FDAnews
www.fdanews.com/articles/61838-merck-dealt-double-vioxx-losses

MERCK DEALT DOUBLE VIOXX LOSSES

August 18, 2006

Merck suffered two legal defeats Aug. 17 involving its pain drug Vioxx, but it is planning to appeal these setbacks, the company said.

Merck, which is facing more than 11,500 lawsuits filed by former patients who claim Vioxx (rofecoxib) caused heart attacks and strokes, was ordered to pay millions in damages in a federal court case while seeing a victory in a state court thrown out just hours later.

A jury in the U.S. District Court for the Eastern District of Louisiana held that Merck knowingly misrepresented or failed to disclose a material fact about the drug's risks to a patient's physicians, awarding the plaintiff $51 million. Meanwhile, the Superior Court of New Jersey overturned a November 2005 verdict that Merck had won. That court has ordered a new trial for early next year based on post-trial evidence presented in an editorial in The New England Journal of Medicine (NEJM).

Merck is rejecting both decisions as unfounded and vows to appeal. "Both the finding and the amount of damages were totally uncalled for in [the federal] case because Merck acted appropriately in providing information to the medical, scientific and regulatory communities in a responsible and appropriate manner," Kenneth Frazier, senior vice president and general counsel of Merck, said in a release. The company is currently exploring several grounds for appeal, including insufficient evidence and the application of incorrect legal standards.

Merck also reasserted its dedication to a strategy of defending each case individually. "While this is not the outcome we had hoped for, our commitment to defending these cases one at a time remains the same," Frazier added.

As for the New Jersey decision, Merck believes that the NEJM editorial should not have affected that decision. "The facts underlying the [editorial] were known to the plaintiff long before the trial, and the jury was aware of the issue because it was presented by the plaintiff's expert," said Ted Mayer, a member of the company's defense team. "The jury did not find the testimony persuasive in the original trial, and we do not believe that the [editorial] would have in any way affected the outcome." The company is currently reviewing its legal options.

(http://www.fdanews.com/did/5_162/)