03/05/2003
Documents presented in court on Tuesday showed a rising sense of alarm at drugmaker Bayer AG about the side effects of the cholesterol-lowering drug Baycol (cerivastatin) even as the company pushed to expand sales of the now-withdrawn medication.
Memos and e-mails among Bayer executives described a growing number of reports that Baycol patients were developing the muscle disorder rhabdomyolysis at much higher rates than other statins.
"There will be much more tremendous trouble in the future," a Bayer marketing partner in Japan wrote in a message urging that the company stop clinical trials of higher doses of Baycol that it viewed as key to boosting sales.
The medication, taken off the market in August 2001, has been linked to more than 100 deaths worldwide.
The documents were presented as evidence in the first of 7,800 Baycol-related lawsuits to go to trial. The plaintiff in this case is 82-year-old Hollis Haltom, who said he developed rhabdomyolysis because of the drug.
Analysts and investors are watching the case closely because it could set a costly precedent for still unresolved Baycol cases.
The embattled 140-year-old company already has doled out $125 million in legal settlements and could have to pay more in future cases if the Texas trial results in a large financial judgment against Bayer.
Analysts say the company could face more than $10 billion in damages if it is proved negligent in its handling of Baycol, which was sold as Lipobay outside the United States.
'WILDLY UNREALISTIC'
Haltom lawyer Mikal Watts, in a weekend interview with German newspaper Frankfurter Allgemeine Zeitung, said Bayer could face damages as high as $50 billion, a figure the company attacked as "wildly unrealistic."
Bayer has said it acted responsibly in developing Baycol and withdrawing it when problems arose.
With Bayer senior vice president Lawrence Posner on the witness stand, Watts showed the jury internal company communications that indicated Baycol was causing rhabdomyolysis at a rate 10 times higher than other statins.
"The steadily increasing numbers of spontaneous reports of rhabdomyolysis associated with Baycol...has overwhelmed the available safety resources," one report said in December 1999.
"There has been a substantial increase in calls from our sales representatives and opinion leaders requesting that scientific affairs liaisons talk to physicians who had cases of rhabdomyolysis," a Bayer executive wrote in June 2000.
In July 2000, Bayer got approval to sell a higher dose of Baycol in the US market, even though it knew that stronger pills meant more side effects, Watts said.
Bayer has said it wanted to offer high doses of Baycol to help patients with severe cholesterol problems, but Watts argued that its intent was to boost sales.
In March 2000, he said top Bayer officials exhorted sales staff "to redouble our efforts, we're going to make this a billion-dollar drug."
Company records showed that Baycol sales totalled $113 million in 1999 and $248 million in 2000. Internal forecasts said sales should reach $1 billion by 2005, the records said.
As evidence against Baycol grew, some executives were less than eager about disclosing the bad news to regulators, fearing that it could hurt sales, Watts charged.
Bayer lawyers have said the company's concern was not sales, but making sure it had accurate information.