UNITED STATES of America, Plaintiff-Appellee, v. LAERDAL MANUFACTURING CORP.; And John L. Karpowicz, Defendants-Appellants

The Amended Memorandum disposition, filed October 31, 1995, is redesignated as an authored opinion by Judge D.W. Nelson, Circuit Judge.

OPINION

Appellant Laerdal Manufacturing Corp. appeals the order of the district court that Laerdal be “perpetually restrained and enjoined from directly or indirectly ... (f)ailing or refusing to furnish information required by or under 21 U.S.C. § 360i, in accordance with” Medical Device Reporting (“MDR”) regulations, 21 C.F.R. § 803 . United States v. Laerdal Manufacturing Corp., 853 F.Supp. 1219 (D.Or.1994). Laerdal is a manufacturer of automated external defibrillators (“AEDs”), which are applied to cardiac arrest victims in order to convert ventricular fibrillation back into regular heartbeats. In its findings of fact, the court determined that Laerdal had violated 21 C.F.R. § 803.1 (a) which requires a manufacturer to file a report with the Food and Drug Administration (“FDA”) “whenever information is received that reasonably suggests that a patient care device ... may have caused or contributed to a death or serious injury.” Id. at 1237 .

Laerdal argues that the court improperly imposed this injunction, because there was no cognizable…