247 Cal. App. 4th 1
Cal. Ct. App.2016Background
- Ashley Glennen sued Allergan after a LAP‑BAND implanted in 2003 eroded into her stomach, small intestine, and liver, causing catastrophic injuries; she alleged Allergan negligently failed to train the implanting physician.
- The LAP‑BAND is a Class III device that received FDA premarket approval (PMA) in 2001; the PMA and approval letter included conditions regarding practitioner training and postapproval studies.
- Glennen filed a second amended complaint asserting a single negligence claim against Allergan for inadequate physician training; Allergan demurred.
- The trial court sustained the demurrer without leave to amend; Glennen appealed; the Court of Appeal reviewed de novo whether federal law preempted her claim.
- The court framed the dispute around MDA express preemption (21 U.S.C. § 360k(a)) and implied preemption (Buckman), and analyzed whether Glennen pleaded a state duty that "parallels" federal requirements or instead conflicts with or seeks to enforce the FDCA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Glennen's negligence claim is expressly preempted under the MDA | Her claim parallels federal law (CGMP/Quality System regs) and is not "different from or in addition to" federal requirements | The device had PMA; state duties that would impose liability beyond or different from federal PMA/regulations are preempted | Held preempted: claim does not parallel federal requirements and is barred by §360k(a) |
| Whether alleged violations of Quality System/CGMP regs (21 C.F.R. §820) supply a parallel state duty | Glennen alleges Allergan failed to implement CGMPs adequate for surgeon training, creating a parallel state negligence duty | Allergan: CGMPs govern manufacturing/design/quality systems, not physician training; regs are not about surgical training programs | Held: CGMPs do not pertain to physician training programs; SAC fails to plead a genuine parallel claim |
| Whether the claim is impliedly preempted as a suit that effectively enforces the FDCA (Buckman) | Glennen says she does not plead fraud‑on‑the‑FDA; her claim is a garden‑variety negligence claim | Allergan: the training duty flowed solely from the FDA condition; enforcing it in state tort would intrude on FDA's exclusive enforcement/oversight | Held impliedly preempted: the alleged duty to provide FDA‑required training "exists solely by virtue of the FDCA," so Buckman bars the claim |
| Whether a manufacturer can be held liable under state law for physician conduct arising from training/installation | Glennen relies on physician harm traceable to training; argues manufacturer can be liable for negligent training | Allergan: manufacturers are not responsible for the practice of medicine; PMA/labeling/training decisions are federal/regulatory matters | Held: manufacturer liability for training in this PMA‑conditioned context would displace FDA authority; no independent state tort duty pleaded |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA‑approved Class III device claims are preempted if state requirements are different from or in addition to federal requirements)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (state claims that exist solely by virtue of FDCA disclosure/agency‑interaction requirements are impliedly preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (MDA does not preempt state claims that "parallel" federal requirements)
- Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (failure‑to‑warn claims may survive preemption analysis to the extent they parallel FDA duties)
- Bausch v. Stryker, 630 F.3d 546 (7th Cir. 2010) (CGMP/quality regs can support a parallel claim where plaintiff alleges a manufacturing/regulatory violation)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (CGMP violations formed basis for parallel state claims tied to manufacturing defects)
- Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) (MDA does not preempt state‑law claims that genuinely parallel federal duties)
- Gomez v. St. Jude Med., 442 F.3d 919 (5th Cir. 2006) (PMA‑approved labeling/training approved by FDA preempts state claims that would second‑guess FDA‑approved warnings and training)