FDAnews Drug Daily Bulletin


April 10, 2006

Merck's loss in its latest product liability case involving the firm's withdrawn arthritis pain drug Vioxx doesn't bode well for the company's chances in thousands of pending cases, an analyst says.

A jury in an Atlantic City, N.J., state court found that Merck had failed to adequately warn two plaintiffs who had heart attacks of the cardiovascular risks associated with Vioxx (rofecoxib).

The case was the first involving patients who had taken the drug for more than 18 months, the point at which cardiovascular incidents have been shown to occur. Plaintiffs John McDarby and Thomas Cona -- both former smokers with high blood pressure and high cholesterol who had multiple cardiac risk factors -- alleged Vioxx was the cause of their heart attacks.

The jury concluded that Vioxx was a significant contributing factor in McDarby's heart attack but not in Cona's. The jury ordered Merck to pay McDarby and his wife $4.5 million in compensatory damages for pain and suffering, but only $45 to Cona for the cost of his medication.

The jurors were set to discuss punitive damages against the company April 7. Under New Jersey law, punitive damages may not exceed five times the amount of compensatory damages, which in this case would be a maximum of $22.5 million.

To date, Merck has lost two and won two of the cases that have gone to trial over Vioxx, which the company pulled in September 2004 after the drug was linked to increased rates of heart attack and stroke.

The outcome of the latest case is of particular interest since it will set a precedent for other cases tried in New Jersey, where most of the state cases have been filed, said Al Rauch, an analyst with A.G. Edwards & Sons. Roughly 5,000 cases are scheduled to go before the court that issued this latest ruling.

"This does not bode well for Merck, considering that Mr. McDarby had several additional risk factors that could have contributed to his heart attack and [the company was] ordered to pay such a large amount in compensatory damages in [its] home state," Rauch said in a research note. (http://www.fdanews.com/did/5_69/)