MORE than 1200 Australian women have won their landmark class action legal case against pharmaceutical giant Johnson & Johnson and related Ethicon companies after they experienced severe and permanent injuries following pelvic mesh surgery.
Federal Court Justice Anna Katzmann has told a packed courtroom that evidence was "overwhelmingly" against the companies after some women experienced "disastrous" results.
In a scathing commentary Justice Katzmann has slammed Johnson & Johnson and related companies Ethicon Inc and Ethicon Sarl for the release of nine pelvic mesh devices from 1999 with little evidence supporting their safe use.
The companies minimised known complications for years, regarded risk management assessments as a largely "tick a box exercise", and failed post-marketing monitoring despite growing evidence of serious injuries to women, Justice Katzmann said.
She has found all the devices for prolapse and incontinence after women had a defect and a risk of significant complications, and no adequate warnings were given to doctors or patients.
The Ethicon devices were "oversold" and carried significant risks, Justice Katzmann said.
The judge has rejected the companies' arguments that the extent of knowledge about the risks posed by the devices was deficient.
The risks were known and the companies did not respond to them, Justice Katzmann said.
Justice Katzmann has found the three lead women, Kathryn Gill, Diane Dawson and Ann Saunders were injured because of defects and the Ethicon companies had engaged in misleading and deceptive conduct.
The two Ethicon companies owed a duty of care to the women about the manufacture of the devices and Johnson & Johnson, as supplier, owed a duty to warn of the risks in material supplied to doctors and patients.
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 said they suffered serious and permanent injuries following mesh surgery.
Justice Katzmann has accepted the women's arguments that the three companies were driven by the commercial potential of the devices and failed to obtain evidence the polypropylene devices were safe to use in women's pelvises before seeking approval for their use.
The devices were cleared for use because medical device approvals were largely self-regulating, Justice Katzmann said.
The TGA cleared the majority of the nine devices without evidence of their safety and efficacy under a system the women's lawyers strongly criticised during the hearing.
Ethicon conducted no adequate clinical trials before putting devices on the market, including the industry-described "gold standard" TVT device for incontinence, Justice Katzmann said. The devices were cleared for use based on restricted doctor studies.
Risk management assessments were largely a "box-ticking exercise" and post-market monitoring was primarily for marketing purposes and failed to comply with standards and regulatory requirements, Justice Katzmann said.
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.
In closing submissions lodged at the end of court proceedings, lawyers for the lead women, Kathryn Gill, Diane Dawson and Ann Saunders, said they had endured surgical revisions in attempts to remove their pelvic mesh implants and were unlikely to experience any relief from their chronic pain.