## Facts

- Laerdal Manufacturing Corporation manufactured automated external defibrillators (AEDs), medical devices regulated under the Federal Food, Drug, and Cosmetic Act (FDCA).
- FDCA reporting duties required manufacturers to submit Medical Device Reports (MDRs) when they received information that reasonably suggested a device may have caused or contributed to a death or serious injury.
- The United States alleged Laerdal received information linking a death to a Laerdal AED but failed to file the required MDR.
- After a bench trial, the district court found Laerdal violated the MDR regulation and entered a permanent injunction ordering Laerdal to furnish MDR information as required by 21 U.S.C. § 360i and 21 C.F.R. part 803.
- On appeal, Laerdal and an individual defendant challenged the propriety and scope of the permanent injunction, arguing the violation was isolated, unintentional, and addressed through corrective measures, and that equities weighed against an injunction.

## Issues

1. Whether the district court abused its discretion in issuing a permanent injunction compelling future compliance with MDR reporting requirements.
2. Whether the record supported a finding of a cognizable danger of recurrent MDR violations despite defendants’ claims of an isolated, unintentional lapse and post-violation remediation.

## Decision

- The Ninth Circuit affirmed the district court’s judgment.
- The court held the district court did not abuse its discretion in ordering permanent injunctive relief requiring compliance with MDR reporting obligations.
- The court rejected defendants’ contention that the injunction was unwarranted due to the asserted absence of future risk.

## Legal Principles

- A permanent injunction may issue in a regulatory enforcement action when past conduct supports a cognizable danger of recurrent violations, even if the proven violation is characterized as isolated.
- MDR reporting obligations are triggered when information reasonably suggests a device may have caused or contributed to a death or serious injury; definitive causation is not required.
- Lack of intent and post-violation remedial measures are relevant to equitable relief but do not bar an injunction where future compliance and public health interests justify judicial oversight.
- Appellate review of the scope of injunctive relief is highly deferential; reversal requires a strong showing that the district court relied on clearly erroneous factfinding or erroneous legal principles.

## Conclusion

The Ninth Circuit upheld a permanent injunction requiring a medical-device manufacturer to comply with MDR reporting duties because the district court could reasonably find a sufficient risk of future noncompliance and prioritize the public interest in complete adverse-event reporting under the FDCA.


United States v. Laerdal Mfg. Corp., 73 F.3d 852 (9th Cir. 1995)