After 21-months, a federal court judge has finally issued her ruling in a massive lawsuit naming Johnson & Johnson and its family of mesh implants and has found the thousands of Australian women should be compensated for the harm they endured from the devices.
This is a loss for Johnson & Johnson in one of the largest class actions ever in Australia and a verdict on its family of nine transvaginal tapes sold around the world to treat incontinence and prolapse in women.
More than 1,350 women who experienced complications from pelvic mesh implants made by the healthcare giant filed the action. More women may join in the action.
It’s estimated J&J and its Ethicon subsidiary of New Brunswick, New Jersey, sold more than 100,000 mesh implants in Australia.
Federal Court Judge Anna Katzmann in issuing her ruling said the evidence was ‘overwhelming” and she found J&J was “negligent”. The risks were “known and not insignificant,” she wrote.
Andrea Walter of Mesh Injured Australia tells Mesh News Desk.
“We feel vindicated, however there will be an appeal and this doesn’t change the lives of mesh injured women in this moment; many of whom will require life-long care.”
“Despite a senate inquiry, and this verdict, not much has changed in the lives of mesh injured women. We urge anyone who sees this media to contact Shine lawyers and register in Australia.”
Katzmann concluded the devices were not tested properly and the companies knew they had not been tested properly to ensure safety.
Reading from a summary of her 1,500 page judgment, there were tears from mesh patients heard in the courtroom.
The actual monetary compensation will be decided by the judge and will be determined in February but is predicted to be multi-millions of dollars.
In a statement, Bloomberg reports Johnson & Johnson says its Ethicon unit "Emphathizes with women who have experienced complications following pelvic mesh procedures."
However, it's important to note pelvic mesh has helped improve the quality of life for millions of women, Ethicon has acted ethically and responsibly in the research, development and supply of these products."
Unlike the U.S., where dozens of product liability lawsuits have been filed against four major pelvic mesh manufacturers, Australia does not hear defective product cases in front of a jury. One judge listens to all of the evidence and render a decision.
It is up to the judge to determine if polypropylene, the plastic that composes mesh implants is “unsafe at any speed.”
Twenty-one months ago the evidence was presented and the trial concluded.
Evidence presented during the six-month trial that began in 2017, showed that polypropylene mesh can shrink, erode, harden and cause pain.
“All of the devices carried risks of complications…against which no adequate warnings were given.” ~ Judge Katzmann
Like the U.S. Food and Drug Administration, in Australia the Therapeutic Goods Administration (TGA) clears the devices for market.
The Guardian says earlier in the trial was evidence about "the multinational’s attempts to stop regulators raising concerns about the products. Internal documents suggested it tried to stop French health regulator, Haute Autorité de Santé, from publishing a report warning against the use of the untested pelvic mesh devices, two years after the company began giving them to Australian women."
JNJ reportedly said work was needed to stop the report.
In defective product litigation in the U.S., about 40,000 lawsuits were filed against the company in multidistrict litigation, the largest number of suits among the seven manufacturers sued. The company has lost more than $416 million in plaintiff verdicts and paid an untold amount in settlements.
Additionally, the result of a California defective marketing lawsuit trial against J&J asking for $1 billion will soon be announced.
The healthcare giant is still fighting lawsuits filed by injured women in state courts and has failed to offer any global settlements to end the pelvic mesh litigation.
Presented to the court were Ethicon marketing materials, “the practice driven physician” which shows how doctors who adapt the new technology can “really enjoy life,” and “Retire rich.”
“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.”
This is one of the largest class actions in the world against J&J now numbering 1,350 women implanted with any one of five different polypropylene mesh implants. Estimates are reported in The NewCastle Herald that as many as 5,500 women could have suffered complications.
Unlike the U.S. where a jury hears the evidence, the judge alone decided the case. It was filed by Shine Lawyers of Sydney in 2012 on behalf of three initial applicants, Kathryn Gill, Diane Dawson, and Ann Sanders. Judge Katzmann found they were injured because of the defective devices and Ethicon and J&J engaged in misleading and deceptive conduct.
According to Shine Lawyers, the Court can divide the compensation to the affected group.
An amendment to the Federal Court of Australia Act in 1992 enabled class actions to be possible in Australia, similar to the U.S. Court system. Among the actions since then has been another action against Johnson & Johnson over its DePuy metal-on-metal hip prosthesis which settled for $250 million.
A separate action filed by 850 women against American Medical Systems is also progressing through the Federal Court. ###
Mesh Injured Australia Press Release (here)
Federal Court of Australia, November 1, 2019
Mesh News Desk, October 15, 2012, Australia’s Vaginal Mesh~ Largest Class Action in History?
ASR Class Action in AU June 2017
Newcastle Herald, Joanne McCarthy Nov 21, 2019
History of Pelvic Mesh in Australia
Mesh News Desk, Surgeons Incentivized with Lamborghinis and Swiss Alps Ski Trips Internal J&J Docs Show, August 14, 2017
Mesh News Desk, Australia Pulls Ethicon TVT Devices Off the Market, January 23, 2018
Mesh News Desk, Pelvic Meshes Removed from Australian Market, September 18, 2017
Mesh News Desk, Mesh Class Action and International Litigation