A federal appeals court has upheld the $18.5 million verdict awarded to four women who suffered serious complications following implantation of Boston Scientific Corp.’s Obtryx transvaginal mesh devices.
The case was decided in November 2014, after a jury in the U.S. District Court, Southern District of West Virginia, found that the company’s Obtryx Transobturator Mid-Urethral Sling System was defectively designed. The four plaintiffs were awarded $18.5 million (damages to each ranged from $3.25 million to $4.25 million).
Two of the women have since agreed to settle their transvaginal mesh lawsuits out of court for undisclosed amounts. However, Boston Scientific appealed the remaining verdicts, arguing that the Court’s decision to consolidate the four individual cases for trial created prejudice and confusion among the jurors.
The Fourth Circuit Court of Appeals disagreed with the company’s assertions in a decision handed down on Tuesday, finding that Boston Scientific had failed to provide any evidence of prejudice or confusion.
“Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate,” the Court wrote in its decision. “What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.”
Boston Scientific is just one of several medical device manufacturers that have been accused of marketing defective pelvic mesh to treat women suffering from pelvic organ prolapse and stress urinary incontinence
In a recent filing with the U.S. Securities and Exchange Commission, the company acknowledged that it had been named a defendant in approximately 48,500 product liability claims involving the implants.
“As of October 25, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 44,000 cases and claims,” the filing stated.
Just this past December, Boston Scientific settled 378 additional transvaginal mesh lawsuits that were pending in the Southern District of West Virginia. The company announced its first transvaginal mesh settlement in April 2015, when it agreed to resolve 2,970 cases for about $119 million.
The U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking transvaginal mesh to serious and life-changing adverse events in 2008. In July 2011, the agency warned that injuries and complications associated with transvaginal mesh prolapse repair were not rare, a change from its previous position on the issue.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. This program allowed the products to come to market without the first undergoing human clinical trials because manufacturers were able to demonstrate that the implants were “substantially equivalent” to a device that had already been through to the agency’s more stringent premarket approval process.