In a statement shared with MassDevice by a spokesperson, Johnson & Johnson and its Ethicon subsidiary said that pending Federal Court approval, they are pleased to reach a settlement that “provides certainty and a path forward for eligible Australian patients.”
The statement added: “Ethicon empathizes with all women who experience medical complications related to pelvic organ prolapse or stress urinary incontinence. These are extremely complex medical conditions, and Ethicon has strived to support the availability of treatment options for women with these conditions.”
In its most recent quarterly report, J&J outlined how the Federal Court of Australia found for the three lead applicants in the class action in March 2020. The pharma and medtech giant has mostly exhausted the appeals process since then.
Johnson & Johnson recorded $300 million in litigation expenses for the first half of the year, according to the form 10-Q filed with the Securities and Exchange Commission. The costs were primarily related to pelvic mesh.
Pelvic mesh — one of medtech’s greatest failures
The products are arguably one of the medical device industry’s great failures so far in the 21st century, ensnaring a host of big medtech companies in costly litigation.
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 through its Ethicon subsidiary from 2008 to 2014. In its annual report posted in February, it said there were 10,100 plaintiffs in the U.S. with claims directly related to the mesh products.
In April, a California appeals court mostly agreed with a lower court that J&J must pay the state $302 million over claims that it engaged in misleading marketing of pelvic mesh.