The Court of Appeals for the Second Circuit has ruled that a products liability claim against a catheter manufacturer are preempted. More specifically, the Court held that “tort claims that allege liability as to a PMA-approved medical device, notwithstanding that device’s adherence to the standards upon which it obtained premarket approval from the FDA, are preempted by Section 360(k)(a)” of the 1976 Medical Device Amendments to the Food, Drug, and Cosmetic Act.
Accordingly, the Court dismissed the claim so far as it alleged “strict liability, breach of implied warranty, and negligent design, testing, inspection, distribution, labeling, marketing, and sale claims as to the Evergreen Balloon Catheter, a PMA-approved medical device.” The claim of negligent manufacturing was found not to be preempted, but it was dismissed on summary judgment because of the absence of a dispute as to material facts.
This is an interesting statement: “We note that our preemption analysis is quite limited in scope, affecting the small universe of cases resting on claims alleging liability despite a PMA-approved device’s adherence to the standards upon which it secured FDA premarket approval. We take care to explain that we do not hold that all state tort claims as to PMA-approved devices are preempted. Thus, tort claims that are based on a manufacturer’s departure from the standards set forth in the device’s approved PMA application – such as the Riegels’ negligent manufacturing claim – are not preempted.”
Judge Pooler’s dissent begins on page 41 of the opinion.
The case is Reigel v. Medtronic, Docket No. 04-0412-cv (May 16, 2006). Read the opinion by going here and searching for the name or number of the case. This case will find its way to the United States Supreme Court.
Read this opinion before accepting representation of a plaintiff in a medical device products case.