• 28
  • November
    2011

Last week, the U.S. Department of Justice announced that pharmaceutical giant Merck agreed to pay $950 million after pleading guilty to criminal charges connected to illegal marketing and sales of Vioxx. According to the Boston Globe, the settlement agreement includes resolution of civil cases as well.

The specific offense Merck plead guilty to illegally introducing a drug into interstate commerce. That charge stemmed from Merck's marketing of Vioxx for the treatment of rheumatoid arthritis prior to receiving FDA approval for that purpose.

As sources point out, while physicians are free to prescribe drugs for any fitting purpose, pharmaceutical companies must not market drugs for any uses outside those approved by the FDA.

Vioxx, which was approved by the Food and Drug Administration in 1999, was removed from the market in 2004 after evidence began to show it placed patients at increased risk for heart conditions, including heart attack, stroke and death. By that time, Merck had been marketed in over 80 countries. The FDA, according to sources, had approved Vioxx for treatment of rheumatoid arthritis in 2002.

As part of the agreement, Merck will be paying a $321 million criminal fine, and another $628 to federal and state Medicaid agencies. The Medicaid program for the state of Massachusetts will be receiving almost $10 million of that money.

In addition to the criminal fines, investors are suing Merck for losses brought on by Merck's understating of risks associated with Vioxx.

The settlement against Merck was reportedly the latest in a series of cases in which federal and state prosecutors have accused pharmaceutical companies of engaging in fraud.

Source: Boston Globe, "Merck to pay $950 million over Vioxx drug," Duff Wilson, November 23, 2011