WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--April 21, 2006--Merck & Co., Inc. said today that it was disappointed a state court jury in Texas found in favor of a 71-year-old Texas man’s family which had claimed VIOXX caused his fatal heart attack in April of 2001. Merck will appeal both the compensatory and punitive aspects of the verdict.
Texas law will automatically limit the punitive damage award to $750,000.
The case was tried in the Rio Grande Valley, described as a “Plaintiff’s Paradise” by the Associated Press and cited as the nation’s most difficult jurisdiction for corporate defendants by the American Tort Reform Association. Texas State Judge Alex W. Gabert of the 229th Judicial District presided over the case.
“There is simply no reliable scientific evidence that VIOXX caused Leonel Garza Sr.'s heart attack,” said Richard L. Josephson of Baker Botts, LLP, lead attorney for Merck’s defense team in the case. “It is also clear that that Merck provided to the U.S. Food and Drug Administration all required information about VIOXX. There was no evidence that Merck acted with gross neglect and under Texas law that means punitive damages should not have been awarded.”
Testimony at trial showed that Mr. Garza battled heart disease for more than two decades, suffering a heart attack in 1981 and undergoing quadruple-bypass surgery in 1985. A lifetime cigarette smoker, Mr. Garza also exhibited almost every major risk factor for coronary disease, including high blood pressure, high cholesterol and obesity.
The FDA has never stated that it saw any evidence linking short-term use of VIOXX to an increased risk of heart attack.
Medical records indicated that Mr. Garza visited his doctor on March 27, 2001, complaining of arm pain and was given a one-week supply of VIOXX, in 25 mg samples. There was no documentary evidence that Mr. Garza received any VIOXX pills after that one-week supply. He died of a heart attack more than three weeks later, on April 21, 2001.
Merck is examining various bases for appeal of the verdict:
Plaintiffs did not meet the threshold issue for general causation because they failed to introduce at least two statistically significant scientific studies showing that use of VIOXX at the same dose and duration as taken by Mr. Garza more than doubled the risk of heart attack. Plaintiffs did not meet the standard for specific causation because they failed to rule out the other plausible causes of Mr. Garza’s death, including a history of heart disease, a previous heart attack, quadruple-bypass surgery, a lifetime cigarette habit, high blood pressure, high cholesterol and obesity. Plaintiffs’ allegations that Merck could or should have changed the VIOXX labeling sooner to incorporate the VIGOR results fail on preemption grounds. The FDA is the federal regulatory body charged with approving warning labels on medication and Merck complied with the FDA’s requirements. Punitive damages in this case are inapplicable because there was no evidence that Merck acted with “gross neglect,” which is the standard under Texas law for such an award. “We have strong points to raise on appeal and are hopeful that the appeals process will correct this verdict,” said Kenneth C. Frazier, senior vice president and general counsel of Merck. “Merck is in this for the long term. We have the resources and the resolve to address these cases, one by one, over many years,” Mr. Frazier added.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the cautionary statements in Item 1 of Merck’s Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.
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Source: Merck & Co., Inc.
