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Accutane Litigation and Verdicts

Approved in 1982, Accutane made billions for Hoffmann-LaRoche. But people who took the drug began filing lawsuits after they say it caused birth defects, depression and suicide, ulcerative colitis and Crohn’s disease. While juries ordered Roche to pay millions to plaintiffs, it appealed the majority of the verdicts.

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People taking the drug Accutane and their families sought legal compensation against the drug's manufacturer after claiming to experience the following conditions:

  • Birth defects
  • Depression
  • Suicide
  • Ulcerative colitis
  • Crohn’s disease
  • Bowel disease

Number of Lawsuits Approximately 7,000

Plaintiff Injuries Birth defects, depression and suicide, ulcerative colitis and Crohn’s disease

Defendants Hoffmann-LaRoche

MDL Location Middle District of Florida, MDL No. 1626

MCL Location Superior Court of New Jersey Atlantic County, MCL No. 271.

Litigation Status MDL inactive, MCL active

People who took Accutane (isotretinoin) and suffered one or more severe side effects claim the manufacturer did not adequately warn consumers and doctors of the drug’s serious risks. These patients filed lawsuits against Hoffmann-LaRoche (Roche) for compensation for medical expenses, lost wages and pain and suffering. Side effects claimed in Accutane lawsuits include birth defects, depression and suicide, ulcerative colitis and Crohn’s disease.

Accutane treats severe acne when other treatments have failed. It was initially developed as a chemotherapy drug.
Then researchers noted the ability of the medication to treat acne. While successful in its dermatological applications, Accutane comes with high risks of complications, including birth defects and serious gastrointestinal side effects.

Accutane's complications include birth defects, gastrointestinal side effects

After the name-brand drug was discontinued, the FDA required strict monitoring of patients who took generic versions of the medication. In addition, there are restrictions on generic drug prescriptions. More than 16 million people worldwide used Accutane since it hit the market in 1982.

Status of Accutane Litigation

At one time, more than 7,000 plaintiffs filed Accutane lawsuits. Judges consolidated many of the cases into a multidistrict litigation (MDL) in the Middle District of Florida. Judges consolidated another group of cases in multicounty litigation (MCL) in New Jersey.

So far, juries ordered Roche to pay millions to plaintiffs, but the company later appealed many of these verdicts and they were overturned. A judge in Florida ruled that a post-2000 warning label on Accutane was adequate, dismissing relevant cases in the MDL.

post-2000 warning label resulted in MDL dismissals

In 2014, the New Jersey MCL judge dismissed more than 600 suits for plaintiff’s failure to respond to discovery requests. Then, in 2015, hundreds more cases filed by plaintiffs who took Accutane after April 10, 2002, were dismissed. According to the judge’s order, the side effects warning label after that date was sufficient.

Another 2,500 to 3,000 lawsuits were cut from the MCL in 2015 because the judge rejected the testimony of plaintiff’s experts linking Accutane to Crohn’s disease. As of March 2017, about 3,347 cases remain in the New Jersey MCL.

In 2017, plaintiff’s attorneys urged a New Jersey appellate panel to revive the New Jersey Accutane litigation.

Accutane Verdicts and Appeals

Juries ordered Roche to pay more than $53 million to Accutane patients so far. This total comes from several large judgments. But the company appealed the verdicts, and appellate trial court judges ruled in favor of Roche in the majority of the retrials.

  • McCarrell v. Hoffmann-LaRoche, Inc. – In 2007, Roche lost its first Accutane trial. A New Jersey jury awarded 36-year-old Alabama plaintiff Andrew McCarrell $2.5 million. McCarrell’s lawsuit claimed he suffered bowel disease after taking Accutane. As a result, he had five surgeries and had his colon removed. That verdict was overturned.

    After another trial in 2011, the second jury awarded McCarrell more than $25 million — the largest Accutane award to date. A judge in that case said that McCarrell’s “testimony and that of his wife and doctors presented a picture of probably the worst case of pain, suffering and loss of quality of life I ever heard described in my eighteen years on the bench.”

    Roche appealed. The appellate court ruled McCarrell waited too long to file suit and threw his case out in 2015.

  • Kendall v. Hoffmann-LaRoche, Inc. – In 2008, a jury awarded 24-year-old Kamie Kendall $10.5 million in compensatory damages and $78,500 for medical expenses. She began taking Accutane at age 12 and was diagnosed with ulcerative colitis at age 14, but the judge said there was not enough evidence for punitive damages.

    Roche appealed and the case was retried. In 2014, a second jury found Roche failed to adequately warn the drug could cause ulcerative colitis. It awarded Kendall $1,587,928 for past medical expenses and pain and suffering.

  • Kathleen Rossitto and Riley Wilkinson – In June 2012, a New Jersey court ordered Roche 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.

    Roche appealed the cases and a judge overturned the original verdict. The appellate court ruled that the trial court judge “seriously erred” in allowing some revelations in court while restricting others, Fierce Pharma reported in 2016.

Roche’s Defense in Accutane Cases

Roche mounted a vigorous defense in its Accutane cases. When juries ruled in favor of plaintiffs, the drug giant immediately appealed. This is standard practice in most plaintiff verdicts. Typically, drug makers argue that either the drug is not dangerous or the plaintiffs’ injuries were caused by something other than the drug.

In Accutane trials, Roche used the following claims in their defense:

  • Causes of plaintiffs’ injuries were unknown.
  • Accutane did not cause plaintiff’s injuries.
  • No scientific studies prove Accutane can cause IBD or suicide.
  • Roche provided ample warning about side effects.

Please seek the advice of a medical professional before making health care decisions.


Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.

Hide Sources

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