ANGLETON, Texas - Jurors held drugmaker Merck & Co. liable yesterday for the heart-related death of a 59-year-old marathon runner who took its prescription painkiller Vioxx, awarding his widow $253.4 million.
It was a staggering loss in the first of 4,200 suits that have been filed against Merck, and it could have far-reaching implications for the pharmaceutical industry, which has been under fire in recent months for its aggressive marketing tactics.
Merck pulled Vioxx, which was being taken by 20 million people, from the market in September after a study found that its use increased the risk of heart attack and stroke. Nevertheless, the bulk of the jury's award, $229 million, was punitive.
Under Texas law limiting punitive damages, that part of the penalty will automatically be limited to $1.6 million, meaning the overall award cannot exceed $26.1 million and could be reduced by Texas appellate courts.
A jury of seven men and five women took less than 11 hours to determine that Merck didn't warn doctors about Vioxx's danger, that the drug was improperly designed and that Merck's negligence caused the death of Wal-Mart produce manager Robert Ernst in 2001.
"I hope this will be a wake-up call to all drug companies," Carol Ernst, Robert's widow, said outside the Brazoria County courthouse. "Consumers and physicians and doctors have a right to know about all of the risks of the drugs they are taking. I know in my heart [my husband] would be proud."
New Jersey-based Merck vowed to appeal the verdict and maintained that Ernst died of an irregular heartbeat, known as a heart arrhythmia, a condition never linked to the use of Vioxx by any study.
The company also argued that it had disclosed its safety data on Vioxx and that it took the drug off the market as soon as it determined that its safety was open to question.
Before yesterday's verdict, analysts estimated that Merck's potential liability for all of the cases filed against it could reach $30 billion. Yesterday's ruling suggested that it could go higher.
Merck stock falls 7.7%
After the verdict, Merck shares fell 7.7 percent to close at $28.06, wiping out almost $5.2 billion in market capitalization.
The repercussions could be significant, first for Merck's profits - it made $2.5 billion a year on Vioxx - and then for other pharmaceutical companies, which might rethink the process for bringing new drugs to market.
Even before the verdict, the Vioxx case had a hand in changing drug company marketing practices. This month, drug companies vowed to be more selective and less aggressive in the way they advertise new drugs to consumers, to avoid the charge that they are pushing new drugs on patients before the drugs' efficacy and side effects are fully understood.
Influential members of Congress said the jurors' action will fuel efforts to rein in drugmakers and push the Food and Drug Administration to enhance its scrutiny of them.
"The Food and Drug Administration was also negligent in the Vioxx case," said Sen. Charles E. Grassley, an Iowa Republican and chairman of the Senate Finance Committee. "A too-cozy relationship with a drugmaker put lives at risk."
Jurors said they were shocked by the behavior of regulators and the drug companies. They said documents dating to 1997 showed Merck knew about Vioxx's risks to the heart and that they were surprised the drug stayed on the market as long as it did.
"This case certainly opened my eyes," said juror Rhonda Wade, a 41-year-old mother of four from nearby Clute, Texas. "They ignored an FDA warning letter about their marketing, and they didn't give [regulators] all of the information.
"I will probably never take another pill without totally investigating it, questioning my doctor and pharmacists and reading all the information I can."
Ten of 12 jurors ruled in favor of Ernst on every question posed to them. Under Texas law, at least 10 of the 12 jurors had to agree on the question regarding Merck's behavior in bringing Vioxx to market and on whether the drug was a "producing cause" of Ernst's death.
Merck said it plans to take on every claim brought against the company over Vioxx.
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June 2000: Merck releases results to the Food and Drug Administration of a study finding that Vioxx users suffered five times as many heart attacks as users of the older painkiller naproxen, sold under the brand name Aleve. Merck attributes the disparity to naproxen's cardioprotective qualities rather than to a defect in Vioxx, garnering a rebuke from the FDA for making that assertion without scientific proof.
May 2001: Robert Ernst, a 59-year-old Wal-Mart produce manager from Keene, Texas, who runs marathons and teaches aerobics classes, dies in his sleep after taking Vioxx for eight months to alleviate pain in his hands. His widow, Carol, suspects that Vioxx is responsible.
September 2001: Merck receives a warning letter from the FDA about the company's promotional campaign "that minimizes the potentially serious cardiovascular findings" and "misrepresents the safety profile of Vioxx."
April 2002: FDA changes warning label on Vioxx to reflect study finding increased risk of heart attacks and strokes.
May 2002: Carol Ernst sues Merck, alleging that Vioxx triggered her husband's death.
September 2004: Merck voluntarily withdraws Vioxx from the market.
February 2005: FDA panel concludes that Vioxx poses heart risks but should be available to consumers.
July 14: The Ernst case, the first of more than 4,000 state and federal lawsuits pending against Merck nationwide, begins.
Aug. 19: Texas jury finds Merck liable in the death of Robert Ernst, awarding his widow $253.5 million in damages.