Supreme Court Backs Medical Device Makers

Scott Kappes

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On Wednesday the Supreme Court sided with medical device makers; delivering an 8-1 decision in favor not allowing patients injured by an FDA approved medical device to file lawsuit against the manufacturer. The Court cited a 1976 law that they say bars state-law claims challenging the safety and efficacy of medical devices that have been received pre-market approval from the FDA. The ruling only applies to the more sophisticated and riskier devices that require FDA approval before being introduced to the market; however, these types of devices seem to be the likely culprits for product liability litigation.

The ruling could benefit other device makers, who have argued that the FDA's judgment that a product is safe and effective should protect companies from being sued for liability in state court.

Justice Scalia wrote the majority opinion justifying the Court's decision. He says "Congress' concern for those injured by FDA-approved devices was outweighed by its 'solicitude for those who would suffer without new medical devices if juries were allowed to apply the (injury) law of 50 states to all innovations." He also noted that the FDA spends and average of 1,200 hours reviewing each medical device application. During this process devices undergo rigorous testing by the FDA and are approved only when providing reasonable assurance of safety and effectiveness.

The implications of this case could reach beyond the medical device industry and into the pharmaceutical litigation. A similar case to be argued this fall with define how this type of logic applies to FDA approved drugs.

Plaintiffs' lawyers see the ruling as being "potentially dangerous for patients." The threat of a product liability lawsuit can persuade device makers to ensure product safety and keep public safety at the top of their interests.