More Vioxx troubles for Merck. 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 pulled off the market in 2004, after it was linked to an increase of risk suddden cardiac deaths, and thousands of oroduct liability lawsuits. In November 2007, Merck announced a proposed $4.85 billion settlement with thousands of Vioxx plaintiffs, and by a January 2008 deadline, 95 percent of those eligible had registered for the settlement.
But today’s reports of a grand jury Vioxx investigation mean that Merck’s Vioxx problems are far from over. According to The Wall Street Journal, on February 2007, Merck disclosed in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company’s research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes. Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.
One lawyer representing Vioxx patients told the Journal that the possibility of a grand jury indictment would give Merck added incentive to resolve Vioxx personal injury suits. However, this lawyer also said that potential of an indictment probably won’t change too many people’s minds about whether to enter the proposed settlement.
The federal government has gone after other drug makers for promoting off-label uses of drugs. According to the Wall Street Journal, Justice Department probes into drug marketing have resulted in settlements of $875 million with TAP Pharmaceuticals in 2001 and $355 million with AstraZeneca in 2003. Eli Lilly & Co. is negotiating with federal investigators regarding its marketing of antipsychotic drug Zyprexa. A report yesterday indicated that Eli Lilly could pay a fine in excess of $1 billion to settle those charges.
According to a Food & Drug Administration (FDA) study, it is estimated that Vioxx 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.
