On March 11, 2014, a New Jersey jury awarded $1.59 million (including about $88,000 in past medical expenses) to a woman who developed bowel disease (ulcerative colitis) as a result of using the acne medication, Accutane (isotretinoin), which was manufactured by Switzerland-based Roche Holding AG (“Roche”).
The New Jersey Accutane case was a retrial of the woman’s first Accutane trial that resulted in a jury’s verdict in her favor in the amount of $10.5 million, which was overturned by an appellate court in 2010 because the trial judge improperly barred Roche from introducing evidence regarding Accutane’s use by other acne-suffers over the years (“Roche was unduly impeded at this trial from adducing and advocating numerical proofs that could have potentially and reasonably led a jury to reach a different verdict”).
During the retrial, Roche presented the results of six epidemiological studies from 2009 to 2013 (which were unavailable during the first trial), which Roche argued showed the lack of an association, or inconclusive results, between bowel disease and the use of Accutane. The plaintiff attacked the methodology of the studies and argued that Roche’s internal documents showed evidence of a potential association between Accutane and bowel disease, as early as 1978.
The plaintiff had started using Accutane to treat severe recalcitrant nodular acne in the 1990s, when she was twelve years old. She developed ulcerative colitis when she was 15, which worsened until she had to have her colon removed in 2006, when she was 21. The New Jersey jury found that Roche had failed to provide the plaintiff’s doctors (and therefore the plaintiff) with adequate warning with regard to the risk of developing ulcerative colitis as a result of using Accutane.
Kendall v. Hoffmann LaRouche Inc., New Jersey Superior Court, Atlantic County, Case no. ATL-L-8213-05.
Accutane has been taken by approximately 13 million people since 1982. Roche lost its patent protection for Accutane in 2002 but continued to market Accutane, along with generic pharmaceutical manufacturers. Roche removed its brand-name Accutane from the market in 2009 after juries awarded millions of dollars in damages to former Accutane users. Accutane has also been linked to birth defects and depression.
Additionally, in February 2010, the FDA warned, “There have been post-marketing reports of erythema multiforme and severe skin reactions [eg, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)] associated with isotretinoin use. These events may be serious and result in death, life-threatening events, hospitalization, or disability. Patients should be monitored closely for severe skin reactions, and discontinuation of Accutane should be considered if warranted.”
There are about 7,000 pending Accutane trials in New Jersey and throughout the United States. Since 2007, Roche has lost ten out of thirteen Accutane lawsuits that have gone to trial. In 2012, a New jersey jury awarded $18 million to two Accutane plaintiffs while at the same time rejecting the claims of two other former Accutane users.
If you or a family member suffered injuries as a result of using Accutane or another drug in the United States, you should promptly seek the legal advice of a drug claim attorney in your state who may assist you with your claim.
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