By Erika L. Maley, a Partner, and Jacquelyn E. Fradette, an Associate, with Sidley Austin LLP in the firm’s Washington, DC office.
A recent decision by a North Dakota trial court has held that claims alleging Purdue Pharma failed to warn of the risks of its prescription opioid analgesics are preempted by federal law. State of North Dakota ex. Rel Wayne Stenehjem, Attorney General, v. Purdue Pharma LP et al., 09-2018-cv-001300 (May 10, 2019). As discussed in our prior WLF Legal Backgrounder, such suits against opioid manufacturers have recently proliferated, raising the potential for conflict with the FDA’s expert regulation in this area. It is therefore encouraging to see courts giving careful and thorough consideration to these federal preemption issues.
Federal Preemption and Prescription Drugs
Under the doctrine of implied conflict preemption, state laws that conflict with federal laws are preempted. For failure-to-warn claims against brand-name prescription drug manufacturers, including claims targeting marketing statements, the leading case is Wyeth v. Levine, 555 U.S. 555 (2009). Wyeth explained that FDA’s “changes being effected” (CBE) process allows manufacturers to add or strengthen warnings without FDA preapproval, but “the FDA retains authority to reject labeling changes made pursuant to the CBE regulation” if it finds they are not sufficiently supported by the science. Id. at 571. Accordingly, where there is “clear evidence that the FDA would not have approved a change to [the drug’s] label,” then claims that the manufacturer should have given such warnings are preempted. Ibid.
The Supreme Court recently returned to the issue in Merck Sharp & Dohme Corp. v. Albrecht, 17-290, 587 U.S. (2019). Merck held that preemption is a question of law for the court to decide, and that the preemption analysis turns on whether the “manufacturer fully informed the FDA of the justifications for the warning” and the FDA stated it “would not approve a change to the drug’s label to include that warning.” Slip Op. at 14.
North Dakota v. Purdue
In North Dakota v. Purdue, the state Attorney General alleged that “the opioid epidemic and a public health crisis in North Dakota were caused, in large part, by a fraudulent and deceptive marketing campaign” by the manufacturer. Id. at ¶ 7. As with similar state tort opioid cases, the Court noted that the Attorney General’s action had distinctly regulatory aims, asserting “that it was improper to promote Oxycontin for chronic pain.” State of North Dakota ex. Rel Wayne Stenehjem, Attorney General, v. Purdue Pharma LP et al., 09-2018-cv-001300. The court closely analyzed the marketing statements alleged to be false or misleading, and found that they were consistent with the FDA-approved product labeling. Id. Accordingly, the court applied the preemption framework of Wyeth v. Levine, 555 U.S. 555 (2009). Id; see also id. at ¶¶ 38-41.
The court found that the complaint alleged no “newly acquired information that could provide a basis for Purdue to change its labeling without prior FDA approval.” Id. at ¶ 28. The court also found there was “clear evidence” that the FDA would not have approved the label changes sought by the State. Id. at ¶¶ 28-29. In particular, the court explained that the FDA’s 2013 denial of a citizen petition requesting that the FDA revise the label of extended release, long-action (“ER/LA”) opioids to include additional warnings and modifications to the label showed that “the FDA has communicated its disagreement with the State’s specific contention that Purdue ‘falsely and misleadingly touted the benefits of long-term opioid use and falsely and misleadingly suggested that these benefits were supported by scientific evidence.’”1 Id. at ¶ 29. The court also noted that the FDA did not direct Purdue to stop marketing the product for its long-term-use indication. Id.
The court further found that the State’s allegations conflicted with numerous statements in the label that the FDA specifically approved, including statements about dosing, 12-hour relief, and managing withdrawal symptoms. Id. at ¶¶ 31-37. The court’s analysis is consistent with the decisions of other courts that have addressed the issue as to whether there was clear evidence the FDA would not have approved the change sought by the litigation. In particular, several courts have found that the FDA denying a citizen’s petition requesting strengthened label warnings or requesting removal of the drug altogether have constituted “clear evidence” that the FDA would not have approved a unilateral manufacturer label change pursuant to the CBE pathway, 21 CFR § 314.70(c)(1).2
Impact of Merck
The North Dakota v. Purdue case was decided shortly before the Supreme Court released its opinion in Merck. Merck clarified several aspects of Wyeth, including confirming (as the North Dakota court held) that preemption is a question of law to be resolved by the court. Merck also further defined Wyeth’s “clear evidence” standard. But Merck also raises new questions, such as how a court should evaluate whether the FDA was “fully informed” of an issue. Slip Op. at 1. Further, in dicta, Merck noted that an FDA action must have been “taken pursuant to the FDA’s congressionally delegated authority” to have a preemptive effect. Slip Op. at 15. While Merck stated that the “question of disapproval ‘method’ is not now before [the court],” id., the dicta could impact lower courts’ analysis. At the same time, Merck largely reaffirmed the Wyeth framework, and the North Dakota court’s analysis appears fully consistent with Merck. The North Dakota court’s careful analysis could provide additional guidance to the many other courts confronting these important questions.
- FDA Response to Citizen’s Petition, FDA-2012-P-0818 (Sept. 10, 2013).
- See Cerveny v. Aventis, Inc., 855 F.3d 1091, 1105 (10th Cir. 2017); Reckis v. Johnson & Johnson, 471 Mass. 272, 28 N.E.3d 445 (2015); Rheinfrank v. Abbott Labs, Inc., 680 Fed. Appx. 369, 385 (6th Cir. 2017); People of the State of California v. Purdue Pharma, 2015 WL 5123273 (Cal. Super. Aug. 27, 2015).