Medical Device Amendments to FDCA Regarding Post-Approval Adverse Event Reporting to FDA Did Not Preempt Arizona Negligence Claim

In 1988 the FDA granted pre-market approval to Medtronic’s SynchroMed Pump and Infusion System. Eleven years later Medtronic obtained supplemental pre-market approval for its SynchroMed EL Pump and Catheter. A year after it was approved, a man had a Medtronic SynchroMed EL Pump and Catheter surgically implanted to deliver pain medication directly to his spine. Medtronic discovered risks associated with the device but failed to report them to the FDA. Just under five years after it was implanted, the device caused the man to become permanently paraplegic. The FDA subsequently inspected Medtronic’s facility and discovered Medtronic had concealed known risks associated with this device. Three years after the man was rendered permanently paraplegic, the device was recalled.


The man and his wife sued Medtronic in Arizona state court. The case was removed to federal court. Upon removal the plaintiffs sought to amend their complaint to include a claim that under federal law, Medtronic had a continuing duty to monitor the product after pre-market approval and to discover and report to the FDA any adverse events that may be attributable to the product, that Medtronic failed to perform its duty under federal law to warn the FDA, and because Medtronic failed to comply with its duty under federal law, it breached its duty to use reasonable care under Arizona negligence law. The United States District Court for the District of Arizona dismissed the plaintiffs’ state law claims as preempted by the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA).


The Ninth Circuit United States Court of Appeals reversed the district court and held that the MDA does not preempt state-law claims for violating a state-law duty that parallels a federal-law duty under the MDA. Under the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA), once the FDA approves a device, the manufacturer is required to report any adverse events to the FDA. An adverse event includes any information that reasonably suggests that the device (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that any recurring malfunction would be likely to cause or contribute to a death or serious injury. Under Arizona law, negligence standards impose a duty to produce products with appropriate warning instructions which continues to apply to dangers the manufacturer discovers after sale. “Conflict preemption” exists when the state requirement actually conflicts with the federal requirement, making impossible compliance with both requirements, or when the state requirement stands as an obstacle to accomplishment execution of the full purposes and objectives of Congress. The Arizona state law claim is not preempted, either expressly or impliedly, by the MDA, even though Arizona law had not previously addressed reporting duties to the FDA specifically. It is a state-law claim that is independent of the FDA's pre-market approval process.


Seven justices concurred with the majority decision and went on to clarify why the state law failure-to-warn claim alleged in the proposed amended complaint was not preempted. Specifically, the plaintiffs’ negligence claim was not expressly preempted because it sought to hold Medtronic accountable only for failing to do what federal law mandated and nothing more. Medtronic's failure to report was more than a mere misrepresentation to the FDA because it simultaneously misled the device's current and potential users, to whom Medtronic owed an independent duty under state law. The court found that the fact Arizona law did not previously address reporting duties to the FDA specifically was irrelevant. The preexisting state law need not mirror the federal requirement at that level of specificity to avoid preemption. It is sufficient that the plaintiffs’ claim is grounded in a traditional category of state law failure-to-warn claims that predated the MDA, and that the claim therefore does not exist solely by virtue of the MDA.


See: Stengel v. Medtronic Inc., 2013 WL 106144 (C.A.9 (Ariz.), January 10, 2013) (not designated for publication).