(CN) - Federal law does not pre-empt failure-to-warn claims over a Medtronic pain pump that paralyzed an Arizona man, the en banc 9th Circuit ruled Thursday.
To treat his pain problems, Richard Stengel underwent surgery in 2000 to get a SynchroMed EL Pump and Catheter implanted in his abdomen. Five years later, he suffered inflammation that led to paralysis.
Medtronic, the pump's maker, recalled the device in March 2008. Stengel and his wife sued the company in 2010, alleging negligence, breach of warranty and product liability.
In a proposed amended complaint, they argued that Medtronic failed to report defects to the Food and Drug Administration, as required by federal regulations.
After a federal judge dismissed the action, the 9th Circuit affirmed
in April 2012 and granted a rehearing
At a hearing
in September, the court discussed how an FDA audit of the Medtronic plant uncovered at least 37 problems with the pump that had previously eluded regulators.
The Stengels said doctors would have been warned if Medtronic had communicated better with the FDA.
Medtronic argued that the medical device amendments to the Food, Drug, and Cosmetic Act pre-empt state-law failure-to-warn claims, but the full court found otherwise Thursday.
"The Supreme Court has decided three preemption cases under the MDA," Judge William Fletcher wrote for the 11-judge panel, abbreviating medical device amendments. "The rule that emerges from these cases is that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA."
Precedent dictates that the lack of a damages remedy in the MDA does not pre-empt states from providing such a remedy, even for violations of parallel state-law duties, according to the ruling.
"The Stengels' proposed new claim under Arizona law, insofar as the state-law duty parallels a federal-law duty under the MDA, is not preempted," Fletcher wrote. "Arizona state law has long been concerned with the protection of consumers from harm caused by manufacturers' unreasonable behavior. Plaintiffs' claim is brought under settled Arizona law that protects the safety and health of Arizona citizens by imposing a general duty of reasonable care on product manufacturers."
Fletcher emphasized that the ruling does not reach the merits of the failure-to-warn claim. It finds only that the claim can proceed.
"The Stengels have not appealed the dismissal of the state-law claims in their original complaint," Fletcher wrote. "We agree with the district court that those claims are preempted as they are currently pled. The Stengels have not specified in those claims a state-law duty that parallels a federal-law duty under the MDA. Now that we have clarified preemption law under the MDA, it is possible that the Stengels could plead nonpre-empted versions of these claims. We leave it to the sound discretion of the district court to determine whether, in light of this opinion, the Stengels should be permitted to file a further amended complaint if they wish to do so."
The pre-emption issue received further treatment in a brief concurring opinion penned by Judge Paul Watford and joined by six of his colleagues.
"Because they predicate their claim on Medtronic's reporting duty to the FDA, as they must to avoid express preemption, the Stengels face a causation hurdle that would not otherwise exist," Watford wrote. "To prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached Mr. Stengel's doctors in time to prevent his injuries. But at this juncture - a request for leave to amend their complaint - the Stengels' allegations of causation are adequate."