Shine Lawyers, the firm representing the patients, said that the Federal Court of Australia still needs to approve the terms of the agreement.
Johnson & Johnson has agreed to settle two pelvic mesh cases in Australia for AU$300 million (about $203.7 million), according to the Australian firm Shine Lawyers, which represented the applicants.
Shine Lawyers announced Sunday that it came to the agreement with J&J and its subsidiary Ethicon in two class action lawsuits alleging that patients suffered injuries after being implanted with pelvic mesh products.
“ The complications which can result from the implants includes erosion of the mesh into surrounding organs, chronic pain, painful sexual intercourse and incontinence,” the firm said in the release.
The agreement, which was reached last Friday, still needs to be approved by the Federal Court of Australia. If the court approves of the agreement, it will be the largest settlement in a product liability class action in Australia’s history, according to Shine.
Nine Gynecare implant products were included in the proceedings.
“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,” a J&J spokesperson said in an emailed statement. “Pending the Federal Court approval, we are pleased to reach a settlement that provides certainty and a path forward for eligible Australian patients.”
The company did not confirm the settlement amount.
The deal settles two class action lawsuits in one agreement. The first lawsuit was filed in October 2012, went to court between July 2017 to February 2018, and was decided in the plaintiffs’ favor in November 2019. J&J’s attempts to appeal failed, with the High Court of Australia rejecting the company’s request to appeal in November 2021.
The second lawsuit was filed in April 2021 on behalf of patients who received implants on or after July 4, 2017, and were not allowed to be part of the first class action suit, Shine stated.
The settlement is another loss for J&J in pelvic mesh cases. In April, a California appeals court ordered J&J to pay $302 million for deceptive marketing of pelvic mesh implants. The three-judge panel upheld a lower court’s ruling that Ethicon omitted or minimized the risk of using the devices in its instructions for the products and marketing to doctors and patients.
J&J also agreed to pay $117 million in 2019 to settle an investigation across 41 states and the District of Columbia alleging the company used deceptive marketing practices for transvaginal surgical mesh products.
Injuries from mesh products have been the center of numerous lawsuits across the medical device industry. Most recently, Becton Dickinson was ordered to pay $4.8 million in damages to a Hawaiian patient who said he suffered severe injuries from hernia mesh products made by the company’s subsidiary C.R. Bard.
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While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.
"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.
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While the guidance encouraged the use of electronic communications in recalls, a change experts have advocated for, some questioned why the agency did not address more problems with the system.
"It truly is like we are operating in about the 1950s," one consultant noted of the process. The FDA has held two meetings in the past year to mull improvements.
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