Federal Appeals Court Refuses to Reverse $6.7 Million Judgment Awarded to Plaintiff in Boston Scientific Transvaginal Mesh Lawsuit

Published on October 31, 2017 by Sandy Liebhard

Boston Scientific Corp. has been denied its bid to reverse the $6.7 million judgement awarded to a woman who suffered serious complications following implantation of the company’s Pinnacle pelvic mesh device.

Amal Eghnayem’s transvaginal mesh lawsuit was initially filed in the multidistrict litigation currently underway in rhw U.S. District Court, Southern District of West Virginia, where thousands of pelvic mesh claims involving Boston Scientific’s devices have been centralized for coordinated pretrial proceedings. Her case was one of four consolidated and transferred to in the U.S. District Court, Southern District of Florida, for trial.

All four plaintiffs were awarded a total of $27 million in November 2104, following an 8-day trial. Eghnayem and Juana Betancout were awarded $6,722,222 each, while Margarita Dotres was awarded $6,766,666, and Maria Nunez was awarded $6,533,333.

In appealing the judgment entered for Eghnayem to the 11^th Circuit Court of Appeals, Boston Scientific asserted that the District Court wrongly consolidated the four lawsuits arguing that individual issues predominated and the consolidation resulted in unacceptable prejudice. The company also maintained that the District Court improperly excluded evidence concerning the Pinnacle’s clearance through the U.S. Food & Drug Administration’s (FDA) 510(K) process.

Consolidation of Four Transvaginal Mesh Lawsuits Was Within District Court’s Discretion

The appellate court found for Eghnayem on October 11^th, ruling that the District Court acted within its discretion when it consolidated the four pelvic mesh claims.

“Although each plaintiff’s proof of causation was necessarily different, generally differences in causation are not enough, standing alone, to bar consolidation of products liability claims,” the appeals court said in its opinion. ‘And any danger of prejudice arising from the consolidation was reduced in this case, because the district court explained the consolidated nature of the trial to the jury and expressly instructed it to consider each plaintiff’s claims separately.”

The appeals court also found that the trial court had acted within its discretion in excluding evidence pertaining to the Pinnacle’s 501(k) clearance, which allows a medical device to come to market without undergoing human clinical trials if a manufacturer can demonstrate “substantial equivalence” to a product that has already gone through the FDA’s premarket approval process.

“BSC claims that the evidence is relevant because the plaintiffs based much of their case on the theory that BSC didn’t perform sufficient safety testing, and because Florida has established a rebuttable presumption that a product is not defective if it complies with applicable safety regulations,” the appeals court said. “But these points simply beg the question; because 510(k) is not a safety regulation, approval under that process cannot show that BSC performed sufficient testing or complied with applicable safety regulations.”

Boston Scientific Reports Transvaginal Mesh Settlements

Court documents indicate that more than 9,500 transvaginal mesh lawsuits remain pending against Boston Scientific in the Southern District of West Virginia. All of the plaintiffs involved in this litigation are alleged to have experienced mesh erosion, chronic pain, organ perforation, and other debilitating complications following implantation of the company’s pelvic mesh devices to treat stress urinary incontinence and pelvic organ prolapse. Boston Scientific is accused of failing to adequately test the implants or inform doctors and patients about their risks.

In a recent filing with the U.S. Securities and Exchange Commission, Boston Scientific acknowledged that it had been named a defendant in more than 48,000 product liability claims involving its transvaginal mesh devices. The cases have been filed in various state and federal courts in the U.S., as well as courts in Canada and the U.K.

“As of July 26, 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 38,000 cases and claims. These master settlement agreements provide that the settlement and distribution of settlement funds to participating claimants are conditional upon, among other things, achieving minimum required claimant participation thresholds,” the filing noted. “Of the approximately 38,000 cases and claims, approximately 14,500 have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.”