## Facts

- TMJ Implants, Inc. (TMJI) manufactured temporomandibular joint implants regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
- FDA regulations required manufacturers to submit medical device reports (MDRs) when they became aware of information that reasonably suggested a marketed device may have caused or contributed to a death or serious injury, or a malfunction likely to do so if it recurred.
- “Serious injury” was defined to include injuries necessitating medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
- The FDA received adverse-event information through MedWatch reports, which it forwarded to manufacturers.
- After a July–August 2003 inspection, the FDA concluded TMJI failed to file MDRs for 22 events involving implant removal and/or antibiotic treatment.
- In February 2004, the FDA issued a warning letter directing TMJI and its founder/president, Dr. Robert W. Christensen, to submit MDRs for those events within 15 days; petitioners disputed that the events met the “serious injury” reporting threshold.
- TMJI submitted MDRs for five events in August 2004 but did not file MDRs for 17 remaining events.
- In July 2005, the FDA sought civil money penalties (CMPs) against TMJI and Christensen for knowingly failing to submit 17 required MDRs.
- An ALJ found knowing violations for all 17 events and assessed $10,000 per violation against each petitioner ($170,000 each; $340,000 total), which the HHS Departmental Appeals Board (DAB) affirmed.
- TMJI and Christensen sought judicial review in the Tenth Circuit under 21 U.S.C. § 333(f)(6).

## Issues

1. Whether the CMP proceeding was premature given petitioners’ ongoing dispute with the FDA after the warning letter.
2. Whether the 17 events were MDR-reportable under the “reasonably suggests” standard and the regulatory definition of “serious injury.”
3. Whether petitioners’ non-reporting was “knowing” within 21 U.S.C. § 333(f).
4. Whether CMP liability could be assessed against Christensen individually, in addition to the corporate manufacturer.
5. Whether the penalties assessed were excessive or an abuse of discretion.

## Decision

- The Tenth Circuit affirmed the DAB’s final decision in full.
- The court held the FDA was not required to delay enforcement after issuing a warning letter and could initiate CMP proceedings once the reporting deadline passed.
- The court upheld the agency’s determination that the 17 events were reportable, including events involving device removal or revision surgery and significant treatment, as meeting the “serious injury” definition or otherwise satisfying the reporting trigger.
- The court agreed that petitioners’ continued refusal to file MDRs after explicit notice supported a finding of a knowing failure to report.
- The court upheld CMP assessments against Christensen based on his responsible role in compliance decisions.
- The court upheld the $10,000-per-violation penalties against each petitioner as within statutory limits and supported by reasoned agency consideration of relevant factors.

## Legal Principles

- MDR reporting duties are triggered by information that “reasonably suggests” a device may have caused or contributed to a serious injury; proof of actual causation or fault is not required.
- An injury can qualify as “serious” when it requires medical or surgical intervention to prevent permanent impairment or permanent structural damage.
- In reviewing FDA MDR enforcement, courts generally defer to the agency’s reasonable interpretation of its own reporting regulations.
- For CMP liability under 21 U.S.C. § 333(f), “knowing” may be shown by actual knowledge or deliberate disregard; specific intent to violate the law is unnecessary.
- Corporate officers may be held personally liable for FDCA-related civil penalties when they have a responsible share in preventing or correcting violations and participate in the compliance decisions at issue.
- Penalty determinations are reviewed deferentially when within statutory bounds and supported by findings regarding gravity, repetition, and persistence of violations.

## Conclusion

The Tenth Circuit sustained FDA-imposed civil money penalties against both a device manufacturer and its president for knowingly failing to submit required MDRs, confirming the breadth of the “reasonably suggests” reporting trigger, supporting deference to FDA’s regulatory interpretations, and permitting individual liability for responsible corporate officers.


TMJ Implants, Inc. v. U.S. Dep’t of Health & Hum. Servs., 584 F.3d 1290 (10th Cir. 2009)