A LANDMARK seven-year pelvic mesh device class action case by more than 1200 women against pharmaceutical giant Johnson & Johnson will reach a conclusion on November 21.
Federal Court Justice Anna Katzmann will deliver a judgment after an 89-day trial in 2017 and 2018 that included evidence of how mesh devices implanted through women's vaginas were marketed to doctors for the speed of surgery and greater reimbursement compared with non-mesh alternatives.
The devices were marketed to treat incontinence and prolapse in women after childbirth.
The Australian class action is one of many large cases around the world against Johnson & Johnson and related companies Ethicon Sarl and Ethicon Inc, in which women allege they have suffered serious and permanent injuries following mesh surgery.
Johnson & Johnson is just one of a number of mesh manufacturers being sued by tens of thousands of women in Australian, American, British and European cases, after at least 100 different devices were cleared for use in America without sufficient evidence of safety and efficacy, leading to approvals in other parts of the world, including Australia.
About 1250 women are registered in the Australian Johnson & Johnson case alleging damages after surgery from as early as 2001 with one of five different polypropylene tape implants or four polypropylene mesh implants.
Shine Lawyers class actions senior associate Bridget Cook, for the women, described the case launched in October, 2012 on behalf of two Western Australian women and one Victorian woman as a "long, tough legal battle".
"The claim has been brought on behalf of Australian women who were implanted with a Johnson & Johnson mesh or tape product and suffered significant complications, including chronic pain, erosion, recurrent prolapse and incontinence as a result," Ms Cook said.
"Shine Lawyers currently has 1250 confirmed registrants and we estimate the number of additional women who suffered complications could be as many as 5500. We feel privileged to have worked alongside these courageous women to, hopefully, achieve justice on their behalf.
"Her Honour's judgment will serve as a landmark decision for future product liability class actions and provide clarity on substantive legal questions."
Mesh Injured Australia founder Justine Watson said the class action was just one way that women had held mesh manufacturers, doctors and the Australian health system to account.
"Not much has changed in the lives of mesh injured women in Australia despite a Senate inquiry," Ms Watson said.
"We hope that the conclusion of this case will bring much deserved validation and recognition and remuneration for the suffering of so many women and their families."
A separate class action by 850 Australian women against mesh device manufacturer American Medical Systems is progressing through the Federal Court, Shine Lawyers said.
In April a Federal Court judge allowed a potential expansion of the number of women able to claim damages based on evidence during the trial about the risks posed by polypropylene in all mesh and tape implants.
Justice Katzmann will rule on whether polypropylene is "unsafe at any speed" for use in women's bodies after evidence mesh devices made of polypropylene could shrink and harden, causing pain.
During the trial Johnson & Johnson denied that its post-market surveillance of mesh devices marketed to doctors and hospitals in Australia was inadequate.
The company argued non-absorbable polypropylene mesh was "designed to allow for an inflammatory response that is necessary for tissue in-growth".
Shine Lawyers tendered documents including marketing material describing the "practice driven physician" who would find mesh devices implanted through the vagina attractive because they sped up surgery, increased fees and allowed doctors to "really enjoy life".
The marketing described doctors being able to implant one Johnson & Johnson device, the TVT-0, in eight minutes.
"You know I use your products because I can do more procedures in less time with better reimbursement," the "practice-driven physician" is described saying.
"Just got back from a week in St Moritz. I picked up the Lamborghini on Friday. I'm finally going to invest in that sailboat this summer so we can cruise to the Caribbean. My practice is now at the level of efficiency where I can take some time away to really enjoy life."
On the first day of the Johnson & Johnson trial in July, 2017 there were gasps from the public gallery when an email from a French pelvic mesh device inventor, Dr Bernard Jacquetin, was read to the court.
"I would not want my wife to undergo this procedure," the French doctor wrote in an email to a colleague in 2005. "And I don't think I'm alone in that."
In 2017 then Australian Medical Association president and Western Australian obstetrician/gynaecologist Michael Gannon said pelvic mesh was "a long way from our proudest hour".
"To call (our support of mesh products) a tragedy is not overstating it at all," Dr Gannon said.
In October, 2018 Health Minister Greg Hunt acknowledged "all of those women with the historic agony and pain that has come from mesh implantation, which has led to horrific outcomes".
"On behalf of the Australian government, I say sorry," Mr Hunt said.
Johnson & Johnson was contacted for comment.