Life Sciences

Merck gets good news on Vioxx front

Pharma Compliance Alert, June 4, 2008

One week after Merck agreed to pay $58 million to settle claims it downplayed the risks of Vioxx in advertising, appeals courts in Texas and New Jersey reversed jury verdicts against the company, Merck said in press release.
 
The Texas case, Ernst vs. Merck, was the first case to go to trial after Merck voluntarily withdrew Vioxx. The case centered on product liability. The court overturned the $26 million settlement.
 
In New Jersey, the appeals court overturned the punitive damage award as well as the consumer fraud award for two plaintiffs in the case, reducing a $14 million award by $9 million. The New Jersey court ruled the state product liability law was pre-empted by federal law.
 
The New Jersey ruling continues a pre-emption trend for the pharmaceutical and medical device industries. The Third Circuit Court of Appeals ruled the failure-to-warn claims conflicted with, and were therefore preempted by, the FDA’s regulatory actions in a case involving Pfizer and GlaxoSmithKline in April. In February, the U.S. Supreme Court ruled medical device makers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review.
 
The Supreme Court is scheduled to hear another pre-emption case, Levine vs. Wyeth, this fall. If Wyeth is successful, the court may bar any suit that questions the adequacy of an FDA-approved packaging insert to ensure drug safety.

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