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In June of 2009, Roche Holding AG, the Swiss manufacturer of Accutane, did a nationwide recall of that drug. Multiple lawsuits had claimed that Accutane, approved for use in treating acne, had a side effect of causing inflammatory bowel disease. Although Roche defended the drug vigorously, juries awarded over $33 million to plaintiffs for their bowel disease.

Roche’s patent expired in 2002, which allowed rival companies to make generic (and cheaper) versions of Accutane. The drug is no longer available in the U.S., although it is available in Canada. However, Accutane lawsuits are still dragging on through U.S. courts.

The Saga of Six Plaintiffs

Most recently, on May 15, six plaintiffs received a setback. Several legal actions in Florida had been consolidated in the U.S. District Court for Florida’s Middle District and in early May, the 11th Circuit Court of Appeals affirmed summary judgment for Roche in these six cases.

In 2008, this Appeals court had affirmed the exclusion of one Dr. Ronald Fogel as an expert witness for previous plaintiffs. He had testified that Accutane did indeed cause the bowel disease. However, these six newer plaintiffs chose him as their causation expert and cited some new scientific evidence against Accutane.

The six plaintiffs moved to supplement the record with their newly-found article, written by one Seth Crockett, M.D. et al, and previously presented at a medical conference. However, District Court Judge James S. Moody Jr. determined that Dr. Fogel’s opinions in these six cases mostly relied on the same data used in the previous cases where he had testified. He denied the motion to supplement the record and granted summary judgment to Roche.

The six plaintiffs appealed, saying that if this new Crockett article had been admitted, Fogel might have relied on it to show causation, and might have been kept as an expert witness, which would all have precluded the summary judgment.

However, the 11th Circuit Court of Appeals said in its decision:

  • “We need not evaluate plaintiffs [sic] 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. 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 suggesting Accutane can cause IBD, the plaintiffs are unable to prove liability.”

One has to wonder why these six plaintiffs chose Fogel as their expert witness, given that he had already been excluded in previous cases. However, one seldom gets a full story in news reports and the decision is now made.

Please see our pages on Prescription Drug Cases and Diseases Caused by Defective Drugs for more about how medications can harm one’s health in some ways while they are improving it in others.

If you have been harmed by a defective drug and are wondering whether you might have a valid legal claim, please contact our Mobile, Alabama law office today. We will be happy to schedule a free case evaluation for you.

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