Richard Stengel v. Medtronic Incorporated
2013 U.S. App. LEXIS 621
| 9th Cir. | 2013Background
- Stengels sue Medtronic under state law after Richard Stengel became permanently paraplegic from a Medtronic SynchroMed Class III device.
- MDA preemption defense argued that all state-law claims, including a proposed new negligence claim, were preempted by federal law.
- District court dismissed the suit under Rule 12(b)(6) and denied leave to amend based on preemption.
- Stengels sought to add a claim that Medtronic failed to report known risks to the FDA, violating MDA reporting duties.
- Stengel’s device received PMA in 1988 and supplemental PMA in 1999; he was injured in 2005; FDA later found risks Medtronic had known and issued warnings/recall in 2007-2008.
- Court held the MDA does not preempt a state-law failure-to-warn claim that parallels a federal-duty under the MDA, and remanded for further proceedings on the non-preempted claim.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Does MDA preempt parallel state-law duties? | Stengels: parallel state duty should not be preempted. | Medtronic: parallel duties are preempted if they add to or differ from federal requirements. | Not preempted when parallel to federal duties. |
| Is the proposed Arizona failure-to-warn claim preempted as Buckman-like fraud-on-the-FDA? | Claim concerns state-law duty to warn via FDA reporting, not misrepresentation to FDA. | Buckman preempts fraud-on-the-FDA style claims entirely. | Not preempted because it rests on traditional state tort duty, not solely on federal process. |
| Can the district court's denial of leave to amend be sustained on preemption grounds? | Amendment should be allowed to plead non-preempted claims. | Preemption bars the new claim as pleaded. | Remand for permissible amendment; merits depend on framing of duty. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (no preemption of parallel state duties; Lohr supports damages remedy for parallel duties)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (fraud-on-the-FDA claims impliedly preempted; exclusive federal grid)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (express preemption when state law imposes stricter safety requirements)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (paralleled federal duties not preempted for failure-to-warn claims)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (parallel federal duties not preempted in state-law tort claims)
- In re Medtronic Sprint Fidelis Leads, 623 F.3d 1200 (8th Cir. 2010) (preempts some failure-to-warn claims; does not address parallel-duty claims)