Recalled Anti-Cholesterol Drug
Linked to Life-Threatening Muscle Injury |
| (updated March 2003) |
| Californian Charles Young began taking the prescription drug Baycol in March 2000 to reduce his cholesterol. Soon, he began experiencing leg pains, which rapidly worsened to the point that he could not walk. Young's physician did not recognize the cause of the leg pains, and prescribed only pain medication. Young's condition continued to deteriorate, and one month he was admitted to the hospital. Within 24 hours of his admission, Young experienced complete kidney failure and was put on kidney dialysis. Subsequently, Young suffered a severe heart attach and died on May 24, 2000. |
| As events unfolded, the tragic death of Charles Young was one of multiple deaths and hundreds of serious injuries that have been reportedly linked to Baycol, known generically as cerivastatin. On August 8, 2001, the Food and Drug Administration (FDA) announced that Bayer, the manufacturer of Baycol, was removing the drug from the market because of 31 reports of fatal rhabdomyolysis, many of which were seniors. Later, in Europe, it was reported that 21 additional persons died after ingesting Baycol. By 2002, the number of deaths associated with Baycol worldwide had risen to over 100. |
| Rhabdomyolysis -- also called rhabdo -- is a potentially life-threatening condition occurs when a large number of skeletal muscle cells die, which results in the release of a massive amount of muscle protein (known as myogloblin) into the bloodstream. The muscle protein can become trapped in the kidneys, clogging up the filtering process of the kidneys and leading to kidney or renal failure. In addition, potassium released from the damaged muscle cells can cause malignant heart rhythms resulting in cardiac arrest. |
| Symptoms of rhabdomyolysis include muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting. The pain may involve specific groups of muscles or may be generalized throughout the body. Most frequently the involved muscle groups are the calves and lower back; however, some patients report no symptoms of muscle injury. |
| Although fatal rhabdomyolysis is an extremely rare drug side effect, almost 11 million prescriptions of Baycol were written in the U.S. from its approval in 1997 to its withdrawal. The FDA recommends that all person taking Baycol consult with their physician to discuss alternative cholesterol-reducing medications, and that any persons who have taken Baycol and have experienced muscle pain, discontinue Baycol's use immediately and contact their physician. |
| The Baycol recall has led to questions and governmental inquiries worldwide as to when Bayer was first aware that fatal side effects were associated with Baycol, and whether it failed to timely inform public health authorities of these side effects. In the United States, the FDA does not provide any compensation to persons injured by recalled drugs. Thus, a number of lawsuits have been filed against Bayer for strict liability for failure to warn, negligence and wrongful death against Bayer. |
| One of the principal allegations in the lawsuits is that following Baycol's introduction, Bayer began receiving mounting clinical evidence and reports from physicians of serious side effects with the drug. At the same time, the plaintiffs allege that Bayer marketed Baycol as safe and highly effective, while minimizing its risks and that Baycol was no more effective than other anti-cholesterol drugs on the market. |
| In September 2002, Bayer announced that it was entering into settlements with injured Baycol patients represented by counsel. Lieff Cabraser is conducting such settlement negotiations on behalf of our clients with Bayer. |
| Stephen H. Cassidy is an attorney with Lieff Cabraser Heimann & Bernstein, LLP. Lieff Cabraser is representing Charles Young's wife in a wrongful death action against Bayer. |