Baycol Litigation Report
“FDA announced on August 8, 2001 that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision.” – CDER (Center For Drug Evaluation & Research)
Baycol, also known as Lipobay or cerivastatin sodium, is one of a commonly prescribed family of cholesterol-lowering drugs called “statins.” Baycol is manufactured by the German pharmaceutical company Bayer Corporation, and was approved by the FDA in 1997
Rhabdomyolysis: Adverse Effect of Baycol
On August 7, 2001, Bayer Corporation announced a voluntary recall of Baycol due to an alarming number of serious side effects and adverse events associated with the drug, including a disease known as Rhabdomyolysis. Rhabdomyolysis is a rare condition characterized by muscle necrosis and the release of muscle components into circulation. Symptoms include unexplained muscle pain, tenderness, or weakness accompanied by malaise or fever. Rhabdomyolysis is known to cause kidney failure, cardiac arrest, liver abnormalities, blood clotting and death.
Plaintiffs sought early successes against Bayer in the first trials of thousands of lawsuits over its cholesterol lowering drug by bringing the cases in east Texas and Mississippi, jurisdictions known for hostility towards big corporate defendants, particularly foreign ones. But the legal strategy of the German pharmaceuticals and chemicals group appears to be working effectively after a second victory in two trials on April 3 in Jackson, Mississippi, prompted more plaintiffs to enter settlement talks. More settlements instead of trials – and the possibility of large damage awards – can significantly reduce the potential liabilities Bayer faces from Baycol and the pressure on the group’s share price.
Since 1990 and through more than 50,000 cases, AMFS, Inc. (American Medical Forensic Specialists) has been providing plaintiff and defense attorneys access to a carefully screened, nationwide panel of 6,000 healthcare professionals practicing in all specialties. With just a single phone call to our office, you reach a board-certified physician who will assist you in clarifying the medical issues present in your case, identifying the medical specialties involved and interviewing prospective experts for the case. As always, our mission is to provide counsel with the most efficient way to retain quality experts in a timely, cost effective manner.
Garth Sullivan, MD
Marketing Director, AMFS, Inc.