Greenblatt v. Roche (Atlantic City, New Jersey).
Representing three plaintiffs allegedly injured by a Hoffman-La Roche acne medication, Michael Hook, of Hook & Bolton, explained to the jury in his opening statement that isotretinoin or "Accutane" had originally been developed as a chemotherapy for the skin and GI tract, and only subsequently was considered as a treatment for severe cystic nodular acne.
Animal studies showed, as early as the 1970s, said Mr. Hook, that isotretinoin posed a severe risk to the gastrointestinal tract. Nonetheless, despite reports of Crohn's disease or Inflammatory Bowel Disease (IBD), and intestinal bleeding, supported by very strong evidence, Roche did not adequately warn of the risk prior to the plaintiff's use of Accutane, according to Mr. Hook.
Plaintiff Kelley Andrews took Accutane at age 17, from 1997-1998, said Mr. Hook, and she was diagnosed with Crohn's Colitis within a few months of completing her Accutane treatment. Ms. Andrews has been hospitalized over 25 times and endured seven major gastrointestinal surgeries, including the removal of her colon and small bowel resection.
Plaintiff Gillian Gaghan took Accutane when she was 22 years old, in 1998, said Mr. Hook, and within a few months she began to experience the symptoms of Inflammatory Bowel Disease, and was diagnosed with Crohn's Colitis. Ms. Gaghan suffered multiple hospitalizations and ongoing severe symptoms that would require continuous and lifetime medical care and treatment.
Plaintiff James Marshall took Accutane when he was 25 years old, in 1992 and 1993, said Mr. Hook, and he was subsequently diagnosed with Ulcerative Colitis. Mr. Marshall then was prescribed another round of Accutane, said Mr. Hook, even though Roche's internal documents showed that Accutane was contraindicated for patients with colitis, because Roche did not put the warning on the label. Mr. Marshall had his entire colon removed, endured major surgeries, and was left permanent and severe symptoms.
The trial continues Wednesday morning with the defense opening statement.
CVN is webcasting the Andrews-Gaghan-Greenblatt Accutane trial live.
