Wyeth Prepares for Supreme Court Preemption Case

September 25, 2008
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million.

Washington, DC (Sept. 15)-On Nov. 3, 2008, the US Supreme Court will hear Wyeth v. Levine, in which the drug company challenges a Vermont Supreme Court decision to award Diana Levine $6.8 million. Levine had an arm amputated when a physician’s assistant inadvertently injected a dose of “Phenergan” (promethazine HCl), a drug to treat nausea, into an artery (known as an "i.v. push"), leading to gangrene.

The Vermont Supreme Court concluded the drug label had inadequate warnings, even though the Phenergan label included cautionary language regarding the risks of the i.v. push route of administration, including gangrene. Wyeth points out that the drug and product label were approved by the US Food and Drug Administration and that the Food, Drug, and Cosmetic Act and other regulations “prohibited Wyeth from changing that labeling without FDA’s prior approval.”

Nonetheless, according to a brief filed by Wyeth, a Vermont jury claimed that under Vermont law, Wyeth was “required” to change the Phenergan labeling “to contraindicate a method of administration that FDA had approved, based on a weighing of risk and benefit different than FDA’s.” 

Wyeth argues that it could not comply with both state and federal law, claiming federal law prohibits “unilateral changes to FDA-approved labeling,” and in this case federal law preempts state product liability laws. 

See the docket filed for this case.