TMJ Implants, Inc. v. United States Dep't of Health & Human Services

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Before TACHA, EBEL, and HARTZ, Circuit Judges.

TMJ Implants, Inc. (“TMJI”) manufactures and distributes temporomandibular joint (“TMJ”) implants. Dr. Robert W. Christensen is TMJI’s founder and president. In July 2005, the Food and Drug Administration (“FDA”) filed a complaint for money penalties (“CMP”) against TMJI and Dr. Christensen (collectively, “petitioners”) after concluding that they had knowingly failed to submit seventeen medical device reports (“MDRs”) relating to TMJI’s implants. That action culminated administratively in a Final Decision by the Departmental Appeals Board (“DAB”) within FDA’s parent agency, the Department of Health and Human Services. The Final Decision affirmed determinations by an administrative law judge (“ALJ”) that petitioners had knowingly failed to submit each of the seventeen MDRs and that petitioners were each liable for penalties of $170,000 ($10,000 per violation).

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TMJ Implants, Inc. v. United States Dep't of Health & Human Services

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