Merck & Co., manufacturer of the painkiller Vioxx, said Friday November 9th that it will pay $4.85 billion to end thousands of state and federal lawsuits over its painkiller Vioxx in one of the largest drug settlements ever.
Vioxx was developed to treat arthritis, but was pulled from the market on September 30, 2004 after its researchers determined that continued use of the product doubled risk of heart attacks and strokes. At the time that the medication was recalled, Merck & Co. was pulling in about $2.5 billion a year in sales of the drug. To qualify for a settlement, plaintiffs must have filed claims by a certain date and meet several criteria, including medical proof that they suffered a heart attack or stroke, that they received at least 30 Vioxx pills and that they received enough pills to support a presumption that they were ingested within two weeks before injury.
Company officials stressed that the agreement is not a class action settlement and that it is not admitting fault. They estimated the deal, if accepted, would end 45,000 to 50,000 personal injury lawsuits involving U.S. Vioxx users who suffered a heart attack or ischemic stroke, the type in which blood flow to the brain is blocked.
The agreement becomes binding only if 85 percent of the plaintiffs in key categories agree to the deal: all pending heart attack and ischemic stroke cases, all cases involving deaths and all cases alleging more than 12 months of Vioxx use. Potential claimants will have to have prior medical documentation of a heart attack or stroke, and they will not be able to later opt out of the settlement. Also, all law firms involved in the “steering committees” directing pretrial discovery and other coordination of both state and federal cases must get every one of their clients to settle.
The numbers involved in this settlement are staggering. While $4.85 Billion may seem like an astronomical number, it is interesting to note that upon announcement of the terms of the agreement, Merck & Co. stock went up 2 percent, to $55.90 – trading near their 52 week high of $58.36. The Food and Drug Administration approved Vioxx in 1999, and in the years following its release, the drug was used by over 84 million people around the world. Although studies conducted around the time that the drug was approved for distribution showed that there were hypertension related side effects associated with Vioxx, the drug was made available across the globe.