Ruling in Texas Vioxx Case
Could Be a Boon for Merck
By HEATHER WON TESORIERO
April 12, 2007 6:15 p.m.
A ruling from a Texas judge coming as soon as Monday is expected to undercut the legal foundation for all 1,000 Vioxx cases brought against Merck & Co. by Texas plaintiffs, providing a potentially significant boon to Merck's defense efforts.
The judge has informed both sides in a state-court Vioxx case that he will dismiss it based on a recently finalized Food and Drug Administration rule, according to a person familiar with the matter. He then told attorneys involved in some of the other 1,000 Vioxx cases in Texas state courts that his ruling could affect the whole group.
Harris County District Court Judge Randy Wilson, who oversees all the Texas Vioxx cases, told the attorneys he will suspend the lawsuits until the state's appeals court rules on his judgment. He said he would issue his written order as soon as next week, according to the person with knowledge of the matter.
Such communications are not uncommon, lawyers say. A clerk for the judge said he had no comment.
Judge Wilson is overseeing a case brought by Ruby Ledbetter, who blamed her heart attack on Vioxx, which she took for more than a year. Merck withdrew Vioxx from the market in September 2004 following a study that linked the painkiller to an increased risk of heart attacks and strokes.
Judge Wilson said he was granting Merck's motion to dismiss Ms. Ledbetter's case, citing an FDA policy rule issued in February 2006. That rule says the agency's approval process "pre-empts conflicting or contrary state law" -- meaning that manufacturers of health-care products are immune from state requirements to warn consumers about potential risks if they've followed FDA guidelines.
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," said Mark Herrmann, a pharmaceutical defense attorney at Jones Day in Cleveland, who isn't involved with the Vioxx litigation. "For Merck, this is huge. If the decision stands, they won 1,000 lawsuits. That's a pretty good day for anybody."
The pre-emption argument is not a silver bullet, however. Since the FDA rule was finalized, there have been about a dozen court rulings on pre-emption in pharmaceutical-liability cases around the country, according to a tally kept by Mr. Herrmann. Courts have ruled in favor of the defense in only four of those cases.
Judge Wilson's decision marks 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 cases around the country, and Texas is one of three states that have consolidated the litigation in an effort to streamline the proceedings.
More than half of the 28,000 cases are consolidated in New Jersey, where Merck is headquartered. There are roughly 4,500 cases consolidated in California.
Judges overseeing Vioxx litigation in other states are also likely to examine Judge Wilson's ruling, Mr. Herrmann said. |
