Accutane Litigation

Although Accutane has been in widespread use for almost 30 years, as general litigation in the United States has proliferated in recent years, so has litigation against manufacturers of Accutane and its generic makers. To date, none of the cases has produced any meaningful evidence of safety issues with Accutane that are not disclosed on the current Accutane labels.

It has been reported that there are over 750 pending lawsuits against makers of Accutane in the United States. Although the allegations in the pending lawsuits vary, the most common allegations in the current lawsuits relate to (a) inadequate warnings of severe depression (in some cases leading to suicide) and (b) whether Accutane caused the plaintiff to suffer inflammatory bowel disease. The latter disease, inflammatory bowel disease refers to two chronic diseases that cause inflammation of the intestines: ulcerative colitis and Crohn's Disease. Ulcerative colitis is a chronic inflammation and ulceration of the inner lining of the cells of the colon. Crohn's disease is similar to ulcerative colitis, in that it causes inflammation and ulcers, but it can attack any part of the digestive tract. Inflammatory bowel disease occurs when a trigger sets off an immune reaction, or inflammation, and for some reason the patient is unable to regulate the body's response. The causes of inflammatory bowel disease remain largely unknown. However, several factors are associated with a statistically-increased rate of inflammatory bowel disease, including family history, prior infections, and the frequent use of antibiotics. The peak age of onset of inflammatory bowel disease is young adulthood. Inflammatory bowel disease is a permanent condition, although the symptoms may remit and recur. The common symptoms of inflammatory bowel disease include diarrhea, gastrointestinal bleeding and rectal bleeding. About seventy percent of patients diagnosed with Crohn's disease undergo surgery to remove their colon.

A large number of the pending Accutane cases were consolidated on a mass tort docket in Atlantic County, N.J., in 2005, but handful were left in Essex County, which claimed psychiatric injury. Hoffman La Roche, the original manufactuer of Accutane is based in New Jersey, which has led to the filing of many of the cases in that state. Most of the cases filed in federal court were consolidated in Florida courts. For some useful materials relating to this mass tort designation, see the various materials submitted by the parties which are provided here and are supplemented here.

1. Inflammatory Bowel Disease Cases.

One of the main issues with the inflammatory bowel disease cases involves whether there is an adequate and provable connection between the taking of Accutane and suffering inflammatory bowel disease.

Many of the recent cases have been dismissed or resulted in judgements in favor of the Accutane manufacturer on the grounds that no connection could be found between the taking of Accutane and the subsequent diagnosis of inflammatory bowel disease. In many cases, the evidence did not show that the incidence of inflammatory bowel disease among Accutane patients was higher than in the general population. Other cases have been resolved in favor of the drug manufacturer on the grounds that the Accutane warning label disclosing risks relating to inflammatory bowel disease were adequate. There are a handful of research studies that suggest some connection between inflammatory bowel disease and Accutane, although none appear to provide any evidence of a direct cause or link.

An illustrative example of the litigation in this area is provided in the recent case of HOFFMANN-LA ROCHE INC. and ROCHE LABORATORIES INC., Appellants, v. ADAM W. MASON, Appellee. Case No. 1D08-2032 (District Court of Appeal of Florida, First District October 27, 2009). In that case, a Florida Appellate Court reversed a trial decision in favor of the plaintiff. The Appellate Court noted that any inadequacies in Accutane's warning label could not have been the proximate cause of Appellee's injury because the prescribing physician understood that there was a possibility that use of the drug could lead to inflammatory bowel disease and he made an informed decision to prescribe the drug despite this risk. The Appellate Court concluded that because the plaintiff presented no evidence to establish proximate cause, the trial court decision had to be reversed.

In another case, ANDREW MCCARRELL, Plaintiff-Respondent, v. HOFFMAN-LA ROCHE, INC., and ROCHE LABORATORIES, INC., Defendants-Appellants, NO. A-3280-07 (SUPERIOR COURT OF NEW JERSEY APPELLATE DIVISION 2009), the plaintiff alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease. The inflammatory bowel disease led to the surgical removal of his colon and other serious medical complications. A jury returned a verdict in plaintiff's favor on his products liability claim against Roche. On appeal, the Appellate Court reversed the decision solely because of certain statements made by the plaintiff's expert and the failure to permit the defendant to offer counter-proof. This case contains an extensive discussion of the various studies addressing Accutane and inflammatory bowel disease. The case was retried and on February 16, 2010, the jury returned a verdict in favor of the plaintiff in the amount of $25 million. An appeal is expected again in the case.


2. Depression Cases.

Many of the cases relating to claims of depression relate to the adequacy of the warnings given. In many of the decided cases, the courts have found the warnings to be adequate.

For example, in the recent case of WILLIAM SNYDER, Plaintiff, v. HOFFMAN-LAROCHE, INC., et al., Defendants, Case No. 8:07-cv-1282-T-30TBM. United States District Court, (M.D. Florida, Tampa Division. October 30, 2008), the District Court dismissed hte plaintiff's case on the grounds that the warnings given relating to depression were adequate. A similar decision was issued by United States Court of Appeals for the 11th Circuit in 2009. In LAURIE A. STUPAK, Plaintiff-Appellant, v. HOFFMAN-LA ROCHE, INC., ROCHE LABORATORIES INC., Defendants-Appellees, No. 07-15980. (United States Court of Appeals, Eleventh Circuit. June 10, 2009), the Court of Appeals affirmed the District Court's dismissal of the plaintiff's case. In this case, the plaintiff claimed that the defendant was liable under negligence and strict liability for failing to warn that Accutane could cause suicide without premonitory symptoms, even though the label warned of risks of depression.

A recent appellate decision in February 2010 involves allegations regarding Accutane and severe depression. This case illustrates some of the difficulties with this line of cases. In CARLA GRAY, Plaintiff-Appellant, v. HOFFMAN-LA ROCHE, INC.; ROCHE LABORATORIES, INC.; ROCHE PHARMACEUTICALS, No. 02-7079 (10th Cir 2010), the Court of Appeals reversed the trial court jury verdict in favor of Hoffman-La Roche on the grounds that the judge improperly refused to admit certain expert testimony regarding the plaintiff's depression. In this case, the plaintiff claimed that Accutane caused her to experience severe depression. The lawsuit alleged that the plaintiff took Accutane to treat acne for a number of years and claims to have suffered from severe depression during that time. The plaintiff filed a complaint against Roche in the United States District Court for the Eastern District of Oklahoma. She alleged Roche was liable because it failed to adequately warn either her or her doctor about Accutane’s possible psychiatric side effects. The plaintiff proceeded under three Oklahoma state law causes of action: (1) manufacturer’s products liability; (2) negligence; and (3) breach of express and implied warranties. A jury returned a verdict in favor of Roche.

The outcome of many of the pending cases is expected to be sorted out over the next few years. In the interim, Roche has discontinued selling Accutane in the United States.