Three Australian women representing patients given vaginal mesh implants won a landmark class action today against international medical giants.
A Federal Court in Sydney found two Johnson & Johnson group manufacturers and its Australian supplier engaged in misleading or deceptive conduct and hid the risks associated with the implants from patients.
More than 90,000 devices were inserted into Australian patients wanting structural support to treat stress urinary incontinence and pelvic organ prolapse.
Studies show more than 10 per cent of cases have resulted in serious adverse side effects.
The court ruled that in instructions for use supplied with all the Ethicon devices, the company knowingly falsely represented that the mesh elicited a minimal to a slight inflammatory reaction that was “transient” or “transistory”.
Justice Anna Katzmann said an email from the Associate Medical Director of Ethicon’s Worldwide Customer Quality division to a colleague stated: “From what I see each day, these patient experiences are not ‘transitory’ at all”.
The admission, coming from the company’s international division, could have a significant impact on similar cases around the world – including in the UK and United States.
Justice Katzmann said one of the Ethicon devices satisfied the essential requirements to support their required certification, and some went to market without clinical trials.
Thousands who underwent the surgery suffered chronic and debilitating acute pain as the supposedly permanent implants eroded. Outside the court plaintiff Julie Davis told local media that the companies “treated women like guinea pigs, lied about it, and did nothing to help”.
Justine Watson, a member of Mesh Injured Australia, said that due to a “weak” government response, there is “a huge number (of patients) out there who don’t know what’s killing them”.
The case will return to the Federal Court in February for damages to be determined. More than 1,300 women have joined the class action by Shine Lawyers with more expected.
In January last year, the UK Government launched a full retrospective audit of all women who have had the surgery since 2005.
NHS England estimated that more than 100,000 women had vaginal mesh surgery to treat urinary incontinence, most often caused by childbirth.
In March this year, the NHS issued a letter to all acute trusts to extend the period of high vigilance restriction on the use of vaginal mesh, which was first put in place in July 2018.
Some women have been left unable to walk, work or have sex after having the implants.
Thompsons Solicitors in the UK has a number of specialist mesh lawyers who are acting on behalf of more than 200 clients who have suffered as a result of mesh implants, and is working with awareness group ‘Sling the Mesh’.
In April this year, the American Food and Drug Administration (FDA) ordered the two remaining medical device companies selling surgical mesh for the repair of pelvic organ prolapse to stop all sales and distribution in the United States.
Litigation over pelvic mesh ranks as one of the largest mass tort cases in the history of the USA.
Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, are paying nearly US$8 billion to resolve the claims of more than 100,000 women.
For years, women and legal advocates have tried to persuade the FDA that the pelvic mesh implant can cause harm and the organisation reclassified the devices as high risk in 2016.
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