TMJ Implants, Inc. v. U.S. Dept. of Health & Hum. Servs., No. 08-9539

In a petition for review of an FDA order imposing civil penalties on a medical device manufacturer for failing to file certain reports, the order is affirmed where: 1) the hearing petitioners received provided them with due process; 2) the events at issue constituted "serious injuries" under 21 U.S.C. section 360i(a)(1)(A); and 3) petitioners were only required to have acted in deliberate indifference to or reckless disregard of the reporting requirements.

Read TMJ Implants, Inc. v. U.S. Dept. of Health & Hum. Servs., No. 08-9539

Appellate Information

Filed October 27, 2009

Judges

Opinion by Judge Tacha

Counsel

For Petitioners:

Lynn M. Watwood, Jr., TMJ Implants, Inc., Golden, CO

For Respondent:

Peter R. Maier, Gregory G. Katsas and Douglas N. Letter, Attorney, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.