J&J Loses Appeal of Australian Pelvic Mesh Class Action

Jane Akre
|
March 4, 2021

Breaking News ~ Mesh Medical Device News Desk, March 4, 2021 ~ A Federal Appeals court has dismissed an appeal by Johnson & Johnson of a landmark $2.6 million awarded three women with defective pelvic mesh implants.

The decision follows the conclusion of a 7-month trial naming defendant Johnson & Johnson (J&J), Ethicon Sarl, and Ethicon Inc., which make the polypropylene pelvic mesh medical devices used to treat incontinence (SUI) and pelvic organ prolapse (POP). 

On November 21, 2019, Judge Anna Katzmann found in favor of the three lead applications in a class action which has now swelled to about 10,000 women, implanted with the devices who claim they suffer serious side effects including chronic pain and infection.  The class action is the largest women’s health action in Australian history.  

Then in April 2020, J&J appealed the verdict.

In a statement ABC/Australia reports J&J says it "empathises [sic] with all women who experience medical complications" but it would consider its options. J&J has the option to seek leave and to appeal the judgment to the High Court of Australia. That is the final appellate court in the country.

If J&J does not appeal further the class action may proceed to individual assessment of damages of the individual group members unless a settlement between Shine Lawyers and J&J is reached.

The original case began in October 2012.

**UPDATE/ CORRECTION**In November 2017, three transvaginal mesh devices used to treat pelvic organ prolapse (POP) were cancelled by the TGA (Therapeutic Goods Administration). Read more here.

In April 2019, the U.S. FDA ordered Boston Scientific to stop selling Uphold LITE, Xenform Soft Tissue Repair and ordered Coloplast to stop selling Restorelle DirectFix Anterior. The single-incision mini-sling also had its approval cancelled. A number of meshes used to treat SUI remain on the market in Australia as they do in the U.S.

The following year, a Senate inquiry found women injured by the devices had been "treated appallingly" and ignored.

Federal Judge Anna Katzmann

Mesh Injured Australia founder,

Andrea Walter tells Mesh News Desk:

"Mesh Injured Australia is delighted that the judgment of 21 November 2019 has been upheld and the appeal by Johnson & Johnson dismissed. we hope that all mesh injured (both men and women) feel validated by this decision, and it will go in some way towards compensation and life long care, eventually for all those affected and their families. We also hope that more will be done to prevent others having to endure the lifelong consequences of these operations."


Background

After the trial, federal Judge Anna Katzmann concluded that thousands of women should be compensated for the harm they endured from the devices.

It’s estimated J&J and its Ethicon device subsidiary sold more than 100,000 mesh implants in Australia. 

Judge Katzmann said the evidence was “overwhelming” and she found the company was “negligent, the risks were “known and not insignificant.”

The companies were driven by “commercial opportunities.” Judge Katzmann concluded the implanted devices were not tested properly and the companies knew they could not ensure safety.  

Unlike the U.S., the Australian legal system presents the evidence before a judge, not a jury.

The action 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.

A federal court in May of last year awarded the three women almost $2.6 million in damages.

Upon hearing the J&J appeal, filed in April 2020, Shine Law client, Carolyn Van Der Jagt was quoted as saying:

“It’s incomprehensible for Johnson and Johnson to continue to debate the damage this product has caused us women,” she said.
“Just when we thought it was over, we are now being made to wait yet again, for the compensation we need to pay for our ongoing medical expenses. Our lives have been ruined. When will enough be enough,” she said.
“That Johnson and Johnson would prefer to spend hundreds of thousands of dollars on legal disputes instead of giving it to the women they’ve wronged, is inhumane.”

Lamborghini

Lamborghini

Included in the evidence was a statement by French pelvic mesh inventor, Dr. Bernard Jacquetin, who said in an email presented at trial “I would not want my wife to undergo this procedure and I don’t think I’m alone in that.”

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.”

Evidence showed polypropylene can shrink, erode, harden and cause pain.

All of the devices carried risks of complications….against which no adequate warnings were given,” said Judge Katzmann.

Like the U.S. Food and Drug Administration, in Australia the Therapeutic Goods Administration (TGA) clears the devices for market.

In the U.S. Ethicon faced more than 40,000 cases filed in multidistrict litigation. The healthcare giant had more cases filed than any of the other 6 defendants filed in that court. 

J&J is still facing plaintiffs in state courts and faces paying millions in jury verdicts from the trials that were held in New Jersey, Philadelphia and West Virginia.

TVT-Obturator

 

Shine Lawyers of AU 

The action was filed in October 2012 against Ethicon and 2012 over Ethicon mesh alleging:

·       That the implants were defective and not fit for their intended purpose

·       That information accompanying the implants did not adequately disclose the severity of risks

·       The devices caused significant and sometimes severe and life-altering complications including erosion and chronic pain.

The implants named in the action are:

  • Gynecare Prolift Pelvic Floor Repair Systems (Anterior, Posterior and Total);
  • Gynecare Prosima Pelvic Floor Repair Systems (Anterior, Posterior and Combined);
  • Gynecare Prolift+M Pelvic Floor Repair Systems (Anterior, Posterior and Total);
  • Gynecare TVT;
  • Gynecare TVT - Abbrevo;
  • Gynecare TVT – Secur;
  • Gynecare TVT Exact;
  • Gynecare TVT - Obturator; and
  • Gynecare Gynemesh PS Nonabsorbable polypropylene Mesh.

Other devices made by J&J are no longer marketed, they include:

  • GYNECARE GYNEMESH PS Nonabsorbable PROLENE Soft Mesh.
  • GYNECARE PROLIFT Total, Anterior and Posterior Pelvic Floor Repair Systems;
  • GYNECARE PROSIMA Anterior, Posterior and Combined Pelvic Floor Repair Systems;
  • GYNECARE PROLIFT+M Total, Anterior and Posterior Pelvic Floor Repair Systems; and
  • GYNECARE TVT SECUR System.


AMS Class Action

Besides Ethicon (Johnson & Johnson), Shine lawyers of Australia and also handling a class action on AMS, American Medical Systems meshes used to treat SUI and POP. Upward of 2,000 women have joined that class action.

The meshes include: 

·  Perigee Transobturator Anterior Prolapse Repair System;

·  Apogee Vaginal Vault and Posterior Prolapse Repair System;

·  Elevate Anterior and Apical Prolapse Repair System;

·  Elevate Apical and Posterior Prolapse Repair System;

·  SPARC Sling System;

·  MONARC Subfascial Hammock System;

·  MiniArc Single-Incision Sling System;

·  MiniArc Precise Single-Incision Sling System;

·  MiniArc Pro Single-Incision Sling System;

·  RetroArc Retropubic Sling System.



LEARN MORE:
 

Therapeutic Goods Administration on Mesh here

Shine Law Firm on J&J Appeal

Mesh Injured Australia, WHO Magazine, by Andrea Walter

MND, November 21, 2019, Latest News!  JNJ Negligent in AU Mesh Case, Must Pay Thousands of Pelvic Mesh Patients

MND, Autoimmune Issues to be Added to AU Women Mesh Claim against  J&J

Mesh News Desk, October 15, 2012, Australia’s Vaginal Mesh~ Largest Class Action in History?

https://www.meshmedicaldevicenewsdesk.com/australias-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 Injured Australia


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