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.
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