A number of entities have continued to weigh in as amici in the Wyeth v. Levine preemption case pending before the Supreme Court. In an amicus brief filed earlier this summer, BIO and PhRMA argued from a policy perspective that state law tort suits challenging the adequacy of FDA approved prescription drug labeling pose significant risks to public health. (BIO is the world’s largest biotechnology organization, providing advocacy, business development and communications services for more than 1,150 members worldwide.) Those suits imperil FDA’s ability to accomplish its mission because they allow state court juries to second guess FDA’s balancing of the risks and benefits of a prescription medicine. State court verdicts inconsistent with FDA guidance will simply encourage manufacturers to warn physicians and patients about risks that are speculative and scientifically unsupported; this ultimately dilutes the impact of scientifically valid warnings and can discourage physicians from prescribing and patients from using beneficial drugs.
On the legal side, these amici argued that the Vermont Supreme Court’s decision now on appeal was at odds with a core premise of the Supremacy Clause: that state law cannot require what federal law prohibits. Absent new scientific information, federal regulations prohibit a manufacturer from changing prescription drug labeling without prior FDA approval. In this case, FDA knew of and considered the relevant risk over a long period of time, and approved carefully crafted warnings and instructions designed to minimize those risks while still encouraging beneficial drug use.
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Last week, in what appears to be a first, the editors of the New England Journal of Medicine weighed in on the preemption legal battle — on the side of the plaintiff below, Levine. While the brief attacks the track record of the FDA, arguing that the agency lacks the resources to do its job, it does not answer the next question: whether experts at the FDA, even with allegedly inadequate funding, are more or less likely to decide difficult scientific questions correctly than are juries of lay people “educated” by trial lawyers. The NEJM spouts the rhetoric of juries “policing” the industry. But a dramatic gulf separates the competence of the FDA from that of state jurors who, absent preemption, are called on to assess the safety of prescription drugs and second-guess federal regulators. Laypersons applying state law cannot substitute for the FDA, the expert agency congressionally delegated the role of meticulously balancing nuanced and sometimes competing nationwide goals. The FDA’s regulation of prescription drugs is governed by a sweeping network of federal law individually applied to each drug. A lay jury lacks the expertise and the broader perspective of the FDA, and thus cannot adequately adjudicate individual plaintiff/patient risks in the context of population benefits – quintessentially the kind of issue that the FDA must confront every day. Without preemption, however, state juries are asked to do just that.
Similarly, the NEJM brief bemoans the fact that FDA is reliant upon information gathered and produced by the drug company, but the fact is that no entity other than the drug company has any incentive or ability to study a not-yet-approved drug. And permitting after the fact tort suits to second-guess the FDA won’t change that. Moreover, how is the situation any different in a tort suit? If a new study comes out about the risks or benefits of a drug or device after a tort suit has been concluded, we don’t go back and start the case again. Would the NEJM advise unwinding the results in Bendectin litigation? Breast implants? The state of the art is by definition time-dependent.
And as pointed out in DRI’s amicus brief, there was an enhancement of the FDA’s powers by the recent FDAAA. This contrasts a one possible way (congressional action) and a clearly worse way (complaining in state court litigation) to deal with perceived deficiencies in FDA action.