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$100 Million Lawsuit Questions Bayer's Handling of Recalled Cholesterol Drug

Mar 8, 2003 | AP

A $100 million lawsuit unfolding in a Texas courtroom has yielded e-mails and internal documents that suggest Bayer Corp. disregarded disturbing research on the cholesterol drug Baycol before it was pulled off the market because of dozens of deaths.

The lawsuit brought by an 82-year-old retired engineer who says a muscle-destroying side effect made his legs stop working - is the first of thousands against Bayer to go to trial in the United States.

The side effect, known as rhabdomyolysis, can clog the kidneys with disintegrating muscle tissue and cause them to fail. The Food and Drug Administration linked Baycol to at least 52 deaths worldwide, including 31 in the United States.

Pittsburgh-based Bayer has acknowledged the link and said it acted responsibly by withdrawing the drug, known clinically as cerivastatin, in 2001.

The lawsuit paints Bayer as a company overly eager to jump into the lucrative U.S. market for the cholesterol-fighting drugs known as statins. About 8 million Americans use statins to lower their risk of heart attacks, making them the third most widely prescribed drug in the nation.

Baycol won FDA approval in 1997 and became the fastest-growing drug in Bayer's history. By the time it was pulled in August 2001, it was Bayer's No. 3 seller, expected to earn some $720 million that year with 6 million patients worldwide, including 700,000 in the United States.

At the trial, which opened Feb. 18, plaintiff's attorney Mikal Watts said Bayer "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' legal team, using an FDA-maintained database, said Baycol was 79 times more likely to cause rhabdomyolysis than competing drugs.

Bayer attorney Philip Beck said that after Bayer finishes presenting its case it began this week, the jury would see that the company worked with the FDA to make sure Baycol was used safely.

The pharmaceutical giant has paid $125 million to settle about 450 cases, and investors are clearly worried. The U.S.-traded stock of German parent Bayer AG has fallen about one-fourth since the Texas trial began.

Internal documents and e-mails released by the plaintiff's lawyers show executives discussing potential dangers long before sales were halted.

In June 2000, an e-mail to a vice president noted that "there have been some deaths related to Baycol," and that people at its marketing partner, SmithKline Beecham, knew it.

"So much for keeping this quiet," the e-mail said.

"How will marketing spin this?" another e-mail wondered.

Beck said the e-mails were taken out of context.

The plaintiff, Hollis Haltom, had his first bypass operation in 1970, but cholesterol drugs had helped keep him sprightly enough for outings with the yacht club, his church and his wife of more than 50 years.

Haltom said he developed problems weeks after his doctor gave him free samples of Baycol in May 2001. He wound up 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 received samples in doses of 0.8 milligrams, a new, larger portion that Bayer had hoped would let Baycol match the effectiveness of rival drugs. An internal letter in June 1999 estimated that the higher dosage would add $25 million a month to Baycol sales.

But the minutes from a teleconference among Bayer executives in April 2001 the month before Haltom got Baycol, show that the company had received "adverse event reports" about the drug. "No samples .8 should be released, and audit of samples and inventory should be done," the minutes said.

An internal e-mail two months later indicated that the company took a different course. It waited two months before sending doctors a letter warning them not to start patients at the higher dosage, and it never printed labels with updated safety information.

"A decision was apparently made to use up the currently existing inventory," wrote Mary Taylor of North American regulatory affairs.

Haltom is seeking $100 million from Bayer and its partner, now known as GlaxoSmithKline.

Bayer said it faces about 7,800 lawsuits from former Baycol users, mostly in the United States. Beck, the Bayer attorney, said the company is taking responsibility for the drug and would rather compensate victims than fight them in court. But he said Haltom's lawyer had backed Bayer up against the wall by demanding a settlement covering 1,600 plaintiffs.

"Most of those cases are meritless," Beck said. "We weren't going to be held hostage like that."

South Texas juries have a reputation of favoring plaintiffs with large awards in personal-injury cases. And Watts, 35, was part of the team that won a $7.5 million settlement in a suit against Ford and Bridgestone/Firestone in 2001. He also won a $43 million verdict against Pfizer over its diabetes drug, Rezulin, though that case was settled in January for a lesser, undisclosed sum.

As a jury was being selected in the Baycol case, Bayer sent a letter to about 2,000 businesses and homes in Corpus Christi, telling people they might soon see negative news about the company and asking them to "keep an open mind."

The letter prompted cries of jury tampering. The district attorney's office is investigating. Beck apologized for the letter but said no jurors never saw it.

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