Zetia and Vytorin Lawsuits Settled for $41.5 Million

Merck & Co. and Schering-Plough Corp. have agreed to pay $41.5 million to settle Zetia and Vytorin class-action lawsuits filed for consumers, which claimed that the drug makers hid data for two years that showed the expensive cholesterol-fighting drugs were no more effective than older, more affordable generics.

The Zetia and Vytorin settlement comes after the companies agreed last month to pay $5.4 million in penalties to resolve investigations by numerous states into whether they acted illegally in the handling of a clinical trial known as ENHANCE. The additional payment of $41.5 million will resolve more than 140 Zetia and Vytorin lawsuits seeking class action status.

Vytorin is a cholesterol drug that combines Zetia (ezetiminbe) with Zocor (simvastin). It was approved by the FDA in 2004 and was heavily marketed as part of a joint venture between Merck and Schering-Plough.

The drug makers advertised Vytorin as being more effective than stand-alone drugs. It was meant to provide better protection against heart attacks by reducing the buildup of plaque in the inner walls of the arteries, and the medication was substantially more expensive than older cholesterol drugs.

In January 2008, after delaying and stalling, Merck and Schering-Plough released data from the ENHANCE study (Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia), which demonstrated that Vytorin provided no significant medical benefits over taking Zocor alone, which is available as a generic.

States and the FDA began to question the companies’ actions months before they released the data, when the drug makers indicated that they were going to change the ENHANCE study’s measure of effectiveness a year and a half after the study had been concluded. These actions also led to a congressional investigation into whether the drug makers were trying to manipulate scientific data.

Plaintiffs in the class action Vytorin and Zetia lawsuits sought compensation for buying the drugs, alleging they were misled to believe the drugs were more effective in treatment and prevention of high cholesterol. The lawsuits accused Merck and Scherin-Plough of sitting on the ENHANCE study results for two years before releasing the data.

According to a statement released by the companies, the $41.5 million Vytorin and Zetia settlement will resolve all of the class-action lawsuits seeking to represent consumers, insurers and other entities. However, they point out that the agreements are not an admission of any misconduct or liability in connection with the marketing and sale of the drugs.