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94% of patients suing Merck over rofecoxib agree to company’s offer

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39513.541296.DB (Published 13 March 2008) Cite this as: BMJ 2008;336:580
  1. Fred Charatan
  1. 1Florida

    A large enough proportion of the litigants suing Merck after taking the drug rofecoxib (Vioxx) have agreed to the terms of the company’s offer to allow the settlement to go ahead.

    Eighty five per cent of claimants had to agree to the settlement to proceed, and by the beginning of this month 94% (44 000 of the 47 000) had done so. The company announced in November a settlement worth $4.85bn (£2.41bn; €3.15bn).

    The individual awards, estimated at $150 000 to $200 000 on average, will be calculated in a three step process to assess the severity of injuries. Plaintiffs must provide evidence of a heart attack or ischaemic stroke; proof that they received at least 30 rofecoxib pills; and evidence that they took at least one of the pills within 14 days of injury.

    Merck withdrew rofecoxib, which averaged $2.5bn in annual sales, in September 2004 (BMJ 2004;329:816; doi: 10.1136/bmj.329.7470.816-a). Clinical studies showed that rofecoxib more than doubled the risk of heart attack and stroke among patients who often used it as an analgesic for joint pain in arthritis.

    Since the drug was withdrawn Merck has faced about 26 000 lawsuits involving 47 000 people. At first Merck planned to fight every lawsuit, setting aside $1.9bn for legal expenses, but last year it decided to offer a settlement.

    The company faced heavy damages after one of the first cases in 2005. The widow of a man in Texas who died after taking rofecoxib won a $234.5m settlement (BMJ 2005;331:471; doi: 10.1136/bmj.331.7515.471). Texan laws on punitive damages reduced that amount to $26.1m, and the case is still under appeal. Of the 20 cases tried since the Texas victory 15 ended either in a win for Merck or a hung jury.

    Despite winning these individual cases, Merck agreed a settlement in November to stop further hearings. Ken Frazier, executive vice president of Merck, said at the time, “Without this settlement the litigation might very well stretch on for years” (BMJ 2007;335:1011; doi: 10.1136/bmj.39398.517176.DB).

    Sidney Wolfe, director of the Washington watchdog Public Citizen’s Health Research Group, was critical of Merck’s settlement when it was first announced in November 2007. He said, “Given what Merck knew, how it misled doctors and others, I don’t think this company has been adequately punished for what it did.”

    Future plaintiffs will have to bring their cases to federal courts, in the light of the US Supreme Court decision to bar tort cases that involve medical devices, and probably prescription drugs, in state courts (BMJ 2008;336:470; doi: 10.1136/bmj.39503.345694.DB).

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