JOHNSON & Johnson should only sell pelvic mesh devices in Australia with warnings that injuries to women are not rare and occur regardless of a surgeon’s skill, that some women’s chronic pain “may not be able to be treated”, and device removal “may be practically impossible”, a class action by hundreds of women against the company has told a Federal Court judge.
Johnson & Johnson and device manufacturers Ethicon have until May 31 to respond to an application by the women to amend a statement of claim against the companies and seek an injunction preventing the supply or promotion of the devices without “proper warning” of alleged consequences.
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The women have also sought a declaration that by marketing, promoting, distributing and supplying the devices without the “proper warning”, Ethicon engaged in misleading or deceptive conduct.
The application came after the end of evidence in February in a six-month legal class action case launched by more than 800 women alleging injuries caused by nine Ethicon devices sold by Johnson & Johnson in Australia.
It also came after Johnson & Johnson withdrew all pelvic mesh devices from the market in January, including its “gold standard” TVT midurethral mesh sling for incontinence, after new regulatory requirements for stronger warnings about adverse effects.
In a decision on Monday Federal Court Justice Anna Katzmann allowed more women to join the case until a cut-off date of July, 2017 after Shine Lawyers, for the women, argued it would be a “harsh and unjust outcome” if a large number of women were shut out from a class action initiated in 2012, after evidence of serious complications years after surgery.
Justice Katzmann rejected an application that women be allowed to join the case up until her judgment, which is not expected until early 2019, or any possible settlement between the parties before that date.
The TGA does not have an exclusive role in protecting the safety of consumers.Federal Court Justice Anna Katzmann
Justice Katzmann rejected the companies’ argument that the “proper warning” injunction sought by the women in their amended statement of claim was the job of the regulator, the Therapeutic Goods Administration.
“The TGA does not have an exclusive role in protecting the safety of consumers,” Justice Katzmann said.
An injunction could serve a public interest purpose to prevent and deter “undesirable trade practices” or “mark the court’s disapproval of a contravener’s conduct”, she said.
Lawyers for the women flagged the injunction issue in final submissions and the companies made no submissions against the application, she said.
The “proper warning” should include that polypropylene pelvic mesh devices cause chronic inflammatory response in all patients for as long as the implant is in the body; that it is not possible to predict the severity of the response in any patient; that severe chronic pain could have life-altering consequences including “psychiatric injury” and that the long term safety of implants “has not been studied and is unknown”, the women said in a submission to the court.
Justice Katzmann also gave the companies until May 31 to respond to a proposed amendment to the women’s statement of claim alleging women, patients and treating hospitals were not warned that pelvic mesh devices were not recommended for women with auto-immune and connective tissue disorders.