Accutane Lawsuits

Thousands of people who suffered Accutane side effects filed lawsuits claiming the drug’s maker, Roche, did not warn them about the dangers of the medication. The bulk of litigation dealt with Crohn’s disease and ulcerative colitis.

Historically, Accutane litigation has favored the manufacturer. Judges dismissed the majority of lawsuits and overturned jury verdicts that had awarded millions of dollars to plaintiffs.

While an appellate court reinstated lawsuits filed in state court in New Jersey in 2017, the state’s high court dismissed more than 500 suits on Oct. 3, 2018.

There have been no known class actions or large-scale settlements for patients injured by the acne medication. As of October 2022, Drugwatch doesn’t know of any lawyers currently accepting these cases.

At one time, close to 8,000 lawsuits against the makers of Accutane were pending in courts across the country. Judges consolidated many of these into federal cases into a federal multidistrict litigation in the Middle District of Florida under MDL No. 1626.

U.S. District Judge James Moody ultimately dismissed all the federal Accutane cases. He ruled that the warning label on the drug was adequate. The MDL dissolved in 2015, and this effectively put an end to federal lawsuits against the manufacturer.

After the MDL dissolved, most of the remaining Accutane cases continued in multicounty litigation in New Jersey in MCL No. 271. At first, juries ordered Roche to pay millions to patients, but judges overturned those verdicts.

After an appellate court in 2017 reinstated more than 2,000 cases that had been dismissed by the New Jersey MCL judge two years earlier, Roche appealed the reinstatements. The state Supreme Court agreed to consider the drug company’s appeals.

On Aug. 1, 2018, the New Jersey Supreme Court ruled that two plaintiff’s expert witnesses would not be allowed to testify. This made litigating the few remaining Accutane cases difficult since the experts’ testimony connected the drug to inflammatory bowel disease and Crohn’s.

Two months later, the New Jersey Supreme Court dismissed 532 failure-to-warn cases.

“As a matter of law, the warnings provided physicians with adequate information to warn their patients of the risks of IBD,” the judges said in their October 2018 decision.

While some people who sued Roche blamed Accutane for psychosis, depression and suicide, the majority of lawsuits claimed the drug caused inflammatory bowel disease (IBD). IBD is a condition that involves chronic inflammation of the gastrointestinal tract. IBD usually manifests in one of two diseases: ulcerative colitis or Crohn’s disease. IBD is a permanent condition.

Accutane lawsuits said the drug is “defective” and “dangerous to human health, unfit and unsuitable to be marketed and sold in commerce.”

Accusing Roche of having knowledge of the link between gastrointestinal symptoms and the acne medication, plaintiffs claimed the drug “lacked proper warnings as to the dangers associated with its use.”

Before the FDA approved Accutane in 1982, it raised concerns about these issues. Despite this, Roche did not include any warnings about the risk of IBD, lawsuits claim.

But the manufacturer argued that there is no reliable evidence linking the drug to IBD or Crohn’s disease. Roche maintained they had given ample warning to patients about potential side effects.

The American Medical Association also supported the manufacturer against what it called “abusive litigation against physicians.”

Before judges overturned their verdicts, juries had ordered Roche to pay more than $53 million to plaintiffs.

Andrew McCarrell won the first major Accutane verdict in 2007. Juries awarded him $2.7 million after he claimed the drug led him to develop IBD. McCarrell’s lawsuit said doctors had to remove his colon and rectum and he continues to suffer from incontinence.

Roche appealed that verdict, and judges ordered a new trial. After the second trial, the jury awarded McCarrell $25 million in 2010. But in 2017, the verdict was overturned yet again.