Featured Expert Contributor, Civil Justice/Class Actions
On June 26, 2023, Reuters published an article labeling federal preemption “one of Corporate America’s most effective liability shields.” Ignoring its complexities and importance, Reuters characterizes federal preemption as a proverbial get-out-of-jail free card for “Big Pharma” and other heavily regulated industries. But the doctrine of preemption is not as one-sided as this article would have you believe.
Federal preemption is rooted in the Supremacy Clause of Article IV of the United States Constitution, which simply provides that federal law will supersede conflicting state law. In practice, preemption takes two forms—express or implied. Express preemption derives from specific language prohibiting state action that would conflict with a federal statute. Implied preemption, on the other hand, arises when Congress has not explicitly stated, but seems to suggest, its intent to preempt state law. Under the umbrella of implied preemption, other forms of preemption like conflict and field preemption emerge. Field preemption exists where Congress has so thoroughly regulated an area of law, no room remains for even complementary state laws. Conflict preemption arises when either: (1) simultaneous compliance of state and federal law is impossible; or (2) when state law creates an obstacle to accomplishing Congress’s objective.
With these technical underpinnings in mind, we will shift to discuss the role federal preemption plays in pharmaceutical product liability litigation. 1
The United States Food and Drug Administration (“FDA”) regulates the manufacture and distribution of all pharmaceutical products to ensure the safety, efficacy, and security of those products.2 This comprehensive regulatory framework touches every aspect of product development, manufacturing, and sale to ensure that the pharmaceuticals on the market are reasonably safe for their intended consumers.3
But this has not always been the case. Before the enactment of the Federal Food Drug & Cosmetic Act (“FDCA” or the “Act”) in 1938, pharmaceutical regulation was left to the states, if those products were regulated at all.4 The passage of this Act, thus, represented a step forward in consumer safety because it imposed uniform requirements on all pharmaceutical products marketed or sold in the United States. In the decades that have followed, Congress has strengthened the Act, expanded FDA’s pre-market regulatory authority, and imposed post-approval requirements on pharmaceutical manufacturers to ensure the ongoing safety and effectiveness of products already on the market.5
Necessarily, as federal regulation has become more comprehensive, the preemption doctrine has become more essential. By protecting pharmaceutical companies from competing federal and state regulations, federal preemption safeguards the public policy interests underlying uniform federal regulation. And although Reuters acknowledges that federal preemption plays an important role in U.S. pharmaceutical litigation, it wrongly suggests that its application places a thumb on the scales of justice favoring pharmaceutical defendants.
Indeed, despite compulsory compliance with this broad federal regulatory system, courts have long held that pharmaceutical manufacturers are ultimately responsible for their products and can be sued under numerous theories of liability. Federal preemption only precludes liability if the company cannot comply with both state and federal requirements.6 In the pharmaceutical context, whether a company can comply with both state and federal requirements rests on whether the company can take action to satisfy state law duties without the FDA’s prior approval.7
Since 2009, the Supreme Court has weighed-in on two landmark cases addressing federal preemption in brand-name pharmaceutical cases: Wyeth v. Levine, 555 U.S. 555 (2009) and Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 (2019). Neither decision “deliver[s] companies a swift procedural win” as suggested by Reuters. In Levine, plaintiff brought a failure-to-warn claim after improper administration of an intravenous (“IV”) drug caused her to develop gangrene and ultimately required amputation of her arm. At trial, the jury found the pharmaceutical company liable for providing inadequate warnings about the danger of improper IV administration.8 The Supreme Court affirmed and held that injured plaintiffs can maintain a failure-to-warn claim against a brand-name pharmaceutical manufacturer unless there is clear evidence that FDA would not have approved the plaintiff’s proposed label change.9 Ten years later, in Albrecht, the Supreme Court clarified the meaning of “clear evidence” first articulated in Levine. 139 S. Ct. at 1672, 1676. The Supreme Court explained that the requirement to show “clear evidence” was not a heightened evidentiary standard but, rather, a requirement to show that FDA would not have approved the proposed labeling change.10 To establish “clear evidence,” the Court explained, there must be proof that the FDA would not approve a label change after being fully informed of “the justifications for the warning required by state law.”11
This guidance, and the body of law that continues to form in its wake, has not “armed” brand-name pharmaceutical companies with a “blueprint” for defeating lawsuits on preemption as Reuters suggests. This case law creates only a narrow avenue of relief for brand-name manufacturers to avoid unwarranted litigation when they have complied with federal regulatory requirements.12
As Reuters points out, the Supreme Court has taken a different stance on federal preemption of claims brought against generic pharmaceutical manufacturers. As set forth in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), the Supreme Court has recognized that generic manufacturers are required to use the same label, active ingredients, route of administration, dosage form, and strength as the generic drug’s brand-name equivalent. Mensing, 564 U.S. at 614; Bartlett, 570 U.S. at 483-84. Because of these federal regulatory requirements, current case law affords generic pharmaceutical manufacturers more protection under the preemption doctrine. But even this doctrine does not bar all state law claims against generic manufacturers, as individual states are free to carve out their own exceptions. See, e.g, Guvenoz v. Target Corp., 2015 IL App (1st) 133940 (endorsing a narrow “stop-selling” exception to preemption for drugs that are too dangerous to have ever been sold).
Perhaps the most glaring omission from Reuter’s analysis was its failure to acknowledge the societal benefit of pharmaceutical innovation. Each year, the pharmaceutical industry faces tens of thousands of product liability lawsuits. These lawsuits add to the already enormous cost of innovating, developing, and marketing novel brand-name pharmaceuticals and their more cost-effective generic equivalents. The federal preemption doctrine, thus, serves an important purpose to protect crucial pharmaceutical innovation by guarding against unwarranted litigation.
- Because Reuters focused on preemption in the context of pharmaceutical product liability, so too shall we.
- What We Do, U.S. Food & Drug Admin.
- See Goldberg, Gramling, and O’Rourke, A Prescription for Pharmaceutical Preemption, 20 Rutgers J. L. & Pub. Pol’y 209, 213 (2023).
- PLIVA, Inc. v. Mensing, 564 U.S. 605, 628 (2011).
- Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1678 (2019).
- Wyeth, 555 U.S. at 562.
- Id. at 580.
- Albrecht, 139 S. Ct. at 1676.
- Id. at 1678.
- Schwartz & Appel, Where’s the Beef?: A Guide to Judges on Preemption of State Tort Litigation Involving Branded Drugs, 89 U. Cin. L. R. 597, 624 (2021).