Stengel v. Medtronic, Inc.
676 F.3d 1159
9th Cir.2012Background
- Stengels filed state-law claims (negligence, express/implied warranty, strict liability) arising from Richard Stengel's injuries from Medtronic SynchroMed pump.
- Medtronic removed the case to federal court and the district court dismissed as expressly preempted under the FDCA Medical Device Amendments (MDA), 21 U.S.C. § 360k.
- Stengels sought to amend to allege failure-to-warn/monitoring duties under FDA regulations; amendment was denied as impliedly preempted.
- The Ninth Circuit reviews de novo preemption rulings and abuse-of-discretion denial of leave to amend.
- Court proceeds to analyze express preemption under Riegel and Buckman-style implied preemption; ultimately affirms district court.
- FDA premarket approval for the device (Class III) and labeling requirements frame the preemption analysis.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are the initial state claims expressly preempted by the MDA? | Stengel asserts state tort duties parallel FDA requirements and may recover damages. | Claims conflict with federal requirements; express preemption applies under 360k and Riegel. | Yes, express preemption applies; initial claims dismissed. |
| Do the amended failure-to-warn claims survive under Buckman implied preemption? | FDA reporting duties could support state claims if not duplicative of federal scheme. | Buckman bars state fraud-on-the-FDA-type claims; implied preemption applies. | Implied preemption applies; amended claims preempted. |
| Was the amendment to add damages under parallel federal and Arizona duties properly denied as futile? | Arizona duties to warn post-market dangers align with federal reporting to FDA. | Buckman and implied preemption foreclose the amendment. | Amendment futile; district court did not err. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (premarket approval imposes federal requirements; parallel state duties may be preempted)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (U.S. 2001) (fraud-on-the-FDA claims preempted; federal scheme controls enforcement)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (parallel vs. exclusive federal requirements; damages remedy can parallel federal rule)
- Readenour v. Marion Power Shovel, 149 Ariz. 442 (Arizona 1986) (post-market duty to warn recognized under Arizona law)
- In re Medtronic, Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (noting narrow gap for state claims to escape preemption)