The Eleventh Circuit Court of Appeals has ruled that a Florida federal judge was right to consolidate the cases of four women who say they were injured by Boston Scientific Corp.’s defective pelvic mesh implants. The court upheld the jury’s $27 million verdict. A three-judge panel said that while each woman may have had different circumstances, their suits came down to the same legal questions: whether the Pinnacle Pelvic Floor Repair Kit was defective and whether the product had sufficient warnings. The jury awarded a total of $27 million in November 2014, but did not award Plaintiffs punitive damages. Plaintiff Mania Nunez received $6.53 million, Juana Betancourt and Amal Eghnayem each received $6.72 million and Margarita Dotres received $6.76 million.
The panel said the court didn’t abuse its discretion in consolidating the claims and made it clear to the jury that each case should be considered separately. The only individual claims that had to be decided were whether the device’s design caused the injury and whether the doctor was sufficiently warned. The difference in awards to the four women proves the women were able to keep the cases separate, the opinion states.
Among a few other rulings tailored to the individual cases, the panel cleared the judge to exclude evidence regarding Boston Scientific’s 510(k) clearance. Under Section 510(k) of the Federal Food Drug and Cosmetic Act, manufacturers must give the U.S. Food and Drug Administration (FDA) 90 days’ notice before bringing a new device to market to see if it’s “substantially equivalent” to a device already on the market. Since 510(k) isn’t a safety regulation, it “does not go to a product’s safety and efficacy – the very subjects of the Plaintiffs’ products liability claims,” the panel said.
Boston Scientific said in a statement that it had “reached a confidential settlement with three of the Plaintiffs in this case earlier this year and recently settled with the fourth Plaintiff.
The appeal is Eghnayem et al. v. BSX, (case number 16-11818) in the U.S. Court of Appeals for the Eleventh Circuit. The MDL is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, (case number 2:12-md-02326) in the U.S. District Court for the Southern District of West Virginia.