Roche has suffered a legal setback with the news that a jury in New Jersey declared that the Swiss company did not warn a plaintiff in the first of 400 lawsuits that its Accutane acne drug can cause inflammatory bowel disease.
The jury awarded Andrew McCarrell $2.62 million after they heard that when he took Accutane (isotretinoin) from June to October 1995, he started to suffer from achy knees and chapped lips. Months later, Mr McCarrell began to suffer abdominal pain, was diagnosed with inflammatory bowel disorder and had his rectum and most of his colon removed.
The plaintiff’s lawyers claimed that the warning on the drug’s label was insufficient and the jury agreed, saying that Roche had not been specific about the real extent of the risk of inflammatory bowel disorder. Nevertheless, the jury did not find that the firm had violated New Jersey's Consumer Fraud Act, which bars misrepresentations about a product's safety, so it will not have to pay any punitive damages.
Roche issued a statement saying that it has significant grounds for appeal and will pursue them, claiming that “the cause of inflammatory bowel disease remains unknown and there is no reliable scientific evidence” that Accutane causes it. The firm believes the present label is adequate and noted that 13 million people have taken the drug since it was introduced in 1982.
Accutane's links to suicidal behaviour and birth defects are more widely recognised and the label includes a bold-typed warning about psychiatric disorders and has the words 'causes birth defects' and 'do not get pregnant' on the packaging, with an illustration of a pregnant woman and a circle with a slash through it. A plain-typed warning states that the drug has been “temporally associated” with inflammatory bowel disease.
Given that this is the first of 400 such cases pending, observers are waiting to see what Roche’s response will be to the other lawsuits and whether it will look to settle them.
Roche signs AIDS technology transfer deals in Africa
On a more positive note, Roche announced that it has agreed free AIDS technology transfers with two laboratories in Africa. Agreements have been reached with Addis Pharmaceutical Factory in Ethiopia and Varichem Pharmaceuticals in Zimbabwe which will see the two laboratories receive free technical know-how enabling them to produce a generic anti-HIV treatment, based on the process for manufacturing the antiviral saquinavir, sold by Roche as Invirase.
Under the Basel-based firm’s technology transfer programme, which was initiated in January 2006, the company has so far signed deals with five African laboratories and received expressions of interest from 32 manufacturers in 15 eligible countries, including Kenya, Ghana, Zimbabwe and Nigeria.