Merck and partner Schering-Plough face an investigation by the U.S. Department of Justice and an increasing number of lawsuits over their marketing of cholesterol drug Vytorin, according to a filing to the Securities and Exchange Commission on Monday, the AP/Miami Herald reports. Merck and Schering, after being pressured by congressional investigators, in January released results of a "long-delayed" study that found Vytorin was no more effective than the generic cholesterol drug Zocor, which costs one-third as much. The findings resulted in investigations by the Senate Finance Committee and the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations regarding whether the companies deliberately delayed the results to maintain sales of Vytorin and Zetia.
In the filing, Merck said it was notified by DOJ's Civil Division in September that the company is under investigation over whether its promotion of Vytorin made false claims to federal health care programs, which could result in such programs seeking reimbursement for money spent on the drug (Johnson, AP/Miami Herald, 11/4). According to the Wall Street Journal's "Health Blog," DOJ is looking into whether Merck and Schering violated the False Claims Act, alleging that Medicare and Medicaid purchased Vytorin under false pretenses (Rubenstein, "Health Blog," Wall Street Journal, 11/4). Skip Irvine, a spokesperson for Merck and Schering, said the companies are cooperating with information requests from DOJ. In addition, Merck reported that 35 state attorneys general are jointly investigating whether Merck and Schering violated state consumer protection laws while promoting Vytorin.
According to the AP/Herald, the filing stated that Merck since January has been served with or made aware of 140 civil class-action lawsuits alleging consumer fraud claims in relation to other cholesterol drugs promoted by the joint venture, some of which allege personal injuries or seek medical monitoring of people who used the drugs. Merck said it was cooperating with the investigations.
According to the AP/Herald, "repeated bad news" regarding Vytorin has caused a 15% decline in revenue since last fall, which has contributed to job reductions at both Merck and Schering (AP/Miami Herald, 11/4).
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