Merck to pay $4.9 billion to end Vioxx claims
pharmafile | November 15, 2007 | News story | Sales and Marketing |Â Â Vioxx, safetyÂ
Merck looks set to pay $4.9 billion in a settlement for the thousands of people claiming injury after taking its painkiller Vioxx.
The massive deal is intended to bring to an end more than three years of litigation claims relating to the drug, although the terms of the deal mean Merck is not admitting fault.
Vioxx was withdrawn in 2004 after clinical trial data confirmed it raised the risk of heart attacks and strokes. Subsequent cases went to court in the US, with some judges finding against the company, and others concluding there was not sufficient evidence to do so.
Observers say the deal is a good one for Merck, helping it to cap its costs and draw a line under lawsuits that threatened to drag on for years.
Merck has set aside $1.9 billion in each of the last three years since Vioxx was withdrawn, giving it a reserve of $850 million beyond the settlement to deal with any further claims.
The deal divides $4.85 billion among the plaintiffs depending on the severity of their injuries, and will only apply to claims that have already been filed.
To qualify for the compensation, claimants must provide evidence that they received at least 30 Vioxx pills, proof of their injury (a myocardial infarction or ischemic stroke), and further confirmation that the drug had been taken at least 14 days prior to the injury.
Russ Herman, the lawyer representing US claimants against Merck, welcomed the settlement deal, and acknowledged that proving Vioxx was to blame for heart attacks and strokes had been difficult.
"Specific causation has been a very difficult issue. This is an opportunity to end a long and difficult litigation that has stretched on for more than three years. A fair resolution is in everybody's best interest," he said.
At least 85% of the claimants must agree to the proposal before Merck pays out anything, and the company still reserves the right to cancel it at any time.
Merck's billion dollar settlement is still dwarfed by the compensation payments Wyeth was forced to pay to people who had used the diet pill combination 'fen-phen'.
Wyeth's Pondimin (fenfluramine) and Redux (dexfenfluramine) – the 'fen's in the combination – were withdrawn in 1997 and the ensuing stream of claims forced the company to set aside $20 billion in compensation.
Vioxx's long term impact
Vioxx was one of the biggest selling drugs in the world when it was withdrawn from the market, earning Merck $2.5 billion a year.
Three years on it is clear the controversy has made the FDA much more cautious in its approach to safety. So far this year the US regulator has rejected more new drugs than ever before, fearful they would demonstrate safety problems once on the market.
Many in the industry feel that the FDA has become too conservative in its safety assessments, and say its change in attitude could stifle innovation and deny patients access to new treatments.
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