More Injuries Caused by Accutane - Maker Pays $2.6 Million for Failure to Warn of Risk of Bowel Injury

by Sandra Cassidy

On May 29, 2007 a New Jersey state court jury handed down a $2.619 million verdict for injuries caused by Accutane against pharmaceutical company Hoffman-La Roche Inc. headquartered in Basel Switzerland with local manufacturer Hoffmann:LaRoche based in Nutley, New Jersey.

Accutane with known links to birth defects, suicide and othere injuries is prescribed for the treatment of acne. Accutane, generically known as Isotretinoin, is a synthetic derivative of Vitamin A and is one of the top three drugs for the most reported adverse side effects on the FDA's database.

Roche submitted its "new" drug application in July 1981 and the FDA approved it less than a year later on May 21, 1982. Within the next five years 1000 babies were born missing ears, major organs and portions of the brain. Others were stillborn. Still others were aborted.

Andrew McCarrell, a 36-year-old computer manager from Moody, Alabama, had to have his colon removed after taking the drug in 1995. McCarrell testified that he had not slept through the night since becoming ill. "On a bad day, I really can't get out of bed," he told jurors "When I wake up, my body just doesn't work. I stay in bed or lay on the couch all day."

Hoffmann-La Roche was represented by company lawyer Andrew See. Attorney Michael Hook and Brian Barr, together with five law firms who jointly represented these claims for nearly 600 plaintiffs argued that Roche's drug Accutane was defective and unreasonably dangerous in that it had the potential to cause inflammatory bowel disease in patients who took the drug and that Roche failed to adequately warn about the potential for the drug to cause bowel injury. The jury found the company failed to warn that its acne drug Accutane can cause inflammatory bowel disease. Roche lawyers said the disease's cause is unknown and drug-label warnings were adequate and they plan to appeal. Andrew McCarrell v. Hoffman-La Roche Inc., et al., No. ATL-L-1951-03 MT, New Jersey Superior Court (Atlantic County). 

According to classAction.com Hoffmann-LaRoche is part of "The Roche Group" the seventh largest pharmaceutical company in the world made up of numerous subsidiaries and active in more than 150 countries. The Roche Group is well known throughout the legal system with regards to both civil and criminal activity and has budgeted over one billion dollars for criminal fines, penalties, and settlement of cases. Their corporate executives have been sentenced to prison for their activities.

French studies since 1997 showed users of Accutane/Roaccutane suffered from severe depression and suicidal ideation and the French warned its consumers.

In 1998, the Food and Drug Administration advised doctors who prescribe Accutane to monitor their patients for signs of depression. Subsequently, the manufacturers of Accutane, Hoffman-LaRoche, notified doctors that the drug "may cause depression, psychosis, and, rarely, suicidal ideation, suicide attempts and suicide."

However, the knowledge of the potential danger associated with Accutane did not become widely known until a Congressman's son committed suicide.

Rep. Bart Stupak stated that his 17-year-old son's suicide may be linked to the popular acne medicine. Bart Stupak, Jr., a popular student, shot himself in the head after a prom-night party. Stupak also stated that, "the average time is 88 days from when you start taking it, and the effect is very sudden…. You are doing strange things at 3:00 a.m. and you are dead at 7:00 a.m." After taking the drug, he developed chronic diarrhea and incontinence, and underwent multiple surgeries resulting finally in the removal of his colon.

Accutane is one of Hoffmann-La Roche's top three drugs, having sales of approximately 1.2 billion dollars annually. Because of Accutane, Hoffmann-LaRoche was the subject of a 2002 Congressional investigation by the Subcommittee on Oversight and Investigations of the House of Representatives Energy and Commerce Committee. Congressman Bart Stupak, stated the following during the Congressional Investigation:

" The drug manufacture, Hoffmann-LaRoche, Roche here in the United States, has continued to put profits before people. They have done everything possible to prevent the American people from learning of the psychiatric injuries and deaths associated with Accutane. Even, today, I'm sure Roche will still deny any casual effect of Accutane with the abortions, deaths, and suicides caused by their product."

The President and Chief Executive Office of Hoffmann-LaRoche, Inc. (USA), George B. Abercrombie, also testified before the Committee. After giving various statements and making representations under oath regarding studies, marketing, clinical trials, and Roche's relationship with entities in Mexico, Mr. Abercrombie was told by two members of the Committee that his testimony was not credible and was given in front of the Committee with a "straight face". Significantly, not a single member of the Committee spoke in support of Hoffmann-LaRoche. This investigation is presently ongoing.

The FDA has restricted the writing of prescriptions for Accutane. They must be written on a valid prescription (telephone, fax, and computer-generated prescriptions are not valid); they must have a yellow sticker with a registration number on it; patient education booklets must be dispensed with every filling; they may not be written for more than a one-month supply; and they must be filled within 7 seven days of being written.

The stated birth defects include deformed eyes, nose, ear or absent ears, enlarged head, small chin and retardation. And just to cover all the bases, Hoffmann-La Roche added a catch-all defects category including "brain, heart, glands, and nervous system," which, combined with the known effects on circulation, bones and muscles... means it is safe to say there isn't a single thing which can go wrong with your body that isn't associated with Accutane, except maybe a bad case of acne.

Of all the symptoms a sudden blindness is probably the most distressing the insert reads: "Vision Problems While taking Accutane you may develop a sudden inability to see in the dark, so driving at night can be dangerous. This condition usually clears up when you stop taking Accutane, but it may be permanent." Perhaps blindness is precisely what the FDA, Hoffmann-la Roche and the corporate minions who walk in lock step to drug profits are suffering from.

Sources
Harvard review
Accutane-lawsuit.htm
Public Citizen links Accutane to Birth Defects

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