In an ironic juxtaposition, confirmation of Vioxx's long-term risks comes just as the New Jersey Supreme Court agrees to consider whether FDA's approval of the Merck painkiller supersedes any state-court liability for the drugmaker. In an appeal of an earlier appeals court ruling, Merck had argued that jurors in the original trial shouldn't have second-guessed the FDA's approval. The agency had blessed labeling that didn't point out any heart attack risks, so no argument allowed.
NJ's highest court said it would take up the issue--which, as you know, falls under the legal theory that federal agency decisions "preempt" state liability. No hearing date was set, however, perhaps because the U.S. Supreme Court is looking at the theory itself. On Nov. 3, the court will hear the much-debated Wyeth v. Levine case, in which a Vermont patient sued the drugmaker over Phenergan, an IV nausea treatment. Wyeth claims that because the FDA approved Phenergan's labeling, it had no further responsibility for warning patients or providers that IV administration might cause limb loss.
What of the Vioxx risk confirmation? Research was released showing that Vioxx doubled the risk of heart attack, stroke, and death for at least a year after people stopped taking the drug. The long-term data comes from the study that prompted Merck to pull Vioxx off the market. Published online today in the Lancet, the data appears to show that the risks began soon after patients started Vioxx. The findings appear to vindicate some doctors, who have argued that Vioxx increased cardiovascular risks early and that the risks continued after therapy stopped. Merck maintains that the risks didn't arise until people took Vioxx for about 18 months.
- read the story in the Star-Ledger
- check out the court news at Pharmalot
- get more on the study from AFP