News & Developments

Supreme Court Considers Federal Preemption in Pharmaceutical Cases

On March 4, 2009, the Supreme Court issued its decision in Wyeth v. Levine, the first Supreme Court case to consider whether preemption applies in pharmaceutical cases.

In a 6 to 3 decision, the Supreme Court upheld the lower courts’ decisions, concluding that Wyeth could have complied with differing state and federal law obligations. In rejecting the preemption argument, the majority opinion relied upon the Changes Being Effected (CBE) provision, which permits brand name drug manufacturers to unilaterally add or strengthen warnings and contraindications on a drug label without prior FDA approval. The Court reasoned that the CBE provision allowed manufacturers to comply with heightened state standards imposed by juries in product liability lawsuits.

The majority opinion put the onus for changing the label firmly on drug manufacturers, holding that the existence of the CBE provision “[made] it clear that manufacturers remain responsible for updating their labels.” Similarly, in language sure to be repeated in front of juries for years, the Court stated that “it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.”

Wyeth involved the brand name drug Phenergan, a drug designed to treat severe nausea associated with migraine headaches. Phenergan can be taken orally, or intravenously when faster relief is necessary. Intravenous delivery is available either through IV-push or IV-drip. Phenergan is corrosive and can cause irreversible gangrene if it enters a patient’s artery. The labeling for Phenergan included multiple warnings of this risk.

Despite these warnings, a physician’s assistant delivered a double-dose of the drug via IV-push to Diana Levine and ignored her complaints of pain while the drug was injected. During the entire three or four minutes of this process, the Phenergan was being injected into an artery in Levein’s arm. As a result, her forearm had to be amputated, ending her career as a professional musician.

After settling with her healthcare providers, Levine sued Wyeth, the manufacturer of Phernergan. The trial court rejected Wyeth’s preemption arguments, and a Vermont state court jury found in Levine’s favor. The Vermont Supreme Court upheld the trial court’s decision rejecting Wyeth’s preemption argument, and the Supreme Court granted certiorari to consider the case.

In its amicus brief and at oral argument, the FDA explained that the CBE provision should only be used to change a label to “reflect newly acquired information.” A final rule recently issued by the FDA further clarified and emphasized this position. Nonetheless, Wyeth destroys any utility in this limitation, finding that newly acquired information is “not limited to new data, but also encompasses analyses of previously submitted data.” In other words, a drug manufacturer’s label will always be vulnerable to hindsight.

In addition to finding that FDA approval does not, by itself, preempt state law claims, the majority opinion also considered whether Wyeth had specifically addressed the risks of the IV-push method with the FDA in drafting the labeling for Phenergan. The majority found that the facts did not support Wyeth’s argument that it had adequately addressed the risks specific to IV-push in its labeling, but rather concluded that Wyeth had not adequately explored these risks with the FDA. This was apparently made clear by the fact that Wyeth’s labeling did not distinguish between the IV-drip and IV-push methods, although the IV-drip method had virtually no risk of arterial exposure. “The CBE regulation permitted Wyeth to unilaterally strengthen its warning, and the mere fact that the FDA approved Phenergan’s label does not establish that it would have prohibited such a change.”

The Wyeth decision left the door open on preemption in pharmaceutical cases involving warning issues, but only slightly open. The majority opinion recognized that the FDA has final authority over all labeling decisions, but stated that “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.” In other words, if the FDA has rejected the same kind of additional warning or contraindication that a plaintiff’s product liability claim would impose, preemption could apply. The Court emphasized, however, that “[i]mpossibility preemption is a demanding defense.”

While Wyeth leaves open the possibility for preemption where the FDA has flatly rejected a stronger warning or contraindication, it also may apply only to branded drugs and not generics. Generic drugs are required to have labeling and active ingredients that are identical to what the FDA has approved for its branded counterpart. As a result, Wyeth does not appear to overrule the growing body of case law holding that it is impossible for generic drug manufacturers to comply with state requirements that are inconsistent in any way with federal laws and regulations.

Wyeth only gave hints at the extent to which preemption could apply in pharmaceutical cases. In the coming months, it will fall upon trial courts to determine whether and when preemption applies.

Submitted by:
Richard G. Morgan and Shane V. Bohnen
Bowman and Brooke LLP
Minneapolis, MN