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The Baycol / Lipobay - Scandal

Bayer faces German probe and US lawsuit

(September 5, 2001) - Bayer is facing an investigation by German prosecutors into possible negligence over its Baycol cholesterol drug, which has been linked to more than 50 deaths.

The move by the Cologne state prosecutor comes as lawyers from more than 50 US firms gather in Chicago today to co-ordinate a class-action suit against the German chemicals and pharmaceuticals group.

The Cologne probe will focus on whether Bayer reacted quickly enough to withdraw the drug, called Lipobay outside the US, after reports of side effects, said Jurgen Kapischke, state prosecutor. At the Chicago meeting lawyers representing hundreds of patients and their families will decide a strategy to extract maximum damages from Bayer.

"It's all about rolling up our sleeves and working together," said Kenneth Moll, one of the lawyers.

Mr Moll said tasks to be shared included examining medical records and Bayer's marketing campaigns.

The firms have already filed a petition to consolidate their moves into a class-action suit. Today, three doctors who specialise in heart disease will address the lawyers.

Experts said the Cologne prosecutor would find it difficult to establish whether Bayer was negligent in not withdrawing the drug earlier.

Marc Pfeffer, a Harvard professor who has studied the safety of Pravastatin, a cholesterol-lowering treatment made by Bayer's rival Bristol-Myers Squibb, said it was extremely difficult for companies to spot rare side-effects, even in big clinical trials.

Determining when Bayer knew about the problem would have been "a mathematics game", he said. "It's a question of who knew what, when and how long does it take them to cry (to the regulators)".

Bayer, which blames the deaths on a cross-reaction with another fat-reducing drug gemfibrozil, said it had acted responsibly and in the interest of patient health and safety.

Analysts have put the potential cost of the litigation at between Dollars 500m and Dollars 3bn. However, lawyers concede that it will not be easy to prove a connection between the drug and the deaths, or to establish fault on the part of Bayer.

Bayer has made no provisions for costs arising from the lawsuits.

The company has said it believes the claims are unfounded, and that it would strongly contest them.

Bayer shares have fallen 20 per cent since the withdrawal on August 8 because of concerns about profit impli-cations and potentially costly legal action from those claiming to have suffered from the drug, as well as uncertainty about the company's future corporate strategy.



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