Ray Wildman v. Medtronic, Incorporated
874 F.3d 862
| 5th Cir. | 2017Background
- Wildman had a Medtronic RestoreUltra neurostimulator (Class III PMA device) implanted for chronic pain; it malfunctioned ~1.5 years after implantation leading to removal, infection, additional surgery, and ~5 months out of work.
- Wildman relied on a Medtronic website statement assuring the device was "reliable for 9 years," asserting Medtronic had "rigorously verified and validated the many components that impact device longevity, not just the battery."
- FDA premarket approval (PMA) reviewed and approved a statement that the Device’s battery life is 9 years and verified that an "End of Service" message would appear after nine years; the administrative record did not show FDA evaluation of longevity for other device components.
- Wildman sued in Texas state court for breach of express warranty alleging the device did not conform to a nine-year device life; Medtronic removed and moved for judgment on the pleadings arguing preemption, failure to plead reliance, and contractual exclusivity.
- The district court dismissed on preemption grounds; the Fifth Circuit reviews de novo and considers the PMA (public record) at the Rule 12 stage.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Wildman's express-warranty claim is preempted by 21 U.S.C. § 360k | Wildman: The website warranty promised 9-year reliability for the device’s many components (not just the battery), a representation not reviewed/approved by FDA and thus enforceable under state law | Medtronic: The PMA-approved 9-year battery life equals "device life," so challenging longevity conflicts with FDA determinations and is preempted | The website statement went beyond FDA-reviewed battery-life statements; the warranty can be read as promising 9-year reliability of many components and is not preempted at this stage (reversed and remanded) |
| Whether an express-warranty claim that duplicates or enforces FDA duties is permissible (parallel claim doctrine) | Wildman: A warranty beyond FDA-reviewed matters is a parallel claim that enforces federal duties against false or misleading representations | Medtronic: Any state-law duty would be "different from, or in addition to" federal requirements and therefore preempted | Court: Parallel claims are allowed when the state claim enforces duties that are the same as federal duties; here a warranty beyond FDA-reviewed topics can survive preemption analysis |
| Whether implied preemption (Buckman) bars Wildman's claim as effectively federal enforcement of FDA regulation | Wildman: The warranty claim seeks traditional state-law redress (breach of contract/warranty) independent of the FDA approval process | Medtronic: The claim effectively regulates FDA matters and thus is impliedly preempted | Court: Buckman does not bar ordinary warranty claims that exist independent of the federal scheme; implied preemption not applied here |
| Pleading sufficiency (reliance and causation of component failure) | Wildman: He identified the specific website warranty and alleges reliance and injury from device failure | Medtronic: Complaint fails to plead reliance with particularity and does not allege that a non-battery component caused the failure | Court: Declined to decide on pleading sufficiency at Rule 12(c); remanded for the district court to consider reliance and causation arguments further |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (§360k preempts state requirements that are different from or in addition to federal PMA requirements)
- Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (implied preemption bars state-law fraud-on-the-FDA claims that exist solely by virtue of the federal scheme)
- Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir. 2006) (express-warranty claims are preempted when the warranty was part of FDA-approved labeling; warranties beyond FDA approval may avoid preemption)
- Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (PMA approval satisfies the first step of the Riegel preemption inquiry; parallel claims premised on violation of FDA requirements may survive)
- Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (courts may take judicial notice of PMA materials at Rule 12 stage)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (analyzing preemption under Riegel step two; state claims premised on violation of FDA regulations can proceed)
- Norris v. Hearst Trust, 500 F.3d 454 (5th Cir. 2007) (courts may take judicial notice of matters of public record when deciding Rule 12 motions)