RICHMOND, Virginia – A federal appeals court has vacated a lower court judgment in a pelvic mesh product liability trial.
In a July 22 opinion, the U.S. Court of Appeal for the Fourth Circuit made the decision to vacate the ruling by U.S. District Senior Judge Irene Keeley and remanded it back to district court after receiving an answer from the West Virginia Supreme Court of Appeals to a certified question regarding jury instructions in design defect cases.
After it was remanded, the case was reassigned to U.S. District Judge Thomas Kleeh.
Segal
| File photo
“I’m very happy for the Shears family and all future mesh litigants that this issue has been resolved in a very clear opinion by Judge (Robert) King through a well-written answer from (West Virginia Supreme Court) Justice (Haley) Bunn,” Scott Segal, one of the attorneys representing the plaintiffs, told The West Virginia Record. “I’m also glad future litigants now have a well-reasoned opinion to provide clarity to the lower courts in their lawsuits.”
In the Fourth Circuit opinion, King lays out the history of the case.
In October 2008, plaintiff Judith Shears of Monongalia County went to her doctor with complaints of stress urinary incontinence and other issues. She eventually was sent to a urogynecologist, who placed a synthetic surgical mesh sling called Tension-Free Vaginal Tape under her urethra. Her symptoms abated at first, but she eventually began experiencing incontinence again as well as urinary tract infections, pelvic pain, urinary frequency and urgency.
In October 2013, a urologist discovered the TVT mesh partially had eroded into Shears’ bladder, and surgery was done to remove the eroded mesh and attached bladder stone. More eroded mesh was found in 2014, and she has since experience recurrent bladder stones and associated bladder and urinary difficulties.
Shears and her husband filed a civil lawsuit in July 2013 against Ethicon Inc, which manufactured and sold the TVT mesh, and parent company Johnson & Johnson. The complaint asserted numerous claims for relief, including a strict liability claim alleging the TVT device was defectively designed. Their case was part of a Multidistrict Litigation before Judge Joseph Goodwin in federal court in the Southern District of West Virginia.
The Shears’ lawsuit was part of an MDL that included almost 28,000 similar cases against Ethicon. There were six other pelvic mesh MDLs also assigned to Goodwin, and those seven MDLs included about 58,000 cases.
In June 2015, the case was consolidated with 36 other West Virginia-based cases to resolve the defective design element of the TVT claims. They were styled Mullins v. Ethicon. The company objected to the consolidation, saying the “existence of a safer alternative design” had to be proven on a plaintiff-specific basis.
After years of pretrial proceedings in the MDL, the lawsuit was transferred to the Northern District of West Virginia in December 2020. There, Keeley began addressing pretrial motions, including Daubert motions regarding expert witnesses.
One of Ethicon’s Daubert motions sought to limit testimony of Dr. Uwe Klinge, a design and material expert. Klinge’s report spoke of two possible alternatives to the design of Ethicon’s TVT mesh that, in his opinion, posed a far lower risk of erosion and was a “safer alternative.”
During a February 2022 hearing, Keeley questioned the Shears’ legal team about Section 411 of the West Virginia Supreme Court’s recently published Pattern Jury Instructions for Civil Cases titled “Design Defect – Necessity of an Alternative, Feasible Design.” The section reflects a so-called Elimination Mandate,” a requirement that an identified alternative, feasible product design “eliminate the risk” of harm suffered by the plaintiff.
“There are many designs which, although they may eliminate a particular risk, are not practicable to product,” Section 411 states. “To prove that a design is defective, (plaintiff) must prove that there was an alternative, feasible design that eliminated the risk that injured (plaintiff).”
Keeley accepted the legal soundness of Section 411’s requirements but said Klinge “never said (the alternative mesh designs) eliminated the risk but rather reduced the risk.”
Klinge’s expert testimony ultimately would not have aided the Shearses in satisfying the Section 411 Elimination Mandate, and Keeley granted Ethicon’s Daubert motion to bar Klinge from testifying, forcing the Shears’ legal team to modify its trial strategy.
“The trial court’s restraint of Dr. Klinge’s testimony essentially foreclosed their ability to establish a defective product design under the standard of 411,” the Fourth Circuit opinion states. “The Shearses pursued their design defect claim under an alternative, so-called ‘malfunction theory’ of liability.”
That malfunction theory allows success on a strict product liability claim using only circumstantial evidence as long as the plaintiff “shows that a malfunction in the product occurred that would not ordinarily happen in the absence of a defect.”
In March 2022, the Shears case went to jury trial. Keeley, however, ended their reliance on the malfunction theory by granting Ethicon’s motion for judgment as a matter of law on the design defect claim and instructed the jury on the Shears’ sole remaining negligent design claim. The jury returned a verdict for Ethicon on that claim later the same day.
The Shears appealed to the Fourth Circuit, and it asked the state Supreme Court the certified question focusing on Section 411 and the elements of a strict liability design defect claim.
Last month, the state Supreme Court delivered a unanimous opinion written by Bunn. In it, the Supreme Court said Section 411 does not correctly specify the plaintiff’s burden of proof for a strict liability design defect claim.
It also said a plaintiff alleging a strict liability design defect claim is required to prove the existence of an alternative, feasible product design to establish the product was not reasonably safe for its intended use. In addition, it also said the plaintiff in a design defect case is required to prove an alternative, feasible design existing at the time would have substantially reduced the risk of the specific injury suffered.
“The Shearses challenge the federal trial court’s embrace of Section 411 of the PJI, insisting that Section 411’s framing of the standard of proof for a strict liability design defect claim lacks support in controlling West Virginia law,” the Fourth Circuit states. “Specifically, the Shearses assert that the trial court’s Daubert ruling is legally unsound because it restricted Dr. Klinge’s expert testimony based on a requirement that does not exist in West Virginia law – the Elimination Mandate.”
The Fourth Circuit says the state Supreme Court’s answer establishes that Keeley abused her discretion by relying on an erroneous legal principle while also saying her exclusion of Klinge “readily satisfied harmless error review.”
The Shears are being represented by Segal, Robin Jean Davis and Jason Patrick Foster of The Segal Law Firm in Charleston. The defendants are being represented by Natalie Rose Atkinson of Thomas Combs & Spann in Charleston and by Amy M. Pepke of Butler Snow in Memphis.
U.S. Court of Appeals for the Fourth Circuit case number 22-1399 (U.S. District Court case number 1:20-cv-264 and West Virginia Supreme Court of Appeals case number 23-192)