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Biotech / Medical : Merck
MRK 100.72+1.5%3:59 PM EST

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From: mopgcw9/27/2006 4:55:20 AM
   of 1580
 
Merck Is Victorious
In New Orleans Vioxx Trial

By HEATHER WON TESORIERO
September 27, 2006; Page A13

A federal jury in New Orleans cleared Merck & Co. of responsibility for a man's heart attack in the 10th case to go to trial over the drug maker's troubled Vioxx painkiller.

VIOXX TIMELINE


Sept. 26, 2006: Jury clears Merck in third federal case.
Sept. 18: Merck appeals first Vioxx verdict, issued by a Texas jury in August 2005.
Sept. 6: An outside investigation ordered by Merck's board largely exonerates the drug maker's management of any wrongdoing over Vioxx.
Aug. 30: Federal judge rules that jury's $51 million award was "grossly excessive." Orders a new trial on damages.
Aug. 17: Federal jury finds Merck negligent. Plaintiff awarded $51 million. A New Jersey judge throws out a Merck victory in a trial from November.
Aug. 2: Jury clears Merck in California case.
July 13: N.J. jury says Merck not liable for patient's heart attack.
June 26: New England Journal of Medicine publishes correction to report critical of Vioxx.
May 17: Merck study indicates Vioxx risk starts earlier than expected.
April 21: Merck found liable in another Texas case.
April 5: N.J. jury finds Merck liable in one case, not liable in a second.
Feb. 18: Merck wins retrial after mistrial in Dec. 2005 case.
Dec. 12, 2005: First federal case ends in a mistrial.
Nov. 3: N.J. jury finds Merck not liable for patient's heart attack.
Aug. 19: Merck found liable for patient's death in Texas.
May 5: CEO Ray Gilmartin steps down.
Nov. 2004: Justice Dept., SEC, Senate launch investigations.
Sept. 30: Merck withdraws Vioxx world-wide.Robert Smith, 56 years old, of Florence, Ky., blamed Vioxx for his February 2003 heart attack. The Smith case is the first that involves an injury that occurred after Merck updated its label for Vioxx in 2002 to include some data on cardiovascular risk. Mr. Smith had prescriptions for 90 days of Vioxx, but he said that he had samples and took the drug for 138 days.

After deliberating for about three hours, the jury of six women and two men voted that Merck adequately warned of Vioxx's heart risks and that the drug wasn't a proximate cause of Mr. Smith's heart attack.

"The jury's decision confirms that Merck acted responsibly and that Vioxx was not the cause of Mr. Smith's heart attack," said Merck outside defense counsel Philip Beck in a company statement. Pointing to Mr. Smith's heart-attack risk factors, Mr. Beck said, "Unfortunately, Mr. Smith would have suffered a heart attack whether he was taking Vioxx or not." The company had argued that Mr. Smith, a supervisor at a chemical manufacturer, had a number of heart-attack risk factors, including obesity, high blood pressure and atherosclerosis. (See Merck's statement.)

Plaintiffs' attorneys challenged the adequacy of the 2002 label update, and in prior trials have asserted that Merck played down data by placing the cardiovascular-risk information in the label's precautions section, as opposed to the more prominently displayed warnings section. Merck has countered that the FDA approved the updated label.

It was two years ago this week that Merck pulled Vioxx from the market after a study linked the blockbuster painkiller to an increased risk of heart attacks and strokes. The first of what are now 14,200 lawsuits went on trial just more than a year ago and resulted in a $253.4 million plaintiffs' verdict. But 10 trials later, no clear pattern has emerged in terms of victories and losses, and the litigation has seen a number of twists and turns.

With the latest verdict, Merck has won five trials and lost four. Another verdict, a Merck win in New Jersey state court, was vacated last month by Judge Carol E. Higbee, who granted a new trial based on information about Vioxx data that emerged after the verdict there in November.

Plaintiffs who have taken Vioxx for short periods of time have prevailed despite Merck's contention that the drug poses risks in people who take it for 18 months or longer. Merck lost the first death case and won the second one. One recurrent theme: In all cases where the plaintiffs have won, juries have voted to award punitive damages. (See a trial scorecard.)

Last month a jury in another federal trial in New Orleans awarded a plaintiff $51 million, but Judge Eldon E. Fallon later tossed out the award, finding it "excessive," and ordered a new trial on damages. A date for that proceeding hasn't been set. A plaintiffs' victory in Rio Grande City, Texas, hangs in the balance after a whistleblower came forward and disclosed a financial relationship between the plaintiff and one of the jurors.

In addition to the personal-injury claims, which Merck has said it will fight on a case-by-case basis, the company faces a potential class-action suit brought by a union and includes third-party payors who paid for Vioxx. The parties await a decision from the New Jersey Supreme Court to determine if the class-action litigation moves forward.
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