Closing arguments begin in federal Vioxx trial | VailDaily.com
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Closing arguments begin in federal Vioxx trial

JANET McCONNAUGHEYAssociated Press Writer

NEW ORLEANS Theres overwhelming evidence that Vioxx causes heart attacks and that Merck & Co. knew about this danger years before it stopped selling the painkiller and that its more likely than not that the drug caused the heart attack that killed a Florida man, his widows attorney told a federal jury Friday.Our burden of proof is to show it is more likely than not. Fifty-one percent, Andy Birchfield told the five men and three women who will decide whether Merck must pay for the death Mercks file cabinet and got these documents that show whats going on. …This is what is going on inside the four walls of Merck, Birchfield said. He highlighted an email from Edward Scolnick, who was president and CEO of Merck in 2000, which said that the side effects are clearly there.The retrial over the May 2001 death of Richard Dickie Irvin may be the first indication of the litigations outcome in federal court, generally seen as more disciplined and friendly to businesses than state courts.Then again, maybe it wont the first trial, moved to Houston because of damage from Hurricane Katrina, ended with a hung jury.The jurors must decide unanimously whether the once popular painkiller caused the heart attack that killed Irvin, whether it was defective or unreasonably dangerous, and whether the drug company concealed its dangers.Irvin was from St. Augustine, Fla. The case wound up before U.S. District Judge Eldon Fallon when he was assigned to handle pretrial matters for all federal cases.As of the end of December, Merck faced more than 9,600 state and federal cases.Mercks state court record is 1-1. It lost a $253 million judgment in Texas, where another trial is under way, and won a case in its home state, New Jersey, where another is to begin later this month.Merck says that it gave what it knew about potential dangers to the U.S. Food and Drug Administration, and that Plunkett hasnt shown any link between Irvins death and its once popular painkiller.In written arguments, Merck said Plunkett lacked any witness to explain why Vioxx was the only likely cause for Irvins heart attack. None of plaintiffs expert witnesses testified that he can rule out, to a reasonable degree of medical certainty, the possibility that Mr. Irvins heart attack resulted from his known risk factors including age, gender, and family history of cardiovascular disease, the attorneys wrote.Plunkett, her son and one of her three daughters testified Tuesday that Irvin, 53, was a healthy man who got plenty of exercise as manager of a seafood distributor, helping to load and unload trucks and fishing boats.Merck withdrew the drug from the market in 2004, when a study called APPROVe found that people who had taken Vioxx for at least 18 months doubled their risk of heart attacks and strokes.Merck contends that shorter periods pose no danger an idea which Dr. Gregory Curfman, executive editor of the New England Journal of Medicine, said he tried to keep out of the published report of APPROVe.In videotaped testimony, Curfman said he tried to get the authors to back away from this contention, because he, other editors, and the scientists who reviewed the article felt that it wasnt reasonable especially because other cardiovascular side effects showed up almost immediately.He also testified that Merck held back data about three heart attacks among patients taking Vioxx in an earlier study which held the first indication that Vioxx might increase danger of heart attacks.The journal published an editorial criticizing that study, called VIGOR, the day deliberations began for the first trial in Houston.Merck executive Dr. Alise Reicin testified the company did report the heart attacks to the FDA, but didnt feel it had to tell the journal because they didnt significantly change the results. With either set of figures, she said, rounding would have made the relative risk figure the same.The figures reported to the journal were 17 heart attacks among patients on Vioxx and four among those taking another drug, called naproxen, or 4 1/4 times as many. The additional three changed that to 20, or five times as many.Merck, saying that the difference was probably because naproxen kept blood clots from forming, framed it as a reduction in the likely risk. Rounding off made that the same in either case, Reicin said: a fivefold difference.Fallon has told attorneys he hopes to work out a settlement after the first four federal cases are heard.Vail, Colorad


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