A Texas jury Friday awarded $253.4 million in damages to the widow of a 59-year-old man who had used the controversial painkiller Vioxx. 

It was the first lawsuit—in either state or federal court—involving the now-banned painkiller, part of a family of drugs called cox-2 inhibitors.

The Texas District Court jury of seven men and five women awarded Carol Ernst, the widow of Robert Ernst, the money as compensation for her mental anguish, as well as the loss her husband’s companionship and earnings, and for punitive damages.

Robert Ernst died suddenly in 2001 after taking Merck & Co.’s pain drug for eight months. His family sued the company, claiming the drug contributed to his death.

Texas District Court Judge Ben Hardin announced the much-anticipated verdict in the Brazoria County Courthouse in Angelton, south of Houston, at about 1:50 Friday afternoon.

“The justice system in America works and it works very well,” said W. Mark Lanier, the lead lawyer for Carol Ernst.

But the large settlement may be reduced through the appeals process, a procedure that often occurs, according to a medical malpractice law professor.

Max Mehlman, professor of biomedical ethics at Case Western University School of Law in Cleveland, said the jockeying for financial positioning is just beginning.

“Merck can petition the trial judge to reduce the award as ‘grossly unfair,’ ” Mehlman said, “and judges often do that if they regard the punitive damages as excessive.” In this case $229 million of the $254 million was in punitive damages.

Vioxx was the first of two highly popular cox-2 inhibitor medications to be pulled from drug store shelves since last September, after a major clinical trial linked its long term use to an increased incidence of cardiovascular problems. The other now-banned drug is Pfizer’s Bextra. The third cox-2 drug, Pfizer’s Celebrex, remains available to consumers but carries a heightened warning about potential heart risks.

In a statement released after the verdict, Merck’s senior vice president and general counsel, Kenneth C. Frazier, said, “We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict. Our appeal is about fundamental rights to a fair trial.”

According to the Associated Press, Jonathan Skidmore, another Merck lawyer, added that “we believe the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst’s death.” The company has instead claimed that Ernst’s death was due to an irregular heartbeat.

The Ernst case is just the first of over 4,000 Vioxx-related lawsuits already filed. Merck has said it plans to fight each and every case in court, but that could be a risky strategy, since many lawyers considered the merits of the now-successful Ernst case particularly weak, the AP reported.

The financial implications, not just for Merck but for the pharmaceutical industry as a whole, could be enormous, experts say. According to the AP, some analysts have estimated that if the Ernst verdict is an indication of future decisions, damages from Vioxx-based lawsuits could top $18 billion. On the other hand, those damages could be much less if the company prevails in future cases.

Merck’s financial survival may rest with the actual amount the Ernst family will receive.

If Merck doesn’t request the trial judge to reduce the damages, it will certainly do so as the case proceeds to appeal, Mehlman added. “Assuming the plaintiff prevails,” he said, “many of the [4,000] pending lawsuits can become class actions, because the circumstances are similar. They’ll be consolidated by the court.”

Because the jury award was so high, Mehlman said, “it gives the plaintiffs a lot of leverage. They can be pretty confident that they can win a number of these cases.”

Mehlman said the Merck case may end up being the test case that puts big pharmaceutical companies at the same risk as the tobacco companies. Prior to the Ernst lawsuit, he said, case law had taken the view that drugs were necessarily risky.

“The analogy of using a sharp knife comes into play,” said Mehlman, who is also the Arthur E. Petersilge Professor at the Case School of Law and director of the Case Law-Medicine Center.

“Just like using a sharp knife, the consumer takes risks when using drugs, and the courts have been restrictive in allowing people to sue drug companies unless there was evidence of a cover-up,” Mehlman concluded.

The possibility of a cover-up may have been heightened earlier this year when a panel appointed by the U.S. Food and Drug Administration heard testimony that Merck suppressed some research that had indicated people who took certain dosages of Vioxx were more susceptible to suffering a heart attack.

According to The New York Times Merck shares fell $2.35, or 7.7 percent, to $$28.06, soon after the verdict was announced.

The first federal Vioxx-related trial, brought by the widow of 53-year-old Richard Irvin, Jr., of Florida, is slated to begin in New Orleans Nov. 28.

The Vioxx story began to first heat up last September when hints of cardiovascular problems linked to its use first surfaced. The drug—which brought Merck $2.5 billion in revenue per year—was voluntarily pulled from the market.

In February, the FDA advisory panel voted to allow Vioxx to return to the market, albeit with strongly worded labeling warning long-term users of possible heart risks. It also advised that the two competing cox-2s, Celebrex and Bextra, be allowed to remain available to American consumers.

However, FDA officials in April ignored the panel’s recommendation and also recommended the withdrawal of Pfizer’s Bextra. Saying it disagreed with the decision, Pfizer nonetheless complied, although its other cox-2, Celebrex, remains the only such medication available in pharmacies today.

In the meantime, troubles have mounted for the makers of Vioxx. As reported in April by the The New York Times, e-mail obtained by that paper appeared to show Merck officials overruling one of its own scientists who suggested that an elderly female patient enrolled in a Vioxx clinical trial may have died of a heart attack. According to the Times, the company instead reported the cause of that death to the FDA as “unknown.”



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