ATLANTIC CITY, N.J. - (Mealey's) A New Jersey state court jury on June 29 issued a split decision in four Accutane injury cases, finding in two that defendant Hoffman-La Roche's failure to adequately warn of the risk of inflammatory bowel disease (IBD) did not cause the plaintiffs' ulcerative colitis but finding in two others that it did cause their injuries and awarding each of those plaintiffs $9 million in compensation (Wilkins Reynolds v. Hoffman-La Roche, No. 002644-03, Kathleen Rossitto v. Hoffman-La Roche, 007481-10, Thomas Wilkinson v. Hoffman-La Roche, No. 004170-09, and Jason Young v. Hoffman-La Roche, No. 008349-05, N.J. Super., Atlantic Co.).
(Verdict form available. Document #28-120712-009V.)
Plaintiffs Rebecca Reynolds, Jason Young, Riley Wilkinson and Kathleen Rossitto each sued Hoffman-La Roche Inc. in the Atlantic County Superior Court, alleging that the prescription oral acne drug caused them to develop IBD or ulcerative colitis, a form of IBD.
In each case, the jury found that Roche failed to provide an adequate warning to prescribing physicians about the risks of IBD from Accutane and that Roche knew or should have known of the risk before certain years in which the plaintiffs started taking the drug. However, the eight-member jury in the cases of Reynolds and Young found that the inadequate warning was not a substantial factor in either plaintiff taking Accutane.
In the cases of Wilkinson and Rossitto, the jury found that the inadequate warning was a substantial factor in both plaintiffs taking Accutane and was a substantial factor in both developing ulcerative colitis. The jury awarded each plaintiff $9 million in compensation for IBD, according to the jury verdict form.
Different Warnings, Different Times
Each case involved warnings that were in effect at different times. In Reynolds' case, the jury was asked about IBD warnings that were in effect prior to November 1992 and June 1998.
In Young's case, the jury was asked about warnings in effect prior to June 1997. For Wilkinson, it was warnings before May 1995, and for Rossitto, it was before December 1997.
The jury was not unanimous in answering most questions. The votes for damages, however, were each 7-1.
Roche Will Appeal
In a press statement, Roche said that while it sympathizes with the plaintiffs and their IBD, it believes the evidence showed that Accutane did not cause their injuries and that the company acted appropriately in providing information to the medical community.
"Roche is pleased that, in two of the four cases, the jury found that Roche was not responsible for plaintiffs' injuries," the company said. "Roche feels strongly that the warnings in place when those plaintiffs took Accutane appropriately described the potential risks of the FDA-approved medicine and Roche will continue to vigorously defend these cases."
Roche said it plans to appeal the two plaintiff verdicts, saying the jury's findings are "unsupported by the evidence."
Experts included Kenneth Buchi, M.D.; Merril Dayton, M.D.; Robert Orme, M.D.; Daniel Reshel, M.D.; David B. Sachar, M.D.; Dr. Cory Siegel; Dr. Sunada Kane; Dr. Stephen Hanauer; John Smelzer, M.D.; Jiayl Li, M.D.; Patricia Sitnitsky, M.D.; Russell Eyre, M.D.; Joel Dickmann, M.D.; Kasia Petchel; and Cheryl Blume, Ph.D.
The trial began May 7, and the jury began deliberating June 28.
Judge Carol E. Higbee presided.
Accutane was approved to treat severe acne. The drug is known to cause birth defects, and the plaintiffs allege that it also causes IBD.
Most Trials Are In New Jersey
New Jersey state court lawsuits are centralized in a mass tort docket in the Atlantic County Superior Court, where the majority of Accutane trials have taken place. Federal cases are centralized in the U.S. District Court for the Middle District of Florida, but that litigation is stalled by rulings from the presiding judge, who at times has been openly at odds with Judge Higbee and her decisions.
Roche stopped making Accutane several years ago because its patent expired, and the generic version, isotretinoin, is made by various other manufacturers.
The plaintiffs are represented by David Buchanan of Seeger Weiss in New York, Jack W. Lurton III of Beggs & Lane in Pensacola, Fla., and Troy Rafferty of Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor in Pensacola.
Roche is represented by Orlando R. Richmond Sr. and William M. Gage of Butler, Snow, O'Mara, Stevens & Cannada in Jackson, Miss., Paul Schmidt of Covington & Burling in Washington, D.C., and Colleen Hennessey of Peabody & Arnold in Boston.
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