In a mass tort product liability, class action and consumer fraud consolidated litigation involving Allergan’s Biocell textured breast implants and tissue expanders, Allergan moved to dismiss plaintiffs’ complaints on preemption grounds and non-preemption grounds. Plaintiffs alleged these type of medical devices, including tissue expanders approved through the 510(K) process and implants which were sold under premarket approval (PMA) but later recalled, caused breast implant associated anaplastic large cell lymphoma (BIA-ALCL).

The federal district court found the claimed failure to properly file adverse event reports, manufacturing defect claims, express and implied warranty claims, negligent misrepresentation claims, breach of state consumer fraud and deceptive trade practice laws and negligence per se claims were not preempted. Plaintiffs’ label-based failure to warn claims, negligent failure to warn claims alleging failure to conduct post-PMA clinical studies and claims concerning investigational devices used in an approved clinical trial were preempted. These preemptions did not apply to tissue expanders and implants sold before the PMA, since they were cleared via the 510(K) process. Insofar as the non-preemption dismissal motions were concerned, manufacturing defect claims were sufficiently pleaded to survive the motion to dismiss. The court addressed claims of negligence per se, adverse event report-based failure to warn, breach of warranty and negligent misrepresentation claims on a state-by-state basis, dismissing or preserving the claims depending upon whether the particular state recognized these claim under its substantive law. Allergan challenged plaintiffs’ class action allegations for medical monitoring of plaintiffs not yet diagnosed with BIA-ALCL and persons who had signed a release of liability prior to the explant. The court found the named plaintiffs did not have standing as class representatives to assert claims for state specific subclasses if they were not residents of the state. Thus, since the named class action plaintiffs were citizens of 39 different states, the court dismissed class action subclasses for the other states without a representative, but allowed plaintiffs to reappoint class representatives to cure these deficiencies. The court declined to dismiss the class action allegations on predominance, typicality and superiority grounds. The court found a Rule 23(b)(2) medical monitoring class was inapplicable and dismissed the nationwide medical monitoring class, but without prejudice.

In Re: Allergan Biocell Textured Breast Implant Products Liability Litigation (U.S.D.C. D.N.J. Case No. 2:19-md-2921-BRM-ESK, MDL No. 2921) (unpublished opinion, March, 19, 2021)

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