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U.S. jury clears Merck in Vioxx federal trial
Updated Fri. Feb. 17 2006 6:14 PM ET Associated Press
New Orleans — A federal jury handed Merck & Co. a major victory when it cleared the drug maker of any responsibility in the death of a 53-year-old Florida man who had a heart attack after taking its once-popular painkiller Vioxx for less than a month.
This was the second court victory for Merck, and the first in a federal court. The company had argued in this case that plaintiff lawyers never proved any link between Vioxx and the heart attack Richard (Dickey) Irvin suffered in 2001. Merck's lawyers contended Irvin's age, gender and diet all put him at risk for heart attacks
It was also the second time jurors heard the case brought by Irvin's family. In Houston, where the case was heard in November and December because of damage from hurricane Katrina, jurors were unable to reach a verdict. Merck won a state case in New Jersey last year, while it lost one in Texas.
Irvin's widow, Evelyn Irvin Plunkett; the youngest of their three daughters, Ashley Irvin; and their only son, Richard Irvin III, all testified that Irvin's health had been excellent up to his heart attack.
Federal Vioxx jury says Merck not liable in death
February 17, 2006 03:57:15 PM PST Reuters
A federal jury said on Friday that drugmaker Merck Co. Inc. was not liable in the 2001 death of a Florida man who used the recalled painkiller Vioxx.
The eight-person jury's verdict was the first in a federal court and the third out of more than 9,000 cases filed against Merck in U.S. and state courts claiming the company hid the once-best-selling painkiller's health risks.
Specifically, the jury found Vioxx was not a defective product, that Merck was neither negligent in making the product nor did it fail to warn users of its risks.
Merck's share price jumped 1 percent to $36.50 in after-hours trade after closing at $36.05 Friday on the New York Stock Exchange.
Analysts said early court victories were good news for the drugmaker.
"This is certainly good for Merck. The more they win these cases early on the better off they are," said Ram Partners LP hedge fund partner Thomas Bundock, who added the fund does not own any shares of the drugmaker due to the legal hurdles facing the company.
"So far, Merck has done an admirable job of fending them off," Bundock said. "The question is: Can they continue? This is going to be a long, drawn-out process."
The case heard in the U.S. District Court for the Eastern District of Louisiana focused on the death of 53-year-old Richard "Dickie" Irvin, whose family claimed Vioxx triggered a heart attack.
Merck argued Irvin's heart attack was due to an unhealthy lifestyle that led to clogging of his arteries.
"The jury's decision confirms there is no medical or scientific evidence showing the short-term use of Vioxx increased the risk of heart attack or contributed in any way to the death of Richard Irvin," Merck said in a statement.
Irvin's widow, Evelyn Irvin Plunkett, shook her fist and cried as she walked out of court with her attorney Andy Birchfield.
Irvin's survivors may consider appealing the verdict, Birchfield said. He added that losses in the early trials did not mean the plaintiffs' cases are weak.
"Merck is taking the position that they are going to fight every one of these cases and we're going to do the same," Birchfield said. "The case only gets stronger and stronger. It paints a darker and darker picture over what Merck did."
Merck's attorney, Phillip Beck, said Friday's verdict strengthens Merck's contention that it acted appropriately and in response to scientific evidence.
"Juries can understand that the Merck people acted appropriately at all times regarding Vioxx," Beck said.
The jury's verdict capped a retrial of the case. In December a nine-member jury could not reach the needed unanimous verdict when one member said Merck was liable for Irvin's death.
Merck recalled Vioxx in September 2004, after it was shown to double heart attack and stroke risks for those who took it at least 18 months.
This case is the first of the Vioxx lawsuits to be tried in federal court. It was originally tried in Houston after Hurricane Katrina temporarily closed the federal courts in New Orleans.
Two other cases have been completed in state courts, with Merck winning one in New Jersey and losing one in Texas, where the widow of a 59-year-old Vioxx user was awarded $253 million in damages. Merck is appealing that verdict.
Analysts have said the company's legal costs to fight the lawsuits could total several billions of dollars.
Scientists Again Defend Study on Vioxx
February 23, 2006
With a crucial personal-injury trial over Vioxx set to begin in New Jersey next week, the debate heated up again yesterday about whether Merck understated the drug's risks in a journal article in November 2000.
In an letter published online by The New England Journal of Medicine, 11 scientists who were co-authors of the article said they stood by its original conclusions, despite heavy criticism from the editors of the journal.
The scientists whose letter was published yesterday are not employed by Merck. The company financed the study and their initial work on the paper, and two Merck scientists were also co-authors. In a separate letter also published by the journal yesterday, those Merck scientists said they, too, stood behind their work.
But in an "expression of concern" also published on the Web site yesterday, the journal's editors reaffirmed their earlier complaint, saying the article "did not accurately reflect the potential for serious cardiovascular toxicity with Vioxx."
Merck sold Vioxx from 1999 to 2004. The company withdrew the drug from the market after a clinical trial showed that Vioxx increased the risks of heart attacks and strokes. Merck now faces about 10,000 lawsuits from people who say they or their family members suffered heart damage as a result of using Vioxx, a painkiller that was taken by about 20 million Americans.
Merck has won two of the three lawsuits that have been decided so far, although plaintiffs' lawyers play down the company's victories since they involved cases in which Vioxx was taken for only a few weeks. Jury selection in the next trial, which includes two plaintiffs who suffered heart attacks after taking Vioxx for at least 18 months, will begin Feb. 27 in state court in Atlantic City.
The letters come two months after the editors of The New England Journal of Medicine published their first "expression of concern" about the November 2000 article, sharply criticizing Merck — and, implicitly, the outside scientists who were co-authors — for failing to present a complete picture of Vioxx's heart risks.
In their letter yesterday, the outside scientists strongly disagreed. They said that the journal's concerns were misguided and that the article in 2000 had adequately disclosed Vioxx's risks. "Our original article followed appropriate clinical trial principles and does not require a correction," the scientists wrote.
Dr. Claire Bombardier, a Toronto rheumatologist, was the lead outside author on the study. The article reported on the results of an 8,000-person trial of arthritis patients taking Vioxx or naproxen, an older painkiller sold under the trade name Aleve. Merck conducted the trial in the hope of proving that Vioxx was less likely to cause gastrointestinal bleeding than naproxen.
The trial confirmed that Vioxx seemed to be safer on the stomach, but it also showed that more patients taking Vioxx than naproxen died and that many more suffered heart attacks. As published, the article reported that 17 patients taking Vioxx and 4 taking naproxen had heart attacks during the trial.
In fact, 20 patients on Vioxx suffered heart attacks, but the final three heart attacks were reported after Feb. 10, 2000, a cut-off date specified by Merck for reporting cardiovascular problems.
In their letter, the outside authors said that they could not report the final three heart attacks in the article because the attacks were reported after the study's results had been unblinded — after the scientists knew which drug had caused which problems. A core principle of scientific research is that data should not be added or removed from a clinical trial once the trial has been unblinded, because the bias of the authors may influence the decision to add or remove the information.
In addition, the outside authors said that the additional three heart attacks would not have materially changed the conclusions of the study, because the difference in heart attack risk between Vioxx and naproxen was too large to be attributed to chance, even without counting the additional heart attacks.
But in their response yesterday, the New England Journal editors said that Merck had made an arbitrary decision to set Feb. 10 as a cut-off date for reporting cardiovascular problems, in contrast to the cut-off date a month later for reporting gastrointestinal problems. Because Vioxx reduced gastrointestinal problems but increased cardiovascular problems, the editors said, setting the earlier deadline for reporting cardiovascular problems had the effect of making Vioxx seem safer than it was.
The journal editors also again criticized Merck and the study's outside co-authors for failing to report the total number of serious thromboembolic events — including heart attacks, strokes and blood clots — among patients taking Vioxx in the trial. An internal Merck memo revealed that 47 patients on Vioxx suffered those problems, compared with 20 taking naproxen, according to the editors.
The BBC are reporting: Vioxx settlement to total $4.85bn
The maker of Vioxx has agreed to pay $4.85bn to settle legal claims that the controversial drug caused many users to suffer strokes and heart failure.
Merck & Co said it was setting up a fund to compensate victims, adding that claimants would only receive payment if certain key conditions were met.
To qualify, individuals must prove they suffered serious illness, at the most two weeks after they bought the drug.
The deal may end multiple lawsuits but Merck has not admitted any liability. ....
Payments could be made as early as next August, although Merck said it reserved the right to rescind the settlement if key conditions were not adhered to.
These conditions include:
Claimants must provide medical proof of serious illness
They must provide evidence they bought at least 30 Vioxx pills
They must provide proof to support the presumption they took Vioxx within two weeks of suffering illness
Only US residents and those who were ill after taking the drug in the US are included
The settlement will only be valid if 85% of all pending claims agree to the offer by 1 March 2008
Merck said the agreement would provide a "significant degree of certainty" that the bulk of lawsuits against the firm would be resolved.