Legal News

Big Pharma?s Latest Tab: $41.5 Million to Settle Vytorin, Zetia Suits

By Ashby Jones

It’s a far cry from the nearly $5 billion Merck & Co. agreed to cough up to settle the Vioxx product-liability litigation, but it’s a sizable payout nonetheless.

Merck and Schering-Plough, which are in the midst of closing a deal to merge the two companies, have agreed to pay $41.5 million to settle lawsuits accusing the companies of marketing their cholesterol drugs in a misleading fashion and failing to disclose the results of a negative clinical study in a timely manner. Click here and here for the WSJ and NYT articles, respectively.

The settlement relates to the jointly marketed cholesterol drugs, Vytorin and Zetia, and resolves more than 140 claims pending in federal court in New Jersey filed by consumers and insurers who bought, used or paid money toward the purchase of Vytorin and Zetia. A U.S. Department of Justice investigation is still pending, as are lawsuits alleging securities-law violations.

Vytorin is a single-pill combination of two drugs: Zetia and simvastatin. In early 2008, Merck and Schering-Plough released a study, titled “Enhance,” that showed that Vytorin was no better than simvastatin alone at mitigating thickening of the arteries, despite producing a greater drop in bad cholesterol levels.

The study cast doubt on the drugs’ efficacy and triggered a drop in sales of both drugs, while a subsequent study raised new safety concerns about the drugs. Merck and Schering-Plough have defended the drugs’ efficacy and safety.

In addition, Merck and Schering waited nearly two years after Enhance was completed to release the results, which led to accusations that the companies purposely delayed the release because they knew the study was negative and would hurt sales.

Full post as published by Law Blog - WSJ.com on August 06, 2009 (boomark / email).