Conklin v. Medtronic
418 P.3d 912
| Ariz. Ct. App. | 2017Background
- Medtronic manufactured the SynchroMed II infusion pump (Class III device) that had FDA premarket approval (PMA) and was subject to post‑market reporting rules.
- Raymond Conklin received the pump in 2008; in 2013 he suffered drug over‑infusion allegedly caused by the pump.
- Plaintiffs alleged Medtronic failed to report post‑PMA adverse events and that the pump had design/manufacturing defects, failed to warn, and breached express warranty; they also sought punitive damages and loss of consortium.
- Medtronic moved to dismiss as preempted by the Medical Device Amendments (MDA) and related federal law; the trial court dismissed all claims with prejudice.
- The Court of Appeals affirmed dismissal of product‑liability (design/manufacturing), breach of express warranty, and certain negligence claims as preempted; it vacated dismissal of failure‑to‑warn, loss of consortium, and punitive damages claims and remanded.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether design and manufacturing strict‑liability claims are preempted | Design/manufacturing defects caused injury despite PMA; state law should apply | Claims attack FDA‑approved design/process and thus are expressly preempted under §360k | Preempted — plaintiffs did not contend device deviated from FDA‑approved specs |
| Whether breach of express warranty survives preemption | Express warranty that device was "safe and effective" was false; claim actionable under state law | Enforcing warranty would impose requirements different from FDA PMA approval | Preempted — would contradict FDA PMA determination |
| Whether failure‑to‑warn (post‑market reporting) is preempted | Medtronic violated federal post‑market reporting regs; that breach supports an Arizona duty to warn and is a parallel claim | Post‑market reporting to FDA is not identical to state duty to warn providers/patients; claim is preempted (expressly or impliedly) | Not preempted — treated as a parallel state claim when premised on failure to report to FDA that would reasonably lead to warnings reaching physicians; plausible causation pleaded |
| Whether negligence per se, loss of consortium, and punitive damages survive | Federal reporting regs can be adopted as negligence‑per‑se standard; derivative claims and punitive damages permissible if underlying claim survives | Negligence‑per‑se would effectively enforce the FDCA; punitive/derivative claims should be dismissed if underlying claims preempted | Negligence per se may be pleaded to support the non‑preempted failure‑to‑warn claim; loss of consortium and punitive damages vacated from dismissal and may proceed on remand |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal PMA for Class III devices can expressly preempt conflicting state‑law requirements)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (state claims that seek to enforce FDCA requirements are impliedly preempted)
- Medtronic, Inc. v. Lohr, 518 U.S. 470 (state claims that parallel federal requirements may survive preemption)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir.) (post‑market reporting‑based failure‑to‑warn claim not preempted as a parallel state duty)
- In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200 (8th Cir.) (design/manufacture claims preempted where they attack FDA PMA risk/benefit approval)
- Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir.) (similar preemption analysis for design/manufacturing claims)
- Watts v. Medicis Pharm. Corp., 239 Ariz. 19 (Ariz.) (manufacturer satisfies duty to warn by warning learned intermediaries; informs analysis of whether FDA notice could discharge state duty)