384 F. Supp. 3d 570
E.D.N.C.2019Background
- Plaintiff sued defendants in state court after a 2013 knee-replacement implant (a device later identified as FDA PMA-approved) allegedly failed and required revision surgery; claims included negligence (duty to warn/warranty), strict liability, breach of warranty, fraud, and other torts.
- Defendants removed to federal court and moved for summary judgment arguing all claims are preempted by the Medical Device Amendments (MDA) because the device had FDA premarket approval (PMA); the court stayed discovery pending resolution of the preemption motion.
- Plaintiff sought to vacate the discovery stay and sought discovery aimed at challenging the integrity of defendants’ FDA submissions and the adequacy of warnings/communications about adverse events.
- The dispositive undisputed fact: the product received FDA premarket approval and subsequent supplements; plaintiff’s counsel acknowledged the PMA in declarations.
- The court framed the dispute as whether North Carolina law recognizes duties that run parallel to federal requirements (so not preempted) — specifically whether there is a state-law duty to report adverse events to the FDA or otherwise provide post-sale warnings that would avoid MDA preemption.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether state-law claims are preempted by the MDA for a PMA-approved device | Plaintiff contends negligence (duty to warn/warranty) can be based on an independent state duty to report adverse events to FDA or otherwise provide post-sale warnings that run parallel to federal duties | Defendants argue PMA approval triggers express and implied preemption: state requirements that differ from or add to federal requirements are preempted, and claims based solely on violations of federal requirements are impliedly preempted | Court held all asserted claims are preempted and granted summary judgment for defendants |
| Whether North Carolina recognizes a state-law duty to report adverse events to FDA that would avoid preemption | Plaintiff argues state law duty-to-warn can include reporting to the FDA and that such reporting could satisfy a parallel state duty | Defendants argue North Carolina law recognizes only duties to warn users or practitioners, not a duty to report to FDA; no authority shows such a parallel duty exists | Court held North Carolina law does not recognize a duty to report to FDA; plaintiff’s theory fails and is preempted |
| Whether discovery into defendants’ FDA submissions and alleged fraud on FDA should be allowed before ruling on preemption | Plaintiff seeks discovery to challenge integrity/timeliness/truthfulness of FDA submissions to defeat PMA preemption | Defendants contend such discovery is irrelevant to the dispositive fact (the device has PMA) and challenges to FDA submissions are barred by Buckman (fraud-on-the-FDA claims are impliedly preempted) | Court denied discovery and denied motion to vacate stay; Rule 56(d) not satisfied because PMA status is undisputed and fraud-on-FDA claims are preempted |
| Whether other remaining claims should be dismissed | Plaintiff conceded many non-negligence claims could be dismissed; she insisted on negligence-based duty-to-warn/warranty claims | Defendants sought dismissal of all claims as preempted | Court dismissed all remaining claims with prejudice as preempted by federal law |
Key Cases Cited
- Riegel v. Medtronic, Inc., 552 U.S. 312 (court holds MDA §360k expressly preempts state-law requirements that are different from or in addition to federal requirements, and explains role of PMA and labeling review)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (state-law fraud-on-the-FDA claims are impliedly preempted because the MDA entrusts enforcement to the federal government)
- Walker v. Medtronic, Inc., 670 F.3d 569 (4th Cir.) (applies Riegel to hold claims against PMA devices are preempted)
- Burrell v. Bayer Corp., 918 F.3d 372 (4th Cir.) (discussed in dicta the possibility of state-law duties predicated on failure to report adverse events to FDA but did not resolve preemption; court treated it as non-dispositive here)