Mesh Medical Device News Desk, June 18, 2018 ~ Product liability lawsuits were filed against American Medical Systems in Multidistrict litigation (MDL) as early as 2012 when the MDL was created in Charleston, West Virginia.
To date, there are 21,178 cases naming AMS filed there listing 19,524 as closed.
That’s because AMS was the first company to begin settling with mesh-injured plaintiffs. Judge Joseph Goodwin hailed AMS as an example the other mesh makers should follow. As a result there were no trials naming AMS, now owned by Endo International.
Image: John Nealon, LinkedIn
But that not-to-distant memory is not stopping some principals of the company from trying again to enter the lucrative medical device arena with a newly branded type of pelvic/ transvaginal mesh.
AMS EXEC WANTS INCONTINENCE DEVICES BACK ON THE MARKET
John Nealon, who in the past headed the AMS Women’s Health Division that made transvaginal mesh, is launching a new company to reintroduce two incontinence devices back onto the market.
Nealon heads UroCure, a privately held medical device company based in Minneapolis, Minnesota, that is developing slings to treat female incontinence. Opened one year ago, Nealon is the President and CEO. He left AMS in 2013 after five years as Senior Vice President and General Manager of Women’s Health Business.
UroCure raised $2.5 million to fund creating of the urethral slings. It has goals of raising upward of $3.5 million. The slings will rely on the same patented technology used to create the AMS slings such as Sparc and Monarc to treat stress urinary incontinence.
Nealon says the new company plans to “build on the long-standing market leadership position,” said Nealon.
How will the new mesh be different from the old mesh that landed AMS in court facing at least 22,000 lawsuits in the U.S, MND asked John Nealon.
“We’re not sharing that at this time. It’s not public. Until we launch we are keeping things private,” he said to MND.
The new products are expected to launch sometime after the first quarter of next year.
An SEC filing from March (here).
701 North Third Street,
Minneapolis MN 55401
Other principals of the company are listed as Dave Staskin, Executive Officer, and Doug Kohns, Executive officer.
A Company statement from gust.com says:
“Re-commercialize slings for female incontinence with IP re-acquired from AMS. We will design, develop and commercialize the products and re-submit for FDA clearance according to previously established 510(k) pathway. Slings are gold standard and are reimbursed in all geographies. During product development phase, the company will use an experienced team of contractors with in-depth knowledge of space, sling design/manufacturing and physicians.”
IP is intellectual property. There is no word here whether or not the slings will be made of polypropylene (PP), a cheap polymer used in most hernia and pelvic meshes.
BACKGROUND – A BAD DEAL
In 2011, Endo International, based in Dublin, Ireland, purchased American Medical Systems Women’s Health Division for $2.9 billion even though at the time it was valued at $2 billion. In doing so, Endo acquired more than 22,000 product liability defective transvaginal mesh lawsuits.
The men’s health urology division was then sold to Boston Scientific for $1.65 billion.
The women’s health division was relaunched and with a new name, Astora Women’s Health.
Astora Women’s Health closed its doors in March 2016 due to the cost of litigation. At that time, Astora announced it suspended commercial activity concerning women’s health products.
On September 30, 2014, American Medical Systems announced a master settlement of $1.6 billion designed to resolve substantially all of its remaining US vaginal mesh lawsuits.
In August, 2017, Endo International agreed to settle 22,000 unresolved pelvic mesh product liability lawsuits. The company set aside $775 million to do so. Totaling that with its previous settlement dollars, the company pledged more than $3.58 billion to resolve its pelvic mesh litigation and vowed it would pay no more settlements to mesh-injured women.
By being one of the first companies in the multidistrict litigation (MDL) to settle, AMS/ENDO did not face multi-million dollar plaintiff awards in court as other defendants in multidistrict litigation have faced.
At this writing, no AMS mesh case has gone to trial, though some are being prepared for trial.
At one time AMS made the Elevate, Apogee/ Perigee and Monarc,Sparc and Mini-Arc meshes for both pelvic organ prolapse and stress urinary incontinence. POP meshes were removed from the market when in 2012, the Food and Drug Administration ordered they go through a more stringent review before being sold. Most companies did not want to put millions of dollars into research & development of a technology that was proving problematic in implanted women.
Mesh News Desk has regular contact with AMS-implanted mesh women who have not had their cases resolved.
AMS has also been one of the most aggressive to pursue legally those involved in alleged “schemes” to profit from encouraging women to undergo additional mesh removal surgeries to increase the value of their case. See MND story here.
Endo is also facing financial difficulties after one of its opioid medications, Opana ER, was withdrawn from the market, cutting sharply into revenues. Its stock price today is $9.17 from a high of over $12.30 in 2018.
In April 2015, Endo enjoyed a stock price over $94 a share. ###
Mesh News Desk, How Cases are Dismissed, Adams v. AMS, August 28, 2017 Here
Mesh News Desk, Endo American Medical Systems Under Investigation for Transvaginal Mesh March 5, 2017 Here
Mesh News Desk– Endo/ AMS set aside $520 Million to Settle,February 2014 Here
Master Settlement, SEC filing, $54.5 Million, Freese & Goss, Matthews & Associates and AMS Here
Mesh News Desk, June 21, 2013, Endo Agrees to Settle Some AMS Vaginal Mesh cases for $55 Million Here