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Weber v. Allergan, Inc.

United States Court of Appeals, Ninth Circuit

October 11, 2019

Nicole Weber, Plaintiff-Appellant,
v.
Allergan, Inc., Defendant-Appellee.

          Argued and Submitted September 13, 2019 Pasadena, California

          Appeal from the United States District Court for the District of Arizona D.C. No. 2:12-cv-02388-SRB Susan R. Bolton, District Judge, Presiding

          Alan C. Milstein (argued), Sherman Silverstein Kohl Rose & Podolsky P.A., Moorestown, New Jersey, for Plaintiff-Appellant.

          GinaMarie Slattery (argued), Slattery Petersen, Tucson, Arizona, for Defendant-Appellee.

          Before: Johnnie B. Rawlinson, John B. Owens, and Mark J. Bennett, Circuit Judges.

         SUMMARY[*]

         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 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.

          OPINION

          OWENS, CIRCUIT JUDGE

         Nicole Weber appeals from the district court's grant of summary judgment in favor of Allergan, Inc. Weber sued Allergan under state law alleging that she suffered injuries when her breast implants bled silicone into her body. We have jurisdiction under 28 U.S.C. § 1291, and we affirm.

         I. BACKGROUND

         A. Weber's Health Problems

         In December 2009, Weber underwent reconstructive surgery after a double mastectomy and received Allergan's Natrelle Style 20 silicone breast implants. Weber then suffered severe health problems, including significant vision loss. In October 2011, Dr. Feng removed the implants and opined that a silicone gel bleed from the implants caused Weber's health issues. According ...


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