In the trial of McCarrell v. LaRoche, judge Carol Higbee did almost everything right. According to the appeals court, her “overall studious and even-handed management of [the] complex case was exemplary.”
But she should have allowed defendant pharmaceutical manufacturer Roche to present statistical evidence, such as the fact that Roche’s acne treatment drug Accutane had five million users when the plaintiff began his treatment.
As a result, a $2.6M plaintiff verdict was reversed, and the parties will do it again before Judge Higbee in New Jersey Superior Court, starting Monday January 11, 2010.
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 defense proffered testimony from Dr. Martin Huber, Roche’s Global Head of Drug Safety, that five million people had been treated with Accutane when the plaintiff began his treatment, thus purporting to show that the defendant might reasonably have interpreted the user complaints as a weak signal of risk. But Judge Higbee concluded that “[t]o suggest that a reasonable company doesn’t explore a rare risk is an unfair suggestion to the jury…it does not matter if the drug is sold to 10 million people or 5 million people or 1,000 people, because if you have a serious risk, it is significant.”
In an unpublished opinion, the Appellate Division summarized the factual record regarding the drug Accutane:
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 sebumunder 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 effectsfrom 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.
CVN will webcast the Accutane trial live from New Jersey. CVN is also offering Free Clips of the first five minutes of each side’s opening arguments.