But drug firm maintains it was not at fault over arthritis drug.
Three years after it pulled its blockbuster painkiller Vioxx from the market, Merck has agreed to pay $4.85 billion to settle nearly 27,000 lawsuits that claim the arthritis drug caused heart attacks and strokes.
The settlement, although specifying that Merck "does not admit causation or fault", is in effect the legal expression of an admission by the company of a medical problem when it withdrew the $2.5-billion-a-year drug in September 2004 after five years on the market. It was prompted to do so when patients taking Vioxx in a Merck-sponsored clinical trial showed a doubled risk of heart attack and stroke (R. Bresalier et al. N. Engl. J. Med. 352, 1092-1102; 2005). At the time, the company promised to fight in court every lawsuit brought against it.
The settlement agreed on 9 November is a qualified positive for Merck. The New Jersey company's Vioxx liability was initially pegged by Wall Street at tens of billions of dollars. What's more, the deal will go ahead if only 85% of eligible claimants agree to it, lowering the risk that thousands of cases will continue to drag on in court.
Both sides claim victory. Plaintiffs' attorney Mark Lanier of the Lanier Law Firm in Houston, Texas, applauded the deal as "a huge opportunity for those who have been hurt by the drug to receive a fair settlement" and said he would counsel the 1,006 plaintiffs he represents to accept it.
Merck does not admit causation or fault.
Bruce Kuhlik, Merck's general counsel, called the settlement "a product of the success that we've had in the litigation so far".
Despite a stunning $253-million judgment against Merck in the first Vioxx trial (see Nature 436, 1070; 2005) ? later reduced to around $26 million under Texas damage law - Merck has won 11 Vioxx cases so far, whereas plaintiffs have prevailed in only 5.
Those numbers reflect the difficulty of proving causation in individual cases, regardless of the soundness of aggregate findings from large randomized clinical trials, when a drug's adverse effects ? and the risk factors that can lead to them ? are broadly and independently prevalent in the population. That helped defence lawyers persuade juries that Vioxx wasn't at fault in the heart attacks suffered by plaintiffs such as Elaine Doherty, an overweight 68-year-old with diabetes and high blood pressure.
"What was so clever about the defence strategy is that they argued it at the individual level. It certainly drove down the estimates of how much this was going to cost them," says Garret FitzGerald, chair of pharmacology at the University of Pennsylvania in Philadelphia, whose mechanistic studies in humans and mice first pointed to the cardiovascular risks of Vioxx and other drugs in its class.
The Vioxx cases are in stark contrast to the lawsuits brought by people who took Fen-Phen, a popular diet-drug combination withdrawn in 1997. The signature, and relatively uncommon, heart-valve damage caused in those cases left drug-maker Wyeth liable for damages of more than $21 billion.
Indeed, for scientists and clinicians, the main message of the settlement may be that reliable, personalized lawsuit victories remain as elusive as personalized medicine itself, and for many similar reasons.
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Wadman, M. Merck settles Vioxx lawsuits for $4.85 billion. Nature (2007). https://doi.org/10.1038/450324b