Attorney General Martha Coakley Files Judgment Against Merck Pharmaceutical For The Company's Deceptive Marketing Of Vioxx

Main Category: Litigation / Medical Malpractice
Also Included In: Arthritis / Rheumatology;  Pharma Industry / Biotech Industry
Article Date: 21 May 2008 - 4:00 PDT

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Attorney General Coakley's Office filed a settlement with New Jersey-based drug manufacturer Merck and Company, Inc.(Merck) resolving concerns about the company's deceptive advertising and promotion of the "Cox-2" inhibitor drug Vioxx which is a non-steroidal anti-inflammatory drug used to treat arthritis. The complaint, filed today in Suffolk Superior Court, alleges that Merck failed to disclose to consumers that Vioxx posed an increased risk of heart attack. The consent judgment, also filed today in Suffolk Superior Court will prohibit Merck from misleading consumers in advertising for any Merck product and requires full disclosure of all known risks of Merck drugs. Additionally, Merck will make a $58 million payment to the participating states. Massachusetts will receive $1.64 million of the payment of which $500,000 will go to the Attorney General's Local Consumer Aid Fund, $144,654 will go to costs and attorneys fees and $1 million will be put into a special fund to benefit low income, disabled or elderly consumers of prescription medications or to educate consumers concerning the cost differences among medications. The payment to the states is the largest consumer protection settlement to date concerning deceptive marketing and promotion of a prescription drug.

"While we are pleased with this monetary payment by Merck, it is the comprehensive injunctive relief that will ensure that Merck does not again mislead consumers about the benefits and risks of its drugs when it engages in aggressive ad campaigns," said Attorney General Coakley. "This settlement protects consumers against deceptive advertising and provides consumers with adequate disclosures regarding the health risks associated with any Merck products."

The complaint alleges that Merck began marketing Vioxx in May 1999 with an aggressive and deceptive promotional campaign directed at both consumers and at health care professionals. When promoting Vioxx directly to these two groups, Merck allegedly misrepresented the cardiovascular safety of the drug. The complaint further alleges that in September 2004, Merck finally admitted that Vioxx caused serious cardiovascular events and withdrew the drug from the market. However, for the entire period the drug was on the market, Merck's advertisements and promotional activities misrepresented Vioxx's cardiovascular safety. When the multistate group began its investigation into Merck in December 2005, it uncovered that in addition to the deceptive direct to consumer advertising, Merck also planted positive articles and studies, otherwise known as "ghostwriting" in the Journal of American Medical Association. Today's judgment puts in place many stipulations for Merck should they wish to present information to media outlets about Clinical Studies attesting to the safety of a Merck product.

Today's judgment requires Merck to submit all "direct to consumer" (DTC) television drug advertisements to the Food and Drug Administration (FDA) and then to wait for approval and comply with FDA comments before running the advertisements. Merck must also comply with any recommendation by the FDA to delay DTC advertising for new Merck pain relieving drugs. Attorney General Coakley's Office and the other states had expressed concerns regarding the negative effect of DTC advertising that commences immediately with the release of a new drug before doctors have a chance to gain experience with the drug and understand its potential side effects. Merck heavily promoted Vioxx in DTC television and print ads from the time of the drug's launch. Merck eventually acknowledged the significant risk of heart attacks associated with Vioxx, a fact not disclosed in Merck's promotions.

"Merck's aggressive advertising of Vioxx drove hundreds of thousands of consumers to seek prescriptions before Vioxx's risks were fully understood," said Attorney General Coakley. "As a result of this consent judgment, the State Attorneys General will be able to ensure that Merck does not circumvent the FDA process that is designed to guard against deceptive advertising."

The judgment will also protect consumers by prohibiting:

- deceptive use of scientific data when marketing to doctors;
- "ghost writing" of articles and studies;
- failure to adequately disclose the conflict of interest of Merck promotional speakers when these speakers present in supposedly "independent" Continuing Medical Education; and
- conflicts of interest in Merck sponsored Data Safety Monitoring Boards.

Joining Massachusetts in today's settlement are: Arizona, Arkansas, California, Connecticut, Florida, District of Columbia, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Michigan, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Vermont, Washington, and Wisconsin.

Assistant Attorney General April English of Attorney General Coakley's Consumer Protection Division handled this matter.

http://www.mass.gov/ago

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