Intended for healthcare professionals


Johnson & Johnson loses class action over vaginal mesh in Australia

BMJ 2019; 367 doi: (Published 22 November 2019) Cite this as: BMJ 2019;367:l6659
  1. Clare Dyer
  1. The BMJ

More than 1350 women have won a seven year class action in Australia against the pharmaceutical company Johnson & Johnson over harm they suffered from its transvaginal mesh and tape devices.

Federal Court judge Anna Katzmann ruled that Johnson & Johnson’s subsidiary Ethicon had sold the products without warning women or doctors of the gravity of the risks and was negligent in rushing them to market without proper testing.

The case, one of Australia’s largest class actions, is one of many lawsuits worldwide over the products, used to treat urinary incontinence and pelvic organ prolapse after childbirth. In October Johnson & Johnson agreed to pay nearly $117m (£91m; €106m) to settle claims brought by the attorneys general of 41 US states and the District of Columbia that it deceptively marketed and advertised the products.

In a trial which started in July 2017, women claimed that they suffered serious and permanent injuries after having the devices implanted. Complications included erosion of mesh into surrounding organs, chronic pain, inability to have sexual intercourse, and incontinence. Surgery to fully remove the mesh is difficult and may be impossible in some cases.

Reading from her 1500 page summary, Justice Katzmann said much of the information the company provided about the devices was “inaccurate” and at times it had made “false representations.”

“The question is whether this conduct considered as a whole was misleading or likely to mislead. I believe it was,” she added.

“The post-market evaluation of all the Ethicon devices was deficient. It fell well below the level of care required of a reasonably prudent manufacturer. The risks were known, not insignificant, and, on Ethicon’s own admission, serious harm could ensue if they eventuated.”

She said Ethicon had “conducted no or no adequate clinical trials on the devices before taking them to market.” When doctors and patients complained, “in some cases they were ignored altogether.”

The court heard evidence during the trial that Ethicon tried to stop the French regulator warning publicly against the use of the pelvic mesh devices, fearing that the warning “could have a major impact on our business if made public.”

Katzmann has scheduled a further hearing in February to consider damages.

More than 100 000 women worldwide are believed to have had the implants and Johnson & Johnson faces thousands of lawsuits in Europe, the Middle East, and North America. It has paid more than $240m in settlements over claims that it hid risks and marketed devices too aggressively in the US.

In a statement, an Ethicon spokeswoman said that the company was reviewing the court’s findings and would be considering its options to appeal. She said it believed it had acted ethically and responsibly in the research, development, and supply of the products.

“Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for women, with the vast majority experiencing an improvement in their day-to-day lives,” she added.

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