Accutane lawsuits claim the acne drug causes severe side effects like inflammatory bowel disease, Crohn's disease, ulcerative colitis, birth defects and depression. More than 2,000 Accutane lawsuits have been filed against drugmaker Hoffman-La Roche, but none have settled to date.
Why People Are Filing Accutane Lawsuits
Most Accutane lawsuits center around digestive problems related to the drug's main ingredient (isotretinoin - a close cousin to vitamin A), including inflammatory bowel disease (IBD), Crohn's disease, and ulcerative colitis. In addition, some plaintiffs have complained about adverse effects like depression and fetal deformities in their legal filings.
The vast majority of claims have been filed against Hoffmann-La Roche, who first marketed isotretinoin as an acne treatment under the brand names Accutane (in the United States) and Roaccutane (outside the U.S.). The acne drug's patent expired in 2002, and since then a number of other manufacturers have begun producing it under a wide variety of brand names, such as Absorica, Amnesteem, Claravis, Myorisan, and Zenatane. Some of these other pharmaceutical companies have also been the subject of isotretinoin lawsuits, but the majority still name Roche as the primary defendant.
Accutane, IBD, Crohn's Disease, and Ulcerative Colitis
The most common Accutane side effect referenced in lawsuits are IBD, Crohn's disease, and ulcerative colitis. Plaintiffs claim that these gastrointestinal conditions were caused by their use of Accutane or a generic version of the drug isotretinoin.
Accutane received approval from the Food and Drug Administration (FDA) in the 1980s, but warning labels only started referencing IBD and other gastrointestinal problems in the early 2000s.
The first case studies to indicate a possible connection between isotretinoin and IBD were published in the 1980s, and a few others have appeared since then. More recent studies have questioned the conclusions of those prior studies, but some researchers still point to a link between Accutane and IBD. Despite having no clear evidence of a causal link, plaintiffs allege that drug companies should have done more to warn them of the risks involved with taking their prescription drugs.
Accutane Birth Defects
Hoffmann-La Roche has also been implicated in numerous lawsuits regarding birth defects. The company paid out millions to families who suffered due to birth defects allegedly caused by Accutane. In 2009 they took the drug off the market, partly due to lawsuit costs.
Today, the FDA requires pregnancy-related risks to be listed on isotretinoin warning labels, and the iPledge program helps female patients avoid pregnancy during treatment for severe acne. However, if your child was exposed to Accutane, or if you were not fully informed of the birth defect risks of isotretinoin while pregnant, you may be eligible for compensation.
Birth Defect Risks of Accutane
- Increased risk of spontaneous abortion
- Premature birth
- Skull abnormality
- Ear abnormalities (anotia, micropinna, small or absent external auditory canals)
- Eye abnormalities (including microphthalmia)
- Facial dysmorphia
- Cleft palate
- Central Nervous System (CNS) abnormalities
- Cardiovascular abnormalities
- Thymus gland abnormality
- Parathyroid hormone deficiency.
- IQ score less than 85 with or without obvious CNS abnormalities
Source: iPledge Program
Accutane and Depression
According to a number of Accutane case reports and literature reviews, patients taking isotretinoin may experience serious side effects including mood swings and suicidal thoughts, with a possibility of self-harm. In fact, the iPledge Program provides both patient and provider information highlighting the mental health risks associated with the drug.
Confusingly, some studies actually show a decrease in depressive symptoms after Accutane treatment. Most researchers attribute the conflicting information to a population subset with a predisposition to the possible negative mental health effects of isotretinoin.
Your doctor should discuss all the risks of Accutane with you and evaluate your mood during each visit of your treatment period. If your doctor fails to inform you of this risk, you may be able to seek legal recourse if you experience mental health side effects.
As of 2018, there are two major groups of Accutane-related lawsuits. One group was assigned to the U.S. District Court in the Middle Florida District (MDL No. 1626), and these have all been resolved. The other is in the New Jersey Superior Court, being handled by the New Jersey Atlantic County Court (MCL No. 271), and these are still working their way through the courts. No class action lawsuits against Accutane have been filed.
MCL No. 271 (New Jersey Accutane Lawsuits)
Most Accutane lawsuits were handled in the state court system of New Jersey. Some of the 5,000 cases filed in NJ courts went to trial, while many others were dismissed after years of litigation. In July 2017 an appeals court reinstated more than 2,000 lawsuits, giving plaintiffs another chance to make their case.
In July 2018, the New Jersey Supreme Court ruled that two expert witness for the plaintiffs in these lawsuits would not be allowed to testify. The state's highest court sided with Hoffmann-La Roche, deciding that the expert witness had not followed standard scientific conventions in developing their conclusions about Accutane.
The New Jersey Supreme Court ended all product liability lawsuits in MCL 271 in October of 2018. In their opinion, the court disagreed with plaintiffs' assertion that label warnings for IBD should have been stronger, affirming the adequacy of the existing warning language.
MDL No. 1626 (Federal Accutane Lawsuits)
The Accutane MDL was terminated in 2015 after all cases transferred to it had either gone to trial or been dismissed. The primary claims of plaintiffs in the multidistrict litigation focused around IBD and other gastrointestinal side effects of Accutane.
U.S. District Court Judge James Moody granted many of Roche Pharmaceutical's motions for summary dismissals, based on the ruling that the drug's labels adequately warned consumers about the risks of taking Accutane. In addition, 40 Accutane lawsuits were dismissed in February 2013 when plaintiffs failed to meet court deadlines to produce an expert witness.
Accutane Settlements and Verdicts
Several Accutane lawsuits have already reached jury verdicts that awarded the plaintiffs millions of dollars in recompense due to the medical problems they suffered after using the drug. Many of these Accutane verdicts have been vacated or reversed on technical grounds or other considerations.
Kathleen Rossitto & Riley Wilkinson - $18 Million
Two Accutane users claimed that use of the drug caused their ulcerative colitis. They were each awarded $9 million in compensatory damages for their injuries in June 2012. Evidence from the trial suggested that Roche knew about the IBD risks of Accutane and withheld that information from doctors and patients. Roche appealed, and the verdict was vacated in 2016.
Gillian Gaghan - $2.1 Million
In April 2011, a jury awarded Gaghan $2 million in compensatory damages, plus just over $100,000 for medical expenses. Gaghan alleged that her IBD was caused in large part by Accutane use. This verdict was reversed in 2012, because the original claim had not been made within the two-year statute of limitations.
Kamie Kendal - $10.5 Million
Kendal claimed that her IBD was caused by Accutane. In 2008, a unanimous New Jersey jury found in favor of the plaintiff and awarded her $10.5 million, but the ruling was reversed in 2010.
Andrew McCarrell - $2.6 Million
McCarrell claimed that Accutane caused his IBD, forcing him to have multiple surgeries, including the removal of his colon. He alleged that the drugmaker Mylan had failed to adequately warn him of Accutane's serious risks. In 2007, a jury agreed with him and awarded him $2.6 million.
This was the first major verdict regarding isotretinoin. Hoffmann-La Roche appealed, and in 2010 the appellate court found in favor of McCarrell again, this time for $25 million. In 2015, the verdict was vacated; it was reinstated in January 2017 and overturned again in May 2017.
Accutane Lawsuit Frequently Asked Questions
Who can file an Accutane lawsuit?
Most people who submit legal claims against Roche related to Accutane have experienced some form of abdominal or intestinal condition, such as IBD, Crohn's disease, or ulcerative colitis. Some lawsuits have also been filed over other types of adverse effects, such as a birth defect in babies whose mothers took the drug while pregnant.
Note that Hoffmann-La Roche discontinued the Accutane brand of isotretinoin in 2009, meaning that it has not been on the market for nearly a decade. The statute of limitations in most states will likely prevent many people from filing new lawsuits, though deadlines for filing may be extended in certain circumstances:
- People who were prescribed Accutane as a minor may be able to extend filing deadlines depending on when they turn 18.
- Some states may base their statute of limitations on when the harmful effects of the drug were discovered, such as when their IBD was diagnosed, rather than when the person actually took the medication.
What compensation could I receive for an Accutane lawsuit?
Typically, damages for personal injury lawsuits can include:
- Past medical expenses - The cost of hospitalization, treatment, and surgeries related to IBD can quickly escalate.
- Loss of income - Frequent medical visits or an inability to work because of your disease can result in lost wages.
- Pain and suffering - Damages may be awarded to help compensate a victim for their pain and suffering after being subjected to the adverse effects of isotretinoin.
- Punitive damages - Accutane and other brands of isotretinoin have made billions for their manufacturers. Punishing Hoffmann-La Roche and others financially lets them know that they need to ensure their drugs are safe for patient use.
- Funeral expenses - In some cases, IBD, depression or birth defects connected to isotretinoin can lead to death. In this tragic situation, a jury may provide awards to help cover burial and funeral costs.
How much does it cost to file an Accutane lawsuit?
People often file drug lawsuits on a contingency basis. When you file on contingency, you aren't required to pay legal fees until you receive compensation for your claim.