Last week, the 9th Circuit U.S. Court of Appeals upheld the dismissal of four lawsuits brought against Mentor Worldwide LLC’s MemoryGel silicone breast implants, stating that the claims are barred by federal law.
According to the memorandum dated February 5, the federal appeals court panel said that the four separate but similar claims were properly dismissed by a California federal judge as preempted under the 1976 Medical Device Amendment (MDA) to the Food, Drug, and Cosmetic Act.
The panel further discovered that the plaintiffs did not allege actual adverse events that the Johnson & Johnson (J&J) unit did not report to the Food and Drug Administration (FDA). According to the panel, state-law claims are preempted unless they are based on a parallel requirement under the MDA.
The lawsuits in which the women alleged fatigue, muscle pain, migraines, and the defects in the implants were tossed in August 2019 in separate orders by U.S. District Judge Andre Birotte Jr.
The panel stated that, in states like California that recognize failure to report claims, an allegation that a company failed to report adverse events could become the basis of a parallel claim that can escape preemption. The plaintiffs made conclusory and speculative allegations, which according to the panel, is insufficient to state a parallel failure to warn claim.
Currently, Allergan is also facing nearly 150 product liability lawsuits and class action lawsuits over its recalled “Biocell” textured breast implants, each claiming that the textured design was unreasonably dangerous and defective, and the manufacturer knew that it increased the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) yet failed to warn about those risks.
