* UPDATE: In October 2018, New Jersey’s Supreme Court dismissed more than 500 lawsuits against Hoffmann-LaRoche, saying warning labels for its Accutane treatment were adequate.
People who took Accutane (isotretinoin) suffered severe side effects. These side effects included depression, suicide, ulcerative colitis and Crohn’s Disease.
Thousands of these patients and their loved ones sued Hoffman-LaRoche. They claimed the drugmaker did not warn them about the dangers of Accutane.
Judges dismissed the majority of Accutane lawsuits. Jury verdicts in favor of Accutane users were overturned.
But, in 2017, an appellate court reinstated Accutane lawsuits filed in state court in New Jersey. The state’s high court dismissed more than 500 suits on Oct. 3, 2018.
There have been no known large-scale settlements for patients injured by Accutane.
Status of Accutane Lawsuits
Accutane lawsuits were previously consolidated in Florida federal court. These cases wrapped up years ago in favor of Hoffman-LaRoche. This effectively put an end to federal Accutane lawsuits against the manufacturer.
More than 7,000 patients and family members filed Accutane lawsuits. Judges consolidated many of the federal cases into a multidistrict litigation in the Middle District of Florida.
Multidistrict litigation (MDL) is a way for federal courts to organize large numbers of similar lawsuits.
U.S. District Judge James Moody ultimately dismissed all the federal Accutane cases. Moody ruled that the warning label on Accutane was adequate.
A New Jersey state court organized thousands of cases filed in the state. The court grouped the cases under a different type of litigation known as multicounty litigation (MCL).
Juries ordered Hoffman-LaRoche to pay millions to patients. But, judges overturned those verdicts.
The New Jersey MCL judge dismissed more than 2,000 Accutane lawsuits. An appellate court reinstated those cases in 2017.
Hoffman-LaRoche appealed the reinstatements. The state Supreme Court agreed to consider the drug company’s appeals.
Injuries Mentioned in Accutane Lawsuits
The majority of Accutane 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.
Some people who sued Hoffman-LaRoche blamed Accutane for psychosis, depression and suicide. Others alleged the drug caused birth defects.
Accusations Against Accutane Manufacturer Hoffman-LaRoche
Accutane lawsuits said the drug is “defective.” The lawsuits also claimed the drug is “dangerous to human health, unfit and unsuitable to be marketed and sold in commerce.”
They said Accutane “lacked proper warnings as to the dangers associated with its use.” Lawsuits claimed Hoffmann-LaRoche had knowledge of a link between gastrointestinal symptoms and Accutane.
Before the FDA approved Accutane in 1982, it raised concerns about these issues. Despite this, Hoffmann-LaRoche did not include any warnings about the risk of IBD.
Hoffmann-LaRoche reportedly settled some individual cases before they went to trial. But, there are no publicized reports of any large-scale settlements.
Hoffmann-LaRoche took Accutane off the market in 2009. It successfully fended off thousands of lawsuits.
The lawsuits alleged the company had endangered patients by marketing a harmful product.
Hoffmann-LaRoche argued people who filed lawsuits could not prove Accutane injured them.
The manufacturer claimed there were no scientific studies linking Accutane to IBD or suicide.
The manufacturer maintained they had given ample warning to patients about the potential side effects of Accutane.
Juries ordered Hoffmann-LaRoche to pay more than $53 million to Accutane patients. This total comes from several large judgments.
But, the company appealed the verdicts. Judges ruled in favor of Hoffmann-LaRoche in the majority of the cases.
In 2002, Julia Bishop filed a lawsuit against Hoffmann-LaRoche. Her 15-year-old son Charles Bishop crashed a Cessna into the 28th floor of the Bank of America Building in Tampa, Florida. Bishop claimed Accutane caused her son to commit suicide. She demanded $70 million from Hoffmann-LaRoche, The Tampa Tribune reported. Five years later, Bishop withdrew her lawsuit. Her attorneys said she was emotionally and physically unable to continue due to personal attacks by the drugmaker.
Carla Gray of Ada, Oklahoma, took her Accutane depression case to trial in 2002. She asked for $3 million because the drug company failed to warn about depression. A jury denied her claim.
Kathleen Rossitto and Riley Wilkinson
Kathleen Rossitto and Riley Wilkinson won their lawsuits in June 2012. Rossitto and Wilkinson claimed Accutane caused them to develop inflammatory bowel disease. A New Jersey court ordered Hoffmann-LaRoche to pay $18 million in compensatory damages. The women were to receive $9 million each. Hoffmann-LaRoche appealed. The appellate court granted the manufacturer's appeal. It found that the trial court judge “seriously erred" when it allowed some revelations in court while restricting others. FiercePharma reported on this ruling in 2016.
Accutane Class Action
To date, there have been no known class action lawsuits involving Accutane. People filed individual lawsuits against the drug’s manufacturer.
A court in Florida managed the federal Accutane lawsuits. The lawsuits were part of a multidistrict litigation (MDL).
State Accutane lawsuits in New Jersey were managed under a multicounty litigation (MCL).
Please seek the advice of a medical professional before making health care decisions.