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11th Circuit: MDL Plaintiffs Didn’t Lay Foundation For Admitting Accutane Study

ATLANTA — (Mealey’s) The 11th Circuit U.S. Court of Appeals on May 7 affirmed summary judgment in six federal Accutane cases, finding that the plaintiffs had not shown that their excluded causation expert relied on a new study linking the acne drug to inflammatory bowel disease (IBD) (In Re:  Accutane Products Liability, Julia Bishop, et al. v. Hoffman-La Roche, Inc., et al., No. 09-16368, 11th Cir.).

Julia Bishop, Christopher M. Perronne, Eileen Baril, Kenneth S. Palmer, Clay R. Seymour and Jason S. Adkins are some of the remaining plaintiffs in the Accutane multidistrict litigation in the U.S. District Court for the Middle District of Florida.  After the 11th Circuit in 2008 affirmed the exclusion of plaintiff causation expert Dr. Ronald Fogel on general causation in earlier cases, the next six plaintiffs named Fogel as their causation expert, citing new scientific evidence.

District Court Judge James S. Moody Jr. found that Fogel’s opinion in the six cases relied on the same scientific data as the first group of cases, with one exception.

The plaintiffs moved to supplement the record with a newly discovered abstract, "Accutane Use Is Associated with Inflammatory Bowel Disease:  A Case Control Study Using Administrative Data," produced by Seth Crockett, M.D., and others, and presented at that time as a study poster at a medical conference.  Judge Moody denied the motion to supplement without explanation and granted summary judgment to defendant Hoffman-La Roche Inc. and related entities.

The plaintiffs appealed to the 11th Circuit, arguing that if the Crockett study was admitted, Fogel could have relied on it to show causation and been admitted as an expert, and summary judgment would have been precluded.

“We need not evaluate plaintiffs’ long string of hypotheticals because, even if the district court had admitted the study, plaintiffs never submitted evidence that Dr. Fogel adopted the study or would have included it in his evaluation,” the panel said in a per curiam decision.  “We can find no abuse of discretion in the exclusion of Fogel’s testimony, and without Dr. Fogel, the district court did not err in concluding that ‘[w]ithout expert testimony that Accutane can cause IBD, Plaintiffs are unable to prove liability.’”

[Editor's Note:  Full coverage will be in the May 20 issue of Mealey’s Emerging Drugs & Devices.  In the meantime, the opinion is available at or by calling the Customer Support Department at 1-800-833-9844.  Document #28-100520-004Z.  For all of your legal news needs, please visit]

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