Johnson and Johnson unit Ethicon is unhappy with and petitioning against the Fourth U.S. Circuit Court of Appeals’ recent decision to uphold a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial. This was the first of the 31,676 lawsuits to go to trial in the New Jersey multidistrict litigation against Ethicon related to the mesh devices.
The trial, which concluded on Sept. 5, 2014. involved plaintiffs Jo and Allen Huskey, who alleged that because of a design defect in Mrs. Huskey’s TVT-O sling she experienced severe pain. The sling had eroded and surgery could not completely remove it, which meant that the pain was long-term.
In August 2015, U.S. Judge Joseph Goodwin affirmed the jury’s verdict and on Jan. 26, the Fourth Circuit again upheld the verdict, dismissing arguments that Ethicon should have been shielded from liability because of a product liability doctrine called “comment k” and FDA’s 510(k) approval of the TVT-O.
According to comment k, some products, such as vaccines, are unavoidably unsafe but not unreasonably dangerous. The FDA’s 510(k) is a shortcut approval process that allows for a device or product to be approved based on its similarity to other products that are already on the market instead of undergoing extensive safety and efficacy testing required of new products.
Ethicon argued that its FDA approval and a post market study by an FDA advisory committee should have been presented as evidence in court.
“The Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm,” said the appeals court, according to Mass Tort Nexus.
“We’re very pleased with the ruling and excited for Jo Huskey and the team that worked on the case,” the Huskeys’ attorney Edward A. Wallace of Wexler Wallace LLP told Law360 in January. “Given the length that the court went to explain its reasoning, we hope it can be used to demonstrate to Ethicon that it needs to go ahead and resolve all of these cases for all of these women.”
That, however, is not how Ethicon responded. The company is now arguing that because the FDA-related evidence was left out of this case, a precedent has been set in most future product liability cases involving “Class II” medical devices.
Whether or not Ethicon is right about the scope, thousands of pelvic mesh cases are likely to be influenced by this bellwether. Litigation also may be affected by an $11.11 million verdict upheld by the New Jersey Supreme Court in December from a February 2013 bellwether trial against Johnson & Johnson unit Ethicon, Inc. over another surgical mesh product. the Gynecare Prolift mesh.
Ethicon also is now facing lawsuits for another kind of mesh product. Its Physiomesh product, which was used to treat hernias and designed to reinforce the abdominal wall, preventing future hernias from occurring, was voluntarily withdrawn from the market in the U.S. and recalled in other countries last May.
In April 2010, Physiomesh, like TVT-O, was approved through a 510(k) submission. Ethicon showed that Physiomesh was substantially similar to its own Proceed mesh, which would be recalled only six months later, in October 2010, due to reports of layers of the mesh separating once implanted.
Now Physiomesh has been linked to more postoperative pain than similar devices, an increased risk of organ perforation, mesh migration, sepsis and even death. Studies have shown that it is related to significantly more recurrent hernias and the need for additional surgeries. It was in response to these studies that Ethicon chose to withdraw the products from the market in 2016, but at that point there were already lawsuits against the company related to Physiomesh. The first trial date is set for Jan. 22, 2018, in Illinois.