238 F.Supp.3d 978
N.D. Ohio2017Background
- Plaintiff received a replacement Medtronic SynchroMed II programmable infusion pump (Model 8637 with mesh pouch) in July 2013 and alleges it leaked medication into his abdominal cavity, causing infection, organ and bowel damage, and multiple surgeries.
- SynchroMed II is a Class III medical device that received FDA Premarket Approval (PMA) initially in 1988 and numerous PMA supplements thereafter; PMA imposes device-specific federal requirements and restricts post‑approval changes.
- Plaintiff sued 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 the Medical Device Amendments (21 U.S.C. §360k(a)) expressly preempt the state claims and that plaintiffs cannot state parallel claims based on specific PMA violations.
- The court applied the two-step Riegel framework: (1) determine whether federal requirements apply (PMA does), and (2) determine whether the state claims impose requirements different from or in addition to federal ones.
- The court concluded plaintiff failed to plead specific violations of PMA requirements or a parallel federal duty causally linked to his injuries and granted Medtronic’s motion to dismiss on express preemption grounds.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal PMA requirements apply to the SynchroMed II | Warstler did not contest PMA applicability | PMA establishes device‑specific federal requirements | PMA applies; federal requirements govern the device |
| Whether manufacturing‑design defect claim is preempted | Warstler says device was defective/manufactured dangerously | Medtronic says allowing the claim would impose requirements different from PMA and is barred by §360k(a) | Preempted; plaintiff failed to allege deviation from specific PMA/manufacturing specs |
| Whether failure‑to‑warn/post‑market reporting claim is parallel or preempted | Warstler alleges failure to monitor, report adverse events, and warn doctors/patients | Medtronic argues federal adverse‑event reporting duty is not identical to state duty to warn and PMA labeling controls warnings | Preempted; postmarket reporting to FDA is not equivalent to a state duty to warn or a parallel PMA violation |
| Whether warranty, misrepresentation, and negligence claims are preempted | Warstler contends device was unsafe/ineffective and Medtronic misrepresented safety | Medtronic contends these claims would require finding product less safe/effective than PMA approved and thus add to federal requirements | Preempted; claims would conflict with FDA’s PMA finding of safety/effectiveness and plaintiff pled no specific PMA violations |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) (PMA creates federal requirements and §360k(a) preempts state requirements that are different from or in addition to federal ones)
- Lohr v. Medtronic, Inc., 518 U.S. 470 (1996) (states retain authority to provide traditional common‑law damages remedies that parallel, but do not add to, federal requirements)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (FDCA’s enforcement is vested in the federal government; private suits asserting federal regulatory violations may be impliedly preempted)
- Ashcroft v. Iqbal, 556 U.S. 662 (2009) (pleading standard: complaint must state a plausible claim for relief)
- Wolicki‑Gables v. Arrow Int’l, Inc., 634 F.3d 1296 (11th Cir. 2011) (to plead a valid parallel claim a plaintiff must identify specific PMA requirements allegedly violated)