A lawsuit brought by an 82-year-old retired engineer has unearthed internal documents that provide a glimpse into how pharmaceutical giant Bayer handled safety warnings about a once-promising drug.
Bayer says it acted responsibly by pulling the anti-cholesterol drug from the market in 2001, after it was linked to dozens of deaths.
But internal documents and e-mails released by the retired engineer’s lawyers show executives discussing the possible dangers of Baycol, especially at proposed higher dosages, long before sales were halted.
The company now faces thousands of lawsuits , the one in South Texas against Bayer’s U.S. subsidiary is the first to go to trial and investors are wary about large verdicts or expensive settlements.
U.S.-traded shares of Bayer have lost nearly one-fourth of their value since the trial began two weeks ago.
The plaintiff, Hollis Haltom, says his legs stopped working weeks after his doctor gave him free samples of Baycol, a substitute for other drugs that block production of harmful cholesterol that builds up on artery walls.
Haltom had his first coronary bypass operation in 1970, but anti-cholesterol drugs called statins had helped keep him sprightly enough for outings with the yacht club, his church, and his wife of more than 50 years.
Within weeks of switching to Baycol in May 2001, Haltom says, he was in a wheelchair, then a hospital. He has recovered much of his energy, but his legs still buckle when he tries to rise from the easy chair in his Padre Island home.
Haltom’s lawyers say his condition is rhabdomyolysis, a muscle-destroying condition, and they are seeking $100 million in damages from Pittsburgh-based Bayer Corp. They say Baycol, sold in Europe before it was approved for U.S. sales by the Food and Drug Administration, caused rhabdomyolysis up to 79 times more often than competing drugs.
Haltom’s doctor testified that he never would have dispensed the medicine if he knew of its problems.
By the time Bayer pulled Baycol from the market in August 2001, at least 52 deaths, including 31 in the United States, were linked to the drug.
Bayer says there are about 7,800 lawsuits pending from former Baycol users, mostly in the United States. The company has paid $125 million to settle about 450 cases and is in negotiations on another 500 cases.
Bayer’s outside attorney, Philip Beck, said this week that the company is taking responsibility for the drug and would rather compensate victims than fight them in court. But, he said, Haltom’s attorney backed the company up against a wall by demanding a settlement for all 1,600 plaintiffs he and a group of other lawyers represent.
“Most of those cases are meritless,” Beck said. “We weren’t going to be held hostage like that.”
Haltom’s lawyer, Mikal Watts, 35, is considered a rising star among trial attorneys in South Texas. He was part of the team that brought a widely watched case against Ford Motor Corp. and tire maker Bridgestone/Firestone to trial in 2001. A $7.5 million settlement was reached as the jury deliberated.
Watts won a $43 million verdict against Pfizer Inc. over its diabetes drug, Rezulin, although the case, on appeal, was settled in January for a lesser, undisclosed sum, Pfizer lawyers said.
In the Baycol case, Watts has introduced Bayer documents that paint a picture of a company so eager to jump into the U.S. market for anti-cholesterol drugs that it ignored or covered up its own troubling research.
“Today was the first day that Bayer’s file cabinets were opened to the world,” Watts said Friday, after grilling Bayer’s head of worldwide regulatory affairs, Lawrence Posner.
“The jury saw documents of a company who knew its drug would kill people, that chose to go ahead and kill people anyway so they could go ahead and make a billion dollars,” Watts said.
About 8 million Americans use statins, making them the third most widely prescribed drug in the nation. Bayer officials say research for cerivastatin, the clinical name for Baycol, began in 1985 and product research continued until it won FDA approval in 1997.
Documents introduced so far in the trial show internal dialogue about Baycol dosages. A stronger dosage would add $25 million a month to sales and allow Bayer to match the effectiveness of competing drugs, but the higher dosage alarmed company scientists.
By the time Baycol was pulled from the market, 6 million patients worldwide were taking the drug, including 700,000 in the United States. It was the fastest-growing drug in Bayer’s history.
But by then, internal company e-mails were circulating, warning of reports that the drug was causing deaths. “So much for keeping this quiet,” read one message. Another said, “how will marketing spin this.”
Beck, the Bayer lawyer, said the e-mails were taken out of context. He said that after Bayer presents its case, it was due to begin late Tuesday jurors would see that the company worked with the FDA to make sure Baycol was used safely.