By Matt Pavich, J.D.
Federal law impliedly preempted a pain pump recipient’s state-law failure to warn claim against the device manufacturer because only federal law, and not Arizona law, imposes a duty on a medical device manufacturer to submit adverse event reports, the Arizona Supreme Court advised. In so ruling, the high court vacated a ruling by the Arizona Court of Appeals that upheld on preemption grounds the dismissal of the patient’s product liability and negligence claims against the pump maker based on alleged design and manufacturing defects (Conklin v. Meditronic, Inc., December 18, 2018, Pelander, J.).
Following a hip injury, an individual had an infusion pump and catheter implanted in 2008 to help him manage the pain. After undergoing hip surgery in 2013, the patient allegedly suffered permanent injury due to over-infusion from his continued use of the pump. He sued the manufacturer for various common-law tort claims, including the failure to provide warnings. He alleged that the Food and Drug Administration (FDA) had sent warning letters to the manufacturer that the pump was adulterated/misbranded and had issued recalls for the pump, and that the manufacturer had failed to submit adverse reports to the agency. The state superior court dismissed the suit but, although affirming the dismissal of the patient’s remaining claims, the court of appeals vacated the trial court’s dismissal of the failure-to-warn claim [see Products Liability Law Daily’s October 23, 2017 analysis]. Citing the U.S. Court of Appeals for the Ninth Circuit’s ruling in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), appellate panel reasoned that the patient’s failure to warn claim neither was expressly nor impliedly preempted. The device manufacturer appealed, arguing that federal law preempts the claim because it was based on the failure to submit adverse event reports to the FDA.
FDA role. The Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act impose rigorous oversight of Class III medical devices such as the at-issue pain pump and require manufacturers to report incidents in which the device either caused or contributed to death or serious injury. The MDA also expressly preempts state law claims that are different from, or in addition to, federal requirements. In order to avoid preemption, plaintiffs must sue for conduct that violates federal requirements, but they cannot sue only because of that violation.
Implied preemption. The high court found that the failure to warn claim was impliedly preempted because the patient did not have a claim under state tort law for the pump maker’s failure to submit adverse event reports to the FDA. Arizona manufacturers have a general duty to warn consumers of foreseeable risks posed by their products and may satisfy that duty by warning a learned intermediary, which must be a health-care provider. The FDA is not a health care provider and, thus, even if the reports constituted relevant warnings, the manufacturer in this case could not satisfy its duty to warn under Arizona law by submitting reports to the FDA. The pump maker could not have a "reasonable assurance" that the information in those reports would reach the public because the FDA is not required to release them, the high court noted, adding that when the agency does release reports, it does so "passively" by uploading them to its website. Therefore, because Arizona law does not impose a duty on manufacturers to submit adverse event reports to the FDA, the patient’s failure to warn claim was impliedly preempted.
Ninth Circuit ruling. In so ruling, the state supreme court found that the Ninth Circuit’s ruling in Stengel incorrectly stated that Arizona law may allow warnings to third parties like the FDA. Consequently, the state court of appeals’ reliance on that case was misplaced, the high court advised.
The case is No. CV-17-0322-PR.
Attorneys: Paul D. Friedman (O’Steen & Harrison, PLC) for Raymond R. Conklin, II and Joanne M. Conklin. Andrew E. Tauber (Mayer Brown LLP) and Michael T. Liburdi (Greenberg Traurig LLP) for Medtronic, Inc., Medtronic PLC and Medtronic Sofamor Danek USA, Inc.
Companies: Medtronic, Inc.; Medtronic PLC; Medtronic Sofamor Danek USA, Inc.
MainStory: TopStory PreemptionNews WarningsNews MedicalDevicesNews ArizonaNews
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