Richard Stengel and his wife sued the medical device maker Medtronic when a medical device manufactured by Medtronic rendered Richard permanently paraplegic. Relying on the state law of Arizona, the Stengels alleged that Medtronic had been negligent.
Medtronic moved to dismiss the lawsuit arguing that the claims were preempted by federal law, namely the Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act (“FDCA”). If preempted by a federal law, a claim is limited to whatever remedies are provided by the federal law. In this instance, the federal MDA provides no right to recover damages. In short, if the Stenglers’ claim is preempted, they have no claim.
The MDA required Medtronic to report known risks to the FDA. The Stengels alleged that Medtronic was negligent—and thus violated state law—by failing to report known risks associated with use of its medical device to the FDA as required by federal law. The district court held that the MDA preempted all of the Stengels’ claims and dismissed the lawsuit. The Stengels appealed to the federal Ninth Circuit Court of Appeals.
The case involves a SynchroMed EL Pump and Catheter, an implantable, programmable drug delivery system. The device uses a catheter to deliver small doses of medication directly into the cerebrospinal fluid for the management of chronic pain.
On October 10, 2000, Richard Stengel had a SynchroMed EL Pump and Catheter surgically implanted in his abdomen to deliver pain relief medication directly into his spine. In February 2005, Stengel collapsed at home. At the hospital, he reported feeling heaviness and decreased sensation in his right leg. He was diagnosed with ascending paralysis in his lower body. A neurosurgeon removed the catheter, but Stengel was left permanently paraplegic. Medtronic’s medical device caused the paralysis.
When it received FDA approval of its SynchroMed EL Pump and Catheter, Medtronic was not aware of certain risks associated with the device. According to the Stengel’s lawsuit, Medtronic had become well aware of those risks before Stengel was paralyzed, but had failed to inform the FDA, even though the MDA required Medtronic to do so. The FDA discovered the risks, and discovered that Medtronic already knew about them, when it inspected a Medtronic facility in late 2006 and early 2007. The FDA sent a Warning Letter to Medtronic in July 2007, stating that Medtronic had “misbranded” its Class III device by concealing known risks, in violation of 21 C.F.R. §§ 803.50(a)(1), 806.10(a)(1). In response to the FDA’s Warning Letter, Medtronic sent a Medical Device Correction letter to doctors in January 2008. Medtronic recalled the device in March 2008. This advice and recall came too late to help Richard Stengel, who had been paralyzed in 2005.
The Stengels alleged 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 complaints about the product’s performance and any adverse health consequences of which it became aware and that are or may be attributable to the product.” They further alleged that Medtronic failed to perform its duty under federal law to warn the FDA. Finally, the complaint alleges that, because Medtronic failed to comply with its duty under federal law, it breached its “duty to use reasonable care” under Arizona law.
The Ninth Circuit has now reversed the district court’s dismissal of the suit. The court of appeals held that 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. Construing a trio of Supreme Court decisions regarding medical devices, the Ninth Circuit stated 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. The Stengels’ case has been sent back to the district court to proceed towards trial.
The federal MDA provides “no State … State may establish or continue in effect with respect to a device intended for human use any requirement— (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.” 21 U.S.C. § 360k(a). An implementing regulation provides the MDA “does not preempt State or local requirements that are equal to, or substantially identical to, requirements imposed by or under the act.” 21 C.F.R. § 808.1(d).
By alleging that Medtronic breached its duty of reasonable care under state negligence law by failing to report adverse events to the FDA, the Stengels were not seeking to impose any requirements “different from, or in addition to” the requirements imposed by federal law— because FDA regulations required Medtronic to file an adverse event report with the FDA if it learned of information “reasonably suggest[ing]” that one of its devices “[m]ay have caused or contributed to a death or serious injury,” as the Stengels have alleged here. 21 C.F.R. § 803.50(a). 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. Because the state law duty, as alleged by the Stengels, is precisely parallel to the duties imposed by federal law, the claim was not preempted, the Ninth Circuit held.
The full opinion in Stengel v. Medtronic Inc., No. 10–17755 (January 10, 2013) is available online by visiting the website of the Ninth Circuit court.
HO&P & Defective Products
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