DALLAS – Texas Attorney General Greg Abbott today reached a $58 million settlement with Merck & Co. Inc. The settlement resolves a three-year investigation by Texas and 29 other states, which charged the company with unlawfully marketing the former prescription drug Vioxx. Texas’ portion of the global agreed judgment will exceed $4 million.
The multi-state investigation revealed that Merck improperly marketed and promoted Vioxx, a “Cox 2-inhibitor” drug. The states charged Merck with marketing Vioxx as a pain killer, despite its knowledge that Vioxx carried major health risks. The company finally pulled the drug from the market in 2004 after Vioxx-related health risks were made public.
Today’s settlement establishes several safeguards that will change Merck’s marketing and promotional practices. Merck must now submit all television advertising to the U.S. Food and Drug Administration (FDA) for review and pre-clearance. Any FDA comments about the proposed drug commercials must be considered by Merck before the commercials are aired publicly. Under the agreement, the FDA can delay the launch of Merck’s pain killer product commercials if the federal regulatory agency needs additional time to complete its review.
The settlement prohibits Merck from presenting misleading scientific data to physicians, and bars the manufacturer from using pro-Merck “ghost writers” to author articles and medical studies. Merck is also prohibited from using “promotional speakers” at continuing medical education events if the speakers’ relationship with the company presents a conflict of interest.
The state of Texas has an active Vioxx-related case in Travis County District Court. In that 2005 case, the Attorney General charged Merck with suppressing critical information to physicians, patients and the Texas Medicaid program. According to court documents filed by the state, Merck failed to disclose the health risks associated with Vioxx. During the time period covered by the state’s enforcement action, Texas spent more than $72 million on Vioxx prescriptions for Medicaid recipients.