Zocor Class Action Lawsuit Filed Over Rhabdomyolysis, Muscle Problems

A class action lawsuit has been filed on behalf of users of Zocor or simvastatin, alleging that the medication was sold without proper warnings about the risk of rhabdomyolysis and muscle injuries, especially with use of the 80 mg dose. 

The Zocor class action lawsuit (PDF) was filed by Irene Richardson on June 1, in the U.S. District Court for the Eastern District of Louisiana. The complaint targets Merck & Co., the makers of Zocor, and a number of other companies which manufactured and distributed 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.

One of the main health risks associated with Zocor is the risk of a muscle injury known as rhabdomyolysis, which can lead to kidney failure or death.

Zocor (simvastatin) is a synthetic statin developed by Merck & Co., which is widely available as generic simvastatin. Before patent protections expired in 2005, it was Merck’s best-selling drug and the second best selling cholesterol lowering drug in the world, bringing in $4.3 billion in 2005.

In June 2011, the FDA placed restrictions on the use of 80 mg Zocor, which could include twice-a-day 40mg doses, due to the risk of myopathy and rhabdomyolysis, warning doctors that no new patients should be placed on the high dose regimen due to the risk of muscle problems.

Rhabdomyolysis causes muscle fibers to begin to break down, releasing a protein called myoglobin, which can damage the kidneys as they attempt to filter it out of the bloodstream. Symptoms of rhabdomyolysis include muscle cramps, tenderness, stiffness, pain or spasms. The illness is usually reported in patients over 65 years of age or those who have renal impairment or uncontrolled hypothyroidism.

The class action suit was filed on the same day as two other Zocor lawsuits were filed in federal court against Merck and generic Zocor manufacturers, including Teva Pharmaceuticals, Lupin Pharmaceitucals, Reddy’s Laboratories and Ranbaxy Laboratories.

One of the lawsuits, filed on behalf of Danielle Woolens (PDF), was also filed in the Eastern District of Louisiana, while another filed on behalf of Kathleen M. Harris (PDF),  was filed in the Western District of Louisiana.

All of the complaints involve similar allegations that the drug makers purposefully concealed information indicating that Zocor could increase the risk of muscle injury and failed to warn doctors and plaintiffs of the potential side effects of simvastatin.

The class action lawsuit calls not only for compensatory damages, but also seeks to create a medical monitoring program for Zocor users to help detect muscle injury and kidney problems caused by the drug.