- AdvaMed has come to the defense of Johnson & Johnson in its $344 million tussle with the California legal system over the marketing of pelvic mesh.
- J&J has spent the 20 months since being hit with the hefty fine trying to fight back against the ruling that it falsely and deceptively marketed the devices, with its current effort focused on appealing the penalty judgment of the trial court. AdvaMed has leant a hand to the effort by filing an amicus curiae brief.
- The brief asks the California Court of Appeal to reverse the original judgment because the court misapplied state law on competition and fair advertising. As AdvaMed sees it, the ruling against J&J "undermines a manufacturer's ability to rely on FDA input when it comes to the adequacy of device labeling."
The California Attorney General first contacted J&J about its marketing of surgical mesh products for hernia and urogynecological purposes almost a decade ago. Since then, the medtech has faced legal actions in states across the U.S. J&J appeared to defuse the situation late in 2019 by reaching a $117 million settlement with a coalition of more than 40 states, only for California to fine the company $344 million months later.
The Court of California denied J&J's motion for a new trial last year but the legal scrap continued. As it stands, J&J is appealing the penalty judgment. AdvaMed, which lists J&J among its members, put its take on the situation down in a brief filed with the appeal court.
Pat Fogarty, deputy general counsel and director of litigation at AdvaMed, said in a statement the trade group believes the court erred in its application of competition and advertising law "by failing to judge the communications from the perspective of the target audience — trained physicians who treat pelvic floor conditions — over 80 of whom confirmed that the marketing materials were not likely to mislead them."
The implications of the application of California law by the court extend beyond the J&J case, according to Fogarty.
The court's decision "undermines a manufacturer's ability to rely on FDA input when it comes to the adequacy of device labeling and marketing based on FDA review and is inconsistent with how medical professionals view manufacturer labeling and marketing," Fogarty said.
AdvaMed's attorneys claim in the brief that the affirmation of the judgment would expose members of the trade group to the threat of unfair competition liability "even when they have complied with applicable federal law." The attorneys argue the California law "precludes the imposition of liability for conduct that has been authorized by state or federal legislation or agency action."
Xavier Becerra, who was California Attorney General at the time of the ruling, had a different view. In a statement made when the court issued the fine early last year, Becerra said J&J "intentionally concealed the risks of its pelvic mesh implant devices" and "robbed women and their doctors of their ability to make informed decisions."
Becerra is now Secretary of Health and Human Services in the Biden administration.