In 1997, Baycol, an anti-cholesterol drug (also known as a "statin") produced by Bayer Pharmaceuticals, was approved by the Food and Drug Administration. Cholesterol is produced in the liver, and plays an important role in the health of cell membranes and in the production of certain hormones. Baycol was represented to lower LDL cholesterol ("bad cholesterol") levels, and also to lower triglyceride levels. The approved dose was 0.3 mg per day.
Unfortunately, Baycol was not effective at the FDA-approved dose. Despite being aware of allegations of negative health consequences including rhabdomyolisis among Baycol users, Bayer sought FDA approval of higher doses. Rhabdomyolisis is a condition which causes symptoms including atrophy of the muscle cells, particularly skeletal muscles, along with muscle pain, weakness, fever, nausea, and in some cases kidney failure and even death. Release of potassium associated with the breakdown of muscle cells can cause heart rhythm irregularities and even cardiac arrest. Muscle pain from this condition tends to be most severe in the lower back and calves, and can interfere with the ability to walk.
Over subsequent years, a large number of Baycol patients were diagnosed with rhabdomyolysis. Despite its growing awareness of problems with Baycol, Bayer chose to warn doctors only about using Baycol in conjunction with another medication called Lopid. It did not disclose the dangers of rhabdomyolisis in its marketing materials. Meanwhile, due to the relatively low cost of the drug, it became a favorite prescription for doctors under pressure from HMO's and other medical insurers to minimize costs.
In August, 2001, Bayer voluntarily removed Baycol from the market at the request of the FDA. By that time, there were at least 52 deaths attributed to Baycol use. Bayer is alleged to have suppressed clinical evidence it acquired relating to Baycol's side effects while it continued to market the medication.