541 S.W.3d 594
Mo. Ct. App.2017Background
- Plaintiff Jessica Williams underwent partial implantation of Bayer's Essure (a Class III, PMA-approved contraceptive device); the device fractured, perforated her uterine wall, and required further surgeries including hysterectomy.
- Williams sued Bayer alleging 14 claims (MMPA, fraud/negligent misrepresentation, express/implicit warranty, negligence per se, strict liability and negligent manufacturing, failure-to-warn, negligent training/supply, civil conspiracy, res ipsa loquitur, etc.).
- Bayer moved to dismiss, arguing federal preemption under the Medical Device Amendments (MDA) to the FDCA; the trial court granted dismissal with prejudice.
- On appeal the Missouri Court of Appeals reviewed whether each state-law claim was expressly or impliedly preempted by the MDA and whether plaintiff could amend.
- The court affirmed dismissal of several claims as preempted (including labeling-based claims, MMPA, fraud/negligent misrepresentation, some warranty and failure-to-warn theories, res ipsa loquitur) but reversed as to others (negligence per se based on failure-to-report, manufacturing-defect and negligent-manufacture claims tied to PMA/CGMP violations, portions of negligent-training and negligent-supply claims, and related conspiracy claims) and remanded for further proceedings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are expressly preempted by the MDA §360k | Williams: most claims parallel federal requirements or allege violations of FDA requirements (so are not preempted) | Bayer: PMA imposes federal requirements; state claims that add/differ are preempted | Court applied Riegel two-step: some claims preempted, others survive (see holdings by claim) |
| Labeling/marketing-based claims (MMPA, fraud, negligent misrep., express warranty) | Williams: website statements are separate from FDA-approved labeling and thus actionable under state law | Bayer: website statements mirror FDA-approved labeling; liability would second-guess FDA | Held preempted: statements mirror PMA-approved labeling; claims require contradicting FDA approval (express preemption) |
| Breach of implied warranty of merchantability | Williams: Bayer failed to report adverse events to FDA causing product unfitness | Bayer: claim contradicts FDA determination of safety/effectiveness | Held preempted: claim seeks to negate FDA approval rather than allege device-specific manufacturing violations |
| Negligence per se for failure to report adverse events (post-PMA reporting) | Williams: alleges violation of MDA/PMA reporting duties and traditional failure-to-warn tort duty causally linked to injury | Bayer: such a claim is effectively a fraud-on-the-FDA or otherwise preempted | Held not preempted: claim pleads a traditional state tort (failure-to-warn) grounded in violation of reporting duties; survives pleading-stage review |
| Manufacturing-defect / negligent manufacturing (PMA & CGMP violations) | Williams: device was made with nonconforming materials and CGMP violations caused device failure | Bayer: claims rest solely on federal violations and thus are preempted | Held not preempted: device-specific manufacturing claims (including CGMP/PMA violations) can state independent state-law causes and avoid implied preemption if tied to concrete defect causing injury |
| Failure-to-warn based on post-PMA risks / removal (post-approval labeling changes) | Williams: Bayer should have added warnings or removed device after adverse reports | Bayer: post-PMA state requirements would conflict with FDA authority | Held preempted: state-required additional warnings or market removal would impose requirements different from federal scheme (express preemption) |
| Negligent training / supervision and supply of ancillary instruments | Williams: Bayer negligently trained/supervised physicians and supplied defective hysteroscopes | Bayer: FDA-approved training and PMA-covered equipment preempt state duties beyond PMA; supply of PMA-reviewed tools is preempted | Held mixed: claims alleging training that deviated from FDA-approved training (and negligent execution of that training) or supply of non-PMA ancillary instruments survive; claims that would impose supervision/training duties beyond PMA or challenge PMA-approved training are preempted |
| Res ipsa loquitur & civil conspiracy; motion to amend petition | Williams: res ipsa and conspiracy tied to underlying torts; sought leave to amend | Bayer: res ipsa could allow recovery contrary to PMA approval; amendment would not cure preemption defects | Held: res ipsa preempted (would permit recovery without showing federal-violation linkage); conspiracy survives only to extent underlying non-preempted claims survive; denial of leave to file proposed second amended petition not reversible error because amendments would not cure preemption defects |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal preemption test for PMA-approved Class III devices) (establishes two-step express preemption analysis and explains PMA limits on state-law torts)
- Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (fraud-on-the-FDA/implicit preemption) (claims that exist solely by virtue of federal requirements are impliedly preempted)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (background on device regulation and preemption landscape) (discusses device classes and federal regulation prior to Riegel)
- In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir.) (describes narrow gap between Riegel and Buckman for viable state claims)
- Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir.) (CGMP and device-specific federal manufacturing requirements can form the basis of non-preempted state manufacturing-defect claims)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir.) (negligence claims based on failure to report adverse events can avoid implied preemption when grounded in traditional state tort duties)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir.) (state-law negligence-per-se claim based on FDA-reporting duties not impliedly preempted)