Bayer has been forced to turn over confidential company documents to U.S. courts in a damages case over the drug Cerivastatin. The documents will reveal how much the pharmaceutical company knew about problems associated with the drug before withdrawing it in 2001.

Cerivastatin, which was marketed in the U.S. as Baycol and Lipobay in Europe, to lower cholesterol, was removed from the market due to increasing reports to the U.S. Food and Drug Administration of Rhabdomyolysis, a rare disorder where muscle tissue breaks down and can lead to organ failure and death.

Prior to this case, suits for damages filed by patients had been met with out of court settlements. Some 7,800 product liability suits were filed against Bayer and GlaxoSmithKline; 450 suits were settled with sums ranging from $200,000 to $1.2 million, according to patients’ lawyers.

The trial, which recently began in Texas courts, means that company documents leading up to the 2001 decision to remove the drug from the market will be released to the public. Bayer has requested that many documents remain sealed, but plaintiff’s lawyers seeking punitive damages, are introducing some in court.

Plaintiff’s lawyers believe Bayer has been aware of problems associated with Baycol since approved by the FDA in 1997.

In 2000, the FDA approved doubling the dose of Baycol, due to the inefficacy of the lower dose. By spring of 2001, the FDA noticed a sudden increase in adverse reaction reports associated with Baycol use, which prompted discussions with Bayer; the drug was withdrawn in August 2001.

At the time Bayer decided to remove the drug, 31 deaths were linked to the drug; of which, 12 had been taking the increased dosage.

SOURCE: British Medical Journal, March 1, 2003; 326:518, www.bmj.com.