Mesh Medical Device News Desk, April 11, 2018~ The class action lawsuit involving more than 800 women against Johnson & Johnson just expanded in numbers and in mesh claim complaints against the healthcare giant.
Autoimmune Issues to be Added to AU Women Claim Against J&J
Image: Au Herald
Since July of last year, more than 800 women have been locked in litigation with global healthcare giant, Johnson & Johnson (JNJ) and its Ethicon division. As the transvaginal mesh claim case comes to a conclusion, the women have added numbers and new grounds to their complaint.
Unlike U.S. courts, Australian courts allow many month for both sides to air their grievances. Then it is up to a judge to conclude this class action. The defendant may offer a settlement to end the action at any time.
Being held in a Sydney federal court, Monday Justice Anna Katzmann, agreed to expand the numbers of women who had joined in this class action up until July of last year. Lawyers for the plaintiffs successfully argued it would be unfair if a large number of women were shut out of the case which began six years ago after complications began emerging among mesh implanted women in that country.
That ruling expanded the class action by more than 100 women.
A newly released Parliamentary report estimates more than 150,000 pelvic mesh devices used to treat incontinence and prolapse, have been distributed in Australia over the last 20 years.
AUSTRALIAN MESH WITHDRAWAL
Australia already led the U.S. in taking action against permanently implanted transvaginal meshes used in women to treat incontinence and pelvic organ prolapse.
Last November, Australia’s medical device regulator withdrew from the market all implantable transvaginal meshes, even those called the “gold standard” by J&J and other manufacturers. The risks outweigh the benefits concluded the Therapeutic Goods Administration, the Australian version of the U.S. Food and Drug Administration (FDA).
Similar to the US, medical societies largely sided with mesh makers. The Australian Medical Association even marketed a mesh as a “medical design breakthrough” despite complication reports coming in, reports The Herald.
The death of Canadian campaigner Christina Brajcic last November, solidified the Australian campaign and push to have mesh removed in that country.
Senator Derryn Hinch has joined forces with thousands of Australian campaigners against mesh calling it “the greatest medical scandal” against Australian women. The mesh issue has been the subject of a Senate inquiry in Australia.
IMMUNE SYSTEM RESPONSE
In another move, Justice Katzmann on Monday gave Ethicon (J&J) until May 31 to respond to the women who claim the company sold its transvaginal meshes without the “proper warning” of alleged consequences and in doing so engaged in misleading and deceptive conduct.
A proper warning might include the chronic inflammatory response to a foreign body implant in the body, as well as “psychiatric injury” to a woman who feels she has been violated by the implant that may be impossible to remove and a medical professional who implanted it.
Discovery, revealed at this trial, has shown doctors suggesting anal intercourse as an alternative for women who can no longer have vaginal intercourse due to chronic pain from their mesh implants.
The Guardian (here) reports a failure to warn would also include that mesh presents a particular risk for patients who might have an autoimmune reaction. That would include women with compromised immune systems.
One biomaterials expert at trial, Prof Paul Santerre, testified that any existing immune problems made it more difficult for polypropylene mesh to integrate with the body.
Immune system response was not included in the original complaint in this class action filed by Shine Lawyers of Australia. Judge Katzmann rejected company claims that expanding the complaint would be unfair to J&J.
Judge Katzmann rejected a request by plaintiffs that more women be able to join until early 2019 when a decision is expected or a settlement is reached. ###
Report- Number of women in Australia who have had transvaginal mesh implants and related matters, March 28, 2018
The Guardian, January 30, 2018, Vaginal mesh complications too severe to be inflicted on patients, court told
MND, October 30, 2017, All Mesh High Risk in Australia
MND, January 23, 2018, Au Pulls All Mesh Devices from the Market