Angry Patients May Be Unable to Pin the Blame on Bayer - Financial Times (London) - September 26, 2001

Angry Patients May Be Unable to Pin the Blame on Bayer: Lipobay’s Withdrawal has Led to Lawsuits
By: David Firn and Adrian Michaels
Financial Times (London)
September 26, 2001

William Kuta's Baycol dosage had been doubled two weeks before, following 11 trouble-free months on the cholesterol-lowering drug. 'I became very weak. I was walking across my living room only by leaning on the furniture. My urine turned very dark brown like chocolate.'

Mr Kuta's condition worsened and he grew weaker. A few days later, when his daughter took him to the hospital: 'I could not lift my legs up to step into the car.'

Mr Kuta, 63, is one of hundreds of people suing Bayer. When the German group withdrew Lipobay - called Baycol in the US - from the market, he heard about it and contacted Kenneth Moll, a lawyer in Chicago.

'I feel I had a lucky escape. One week later and I might not be here talking,' Mr Kuta says.

There is a legal submission to combine all the complaints into one class-action suit. If granted, Bayer could face payments of restitution and damages stretching into billion of dollars.

American Home Products, implicated in diet drugs that were linked to heart problems, has set aside more than Dollars 12bn to cover claims. The legal fight has hung over the company for years and played a part in scuppering merger plans. Only recently have AHP's shares started to emerge from the resultant gloom.

However, lawyers think Bayer has a reasonable chance of defeating the suits. Only a tiny number of the hundreds of lawsuits filed against pharmaceutical companies each year end in a payout - even then compensation awards set by juries are often cut on appeal.

Bayer's case is that its products exhibited warnings on the labels. The company had tried in vain to change prescription behaviour to keep doctors from endangering patients, even writing to every family doctor and cardiologist to warn them of the risks of prescribing high doses of Baycol.

But after more than 50 people died around the world while on the drug, Bayer decided to give up on influencing doctors and withdrew the drug. It remains unclear whether these deaths were caused by taking the drug on its own or by taking it in conjunction with any other drug.

Whatever the legal outcome, there are likely to be some chilling lessons for the entire US medical community - companies and doctors alike.

Companies have traditionally been shielded from litigation by the fact that products are licensed by government agencies such as the US Food & Drug Administration. They also rely on the fact that drugs are not sold directly to consumers, but prescribed by doctors.

However, the string of high-profile drug withdrawals has left regulators looking less than infallible. At the same time, the legalisation of direct-to-consumer advertising of prescription medicines in the US, and a boom in internet access, making US information available globally, has turned medicines into fast moving consumer goods.

The issue of whether, and if so, how any warnings on the medication's labels were conveyed to Mr Kuta has yet to be resolved.

He points out that, in his sixties, it is very difficult to distinguish side-effects from other ailments. 'I'm 63 years old. I've had colds. I've had 'flu. I could not correlate my condition with Baycol until my urine changed colour.'

Mr Kuta was in hospital for four days and was taken off the drug immediately. Back at home in Davis, Illinois, a few weeks later, he says he still lacks stamina. Doctors have not yet told him if he suffered permanent damage, which could affect the case crucially.

Bayer says it acted correctly at all times. After all, every drug has side effects that must be weighed against the benefits. Baycol saved tens of thousands of lives by preventing heart attacks and German regulators cleared Bayer of allegations it hid information.

But Mr Kuta is angry at Bayer and says the drug should have been withdrawn earlier. 'They knew about a year in advance that people were having problems. I feel they were wrong.'