North Carolina Case Claims Financial Calamity from Bayer Drug Trasylol

Friday, May 2, 2008
Triangle Business Journal
by Frank Vinluan

RALEIGH - North Carolina could become a battleground in the fight over Bayer Corp.'s embattled bleeding-control drug Trasylol, but for a different reason than safety. A lawsuit filed April 11 in the United States District Court for the Eastern District of North Carolina claims no physical injury from the drug. Instead, plaintiff Jerry Saine of Catawba County claims he suffered "economic injury" from his 2006 heart surgery.

The suit claims Bayer actively marketed the drug despite knowing that Trasylol carried greater health risks than cheaper and safer alternatives, violating the state's Unfair and Deceptive Trade Practices Act.

"Had defendants honestly disclosed the true efficacy and dangers of Trasylol, physicians and patients would have used less expensive and safer alternatives," the suit reads. Trasylol can cost as much as $1,000 per injection. Alternatives are available for as little as $50. No specific dollar claim was offered in the lawsuit.

Bayer has not filed an answer to the complaint. The suit is one of dozens filed against the German pharmaceutical company since it agreed to stop marketing the drug last fall after studies suggested its use could lead to serious side effects, even death.

Bayer acknowledges the lawsuits in its securities filings, stating that it is working with health authorities to resolve questions surrounding the drug and that it has "taken accounting measures for anticipated defense costs."

Trasylol, a drug made from cow lung tissue, was approved by the U.S. Food and Drug Administration in 1993 to reduce bleeding during heart bypass surgery. Its generic name is aprotinin. In 2006, studies published in The New England Journal of Medicine and the journal Transfusion suggested that the drug could be associated with higher risks for kidney problems, heart attack and stroke.

In November, the FDA announced that at its request, Bayer would stop marketing Trasylol pending further review of a Canadian study that suggested it increases the risk of death. Dr. Brett Sheridan, a cardiothoracic surgeon at the University of North Carolina at Chapel Hill's medical school, says he stopped using Trasylol in 2002. He had no data, only experience suggesting kidney problems associated with the drug. Sheridan says alternative drugs are not as "robust" as the Bayer product, but he did not want to risk harming patients. He says if there is more bleeding, he can turn to blood transfusions.

But Dr. T. Bruce Ferguson, a cardiothoracic surgeon at East Carolina University, says the loss of Trasylol removes a tool for doctors in complicated cases. Ferguson cites Jehovah's Witnesses, who refuse blood products such as transfusions on religious grounds.

"In the right patients, selected appropriately, aprotinin is a very effective drug," Ferguson says. "But you have to meet those caveats." The North Carolina suit, which seeks class-action status, specifically excludes from the potential class those pursuing any personal injury or wrongful death claim.

Dallas, Texas, attorney Angel Reyes, who is representing individuals suing Bayer on either injury or death claims, says Bayer reaches agreements with hospitals to use its drug. He also claims that some studies indicate Bayer's drug is not more effective than alternative bleeding-control drugs. Meanwhile, Stewart Weltman, a Chicago attorney who has filed and defended class-action suits, is not convinced of the strength of the North Carolina case. He calls it a "tag-along" lawsuit, a genre that follows in the path of personal injury claims.

Weltman says that if there is a claim, it should be a personal injury one, and if patients suffered no physical harm, they could not have suffered economically. He says doctors likely chose Trasylol for their patients because it was more effective than the alternatives.

TRASYLOL
• Drug name: Trasylol (generic name is aprotinin)
• Uses: Injectible drug used to control bleeding during heart surgery
• Pharmaceutical company: Bayer Corp., based in Leverkusen, Germany.
• FDA approval date: Dec. 29, 1993
• Sales: From 1Q through 3Q 2007, Trasylol sales amounted to $135 million worldwide; $91 million from the U.S.
• Risks: In January 2006, The New England Journal of Medicine published an article that associated Trasylol withrenal toxicity, heart attack and stroke. Another publication, Transfusion, suggested the drug causes renal failure.

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