Has AMS Paid All Transvaginal Mesh Claims?

Jane Akre
March 28, 2017

Image from the Guardian

Mesh Medical Device News Desk, May 27, 2017 ~ American Medical Systems/ Endo International says they are settling NO MORE CLAIMS, reports "Samantha" after a conversation with the national settlement firm.

Samantha has vigorously pursued AMS for its patented surgical tools used in the Caldera mesh kit that injured her.

Samantha was implanted in the T-Sling made by Caldera in 2004, before it was even cleared for experimental use, at HealthSouth in Birmingham, Alabama. Her implanting surgeon was one of the co-inventors, she says, something she was not told at the time but which she discovered later.

"If you believe you will obtain a settlement from AMS you might want to know that it is most likely not going to happen. They are on defensive now that the novel surgical tools are identified and are a new viable set of claims against their national settlement funds," she tells MND.

Samantha, who is not represented legally but may be in the future, prefers not to be identified. She spoke with the law firm overseeing the AMS/Endo $1.6 billion Qualified Settlement Fund (QSF) March 17.

In a series of e-mails, Amy Rhoe, attorney for Reisman Karron Greene LLP, confirmed the new national legal position for Astro Endo Pharma Position is NO MORE SETTLEMENTS will be paid.

In response to clarification, whether AMS/Endo was ending transvaginal mesh settlements, Rohe wrote MND, "The statements in your email are incorrect."

From whistleblower law

Negotiations between plaintiffs' lawyers and the company are reportedly still resulting in some case resolution, but Samantha is proceeding Pro Se, after she fired he law firm. With no one representing her interests, and being implanted outside of the years Caldera Medical had insurance coverage, Samantha is further disadvantaged in this litigation.

What's unclear is whether future claims may be filed against the $1.6 billion QSF or whether the pending mesh product liability cases will be satisfied.

There are already limitations to covered claims. The QSF does not pay for future injuries and there is a cut-off date of December 31, 2016 for applying for a supplemental settlement amount.

Judge Joseph Goodwin

At one time, Judge Goodwin, overseeing pelvic mesh litigation, heralded AMS as the example the other six mesh manufacturers should follow to the settlement table. Now that progress has reportedly stalled.

Older AMS cases are lingering after dollar amounts were rejected by the mesh-injured plaintiffs, and according to Endo, an additional 9,700 product liability pelvic mesh claims have been filed.

The pelvic mesh litigation that was supposed to be the first resolved has failed to do so.

Is the AMS/Endo Settlement Near the End?

In 2011, Endo Pharmaceuticals agreed to acquire American Medical Systems for $2.9 billion in cash for its urology medical devices. The AMS deal would be a bad one for Endo. The merger resulted in Astora Women's Health, which closed its doors one year ago due to the mounting cost of pelvic mesh litigation.

In September 2014, AMS/Endo announced it was committing $1.6 billion into the Qualified Settlement Fund to close its pelvic mesh cases.

Its latest securities filing for 2016, Endo International, based in Dublin, Ireland, shows cash payments to mesh-related product liability and other litigation matters in excess of the $1.6. billion QSF. The mesh-related activities include cash payments to claimants in 2016 of $1.1 billion and $676 million for 2015. See the Endo SEC 10-K here and here.

According to the filing, AMS/Endo settled 49,000 filed and unfiled mesh claims with, no admission of liability or fault as of December 31, 2016.

The SEC filing says, "It is currently not possible to estimate the number or validity of any such future claims." The company no longer has product liability insurance to cover the claims in connection with the mesh-related litigation settlement.

Is it accurate to say then that Endo payments into the settlement fund, for the time being, have been satisfied? I asked Amy Rohe for a second time.

“That is not correct. My client has no additional comments with respect to settlements at this time," writes Rohe in an email.


The settlement is a drain on a company already in a steep decline.

Last June, Endo stock plummeted and by December, Fierce Pharma reported Endo planned to cut loose 375 sales reps and staffers.

Today Endo International plc is near its lowest point in a year, closing up today at $10.50 USD. The week of January 31, 2017, Endo was the worst performing stock in the S&P 500, in fact, twice in one week.

Adding insult to injury, last week two FDA advisory panels said that Endo's moneymaker opioid, OPANA and OPANA ER do not provide more benefit than risk. The extended release, which was supposed to be an improved version, might be even more dangerous than the original, concluded Public Citizen.

It will be up to the FDA to decide whether to require label changes, restrict prescriptions or take OPANA off the market. For the present time, OPANA remains on the market with additional warnings.


Barbara Binis, Reed Smith for AMS

Endo continues to pay hundreds of thousands of dollars in legal fees to defend all of its problematic products but appears to have given a green light to lawyers pursing a mesh-related alleged"scheme" to undergo additional surgeries for additional settlement dollars.

According to recent filings in the federal multidistrict litigation in Charleston WV, AMS/ Endo is pursuing Broward Outpatient Medical Center and Beth Israel Surgical Center to provide medical records on 32 plaintiffs, women implanted with AMS transvaginal mesh. To date, the hospital had not complied with the subpoenas requested by AMS attorneys on or about November 23, 2016. See PTO # 236 here.

Attorneys for Reed Smith law firm representing AMS/Endo believe mesh-injured women are willing to undergo additional pelvic surgeries to increase their settlement dollars. The Tier system used to gauge injury and compensation is based on the number of mesh-removal surgeries a woman undergoes. See MND Pain for Profit story here.

The alleged "lured into needless surgeries" scheme has been reported numerous times by Reuters and is repeated in this recent column.

As if there was not enough litigation to go around,
Reed Smith, is facing accusations of questionable practices of its own, as reported by ReedSmithWatch.com, The website says partners, bill upwards of $700 an hour.

from AMS patent for surgical tools


For Samantha, her argument is that the surgical tools included in the Caldera T-Sling were patented and owned by AMS, therefore she believes have value to her case.

Samantha continues, " My journey has been long and difficult. All Caldera Medical Inc. victims should file a short form in the American Medical System MDL and demand payment from the national fund. I have an open insurance claim against AMS/Endo. I filed with ACE Chubb Group after locating the general liability policy through an insurance agent, Marsh U.S.A. I opened my claim on March of 2016 which is based in my injuries by the predevelopment use of AMS patent US6911003.

"The patent is for the helical introducer, inside-out introducer, hook introducer for the transobturator procedure are instruments whose use and IP method have injured me.

"After more than a year of communicating with an adjuster, my claim was directed to American Medical Systems National Settlement law firm and attorney Amy Rhoe."

The context of the communication was as follows:

AMS patent US 6911003

"It is my hope you are able to authorize a settlement offer as Astro / Endo Reached Master Settlement Agreement to Resolve Substantially All Remaining AMS Mesh Litigation Claims, in September of 2014. I was implanted with an assembly kit which contained the AMS novel surgical tools during the window of time where AMS was infringing upon Mentor and AMS and Caldera Medical, Inc. agreed to a royalty agreement for the novel surgical tools.

I was an unethical human experiment 22 months before the FDA was aware of the Caldera mesh assembly kit. It should be of concern to you as to how AMS was involved with HealthSouth in participating in my harm. Funds are set aside for settlement and ACE Chubb's insurance adjuster directed me to contact Endo directly because all proceeds from the general liability policy had been paid into the fund. You can authorize the payment of my claim.

I am asking you authorize a settlement from the fund for my claim. My harm has never been denied by the insurance company. Life Science policies do not cover for harm outside of clinical trials of which I was not. Clinical trials did not begin until 2006. If Endo is unaware of the unethical human experimentation that American Medical Systems used to bring products to market, that should be addressed internally I, however, should be compensated for my harm.

I do not have legal representation because Multidistrict Litigation attorneys operate within collusive private deals which have hidden the criminal unethical human experimentation surrounding my harm, the Stark's Law and False Claims violations and avoid prosecution so they can take their monies for legal fees and commissions while ignoring the predevelopment unethical human experiment that brought devices to market.

from AMS patent

When I had initial contact with you, I indicated that I had information that you might not be aware of. That information concerns this question.

Do you know how American Medical Systems helical passer needles were used in the assembly kit use to implant me on April 20, 2004, at HealthSouth Alabama, 22 months before the FDA was aware of the implant?

Please review all 42 images of the patent, it will provide images for my harm. Here is the patent for Transobturator surgical articles and methods. My claim is based upon Patent 6911003 B2 CLAIMS (14) (here).

I look forward to our phone conversation today. Please review all 42 images of patent, I have provided image 11.

Again, I ask you to authorize a settlement offer from the current 2014 settlement fund."


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