The Supreme Court of the State of Arizona (“Arizona Supreme Court”) held in its opinion filed on December 18, 2018 that the plaintiff’s pain pump failure to warn state law claims were preempted under federal law (i.e., federal law preempts a failure-to-warn claim predicated on a medical device manufacturer’s failure to submit adverse event reports to the FDA).
In 2008, a surgeon had surgically implanted a pain pump in the plaintiff. The plaintiff had hip surgery in 2013 after which he suffered permanent injury allegedly caused by drug over-infusion from his continued use of the pain pump manufactured by the defendant, Medtronic, Inc. (“Medtronic”). The plaintiff and his wife thereafter sued Medtronic, alleging several common law tort claims, including both strict liability and negligence claims for failure to provide adequate and timely warnings. In those claims the plaintiff alleged that before his 2013 injury, the FDA sent warning letters to Medtronic, advising it that the pain pump was adulterated and misbranded and stating that Medtronic had failed to report adverse events to the FDA after the FDA approved the pain pump in its pre-market approval (“PMA”) process.
The plaintiff further alleged that before his 2013 injury, the FDA issued two recalls of the pain pump regarding the unintentional injection or cessation of drugs, and that after his injury, the FDA issued another recall relating to the pain pump’s unintended delivery of drugs that could result in a drug overdose. The plaintiff contended that Medtronic’s failure to report post-PMA adverse events to the FDA in violation of federal law gives rise to liability under Arizona common law.
Medical Device Amendments
In 1976, Congress enacted the Medical Device Amendments (“MDA”), Pub. L. No. 94-295, 90 Stat. 539, that imposed a regime of detailed federal oversight for medical devices. The MDA’s most rigorous level of oversight, which includes an extensive PMA process and review of proposed product labeling, applies to medical devices categorized as Class III devices. Medtronic’s pain pump is a Class III device. The FDA granted PMA for the pain pump before the device was surgically implanted into the plaintiff’s body in 2008.
Once a device has received PMA, the MDA forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness. If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental PMA, to be evaluated under largely the same criteria as an initial application.
Even after the FDA grants PMA for a device, the device is subject to reporting requirements. Those requirements include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of, or reasonably should know of, and to report incidents in which the device may have caused or contributed to death or serious injury or malfunctioned in a manner that would likely cause or contribute to death or serious injury if it recurred. 21 C.F.R. § 803.50(a)). The documents to which this latter requirement refers are called “adverse event reports.” The plaintiff’s failure-to-warn claim is based solely on Medtronic’s failure to submit adverse event reports in compliance with that requirement.
The MDA contains an express preemption provision that states, in part: [N]o State or political subdivision of a 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).
The U.S. Supreme Court has interpreted that provision as setting forth the following two-part test for determining whether the MDA expressly preempts a claim: (1) Has the Federal Government established requirements applicable to the medical device? (2) If so, are the common law claims based on state law requirements with respect to the device that are different from, or in addition to, the federal ones, and that relate to safety and effectiveness?
The Arizona Supreme Court stated that the first prong is “indisputably met” in the case it was deciding: the PMA process imposes requirements under the MDA because that process is specific to individual devices – therefore, Congress has established requirements applicable to the Medtronic pain pump. With regard to the second prong, if the state law requirements are different from, or in addition to the requirements imposed by federal law, then the state law claims are expressly preempted. If not, however, the claims are not expressly preempted because § 360k(a) does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.
The MDA also impliedly preempts certain state law claims. Specifically, the MDA provides that “all . . . proceedings for the enforcement . . . of this chapter shall be by and in the name of the United States.” 21 U.S.C. § 337(a). The U.S. Supreme Court has interpreted this provision to mean that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions. Thus, state law claims based not on traditional state tort law which predated the federal enactments in question but rather solely on noncompliance with the MDA are impliedly preempted because Congress intended that the MDA be enforced exclusively by the Federal Government.
Read together, these two types of preemption, operating in tandem, have created a ‘narrow gap’ for pleadings: a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violates that federal requirement (avoiding implied preemption).
The Arizona Supreme Court stated that the plaintiff’s failure-to-warn claim is based solely on Medtronic’s alleged failure to submit to the FDA post-PMA adverse event reports regarding the pain pump, and to the extent the plaintiff alleges a violation of any state-law duty to directly warn him or his physicians, such claims are expressly preempted because those duties would be in addition to requirements imposed by federal law. The Arizona Supreme Court further stated that to the extent the plaintiff argues that the FDA either has or assumed a duty to convey information from adverse event reports to treating physicians, patients, or more broadly public consumers (thereby implicating Medtronic for its failure to submit such reports), the plaintiff’s claim is expressly preempted because it likewise would impose under state law a requirement that is different from, or in addition to, any applicable federal requirement.
The Arizona Supreme Court held that the plaintiff’s failure-to-warn claim is impliedly preempted under federal law, and therefore did not address whether it is also expressly preempted (“Because only federal law, not state law, imposes a duty on Medtronic to submit adverse event reports to the FDA, [the plaintiff’s] failure-to-warn claim is impliedly preempted under 21 U.S.C. § 337(a)”). The dispositive issue was whether the plaintiff would have a claim under traditional state tort law based on Medtronic’s failure to submit adverse event reports to the FDA; if not—and the claim instead is one only for violation of FDA reporting requirements—then it is impliedly preempted because only the federal government can seek redress for a violation. The Arizona Supreme Court stated, “even if we assume that adverse event reports may constitute relevant warnings, Arizona law does not permit a manufacturer to satisfy its duty to warn end-user consumers by submitting adverse event reports to the FDA. And conversely, a manufacturer does not breach its duty to warn end users under Arizona law by failing to submit adverse event reports to the FDA.” “Arizona law would recognize a claim for a failure to provide an adequate warning to the patient directly or through certain third parties (including health care providers), but established law does not recognize a claim merely for failing to provide something like adverse event reports (which may not qualify as “warnings” under Arizona law) to a government agency that has no obligation to relay the information to the patient … our case law contemplates that a medical device manufacturer may satisfy its duty to warn consumers by properly warning a third party, such as a learned intermediary … But the FDA is not a learned intermediary or other relevant third party in that analysis. And we are not aware of any case that supports the proposition that a manufacturer is independently required under Arizona law to warn a governmental regulatory body.”
Source Conklin v. Medtronic, Inc., No. CV-17-0322-PR.
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