By Elena Eyber, J.D.
An injured patient failed to show that the implant manufacturer deviated from a pre-market approval or other FDA requirement applicable to the Class III medical device.
A federal appellate panel affirmed a district court’s summary judgment ruling in favor of a breast implant manufacturer in a patient’s action under Arizona law alleging that she suffered injuries when her breast implants "bled" silicone into her body. According to the U.S. Court of Appeals for the Ninth Circuit, the patient failed to raise a genuine dispute of material fact that the manufacturer violated a federal requirement for its Style 20 implant. The panel held that the patient had to show a violation of a Food and Drug Administration (FDA) requirement for her state-law claims to survive express preemption under the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDC Act) (Weber v. Allergan, Inc., October 11, 2019, Owens, J.).
Procedural history. The patient appealed from the district court’s grant of summary judgment in favor of Allergan, Inc., the manufacturer of the breast implants at issue in this case [see Products Liability Law Daily’s October 27, 2015 analysis]. The patient had sued the company under state law, alleging that she suffered injuries when her breast implants bled silicone into her body. She asserted claims under Arizona law for strict product liability (manufacturing defect) and negligence.
Preemption. The appellate panel explained that the MDA expressly preempts state-law regulation of medical devices, and for a state-law claim to survive preemption, a patient must show that a breast implant manufacturer deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device.
Here, the panel held that the patient failed to show that the manufacturer violated an FDA requirement. Specifically, the patient failed to raise a genuine dispute of material fact that the manufacturer violated a requirement of the FDA’s pre-market approval. The patient’s physician’s opinion that the implant was defective and malfunctioned was not evidence that the manufacturer deviated from the FDA’s pre-market approval procedures.
Further, the panel held that the patient 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 mere evidence suggesting that her particular breast implant was defective did not show that the manufacturer failed to comply with the practices.
The case is No. 18-15212.
Attorneys: Michael Jason Dube (Sherman, Silverstein, Kohl, Rose & Podolsky, P.A.) for Nicole Weber; Ginamarie Slattery (Slattery Petersen PLLC) for Allergan, Inc.
Companies: Allergan, Inc.
MainStory: TopStory PreemptionNews MedicalDevicesNews DesignManufacturingNews AlaskaNews ArizonaNews CaliforniaNews HawaiiNews IdahoNews MontanaNews NevadaNews OregonNews WashingtonNews GuamNews
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