United States Tenth Circuit

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.

Appellate Information

• Decided 10/27/2009
• Published 10/27/2009

Judges

• TACHA, Circuit Judge., Before TACHA, EBEL, and HARTZ, Circuit Judges.

Court

• United States Tenth Circuit

Counsel

• For Appellant:
  
• Lynn M. Watwood, Jr., Counsel, TMJ Implants, Inc., Golden, CO, appearing for Petitioners.


• For Appellees:
  
• Peter R. Maier, Attorney, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C. (Gregory G. Katsas, Assistant Attorney General, and Douglas N. Letter, Attorney, Appellate Staff, Civil Division, United States Department of Justice, Washington, D.C.;  Thomas R. Barker, Acting General Counsel, Gerald F. Masoudi, Chief Counsel, Food and Drug Division, Eric M. Blumberg, Deputy Chief Counsel, and Michele Svonkin, Attorney, Food and Drug Administration, Rockville, MD, with him on the brief), appearing for Respondent.