What is Amy Coney Barrett’s Record on Federal Preemption and What Does it Mean for Future SCOTUS Rulings in Drug and Medical Device Litigation?
Federal preemption has been the subject of numerous SCOTUS drug and medical device decisions in the past decade. Several recent decisions have had a profound impact on liability in drug and device litigation cases. With Amy Coney Barrett confirmed by the Senate and sworn on to the Court on Monday night, it is important to look at her record on federal preemption and how her addition to the Court might impact future rulings in this critical area of life sciences law.
I. Federal Preemption
The doctrine of federal preemption of state laws is rooted in the Supremacy Clause of the United States Constitution, which states that federal law is “the supreme Law of the Land...anything in the Constitution or Laws of any State to the Contrary notwithstanding.” Essentially, preemption means that if state and federal law directly conflict, then state law must give way. In making a determination on preemption, courts are to consider whether federal intent is to completely regulate the subject matter.
II. Barrett on Preemption
Barrett served on the Seventh Circuit Court of Appeals starting on October 31, 2017. She served for just under three years, and prior to that was a law professor, so her library of written judicial opinions is not voluminous. Barrett’s lone Seventh Circuit opinion on the topic of preemption came in May of 2018 in the case of Boogaard v. National Hockey League, 891 F.3d 289 (7th Cir. 2018). There, the parents of a former professional hockey player filed a wrongful death lawsuit against the National Hockey League (“NHL”) after their son, Derek Boogaard, allegedly became addicted to opioids prescribed to him by doctors of numerous professional hockey teams and eventually suffered an overdose and died. In response to the lawsuit, the NHL sought dismissal of the case arguing that the Boogaard’s state law claims were preempted by the Labor Management Relations Act, a federal statute, because Derek Boogaard had been a member of the NHL players union and was subject to the Collective Bargaining Agreement (“CBA”) between the NHL and its players. Thus, the NHL was bound by the terms of the CBA under federal law. The district court eventually granted the NHL’s motion for summary judgment on the preemption issue and the Boogaard’s appealed to the Seventh Circuit.
Barrett authored the Seventh Circuit opinion affirming the district court’s ruling, stating plainly, “the district court did get it right.” She wrote that the doctrine of federal preemption “confers exclusive federal jurisdiction in certain instances where Congress intended the scope of federal law to be so broad as to entirely replace any state law claim.” Id. at 293. Because the late-Boogaard was a member of the NHL players union and, thus, bound by the collective bargaining agreement between the union and the NHL, the federal Labor Management Relations Act “displace[d] entirely any state law cause of action for violation of a collective bargaining agreement.” Id. at 294. In response to the Boogaard’s claims that their lawsuit sounded in negligence as opposed to breach of contract against the NHL, Barrett wrote that “[i]t does not matter that the lawsuit styles itself as something other than a breach-of-contract action.” Id. She went further saying “[i]f the suit’s claims are ‘founded directly on rights created by collective bargaining agreements’ or ‘are substantially dependent on analysis of a collective bargaining agreement,’ then §301(a) [of the Labor Management Relations Act] governs those claims.” Id. citing Caterpillar, Inc. v. Williams, 482 U.S. 386, 394 (1987). Barrett’s opinion in Boogard is short and concise and takes a hard-line stance on federal preemption of state law in the context of labor relations law.
The only other published writing in which Barrett addressed the issue of preemption came in a law review article entitled “Substantive Canons and Faithful Agency,” 90 Bos. Univ. L.R. 109 (2010), in which she analyzed how to be a “faithful agent” of strict textualism across numerous legal doctrines, one of which was federal preemption. In that article Barrett noted preemption’s root in the Supremacy Clause and cites to preemption cases in which Justice Thomas and Justice Scalia, for whom she served as a law clerk, dissented by taking the position that “the presumption against preemption has no place in the construction of an express preemption clause.” Id. at 122, Fn. 56. The “presumption against preemption” is the concept that federal law should not preempt state law unless it “was the clear and manifest purpose of Congress” to do so. Medtronic, Inc. v. Lohr, 578 U.S. 470, 485 (1996). In that article, as in Boogaard, Barrett adopted a strict reading of the supremacy clause and clearly rejected “the presumption against preemption.” Given her outspoken textualist interpretation of the Constitution, Barrett’s strict view of federal preemption is not surprising.
III. Preemption in Drug and Medical Device Litigation
Federal preemption in drug and medical device litigation stems from the conflict between state tort laws (negligence and product liability) and the federal Food Drug and Cosmetic Act and its subsequent amendments. This conflict has been a frequent topic for SCOTUS decisions in the last decade and a review of all opinions would well exceed the scope of this article. However, two example opinions show how impactful preemption can be in drug and medical device litigation.
In the medical device realm, the Supreme Court recently held that manufacturers of devices that undergo the Food and Drug Administration’s (“FDA”) strenuous pre-market approval process, cannot be subject to state tort lawsuits for failure to provide proper warnings or defects in design of their products because they have complied with federal law and any state law claims are preempted. Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). Likewise, the Court found that manufacturers of generic (not brand name) prescription drugs who comply with the FDA’s mandate that those drugs be identical in composition and contain identical warnings to those of their brand name drug counterparts cannot be sued under state law tort theories of failure to warn or design defect because they are in compliance with federal law. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011). The Riegel and PLIVA decisions provide drug and medical device manufacturers with powerful tools for protection against liability in personal injury litigation.
IV. Coney Barrett’s Potential Impact on Preemption in Drug and Device Litigation
Given her commitment to strict textualism, the fact that preemption is rooted in the Constitution’s supremacy clause, the writings addressed above and, specifically, her dismissal of “the presumption against preemption” theory, Barrett’s addition to the Court is highly unlikely to jeopardize the Riegel and PLIVA decisions. The survival and continued application of the doctrine in these contexts has become even more likely given the now further enhanced conservative majority on the Court. Further, it is entirely possible that we could see the Court strengthen and, potentially, expand the preemption language from those opinions creating even greater protection for drug and medical device companies. While this would be a welcome development for defendants in life sciences litigation, it will further muddy the waters for manufacturers as they seek to accurately assess and plan for potential future liability in cases based on state tort law. We will be monitoring this situation carefully moving forward.
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