431 P.3d 571
Ariz.2018Background
- Raymond Conklin had a Medtronic SynchroMed II infusion pump (a Class III device) implanted in 2008 and suffered an alleged drug over‑infusion injury in 2013.
- Conklin alleged Medtronic failed to submit required post‑PMA adverse event reports to the FDA and that this failure-to-report deprived him of warnings that would have prevented his injury.
- Medtronic moved to dismiss under Rule 12(b)(6), arguing federal preemption (express and implied) under the Medical Device Amendments (MDA) to the FDCA. The superior court dismissed with prejudice.
- The court of appeals affirmed dismissal of design/manufacturing and express‑warranty claims as expressly preempted, but reversed dismissal of the failure‑to‑warn claim, relying on Ninth Circuit precedent (Stengel).
- The Arizona Supreme Court granted review and held Conklin’s failure‑to‑warn claim (based solely on alleged failure to submit adverse event reports to the FDA) is impliedly preempted, affirming the superior court’s dismissal and vacating portions of the court of appeals’ opinion.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether federal law preempts an Arizona failure‑to‑warn claim premised on a manufacturer’s failure to submit post‑PMA adverse event reports to the FDA | Conklin: Arizona common law independently requires manufacturers to warn (and can be satisfied by warning a third party such as the FDA); he sues under state law, not to enforce the FDCA | Medtronic: Such a claim would enforce FDA reporting requirements and is therefore preempted (expressly and/or impliedly) under the MDA and FDCA | Held: Impliedly preempted. Arizona law does not impose an independent duty to warn the FDA; the claim would effectively enforce federal reporting duties reserved for the federal government, so it is impliedly preempted |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (federal express‑preemption framework for PMA devices)
- Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (MDA implied preemption where private suit would enforce federal regulatory regime)
- Watts v. Medicis Pharm. Corp., 239 Ariz. 19 (adopting learned intermediary doctrine for warnings under Arizona law)
- Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. decision holding no preemption for similar failure‑to‑report claim; Arizona Supreme Court declined to follow)
- Mink v. Smith & Nephew, Inc., 860 F.3d 1319 (failure‑to‑report theory falls outside traditional state torts; impliedly preempted)
- In re Medtronic, Inc., 623 F.3d 1200 (claims attempting to enforce MDA reporting requirements are preempted)
- Marsh v. Genentech, Inc., 693 F.3d 546 (similar conclusion: failure‑to‑report claims sought to enforce federal duties and were preempted)
- Hughes v. Bos. Sci. Corp., 631 F.3d 762 (discusses contours of state failure‑to‑warn claims based on reporting and preemption)