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New York Sues Vioxx Maker over Drug’s Risks

Suit charges taxpayers were defrauded and endangered by Merck

September 20, 2007

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New York Attorney General Andrew M. Cuomo and New York City Mayor Michael Bloomberg have filed a joint lawsuit against the maker of Vioxx for allegedly misrepresenting the dangers the drug posed to its users.

The lawsuit seeks damages and civil penalties in addition to restitution for tens of millions of taxpayer dollars spent on Vioxx prescriptions, and marks the first time the state and city have brought a joint action to fight Medicaid fraud.

The civil suit accuses Merck & Co., Inc. of deliberately suppressing and concealing information about the seriousness of the cardiovascular risks associated with Vioxx. The suit claims many of those prescriptions would never have been written had doctors been properly informed.

“Merck's irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars. As alleged in the complaint, even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else and put thousands at risk by continuing to push Vioxx inappropriately on doctors and patients,” Cuomo said.

“New Yorkers were put at risk, and taxpayers were stuck with the bill and that's unacceptable,” said Bloomberg. “Drug companies are on notice that engaging in this type of behavior just isn't worth it.”

Approved to treat the symptoms of osteoarthritis, dysmenorrhea, rheumatoid arthritis, migraine headaches and juvenile rheumatoid arthritis, Vioxx quickly began to demonstrate adverse effects including increased incidence of heart attacks and strokes among its users.

In fact, the suit alleges, Merck's own research found that patients who took Vioxx had five times the risk of having a heart attack compared to those taking naproxen, a similar drug.

Further, the suit charges that court documents show Merck researchers discussed tailoring clinical trials of Vioxx to minimize negative outcomes. Internal emails proposed allowing test subjects to take aspirin during trials to prevent heart attacks, and suggested "excluding high-risk CV (i.e., cardiovascular) patients" from an initial study.

A later independent study corroborated these initial findings, estimating that Vioxx had contributed to 27,785 heart attacks and sudden cardiac deaths among Americans who had taken the drug between 1999 and 2003, Cuomo said.

Nevertheless, Merck significantly ramped up its marketing operation in anticipation of Vioxx entering the market. In 1998, Merck added 700 representatives to its national sales force, engaging 3,000 in marketing the drug directly to doctors. According to the suit, these marketers were given explicit instructions on downplaying or distorting data when questioned about Vioxx's cardiovascular risks.

At the same time, Merck waged an aggressive direct-to-consumer advertising campaign that the suit says likewise misrepresented the safety of Vioxx.

As a result, Merck is accused of having caused New York doctors to prescribe Vioxx to patients whose cardiovascular conditions made them especially susceptible to the drug's negative effects. Had the doctors been adequately informed, the suit alleges, they would not have prescribed Vioxx.

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