Specifically, Clement disagreed with the Vermont Supreme Courtâ€™s ruling that a patient could sue Wyeth over the labeling of its anti-nausea drug Phenergan (promethazine). In the case of Wyeth v. Diana Levine, Clement opined that the state court, â€œerroneously interpretedâ€ the law by saying the FDAâ€™s approval of a drug label is only a â€œfirst step.â€ He also noted that federal law prohibits a company from unilaterally changing the FDA-approved label.
Clement writes, â€œIf manufacturers were free to make unilateral changes to labeling the day after the FDAâ€™s approval, based on information that was previously available to the FDA, the approval process would be greatly undermined and the agencyâ€™s careful balance of risks and benefits thwarted.â€
The Solicitor Generalâ€™s full opinion can be viewed at
Clement also suggests that the Supremes hold the petition for writ of certiorari until the court decides two other preemption cases, Riegel v. Medtronic and Warner-Lambert v. Kent. According to the Solicitor General, these cases "may shed significant light on the question presented on this case."