Accutane is a well-known drug used to treat severe recalcitrant nodular acne that is unresponsive to conventional therapy. It is a retinoid (related to vitamin A) that was originally developed as a chemotherapy drug used to treat neuroblastomas. Accutane was first approved by the Federal Drug Administration for the treatment of acne on May 7, 1982. According to its drug label, Accutane inhibits sebaceous gland function and keratinization. Basically, the drug is designed to reduce oil production and assist in sloughing away dead skin cells before they become trapped in pores.
Accutane is commonly referred to as a “last resort” drug because of the severity of the potential adverse reactions it may cause. Suits alleging improper warnings for birth defects, psychological side effects and gastrointestinal side effects have been filed against Hoffman LaRoche, Accutane’s manufacturer, since the early 2000’s. Early lawsuits related to paternal exposure birth defects and psychological side effects were never taken to trial, though many resulted in settlements.
The majority of the Accutane litigation surrounds inflammatory bowel disease, including Crohn’s disease and ulcerative colitis, caused by Accutane. Plaintiffs in those suits allege that the Accutane warning label provided insufficient notice of the risk of gastrointestinal side effects to potential patients. They say that had Hoffman LaRoche provided proper warnings, they would not have ingested Accutane.
The multitude of gastrointestinal cases were consolidated in a multidistrict litigation in New Jersey Superior Court in Atlantic City. In May 2007, the first jury trial resulted in a verdict of over $2.6 million for Plaintiff Andrew McCarrell. In October 2007, the second jury trial resulted in a verdict of $7 million for Plaintiff Adam Mason and in April 2008, the third straight verdict against Roche totaled over $10.5 million in favor of Plaintiff Kamie Kendall.
However, Roche has regularly fought verdicts in these cases. For instance, Mr. McCarrell’s case was retried in 2010 after the initial verdict was reversed on appeal. The second trial resulted in a $25 million verdict and, as anticipated, Roche again appealed. On August 11, 2015, the Appellate Division of the New Jersey Superior Court reversed the $25 million judgment and ordered the trial court to dismiss Mr. McCarrell’s complaint. Because the deadline to appeal to the New Jersey Supreme Court has not expired, it is unclear whether Mr. McCarrell will appeal the intermediate court’s ruling. However, after nearly seven years in the court system and suffering through two separate, lengthy trials, one would expect Mr. McCarrell’s counsel to appeal this recent decision.
As there are currently 6,000 cases pending in New Jersey, a full history of each Accutane case is beyond the scope of this article. However, one thing is certain: Roche is not giving up the battle, and neither are the Plaintiffs’ attorneys who continue fighting for their clients.
Written by:
Jennifer Bruning
Approved by Francisco Guerra, IV
WATTS GUERRA, LLP
Four Dominion Drive, Bldg. Three, Suite 100
San Antonio, Texas 78257
Phone: (210) 447-0500
*This information is provided only to supply information and should not be received as legal advice. Legal advice is only given to persons or entities with whom Watts Guerra LLP has established an attorney-client relationship.
© Watts Guerra LLP 2015
