Against the background of pending litigation in the U.S., Bayer AG (G.BAY) has for some time not been in a position to comment directly on the facts relating to the cholesterol-lowering drug Baycol/Lipobay, the company said Wednesday.

Bayer now would like to comment as follows: Bayer continues to believe firmly that the company acted responsibly, promptly and appropriately in the management of Baycol.

Without concession of liability, in the context of the lawsuits concerning Baycol the company has to date entered settlement agreements with around 450 individuals who experienced serious side effects; this figure includes several fatalities. A total of about $125 million has been paid.

Bayer is currently negotiating settlement agreements in a further 500 cases. At the same time, Bayer is continuing to defend itself vigorously in all cases in which there is no connection between Baycol and the health problems which are the subject of the claims or where a fair settlement cannot be reached.

To date there are approximately 7,800 lawsuits. As permitted in the United States legal system there is no mechanism to screen cases before they are filed. A single law firm has filed 4,300 virtually identical complaints and providing no medical detail. Where medical records have been made available it appears that only a small percentage of people who have filed lawsuits suffered a side effect from Baycol and that the vast majority of people who did experience a side effect made a complete recovery.

Recent media coverage may have created the impression that the company was aware of possible dangers with Baycol long before it voluntarily withdrew the cholesterol-lowering drug from the market. This is not the case. Baycol was a well-researched and thoroughly tested drug. It was prescribed for over six million patients worldwide over 700,000 of them in the USA. The overwhelming majority of these individuals took it safely and effectively, with no serious side effects.

Bayer continuously monitored ongoing Baycol data post-launch to ensure that the drug was being used safely and correctly, and in accordance with labeling recommendations. The company kept the FDA fully informed about all pertinent safety information, including adverse event reports.

When Bayer became aware of an increased rate of reports of rhabdomyolysis in patients taking Baycol, particularly in co-prescription with gemfibrozil, it took appropriate action. The company strengthened the labeling and undertook comprehensive scientific studies to analyze the problem and took a series of increasingly strong steps to educate healthcare professionals. When Bayer concluded that, despite these aggressive communication efforts, the drug continued to be prescribed in ways that increased safety concerns, the company withdrew the product voluntarily.

Plaintiffs' lawyers may have made selected documents available to the media; the content of these documents has been taken out of context and has created a false impression. Bayer will show the courts the full context of many of the partial documents referenced in the media.

For example, an e-mail allegedly from senior Group management at Bayer AG allegedly called for sales to be maximized. However, this wording does not originate from a management communication; it appeared in a proposal authored by an assistant for a marketing presentation intended for an audience of marketing employees in the USA.