WHITEHOUSE STATION, N.J., April 20, 2007 - Merck & Co., Inc. said today that a Texas court overseeing the Texas litigation rejected a plaintiff's claim that she was not properly informed of the medicine's alleged risks because, in fact, the VIOXX label contained a U.S. Food and Drug Administration (FDA)-approved warning. The court order in the case, Ledbetter v. Merck, could have an impact on most Texas cases alleging that there was a failure to warn.
Last August, Merck sought to dismiss all such failure-to-warn claims under Texas law because the Company had properly informed the FDA about VIOXX and the FDA had approved the label. Merck based its dismissal request on a 2003 Texas law which generally does not permit failure-to-warn claims against prescription drug manufacturers if the drug at issue was accompanied by FDA-approved warnings, as was the case with VIOXX.
"Merck acted responsibly by providing the FDA with the required data and updating the label with FDA-approved language to reflect what was known at the time," said Ted Mayer of Hughes, Hubbard & Reed, counsel for Merck. "The label provided physicians with the relevant information available to help them determine whether to prescribe the medicine to a given patient."
In Texas, more than 1,300 cases were filed after the 2003 Texas law was enacted. In addition, there are approximately 2,000 cases pending in other jurisdictions that may be subject to this Texas law. The failure-to-warn claim has been the primary theory asserted by plaintiffs' attorneys in the VIOXX trials to date. Plaintiffs have asserted other alleged theories and the effect of the ruling on cases that include such other theories remains to be determined.
Judge Randy Wilson, who presides over the statewide coordination of VIOXX cases in Texas, held that, to prevail under Texas law, the plaintiff would have to show that Merck withheld required, material and relevant information from the FDA that would have led to a different decision regarding the approved labelling of VIOXX.
Relying on the U.S. Supreme Court, Judge Wilson also held that such a determination can only be made by the FDA, not a Texas jury. However, the FDA has never made any such determination.
Merck also had argued that it did not misrepresent or withhold required, material and relevant information from the FDA, further justifying the dismissal of the failure-to-warn claims at this early stage. Because the Court held that this issue was pre-empted by federal law, it did not need to reach a decision on the issue.
Judge Wilson certified the decision for an expedited appeal to the Texas Court of Civil Appeals.
"The Texas Legislature enacted its law to ensure that jurors are not asked to second-guess the doctors and scientists at the FDA who conduct an extensive review," added Mayer. "The nation's highest court has affirmed that the FDA's role is paramount and that state law cannot be allowed to undermine the FDA's statutory responsibility to ensure the safety and availability of prescription medications for all Americans."
Travis Sales of Baker Botts LLP and Katherine Mackillop of Fulbright and Jaworski LLP argued the Company's dismissal request before Judge Wilson of the Harris County, TX District Court."
Status of Litigation
As of March 31, 2007, the claims related to more than 4,600 alleged VIOXX users have been dismissed before being scheduled for trial.
Juries have found in favor of the Company 10 times and in favor of plaintiffs five times. There are two unresolved mistrials as a result of hung juries after plaintiffs failed to prove their claims. Another 15 cases scheduled for trial were either dismissed or withdrawn from the trial calendar by plaintiffs before a jury could be selected.
Just last Monday a California plaintiff asked the Court to dismiss his suit which was scheduled to begin last week in Los Angeles.
Merck is pursuing its options for post-trial relief and appellate review with respect to each of the plaintiffs' verdicts.
For information regarding additional cases scheduled for trial in 2007 visit http://www.merck.com/newsroom