Winner of vaginal mesh implant court victory says fight is not over

Winner of vaginal mesh implant court victory says fight is not over
Copyright 2019 CNN
The implants caused many victims chronic pain, bleeding, tissue and organ damage, incontinence, mental stress, and left many unable to have sex or walk.

The woman at the center of a landmark legal victory against pharmaceutical giant Johnson & Johnson over defective vaginal mesh implants said the battle has been won “but the war will still go on.”

Julie Davis is one of three women named in the Australian class action lawsuit on behalf of thousands of women who suffered serious complications with the implants — surgical devices that are used to repair pelvic organ prolapse and treat incontinence, usually after childbirth.

The implants caused many victims chronic pain, bleeding, tissue and organ damage, incontinence, mental stress, and left many unable to have sex or walk. Many women suffered mesh erosion, which is where the implant cuts into other parts of the body.

It’s a global issue. Hundreds of thousands of women in the United States, United Kingdom, Canada and Europe have reported debilitating problems with the mesh, and have taken legal action against manufacturers.

The US, Australia, and New Zealand have banned the devices. The UK stopped mesh operations in 2018 but a health watchdog said earlier this year that the implants could be used once certain conditions are met, according to the BBC.

Following a seven-year legal battle and a seven-month trial, Australia’s federal court ruled Thursday that Johnson & Johnson and two affiliated companies that made the devices, Ethicon Sarl and Ethicon Inc, misled patients and doctors about the safety of the implants and were negligent in pushing the products to market without proper clinical tests.

In a scathing 1,500-page ruling, Justice Anna Katzmann said Ethicon “engaged in misleading or deceptive conduct,” and that the companies knew about the risks but they were “minimized or not mentioned at all.” She also said that the consumers of the device should be compensated.

Davis told CNN that the judgment was a “validation” for all the women whose lives had be ruined because of the implants.

“We can finally stand up and say, we’re not imagining things, we’re not a bunch of whinging women. This is real and these are the people that are accountable for it,” she said.

“It’s just horrifying that in this day and age that that can happen. And it has such devastating results for women.”

Rebecca Jancauskas, special counsel at Shine Lawyers and lead lawyer in the case, told CNN that it was a “very significant day” for the “thousands of Australian women who have suffered horrific and often life altering complications as a result of these products.”

“We need our manufacturers to be acting in our best interests and only selling products that have been tested and established to be safe and effective,” she said.

In a statement, Ethicon said it “empathizes with women who have experienced complications following pelvic mesh procedures” but said millions had benefited from the mesh.

“Ethicon believes that the company acted ethically and responsibly in the research, development and supply of these products,” the statement said, adding that it would review the federal court’s decision.

CNN has reached out to Johnson & Johnson for comment.

Profit over patient safety

In her ruling, Justice Katzmann said that Ethicon was driven by commercial gain and rushed their products to market without adequate clinical trials or risk assessments.

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

The companies had “neglected to define the different physiological forces at work in the female pelvis or incorporate these considerations into the development of the Ethicon devices,” she said.

According to special counsel Jancauskas, part of the problem with the implants “is that the mesh is designed to integrate into the body’s tissue, making it very difficult and sometimes impossible to remove the implant and therefore alleviating these women’s suffering is sometimes very difficult.”

Katzmann said the company “did not inform doctors or patients” as to the risks of the devices.

“I held that each of the respondents was negligent. The risks were known, not insignificant, and on the respondents’ own admission, could cause significant and serious harm if they eventuated,” she said.

The judged ruled that the thousands of women affected by the devices should be compensated for the damage caused, and has scheduled another hearing in February.

Currently 1,350 women have joined the class-action suit and would stand to benefit from any compensation. But there could be thousands more women who will come forward — around 90,000 implants have been supplied in Australia.

Some women who have had mesh complications told CNN they felt like a knife was constantly cutting their insides, or that they were living with “rotting pelvises.”

Davis, who suffered serious complications with her device for years after it was implanted in 2008, said it made her feel like less of a mother and a wife.

“No amount of money can pay for the loss of quality time that I haven’t had with my children or me not being the mother that I started off to be, but now can’t be, or me not being the wife that now I can’t be,” she said.

What needs to be done

An Australian Senate inquiry in 2018 recommended the need for greater regulation and oversight by government agencies regarding implantable products.

It also urged for the formation of a registry to track patient outcomes and complication rates.

But there are calls for greater international transparency and communication, so regulators can react to problematic devices across countries.

“These global health crises are showing no signs of abating,” Jancauskas said.

“I think the first step would be if there was a recognition that this was a shared desire and if that was followed up by a task force that made a series of recommendations, I think that would be a good start,” she said.

Johnson & Johnson has faced multiple lawsuits over the mesh implants including in the US, Europe and Canada.

In April 2019, the US Food and Drug Administration ruled that manufacturers of surgical mesh products must stop selling and distributing their products in the US immediately, citing concerns over safety and effectiveness.

Davis said that many women are still struggling to cope with life-altering injuries and that she hopes Thursday’s judgment will lead to others receiving justice around the world.

“I believe strongly that, not just in the case for us who’ve been directly affected by this specific case, but for all human beings, who have the potential to be abused by greedy corporates,” she said. “It’s mesh today, what else could it be tomorrow?”

CNN’s Pauline Lockwood and Angus Watson contributed.