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Accutane Litigation

Accutane is a drug manufactured by Roche Pharmaceuticals for the treatment of severe and non-responsive forms of acne – primarily, cystic acne – from June 1982 to June 2009. Roche reported in 2000 that 13 million people had been prescribed Accutane worldwide, some 5 million of whom resided in the United States – all at a profit of approximately $1.2 billion for Roche Pharmaceuticals.

Accutane Side Effects

Accutane has since been linked to a number of serious side effects, including life-threatening birth defects, clinical depression and suicidal tendencies, seizures, and an assortment of serious gastro-intestinal and bowel injuries, as well as a potentially elevated risk for colon cancer.

Accutane and Suicide

Psychologically, Accutane has a strong enough association with depression, suicidal ideation, and suicide attempts that Accutane was the first medication the FDA required to include a strongly worded warning about the possibility of suicide and other emotional side effects – a measure which the FDA soon duplicated with other similar-risk drug categories, including anti-depressants prescribed for adolescents. Additionally, the FDA convinced Roche to require potential Accutane users (or their parents) to sign an "informed content" form that details these risks of Accutane.

Accutane Suicide Lawsuits

About 200 suicides have been reported in alleged association with Accutane, and a number of lawsuits have been filed, including lawsuits from the families of Charles Bishop and Steven Wertheimer, two adolescent boys who committed suicide, the families claim, as a result of their use of Accutane. Bishop flew a small propeller plane into the Bank of America Tower in Tampa, Florida; Wertheimer stepped in front of a commuter train that ran near the football field of his high school in Palo Alto.

While many lawsuits regarding Accutane-related suicides have not been pursued to their conclusion - the Bishop family withdrew their case due to emotional stress, for example - many of these suits have been settled by Roche under confidential terms. The lawsuits that remain are, generally, still in progress.

In Feburary 2010, for example, a suit filed by Virginia Palazzolo, the mother of an alleged Accutane suicide victim, made a promising technical victory in a New Jersey appeals court that allows the admission of expert testimony which claims a direct link between the development of suicidal tendencies and Accutane.

Manufacturer Liability

Additionally, a larger number of lawsuits have been successfully brought against both Roche Pharmaceuticals and individual health care providers for their failure to inform some patients of the potential physical side effects of Accutane; the liability lawsuits against Roche have resulted in over $33 million dollars in judgments awarded to consumers.

Accutane Litigation Settlements

A May 2007 trial saw one man awarded $2.5 million dollars from Roche; a subsequent trial in April 2008 resulted in an awards against Roche for $10 million dollars, to a woman who required removal of a substantial length of her intestines after taking Accutane.

Most notably, a New Jersey jury convened in November of 2008 found that Roche was liable for $13 million dollars worth of injuries to three plaintiffs who had developed gastro-intestinal illnesses and disorders, including inflammatory bowel disease, for their failure to properly advise physicians as to the serious risks of Accutane treatment.

Successful Manufacturer Appeals

Roche has actively appealed all judgments for physical injury; however, Roche's appeals have rarely been fruitful for the company. A separate New Jersey lawsuit, regarding Accutane's connection to birth defects, was reversed on appeal after the court found that Roche had not been negligent in warning health care providers of the risks of taking Accutane during pregnancy after being presented evidence of Roche's efforts independently and in cooperation with the FDA to prevent pregnant women or women at risk of pregnancy from being prescribed Accutane. A Florida award against Roche in October 2007 for $7 million dollars, to a man who required a colon removal after taking Accutane, was overturned on second appeal two years later on the grounds that Roche's labeling was sufficient to inform prescribing physicians of Accutane's risks.

Cessation of Accutane Sales

Appeals against the other awards have been unsuccessful, however, and Roche has since stopped manufacturing Accutane, citing falling profitability due to the rise of generic isotretinoin production. This was coupled with an increase in litigation-related costs, including attorneys fees and awarded damages. Roche is still liable for injuries suffered by consumers as a result of their Accutane use while they produced the drug, however.