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Merck battling more lawsuits over Vioxx

Published on 27/01/06 at 02:00pm

Merck says that it will conduct a vigorous defence in the lawsuit brought by the family of Leonel Garza, who died of a heart attack in 2001.

Lawyers for the family are arguing that Garza's heart attack was the result of a sudden reaction to Vioxx and not, as Merck contends, the result of long-term heart disease.

The case is underway in a Texas court, with a second case scheduled to begin in New Orleans in February, following a mistrial in the original litigation. Merck lost another case in Texas, but won in New Jersey. The company is facing hundreds of lawsuits from people who took the once-popular painkiller, which was removed from the market in September 2004.

Merck note that 71-year-old Garza died of a heart attack on 21 April 2001 after suffering from cardiovascular disease for 23 years and suffering a previous myocardial infarction. About a month before his death, Garza received a one-week supply of Vioxx (rofecoxib) 25mg.

"There is no reliable scientific evidence that Vioxx caused Mr Garza's heart attack," said Ted Mayer of Hughes Hubbard & Reed, outside counsel for Merck.

"At the time of Mr Garza's heart attack, he exhibited numerous major risk factors for coronary artery disease. His autopsy report lists acute myocardial infarction as the cause of his death and notes evidence of severe atherosclerotic disease in all of Mr Garza's coronary arteries. We are confident that any fair jury will find that Vioxx had nothing to do with the unfortunate passing of Mr Garza since there is no reliable scientific evidence that short-term use of Vioxx increases cardiovascular risk."

Evelyn Irvin Plunkett brought the New Orleans case following the death of her husband in 2001. He had taken Vioxx for a month before suffering a fatal heart attack. Jurors in the original trial, held in Houston, were unable to reach a verdict and the case is due to be retried starting 6 February.

Around the time the Huston jury began deliberating, The New England Journal of Medicine published an editorial concerning the VIGOR (Vioxx Gastrointestinal Outcomes Research) study, which it published in 2000. VIGOR compared gastrointestinal events in patients with rheumatoid arthritis treated with Vioxx or naproxen.

"Three myocardial infarctions, all in the rofecoxib group, were not included in the data submitted to the Journal," the editorial says. "The editors first became aware of the additional myocardial infarctions in 2001 when updated data were made public by the Food and Drug Administration."

Until the end of November last year, the Journal believed that "these were late events that were not known to the authors in time to be included in the article".

However, the editorial argues that a memorandum dated July 2005 obtained by subpoena during the litigation suggests at least two of the authors knew about the three additional myocardial infarctions at least two weeks before the authors submitted the first of two revisions and four and a half months before publication.  

The Journal also claims that other data on cardiovascular events in the memorandum would have been relevant to the paper.

Merck says that they "promptly and appropriately" disclosed the findings to the scientific and medical communities, and the press. They add the paper "fairly and accurately" reflects the results before the pre-specified cut-off date.

More positive news for Merck came in the form of the FDA announcing a new 'preemption' policy last week that, despite not having the force of law, could , according to The Washington Post weaken Vioxx lawsuits in some states. The FDA said drug manufacturers that follow the FDA's drug approval and labelling requirements should be immune from state lawsuits alleging that the company failed to warn consumers of the dangers of their drugs.

Wall Street analysts have estimated the total cost of Vioxx lawsuits could reach as high as $20 billion.

Related articles:

Merck disappointed after jury undecided in Vioxx case

Tuesday , December 13, 2005



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