The Supreme Court’s pending, and perhaps imminent, decision on the preemptive effective of FDA drug labeling approvals in Wyeth v. Levine has stimulated a flood of legal and public policy debate on the roles that federal regulation and state-law based tort litigation should play in regulating pharmaceutical manufacturers. That debate, which is almost certain to continue in a legislative forum should Wyeth prevail before the Court, may determine the future of the now-lucrative litigation industry. More importantly, arguments made in the debate by those seeking to protect or expand litigation opportunities may exacerbate an onslaught of public policy initiatives that threaten the future viability of a private enterprise, research-based pharmaceutical industry.
The Wyeth v. Levine case itself presents a relatively narrow preemption issue. Ms. Levine lost her right forearm to gangrene when Wyeth’s drug Phenergan was improperly administered by intravenous push injection to deal with her severe migraine-related nausea. The drug entered an artery and caused gangrene. The administering clinic failed to observe a number of cautions prominently displayed on Phenergan’s label relating to the maximum total dosage, rate of administration, cessation of treatment on complaint of pain and extreme caution in avoiding exposure of Phenergan to arterial blood. Nevertheless, after settling her claim against the administering clinic, Ms. Levine successfully sued Wyeth under Vermont law for failing to totally foreclose push injection of Phenergan in its labeling and thus allegedly making the product unreasonably unsafe.
Wyeth’s constitutional preemption defense was two pronged. Wyeth first argued that, under federal law, it could not have complied with Vermont’s labeling standard. The FDA, in first approving Phenergan in 1955 and then repeatedly approving Wyeth’s evolving label, had determined that push injection – the fastest and most efficacious method of administration – was safe given the cautions included in the label. Wyeth’s post-approval experience had provided no additional information that would authorize a deviation from FDA’s position and any unauthorized deviation would put Wyeth in violation of federal law. Wyeth also argued that Congress had given FDA national authority to optimize prescription drug use by balancing benefit and risk and that state law – particularly case-by-case setting of labeling standards in jury trials – should not override FDA’s scientific risk assessments. Wyeth presented both arguments to the Supreme Court in seeking certiorari and in arguing the merits of its case.
Ms. Levine’s response to Wyeth was that FDA’s balancing determinations should be viewed as minimum standards subject to imposition of added safety requirements under state law. Congress had not included an express preemption clause in FDA’s prescription drug authority as it had, for example, in FDA’s medical device authority and thus a presumption against preemption should prevail. In any case, Ms. Levine argued, Vermont’s labeling standard only required Wyeth to compensate Ms. Levine and did not force Wyeth to change its federally-approved label.
The legal arguments of the parties, and the incremental approach typical of the Supreme Court, strongly suggest that the Court will issue a narrow legal ruling addressing FDA preemption only in the context of fully-informed FDA labeling decisions directly challenged in state tort actions. The Court is unlikely to rule on the consequences of allegedly fraudulent representations to the FDA or of pharmaceutical company failures to disclose or act upon new safety information available to the manufacturer after FDA approval. If other cases present those issues the Court will be able to deal with them on a full factual record.
Still, a number of organizations have filed amicus curiae (“friend of the Court”) briefs making “policy” rather than legal arguments regarding the importance of this case. Many, including the American Association for Justice (“AAJ”, formerly known as the Association of Trial Lawyers of America) have disregarded the narrow facts presented in Wyeth v. Levine to argue that preemption ought to be denied because of a need for additional tort-based supervision of the pharmaceutical industry. I will discuss the merits of these policy arguments in my next post.
[Editor’s Note: Bert Rein, a founding partner in the Washington, DC law firm Wiley-Rein and a long-time friend of CEI, represents Wyeth in this case. This post appears by invitation.]