Wyeth filed its brief yesterday in the U.S. Supreme Court in the Levine case, the closely-watched, much-anticipated, case regarding FDA preemption. The drug at issue is the company’s anti-nausea drug, Phenergan. Levine claims that the drug’s labeling should have foreclosed IV push injection of Phenergan because of the risk of injury. Wyeth has argued that the FDA’s approval of the Phenergan labels/warnings preempted any such state-law claims over the product.
In October 2006, the Vermont Supreme Court upheld a $7 million judgment for Levine and ordered Wyeth to modify the drug’s label to reflect the alleged risk, citing a “presumption against preemption.”
The Supreme Court granted cert in January, and in the brief, Wyeth notes that the FDCA prohibited it from modifying the drug’s label in most cases without approval from the FDA. Vermont law, by contrast, imposed a tort-law requirement that Wyeth alter that labeling (to foreclose IV administration) regardless of FDA action.
In the FDCA, Congress established a drug-approval regime in which an expert scientific agency makes uniform, national judgments about the safety and effectiveness of prescription drugs by balancing therapeutic benefits against safety risks ex ante, taking into account the interests of all potential patients. Wyeth argues that FDA struck precisely that type of balance in approving IV administration of Phenergan and in determining what warnings and instructions were appropriate to manage its associated risks.
Plaintiff has until August 1 to file the reply brief.