Mixed Bag in New Jersey Medical Device Preemption Opinion

On May 4, 2021, New Jersey Superior Court Judge Rachelle Harz issued an opinion that may be of interest to readers who follow medical device preemption decisions. Judge Harz, who oversees the centralized multicounty litigation in New Jersey state court involving product liability claims with respect to Allergan’s Biocell line of textured breast implants and tissue expanders, agreed with the defendants in dismissing some of the claims asserted in the plaintiffs’ master long form complaint on preemption grounds, but disagreed and declined to dismiss other claims.

Because the defendants’ motion was limited to whether the plaintiffs’ claims were preempted by federal law, Judge Harz did not address any other potential bases for dismissal, such as whether plaintiffs’ negligence-based claims and/or consumer fraud claims were subsumed by the New Jersey Product Liability Act.

After discussing the specific products and the regulatory approval processes at issue, Judge Harz proceeds to address the bases for both express and implied federal preemption in the context of the various claims asserted by the plaintiffs, including failure to warn, manufacturing defect, design defect, breach of express warranty, and consumer fraud. Medical device preemption is, of course, a complicated issue, but a common theme in her opinion is the idea that to avoid preemption, a claim must be premised on a violation of an FDA requirement and based on a state common law duty that is parallel to, but not in addition to, the federal requirement. Much of her analysis focuses on the specific allegations raised by the plaintiffs with respect to the various products and various claims and whether those claims can meet this test. As noted above, some of the plaintiffs’ claims survive this analysis, but others do not.

Judge Harz’s opinion, nuanced and fact-based as it is, is worth reading for anyone who regularly practices in the area of medical device preemption, as well as by anyone who defends medical device product liability claims in New Jersey.


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