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Accutane

Have you been diagnosed with Ulcerative colitis, Crohns disease or Inflammatory bowel disease (IBD)? Are you experiencing the symptoms of IBD, including chronic pain in the intestines, cramping, diarrhea, weight loss and bleeding? Have you had part or all of your colon removed as a result of the chronic pain? If so, have you been prescribed Accutane (or another isotretinoin) as a solution for acne in the past?

Use of the acne medication isotretinoin (Accutane) is associated with an increased risk of inflammatory bowel disease (IBD), according to researchers from the University of San Diego. Inflammatory bowel disease refers to two chronic conditions that cause inflammation of the digestive tract, known separately as ulcerative colitis and Crohns disease.  

Accutane has been used by more than 13 million people worldwide and was one of Roche Pharmaceutical’s best-selling drugs, with about $200 million a year in sales before its patent expired in 2002. 

During a New Jersey trial in 2010, startling evidence was released that showed that Accutane maker Hoffman-LaRoche was aware of the Accutane side effects as early as 1978.   Despite studies that showed the drug's tendency to cause gastrointestinal disorders in more than 20% of patients treated with Accutane, the FDA approved the drug for prescription and use of severe nodular acne in 1982.  
 
Furthermore, when the drug was approved in 1982, the drug was known to cause birth defects if taken during pregnancy and was labeled with warnings to that effect. In 2005, the Food and Drug Administration (FDA) implemented the stringent iPledge program, requiring patients, doctors and pharmacists to join a risk-management registry to try to ensure that women didn’t become pregnant while on the drug.

In June 2009, Roche pulled Accutane from the market sighting competition from generic versions of the drug and the costs of personal injury lawsuits as the reason. Although the scientific studies have not been conclusive, juries presented with the evidence have sided with the plaintiffs in the seven lawsuits against Roche so far.   These lawsuits have cost Roche $50 million in damages so far. To date, approximately 5,000 personal injury lawsuits have been filed against Roche, and since many people who are diagnosed with IBD don’t make the connection to their use of the acne medication Accutane initially, the number of lawsuits is likely to increase.  

There are currently three different generic versions of Accutane on the market in the United States and because these medications contain Isotretinoin, they carry the same risk of developing IBD as Accutane. The generic names of these drugs are Amnesteem, Claravis and Sotret.   

NJ Accutane Verdicts

There are thousands of lawsuits facing Hoffman-LaRoche, many of which will go to trial in New Jersey because Roche’s USA unit, Hoffman-LaRoche, Inc. is based in Nutley, NJ. For that reason, it is important to understand the New Jersey Court’s treatment of the Accutane Verdicts. Following is a timeline of Verdicts in cases against Swiss drug giant Roche as a result of problems caused by the acne drug, Accutane. 

McCarrell Litigation 

The First of the Accutane cases to go to trial in Atlantic County, NJ

May 2007 - A jury in Atlantic City, New Jersey awarded $2.5 million to Andrew McCarrell, 36, of Alabama, who doctors said suffered severe inflammatory bowel disease (IBD) as a result of taking the Accutane. Roche promised an appeal and disagreed with the verdict. See McCarrell v. Hoffman-LaRoche, Inc., No. L-1951-03 (Law Div. Mar. 12, 2008).

March 2009 – A panel of the Atlantic City, NJ court vacated the judgment for the plaintiff and remanded the matter for a new trial because the court had erroneously restricted the quantitative evidence that Roche was allowed to present to the jury in an effort to contests its liability. See McCarrell v. Hoffman-LaRoche, Inc., No. A-3280-2807 (App. Div. March 12, 2009)

February 2010 – A new jury awards Andrew McCarrell $25.16 million – more than 10 times the originally appealed verdict – after finding that Roche knew or should have known that Accutane caused IBD and failed to warn prescribing physicians. This second verdict is currently on appeal.

Kendall Litigation

The trial court did not have the benefit of the court’s extensive opinion in McCarrell before it proceeded with the Kendall case. However, upon appeal, the Kendall court refers to the McCarrell case several times not because it is precedential, but, because the Kendall court substantially agrees with the McCarrell court’s analysis of the overlapping legal issues.

April 2008 – A jury in Atlantic City, New Jersey awarded $10.5 million to Kamie Kendall, a resident of Utah who took six courses of Accutane between 1997 and 2004. Kamie claimed that Accutane was the cause of her IBD, which resulted in multiple surgeries. Roche appealed this decision.

August 2010 – The Atlantic, NJ court remands this case for a new trial to allow Roche to present similar numerical proofs as was permitted in the McCarrell retrial. 

February 2012 - The New Jersey Supreme Court ruled in favor of Kamie Kendall stating that she filed her lawsuit on a timely basis allowing the case to move forward.

We are hopeful that the forthcoming retrial of the Kendall case will result in a successful jury award for Kamie Kendall, just as the McCarrell case retrial before it. We will continue to update these cases as they continue through the NJ courts.   

Actor James Marshall Trial Update - Greenblatt v. Hoffman-LaRoche 

James Marshall (born James Greenblatt) got his first break when he was cast in the TV series Twin Peaks.  He followed up his television acting debut with a movie role in "A Few Good Men."   While Marshall was pursuing his promising acting career following the buzz of his two roles, he learned that he had IBD and, as a result, needed to remove his colon.  

Sadly, Marshall's role this week is as plaintiff in a New Jersey courtroom as he attempts to hold Hoffman-LaRoche responsible for disrupting his career and creating unnecessary medical troubles as a result of his use of Accutane.

 

Latest Accutane News

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    Everyday Health provides a helpful overview of dietary tips for managing ulcerative colitis symptoms.  Please check our blog updates below for other ways to manage this debilitating disease.