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The Baycol / Lipobay - Scandal

First Trial Set to Start for Bayer's Baycol

(Law.com / February 18, 2003) - The sixth and last cholesterol fighter to be approved by the U.S. Food and Drug Administration was meant to be Bayer Corp.'s billion-dollar drug, says Texas plaintiffs' lawyer Mikal C. Watts.

Instead, Baycol has become the target of 7,655 products liability suits filed against the company. Complaints allege that the drug caused debilitating muscle damage and, in approximately 100 instances, death. Today, Watts will take the first Baycol case to trial when jury selection begins in Haltom v. Bayer Corp., No. 02-60165-2, in a Corpus Christi, Texas, state court.

Noting that only a handful of mass tort cases actually go to trial, Watts says, "It's extremely important that the first case be tried so that Bayer can see what these cases are worth."

Bayer's chief outside counsel, Philip S. Beck of Chicago's Bartlit Beck Herman Palenchar & Scott, disputes that, saying he doubts the outcome of the Corpus Christi trial will be a harbinger of things to come for either side. "These cases are going to trial to rise and fall on their individual merits," he says.

Watts, who is seeking more than $100 million in punitive damages, represents 1,500 plaintiffs who are suing Bayer over Baycol. None of his cases has settled yet.

Beck says that even though this case will be tried, Bayer is aggressively pursuing a claims-settlement policy and has settled more than 400 cases so far for amounts ranging from $100,000 to more than $1 million.

He emphasizes that each case must be examined for its individual merits. He says more than 900,000 people took Baycol, but that only a tiny percentage experienced serious side effects. "Some side effects are unavoidable," he says.

Watts, declining to reveal the details of his negotiations with Bayer in the Haltom case, disparages the other deals as offering "grossly inadequate compensation" to Baycol's victims. "This company knew this drug was going to kill people and they sold it anyway," he alleges.

Meanwhile, in a U.S. district court in Minneapolis, 4,616 Baycol cases filed in various federal courts against Bayer recently were administratively consolidated into a multidistrict litigation (MDL) before Judge Michael J. Davis. A class-certification motion is pending.

BAD SIDE EFFECTS

Watts said that his client, 82-year-old Hollis Haltom, took Baycol for just two weeks before developing rhabdomyolysis. Called "rhabdo" for short, rhabdomyolysis is a condition where large skeletal muscle cells die. As those dead cells break down, toxins are released into the bloodstream, where they ultimately flow into the kidneys, causing acute and potentially fatal renal-system failure.

Haltom was taking sample doses of the drug when he was felled. Now he is "significantly weakened and unable to care for himself," Watts says. Haltom's own internist, Dr. Lee Guinn, will likely testify at the trial as both a fact witness and as an expert, Watts says. Guinn had been treating Haltom with other cholesterol fighters without incident, he says.

But Beck, calling Haltom "a medical miracle," says the octogenarian's medical problems were caused by poor health -- he has high cholesterol and had already undergone coronary bypass surgery and was at high risk for a heart attack.

Those ailments and others accounted for Haltom's debilitated condition, Beck says, adding that Haltom had recovered from his bout with rhabdo.

SCIENTIFIC EVIDENCE

Jurors at the trial are expected to hear expert testimony about the class of drugs called statins, of which Baycol is a member. Statins block an enzyme the body needs to make cholesterol, lowering the body's low-density lipoprotein, or "bad" cholesterol, levels.

The FDA had approved five cholesterol-lowering drugs before Baycol: Zocor, Lipitor, Mevacor, Pravachol and Lescol. Bayer is sure to point out during the trial that rhabdomyolysis is a potential side effect of all of them.

Beck claims that Haltom had used the other drugs without success. While he stopped short of faulting Guinn, Beck says that the doctor had given Haltom an 0.8-milligram dosage when a 0.3-milligram dose was available. Attorney Charles S. Zimmerman of Minneapolis' Zimmerman & Reed and co-lead plaintiffs' counsel in the MDL, says that Baycol's flaw was that the dosage had to be at least 0.8 milligrams for the drug to be effective.

Under pressure from the FDA, Bayer withdrew the medication from the market in August 2001 after a four-year run.

At trial, the plaintiffs will introduce a letter written by an FDA director that states that the agency had "grave reservations regarding the overall safety of this drug." Dr. David G. Orloff, the author of the letter, wrote that what piqued the agency's concern was what he called "an alarming number of spontaneous reports of rhabdomyolysis" in patients taking those pills.

What set Baycol apart from the other statins, Orloff wrote, was it had a higher incidence of that side effect. And, the higher the dosage of Baycol, the more severe the reaction.

In addition, Watts will rely on internal documents from Bayer that he uncovered during pretrial discovery. He called them "the most damning documents I've ever reviewed." He says the documents, which are under seal until trial, show that Bayer withheld from the FDA negative results of Baycol's clinical trials and rammed through testing of its 0.8-milligram version even though Bayer's own testing revealed that it could by highly cytotoxic.

"All of that is false," Beck says. "Rhabdo is a well-known and well-recognized side effect of all the statin drugs ... and we warned about it."

Watts asserts that Bayer was less than candid with the FDA about its efficacy. "Frankly, they just lied to the FDA about the clinical testing of the drug," he says.

Beck says "the evidence is going to show that's just not true." He says he will call as witnesses employees from Bayer who will testify about Bayer's research and development, about why Bayer decided to withdraw the drug and about how doctors were warned about Baycol's side effects.

Beck will also have to counter another piece of evidence from the plaintiffs at trial. Plaintiffs' research shows that the serious side-effect rate of Baycol is closer to 10 percent to 12 percent, as compared to the 2 percent rate for competitor Lipitor, says Minneapolis lawyer Richard A. Lockridge, the other lead counsel for the MDL plaintiffs.

Beck called that figure "very very very high," adding, "that's not a figure that came out of our files and not from the FDA."

The trial is expected to last two to three weeks. Lockridge says, "We're all watching it carefully."