Pelvic mesh maker Johnson & Johnson to pay $2.6m in damages

Johnson & Johnson has been ordered to pay almost $2.6 million in damages to three women over faulty vaginal mesh products.

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

The Federal Court has ordered global healthcare giant Johnson & Johnson and two subsidiary companies to pay almost $2.6 million in damages to three women who led a landmark class action on defective pelvic mesh implants.

In what is likely to be the first wave of compensation payouts to thousands of affected women, Justice Anna Katzmann on Tuesday ordered Johnson & Johnson and its related companies to pay Ann Sanders, Kathryn Gill, and Diane Dawson damages in the range of $555,555 to $1.27m.

In a decision last November, Justice Katzmann found 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.

More than 1350 women signed on as part of the class action and the parties said on Tuesday they would develop a process to assess individual claims by June 30.

Outside court, one of the women who is a part of the class action, Rachael Wise, said she lived with the “trauma” and the “irreparable harm” caused by the mesh every day.

“It has affected our womanhood, our relationships with our partners, our time with our children and has led to significant financial losses.”

“No amount of money can really reflect the lifetime of damage, pain and suffering the mesh has caused,” she said.

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 remove.

Many women experienced a chronic inflammatory response, causing the mesh and the scar tissue that grew between it, to contract and shrink. That caused “shortening and narrowing of the vagina, chronic pain, and pain with sexual intercourse“.

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

Justice Katzmann found the mesh manufacturers, Ethicon Sarl and Ethicon Inc, both members of the Johnson & Johnson Group, negligent and 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 in November.

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.”

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 product’s risks, breached legislation and failed in their duty of care to consumers.

In a statement, Johnson & Johnson’s head of communications in Australia said: “Ethicon empathises with those women who have experienced complications following pelvic organ prolapse and stress urinary incontinence surgical procedures.”

Ethicon, however, maintained it had “acted ethically and responsibly in the research, development and supply of these products.”

Johnson & Johnson said it was reviewing the decision and would consider its options for an appeal.