Currently, there are over 7,000 Accutane lawsuits filed, with the majority being against Hoffmann-La Roche, the original marketer of the drug. While many of these center around digestive problems like IBD and ulcerative colitis, claims of depression and fetal deformities are also included.

Why File an Accutane Lawsuit?

As a patient, you have the right to safe medical care, including safe prescriptions, and informed consent about any and all side effects and risks of your medical care. When a pharmaceutical company, hospital or doctor fails to inform you of risks, you may be eligible for legal recourse. Most Accutane lawsuits are filed against the pharmaceutical companies, for not fully warning of risks related to IBD.

Compensation awarded during a trial can cover:

  • 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.

Common Claims in Accutane Lawsuits

Birth Defects

Hoffmann-La Roche, who first marketed the brand name drug Accutane, has been implicated in numerous lawsuits regarding birth defects. The company paid out millions to parents who were uninformed about the risk to their unborn child, and whose families suffered from the resulting defects. In 2009, the branded drug Accutane was taken off the market, in part because of lawsuit costs.

Today, pregnancy warnings are required on isotretinoin brands, and the iPledge program helps female patients avoid pregnancy during treatment for acne. However, if your child was exposed previous to 2009 via the Accutane brand, or if you were not fully informed of the birth defect risks of isotretinoin, you may be eligible for compensation and should speak with a lawyer.

A fetus exposed to isotretinoin may have IQ deficits or significant congenital deformities.  Isotretinoin exposure has been connected with the following defects:

Accutane Birth Defects
  • 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, Crohn’s and Ulcerative Colitis

There have been several studies showing an association between isotretinoin and diseases including Inflammatory Bowel Disease (IBD), Crohn’s Disease, and Ulcerative Colitis (UC). Doctors are recommended to warn patients about possible dietary side effects during isotretinoin treatment. If you were not warned properly and were diagnosed with IBD, Crohn’s, or UC during or after isotretinoin treatment, speak with a lawyer about your legal options.

Accutane and Depression

In about 1% of cases, patients taking isotretinoin may experience side effects including mood swings and depressive thoughts, with a possibility of self-harming or suicidal actions. 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.

Not only should your doctor discuss this risk with you, but they should 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. You may also be able to seek compensation from the pharmaceutical company producing your brand of isotretinoin, especially if they did not inform you of the psychiatric risk in the medication’s information packet or packaging materials.

FDA Accutane Warnings and Regulations

1984: FDA Black Box Warning

The harshest warning the FDA can require, the black box warning was required to cite risks of fetal abnormalities in women who got pregnant while taking Accutane.


Recommended close observation of patients treated with isotretinoin for symptoms including, “sad mood, irritability, acting on dangerous impulses, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down, or trouble concentrating, or for mood disturbance, psychosis, or aggression.”  A labeling revision reflecting this recommendation was made in August 2005.

2005: FDA Introduces iPledge

iPledge aims to reduce the incidence of pregnancy in female patients taking isotretinoin. iPledge was updated in 2007 and 2010, to include measures such as a patient agreement to using 2 forms of birth control, monthly pregnancy tests, and prescriber and pharmacist certification.

2007: FDA Warning

The FDA issued a significant warning against the online purchase of Isotretinoin, under any brand name. As the warning states, “Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely.”

Current Litigation

In Florida, cases are operating under MDL No. 1626. At this time, this MDL is inactive. The Superior Court of New Jersey Atlantic County houses its cases in MCL No. 271. This MCL is active at this time.

Major Verdicts

Kathleen Rossitto & Riley Wilkinson — $18 Million — June 29, 2012 — These 2 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 this verdict was vacated in 2016.

Gillian Gaghan — $2.1 Million — April 4, 2011 — Gaghan received $2 Million in compensatory damages, plus just over $100K 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 $25 Million verdict was vacated; it was reinstated in January 2017 and overturned again in May 2017.