A ruling could come as soon as Monday that would pull the rug out from under lawyers with some 1,000 Vioxx lawsuits in the Lone Star State. Harris County District Court Judge Randy Wilson, who oversees Vioxx litigation in Texas, plans to dismiss a case that Merck lost based on an FDA rule that says agency approval of a drug preempts challenges in state courts.

Moreover, Wilson informed both sides that his ruling could affect the whole group of lawsuits, The Wall Street Journal reports. He plans to suspend the lawsuits until the state’s appeals court rules on his judgment, and that he would issue his written order as soon as next week.

In reaching his decision, Wilson cites an FDA rule issued early last year, which says the FDA approval process “pre-empts conflicting or contrary state law.” This means drugmakers are immune from state requirements to warn consumers about potential risks if they’ve followed FDA guidelines.

As the Journal notes, the vast majority of pharmaceutical product-liability cases hinge on whether or not a drug maker adequately warned of a drug’s risks—as have most of the Vioxx trials to date, of which Merck has won 10 and lost 5.

“Pre-emption is a tremendously strong defense for pharmaceutical manufacturers,” says Mark Herrmann, a Jones Day attorney, who defends drugmakers, but isn’t involved with Vioxx. “For Merck, this is huge. If the decision stands, they won 1,000 lawsuits. That’s a pretty good day for anybody.”

This would mark the largest and most significant application of the FDA rule because of the number of cases it stands to affect. Merck faces some 28,000 lawsuits. However, pre-emption isn’t a foolproof defense. So far, the industry has prevailed in fewer than half of the dozen cases in which pre-emption was argued, says Herrmann.

The complete story in The Wall Street Journal (subscription required).[tags]FDA, Merck, Pre-emption, Vioxx[/tags]