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New Haven to Sue Merck and Schering-Plough

Oct 16, 2008 | Parker Waichman LLP

The city of New Haven, Connecticut, is reporting that over $400,000 in tax dollars were spent on Vytorin and Zetia for employees.  Now, corporation counsel John Ward is seeking return of that money over ongoing claims that Vitorin “doesn’t work” he said in an interview with The New Haven Independent.  Vytorin is a combination cholestral pill comprised of Zetia and Zocor.

Ward has issued an RFP—Request for Proposal—to hire an outside law firm to sue Merck and Schering-Plough.  Both Merck and Schering-Plough are currently under Congressional investigation into their handling of Vytorin clinical trial data that called into question Vytorin’s effectiveness.  For the suit, Ward is looking to use the “no win, no pay” approach, meaning that the law firm chosen to represent New Haven in the lawsuit would not receive any fee if the city loses the case.  Although Ward sought to join a class-action lawsuit, he was unable to find an existing case that matched his needs.  In the meantime, New Haven is seeking a firm with experience suing drug makers.  “There are no guarantees,” that there’s a firm who wants to take the case, or that the city would win, Ward told the paper, “but I’m just giving it a shot.”

Company spokeswoman, Rosemarie Yancosek, said, “Schering-Plough stands behind our products, and we will defend ourselves vigorously,” noting that Vytorin and Zetia “have consistently demonstrated significant reduction in LDL cholesterol in numerous clinical studies,” and that lowering LDL levels is a “key factor” in lowering cardiovascular risk.

The Vytorin controversy has spurred a rash of over 50 class-action lawsuits.  When Ward heard about the controversy, he decided to take action, too, and on September 26, issued an RFP seeking “Legal Services to Recover Excessive Payments of Pharmaceuticals.”

We have long been reporting on the issues with Vytorin, which was developed and marketed jointly by Merck and Schering-Plough and is a combination of cholesterol-lowering Zetia and the statin Zocor.  Vytorin was approved by the Food & Drug Administration (FDA) in 2004 to treat both sources of cholesterol:  Absorption in the intestine of both biliary and dietary cholesterol, and production in the liver and peripheral tissues.  It was believed that the treatment of cholesterol from both sources would likely result in lower cholesterol levels.  It was likewise theorized that this reduction in cholesterol would, in turn, reduce the amount of plaque buildup in the arteries, thus reducing the risk of heart attack and stroke.  Not so, according to this year’s released ENHANCE study that revealed that Vytorin brought about no measurable reduction in the amount of artery plaque buildup.  The ENHANCE study was released this January and found that Vytorin worked no better to reduce clogged arteries than a high dose of a less-expensive, generically available statin alone.

Even more controversy surrounded the way the ENHANCE study was handled with Merck and Schering-Plough delaying its release for over a year, something critics have likened to fraud.  Also, the companies attempted to change the study’s endpoint—the main result it was meant to measure—after it was completed.


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