Alton Bass v. Stryker Corporation
2012 U.S. App. LEXIS 1789
| 5th Cir. | 2012Background
- Bass underwent left hip replacement in August 2007, involving Stryker components including a Trident Shell.
- Bass alleges the Shell failed, causing pain, and a revision revealed the Shell was loose due to manufacturing residuals hindering bony ingrowth.
- Bass filed suit October 23, 2009 in the Northern District of Texas asserting state-law claims (strict liability, negligence, breach of warranty, and DTPA).
- Stryker moved to dismiss arguing federal preemption under the MDA/FDCA and 21 U.S.C. § 337(a); the district court granted dismissal. Bass appeals.
- The court analyzes whether the Shell was PMA-approved, whether Bass’s claims are parallel to FDA requirements, and whether claims survive § 337(a) preemption.
- The panel affirms some dismissals and reverses/remands others, narrowing surviving claims to certain manufacturing-defect theories aligned with FDA regulations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Was the Shell subject to PMA testing under Riegel? | Bass contends Shell lacked PMA approval, so PMA requirements may not preempt. | Stryker contends the Shell, as part of the Trident system, was PMA-approved; thus federal requirements apply. | Shell deemed PMA-approved; federal requirements satisfied. |
| Do Bass's claims parallel FDA requirements and survive preemption? | Bass argues FDA manufacturing regulations create parallel claims not adding new requirements. | Stryker argues claims add state duties beyond federal requirements or are preempted. | Some parallel manufacturing-defect claims survive; others (e.g., certain marketing/warning theories) do not. |
| Is there preemption under 21 U.S.C. § 337(a) for state-law claims? | Riegel allows parallel state-law claims despite preemption under Buckman principles. | § 337(a) preempts state actions seeking enforcement of FDCA provisions. | § 337(a) does not bar parallel claims; some claims survive if grounded in FDA-regulation violations. |
| Which claims survive preemption as to manufacturing defects? | Manufacturing-defect claims tied to FDA regulations should survive as parallel claims. | Manufacturing-defect claims framed as implied warranties or negligence to warn may be preempted. | Strict liability/manufacturing defects and negligent manufacturing may survive; implied warranties survive if linked to FDA-regulatory violations; express warranty and marketing/warning theories largely preempted. |
| What is the status of implied and express warranty claims? | Implied warranties may rest on FDA-regulatory violations; express warranty cannot broaden FDA requirements. | Warranties cannot impose stricter standards than FDA approvals; some claims preempted. | Express warranty dismissed; implied warranties survive to the extent based on FDA violations; otherwise preempted. |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (U.S. 2008) (parallel state claims survive when grounded in FDA-required regulations)
- Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (parallel claims require plausible pleadings tying FDA regs to injury)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011) (parallel state-law claims may proceed without a formal FDA finding)
- Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (U.S. 2001) (distinguishes between federal regulation violations and independent state claims)
- In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (post-Riegel context on FDA requirements and parallelism)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (recognizes confidential FDA information can affect pleading parallel claims)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (U.S. 1996) (PMAs and FDA requirements; contrast with 510(k) process)