When more than 1300 women with pelvic mesh devices won a seven-year legal battle against Johnson & Johnson in November, the judgement was so lengthy that one Federal Court staffer remarked they’d “need a forklift” to carry the printed version.
In Justice Anna Katzmann’s one-hour summary of the hefty document, she detailed how Johnson & Johnson subsidiary Ethicon acted “negligently” and engaged in “misleading or deceptive conduct” before ordering that the women be compensated.
She described debilitating complications experienced by the three lead applicants after they had been fitted with Ethicon’s urogynaecological meshes, sometimes known as transvaginal meshes, which are frequently used to treat pelvic organ prolapse or urinary incontinence.
The women, many of whom travelled interstate for the verdict, hugged and cried on the steps of the Federal Court in Sydney.
In March, the court ruled the lead applicants would get a share of $2.6 million in damages, and the claims of the hundreds of other class action members would be assessed.
In April, the pharmaceutical giant confirmed it would appeal.
In New Zealand, mesh-injured women can access compensation through that country’s accident compensation scheme, but the only way Australian women can recoup their ongoing medical costs has been to sue their operating surgeon or, if their device was Ethicon-branded, join this class action.
“We are feeling a deep sense of frustration,” says Justine Watson, who was fitted with an Ethicon product in 2010 and still suffers complications.
The average mesh settlement in the United States is less than AU$90,000. Watson says she’s spent more than AU$100,000 in medical expenses alone.
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“The lifelong impacts of chronic pain, systemic illnesses, sexual dysfunction and ongoing psychological damage remain unresolved and life threatening for some,” she says. “There is no hope of financial support any time soon.”
The fleeting legal triumph followed a Senate inquiry which in March 2018 concluded thousands of mesh-injured women had been “ignored” and “let down” by health professionals and regulatory bodies.
Then-senator Derryn Hinch, who co-chaired the inquiry, said this was “one of the biggest medical scandals” Australian women had ever been subjected to. Patient submissions to the inquiry told stories of chronic pain and multiple erosions, when the product pierces through the surrounding tissue into the vaginal wall or surrounding organs.
One woman testified her vagina “felt like it was full of barbed wire and shards of glass” after mesh insertion, another that the side effects had transformed her from a “passionate primary school teacher” into a “victim”.
The inquiry concluded the surgery, which it estimated had been performed on about 150,000 women in Australia, should be a “last resort”.
There are resources to help guide doctors in patient informed consent; hospitals and doctors can now get credentials to implant mesh medical devices; and patients will be given leaflets with details about the device, and lists of potential side effects and information about reporting any adverse effects.
In 2017, the Therapeutic Goods Administration (TGA) determined that the risk from some transvaginal meshes “outweighed the potential benefits” and cancelled its approval of two types, including that at the centre of the class action.
It can take multiple expensive “corrective surgeries” to remove a transvaginal mesh device and for years women would travel at immense personal expense to St Louis, Missouri to see the same obstetrician-gynaecologist, Dr Dionysios Veronikis.
The Australian government says some local doctors have now been trained in the United States in mesh removal, and 14 mesh-specific units have been set up, but patients are wary of trusting newly-trained doctors. Some plan to use their compensation to go to Missouri instead.
Meanwhile, the legal fight drags on — the appeal isn’t until February 2021.
In May, Johnson & Johnson was hit with indemnity costs for “unreasonable conduct” because it had denied aspects of the case “without reasonable grounds”, forcing the women’s lawyers to go to the trouble and expense of producing unnecessary evidence.
On Friday Katzmann declined to amend the warning she ruled Johnson & Johnson must put on some mesh products still on the market. The warning makes clear that patients will have an inflammatory response to the device and it isn’t possible to predict the severity of that response in any individual patient but that it could result in side effects from infection to chronic pain.
“Our ladies want to know when will Johnson & Johnson accept full responsibility for their wrongdoing,” Jan Saddler, head of litigation and loss recovery at Shine Lawyers, the firm running the class action, says.
Johnson & Johnson maintains that Ethicon has acted “ethically and responsibly” in the research, development and supply of pelvic mesh devices.
In October 2018 Health Minister Greg Hunt apologised to mesh-injured women for the “historic agony and pain” the devices had caused. But these words, nor the withdrawal of products from market, won’t help those living in pain or waiting for enough money for corrective surgeries.
“We strongly feel the government and medical profession have learned very little from this medical disaster as women are still being implanted daily with the same product with inappropriate informed consent,” Watson says.
“Maybe when the men affected by hernia mesh products take up the gauntlet they may have more impact.”
NOTE: A previous version of this story stated Veronikis trained Australian doctors in mesh removal. While Australian doctors have travelled to the United States to observe his techniques in mesh removal, he is yet to formally train any.