The Fourth US Circuit Court of Appeals upheld a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial, dismissing defense arguments that the FDA’s 510(k) shortcut approval process shielded them from liability. The court ruled that the plaintiffs offered sufficient evidence and that the trial judge committed no reversible error.
The case is Jo and Allen Huskey v. Ethicon, Inc. and Johnson & Johnson, No. 15-2118, 4th Cir.; 2017 U.S. App. LEXIS 1402. It is one of 31,676 lawsuits filed in Ethicon, Inc., Pelvic Repair System Products Liability Litigation in MDL 2327 supervised by US District Judge Joseph R. Goodwin in the Southern District of West Virginia in Charleston.
In 2014 a jury found Ethicon liable for design defect, failure to warn and loss of consortium claims. “The Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm,” the appeals court said.
On appeal, Ethicon argued that:
- The Huskeys failed to prove a specific flaw in the TVT-O’s design — as opposed to a general complication flowing from implantation.
- Comment k of the Restatement (Second) of Torts § 402A shielded it from liability.
- It was error to exclude evidence about the FDA 510(k) approval of the TVR-O and a study about pelvic mesh by an FDA advisory committee.
Flaws in TVT-O’s design
The first design flaw was making the TVT-O out of polypropylene. Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and one of the Huskeys’ expert witnesses, testified 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.”
The second flaw was using heavy-weight mesh, which also 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.”
“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,” the court ruled.
Ethicon 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 because “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.”
No error excluding FDA evidence
Ethicon argued that the district erred in excluding 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.
In 2003 Ethicon received FDA clearance under the 510(k) shortcut to market the TVT-O because it was substantially equivalent to a pre-existing device, the Gynecare TVT. The appeals court ruled that excluding this was correct, because “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 correct to exclude a 2011 review by an FDA Obstetrics and Gynecology Devices Advisory Committee of published literature about 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 said.
Three unsuccessful surgeries
Jo Huskey of Illinois had the Tension-Free Vaginal Tape-Obturator (“TVT-O”) implanted in 2011 to treat stress urinary incontinence. It is a sling made of polypropylene in a heavy-weight laser-cut mesh. A few weeks later the surgeon discovered that the mesh had eroded, causing her to experience pelvic pain. On June 29, 2011 he had a second surgery to cover the exposed mesh, but it did not relieve the pain. She had a third surgery on November 18, 2011, revealing an infection the complete erosion of the right side of the mesh.
She and her husband filed suit in 2012. In 2014 the jury awarded Mrs. Huskey $3.07 million in total damages, allocated between past expenses for medical care, previous pain and suffering, and future pain and suffering. The jury awarded Mr. Huskey an additional $200,000 for his loss of consortium.
“To this day, the remaining mesh and scar tissue from her operations cause Mrs. Huskey 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 said.