Since January 2008, Merck and Co., Inc. (“Merck”) and its joint venture partner, Schering-Plough, Corp. (“Schering-Plough”) have been under investigation for their marketing of the cholesterol lowering drug Vytorin. Last week, Merck announced in its third quarter Form 10-Q that it received notice of further investigations and additional lawsuits, including an investigation by the U.S. Department of Justice (“DOJ”).
The Vytorin controversy began in December of 2007 when the U.S. House Committee on Energy and Commerce wrote letters to Merck and Schering-Plough inquiring about the ENHANCE patient study that was completed in April of 2006. When the ENHANCE study was released in January of 2008, it revealed that Vytorin (a combination of Zocor and Zetia) was no better at reducing plaque buildup than the generic cholesterol drug, Zocor, taken on its own. Zocor costs approximately one-third the price of Vytorin.
The delayed release of the ENHANCE study led to congressional investigations by the House Committee on Energy and Commerce, its Subcommittee on Oversight and Investigations, and the Ranking Minority Member of the Senate Finance Committee. These investigations sought to uncover whether Merck and Schering-Plough deliberately delayed announcing the negative results of the ENHANCE study so that sales of Vytorin would remain profitable and stock prices of the companies would remain high. Merck stated that these congressional investigators have requested (1) witness interviews; (2) documents and information related to the companies’ marketing and sale of Vytorin; (3) documents and information on the ENHANCE study, and (4) information regarding stock sales by officers of the companies.
The Oversight and Investigations subcommittee made further requests in August and September for documents and information related to SEAS, another patient study. This study shows that Vytorin does not prevent deterioration, surgery or death in patients with diseased hearts, and may even be associated with an elevated risk of cancer.
In addition to the congressional investigations, Merck announced that the DOJ, the New York Attorney General, New Jersey Attorney General, the Connecticut Attorney General, and a multi-state group of 35 State Attorneys General are investigating various aspects of the marketing of Vytorin. The Civil Division of the DOJ is investigating whether Merck’s promotion and sales of Vytorin caused false claims to be submitted to federal health-care programs. The State Attorneys General are investigating whether the companies violated state consumer protection laws by making consumers believe that Vytorin was more effective than the generic drug Zocor. Merck stated that they are working with Schering-Plough to respond to all the inquiries.
Finally, Merck announced that, since mid-January 2008, it has become aware of or been served with approximately 140 civil class action lawsuits. These suits allege common law and state consumer fraud claims in connection with the sale and promotion of Vytorin, and seek damages for personal injuries and/or seek medical monitoring.
For a copy of Merck & Co, Inc.’s Form 10-Q, please click here.