One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA’s regulations governing the content of labels for prescription drugs. Essentially, defense lawyers argue that the labeling’s warnings cannot be altered in a manner sought by the plaintiff when the manufacturer is faced with conflicting directives from the FDA regarding that very content.
In ruling on this very issue, Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) (“Levine”), the Supreme Court held that a “clear evidence” standard of proof was required to support a manufacturer’s claim of conflict preemption defense. The Supreme Court held that unless the manufacturer presents “clear evidence that the FDA would not have approved a change” to the drug’s label, which would make compliance with both the federal standard and the state standard espoused by the plaintiff “impossible,” conflict preemption could not apply.
Post-Levine cases have grappled with this standard, with defendant manufacturers commonly failing to meet this “clear evidence” standard in asserting the defense of conflict preemption. Except recently. The latest decision from the Western District Court of Oklahoma demonstrates how the “clear evidence” of conflict standard provided (but not defined) in Levine could be met. Dobbs v. Wyeth Pharmaceuticals, No. 5:04-cv-01762 (W.D. Okla. June 13, 2011). In doing so, the District Court distinguished or rejected as unpersuasive five other decisions where courts applied the Levine evidentiary standard in failure to warn claims involving the same class of anti-depressant prescription drugs. Id. at p.21.
Dobbs is a case brought by the widow of a depressed patient who took several days’ worth of a prescribed antidepressant called Effexor, before committing suicide. Among her claims, the widow plaintiff contended that Effexor’s FDA-approved statements regarding suicidality in patients diagnosed with depression was inadequate in its failure to fully warn of the risk. Id. at p. 2. Wyeth, the manufacturer of Effexor, contested this assertion by pointing to a variety of the factors that the District Court found persuasive: 1) the FDA is statutorily responsible for continually monitoring the safety of approved drugs, and proposed changes to the labeling “must be ‘based on ‘reasonable evidence of’ an association between a hazard and the drug at issue….” [id. at p.10-11]; 2) the FDA had repeatedly considered the “proper scope and content of suicidality warnings for the class of drugs that are used to treat depression [id. at p. 12]; 3) in addition to such consideration, the FDA had “consistently expressed concern that an enhanced suicidality warning [was] not supported by scientific evidence” which could create the adverse consequence of a “potential reduction” in the use of drugs for the treatment of depression [id.]; 4) in 2002, the same year the decedent committed suicide, the FDA concluded that a more extensive suicidality warning was not supported by scientific evidence (and thus, would not have approved of the warning that the plaintiff argued should have been used) [id. at *16]; and 5) in 2004 and 2006, the FDA concluded that increased suicidal thinking or behavior in pediatric patients and patients under the age of 25 years using these class of drugs was supported by sufficient scientific evidence, but the decedent in this case was 53 years old when he committed suicide [id. at 17]. In sum, the District Court found that the “FDA’s ongoing study and analyses” regarding these warnings, and the FDA’s lack of any findings regarding scientific evidence to support the addition of suicidality warnings for patients in the decedent’s age pool, compelled a finding of conflict preemption. Id. at p. 18-9; see also p. 21.
The District Court’s extensive and careful recitation of the facts, along with its review and treatment of the other post-Levine decisions, provides a useful framework in which to advocate and win on the defense of conflict preemption for failure to warn claims.