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 (FDA) 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.
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.
The Vioxx recall spawned thousands of product liability lawsuits. In 2007, Merck agreed to settle most of those Vioxx claims for $4.85 billion.
Serious questions continue to be raised about the way Vioxx was marketed. For instance, last April an analysis of court documents uncovered in the course of Vioxx injury lawsuits found that Merck & Co. employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies. According to the analysis, which was published in the Journal of the American Medical Association, Merck’s involvement in producing the data wasn’t disclosed in many cases.
According to the Associated Press, Merck revealed yesterday that it had received a letter from the U.S. Attorney in Massachusetts notifying the company it is “a target” of a grand jury investigation involving the painkiller Vioxx. Merck has previously disclosed the investigation, which the company said has been ongoing since 2004, the Associated Press said.
The company said it “has responded and is continuing to respond to requests from the U.S. Attorney’s Office for documents and information in connection with the ongoing investigation. The investigation also includes subpoenas for witnesses to appear before a grand jury, Reuters said.