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SAN FRANCISCO - (Mealey's) In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme Court case law (Richard Stengel, et al. v. Medtronic Incorporated, No. 10-17755, 9th Cir.).
(Opinion. Document #28-120419-017Z.)
In 2000, Richard Stengel had a SynchroMed EL drug pump and intrathecal catheter implanted to deliver pain drugs to the intrathecal space in his spine. In 2005, Stengel experienced ascending paralysis in his lower extremities.
Doctors found that a granuloma had formed at the tip of the catheter and that it was causing the paralysis. Doctors removed the medical device and most of the granuloma but not before Stengel was rendered permanently paraplegic.
Stengel and his wife, Mary Lou, sued Medtronic in the U.S. District Court for the District of Arizona, alleging negligence, breach of express and implied warranty and strict liability. The District Court granted Medtronic's motion to dismiss on the ground that the Stengels' claims are expressly preempted by federal law.
Failure To Evaluate Complaints
While the motion to dismiss was pending, the Stengels moved to amend the complaint to allege that his injury was caused by Medtronic's failure to evaluate complaints about its pain pump and report that information to the Food and Drug Administration. They argued that if Medtronic had complied with FDA regulations, the company would have warned doctors about the new risk of the device and Richard might have been diagnosed sooner and not become paralyzed.
The District Court denied the motion to amend on the grounds that his failure-to-warn theory was preempted both explicitly and by implication.
The Stengels appealed.
Riegel Express Preemption
The Ninth Circuit majority said the claims in the Stengels' original complaint are preempted by the U.S. Supreme Court's medical device preemption ruling in Riegel v. Medtronic, Inc. (552 U.S. 312, 315 ) and Section 360(k) of the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) (21 U.S. Code). "To be successful, the claims would have required the trier of fact, as a matter of state tort law, to conclude that the device should have either been designed differently from what the FDA required through premarket approval, or labeled with warnings different from what the FDA required," the majority said.
To the extent that the Stengels say Medtronic should have sent out a medical device correction notice to physicians, whether or not the FDA ordered one, the majority said that is also expressly preempted.
The majority said portions of the Stengels' claims could be interpreted to survive express preemption. "To the extent Medtronic's alleged violations of FDA regulations are actionable under state law, the state obligations parallel the federal requirements and are thus not expressly preempted," the majority said.
Parallel Claims, Meet Buckman
However, the majority said that theory fails under the U.S. Supreme Court's fraud-on-the-FDA preemption ruling in Buckman Co. v. Plaintiffs' Legal Committee (531 U.S. 341 ). "There is no meaningful distinction between the Stengels' failure-to-warn claims and the 'fraud-on-the-FDA' claims held to be preempted in Buckman," it said.
"Therefore, following Buckman, we hold that the Stengels' claims are impliedly preempted," the majority said.
Although Arizona law imposes liability on a manufacturer that fails to exercise reasonable care to inform consumers of a dangerous condition, the majority said, "The federal regulations that Medtronic is alleged to have violated, which require investigation and disclosure to the FDA in a particular manner so that the FDA can make a decision whether notification of consumers is necessary, are not tied to this general duty to warn consumers under Arizona law."
"Thus, the Stengels' failure-to-warn claims, to the extent they survive express preemption, exist solely by virtue of the FDCA disclosure requirements and are, therefore, impliedly preempted," the majority said.
Preemption Not Absolute
The majority added, "Nothing in our holding requires preemption of all state claims challenging the safety of a medical device that has received premarket approval." However, citing case law, it said plaintiffs must fit through a "narrow gap" to escape express or implied preemption.
"We offer no opinion as to whether a particular state claim that is tied directly to compliance with federal law would be preempted under federal law to report to the FDA information regarding their devices that is not tied directly to the duty of manufacturers under state law to warn consumers of a device's dangerous condition," the majority said.
The Stengels argued that their claim escapes Buckman because of an FDA letter warning Medtronic that the company failed to meet its disclosure obligations. The majority said it was not convinced because the Stengels' argument is based on a concurrence by Supreme Court justices in Buckman that was not part of the high court majority opinion.
Don't Take The 5th
The majority said the Eighth and Fifth circuit courts are split on whether state failure-to-warn claims are preempted by Buckman. It said the Fifth Circuit opinion is not persuasive.
The Stengels also argued that the District Court erred in not allowing them to replead their complaint. The majority said the complaint was not dismissed on pleading standards but on preemption grounds.
The Stengels also argued that the trial court erred by not converting Medtronic's dismissal motion to a summary judgment motion and by refusing to grant the plaintiffs a continuance for discovery. The majority said the District Court properly took judicial notice that the Medtronic pump received premarket approval.
Medtronic Correction Letter
Finally, the Stengels argued that the trial court erred in not taking judicial notice of Medtronic's correction letter and a document showing that the drug pump was recalled in 2008. The majority said the court did not need to take judicial notice of the letter because it was an exhibit to a proposed amended complaint.
In addition, the majority said the correction letter would not affect the preemption analysis.
"We recognize that it may seem harsh to deny compensation to a person who alleges serious injury from a medical device," the majority concluded. "But such is the direction from the Supreme Court for cases like the one before us."
Circuit Judge J. Clifford Wallace wrote the opinion, which Circuit Judge Milan D. Smith Jr. joined.
Dissent: Freedom From Liability?
Circuit Judge John T. Noonan dissented, writing: "Has Congress or the Supreme Court created such freedom from liability for the manufacturers of such sensitive devices that only in nonexistent cases are the manufacturers subject to suit for damages? Are individuals injured by the malfunction of such devices without remedy against the manufacturers of them?"
"That appears to be the conclusion of this court today with its holding that the MDA explicitly preempts and implicitly preempts any state remedy of damages for violation of a state requirement paralleling the MDA," Judge Noonan continued. "This conclusion, astonishing in its comprehensiveness, is equally astonishing in the light of binding federal law as determined by the United States Supreme Court."
Stengel is represented by Thomas G. Cotter, Stanley G. Feldman and Stephen T. Portell of Harralson, Miller, Pit, Feldman & McAnally in Tucson, Ariz. Medtronic is represented by Michael K. Brown, Ginger F.H. Pigott and Lisa M. Baird of Reed Smith in Los Angeles.
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