Vytorin makers Merck and Schering-Plough are facing yet another lawsuit, this time from the plaintiffs in Nevada. The Nevada Vytorin consumer fraud lawsuit alleges that Merck and Schering-Plough deceived heart patients in that state by leading them to believe that Vytorin was more effective than a cheaper generic statin. The makers of the beleaguered cholesterol drug face similar lawsuits in several states, including California, Florida, New York and Ohio.
Merck and Schering-Plough’s Vytorin troubles started on Jan. 14, when the companies released the long-awaited results of the ENHANCE study. The point of the ENHANCE study was to determine how well Vytorin prevented clogged arteries by reducing the formation of plaque. ENHANCE focused on a group of 720 patients with a rare condition predisposing them to high cholesterol. The patients were given either Vytorin or a high dose of simvastatin, the generic form of Zocor.
Vytorin did not provide any significant benefit versus the statin drug Zocor in slowing down clogging of the arteries. Overall, the study failed to meet its primary goal, which was to show whether Vytorin was more effective than Zocor alone in preventing progression of atherosclerosis in the carotid artery, which is in the neck. What’s worse, instead of clearing plaque from artery walls, Vytorin appears to have led to, or at least allowed, a thickening of that plaque.
Such plaque buildup is a major risk factor for heart attacks and stroke. Many doctors had been prescribing Vytorin on the theory that the drug would reduce this risk in people with high cholesterol. The ENHANCE study is a serious blow to this theory.
Even though ENHANCE was finished in April 2006, Merck and Schering-Plough did not register ENHANCE with the Clinical Trials Database until October 2007 – and even then they did not register the results. In fact, Merck and Schering-Plough delayed releasing the ENHANCE results twice, and the data was only made public in early January. At one point, the companies even tried to change the study’s endpoint – the main medical result it was supposed to measure. But a public outcry and a congressional investigation kept that from happening.
Lawyers involved in the Nevada Vytorin lawsuit assert that the nearly two year delay in releasing ENHANCE constitutes fraud, as do the lawsuits filed in other states. Many of the Vytorin lawsuits seek to recoup the difference in cost between generic cholesterol drugs that cost about one-third as much as Vytorin.
Unfortunately for Merck and Schering-Plough, plaintiffs’ attorneys are not the only ones looking into the Vytorin debacle. Several state attorneys general have started their own probes that could eventually lead to civil and/or criminal penalties. Last week, the Connecticut Attorney General’s Office announced it was investigating Merck and Schering-Plough to see if “state funds were spent on false assurances about the safety and effectiveness of” Vytorin and Zetia. New York Attorney General Andrew Cuomo wants to know if Merck and Schering-Plough purposely withheld the results of ENHANCE in an effort to protect sales of Vytorin. Cuomo has also questioned the timing of stock sales made by company executives prior to the release of ENHANCE. Vytorin is also the subject of several investigations in the US Congress.
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