Outside federal courthouse, Sydney, News.com.au
Mesh Medical Device News Desk, July 5, 2017 ~ As the U.S. celebrated its Independence Day, more than 700 Australian women joined in a pelvic mesh trial blaming Johnson & Johnson for their mesh-related injuries.
The largest class action in Australia may take up to six months.
It's estimated as many as 100,000 Australian women may have been implanted with pelvic meshes made by Johnson & Johnson, C.R. Bard, Boston Scientific and AMS (American Medical Systems).
Tuesday, July 4, hundreds of those women took Johnson & Johnson (J&J) and its Ethicon medical device division to court in the largest class action in recent memory in Australia that's expected to last up to six months.
This is the first legal action in Australia naming a defendant pelvic mesh maker. Australia fashions its regulatory approval of transvaginal mesh after the U.S. Food and Drug Administration (FDA) and the meshes named have all had FDA clearance for use.
This trial is headed by Shine Lawyers of Australia and will be held in federal court in Sydney.
Attorney Jan Saddler tells CTV News that the women involved have experienced chronic pain, mesh erosion, chronic inflammatory response, as well as an inability to have intimate relations.
Nine pelvic meshes are named, five are off the market, voluntarily recalled by J&J.
See MND story on J&J pelvic mesh voluntary recalls here.
ALLEGATIONS OF INJURY
Allegations are that while J&J aggressively marketed its meshes, it was negligent for failing to warn doctors and inform patients about the risks associated with transvaginal mesh. Testing was inadequate before marketing and the transvaginal mesh was defective in its design, not fulfilling the purpose for which it was created, says the plaintiffs' complaint.
Gai Thompson tells CTV News in Canada, "No amount of compensation, money, could ever replace what we've lost with our lives, with our families, our health, our emotional health," Thompson told reporters outside court. "My prayer is that this mesh would be banned and that no woman would suffer what we suffer."
In a statement, Johnson & Johnson said the use of mesh to treat pelvic organ prolapse and urinary incontinence has successfully helped millions of women worldwide, and said the majority of women who undergo the surgery have had a positive result.
The New Jersey-based healthcare giant says it’s only aware of 200 complication reports in Australia, reports Reuters.
"It is always a concern to us when a patient doesn't get the outcome they had hoped for, or believes they have experienced an adverse event," spokeswoman Meshlin Khouri said in a statement.
In the U.S., an estimated 140,0000 women have filed defective product actions against mesh makers, many in multidistrict litigation (MDL).
Johnson & Johnson and its Ethicon division represent the largest number of U.S. actions filed, with 38,921 lawsuits filed in the federal MDL court as of today, July 5. Among those, 7,420 are listed as closed.
An Australian Parliament Committee is holding an inquiry into transvaginal mesh implants and a report is expected to be issued in November.
Australia has not recalled any pelvic meshes, following in the footsteps of the U.S. Food and Drug Administration, which also has not recalled or banned use of transvaginal mesh.
U.S. companies regularly send their medical devices overseas, including Australia. It’s estimated at least 100,000 transvaginal mesh medical devices have been sold in Australia.
Joanne Maninon tells The Guardian, “It can’t go on. There’s too many women who have gone through the pain, the complications, it’s lifelong.”
Women in Australia have not found doctors who can remove the mesh which is intended to be a permanent medical device. A few doctors in the U.S. have had some success at full mesh removal, best known among them is UCLA and Dr. Shlomo Raz.
OPENING DAY- VALUABLE MARKET
In the opening day of this class action,
Tony Bannon spoke for the plaintiffs. He said the risks were either minimized or not communicated to the surgeon or patient by J&J.
“[They were] overwhelmed by a tidal wave of aggressive promotion, designed to persuade both surgeons and patients of the quick, easy one operation able to resolve the particular difficulties,” Bannon told the court.
Prof. Bernard Jacquetin, TVM patent
He said the company saw a “valuable market” to be gained and convinced doctors it would be easy and quick to implant a pelvic mesh device.
Bannon quoted one of the French Ethicon team, Bernard Jacquetin, who said he wouldn’t like his wife to undergo that treatment and, “I don’t think I’m alone.”
Jacquetin was a consultant to J&J who received royalties from the healthcare giant.
Read about him from the Linda Gross trial held in New Jersey in 2013 here.
MORE CLASS ACTIONS AHEAD
News.com.au reports another 300 women in Australia have enrolled in a second class action lawsuit against American Medical Systems (AMS). The AMS Apogee was developed in Australia and cleared for use in the U.S. by the FDA in 2004.
It was quietly removed from the market by AMS. Read MND about AMS recalls here.
Australia’s regulatory authority, the Therapeutic Goods Administration (TGA), has not banned mesh devices in that country, similar to the U.S. Food and Drug Administration which, despite a Safety Communications that implant injuries are "not rare," has taken no action to curtail pelvic mesh implantation.
In the U.S., there are approximately 140,000 lawsuits pending against seven mesh makers and an unknown number of cases have been prepared for settlement but have not been filed.
Besides Australia and the U.S., J&J/Ethicon is facing defective product lawsuits over its pelvic mesh in Canada, England, Israel, Italy, Belgium, the Netherlands, Scotland and Venezuela. ###
Mesh News Desk, June 2012- J&J Will Remove Four Meshes From the Market
MND, Day 20 Linda Gross Trial , February 8, 2013
MND, Australian Inquiry into TVM leads to Inquiry and Trial, March 16, 2017