June 7, 2012 – Last week, a class action lawsuit was filed on behalf of Zocor users, alleging that the widely-prescribed cholesterol lowering drug was marketed without proper warnings about the risk of rhabdomyolysis and muscle injuries. Rhabdomyolysis is a rare but extremely serious disease in which muscle fibers begin to break down, releasing a protien called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. The class action lawsuit was filed on the same day as two other Zocor lawsuits were filed in federal court against Merck and four of its generic manufacturers.
What’s the problem?
The Zocor class action lawsuit was filed on June 1 on behalf of Irene Richardson in the U.S. District Court for the Eastern District of Louisiana. The suit targets pharmaceutical giant Merck & Co., as well as a number of other companies that manufacture simvastatin, the generic version of Zocor.
“Plaintiff maintains that the pharmaceutical drug, Zocor, is defective, dangerous to human health, unfit and unsuitable to be marked and sold in commerce, and lacked proper warnings as to the dangers associated with its use,” the lawsuit states.
Zocor is a statin drug designed to be used together with diet and exercise to reduce blood levels of low-density lipoprotein (LDL) cholesterol (”bad cholesterol”). Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best-selling cholesterol drug in the world, generating $4.3 billion in sales in 2005 alone.
In June 2011, the U.S. Food & Drug Administration (FDA) placed restrictions on the use of 80 mg Zocor due to the risk of rhabdomyolysis and myopathy, warning prescribing physicians that no new patients should be placed on the high dose regimen due to the potential for these complications. Rhabdomyolysis usually occurs in patients over the age of 65, and in those who have renal impairment or uncontrolled hypothyroidism. Signs and symptoms may include:
- muscle cramps
The class action lawsuit accuses Merck of concealing information indicating that Zocor could increase the risk of muscle injury, and failing to warn doctors and plaintiffs of the potential side effects associated with the drug. The claim seeks compensatory damages, as well as the creation of a medical monitoring program for Zocor users to help detect muscle injuries and kidney problems caused by the drug.