The Accutane lawsuits claim that the acne drug causes serious 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 been settled to date.
Why people are suing Accutane
Most of Accutane’s lawsuits relate to digestive issues related to the drug’s main ingredient (isotretinoin – a close cousin of vitamin A), including inflammatory bowel disease (IBD), Crohn’s and ulcerative colitis. In addition, some complainants have complained of side effects such as depression and fetal malformations in their legal files.
The vast majority of the complaints have been brought against Hoffmann-La Roche, which first marketed isotretinoin as an acne treatment under the brands Accutane (in the US) and Roaccutane (outside the US). The patent for the acne drug expired in 2002, and since then a number of other manufacturers have started producing it under a wide variety of brand names, such as Absorica, Amnestimate, Claravis, Myorisan, and Zenatane. Some of these other drug companies have also faced isotretinoin lawsuits, but the majority still name Roche as the main defendant.
Accutane, IBD, Crohn’s disease and ulcerative colitis
The most common Accutane side effects mentioned in lawsuits are IBD, Crohn’s disease, and ulcerative colitis. The complainants claim that these gastrointestinal disturbances 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 didn’t start referring to IBD and other gastrointestinal issues until the early 1980s. 2000.
The first case studies indicating a possible link between isotretinoin and IBD were published in the 1980s, and a few more have emerged since then. More recent studies have called into question the findings of these earlier studies, but some researchers still point to a link between Accutane and IBD. Although they have no clear evidence of a causal link, the complainants allege that drug companies should have done more to warn them of the risks of taking their prescription drugs.
Accutane birth defects
Hoffmann-La Roche has also been involved in numerous lawsuits concerning birth defects. The company has paid millions to families who suffered from birth defects allegedly caused by Accutane. In 2009, they pulled the drug off the market, in part because of the lawsuit costs.
Today, the FDA is requiring that pregnancy-related risks be listed on isotretinoin warning labels, and the iPledge program is helping patients avoid pregnancy during treatment for severe acne. However, if your child has been exposed to Accutane, or if you were not fully informed about the risks of isotretinoin birth defect during pregnancy, you may be eligible for compensation.
- Increased risk of spontaneous abortion
- Premature birth
- Skull abnormality
- Ear abnormalities (anotia, micropinna, small or absent external auditory canals)
- Eye abnormalities (including microphthalmia)
- Facial dysmorphism
- Cleft palate
- Central nervous system (CNS) abnormalities
- Cardiovascular abnormalities
- Thymus 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 reviews of the literature, patients taking isotretinoin may experience serious side effects, including mood swings and suicidal thoughts, with the possibility of self-harm. In fact, the iPledge program provides both patients and providers with information highlighting the mental health risks associated with the drug.
Confusingly, some studies actually show a decrease in depressive symptoms after treatment with Accutane. Most researchers attribute the conflicting information to a subset of the population predisposed to the possible negative effects of isotretinoin on mental health.
Your doctor should discuss all the risks of Accutane with you and assess your mood at each visit during your treatment period. If your doctor does not tell you about this risk, you may be able to take legal action if you experience any mental health side effects.
In 2018, there are two main groups of lawsuits related to Accutane. One group was assigned to the United States District Court in the District of Middle Florida (MDL # 1626), and all of these issues were resolved. The other is in the New Jersey Superior Court, and is being dealt with by the New Jersey Atlantic County Court (MCL # 271), and these are still pending in court. No class action lawsuit against Accutane has been filed.
MCL # 271 (Accutane lawsuits in New Jersey)
Most Accutane lawsuits have been processed in the New Jersey state court system. Some of the 5,000 cases filed in NJ courts have been tried, while many others have been dismissed after years of litigation. In July 2017, an appeals court restored more than 2,000 lawsuits, giving plaintiffs another chance to present their case.
In July 2018, the New Jersey Supreme Court ruled that two expert witnesses for plaintiffs in these lawsuits would not be allowed to testify. The state’s highest court sided with Hoffmann-La Roche, ruling that the expert witness did not follow standard scientific conventions in framing his conclusions on Accutane.
The New Jersey Supreme Court terminated all product liability claims in MCL 271 in October 2018. In its view, the court disagreed with the plaintiffs’ assertion that the warnings on the labels for IBD should have been stronger, affirming the adequacy of the existing warning language.
MDL # 1626 (Federal Accutane prosecutions)
Accutane MDL ended in 2015 after all cases transferred to it were either adjudicated or dismissed. The main claims of the plaintiffs in the multidistrict litigation focused on IBD and other gastrointestinal side effects of Accutane.
United States District Court Judge James Moody has granted many of Roche Pharmaceutical’s requests for summary dismissals, based on the ruling that the drug’s labels adequately warn consumers of the risks associated with the drug. 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 Rules and Verdicts
Several Accutane lawsuits have already resulted in jury verdicts which awarded the plaintiffs millions of dollars in restitution due to the medical problems they suffered after using the drug. Many of these Accutane verdicts have been overturned or overturned for technical reasons or other considerations.
Kathleen Rossitto & Riley Wilkinson – $ 18 million
Two Accutane users claimed that using the drug caused their ulcerative colitis. They each received $ 9 million in compensatory damages for their injuries in June 2012. Evidence from the trial suggests Roche was aware of Accutane’s IBD risks and withheld this information from doctors and patients. Roche appealed and the verdict was overturned 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 costs. Gaghan alleged that his IBD was caused in large part by the use of Accutane. This verdict was overturned in 2012, because the original request was not made within the two-year limitation period.
Kamie Kendal – $ 10.5 million
Kendal claimed his IBD was caused by Accutane. In 2008, a unanimous New Jersey jury ruled in favor of the plaintiff and awarded her $ 10.5 million, but the decision was overturned in 2010.
Andrew McCarrell – $ 2.6 million
McCarrell claimed that Accutane caused his IBD, requiring him to undergo several surgeries, including the removal of his colon. He alleged that the drugmaker Mylan had not warned him enough about the serious risks of Accutane. 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 appeals court ruled in McCarrell’s favor again, this time for $ 25 million. In 2015, the verdict was overturned; it was reinstated in January 2017 and overturned again in May 2017.
Frequently Asked Questions About The Accutane Trial
Who can file an Accutane complaint?
Most people who bring Accutane-related legal claims against Roche have suffered from some form of abdominal or bowel disease, such as IBD, Crohn’s disease, or ulcerative colitis. Some lawsuits have also been filed for other types of side effects, such as a birth defect in babies whose mothers took the drug during pregnancy.
Note that Hoffmann-La Roche discontinued the Accutane brand of isotretinoin in 2009, which means it hasn’t been on the market for almost a decade. The statute of limitations in most states will likely prevent many people from suing again, although filing times may be extended in certain circumstances:
- People who have been prescribed Accutane as a minor may be able to extend the filing times depending on when they are 18 years old.
- Some states may base their prescription period on when the drug’s harmful effects were discovered, such as when their IBD was diagnosed, rather than when the person actually took the drug.
What Compensation Could I Receive For An Accutane Lawsuit?
Generally, damages for personal injury lawsuits can include:
- Past medical expenses – The costs of hospitalization, treatment and surgery related to IBD can increase rapidly.
- Loss of income – Frequent medical visits or inability to work due to your illness may result in loss of wages.
- Pain and suffering – Damages may be awarded to help compensate a victim for pain and suffering after suffering the adverse effects of isotretinoin.
- Punitive damages – Accutane and other brands of isotretinoin have grossed billions from their manufacturers. Punishing Hoffmann-La Roche and others financially lets them know they need to make sure their drugs are safe for patients.
- Funeral expenses – In some cases IBD, depression or birth defects related to isotretinoin can lead to death. In this tragic situation, a jury may offer awards to help cover burial and funeral costs.
How much does it cost to file an Accutane complaint?
People often sue drugs on an emergency basis. When you file an emergency case, you are not required to pay legal fees until you receive compensation for your claim.