• Dorsey v. Allergan, Inc. and Allergan Sales, LLC No. 3:08-0731 (M.D. Tenn. Mar. 11, 2009)
  • May 5, 2009 | Authors: Karen A. Gibbs; Bernadette M. Stafford
  • Law Firm: Crowell & Moring LLP - Irvine Office
  • The U.S. District Court for the Middle District of Tennessee granted summary judgment for defendants Allergan, Inc. and Allergan Sales, LLC (together, “Allergan”) in a product liability action alleging that silicone breast implants were unreasonably dangerous, holding that approval of the implants by the Food and Drug Administration (“FDA”) preempts the plaintiff’s strict liability tort claim regardless of the fact that the FDA approval post-dated implantation of the device into the plaintiff.

    Plaintiff Susan Dorsey participated in an adjunct clinical study conducted pursuant to an FDA agreement by McGhan Medical Corporation, predecessor to the defendant Allergan, Inc. In November 2005, Dorsey received McGhan® Style 20 silicone breast implants. In September 2006, the implants were surgically removed after examination revealed both implants had contracted. The Style 20 implants received premarket approval from the FDA on November 17, 2006. Dorsey later sued Allergan on a theory of strict liability, alleging that the implants were defective and/or unreasonably dangerous.

    Allergan moved for summary judgment on the ground that Dorsey’s strict liability claim was preempted by the Medical Device Amendments (“MDA”) to the Food, Drug and Cosmetic Act. Allergan relied on the Supreme Court’s holding in Riegel v. Medtronic, Inc. that the MDA preempts state law claims imposing requirements different from or in addition to federal laws regarding medical device safety and effectiveness. Dorsey argued that Riegel was distinguishable because, in that case, the device at issue had received FDA approval before its implantation.

    While acknowledging that Riegel is distinguishable with respect to the timing of the premarket approval, the court found this to be “a distinction without a difference” and held that “the subsequent approval by the FDA is a bar to [Dorsey’s] strict liability claim because the FDA has determined that the implants at issue are reasonably safe for consumers and there is no suggestion that the implants she received were somehow different than those ultimately approved by the FDA.”

    The court also held that adjunct studies are not per se outside the scope of the MDA and that the MDA’s preemption provision applies regardless of whether a device is made publicly available through premarket approval, a finding of substantial equivalence, or an investigational device exemption.