Merck moves for a new trial and an appeal on FDA label ruling

Newsday published an article discussing the current status of the federal Vioxx cases that U.S. District Judge Eldon Fallon is presiding over. Earlier this month, Judge Fallon denied Merck’s motion for a summary judgment, where the defendant argued that FDA labeling of a drug preempts an individual or company’s right to sue the drug manufacturer for product’s liability. Judge Fallon was “unpersuaded” by this argument and allowed the two cases in question to proceed to trial. Now Merck is asking permission to immediately appeal Judge Fallon’s ruling that the “FDA’s approval of a label does not protect drug makers from lawsuits claiming a label’s warnings are inadequate.” Merck has asked to appeal the issue now instead of waiting to appeal once final rulings on the two cases have been made. Permission for the immediate appeal has not yet been granted because the court is awaiting testimony from Governors Barbour (Mississippi) and Daniels (Indiana) regarding the question of “whether the new [FDA] label rules would violate states’ rights?” The question was put to the governors by the FDA and the plaintiffs’ attorneys have subpoenaed their videotaped responses. Once the testimony is available to the court, proper judgment can be made on whether Merck will be allowed to immediately appeal Judge Fallon’s ruling.

Also discussed in the article is Merck’s request for a new trial in the only federal case (out of five) that it lost, which involves plaintiff Gerald Barnett, a retired FBI agent who had a heart attack in 2002 after taking Vioxx. Merck’s request for a new trial is based on it’s contention that “Fallon usurped a jury’s job when he proposed a $1.6 million award to Barnett to replace the $51 million jury judgment he had found excessive.” Merck argues that the judge should not have made a recommendation to the plaintiff regarding damages, but rather, he should have allowed the jury to make such a recommendation. Merck feels that the court does not really know what damages the jury would have awarded based on the injuries suffered by the plaintiff; hence, no damages should have been awarded based solely on the judge’s recommendation. Once a decision is made on whether a new trial will be granted, it will be posted here.

For now, Merck faces approximately 27,000 lawsuits, 8,575 of which are federal lawsuits and 16,400 which are in the state courts of New Jersey alone. In total, Merck is being sued by approximately 45, 225 plaintiffs and it “has agreed to let another 14,450 potential claimants sue after their statute of limitation expires.”

Click here to read the full article Vioxx federal judge: stroke cases may take up 2008