Mistrial in Texas Vioxx case

Merck has expressed its disappointment in a federal court jury in Houston, Texas, US, that failed to return a verdict in the Plunkett v. Merck case concerning Vioxx's relation to a man's fatal heart attack.

The company, who voluntarily withdrew Vioxx in September 2004 following clinical trial data which revealed an increased relative risk of heart attack and stroke, has stated that if a retrial becomes necessary it will be 'right back with the same facts'.

'We presented evidence that there is no medical or scientific evidence showing short-term use of Vioxx increases the risk of heart attack and no evidence that it contributed in any way to the unfortunate death of Richard Irvin,' said Philip Beck, of the law firm of Bartlit Beck, Merck's lead trial lawyer in the case. 'Mr. Irvin only took Vioxx for less than a month. He suffered multiple long-standing risk factors for a heart attack, including partially clogged arteries, and we believe that he would have suffered a heart attack when he did, whether he was taking Vioxx or not.'

The mistrial comes hot on the heels of allegations from the New England Journal of Medicine that the authors of the VIGOR (Vioxx Gastrointestinal Outcomes Research) study, published in the NEJM on 23 November 2000, deliberately concealed data revealing three additional myocardial infarctions (heart attacks) in the study group as a result of treatment.

The lawsuit, originally filed in Palm Beach County, Florida in May 2003 by Mr. Irvin's surviving spouse, Evelyn Irvin Plunkett, is just one of up to 6,000 that the company is facing up to. Refiled in the federal Multidistrict Litigation (MDL) in New Orleans but tried in Houston because of the effects of Hurricane Katrina, the Judge presiding over the MDL has said he plans to schedule three additional trials on a monthly basis, starting in February 2006.

'The Vioxx litigation will go on for years,' said Kenneth C. Frazier, senior vice president and general counsel of Merck. 'We have the resources and the resolve to address these cases, one by one, in a reasonable and responsible manner.'

Merck was found liable in the first Vioxx case to go to trial and was ordered pay damages of $253m to the widow of a 59-year-old user. While it is appealing that decision, it recently won a case in which Frederick Humeston, from Boise, Idaho, alleged that he suffered a heart attack at the age of 56 as a result of intermittent use of Vioxx over a two-month period. The company was ruled to have provided adequate warning to doctors about health risks associated with Vioxx; to not have committed consumer fraud in marketing the drug; and to not have misrepresented, suppressed or concealed information about increased risks of heart attack and stroke.