The Supreme Court’s decision in Wyeth v. Levine, 129 S. Ct. 1187 (U.S. 2009), represents a victory for consumer advocates and a change in tide within the preemption debate. On March 4, 2009, the Court found Wyeth, the pharmaceutical giant, liable for the adverse affects of one of its drugs. Phenergan, which is administered intravenously to treat migraine-induced nausea, caused plaintiff Levine to suffer the amputation of her arm after an “IV push” injection of the drug caused irreversible gangrene. Wyeth argued that the Food and Drug Administration’s (“FDA”) regulations preempted Levine’s lawsuit, but the Court disagreed.
The Court expressly rejected Wyeth’s preemption argument for two reasons: (1) state law claims did not obstruct the FDA’s authority to regulate drug labeling; and (2) the evidence actually suggested that Wyeth had long ignored reports showing the dangers of injecting the drug using the IV push method. In fact, the Court observed that Wyeth could have “analyzed the accumulating data and added a stronger warning about IV push administration of the drug.” The Court also rejected Wyeth’s companion arguments, which spouted the impossibilities of complying with both state law and the FDA’s regulatory scheme and the danger of allowing a “lay jury’s decision about drug labeling” act as a substitute for the “expert judgment of the FDA.”
The Court’s decision was welcomed by consumer advocates who previously feared that pharmaceutical companies like Wyeth would be insulated from liability, especially given the Bush Administration’s expansive view of preemption. Following the Wyeth decision, President Obama made his narrowed view of preemption known when the White House released a memorandum on the subject. On May 20, 2009, President Obama asked heads of agencies and departments to reevaluate their preemption policies, advising them only to issue preemptive statements “if [they are] supported by sufficient legal principles.” President Obama’s memorandum symbolizes a return to traditional federalist ideals, emphasizing the importance of state laws and the ways in which they work in tandem with federal laws to create safeguards for the public.
In the months following Wyeth, advocates on both sides of the preemption debate have spoken out. Those in favor of preemption call the Wyeth decision “catastrophic” for patients and doctors. They foresee an insurmountable stall on new drugs entering the market; new drugs that could help combat serious illnesses like cancer and HIV/AIDS. Other analysts are shocked that this medical malpractice case reached the Supreme Court at all, let alone resulted in a lay jury determining the adequacy of a federal agency’s regulatory scheme. Consumer advocates, on the other hand, view the decision as a triumph for the little guy, meaning consumers like Levine. . However, both sides agree on one thing: consumers will test the durability of the Wyeth decision to see just how much liability pharmaceutical companies will bear in the future.
In any case, Wyeth is not the last time we will see the preemption issue under scrutiny. But, for now, consumer advocates and victims of pharmaceutical drug companies can relish in this victory and rest assured that they have preserved their right to hold pharmaceutical companies accountable in court.
