Bayer denies Lipobay cover-up
pharmafile | October 27, 2003 | News story | |
Bayer has refuted allegations that it concealed serious side-effects of its statin Lipobay before it was withdrawn in July 2001.
US lawyer representing patients have uncovered e-mail evidence that they say proves Bayer executives covered up of the drug potentially fatal side-effects.
Denying the accusations, Bayer said Lipobay (Baycol in the US) was a "well-researched and thoroughly tested drug" and believed it had acted "responsibly, promptly and appropriately" in its monitoring of the drug.
The company says evidence leaked to the media has been taken out of context, and intends to clarify the point during pending court appearances.
Around 100 people taking Lipobay died of the rare condition rhabdomyolysis, where breakdown of muscle can lead to kidney failure and death. Some doctors persisted in also prescribing patients gemfibrozil, despite repeated warnings of its dangerous interaction with Lipobay.
"The majority of cases came from the minority of cases where doctors were not using it as directed on the label", Philip Beck, Bayer's Legal Counsel, told CNN. "We concluded that we could not get doctors to use it as directed, and that was the principle for removing it from the market".
Bayer has already settled around 450 cases at a cost of $125 million, without admitting liability, and is negotiating a further 500. It said only a small percentage of the litigation represented actual cases of side-effects caused by Lipobay, adding that because US law has no way to screen cases before they are filed, one law firm has filed 4,300 almost identical cases but has not supplied any medical details.
Around 7,800 separate lawsuits have been filed against the company, which claim that patients suffered from serious and sometimes fatal side-effects after taking Lipobay. A federal judge is due to rule on whether the legal proceedings should be awarded class action status.
Last year, Morgan Stanley estimated Bayer's liability could reach $1.58 billion, which could rise significantly if Bayer is shown to have withheld information.
Lipobay was one of Bayer's most important prospects for future growth and its withdrawal and subsequent loss of sales has proven to be catastrophic for the company. Its shares have hit a 10-year low and Chief Executive Werner Wenning said at the end of last year that the company was open to a takeover bid.
