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Old 08-20-2005, 08:10 AM   #1 (permalink)
ngdawg
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Merck loses Vioxx lawsuit

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ANGLETON, Texas - A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country.

The panel deliberated for 10½ hours over two days before returning the verdict in a 10-2 vote. But the damage award is likely to be drastically cut to no more than $26.1 million because Texas law caps the punitive damages that made up the bulk of the total.

Plaintiff Carol Ernst began to cry when the verdict was read while her attorneys jumped up and shouted, “Amen!”

Jurors in the semi-rural county rejected Merck’s argument that Robert Ernst, 59, died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia. Ernst, a produce manager at a Wal-Mart store, ran marathons and taught aerobics classes on the side.

The case drew national attention from pharmaceutical companies, lawyers, consumers, stock analysts and arbitrageurs as a signal of what lies ahead for Merck, which has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits pending across the country. Merck said it plans to appeal.

A 'wake-up call' for drug companies
Ernst called the verdict a “wake-up call” for pharmaceutical companies. “This has been a long road for me,” she told reporters later. “But I felt strongly that this was the road I needed to take so other families wouldn’t suffer the same pain I felt at the time.”
After news of the late-afternoon decision, Merck shares fell 7.7 percent to close at $28.06, wiping away almost $5.2 billion in market capitalization.

Merck lawyer Jonathan Skidmore said the appeal would center on what he termed “unreliable scientific evidence.”

“It’ll be based on the fact that we believe unqualified expert testimony was allowed in the case; there were expert opinions that weren’t grounded in science, the type that are required in the state of Texas,” he said. “We don’t believe they (plaintiffs) met their burden of proof.”

The seven-man, five-woman jury awarded $450,000 in economic damages for Robert Ernst’s lost pay, $24 million for mental anguish and loss of companionship and $229 million in punitive damages.

But the punitive damage amount is likely to be reduced since state law caps punitive damages at twice the amount of economic damages — lost pay — and up to $750,000 on top of non-economic damages, which are comprised of mental anguish and loss of companionship.

That would give Ernst a maximum of $1.65 million in possible punitive damages, meaning her total damage award could not exceed $26.1 million.

“This case did not call for punitive damages,” Skidmore said in a prepared statement. “Merck acted responsibly — from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients — to monitoring the medicine while it was on the market — to voluntarily withdrawing the medicine when it did.”

'It could have been prevented'
Juror Derrick Chizer, who voted for Ernst, said the 10 like-minded jurors believed a heart attack triggered the Texas man’s fatal arrhythmia, or irregular heartbeat. “It could have been prevented,” Chizer, 43, said. “That is the message (to pharmaceutical companies). Respect us.”

But juror James Fruidenberg, one of the two who voted for Merck, said he “couldn’t go with the probabilities” of what caused Robert Ernst’s death. “I think there are a lot of good people there who care,” he said of Merck.

Merck pulled Vioxx, a $2.5 billion seller, from the market in September 2004 when a long-term study showed it could double risk of heart attack or stroke if taken for 18 months or longer. By then, more than 20 million Americans had taken the medicine, which along with Pfizer Inc.’s Celebrex, was one of a class of COX-2 inhibitor drugs once dubbed as super aspirin.

Another Vioxx trial is set to begin in New Jersey, where Merck is based, next month, and the first federal trial in New Orleans is slated for late November.

If Merck loses in those cases, experts predict it will open the floodgates for more lawsuits and could force the drug company to settle cases. Analysts have speculated Merck’s liability could reach $18 billion. But if Merck prevails in future cases, lawsuits could fade away, easing some of the pressure on its stock.

Unlike many other pending lawsuits involving obvious heart attacks, the Ernst case centered on an autopsy that attributed his death to an arrhythmia secondary to clogged arteries. That autopsy — and the coroner who performed it — proved critical to the trial’s outcome.

Case centered on autopsy report
Merck pointed to the autopsy as proof that Vioxx could not have caused the death of Ernst, who ran marathons and taught aerobics.

However, Dr. Maria Araneta, the pathologist who performed Ernst’s autopsy, testified for Ernst that a blood clot that she couldn’t find probably caused a heart attack that triggered Ernst’s arrhythmia. She also said the heart attack killed Ernst too quickly for his heart to show damage.

While Araneta couldn’t say definitively that he had a blood clot and heart attack, she insisted they were the likely culprits in triggering an arrhythmia, which she said wouldn’t happen on its own.

Araneta didn’t blame Vioxx, however, noting she knew little about the drug when she performed Ernst’s autopsy. But three plaintiff’s experts in arrhythmia, cardiology and public health did.

Merck’s experts agreed with Araneta’s conclusions in the autopsy, but not her undocumented theory of what triggered the arrhythmia.

Vioxx inhibits an enzyme known as Cox-2, which thins the blood. That feature allows it and other drugs in its class — Pfizer’s Bextra and Celebrex — to relieve acute pain and arthritis without causing stomach bleeds or ulcers, as painkillers such as aspirin can.

A U.S. Food and Drug Administration panel concluded in February that Vioxx, Celebrex and Bextra all pose heart risks but should be available to consumers. But in April, Pfizer withdrew Bextra from the market at the FDA’s request when the agency said it carries risk of serious and sometimes fatal skin reactions in addition to heart attacks and strokes.

The FDA also said that all prescription nonsteroidal, anti-inflammatory drugs, not just Cox-2 inhibitors, should carry a so-called “black box” warning label about cardiovascular risk. Celebrex remains available to consumers.

There are still 4200 cases pending regarding deaths and illness resulting from the use of Vioxx. There is no way of knowing what may have occurred in any of these lives had the drug not been used. I have two friends who depended on it for pain relief, niether of which had any health issues related to its use. There are far more dangerous medicines still being prescribed. Is this a case of 'let's jump on this bandwagon'?
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