . serious injury reports should have been submitted to FDA by 30 days from the date of your receipt of our July 14, 2004 letter. . . . Please submit all outstanding MDR reports within the next 15 working days. The letter concluded: FDA's regulations provide avenues for individuals to appeal decisions within the agency. In particular, individuals may appeal the decision of an FDA employee to the employee's supervisor under 21 CFR Part 10.75, Internal agency review of decisions. Under this regulation, the proper avenue of appeal of the Center for Devices and Radiological Health's decision that you are required to submit the . . . additional MDR reports identified in the February 24, 2004, Warning Letter, as well as any other additional reports concerning other adverse events that meet the requirements of 21 CFR Part 803MDR regulation, is to the Commissioner of the Food and Drug Administration. After petitioners again refused to submit additional MDRs and instead reiterated their explanations as to why each event was not reportable, CDRH responded on November 10 with an offer to treat the explanations as MDRs in full satisfaction of petitioners' statutory and regulatory obligations. CDRH further explained that the agency had expended significant resources responding to petitioners' correspondence and that they had exhausted their appellate rights at that level of the agency. Finally, CDRH again explained petitioners' appellate rights: As stated in [the] letter of September 7, 2004, FDA's regulations provide avenues for individuals to appeal decisions within the agency. In particular, individuals may appeal the decision of an FDA employee to the employee's supervisor under 21 Code of Federal Regulations (CFDR) part 10.75, internal agency review of decisions. Under this regulation, the proper avenue of appeal of CDRH's decision that you are required to submit the . . . additional MDR reports identified in the February 24, 2004, Warning Letter as well as any other reports concerning adverse events that meet the requirements of 21 CFR Part 803MDR regulation, is to the Commissioner of the Food and Drug Administration. Accordingly, any further correspondence from TMJ Implants, Inc. to CDRH contesting the reportability of the MDR events listed in our February 24, 2004, Warning Letter will be considered an appeal and forwarded to the Commissioner. You should be aware that pendency of such an appeal does not preclude the Agency from taking action to enforce the requirements of the Food, Drug, and Cosmetic Act. See 21 C.F.R. § 10.35(d). (Emphasis added.) On November 16, petitioners refused FDA's offer to consider their explanations as MDRs and requested internal agency review under 21 C.F.R. § 10.75. On July 14, 2005, CDRH filed a CMP against petitioners based on their failure to submit MDRs for the remaining seventeen events identified in the February 2004 Warning Letter. [1] One week later, FDA denied petitioners' request for agency review under 21 C.F.R. § 10.75. The agency reasoned that because the issues were now the subject of a CMP and would be fully developed and determined by a neutral ALJ, it would be inefficient and duplicative for FDA simultaneously to review the matter at that point. Petitioners and FDA conducted extensive discovery and submitted comprehensive briefs in the CMP action. The ALJ held an evidentiary hearing and ultimately issued an Initial Decision against petitioners on July 6, 2007. In its Final Order of September 25, 2007, the ALJ imposed sanctions in the amount of $170,000 on both TMJI and Dr. Christensen individually. Petitioners appealed to the DAB, see 21 C.F.R. § 17.47, which affirmed the ALJ's decision and order against them. Petitioners now petition for judicial review in this court.