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Tuesday, April 16, 2024

11th Circuit Court of Appeals upholds ruling against Boston Scientific

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The U.S. 11th Circuit Court of Appeals has upheld a lower court’s ruling that consolidated cases filed by four women who alleged injuries by a defective pelvic mesh implant by Boston Scientific Corp.

The 11th Circuit ruling also upheld a ruling by a U.S. District Court for the Southern District of Florida jury in 2014 that awarded four women a $27 million verdict in the case.

The jury did deny the women punitive damages.


The U.S. 11th Circuit Court of Appeals.

The panel hearing the case included Justices Frank M. Hull and Stanley Marcus. Justice John M. Rogers, U.S. circuit judge for the Sixth Circuit, was sitting by designation. Marcus wrote the opinion.

On appeal, Boston Scientific sought a new trial and alleged the lower court erred when it consolidated the cases of the four plaintiffs. It also maintained the judge was wrong to explode evidence connected to the Food and Drug Administration’s clearance of the Pinnacle Pelvis Floor repair kit for sale through a “substantial equivalence” process.

However, the plaintiffs, according to the opinion, made the same basic claim that the Pinnacle kit was defective and lacked sufficient warnings.

Marcus noted that the lower court rejected the FDA evidence under both Federal Rule of Evidence, which notes that irrelevant evidence isn’t admissible, and Federal Rule of Evidence 403, which, according to court documents, details that relevant evidence may be excluded “if its probative value is substantially outweighed by a danger of unfair prejudice, confusing the issues, misleading the jury, undue delay, [or] wasting time.”

In upholding the ruling, the appeals court panel ruled the Florida court wasn’t out of bounds in its decision.

“The district court acted well within its discretion in consolidating each of these four lawsuits,” Marcus wrote in the opinion. Under Federal Rule of Civil Procedure 42(a), a district court may consolidate multiple actions that ‘involve a common question of law or fact.’”

Moreover, the court noted that a district court’s decision to consolidate cases is discretionary.

The appeals court also ruled the district court was on pit when it denied judgment to Boston Scientific on plaintiff Amal Eghnayem’s claims of failure to warn.

Marcus noted that Eghnayem offered expert testimony that supported her position and warnings didn’t inform doctors that multiple procedures could be required to remove the mesh.

Further, the Florida court didn’t err when it denied judgment to Boston Scientific on its claim that Eghnayem’s claims were time barred.

“It was not unreasonable for the jury to find that Eghnayem’s claims accrued after April 11, 2009 -- the cut-off point for the state’s four-year statute of limitations,” Marcus wrote in the opinion.

“The long and short of it is that the district court properly exercised its broad discretion in consolidating these actions and refusing to admit FDA evidence, and the contested fact questions were properly presented to the jury,” Marcus concluded in the opinion, affirming the lower court ruling.

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