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January 11, 2013

An injured patient's allegations of parallel state and federal-law claims against a medical device manufacturer were not preempted by the Medical Device Amendments

By Danielle H. Capilla, JD

A patient that was rendered a paraplegic by a faulty catheter used to deliver pain relief medication into his spine has successfully appealed a district court ruling that Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) preempted his state law claim that parallels a federal-law duty under the MDA (Stengel v Medtronic Incorporated, January 10, 2013, Fletcher, W). The patient, Richard Stengel (Stengel), and his wife, sued Medtronic Incorporated (Medtronic) under state law after Stengel became a permanent paraplegic, and during litigation moved to amend their complaint to allege Medtronic violated a state-law duty of care by failing to report known risks associated with the use of the medical device to the FDA, which is also required by the MDA. The Ninth Circuit determined that the original allegations were preempted as they were originally pled, but reversed the determination that the proposed claim was preempted, remanding the case back to the district court for a determination of whether or not the Stengel's should be permitted to file a further amended complaint.

Background. In 2000, Richard Stengel had a SynchroMed EL Pump and Catheter surgically implanted into his abdomen to deliver pain relief medication delivered directly into his spine. In 2005, after a hospitalization, he was diagnosed with ascending paralysis of his lower body, caused by the catheter, and a neurosurgeon removed the catheter. Stengel remained paralyzed after the surgery. In 2006, the FDA inspected a Medtronic facility and discovered that Medtronic was aware of the risks associated with the pump and catheter, and had known about them prior to Stengel's paralysis. The FDA issued a warning letter to Medtronic, stating that Medtronic has misbranded the device by concealing known risks. Medtronic recalled the device in the spring of 2008, three years after Stengel's paralysis. In subsequent litigation, the district court held that the MDA preempted all of the Stengel's claims, including the newest claim, and denied the Stengel's motion to amend their complaint and dismissed their case.

Supreme Court precedent. On appeal, the Ninth Circuit held that three Supreme Court cases discussing preemption under the MDA illustrate that the MDA does not preempt a state-law claim for violation of a state-law duty, if the state-law duty parallels a federal-law duty under the MDA. Although there are three categories of preemption (express, field and conflict), the Supreme Court was clear that there was no preemption issue for parallel state-law claims under any of the three categories. The Ninth Circuit also noted that sister circuits have come to the same conclusion regarding parallel claims and the MDA.

Proposed claim. The claim the Stengel's attempted to add to their complaint alleged that Medtronic had a "continuing duty to monitor the product after pre-market approval and to discover and report to the FDA any complaints about the product's performance and any adverse health consequences of which it became aware and that are or may be attributed to the product." They also alleged that Medtronic failed to perform its federal-law duty to warn the FDA of its findings, and when it failed to do so, it breached its duty to use reasonable care under Arizona law. According to the Ninth Circuit, the new claim properly alleges, as a violation of state law, a failure to warn the FDA, which is required by the MDA. The court found that this proposed claim was not preempted, and remanded the case back to the district court for proceedings consistent with their findings.

The case number is 10-17755.

Attorneys: Thomas G. Cotter (Haralson Miller Pitt Feldman & McAnally, PLC) for Richard Stengel, Mary Lou Stengel, Appellants. Michael Kevin Brown and Lisa Marie Baird (Reed Smith, LLP), Timothy James Casey (Schmitt, Schneck, Smyth & Herrod PC) for Medtronic Incorporated, Appellee.

Companies: Medtronic Incorporated.

MainStory: TopStory PreemptionNews MDWarningNews MisbrandingNews MDApprovals AlaskaNews ArizonaNews CaliforniaNews HawaiiNews IdahoNews MontanaNews NevadaNews OregonNews WashingtonNews

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