3d Cir.: Some drug warning claims preempted
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The court so held “notwithstanding that the agency’s view was not subject to notice-and-comment rulemaking.” The court also stressed that it did not reach broader questions of drug preemption, such as whether the FDA’s mere approval of one drug label preempts any tort claims based on the failure to provide additional warnings.
The decision was in two consolidated cases, both based on the failure of drug makers to warn of a purported increased risk of adult suicidality from antidepressant drugs known as selective serotonin reuptake inhibitors (SSRIs). The district courts below came to opposite conclusions on the preemption question. The panel based its decision on the narrow ground that the FDA had “actively monitored the possible association between SSRIs and suicide for nearly twenty years,” repeatedly rejected petitions to add such warnings, and in 2003 issued public statements concluding there was no evidence of an association between SSRIs and suicide risk in adults.
The opinion contains a convoluted discussion of the presumption against preemption. The panel begins by saying that the Supreme Court has acknowledged this presumption but has been unclear on when it applies. After examining several cases, the panel concluded that the presumption applies but has limited force in cases of “implied conflict preemption,” i.e., where Congress has not written an express clause regarding preemption but a party asserts that state law stands as an obstacle to the purpose of federal law.
The opinion also discusses the deference owed to the FDA. The court gave significant deference to the FDA’s expert judgment that “the imposition of liability under state law for defendants’ alleged failure to warn would interfere with FDA’s accomplishment of regulatory objectives.” By contrast, it gave less deference to the FDA’s view of its legal authority to preempt state law.
In holding that the FDA’s failure to regulate this matter could preempt state law in the absence of formal rulemaking, the court relied primarily on Geier v. Am. Honda Motor Co., 529 U.S. 861 (2000). Geier held 5-4 that the Department of Transportation’s decision to require airbags in some but not all 1987 automobiles preempted tort claims based on the failure to install airbags in those vehicles.
The court underscored the limited scope of its holding, stating:
[W]e do not decide whether the FDA’s mere approval of drug labeling is sufficient to preempt state-law claims alleging that the labeling failed to warn of a given danger, whether FDA approval of drug labeling constitutes minimum standards in the absence of the FDA’s express rejection of a specific warning, or whether actions against generic drug manufacturers are preempted on the basis of their obligations under the Hatch-Waxman Amendments.
The majority specifically distinguished a case now pending before the Supreme Court, in which there is no indication that the FDA rejected the warning the plaintiff claimed should have been used. Levine v. Wyeth, --- A.2d ----, 2006 WL 3041078 (Vt. 2006), cert. granted, 128 S. Ct. 1118 (2008).
Judge Ambro wrote a lengthy dissent. His main points were:
- - Congress, courts and the FDA have long understood state tort law and FDA regulations to be complementary, not conflicting.
- - The presumption against preemption applied in full force here, and “Congress has not given us a clear statement” to overcome it.
- - The FDA’s view of preemption deserves little deference in light of its limited expertise, failure to engage in formal rulemaking, and its “180-degree reversal” on the issue in recent years.
- - Federal law leaves manufacturers free to use additional warnings beyond what the FDA requires, and tort law provides one motivation to do so.
- - Tort judgments are not likely to distort the balance of safety and efficacy in the drug market because state negligence standards incorporate this balance.