J&J Found Negligent by Australian Court in Vaginal-Mesh Suit

Johnson & Johnson lost the latest battle in a string of global lawsuits over its vaginal-mesh products, with an Australian judge ruling the company was negligent and that women left in chronic pain by defective devices should be compensated.

Justice Anna Katzmann told the Federal Court in Sydney on Thursday that the U.S. company and its Ethicon business had failed to inform patients of the potential risks and that promotional material was likely to mislead doctors. She deferred ruling on damages until at least February next year.

The class action, initially launched on behalf of 700 women in Australia, alleged the meshes — used to prop up sagging organs and treat incontinence — were defective and warnings accompanying them were inadequate. The court heard that no warnings were issued for a string of complications including infection, erosion of the mesh into surrounding organs, chronic pain and psychiatric injury.

In a judgment that took more than an hour to read out, Katzmann said the devices were unfit, yet were marketed as safe and effective.

Considering Options

Johnson & Johnson said in a statement that Ethicon was reviewing the court decision and will “consider its options to appeal.”

The ruling marks a significant step on a trail of mesh-related suits against New Brunswick, New Jersey-based Johnson & Johnson, the world’s largest maker of health-care products. Thousands of cases have been filed in North America, Europe and the Middle East and the company still faces nearly 20,000 lawsuits from women who allege their vaginal meshes caused them injury, according to its latest securities filing.

The devices, often implanted after childbirth, were designed to repair pelvic organ prolapse. It’s a common condition in women that develops when the muscles holding in the bladder and uterus weaken and organs start to protrude from the vagina. Thousands of patients used the device in Australia among more than 100,000 worldwide.

Sharp Pain

Justice Katzmann, in her ruling, recounted the pain described by the three women who initiated the suit after suffering complications from the mesh devices. One experienced a sharp, tearing sensation as the mesh eroded and a piece pierced the wall of her vagina. Another described the feeling of something sharp in her vagina, “like a blade.”

The women said complications from the devices have diminished their quality of life, made sexual intercourse difficult and taken a toll on their relationships.

Rebecca Jancauskas, special counsel at Shine Lawyers, which led the suit — one of the largest class actions in Australia — called it a landmark decision.

“It recognizes the years of suffering they have endured and recognizes they are entitled for compensation,” Jancauskas said after the ruling. “The court was scathing in its findings with respect to Ethicon and Johnson & Johnson.”

In a statement, Johnson & Johnson said its Ethicon unit “empathizes with women who have experienced complications following pelvic mesh procedures.”

“It’s important to note pelvic mesh has helped improve the quality of life for millions of women worldwide,” it said. “Ethicon believes that the company acted ethically and responsibly in the research, development and supply of these products.”

Since vaginal mesh complaints began to emerge almost a decade ago, Johnson & Johnson has been hit with more than $200 million in damage awards to compensate women for their injuries, data compiled by Bloomberg show. Some of the payments have been thrown out on appeal and the company also has won a number of cases at trial.

Johnson & Johnson also has paid more than $240 million in settlements over claims it hid risks and marketed the device too aggressively to U.S. doctors and patients, according to Bloomberg data, public court records and people familiar with those accords.