BY DAVID SIEGEL
Atlantic City, NJ – Opening statements began today at a trial involving claims, that the widely prescribed acne medication Accutane caused inflammatory bowel disease, known as IBD, in a female plaintiff which led to the removal of her colon.
Hoffman-La Roche, the Switzerland-based manufacturer of Accutane, is accused by plaintiff Kamie Kendall of not adequately warning her or her prescribing physician about known risks of gastrointestinal disease associated with taking Accutane. Kendall began taking Accutane in 1997 at the age of 12 to treat cystic acne.
Today’s proceedings are part of a retrial, after a jury in 2008 found in favor of Kendall and awarded her compensatory damages of $10.5 million. In 2010 a New Jersey appellate court vacated the verdict and ordered a new trial on the basis that Roche should have the opportunity to present jurors with statistical evidence related to the background rate of IBD in the general public as compared with the background rate in Accutane users. That evidence was not permitted during the first trial. The trial judge in the case, Hon. Carol Higbee, also referred to Roche’s evidence as “unscientific” in instructions to the jury.
The Supreme Court of New Jersey briefly stayed proceedings in the case earlier this month while Roche appealed Judge Higbee’s decision not to recuse herself from presiding over the thousands of Accutane cases consolidated before her in Atlantic City. Roche alleges various court rulings show a bias against the drug company, but their requests to have the case re-assigned were eventually rejected by the higher court, and Judge Higbee will preside over the Kendall retrial.
During his opening statement to the jury, attorney Michael Hook of Hook Bolton P.A. said Roche knew about the risks of intestinal disease associated with Accutane as far back as the early phases of animal research, when the drug was tested on dogs, according to a Courtroom View Network webcast of the trial proceedings. Hook told jurors that according to internal Roche documents, the body of evidence to support a causal relationship between Accutane and intestinal problems steadily grew throughout the 1980’s. “Their animal studies showed the risk. The human clinical trials showed the risks. The post marketing reports showed the risks,” said Hook. He then showed jurors the label on Accutane from 1984 next to a label from 1999 and highlighted how despite allegedly increased knowledge about risk of IBD, no changes were made.
Opening statements by attorneys for the defense are scheduled for tomorrow morning. During earlier trials involving Accutane, attorneys for Roche have argued IBD in some of the individuals who took Accutane was not caused by the drug, and adequate warnings were provided to patients and physicians.
In 2009, Roche discontinued the production of Accutane, known generically as isotretinoin, after juries awarded millions of dollars to other plaintiffs in cases in New Jersey, Florida and New York. In its statement to the U.S. Food and Drug Association notifying the agency of their withdrawing the drug from the market, Roche specifically cited high costs from personal-injury lawsuits as well as competition from generic manufacturers.
The current trial is expected to last from six to eight weeks. Courtroom View Network (“CVN”) is providing a gavel-to-gavel video webcast of the full proceedings. The underlying case is Kendall v. Hoffmann LaRoche Inc., ATL- L-8213-05, New Jersey Superior Court, Atlantic County (Atlantic City)