Glennen v. Allergan, Inc. (Apr. 29, 2016, A145367) ___ Cal.App.4th ___ [2016 WL 1732243].
Ashley Glennen sued Allergan, Inc., alleging that it negligently failed to train the surgeons who implanted Allergan’s Lap-Band adjustable gastric banding in her body, resulting in numerous complications. The trial court sustained Allergan’s demurrer without leave to amend, ruling that Glennen’s claim was preempted by federal law.
The Court of Appeal affirmed on two grounds. First, it held that Glennen’s “failure to adequately train physician” claim was expressly preempted by the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act (FDCA). (See 21 U.S.C. § 301 et seq.). The MDA expressly preempts state law requirements that are different from or in addition to federal requirements. (21 U.S.C. § 360k(a).) Thus, if state law could impose liability notwithstanding compliance with federal requirements, then the state claim is preempted. Here, Glennen’s negligence claim was based solely on her contention that Allergan provided inadequate training to the surgeon who installed her Lap-Band. However, because plaintiff did not dispute that Allergan provided the physician training required by the FDA’s premarket approval process (PMA), and no other training was required by federal law, a state law verdict for Glennen would necessarily impose liability for something different than federal law requires. Thus, her negligence claim was expressly preempted.
The Court of Appeal also held that Glennen’s claim was impliedly preempted by federal law. Implied preemption bars state law claims seeking to enforce the FDCA. The court observed that there is no state law duty requiring a medical device manufacturer to train physicians regarding the use of its devices, and Allergan did not voluntarily undertake to train physicians to use the Lap-Band. Rather, the FDA’s PMA mandated certain physician training by Allergan as a condition of its approval for the Lap-Band. Therefore, but for the FDA’s requirement that Allergan provide training to physicians implanting the device, Glennen would have no basis on which to allege the facts underlying her negligence claim. Thus, her claim did not “exist independently of the FDCA, and . . . [was] impliedly preempted.”
In sum, the Court of Appeal’s opinion teaches that there is a narrow gap through which state-law claims regarding medical devices must fit in order to escape federal preemption: the state claim must be premised on conduct that both (1) violates the FDCA (i.e., the state duty must perfectly parallel the federal duty), and (2) would give rise to recovery under state law even in the absence of the FDCA. Because Glennen’s claim did not fit in this narrow gap, it was preempted.
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