Since its approval by the U. S. Food and Drug Administration (FDA) in 1982, Accutane, the brand name for isotretinoin, has been used by more than 13 million people.  Manufactured by Nutley, New Jersey-based pharmaceutical company Hoffmann-LaRoche, Inc. (LaRoche), Accutane was prescribed for severe recalcitrant nodular acne treatment. LaRoche lost its patent protection in 2002 and pulled Accutane off the market in 2009, claiming debilitating losses due to generic-brand market competition.  Yet, many theorize LaRoche pulled its product because of the increase in the number of lawsuits filed against the company. One estimate maintains over 5000 personal injury claims have been filed in the last twelve years.

One of the earliest lawsuits was filed by Adam Mason of Pensacola, Fla.  The plaintiff began taking Accutane as a teen when prescribed by his doctor to combat severe acne.  In 2000, after nine years of Accutane use, Mason, who suffered from fatigue, diarrhea, and depression, was diagnosed with Crohn’s disease, a form of inflammatory bowel disease (IBD).  Unable to work full-time, Mason held LaRoche responsible for his condition claiming the manufacturer did not provide sufficient warning against. His case went to trial in 2007.

During trial, LaRoche’s attorney’s argued that their client had a warning printed on Accutane’s label regarding IBD, and that the warning was sufficient to put consumers on notice of the risk of these side effects.  Yet, Dr. David Sachar, an expert on gastroenterology testifing for the plaintiff, asserted LaRoche seemed not to have done any clinical studies regarding inflammatory bowel diseases in regards to Accutane use.  He concluded that Accutane was the proximate, or direct, cause of the plaintiff’s condition.

The Florida jury agreed with the plaintiff and concluded that the warning provided by LaRoche was insufficient, as it did not indicate the severity of the problem. They awarded Mason a total of more than $7 million: $5,146,500 for future pain and suffering, $766,500 for prior pain and suffering, and $387,561 for future medical expenses. Additionally, he received $617,599 for the lost earning capacity and $110,134 for lost earnings.  After the verdict was read, LaRoche spokeswoman Shelley Rosenstock said in a statement that the company was disappointed and would appeal the verdict.

Accutane users should be aware of the symptoms of Inflammatory Bowel Disease.  If you experience any of the following, contact your doctor immediately.

  • Rectal Bleeding
  • Severe Diarrhea
  • Excessive Bowel Movements
  • Frequent Urges to Have Bowel Movements
  • Blood in Stool
  • Mucus in Stool
  • Abdominal Pain
  • Abdominal Cramping

Have You Been Affected by Accutane?

Any individual or the relative of an individual who has suffered due to Accutane’s side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).  If you need further information about the harmful side effects of Accutane or legal advice concerning personal injury matters, we invite you to contact us or to fill out our form on this website for a free case evaluation.