Medical device trade group AdvaMed announced today that it has filed an amicus curiae brief supporting an appeal to overturn a $344 million pelvic mesh ruling against Johnson & Johnson in California.
Lawyers for AdvaMed tell the California Court of Appeal that the San Diego Superior Court judgment violated safe harbor protections because the case involved J&J communications about pelvic mesh that were FDA-approved.
“We believe the trial court misapplied California’s Unfair Competition Law and Fair 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,” said Pat Fogarty, AdvaMed’s SVP, deputy general counsel and director of litigation.
“The 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 in an AdvaMed news release.
Pelvic mesh was arguably one of medtech’s greatest failures so far in the 21st century. The mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. But FDA in 2019 ordered Boston Scientific and Coloplast — the remaining companies selling the devices — to halt pelvic mesh distribution. At that point, there were already thousands of lawsuits and millions of dollars worth of settlements as women reported pain, excessive bleeding and loss of sexual function.
Johnson & Johnson sold more than 470,000 pelvic mesh products nationally from 2008 to 2014.