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Article: April 2015: Product Liability Litigation Update

Business Litigation Reports

Defenses to Public Nuisance Claims in Pharmaceutical Products Litigation. For many years, plaintiffs have asserted the tort of nuisance to address purported harms from all sorts of products—including firearms, lead paint, chemicals, and energy products—that are alleged to endanger the “health, morals, safety, comfort, convenience, or welfare of the community.” Recently, nuisance has been asserted on behalf of governmental entities to address alleged harms arising from pharmaceutical products. As discussed below, these claims are subject to a variety of defenses.

The new nuisance lawsuits have been brought on behalf of governmental entities alleging wrongdoing in connection with prescription pain medications manufactured or distributed by a number of pharmaceutical defendants. In separate actions, the City of Chicago and two California counties are suing the drug industry for its “aggressive marketing” of opioid pain medications, which they allege has led to an epidemic of addiction that has cost taxpayers millions of dollars in insurance claims and other healthcare costs, criminal use of the medications, and an expanded market for heroin. E.g., Compl. at 94-97, California v. Purdue Pharma LP, No. 30-2014-00725287-CU-BT-CXC (Cal. Super. Ct. May 21, 2014); Compl. at 126-55, City of Chicago v. Purdue Pharma L.P., No. 14-cv-04361 (N.D. Ill.. Oct. 21, 2014).

Federal preemption may be a significant defense to public nuisance suits brought against pharmaceutical manufacturers. Long a staple defense in pharmaceutical products liability litigation, preemption has also been held to bar public nuisance claims in other contexts. For example, the Fourth Circuit held that air pollution claims were barred by the Clean Air Act’s “system for accommodating the need for energy production and the need for clean air,” N. Carolina, ex rel. Cooper v. Tenn. Valley Auth., 615 F.3d 291, 296 (4th Cir. 2010), and the Supreme Court has held that federal common law nuisance claims regarding carbon dioxide emissions alleged to cause global warming were displaced by the Clean Air Act. Am. Elec. Power Co. v. Connecticut, 131 S. Ct. 2527 (2011).

Defendants may assert that preemption similarly bars or substantially limits public nuisance claims against pharmaceutical companies. At the outset, defendants may argue that any claims involving generic medications would be significantly curtailed by the Supreme Court’s decisions in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), because federal law requires generic manufacturers to use both the same labeling and design as the branded medication and limits communications to physicians regarding generic medications. Further, to the extent these actions are based on alleged violations of the Federal Food, Drug, and Cosmetic Act (“FDCA”) requirements, defendants may argue that they would be barred by Buckman Company v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2011), contending that the enforcement of those requirements is the exclusive prerogative of the federal government. And to the extent such public nuisance claims address reimbursement for prescription medications under state Medicaid programs, defendants may argue that these claims impermissibly conflict with federal law governing Medicaid programs. Moreover, even to the extent these claims were not found to be preempted, defendants may argue that the courts should defer to the FDA in resolving these matters under the doctrine of primary jurisdiction, which generally provides that issues committed to an administrative body should be addressed by it before being litigated.

In addition to preemption, defendants in these actions also may argue a failure of proximate causation due to the attenuated nature of the harm the plaintiffs allege. To the extent the suits are prosecuted in federal court, defendants may assert that the issue of causation may affect not only the merits of the action, but also the court’s jurisdiction, due to the plaintiffs’ lack of standing to bring the action in the first place. For example, courts generally have rejected public nuisance claims against producers of fatty foods for lack of standing on the ground that plaintiffs could not trace any health harm to those specific products, much less show that isolated uses of those products had caused harmful effects. Simpson v. Cal. Pizza Kitchen, Inc., 989 F. Supp. 2d 1015, 1022, 1025 (S.D. Cal. 2013). With similar reasoning, some judges have stated that global warming nuisance claims fail because the alleged harmful effects cannot be fairly attributed to particular defendants. Kivalina v. ExxonMobil Corp., 696 F.3d 849, 868 (9th Cir. 2012) (Pro, J. concurring). Pharmaceutical defendants may similarly contend that the harm alleged in the opioid nuisance litigation—increased healthcare costs to taxpayers from addiction—is not traceable to the defendants given the large number of factors that can cause or contribute to addiction. Defendants may also argue that an alleged link between the alleged conduct and injury was broken by other factors, including the criminal actions of third parties.

Finally, defendants may assert that public nuisance claims against pharmaceutical defendants fail because they do not allege interference with a “public right,” which is one of “those indivisible resources shared by the public at large, such as air, water, or public rights of way.” State v. Lead Indus. Ass’n, Inc., 951 A.2d 428, 453 (R.I. 2008); City of Chicago v. Am. Cyanamid Co., 823 N.E.2d 126, 131 (Ill. App. Ct. 2005). Courts generally have rejected nuisance claims against the firearms industry due to the lack of a public right to be “free from unreasonable jeopardy to health, welfare and safety . . . caused by the presence of illegal weapons.” City of Chicago v. Beretta U.S.A. Corp., 821 N.E.2d 1099, 1114 (Ill. 2004); accord City of Philadelphia v. Beretta U.S.A., Corp., 126 F. Supp. 2d 882, 909, 911 (E.D. Pa. 2000), aff’d, 277 F.3d 415 (3d Cir. 2002). Pharmaceutical defendants may assert that the new nuisance actions are on similar footing, because they allege harm due to illegal, not legal, use of the products. Defendants should continue to monitor the assertion of public nuisance claims against the pharmaceutical industry and be prepared to develop these and other potential defenses to such claims.