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Roche loses trial over anti-acne drug in US

The verdict could open the floodgates to other claims about Accutane's safety

(Ex-press)

Swiss pharmaceutical company Roche has lost the first of 400 lawsuits in the United States, which claim that its anti-acne drug, Accutane, causes inflammatory bowel disease.

Jurors in New Jersey awarded the complainant $2.6 million (SFr3.2 million) after finding that the company had failed to adequately warn patients of the disease risk.

This failure contributed to the complainant contracting the condition, said the jury.

Andrew McCarrell, a 36-year-old manager from Alabama, won $119,000 to cover past medical expenses and $2.5 million in damages to cover future medical costs, pain and suffering.

However, the jury added that Roche had not violated New Jersey's Consumer Fraud Act, which prohibits misrepresentations about a product's safety.

The case was heard in this state as Accutane is manufactured by the Roche unit, Hoffmann-LaRoche, which is based in Nutley, New Jersey.

McCarrell has permanent diarrhoea and had to undergo a series of operations, including one to remove his colon. He took Accutane – which combats cystic acne – in the mid-1990s.

Appeal

Roche says it will appeal against the verdict, emphasising that the drug's packaging has contained a warning about inflammatory bowel disease for over 20 years.

"The cause of inflammatory bowel disease remains unknown and there is no reliable scientific evidence that Accutane causes [the]... disease," the company said in a statement.

Accutane's links to suicidal behaviour and birth defects are better documented.

In 2002 the mother of a boy who had killed himself sued Roche, claiming the drug made him psychotic and suicidal. The company, however, won the case.

The drug's packaging is said to contain detailed instructions on not using the product when pregnant or trying to conceive.

More than 13 million people worldwide have been prescribed Accutane in the 25 years it has been on sale, according to Roche.

swissinfo with agencies

Key facts

Roche, which was founded in 1896 in Basel, has core businesses in pharmaceuticals and diagnostics.
The group is the number one in the global diagnostics markets and is a leading supplier of medicines for cancer and transplantation.

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In brief

Roche 2006 results:
Net profit: SFr9.17 billion
Full-year sales: SFr42.04 billion
Operating profit: SFr11.73 billion
Novartis 2006 results:
Net profit: $7.20 billion
Full-year sales: $37.02 billion
Operating income: $8.2 billion

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