The litigation over injury claims from withdrawn painkiller Vioxx enters a critical new phase today, as manufacturer Merck faces its first trial in federal court.

Overall, the federal trial beginning in Houston marks round three between the US drugmaker and thousands of plaintiffs suing it for fraud and negligence.

The first two high-profile Vioxx trials were in state courts – in August the plaintiffs won in Texas, and Merck won early this month in New Jersey. About 45 per cent of the current tally of 6,400 outstanding lawsuits against Merck have been consolidated in federal court, and about 43 per cent will be in state court in New Jersey, before an Atlantic City judge.

These two large chunks of litigation represent enormous opportunities for plaintiffs and their attorneys. A string of victories could prompt the judges to put pressure on Merck to reach some larger settlement, which could snowball into billions of dollars.

Yet the federal cases, all overseen by one judge, have an added importance. Federal court rules and the judge’s experience of pharma mass tort cases are expected to bring a consistency to the array of litigation so far.

Presiding US Judge Eldon Fallon has heard litigation including the long-running litigation claiming that Johnson & Johnson’s ulcer medicine Propulsid caused heart damage.

The first of at least four federal cases to be tried through the course of next year involves widow Evelyn Irvin Plunkett, who is claiming Vioxx triggered her husband’s fatal heart attack in 2001. Her lawsuit alleges that Dicky Irvin died of a heart attack on May 15 2001, because he took Vioxx for one month.

It accuses Merck of fraud and negligence for downplaying Vioxx’s heart risks and selling a drug that can trigger heart attacks.

One of its claims is that Merck “concealed from the public its internal analysis” that its pivotal study – Approve – showed that Vioxx caused heart attacks and strokes no matter how long patients took it for. The suit says the Approve study, when published, excluded this analysis.

Merck withdrew Vioxx from the market last year, saying Approve showed an increase in cardiovascular risks but only after at least 18 months of continuous use.

Merck argues that it always acted ethically; it tested Vioxx sufficiently in trials; and short-term use of Vioxx – in particular, for a month – cannot cause heart problems.

It says Mr Irvin died aged 53 because of hardening of his arteries.

Kenneth Frazier, general counsel for Merck, says: “Mr Irvin would have suffered a heart attack when he did, whether he was taking Vioxx or not.” But lawyers for Mr Irvin’s widow answer that Merck was misleading that Vioxx is safe in short-term use.

Andy Birchfield, attorney at Beasley Allen, says: ”(Merck’s argument) is absolutely nothing more than a myth. “What happened to Dicky Irvin is exactly what Merck’s scientists (years ago) said would happen.”

Merck is now also aggressively challenging the credibility of plaintiffs. “We know their strategy now,” says Jere Beasley, another lawyer for Mr Irvin’s widow. “They very successfully attacked the plaintiff in New Jersey, and they did it with a vengeance.”

Merck is represented this time by Philip Beck, a defense lawyer who won key Baycol cases for German drugmaker Bayer. The company has vowed to fight each case for as long as they take.

James Dorr, mass tort expert and defense attorney at Wildman Harrold, says that early efforts to settle can add fuel to a fire. “You end up with a large amount of fraudulent claims – people jumping on to the bandwagon.

“The experience that many companies have had is: unless you can really clearly determine that you have put all claims to bed, it is usually better to fight the litigation (in trials).”

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