McCarrell v. Roche (Accutane)

Andrew McCarrell v. Hoffmann LaRoche et al

Description:Andrew McCarrell sued Hoffman-LaRoche and Roche Laboratories, which manufactured and distributed the prescription drug Accutane. McCarrell alleged that as a result of taking Accutane for an acne condition, he developed inflammatory bowel disease (IBD), which led to the surgical removal of his colon. The jury returned a $2.6M verdict.

View the original trial McCarrell v. Hoffman LaRoche Also available: the October 2008 trial, In re: Accutane.

The Superior Court's appellate division ruled that the defendants in the McCarrell trial should have been allowed to present the background statistics showing that there were five million Accutane users.

"With all due deference to the trial judge, whose overall studious and even-handed management of this complex case was exemplary, she erred in forbidding Roche from placing into evidence statistics about Accutane usage that could have made Roche's conduct and labeling decisions appear far more reasonable to the jury. For instance, the "five million users" statistic proffered by Dr. Huber could have given the jurors very relevant contextual background, and possibly led the jury to be more indulgent of Roche's delay in upgrading the risk information on Accutane's label and package insert."

Openings in the retrial were January 13, 2010. Request FREE VIDEO CLIPS of Opening Argument. On February 16, 2010, the jury returned a $25M verdict in favor of the plaintiff. For more on the Accutane trial, see the CVN Blog.




Background Information from the Appellate Division's unpublished opinion:

Accutane is a prescription medication developed by Roche. It was approved by the Food and Drug Administration (FDA) in 1982 to treat recalcitrant nodular acne, a severe and disfiguring skin disease characterized by large, inflamed cystic lesions on the patient's face and back.

Although the exact mechanism of action for how Accutane works is unknown, Roche discovered that the drug was effective in suppressing the production of oil and waxy material produced in the sebaceous glands. Nodular acne is caused by the accumulation of sebum under the skin, which ultimately ruptures the follicle wall, forming an inflamed nodule. Accutane was found to be highly effective in treating nodular acne that has been recalcitrant to standard treatments.

Accutane is a teratogen, meaning that there is a high risk that if a woman takes the drug while pregnant, her child will be born with life-threatening birth defects. Additionally, common adverse effects from Accutane include dry skin, lips, and eyes, conjunctivitis, decreased night vision, muscle and joint aches, and elevated triglycerides.

Prior to receiving FDA approval for Accutane, Roche conducted several pre-clinical studies of the drug, using dogs. Those studies revealed instances of gastrointestinal bleeding in the treated dogs.