238 F. Supp. 3d 978
N.D. Ohio2017Background
- Plaintiff received a Medtronic SynchroMed II implant (PMA-approved Class III device) as a replacement pump in July 2013 and alleges medication leaked from the pump causing infection, bowel and organ injury, mesh dissolution, and extensive future surgeries.
- SynchroMed II obtained original PMA in 1988 and numerous supplements thereafter; Class III devices and PMA approvals impose specific federal requirements and post-approval controls, including change approval and adverse-event reporting.
- Plaintiff sues under Ohio law asserting seven state-law claims: manufacturing defect, failure to warn, breach of express and implied warranties, negligent misrepresentation, negligence, and fraudulent misrepresentation/omission.
- Medtronic moved to dismiss under Rule 12(b)(6), arguing (1) express preemption under the MDA’s §360k(a) because PMA establishes federal device requirements, and (2) implied preemption/no private right of action under §337(a) (which the court did not reach after deciding express preemption).
- Court applied a two-step Riegel test: (1) whether federal requirements apply to the device (yes, via PMA), and (2) whether the state claims impose requirements different from or in addition to the federal ones (parallel claims survive only if they allege specific PMA/FDA violations).
- The court found plaintiff failed to plead specific federal requirements violated or causation linking alleged GMP/FDA issues to his device and held all seven claims expressly preempted by 21 U.S.C. § 360k(a); dismissal granted.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal PMA requirements apply to SynchroMed II | Warstler did not contest PMA applicability but relies on state claims | PMA imposes federal requirements that govern the device | PMA established federal requirements applicable to SynchroMed II (Riegel test step 1) |
| Whether manufacturing-defect claim is preempted | Plaintiff alleges a manufacturing defect and general CGMP violations | Medtronic: claim would impose requirements different from PMA; no specific PMA violation alleged | Preempted: plaintiff failed to allege specific FDA manufacturing/GMP violation or causation |
| Whether failure-to-warn / post-market reporting-based warning claims are parallel | Plaintiff asserts Medtronic failed to warn patients/doctors and failed to monitor/report adverse events | Medtronic: state warning duties differ from PMA labeling and federal adverse-event reporting; reporting is not equivalent to a public warning | Preempted: failure-to-warn claim not parallel; adverse-event reporting duty is not identical to a state duty to warn |
| Whether warranty, negligence, and misrepresentation claims are preempted | Plaintiff alleges device was unsafe/defective and Medtronic misrepresented safety | Medtronic: these claims would require findings contrary to FDA’s PMA-based safety/effectiveness determinations | Preempted: all claims would impose requirements different from or in addition to federal PMA requirements |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (explains §360k preemption of state requirements that are different from or in addition to PMA requirements)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (holds states may enforce common-law duties that "parallel" federal requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (private parties may not bring claims that effectively enforce the FDCA; enforcement is for the United States)
- Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141 (field preemption and scope of federal regulatory schemes)
- Bausch v. Stryker Corp., 630 F.3d 546 (parallel claims premised on violation of FDA regulations may avoid §360k preemption)
- Bryant v. Medtronic, Inc., 623 F.3d 1200 (holding that state claims premised on FDA-regulation violations are parallel and distinguishing preempted claims)
- Wolicki-Gables v. Arrow Int'l, Inc., 634 F.3d 1296 (requires pleading specific PMA requirements allegedly violated to state a parallel claim)
- Ashcroft v. Iqbal, 556 U.S. 662 (standard for plausibility on a Rule 12(b)(6) motion)