A group of close to 300 plaintiffs contend that Allergan Inc. and Allergan USA Inc (Allergan) failed to disclose the link between breast implants and Breast-Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), an immune system cancer. In addition, the Plaintiff’s alleged Allergan failed to maintain adequate product labeling, and asserted that Allergan disregarded submitting adverse event reports to the FDA. The implants had been subject to a July, 2019, voluntary recall requested by the FDA.
In August 2020 Allergan filed a dismissal motion arguing that federal medical device law preempts the claims over those devices that went through the premarket approval process. It has also sought dismissal of a class complaint that seeks medical monitoring. Plaintiffs assert that none of their claims are expressly preempted because the complaint does not challenge FDA’s premarket approval process or attempt to impose additional or differing requirements from those currently established. Instead, plaintiffs base their claims upon conduct that is in violation of state law duties, which parallel federal requirements. In this manner, plaintiffs’ stance is that their claims are not preempted because they do not rest exclusively on violations of federal requirements.