By KRISTEN HAYS and THERESA AGOVINO
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.
A seven-man, five-woman jury deliberated for 10 1/2 hours over two days before returning the verdict in a 10-2 vote.
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.
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.
After the verdict Friday, Merck shares dropped $2.35, or 7.7 percent, to close at $28.06, approaching the 52-week low of $25.60. Merck lost almost $5.2 billion in market capitalization.
"I'm relieved," Ernst told reporters later. "This has been a long road for me. 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."
Ernst called the verdict a "wake-up call" for pharmaceutical companies.
Merck lawyer Jonathan Skidmore said the appeal would center on what he believes was "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 jury broke down the award as $450,000 in economic damages _ Robert Ernst's lost pay as a Wal-Mart produce manager; $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 as 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."
Juror Derrick Chizer, who voted for Ernst, said the 10 like-minded jurors believed a heart attack triggered the Texas man's fatal arrhythmia.
"It could have been prevented," Chizer, 43, said. "That is the message (to pharmaceutical companies). Respect us."
But juror James Fruindenberg, 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.
If the first wave of verdicts go against Merck, 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.
If Merck prevails in future cases, however, lawsuits could fade away, easing some of the pressure on its stock.
Another 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.
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.
But 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.
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 she 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.
washingtonpost.com
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Friday, August 19
Jury Awards Widow $253.4M in Vioxx Trial
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:18 PM EDT
CDERWEEK 8/15 - 19/2005
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:17 PM EDT
Outsourcing Medical Products to Asia
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:54 AM EDT
Asian countries, particularly India and China, are making vast regulatory and industry improvements to attract more outsourcing business. And Western countries are responding favorably.
Link to Article www.devicelink.com
A Look at Parylene Coatings in Drug-Eluting Technologies
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:53 AM EDT
The continued success of drug-eluting stents relies heavily on little-known technologies. Parylene, for example, could have far-reaching applications.
Link to Article www.devicelink.com
Advances in Devices Lead to Hope for Heart Patients
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:52 AM EDT
As cardiovascular technologies and the devices that incorporate them continue to improve, heart patients have a host of new options for treatment.
Link to Article www.devicelink.com
M.R.I. Scanners' Strong Magnets Are Cited in a Rash of Accidents
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:50 AM EDT
By DONALD G. McNEIL Jr.
As the number of magnetic resonance imaging scanners has soared, and as magnets have quadrupled in power, careless accidents have become more frequent. Link to Article NYTimes.com
Racial Disparities Narrowing in Medicare Managed Care
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:48 AM EDT
Healthorbit.ca
Glaxo, HGS to Team Up on Cancer Drug
by
Alex Hsieh on behalf of Professor Henry Wang
on Fri 19 Aug 2005 11:25 AM EDT
By Michael S. Rosenwald
Human Genome Sciences Inc. said yesterday that British pharmaceutical giant GlaxoSmithKline PLC has agreed to co-develop another drug with the Rockville biotech firm, this one a potential treatment for several difficult-to-treat cancers. The drug, called HGS-ETR1, seeks out a receptor on the surface of cancer cells and provides biological instructions for the cells to die, rather than to keep growing. The drug, when used alone, has had promising results in early human testing -- for example, stabilizing lung cancer tumors in nine of 32 patients. The announcement of Glaxo's participation comes nearly two months after the British company agreed to partner with Human Genome Sciences on its lead product, a treatment for lupus and rheumatoid arthritis. Beyond millions of dollars in development costs, the deals offer the 13-year-old biotech company confidence that it is inching closer to selling its first product. "I think Glaxo brings credibility, capital and expertise to the development process," said David C. Stump, executive vice president of drug development for Human Genome Sciences. Glaxo spokeswoman Gaile Renegar said, "We feel like this relationship is starting to bear fruit." Glaxo decided to help fund both drugs under a collaboration agreement dating to 1996. The companies will equally share development costs, marketing expenses and -- if the drugs make it to market -- the profits (or losses). In pursuing the anti-cancer drug, Human Genome Sciences and Glaxo are joining what has become the gold rush of biotech. Genentech Inc., one of the country's most successful biotech companies, launched the cancer drug Avastin last year and had $554.5 million in sales. Rituxan, another of the company's cancer treatments, has been on the market nine years. Total sales so far: more than $7 billion. Although cancer therapies have become financial boons, they are expensive and complicated to develop. Securing a partner with deep pockets is desirable, particularly in this case, because Human Genome Sciences is testing its drug on three types of cancers: non-Hodgkin's lymphoma, non-small-cell lung cancer and colorectal cancer. "The potential for this drug to work in a number of cancers is what makes it so appealing," said Alexander A. Hittle, an analyst with A.G. Edwards & Sons Inc., who, like other analysts, responded positively yesterday to the deal. Human Genome Sciences is also testing HGS-ETR1 in combination with chemotherapy, a strategy that has boosted the success of other biotech drugs in shrinking tumors. Shares of Human Genome Sciences closed yesterday at $13.26, up 76 cents. washingtonpost.com |
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