$3.27 Million Jury Award Upheld in Ethicon Pelvic Mesh TrialFeb 28, 2017
The Fourth U.S. Circuit Court of Appeals Uphold Multi-Million Dollar Pelvic Mesh Jury Award
The Fourth United States Circuit Court of Appeals just upheld a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial. The court dismissed defense arguments that the U.S. Food and Drug Administration's (FDA) rapid clearance route, known as the 510(k), shielded them from liability. The court ruled that the plaintiffs offered sufficient evidence and that the trial judge did not commit a reversible error.
The lawsuit is one of 31,676 lawsuits that are filed in the Ethicon multidistrict litigation (MDL): Ethicon, Inc., Pelvic Repair System Products Liability Litigation in MDL 2327 supervised by U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia in Charleston.
Parker Waichman LLP represents numerous individuals in the transvaginal mesh litigation. If you or someone you know suffered complications related to pelvic mesh inserts, contact our firm today for more information about your legal rights.
In 2014, a jury found Ethicon liable for design defect, failure to warn, and loss of consortium claims. The appeals court found that the plaintiffs "offered sufficient evidence to sustain the jury's verdict and the district court committed no reversible error. Accordingly, we affirm." Ethicon, on appeal argued that the plaintiffs neglected to prove a specific flaw in the design of the Gynecare TVT-Obturator system (TVT-O), that Comment K of the Restatement (Second) of Torts § 402A shielded the device maker from liability, and that it was erroneous to exclude evidence about the FDA 510(k) approval of the TVT-O and a study concerning pelvic mesh conducted by an FDA advisory committee.
Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and a plaintiffs' expert witnesses, testified that the first design flaw was in the manufacture of the TVT-O out of polypropylene, noting that, "the body recognizes [the polypropylene mesh] as a foreign material, and ... will continue to attack it in this way until it's removed or destroyed or it's gone." According to the plaintiffs, the second flaw involved using heavyweight mesh, which causes a foreign body response. Dr. Brigitte Hellhammer, a former Ethicon employee, testified that lightweight mesh "would help in reducing a foreign body response, inflammatory response, and would reduce the potentiation for scar plating." The court ruled that, "A reasonable jury could conclude from this expert testimony that Ethicon's use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect."
As for Ethicon, it argued that Comment K of the Restatements shielded it from strict liability because "some products ... are quite incapable of being made safe for their intended and ordinary use." The appeals court rejected the argument writing that, "the expert testimony allowed the jury to infer that Ethicon could have designed the TVT-O with lightweight mesh without sacrificing any performance. Consequently, the jury could reasonably conclude that the TVT-O was not unavoidably unsafe." The TVT-O is a sling-constructed polypropylene in a heavyweight, laser-cut mesh.
Ethicon also argued that the district was mistaken to exclude evidence of the TVT-O's compliance with the FDA's Section 510(k) evaluation process and that a 2011 FDA Advisory Committee deemed mesh slings-including the TVT-O-safe and effective. Ethicon received FDA clearance under the 510(k) route in 2013 to market the TVT-O indicating that the device was substantially equivalent to a pre-existing device known as the Gynecare TVT. The appeals court ruled the exclusion was correct as "the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only 'tangentially' examines the safety of the product going through the process."
It was also found correct to exclude a 2011 review by an FDA Obstetrics and Gynecology Devices Advisory Committee of published literature concerning pelvic mesh treatment. "While the district court did not permit Ethicon to present evidence as to the FDA's view of the underlying studies, it did permit Ethicon to introduce those studies themselves. The FDA did not use its own analysis of the TVT-O to reach a conclusion regarding the device's safety and efficacy. Rather, it simply opined on the work others had done," the court indicated.
The Illinois woman was implanted with the Tension-Free Vaginal Tape-Obturator in 2011 to treat stress urinary incontinence (SUI). A few weeks following implantation, her surgeon found that the mesh eroded, which caused pelvic pain. On June 29, 2011, the surgeon conducted a second surgery to cover the exposed mesh; however, the pain was not relieved. The woman underwent a third surgery on November 18, 2011. During that surgery an infection and complete erosion of the right side of the mesh was discovered.
The woman and her husband filed a lawsuit in 2012. In 2014 the jury awarded the woman $3.07 million in total damages and her husband $200,000 for his loss of consortium.
"To this day, the remaining mesh and scar tissue from her operations cause" the plaintiff "to experience severe pain, particularly when engaging in physical activity and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, she will require medication for pain management; no surgical intervention can permanently cure her," the Fourth Circuit indicated.
Meanwhile, in March 2013, a New Jersey state court jury awarded $11.1 million in damages against Ethicon. The award included punitive damages due to the medical device manufacturers' actions surrounding the manufacture and sale of their vaginal mesh products. The woman in this lawsuit underwent least 18 surgeries due to complications from Gynecare Prolift mesh. In 2016, a Texas jury awarded $1.2 million in damages to a woman who alleged that she suffered severe and debilitating injuries after being implanted with an Ethicon TVT-O sling for the treatment of SUI.
What is Transvaginal Mesh?
Pelvic mesh or transvaginal mesh, is approved for the treatment of pelvic organ prolapse (POP) and SUI and is meant to strengthen the pelvic wall and lift sagging organs. Transvaginal mesh has become an increasingly controversial medical device given safety concerns discussed in thousands of transvaginal mesh lawsuits filed against various mesh makers, including Boston Scientific and Johnson & Johnson. Johnson & Johnson is the parent company of Ethicon.
Lawsuits allege that transvaginal mesh implants caused serious, often permanent injuries and that women also allege that the mesh caused injuries, including mesh erosion through the vagina-known as exposure, extrusion, or protrusion-, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems.
Filing a Transvaginal Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a transvaginal mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).