endo logo two*This Just In*

Late this afternoon, Endo Health Solutions announced it had reached an agreement with several law firms to settle in principle about 20,000 defective pelvic mesh lawsuits sold by its subsidiary American Medical Systems.

Here is Endo’s news release.

Here is Exhibit A: Resolution Framework:

http://www.motleyrice.com/files/medical-devices/exhibit_a.pdf

MR press release about the settlement here:

http://www.motleyrice.com/news/view/motley-rice-enters-settlement-regarding-tvm-1086

That would amount to an average of $40,000 per case before legal fees are subtracted. Settlements of a mass tort are usually organized in “Tiers” of injury resulting in a range of compensation. In this case, women will be required to provide their medical records and a majority of women, or their estate, must agree to the settlement.

For women hoping to get back on their feet after the physical and financial losses associated with the injuries from pelvic mesh, or for those seeking removal or reconstruction surgeries, that amount of money is too little too late.

Apogee AMS

Apogee AMS

“I think this is Pure BS” says one Mesh News Desk reader. 

Women have been encouraged not to speak to the media if they are involved in litigation.  They spoke to MND on the condition of anonymity.

Joanna C. told MND “I’m disgusted, I’m angry. I will not accept this small amount of money absolutely not! I will fight this until the end. I’m sick.”

Rene B. said “Women have been injured. There is no way they’d accept that if it’s in their mother or sister. Do they think women are stupid?”

The settlement, if approved,  would resolve the majority of the lawsuits. There are still about 5,000 cases facing Endo/AMS, some of which are consolidated in federal court in West Virginia.

The four law firms behind the agreement are Motley Rice LLC, Blasingame, Burch Garrard & Ashley, PC, Levin Simes LLP and Clark, Love & Hutson, G.P

With legal fees beginning at 40% would result in approximately $332 million for the law firms involved.

There will be no admission of liability by the company and women who sign are typically expected to sign a confidentiality agreement. In the past there must  be a majority of the plaintiffs willing to agree to any settlement numbers.

ENDO/ AMS 

Endo Health Solutions took over AMS in 2011 for $2.9 billion and in doing so acquired more than 22,000 lawsuits claiming the polypropylene mesh is defective and doctors were not adequately warned about the complications associated with the mesh.

In the company’s Securities and Exchange Commission filing last year, AMS said it plans to “vigorously defend themselves in the remaining mesh product liability cases and in any new cases that may arise.”

AMS makes the Perigee, Apogee, Elevate, SPARC, BioArc, In-Fast Ultra, MiniArc, Monarc and Straight-In meshes used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

According to the company’s website the Apogee Vaginal Vault Prolapse Repair System and the Perigee Transobturator Anterior Prolapse Repair System are “not available for sale in the U.S.”

Endo logoOn The Settlement Track

Last June, Endo Health Solutions Inc. agreed to pay $54.5 million to settle some outstanding lawsuits that have been filed by women who were implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.

Last month the company announced it had put aside $520 million to cover the cost of litigation or settlement.  Endo also recorded a pretax charge off about $316 million at the end of 2013 which brought its product liability fund to about $520 million.

In its SEC filing, Endo Health Solutions Inc. said that an estimated 500 million women worldwide may suffer from urinary or fecal incontinence and around 400,000 surgeries are performed around the world annually to correct some form of pelvic organ floor prolapse.

Endo Under Investigation by AG Office

Then last month in its annual report released by the Securities and Exchange Commission,  Endo admitted it had received subpoenas from several states investigating the overpayment for its pelvic mesh products. The California Attorney General’s office is one of those states which issued a subpoena last November.

As of April 30, 2014, Endo/AMS is facing 17,369 lawsuits consolidated in federal court in West Virginia, just behind Ethicon at 17,790 cases. This does not include product liability cases filed in state courts around the country.

The company is still required by the FDA to conduct post-approval monitoring on the rates of organ damage and complications among the women implanted with its pelvic and transvaginal meshes.  See background story here.

AMS originally received received 19 orders in January 2012 but, according to the SEC filing, that has been reduced to 16 orders “for various commercial reasons” says its filing.

When AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market, it was relieved of complying with the studies.

“AMS is continuing to work with the FDA to comply with these outstanding orders,”says the filing. #

Learn More:

Bloomberg News, Endo Pay $830 Million to Resolve Vaginal Mesh Suits, April 30, 2014 here

Reuters, Endo Agrees to $830 million to Settle Vaginal Mesh Cases, April 30, 2014 here

Mesh News DeskEndo/ 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