Just as Vioxx maker Merck gets closer to settling thousands of lawsuits against the defective pain reliever, reports have surfaced that a grand jury is investigating the company over the way it marketed Vioxx. According to the Wall Street Journal, the health-care-fraud unit of the U.S. Attorney’s Office for the District of Massachusetts is investigating whether Merck promoted Vioxx to health-care professionals for uses other than those approved by government regulators, a practice known as off-label marketing.

Vioxx was removed from the market in 2004, after a Food & Drug Administration (FDA) study estimated that the defective drug could have contributed to 27,785 heart attacks and sudden cardiac deaths between 1999 and 2003. After Vioxx was pulled from the market in 2004, it was revealed that the FDA had tried to silence the drug expert who headed that study. Dr. David Graham, associate director for science in the FDA Drug Center’s Office of Drug Safety, told Senate investigators that he had been subjected to veiled threats and intimidation when he informed the FDA of his findings. (more…)

Vioxx plaintiffs in Florida are petitioning a federal court to expand Merck’s proposed $4.85 billion settlement to include those who did not file suit against the company by Nov. 9, 2007.  But many lawyers involved in the Vioxx settlement oppose the petition, fearing that adding more plaintiffs to the Vioxx settlement would lessen the awards each eligible participant would receive.  However, if the situation is not resolved, Vioxx patients who did not file suit against Merck by the November 9 deadline could still bring their own lawsuits.  But that means Merck’s Vioxx troubles – which the $4.85 billion settlement was supposed to resolve – would be far from over.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. (more…)

Vioxx maker Merck will spend $4.85 billion to settle a significant number of lawsuits filed against it for injuries caused by the painkiller. Under the agreement, which was announced late yesterday, Merck will set up two separate settlement funds to cover heart attack and stroke claims filed over Vioxx. The development is a surprising one, considering that until very recently Merck had vowed to fight every one of the 27,000 cases filed against Vioxx individually.

In order to be eligible for the settlement, Vioxx claimants will have to enter into a resolution process. Merck will set up a $4 billion fund for people who claim they suffered heart attacks as a result of Vioxx, and another $850 million fund for those who suffered ischemic strokes. The settlements will be awarded on an individual bases, and the amount of money each plaintiff ultimately receives will vary. Merck said that at this time, it has not determined how many former Vioxx users might be covered by the agreement.

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