TMJ Implants, Inc. v. United States Department of Health & Human Services

TMJ Implants, Inc. (TMJI) (plaintiff) manufactured and distributed temporomandibular joint (TMJ) implants. TMJ implants are used to treat patients who suffer from TMJ dysfunction, which can severely impact jaw function and impede speaking, eating, breathing, and other daily activities. TMJ implants are medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, the Food and Drug Administration (FDA) (defendant) required that every medical-device manufacturer file a medical-device report (MDR) whenever the manufacturer becomes aware of information that reasonably suggests one of its marketed devices may have contributed to a death or serious injury. The FDCA defined a serious injury as one necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. Medical-device manufacturers commonly received reports about adverse events or problems with devices from the FDA’s MedWatch program. Patients provided voluntary reports about medical devices to the FDA through the MedWatch forms, and the FDA forwarded the report to the manufacturer. From July to August 2003, the FDA conducted an inspection of TMJI’s facility and its MDR files. The FDA determined TMJI should have submitted MDRs for 22 events relating to the removal of TMJ implants or antibiotic treatment. In February 2004, the FDA sent a warning letter to TMJI and Dr. Christensen stating that MDRs for the 22 events must be submitted within 15 days. TMJI contacted the FDA multiple times to dispute the requirement and what constituted a serious injury. In August 2004, TMJI submitted MDRs for 5 events that TMJI determined to be the result of user error. In July 2005, the FDA filed a complaint for money penalties against TMJI and Dr. Christensen. The FDA concluded TMJI had knowingly failed to submit 17 MDRs relating to TMJI’s implants. TMJI and Dr. Christensen appealed to the Department of Health and Human Services Appeal Board, and an administrative-law judge decided in the FDA’s favor and imposed $170,000 of sanctions on TMJI and Dr. Christensen. TMJI and Dr. Christensen appealed to the Tenth Circuit.