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SAN FRANCISCO- (Mealey's) The Ninth Circuit U.S. Court of Appeals, sitting en banc, ruled Jan. 10 that federal law does not preempt, expressly or by implication, a state law failure-to-warn claim alleging that Medtronic Inc. violated its federal duty to report problems with a drug pump (Richard Stengel, et al. v. Medtronic Incorporated, No. 10-17755, 9th Cir.).
(Opinion available. Document #28-130125-002Z.)
In 2000, Richard Stengel had a SynchroMed EL drug pump and catheter made by Medtronic implanted in his abdomen to deliver pain drugs directly to his spine. In 2005, Stengelbecame a paraplegic, allegedly because of the drug pump.
Stengel and his wife, Mary Lou Stengel,sued Medtronic in the U.S. District Court for the District of Arizona, alleging that Medtronic was aware of certain risks from the SynchroMed pump but failed to inform the Food and Drug Administration about the risks even though it was required to do so by federal law. The FDA discovered the risks and Medtronic's knowledge about them in late 2006 and early 2007.
The FDA sent Medtronic a warning letter that the pump was misbranded because the company concealed a known risk. Medtronic sent a medical device correction letter to doctors and recalled the pump in 2008.
Preemption Found Twice
The District Court found that the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act preempted all of the Stengels' claims, including one for state law negligence.
The Stengels appealed, and in April a panel of the Ninth Circuit affirmed preemption on a 2-1 vote. The Stengels then moved for an en banc rehearing, which the court granted.
The question presented to the en banc court was whether the MDA preempts a statelaw claim in which the state law duty of care parallels duty imposed by the MDA.
Claims Parallel MDA
The en banc court held that Stengel's amended state law complaint is not preempted insofar as it parallels a federal duty under the MDA. Reviewing Arizona law, the court said, "If a more precise parallel were necessary, the Stengels have alleged it and Arizona law provides it. The Stengels' new claim specifically alleged, as a violation of Arizona law, a failure to warn the FDA.
"Arizona law contemplates a warning to a third party such as the FDA," the court continued.
The court said it held that the Stengels' claim is not preempted, "either expressly or impliedly," by the MDA, citing U.S. Supreme Court medical device preemption rulings in Medtronic, Inc. v. Lohr (518 U.S. at 474, 480-81) [enhanced version available to lexis.com subscribers], Buckman Co. v. Plaintiffs' Legal Comm. (531 U.S. ) [enhanced version] and Riegel v. Medtronic, Inc. (552 U.S. 312 ) [enhanced version]. "It is a state-law claim that is independent of the FDA's pre-market approval process that was at issue in Buckman," the court said.
"The claim rests on a state-law duty that parallels a federal-law duty under the MDL, as in Lohr," the court continued.
Other Courts Agree
The court said that in finding the Stengels' failure-to-warn claim not preempted, it joins the Fifth Circuit and Seventh Circuit courts, which reached the same conclusion.
Despite its finding, the court said it is up to the Stengels to plead non-preempted versions of their claims and the District Court has the discretion to determine if it will permit an amended complaint to be filed.
Circuit Judge William A. Fletcher wrote the opinion. He was joined by Chief Judge Alex Kozinski and Circuit Judges Sidney R. Thomas,Barry G. Silverman, Susan P. Graber, M. MargaretMcKeown, William A. Fletcher, Ronald M. Gould, Johnnie B. Rawlinson, Richard R. Clifton and N. Randy Smith.
Circuit Judge Paul J. Watford concurred separately, commenting on why state law failure-to-warn claims are not preempted. He noted that the Stengels' claims are for Medtronic's failure to report adverse events involving the SynchroMed pump to the FDA.
"Framed in this fashion, the Stengels' negligence claim is not expressly preempted because it seeks to hold Medtronic accountable only for failing to do what federal law mandated - nothing more," Judge Watford wrote. "The state law duty, as alleged by the Stengels, is precisely parallel to the duties imposed by federal law."
The judge also noted that the Stengels will have to prove that if Medtronic had reported the adverse events as required by federal law, that information would have reached Richard Stengel's doctors in time to prevent his injuries.
Law Predated Buckman
Judge Watford rejected Medtronic's arguments that the Stengels' claims are preempted by the Supreme Court's fraud-on-the-FDA ruling in Buckman. He said that Buckman "left intact claims 'relying on traditional state tort law which had predated the federal enactments' in question."
Medtronic's failure to report also misled users of the SyncroMed pump, "to whom Medtronic owed an independent duty under state law," the judge said.
Stengel is represented by Thomas G. Cotter of Haralson Miller Pitt Feldman &McAnally in Tucson, Ariz.
Medtronic is represented by Michael Kevin Brown and Lisa Marie Baird of Reed Smith in Los Angeles and Timothy James Casey of Schmitt,Schneck, Smyth & Herrod in Phoenix.
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