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 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 U.S.) and Roaccutane (outside the U.S.). The acne drug’s patent expired in 2017, 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 inflammatory bowel disease (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. Marketing pamphlets and warning labels have referenced the association of Accutane and IBD, as well as other gastrointestinal problems, as far back as 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. However, more recent studies have questioned the conclusions of those prior studies. Even so, 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, and in 2009, the drug was taken 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 and should speak with a lawyer.
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
Accutane and Depression
In about 1% of cases, patients taking isotretinoin may experience side effects including mood swings and suicidal thoughts, with a possibility of self-harm. In fact, to participate in the iPledge program, patients with a history of psychiatric disorders must prove that they are being treated for their disorder and receive written consent from their psychologist or psychiatrist before beginning to take isotretinoin.
Your doctor should discuss this risk 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.
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 active Accutane lawsuits are currently being handled 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. However, 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. While this does not mean the end of Accutane lawsuits, it remains to be seen whether plaintiffs can make their case at trial without these experts.
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. Unfortunately, many of these Accutane verdicts have been vacated or reversed on technical grounds or other considerations.
Kathleen Rossitto & Riley Wilkinson ($18 Million; June 29, 2012)
Two Accutane users claimed that their use of the drug caused their ulcerative colitis. They were each awarded $9 Million in compensatory damages, for their injuries. 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; April 4, 2011)
Gaghan received $2 million in compensatory damages, plus just over $100,000 for medical expenses when a jury found in her favor. Gaghan alleged that her IBD was caused in large part by Accutane usage. 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; May 5, 2008)
Kendal claimed that her IBD was caused by Accutane. This was a unanimous jury verdict in a Superior Court of New Jersey. This ruling was reversed in 2010.
Andrew McCarrell ($2.6 Million; July 2, 2007)
McCarrell claimed that the drug Accutane had 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. This was the first major verdict regarding isotretinoin. Hoffmann-La Roche appealed this verdict, 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 FAQs
Frequently asked questions about Accutane lawsuits are listed below with responses.
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 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 statutes 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.
If you have experienced a severe side effect after taking Accutane, you should talk with a lawyer to discuss your ability to file a lawsuit.
What compensation could I receive for an Accutane lawsuit?
Typically, compensation for personal injury lawsuits can be awarded to cover a number of different things. These 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 action – 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 take better care 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.
When talking with your lawyer during a free case review, you can discuss which types of compensation you could receive and which you would like to pursue as part of your legal claim.
How much does it cost to file an Accutane lawsuit?
For lawsuits that involve harmful drugs or medical devices, most law firms will work on a contingency basis. This means that your lawyers will not get paid unless they help you recover money based on your claims. The exact amount they receive will be determined during your free case review, and the payment is typically a percentage of the compensation recovered.