In September 2022, Johnson & Johnson reached a $204.90 million (A$300 million) settlement in two Australian class action lawsuits over defective pelvic mesh implants. The settlement is the largest settlement in a product-liability class action case in Australian history, and covers more than 11,000 claimants.
Background
The first class action was filed in October 2012 and the trial took place from July 2017 to February 2018. The Claimants included in the class action against Ethicon Sarl, Ethicon Inc., and Johnson & Johnson suffered complications after receiving one or more Gynecare prolapse mesh and incontinence tape implants.
In November 2019, the Court found in the Claimants’ favor. An Australian federal court judge found that Ethicon sold the implants without warning women or surgeons about potential risks, and had rushed the products to market before proper testing. Johnson & Johnson was ordered to pay $1.7 million to three Australian women in March 2020. Johnson & Johnson and Ethicon appealed that decision, and the appeal was dismissed in March 2021. In April 2021, a second class action was filed on behalf of women who received their implants on or after July 4, 2017 (and who were ineligible to join the first class action as trial had already started). In November 2021, the Court dismissed Johnson & Johnson’s application for special leave to appeal.
In a statement released by Johnson & Johnson and Ethicon, they were pleased to reach a settlement that “provides certainty and a path forward for eligible Australian patients.” The statement went on to say, “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.”
Additional Lawsuits and FDA Restrictions
Johnson & Johnson – and other pelvic mesh manufacturers – have faced thousands of lawsuits from women around the world who have suffered pain, urinary problems, and other serious injuries from the implants. Total pelvic mesh settlements amount to more than $8 billion, which is continuing to rise. Johnson & Johnson has faced similar lawsuits in the United States, Canada, and Europe, and was just ordered earlier this year by a California court to pay $302 million for concealing the risks of Ethicon’s pelvic mesh products.
In 2019, the United States Food and Drug Administration (FDA) ordered all pelvic mesh makers to halt sales of the devices. “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”