940 F.3d 1106
9th Cir.2019Background
- Nicole Weber received Allergan Natrelle Style 20 silicone breast implants after reconstructive surgery and later suffered severe health problems, including significant vision loss.
- Dr. Feng removed Weber’s implants in 2011 and reported the right implant lost roughly 2.8% of its mass; she testified the bleed was a “departure from the manufacturer’s specifications” and a “defect.”
- The FDA granted premarket approval (PMA) for the Style 20 implant in 2006; the product label stated laboratory testing showed over 99% of silicone stayed in the implant and characterized gel bleed as extremely low and of no clinical consequence.
- Weber sued Allergan in state court (strict product liability — manufacturing defect, and negligence). After discovery, Allergan moved for summary judgment on MDA preemption grounds.
- The district court held Weber failed to present evidence that Allergan violated an FDA requirement (PMA specifications or CGMPs), so her state-law claims were preempted; the Ninth Circuit affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law product-liability/negligence claims against a PMA-approved Class III device are preempted by the MDA | Weber contends her state-law claims can proceed under the MDA’s parallel-claims exception because Allergan’s implant malfunctioned and caused injury | Allergan argues the MDA preempts state claims unless plaintiff shows a violation of an FDA requirement (PMA or other federal requirement) | Court: MDA preempts unless plaintiff shows defendant violated an FDA requirement; mere malfunction/defect is insufficient |
| Whether the implant label statement (">99% stayed in the implant") is a binding FDA PMA requirement | Weber argues the labeled bleed-rate statement is part of FDA-approved PMA requirements, so exceeding it shows a federal violation | Allergan argues the label statement reflects test results/typical performance, not a guarantee or enforceable PMA mandate | Court: Label statement is not shown to be a guaranteed PMA requirement; treating it as a guarantee would impose a stricter standard than FDA’s approval |
| Whether Weber raised evidence that Allergan violated Current Good Manufacturing Practices (CGMPs)/Quality System Regulations | Weber asserts CGMP violations could be shown by the defective implant and other alleged defects, establishing a federal violation | Allergan offered evidence the implant and manufacturing complied with PMA and inspections; a single defective unit or other defects without specific proof of CGMP violation is insufficient | Court: Weber failed to present specific evidence that Allergan violated CGMPs; general evidence of malfunction or recalls does not establish CGMP violations |
| Whether Weber preserved appellate review of the district court’s cost award | Weber requested reversal of the cost award on appeal | Allergan noted Weber did not object below or move for review under Rule 54(d)(1) | Court: Weber waived appellate review of the costs because she failed to raise objections or seek district-court review |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA approval preempts state-law claims that impose requirements different from or additional to federal PMA requirements)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (discusses FDA device review and limits of preemption)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc) (MDA does not preempt state-law duties that parallel federal requirements)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (to avoid preemption plaintiff must show violation of PMA or other FDA requirement)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (MDA shields compliant manufacturers; CGMPs can be relevant to parallel-claim theory)
- Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir. 2012) (PMA statements may reflect typical/optimal performance and are not necessarily enforceable guarantees)
- Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (res ipsa loquitur is insufficient to prove an FDA violation to avoid preemption)
- Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) (recognizes narrow parallel-claim exception to MDA preemption)