Patients who said taking Accutane for their acne caused serious side effects sued the drug’s maker, Hoffmann-LaRoche, seeking compensation for medical expenses, lost wages, and pain and suffering. The majority of Accutane lawsuits have been dismissed.
Number of Lawsuits About 7,000 at peak of litigation
Plaintiff Injuries Birth defects, depression, suicide, ulcerative colitis and Crohn’s disease
Defendants Hoffmann-LaRoche (now Roche)
MDL Location Formerly in Middle District of Florida
MCL Location Superior Court of New Jersey
Litigation Status MDL closed; MCL active
People who took Accutane (isotretinoin) suffered severe side effects, including depression, suicide, ulcerative colitis and Crohn’s Disease. Thousands of these patients and their loved ones sued the drug’s maker, Hoffman-LaRoche, saying they were not warned about the dangers of the drug.
Judges dismissed the majority of Accutane lawsuits. However, an appellate court in 2017 reinstated more than 2,000 lawsuits filed in state court in New Jersey, and the state Supreme Court was considering whether they should be allowed to move forward.
There have been no known large-scale settlements, and jury verdicts in favor of Accutane users have been overturned. Drugwatch’s legal partners are not taking Accutane cases at this time.
Accutane lawsuits consolidated in Florida federal court wrapped up years ago in favor of Hoffman-LaRoche, effectively putting an end to federal Accutane lawsuits against the manufacturer. However, an appellate court in 2017 revived consolidated proceedings in state court in New Jersey when it reinstated 2,000 Accutane lawsuits.
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, or MDL, is a means for federal courts to organize large numbers of similar lawsuits filed around the country by having a single judge issue all pretrial rulings.
U.S. District Judge James Moody ultimately dismissed all the federal Accutane cases. Moody ruled that the warning label on Accutane was adequate.
State court in New Jersey organized thousands of cases filed there under that state’s equivalent to an MDL, known as multicounty litigation, or MCL. Juries ordered the drugmaker to pay millions to patients, but judges overturned those verdicts.
The New Jersey MCL judge dismissed more than 2,000 Accutane lawsuits. But an appellate court in 2017 reinstated those cases. The state Supreme Court has agreed to consider the drug manufacturer’s appeals of the reinstatements.
The majority of Accutane lawsuits claimed the drug caused inflammatory bowel disease (IBD) — a condition that involves chronic inflammation of the gastrointestinal tract. IBD typically manifests in one of two diseases: ulcerative colitis or Crohn’s disease. IBD is a permanent condition.
Inflammatory bowel disease (IBD) and suicide were among the injuries mention in Accutane lawsuits.
Other patients and family members claimed in lawsuits that Accutane was unsafe because it caused psychosis, depression and suicide. Still others alleged the drug caused birth defects.
Accutane lawsuits say the drug (also known as Roaccutane and generically as isotretinoin) is “defective, dangerous to human health, unfit and unsuitable to be marketed and sold in commerce, and lacked proper warnings as to the dangers associated with its use.”
Hoffmann-LaRoche had knowledge of a link between gastrointestinal symptoms and Accutane, according to lawsuits. 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. However, there have not been publicized reports of any large-scale settlements.
Hoffmann-LaRoche took Accutane off the market in 2009. It successfully fended off thousands of lawsuits alleging it had endangered patients by marketing a harmful product. When it lost jury trials, the company often filed successful appeals.
Hoffmann-LaRoche argued that people who filed lawsuits had not proven that Accutane caused their injuries and that there were no scientific studies proving Accutane can cause IBD or suicide. Moreover, Hoffmann-LaRoche maintained it had given ample warning to patients about potential side effects.
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, and judges ruled in favor of Hoffmann-LaRoche in the majority of the cases.
In 2002, Julia Bishop filed suit against Hoffmann-LaRoche after 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 and 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 following what they described as 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
In June 2012, a New Jersey court ordered Hoffmann-LaRoche to pay $18 million in compensatory damages to Kathleen Rossitto and Riley Wilkinson. Both women claimed Accutane caused them to develop inflammatory bowel disease. They were to receive $9 million each. Hoffmann-LaRoche successfully appealed. The appellate court ruled that the trial court judge “seriously erred” in allowing some revelations in court while restricting others, FiercePharma reported in 2016.
To date, there have been no known class action lawsuits involving Accutane. People instead filed individual lawsuits against the drug’s manufacturer in both federal and state courts.
The Judicial Panel on Multidistrict litigation consolidated federal Accutane lawsuits into a multidistrict litigation (MDL) in Florida, while state Accutane lawsuits in New Jersey were managed under a multicounty litigation (MCL).
MDLs and MCLs are intended to help move lawsuits through the legal process more quickly and with fewer resources.
Please seek the advice of a medical professional before making health care decisions.
Elaine Silvestrini is a career journalist with a strong desire to learn, explain, and help people. At Drugwatch, Elaine has reported about trials over whether talcum powder caused ovarian cancer and allegations that Androgel causes heart problems in patients who use it. She has chronicled the billions of dollars generated for big pharmaceutical companies by certain drugs and efforts to warn consumers about the dangers of specific medical problems. Elaine has received six health literacy certificates for completing courses offered by the Centers for Disease Control and Prevention. She brings more than 20 years of experience covering state and federal court systems, learning the intricacies of criminal and civil law, developing investigative pieces about how the law affects people’s lives and digging through and digesting reams of court records on a daily basis.