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Plourde v. Sorin Group USA, Inc.

judge holding a book and gavel

Court: US Court of Appeals for the First Circuit

Docket: 21-1145

Opinion Date: January 11, 2022

Judge: Ojetta Rogeriee Thompson

Areas of Law: Personal Injury, Products Liability

This case law update is brought to you by Freeway Law auto accident and personal injury lawyers in Orange County. The following is not one of our cases, but it is of some significance, and we thought we should share it with our readers for informational purposes. The information above is for informational purposes only and not to be construed as legal advice.

The First Circuit posed a question of Massachusetts state law to the Massachusetts Supreme Judicial Court (SJC) in this negligence and failure to warn case, holding that this case met both the SJC’s and this Court’s certification standards.

Appellants sued Sorin Group USA, Inc. in Massachusetts state court alleging negligence and failure to warn claims predicated on Sorin’s not reporting adverse events to the Food and Drug Administration (FDA) concerning Mitroflow malfunctions in young patients. Sorin removed the lawsuit to federal court under diversity jurisdiction. The trial court judge granted summary judgment to Sorin, concluding that Appellants’ claims were preempted. At issue on appeal was whether Massachusetts law imposes a duty on medical device manufacturers to report adverse events to the FDA that no more than parallel the Food, Drug, and Cosmetic Act and FDA regulations. The First Circuit certified to the SJC the question of whether a manufacturer’s failure to report adverse events to a regular such as the FDA gives rise to liability under Massachusetts law.

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