Court Finds Sufficient Evidence for Pelvic Mesh Verdict
A $3.27 million transvaginal mesh verdict issued against Ethicon and parent company Johnson & Johnson will stand, an appeals court has ruled. The verdict resulted from the second bellwether trial in the Ethicon pelvic mesh litigation. The plaintiff alleged that the Tension-Free Vaginal Tape-Obturator (TVT-O) was defective and caused painful injuries such as erosion, prompting the need for additional surgeries.
The transvaginal mesh lawyers at Parker Waichman LLP are well-versed in transvaginal mesh litigation. The firm, which has decades of experience in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh lawsuit.
According to court records, Ethicon had tried to argue that it was not liable for the plaintiff’s injuries because the TVT-O pelvic mesh was cleared through the U.S. Food and Drug Administration’s (FDA) 510(k) approval route. 510(k) is an expedited approval process that allows devices onto the market without substantial clinical testing. To gain approval through this route, manufacturers must show that their product is “substantially equivalent” to an older device (called a “predicate”). By FDA definitions, substantial equivalence means that the new product is at least as safe as its predicate.
During the trial, the court had excluded evidence of TVT-O’s compliance with 510(k). Ethicon argued that the court had erred in doing so. However, the appeals court disagreed and pointed out that this route only compares the safety of the mesh to one other product.
Many medical device injury lawsuits are filed over products approved through 510(k). Given that some controversial products, were approved in this manner, safety advocates have argued that 510(k) should not be used for certain medical devices. The FDA approved the TVT-O in 2003.
Ethicon also argued that the plaintiff failed to demonstrate that the TVT-O had a specific design flaw, and that Comment K of the Restatements shielded it from strict liability, claiming “some products…are quite incapable of being made safe for their intended and ordinary use.”
However, the court rejected this argument, citing expert testimony. Court records state, “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 pelvic mesh is made of a heavyweight polypropylene material. At trial, jurors heard expert testimonies for the plaintiff. One expert, an associate professor of chemical engineering at Vanderbilt University, told jurors “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.”
Another expert, a former Ethicon employee, said using lightweight mesh “would help in reducing a foreign body response, inflammatory response, and would reduce the potentiation for scar plating.”
The court cited these expert testimonies and 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,”
Ethicon also tried to have the verdict tossed by arguing that the court made an error when excluding a 2011 review by the FDA Obstetrics and Gynecology Devices Advisory Committee on pelvic mesh products. The court countered that “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,”
Jurors Award $3.27M to Pelvic Mesh Plaintiff
The plaintiff in the lawsuit had the TVT-O implanted in 2011 to treat stress urinary incontinence. This condition causes the involuntary release of urine during normal, everyday activities such as laughing or sneezing. Transvaginal mesh is approved to treat stress urinary incontinence and pelvic organ prolapse.
After the mesh was implanted, doctors found that the mesh had eroded, causing pelvic pain. To correct the mesh exposure, the plaintiff underwent a second surgery in June 2011. Unfortunately, the procedure did not alleviate the pain. The plaintiff underwent surgery for the third time in November 2011. During the operation, doctors discovered complete erosion on the right side of the mesh.
A lawsuit was filed on behalf of the plaintiff and her husband in 2012. At the conclusion of the trial in 2014, jurors awarded $3.07 million in total damages and an additional $200,000 to the plaintiff’s husband for loss of consortium.
Ethicon was found liable for design defect, failure to warn and loss of consortium. Overall, 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,”
The Fourth Circuit stated, “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 trial was the second bellwether case in the Ethicon pelvic mesh multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia in Charleston, before U.S. District Judge Joseph R. Goodwin. Court documents show that 31,676 lawsuits were transferred into the MDL.
MDLs are created to make complex litigation proceed faster; they transfer similar lawsuits to one court to streamline the pretrial process. A bellwether case is viewed as a test case, because both parties get to see how their legal arguments are received by jurors in court. The outcome of bellwether trials is used to gauge the remaining litigation.
Filing a Transvaginal Mesh Lawsuit
If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).