Product Liability Attorney Blog

The Coalition against Bayer Dangers has filed a countermotion to Bayer AG’s annual stockholder meeting agenda. The countermotion asserts that the company’s conduct violated the rules of corporate management and cites the marketing of Trasylol as one such instance of allegedly irresponsible corporate conduct.

The filing is a response to a motion made by Bayer which would ratify the actions of management during 2007. The Coalition against Bayer Dangers is urging shareholders to vote against ratification.

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Bayer, the maker of the clotting drug Trasylol, has many faces. Last September, Bayer’s representatives stood before a U.S. Food and Drug Administration advisory board and argued against changing the drug’s warning label. What they didn’t tell the board was that a Bayer-funded study found that patients given Trasylol had a 64 percent higher risk of death than patients given a comparison drug.

In an about face, Bayer agreed in November to suspend marketing of the drug after a Canadian study linked the heart surgery drug with an increased risk of death.

But in December, a straight-faced Bayer sponsored a continuing medical education program that defended Trasylol’s safety and sought to undermine earlier studies, Pharmalot reports. During the 28-minute course, four doctors not only reassured the audience that Trasylol was safe, they criticized an earlier study that warned of dangerous side effects.

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NEWS RELEASE

March 14, 2008

St. Louis – A lawsuit has been filed in a St. Louis federal court against Bayer AG, the maker of the anti-bleeding drug Trasylol, on behalf of a widow whose husband died of kidney failure after open-heart surgery.

On Dec. 16, 2005, Samuel Nakis, 81, underwent open-heart surgery at St. Luke’s Hospital in Chesterfield, Mo. During the surgery he was given Trasylol (also known as aprotinin), a clotting drug used to prevent bleeding. Shortly after the surgery, Nakis experienced kidney failure and underwent dialysis. He died a short time later.

The U.S. Food and Drug Administration approved Trasylol in 1993. On Jan. 20, 2006, the medical journal Transfusion published an article suggesting a link between Trasylol and renal toxicity. Later that same month, the New England Journal of Medicine published an article, by Dr. Dennis Mangano of the nonprofit Ischemia Research and Education Foundation, linking Trasylol to a higher risk of stroke, heart attack and kidney failure.

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Pharmalot notes that doctors at Duke University Medical Center figure prominently on both sides of the debate over Trasylol’s safety.

On one side is Dr. Peter Smith, Duke’s chief of thoracic and cardiovascular surgery. Smith is a consultant for Bayer AG, the maker of Trasylol. Last September, Smith appeared before an FDA advisory committee and testified that the anti-bleeding drug is safe and effective.

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Bayer AG, the maker of the anti-bleeding drug Trasylol, received more bad news yesterday when a federal judge in New Jersey invalidated a patent the company held the contraceptive Yasmin.

The ruling means not only that another company may be able to sell a generic version of the drug but it also calls into question whether a newer version of Yaz, which relies on the patent, will receive legal protection.

Bloomberg News reports that Yasmin is part of a group of contraceptives that brought in $1.58 billion worth of sales last year.

Ulle Woerner, an analyst at Landesbank Baden-Wuerttemberg in Stuttgart, Germany, told Bloomberg News in an interview, “Bayer's lacking a lot of positive news flow at the moment so the market is quite nervous.”

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