The suit alleges that in May of 1999, Merck began an aggressive and deceptive promotional campaign of Vioxx directed at both consumers and health care professionals. When Merck announced, in a press release, that the Food and Drug Administration (FDA) had approved Vioxx for the relief of osteoarthritis, menstrual pain, and other forms of acute pain, it failed to mention any reference to increased risk of cardiovascular events when it listed common side effects.
Merck was aware of the potential for dangerous cardiovascular side effects, including heart attack and stroke, associated with Vioxx through internal studies, including Study 090, which was conducted in 1998. The results of Study 090 were not disclosed to the FDA or the public at the time Vioxx was introduced to the public.
“Consumers have a right to know all of the risks associated with the prescription drugs they take,” said General Conway “Merck relied on an aggressive marketing campaign to lure consumers into taking Vioxx and then concealed the increased health risks associated with the drug. This kind of deception puts consumers at risk and will not be tolerated in Kentucky.”
For more than five years, Merck continued to market and advertise Vioxx within the Commonwealth of Kentucky. As part of that campaign, Merck represented Vioxx as a safer alternative to traditional Non-steroidal Anti-Inflammatory Drugs (NSAIDS), such as aspirin or ibuprofen, even though the drug posed a risk of ulcers and gastrointestinal side effects, in addition to the increased risk of cardiovascular events.
General Conway’s lawsuit also accuses Merck of engaging in an elaborate scheme to create or publish scholarly articles under fake or ghost authors in order to further develop support for Vioxx. These articles appeared in medical journals and other industry publications including the Journal of the American Medical Association.
In 2004, Merck admitted that Vioxx caused serious side effects and pulled the product from the market.