Pelvic mesh implant manufacturer Johnson & Johnson group has reached a $300m settlement in two class actions, after thousands of women worldwide reported complications from the mesh products including chronic pain, painful sexual intercourse and incontinence.
It marks the largest settlement in a product liability class action in Australian history, and is subject to federal court approval.
The net-like meshes, which come in a number of forms, including a “sling”, “tape”, “ribbon”, “mesh” and “hammock”, aim to treat pelvic organ prolapse by giving permanent support to weakened pelvic organs, and to repair damaged tissue.
Shine Lawyers led the Australian class actions and alleged Johnson & Johnson failed to properly test the devices and played down their risk to both surgeons and patients. Women have suffered complications including mesh exposure and erosion – when the mesh pokes through the vaginal wall or cuts through internal tissue – vaginal scarring, fistula formation, painful sex, and pelvic, back and leg pains. Some of these complications may occur years after surgery and can be difficult to treat.
The first class action was filed in the federal court on 15 October 2012, and ran to trial over seven months between July 2017 and February 2018. In November 2019, a landmark judgment was delivered in favour of the 1,350 women who were part of the class action and who had mesh and tape products implanted to treat pelvic prolapse or stress urinary incontinence.
Johnson & Johnson Medical and Ethicon appealed to the full court of the federal court, which dismissed the appeal in March 2021.
The full court agreed with the primary judge’s finding that the marketing of the mesh devices was likely to mislead or deceive.
The court rejected arguments from lawyers representing Johnson & Johnson that manufacturers are excused from liability with respect to risks or complications that should be known to doctors, or which doctors and surgeons are able to discover and warn of for themselves. The court found that while medical goods can not all be risk-free, patient should expect those devices to carry appropriate warnings about risks even if those risks are rare.
In November 2021, the high court dismissed Johnson & Johnson Medical’s application for special leave to appeal.
The second class action was filed in April 2021 on behalf of women who received their implants on or after 4 July 2017 and were not eligible to join the first class action.
Shine Lawyers’ Rebecca Jancauskas said the settlement would help support women’s ongoing treatment needs.
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“We welcome this settlement which brings the litigation to an end,” she said. “If the federal court approves the settlement our focus will shift to the important task of distributing the settlement to group members.”
Other manufacturers of the slings and meshes, including Astora Women’s Health and Boston Scientific, have also been the subject of class actions in Australia. In July, Shine Lawyers reached a settlement worth $105m with Boston Scientific.
Women implanted with one or more of the devices in Australia up to 30 June 2020, and who suffered one or more complications as a result, may be eligible for compensation.
Similar class actions involving thousands of women are also under way in the UK and US. In 2018 the then Australian health minister Greg Hunt issued a national apology on behalf of the government to women affected by the transvaginal mesh scandal, after a Senate inquiry into transvaginal mesh procedures found many women experienced great difficulty in finding medical practitioners who believed that the symptoms they were experiencing were a result of the mesh, and that the symptoms were as severe as they described.