Wyeth v. Levine

The Court has agreed to decide whether a musician who lost her arm after receiving an anti-nausea drug via an off-label injection method may recover under Vermont tort law despite FDA approval of the drug's label.

The case, Wyeth v. Levine, No. 06-1249, arose when Diana Levine went to the hospital suffering from nausea associated with a migraine headache. Physicians initially gave her Phenergan, a drug manufactured by Wyeth, by injecting it into her muscles. When her nausea persisted, they gave her the drug using the so-called "IV push" method, involving injection of the drug into her vein. They bypassed administration via an IV drip. The drug made contact with her arteries, leading to gangrene and forcing doctors to amputate her arm.

The Phenergan label had been approved by the FDA in 1955, and re-evaluated and approved in the late 1980s. Wyeth knew that if the drug reached the arteries it could cause gangrene. Its approved label cautioned that if the drug were administered by and IV drip, care should be taken to avoid arterial exposure and noted the risk. The label did not mention the IV push method of injection, and evidence suggested that the FDA did not evaluate whether the label should address the risk associated with the IV push method.

After settling with her health care providers, Levine went to trial against Wyeth. A Vermont jury awarded her $6.7 million, concluding that Wyeth had failed to warn of the risks associated with IV push administration of Phenergan.

On appeal, the Vermont Supreme Court ruled that the state tort claim was not preempted by the FDA approval of the Phenergan label. The state high court reasoned that it would have been possible for Wyeth to provide the FDA-approved label and additional warnings cautioning against IV push administration. It further found that requiring Wyeth to do so would not obstruct any goals of the federal Food, Drug and Cosmetic Act.

Seeking certiorari, Wyeth argued that state court are often asked to hold drug manufacturers to different standards than those set by the FDA, creating a situation of national urgency. Moreover, the drug company contended, the FDA's labeling requirement did not merely set a minimum standard for release of drug information, but took into account all the risks and benefits associated with Phenergan and opted for a label that reflected the best level of information to achieve optimal use of the drug. Finally, the company argued, compliance with the Vermont tort standard would frustrate the FDA's goal of optimal Phenergan use by basically prohibiting its administration via IV push.

Resisting review, Levine compared the case to Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), where the Court held that an Illinois tort recovery for boat injuries that could have been avoided with a propeller guard were not preempted where a federal agency had considered requiring guards but eventually dropped the issue. Here, Levine argued, Vermont should not be prevented from applying its tort law where the FDA never considered whether to include a prohibition on the IV push method on its label.

The case may be scheduled for oral argument as soon as this spring.

food and drug regulation, preemption, federalism

The Supreme Court ruled today that a musician who lost her arm after receiving an anti-nausea drug via an off-label injection method may recover under Vermont tort law despite FDA approval of the drug's label.

The case, Wyeth v. Levine, arose when Diana Levine went to the hospital suffering from nausea associated with a migraine headache. Physicians initially gave her Phenergan, a drug manufactured by Wyeth, by injecting it into her muscles. When her nausea persisted, they gave her the drug using the so-called "IV push" method, involving injection of the drug into her vein. They bypassed administration via an IV drip. The drug made contact with her arteries, leading to gangrene and forcing doctors to amputate her arm.

The Phenergan label had been approved by the FDA in 1955, and re-evaluated and approved in the late 1980s. Wyeth knew that if the drug reached the arteries it could cause gangrene. Its approved label cautioned that if the drug were administered by and IV drip, care should be taken to avoid arterial exposure and noted the risk. The label did not mention the IV push method of injection, and evidence suggested that the FDA did not evaluate whether the label should address the risk associated with the IV push method.

After settling with her health care providers, Levine went to trial against Wyeth. A Vermont jury awarded her $6.7 million, concluding that Wyeth had failed to warn of the risks associated with IV push administration of Phenergan.

On appeal, the Vermont Supreme Court ruled that the state tort claim was not preempted by the FDA approval of the Phenergan label. The state high court reasoned that it would have been possible for Wyeth to provide the FDA-approved label and additional warnings cautioning against IV push administration. It further found that requiring Wyeth to do so would not obstruct any goals of the federal Food, Drug and Cosmetic Act.

Seeking certiorari, Wyeth argued that state court are often asked to hold drug manufacturers to different standards than those set by the FDA, creating a situation of national urgency. Moreover, the drug company contended, the FDA's labeling requirement did not merely set a minimum standard for release of drug information, but took into account all the risks and benefits associated with Phenergan and opted for a label that reflected the best level of information to achieve optimal use of the drug. Finally, the company argued, compliance with the Vermont tort standard would frustrate the FDA's goal of optimal Phenergan use by basically prohibiting its administration via IV push.

Resisting review, Levine compared the case to Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), where the Court held that an Illinois tort recovery for boat injuries that could have been avoided with a propeller guard were not preempted where a federal agency had considered requiring guards but eventually dropped the issue. Here, Levine argued, Vermont should not be prevented from applying its tort law where the FDA never considered whether to include a prohibition on the IV push method on its label.

On March 4, 2009, the Supreme Court affirmed 6-3 the lower court order.

“Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration,” Justice John Paul Stevens wrote for the majority.

Justice Stephen G. Breyer filed a concurring opinion. Justice Clarence Thomas filed an opinion joining in the judgment. Justice Samuel A. Alito filed a dissenting opinion, joined by Chief Justice John G. Roberts Jr. and Justice Antonin Scalia.

Question presented:
Whether federal law preempts state torts claims imposing liability on drug labeling that the FDA had previously approved.