Alton v. Medtronic, Inc.
970 F. Supp. 2d 1069
D. Or.2013Background
- Alton sues Medtronic for Infuse device complications after PLIF surgery; PMA approval occurred July 2, 2002 for lumbar fusion in one level L4-S1; device includes rhBMP-2 with collagen sponge and interbody cage; Medtronic promoted off-label uses and allegedly suppressed adverse-data reports; Alton underwent PLIF in 2010 using protein component without cage, leading to exuberant bone growth and pain; court has subject-matter jurisdiction under 28 U.S.C. § 1332; Medtronic moved to dismiss, and both parties moved for judicial notice; judge granted some notices and denied others, and ruled on preemption and related issues.
- Alton alleges fraud, strict products liability for failure to warn, defective design, misrepresentation, negligence, and breach of express warranty related to off-label Infuse use; Infuse PMA framework governs device-specific duties; off-label uses are not generally prohibited but misbranding and FDA labeling duties create potential preemption.
- The court analyzes each claim under FDCA/MDA preemption (Lohr, Buckman, Riegel; Stengel adoption) and Oregon state-law standards; the decision resolves preemption for several claims and allows others to proceed.
- Alton’s fraud claim is treated as a parallel state-law duty not preempted; the failure to warn claim is partially preempted where it would impose labeling requirements beyond FDA directives, but not where it aligns with Oregon law and off-label promotion.
- The design-defect claim is preempted under 360k(a); the express warranty claim survives preemption if premised on voluntary statements outside FDA labeling; Rule 9(b) pleading is found adequate.
- Judicial notices granted include several FDA advisories and reports, while some content was disregarded as non-adjudicative.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| FDCA/MDA preemption framework applies to PMA device claims | Alton’s claims parallel federal duties and survive preemption | Many claims impose device-specific requirements not allowed by 360k | Framework applied; some claims survive, others preempted |
| Fraud claims preemption status | Fraud claim rests on off-label promotion; not preempted | Fraud-on-FDA is preempted; off-label fraud not parallel | Not preempted as parallel to general duties under Lohr/Stengel (fraud claim allowed) |
| Failure to warn preemption status | Not preempted for off-label promotion and general duties | Preempted where it imposes FDA labeling requirements | Not preempted for off-label promotion claims; partially preempted where labeling duties would be added |
| Defective design claim preemption | Design defect under Oregon law independent of FDA PMA | PMAs impose device-specific design requirements; preempted | Preempted under 360k(a) as device-specific design requirement |
| Breach of express warranty and Rule 9(b) pleading | Warranties arose from voluntary statements; not barred by labeling disclaimer | Labeling disclaimer precludes warranty claims based on FDA labeling | Express warranty claim survives preemption; 9(b) pleading adequate |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (U.S. 1996) (FDCA/MDA preemption framework; parallel vs. conflicting state-law claims)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (U.S. 2001) (Fraud-on-the-FDA preemption; implied preemption limits private actions)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (PMA-imposed requirements; parallel vs. conflicting state duties; preemption scope)
- Stengel v. Medtronic, Inc., 704 F.3d 1233 (9th Cir. 2013) (Adopts Lohr/Buckman/Riegel framework; parallel claims not preempted)
- Perez v. Nidek Co., 711 F.3d 1109 (9th Cir. 2013) (Off-label use claims; preemption distinctions for FDA-regulated disclosures)
- Cornett v. Johnson & Johnson, 211 N.J. 362, 48 A.3d 1041 (N.J. 2012) (State duty not preempted when FDA labeling not implicated; manufacturing/warning claims may survive)