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.
Filed October 27, 2009
Opinion by Judge Tacha
Lynn M. Watwood, Jr., TMJ Implants, Inc., Golden, CO