Pelvic mesh maker Johnson & Johnson loses class action in landmark legal win

Johnson & Johnson is likely to be liable for a multi-million-dollar compensation payout to women damaged by vaginal mesh.

Johnson & Johnson have been ordered to compensate women affected in the pelvic mesh class action.

Health products giant Johnson & Johnson is likely to be liable for a multi-million-dollar compensation payout to women damaged by vaginal mesh, in a case that has exposed deficiencies in Australia’s regulation of medical devices.

The Federal Court ruled on Thursday that the manufacturers of several vaginal mesh products, surgically implanted into women suffering stress incontinence or prolapse, had breached consumer law and were negligent in failing to warn patients and doctors of the products’ safety risks.

The ruling came after a seven-month class action trial that heard from 48 witnesses and in which 164,000 pages of documents were tendered.

The court was told that three of the lead claimants in the action had suffered debilitating chronic pain that had negatively affected their relationships, ability to work and mental health.

Up to 90,000 women have had the vaginal mesh implanted, and it’s estimated thousands have experienced adverse effects.

The devices eroded within some womens’ bodies and were impossible to fully remove. Many women experienced a chronic inflammatory response, causing the mesh and the scar tissue which grew between it, to contract and shrink. That caused “shortening and narrowing of the vagina, chronic pain, and pain with sexual intercourse”.

One woman’s pain was so severe she “sometimes struggled to breathe”, and another often “felt as if there was a blade inside her vagina”.

Women wept in court as the judgement was handed down.

One of the women damaged by the mesh, Julie Davis, said the ruling was a victory for justice. “They have treated women essentially like guinea pigs,” she said.

“We can now probably start to heal a little bit.”

Judge Anna Katzmann found the mesh manufacturers, Ethicon Sarl and Ethicon Inc, both members of the Johnson & Johnson group, had put commercial interests above patient safety in rushing the medical devices to market.

“The respondents saw the commercial opportunities presented by the new devices and were keen to exploit them before their competitors beat them to it,” Justice Katzmann said.

The judge found Ethicon failed to test the products’ safety, conducting no adequate clinical trails of the devices before taking them to market, failed to warn consumers and doctors of the products’ risks, breached legislation and failed in their duty of care to consumers.

Complaints by surgeons following implantation of the devices were often ignored, Justice Katzmann found.

Evaluations completed by the manufacturer many years after the products entered the market were inadequate. “Conclusions were formulaic …. text was copied and pasted,” Justice Katzmann said. “For the most part these reports could scarcely be described as evaluations at all.”

The court found the Therapeutic Goods Administration conducted no independent evaluations of the devices’ safety.

“The medical devices industry is largely self regulating,” Justice Katzmann said. “The evidence revealed widespread and systematic non-compliance with regulatory requirements, standards, and guidelines.”

Johnson & Johnson said in a statement it was reviewing the Federal Court decision and would “consider its options” in an appeal.

Compensation for the women will be determined at a later date.