Attorney General Gansler Enters into Consent Decree with Merck Resolving an Investigation into the Marketing of Vioxx; Judgment Requires Merck to Improve its Disclosure of Potentially Dangerous Side Effects
BALTIMORE (May 21, 2008) - Attorney General Gansler's Consumer Protection Division yesterday filed a Complaint in the Circuit Court for Baltimore City, as well as a Final Judgment and Consent Decree with Merck & Company, Inc. that resolves an investigation by 30 states concerning Merck's deceptive promotion of the drug Vioxx. The Complaint filed by Attorney General Gansler alleged that Merck violated the Consumer Protection Act by failing to inform consumers that the use of Vioxx could cause serious cardiovascular side effects. Merck denied that allegation.
Attorney General Gansler alleged that Merck engaged in deceptive "direct-to-consumer" ("DTC") advertising that misrepresented Vioxx's cardiovascular risks. Today's Consent Decree requires Merck to seek Food and Drug Administration (FDA) approval of all of its DTC television drug advertisements and to wait for approval and comply with FDA comments before running the advertisements. Merck also must comply with any request by the FDA to delay DTC advertising for any new, Merck pain-relieving drugs.
The Consent Decree also addresses:
-- Merck's use of scientific data when marketing drugs to doctors;
-- Merck's "ghost writing" of articles and studies that purportedly were written by independent researchers;
-- Merck's disclosure of conflicts of interest when its paid promotional speakers present information in supposedly "independent" Continuing Medical Education; and,
-- Conflicts of interest in Merck sponsored Data Safety Monitoring Boards.
"Consumers have a right to know about the side effects that their medications can cause," said Attorney General Gansler. "This judgment will help ensure that Merck provides that information to consumers in the future."
Source: Maryland Attorney General Gansler