Weber v. Allergan, Inc., No. 18-15212 (9th Cir. 2019)Annotate this Case
The Ninth Circuit affirmed the district court's grant of summary judgment to Allergan in an action under state law alleging that plaintiff suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), Congress permitted FDA oversight of medical devices; the MDA expressly preempts state law regulation of medical devices; and for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement.
In this case, the panel held that plaintiff failed to show that Allergan violated a federal requirement for its Style 20 breast implant. The panel held that plaintiff failed to raise a genuine dispute of material fact that Allergan violated the FDA's pre-market approval and Current Good Manufacturing Practices. Therefore, plaintiff has not shown a violation of an FDA requirement, which she must for her state law claims to fit through the narrow exception to MDA preemption.