August 19, 2005 4:19 p.m. EDT
Merck & Co. hit pay dirt in 1999 when it launched Vioxx, a major entrant in a new class of prescription painkillers known as Cox-2 inhibitors. Five years and billions of dollars in world-wide sales later, the company voluntary pulled the drug from the market amid studies that showed increased risk of heart attacks and strokes in users. Since then, the entire class of Cox-2 drugs has come under scrutiny and thousands of lawsuits have been filed against Merck. On Friday, Merck was found negligent in the death of a 59-year-old triathlete who used Vioxx, the first case to go to a jury. Here's a look at Vioxx's move from the market to the courthouse.
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May 1999 -- Merck launches Vioxx in the U.S. and markets it in more than 80 countries.
February 2001 -- FDA approves Merck request to label Vioxx as safer for the stomach than older painkillers, giving the drug a slight but important edge over rival Celebrex, made by Pfizer.
April 2002 -- After reviewing two years of study results, FDA changes Vioxx's label to say the drug may protect against ulcers but may increase heart risks. Pfizer and Pharmacia launch Bextra as a complement to Celebrex.
October 2003 -- Merck-funded study finds patients taking Vioxx are at a 39% increased risk of heart attack within the first 90 days, compared with those taking Celebrex.
August 2004 -- HMO Kaiser Permanente reconsiders covering Vioxx for its member patients after an FDA study finds that patients who had taken more than 25mg a day were 3.15 times as likely to have a heart problem.
September 2004 -- Merck announces a voluntary world-wide withdrawal of Vioxx, in the same month that the FDA approves the drug to treat juvenile rheumatoid arthritis.
Oct. 29, 2004 -- FDA tells Merck it will approve sales of Arcoxia, a possible successor drug to Vioxx, if the company offers more safety and efficacy data.
November 2004 -- The Justice Department and the Securities and Exchange Commission launch investigations into Merck's handling of Vioxx. Senate begins hearings on how Merck and the FDA responded to safety concerns about Vioxx.
February 2005 -- Federal Vioxx suits against Merck are transferred a judge in Louisiana for coordinated pretrial proceedings and a ruling on class-action status. An FDA panel of experts narrowly votes to recommend that Vioxx can return to market for certain patients, as long as it contains a strong warning label and other restrictions.
May 5, 2005 -- Merck announces long-serving CEO Ray Gilmartin will step down and be succeeded by manufacturing chief Richard Clark.
July 14, 2005 -- First court trial of Vioxx opens in Angleton, Texas. The plaintiff, Carol Ernst, filed suit over the death of her husband, Robert, a triathlete who died of arrhythmia, or irregular heartbeat, after taking Vioxx for about eight months to ease pain in his hands.
August 1, 2005 -- Jury views video deposition of coroner's testimony that Mr. Ernst most likely had a heart attack before succumbing to the arrhythmia that ultimately caused his death. Merck, which lost a bid to block the jury from seeing the video, argues there is no connection between Vioxx and arrhythmia but does recognize the risk of heart attack and stroke.
August 4, 2005 -- Merck opens defense in Texas trial.
August 17, 2005 -- Lawyers deliver closing arguments in the Texas case and the judge instructs the jury to decide whether a "preponderance of the evidence" shows that Vioxx was a cause in Mr. Ernst's death.
August 19, 2005 -- Jurors find Merck liable in the death of Robert Ernst.
Source: WSJ research• Return to main article.1
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