and Submitted September 13, 2019 Pasadena, California
from the United States District Court for the District of
Arizona D.C. No. 2:12-cv-02388-SRB Susan R. Bolton, District
C. Milstein (argued), Sherman Silverstein Kohl Rose &
Podolsky P.A., Moorestown, New Jersey, for
GinaMarie Slattery (argued), Slattery Petersen, Tucson,
Arizona, for Defendant-Appellee.
Before: Johnnie B. Rawlinson, John B. Owens, and Mark J.
Bennett, Circuit Judges.
Device Amendments / Preemption
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.
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.
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
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
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.
Weber's Health Problems
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 ...