Johnson & Johnson faces huge payout after losing vaginal mesh case against women who suffered devastating side effects from the implants
- Johnson & Johnson manufacturers and Australian supplier misled customers
- Thousands of women were given defective vaginal mesh implants
- Was revealed that some devices went to market without clinical trials
Three women representing thousands of patients given defective vaginal mesh implants have won a landmark class action against an international medical giant.
The Federal Court on Thursday found the nine implants were defective and that two Johnson & Johnson group manufacturers and its Australian supplier misled customers and were liable for the injuries caused.
Damages will be awarded early next year.
Thousands of women were given defective vaginal mesh implants (pictured)
Lawyer Rebecca Jancauskas (left) joins members of the class action against Johnson & Johnson, Gai Thompson, Joanne Maninon and Carina Anderson
More than 90,000 devices were inserted into those wanting structural support to treat stress urinary incontinence and pelvic organ prolapse.
But hundreds, if not thousands, who elected to undergo surgery suffered chronic and debilitating acute pain as the supposedly permanent implants eroded and extruded.
One of those in the class action, Victoria’s Diane Dawson, remains beset by pain despite five additional surgeries to address her complications, Justice Anna Katzmann SC said.
‘She is understandably angry, frustrated and distressed by her plight,’ the judge said on Thursday.
Reading a 24-page summary of a 1500-page judgment, Justice Katzmann said she found the applicants had shown all devices by manufacturer Ethicon were defective, weren’t fit for purpose and were supplied with misleading instructions.
Further the Johnson & Johnson companies failed to take ‘reasonable care to evaluate the safety’ of the devices before and after they were first marketed and that the applicants were entitled to compensation.
Some of the devices went to market without clinical trials – let alone a randomised control trial that compared them to other treatments.
More than 90,000 devices were inserted into those wanting structural support to treat stress urinary incontinence and pelvic organ prolapse (pictured: transvaginal mesh)
Ethicon’s post-market surveillance was also deficient on multiple fronts, Justice Katzmann said.
Essentially passive, the surveillance was conducted primarily for marketing purposes, lacked genuine risk analysis, didn’t comply with regulatory requirements and, in some cases, ignored altogether the complaints of patients and surgeons.
Some clinical evaluation reports included text copied and pasted from other reports without regard for the new context.
‘For the most part, these reports could scarcely be described as evaluations at all, let alone critical analyses,’ Justice Katzmann said.
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’.
‘As the Associate Medical Director of Ethicon’s Worldwide Customer Quality division said in an email to a colleague: ‘From what I see each day, these patient experiences are not ‘transitory’ at all’,’ Justice Katzmann said.
The Federal Court (pictured) on Thursday found that two Johnson & Johnson group manufacturers and its Australian supplier misled customers
The judge said the Ethicon devices were ‘oversold’ and none satisfied the essential requirements to support their CE certification marking.
‘Even if they could be said to have been suitable for use in the treatment of severe cases of pelvic organ prolapse or where alternative surgical treatment had failed or where there was a high risk of recurrence or in highly experienced hands and for a highly select group of patients, they were sold without limitations.’
The class action concerned five ‘tapes’ used to treat stress urinary incontinence and four mesh implants meant to reduce pelvic organ prolapse.
Some 1350 women have already signed up to the class action but Shine Lawyers says there is still time for other affected women to register.
The case will return to the Federal Court in February.
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