Bausch v. Stryker Corp.
2010 U.S. App. LEXIS 26094
| 7th Cir. | 2010Background
- Bausch, a plaintiff in a diversity case, alleges state-law negligence and strict-liability claims against Stryker for a defective Class III hip replacement device (Trident).
- The Trident is a ceramic-on-ceramic hip system approved under FDA regulation; a component was deemed adulterated and the device implanted in Bausch six days after FDA notice.
- The implanted Trident failed, necessitating revision surgery, and a later recall covered a device bearing the same catalogue number.
- District court dismissed the case under Rule 12(b)(6) as preempted by federal law and denied leave to amend the complaint.
- Seventh Circuit reverses, concluding the claims premised on federal-law violations are not preempted and that dismissal with prejudice was error.
- The court analyzes express preemption under 21 U.S.C. § 360k(a), implied preemption under Buckman, and pleading standards for parallel claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Scope of express preemption under §360k(a) | Bausch argues federal-law violations are not preempted by §360k(a). | Stryker contends claims are preempted as extra or different requirements relating to device safety. | Not expressly preempted; parallel state claims allowed. |
| Consequence of consolidated federal regulations (general vs concrete requirements) | FDA requirements, including CGMP/QSR, can support parallel state claims. | Only concrete, device-specific requirements can support parallel claims; general regs are too vague. | General FDA requirements can support parallel state claims; not precluded. |
| Implied preemption under Buckman | Claims are not fraud-on-the-FDA; not impliedly preempted. | Buckman supports implied preemption to protect FDA regulatory framework. | Not impliedly preempted; Buckman does not bar these tort claims. |
| Pleading and amendment standard for parallel claims | Original complaint was sufficiently pled; discovery would enable specificity. | Complaint lacked device-specific federal violations; amendment futile. | District court abused discretion by denying leave to amend; remand for considering amended pleading. |
Key Cases Cited
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (parallel state-law claims for violations of federal requirements permitted)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMAs preempt state-law claims that add/differ from federal requirements; parallel claims allowed for violations of federal law)
- McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir. 2005) (state requirements not preempted when genuinely equivalent to federal requirements)
- Chambers v. Osteonics Corp., 109 F.3d 1243 (7th Cir. 1997) (medical-device-related claims not preempted when based on federal regulatory violations)
- Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997) (negligence claims not preempted when based on FDA standards)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA claims impliedly preempted; not applicable to parallel tort claims)