The U.S. Department of Justice has launched an investigation of drug maker Merck and its partner, Schering-Plough, concerning the companies’ marketing of the cholesterol drug Vytorin. The investigation comes after congressional investigators pressured Merck and Schering into finally releasing results of a study finding that Vytorin was no more effective in treating cholesterol than the generic drug Zocor, which is a third of the cost. The Senate began investigating whether the study results were intentionally delayed so that Merck and Schering could maintain sales of Vytorin and Zetia.
Now DOJ has joined the fray. According to Merck, the DOJ’s Civil Division notified the company in September that DOJ is looking into whether Merck made false claims to federal health care programs when it promoted Vytorin. The claims could have prompted such health care programs to ask for reimbursement for money spent on the cholesterol drug. DOJ is also investigating whether Merck and Schering violated the False Claims Act, given that Medicare and Medicaid may have purchased Vytorin under false pretenses. Indeed, 35 state attorneys general have similarly banded together to determine whether Merck and Schering violated state consumer protection laws in the marketing of Vytorin.
Since the start of the year, Merck has been served with or learned of 140 civil class action lawsuits regarding other cholesterol drugs made by Merck and Schering. These suits seek compensation for personal injuries suffered by or for medical monitoring required for people who used the cholesterol drugs.
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