Chinan pelvic mesh victims want to sue state health departments and regulators
Inquiry: Greens Senator Rachel Siewert, who is chairing a Senate inquiry into pelvic mesh devices in .WOMEN victims of pelvic mesh surgery are investigating legal action against not only device manufacturers and surgeons, but statehealth departments and n regulators they hold responsible forfailingto protect them.
The Western n Health Department isalready a focus, said solicitor Adrian Barakat of AJB Stevens Lawyers in Sydney, afterwomenalleged a cover-up of mesh device surgical trials in WA public and private hospitals.
This followedNewcastle Heraldarticles revealingtwo senior Western n doctors releasedresearch papers from 2005 about surgical trials in Western n public and private hospitalsusing apelvic mesh device invented by one of the doctors, and a secret settlement in 2013 paid by WA Health to a woman implanted with the device in a public hospital in 2003.
Although the research papers stated the trials had ethics committee approvals,WA Health said it could not locate records of ethicsapprovals for trials of the device.
“The majority of the cases we have at the moment are in Western so that’s our focus, but we have a large number of clients and they’re from all over the country. We’re definitely looking at health departments in each state,” Mr Barakat said.
TheHeraldhas also revealed research papers citing ethicsapproval of a surgical trialusing the device at a Victorian public hospital. Victoria’s new health care watchdoglaunched an investigation in June after Health Minister Jill Hennessy was told there wasno record of the trial,ethics approval or hospital credentialing of the device inventor who assisted with surgery on some of the women.
Lawyer Adrian Barakat on pelvic mesh device legal action
Mr Barakat said hisfirm had engaged a senior barrister to advise how ’sdrug and device watchdog, the Therapeutic Goods Administration, could be sued after multiple pelvic mesh devices were registered for use more than a decade ago with little or no evidence of safety and efficacy.
“Somebody needs to find a way to make the TGA accountable. We really think that’s one of the most important ways forward,” Mr Barakat said.
The TGA’s role in the pelvic mesh scandal led University of Canberra academics Dr Wendy Bonython and associate professor Bruce Arnold to call for a complete overhaul of the regulator, in a submission to a Senate inquiry on pelvic mesh devices.
They argued there were legislated indemnity provisions that protected the TGA from being sued for negligent performance of its regulatory functions, which was “problematic because it removes any incentive towards carefulness”.
More than 1350 n women are now registered in legal class actions against major mesh manufacturers Johnson & Johnson and American Medical Systems, with an unknown number ofindividual settlements after legal suitsby women against doctors who implanted the devices.
Mr Barakat said his firm, which has successfully litigated child sexual abuse cases against institutions, would run individual cases against device manufacturers, doctors and regulators, rather than class actions.
“We’re looking at the women individually because they’ve all suffered immensely, in different ways. I’ve got women who have had to give up their businesses and jobs. Most of them have suffered in terms of their marriages. Some have lost their marriages because of this. Most of them can’t have intercourse.”
Women implanted with Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) devices have engaged the firm, along with others considering action against American Medical Systems, Boston Scientific and Johnson & Johnson.
WA Health did not respond to questions about the 2013 secret settlement or how public hospitals responded to complications experienced by women during an early pelvic mesh trial.