Weber v. Allergan, Inc., No. 18-15212 (9th Cir. 2019)
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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.
Court Description: Medical Device Amendments / Preemption. The panel affirmed the district court’s summary judgment in favor of Allergan, Inc. in plaintiff’s action under Arizona law alleging that she suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act, Congress permitted the Food and Drug Administration (“FDA”) oversight of medical devices. In November 2006, the FDA provided Class III pre-market approval for the implants. The MDA expressly preempts state law regulation of medical devices. The panel held that for a state law claim to survive express preemption under the MDA, a plaintiff must show that the defendant deviated from a particular pre- market approval or other FDA requirement applicable to the Class III medical device. The panel held that plaintiff failed to show that Allergan violated an FDA requirement. Specifically, the panel held plaintiff failed to raise a genuine dispute of material fact that Allergan violated a requirement of the FDA’s pre-market approval. The panel further held that plaintiff had not shown a violation of the FDA’s Current Good Manufacturing Practices found in the Quality System Regulations applicable to all medical devices. The panel concluded that WEBER V. ALLERGAN 3 plaintiff failed to raise a genuine dispute of material fact that Allergan violated a federal requirement for its Style 20 implant, which she must have for her state law claims to fit through the narrow exception to MDA preemption.
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