Personal Injury Blog

Merck to Pay $950 Million due to Unethical Marketing Practice

November 29th, 2011
Unethical Marketing Practice

Vioxx was taken off the market in 2004, after it was linked to heart disease and risk of stroke in users

Pharmaceutical company Merck will pay $950 million due to its unethical marketing practice related to the painkiller, Vioxx.  According to the Department of Justice, Merck will pay $321.6 million in criminal fines to the agency, and will also pay $628.4 million in a civil settlement.

The settlement relates to charges that Merck made false, unproven or misleading statements about the safety of its Vioxx painkiller to increase sales.  The company was also accused of making false statements to Medicaid agencies about the safety of the painkiller.

Vioxx was taken off the market in 2004, after it was linked to heart disease and risk of stroke in users.  The company faced thousands of personal injury and wrongful death lawsuits filed by people who suffered heart disease and stroke as well as families of people who died of heart attacks from using Vioxx.  In 2007, the company settled with these plaintiffs by paying $4.85 billion.  In all, the company faced more than 50,000 Vioxx -related lawsuits.

The company insists that this settlement with the Department of Justice does not mean that the company has admitted wrongdoing in its marketing of Vioxx.  It also denies that upper level management of the company had any knowledge of the unethical marketing.

According to the Department of Justice, under the terms of the settlement, there will be increased oversight of the company.  Top officials at Merck will be required to complete annual compliance certifications.  The company will also be required to post information about physician payments on its website.  Under the terms of the settlement, the company will also plead guilty to criminal misdemeanor charges.

Vioxx was approved by the Food and Drug Administration in 1999.  However, it was not approved for the treatment of rheumatoid arthritis.  That however, did not stop Merck sales representatives from pushing for the prescription of Vioxx for the treatment of rheumatoid arthritis.  According to the Department of Justice, Merck continued to promote Vioxx for the treatment of rheumatoid arthritis for at least three years.  The company continued to promote the drug, even after it received a letter from the Food and Drug Administration warning about these practices in September 2001.  In 2002, the Food and Drug Administration finally approved the use of Vioxx for the treatment of rheumatoid arthritis.

When a drug has not been approved for a particular purpose, a company is prohibited from promoting the drug for that particular use.  Doctors are not prevented from using the drug for off-label or unapproved purposes, but companies are strictly prevented from promoting the drug for that purpose.  Unfortunately, as San Diego defective product lawyers see, this doesn’t mean that companies refrain from such unethical marketing practices.  Promotion of drugs for off-label uses is a widespread practice in the pharmaceutical industry.

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