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Endo/American Medical System Sets Aside $520 Million for Mesh Litigation Costs

AMS logoWhether you settle a lawsuit or fight it to the bitter end, it costs a lot to be involved in transvaginal mesh litigation. Endo Health Solutions, the parent company of American Medical Systems (AMS) has set aside approximately $520 million to cover those costs according to its Securities and Exchange Commission filing (SEC) just released here.

Endo purchased American Medical Systems (AMS) in 2011 for $2.9 billion and in doing so inherited the company’s product liability lawsuits.

AMS Apogee for POP

AMS Apogee for POP

According to the filing, AMS is facing 22,000 product liability cases involving its polypropylene mesh devices used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Of the 22,000, there are 16,317 lawsuits filed in federal court in the Southern District of West Virginia.

Endo/AMS makes the Apogee, Perigee and Elevate, among other mesh slings and pelvic organ repair mesh devices. The company says 850,000 units of the AMS sling have been sold worldwide, that include the Monarc Subfascial Hammock and the SPARC Self-Fixating Sling System.

The money set aside to cover whatever eventuality, comes from a pretax charge last year of $316 million, reports Fierce Medical Devices.

Despite a promise to “contest vigorously” all litigation, AMS last year agreed to pay $54.5 million to resolve an unnamed number of pending transvaginal mesh injury cases.  See the background story here. See the SEC filing on the Master Settlement here.

According to the company’s SEC 8-k Filing:

“The Company believes that certain settlements and judgments as well as legal defense costs, relating to product liability matters are or may be covered in whole or in part under its product liability insurance policies with a limited number of insurance carriers.”

However in certain circumstances an insurance carrier may contest or deny coverage.

AMS/Endo is also facing a number of investigations by states Attorneys General which could result in penalties or fines if it is determine that the states paid for surgeries using a defective product.

The company is still required by the Food and Drug Administration (FDA) to conduct post-approval studies on women who have already received these mesh products.  There were 19 AMS SUI and POP meshes that fell under the orders but for some reason, the FDA has agreed to put a hold on 16 of those studies, according to the filing.

That means three of the post-market inquiries are still alive and should be released next January.

16 Comments

  1. Annie says:

    Why should I have to lay here in bed day after day in pain suffering unbearable pain and sadness. I’m now damaged and I can’t imagine having to live the rest of my life in this amount of pain just because someone down the line failed to study these products. I’ve been in and out of the hospital had several infections and I’m still going through infections. I can feel the mesh poking me its painful. I now see a pain specialist a neurologist a Gyn on a regular monthly basis I go to physical therapy oh and the doctor of urology who is a hour away from my home. That’s not fair to me or any other woman. I was just told I have pelvic floor damage. Now I have to go to a pelvic floor specialist basically physical therapy how degrading on top of that I was told by the urologist that he can remove the monarchy sling but he cannot remove the arms. I hate this he said I will need another surgery after mesh removal to use my own skin to repair the excessive leakage that will occur. Once the mesh is gone. All this while some person at American medical systems and the Fda sit back and continue to allow this product to be put in other women’s bodies. I’m disgusted.

    • londa says:

      They don’t care about us. I have chronic infections and none stop pain also. The sad part is the doctors have no clue how to treat us. My doctor told me there’s a good chance my infections will not stop and I will definitely leak again after removal of my sling. Soon after that I started leaking so now I’m on medication for incontinence with a bladder sling in me.I haven’t felt like myself since the surgery in 2009 so I know your pain and you’re not alone. The part that make me so angry is I went to the doctor three weeks after the surgery and the infections haven’t stopped yet and it took me to scream at the doctors in 2012 and say something is very wrong here.I am miserable everyday, my life has competely changed, I can’t stand over an hour sometimes two without being in severe pain and sitting too long is also painful. My body is getting used to the pain but my pain level never goes below a seven out of ten.Everything I was trained to do requires me to stand for hours so I had to stop working. I’ve been living in my own private hell. My family don’t really understand and I know unless you live with it you won’t understand. You are in my prayers!!!!

  2. Nichole Klein says:

    This is a message to the FDA. I am an understanding person. I know that people make mistakes. We are human after all. I understand that you work with so many rules and policies that my head would spin. So, this product got by you and it wasn’t as safe as expected. I understand how that can happen. But now you the people who are put in your seat to help protect people like me have a moral decision to make. Please do what is right and stop this device from destroying anyone else’s life. It is not a matter of ” if we do that it will make us look weak, or like we are admitting we did something wrong”. It’s an honest mistake on your part. With all the pressure out there coming at you from every side It’s easy to overlook some things, what is hard….is standing up and admitting you made a mistake and doing everything in your power to fix it. My father, my hero, who just died last year told me “anyone can make a mistake but it takes a real person with good morals and a conscience to stand up and admit fault and correct it.” Please do the right thing….stop the implantation of these devices into woman that are not aware of the risks. Please. My prayers will be to give you the strength you need to stand tall and fix this mistake. Thank you for your time.

  3. Sandy says:

    I have never felt so helpless in my life. I too am in pain all day. I try to work but it is getting harder and harder. If I stop working I could lose my house and everything I have worked so hard for my whole life. So what do I do AMS? What do I do Judge Goodwin? I trusted the people who make these things never to make something that would change my life forever. I too understand about making mistakes. But now to AMS and Judge Goodwin I say to you, stand up and do the right thing. Support the women who have been hurt. Pay them what they deserve, help them with medical cost and job loss and loss of family time and a normal life. Don’t sit back and line your pockets while we lose everything because we trused people. Has all moral values left the United States? You don’t do this to people. I tried to read the legal papers and it sounds like they won’t pay for income loss. I face yet another surgery and I am afraid I will lose my job then or not be able to work, they did this to me. They need to stand up and make things right. Hey ladies what do you think the chance of this ever happening. What is the amount you would put on your suffering, your loss of everything that use to be normal. I am ready to write to my congress people and start bugging them a lot. This is wrong and needs to be corrected but I believe every day I am screwed. I will end up losing my house and every thing because I trusted people. It’s sad I live in depression every day due to pain and loss of hope. I believed things would be taken care of but now I believe they never will be and if they throw us a bone so to speak it won’t be enough to undo what they did. I will never be the same but they could help me to live a little easier while I try to live out the rest of my life. I will forgive but they have scared me for the rest of my life and I will never forget.

  4. pam says:

    Time was most important to the women that had the mesh implanted to get it out and removed before more damage was done to them, and it was those doctors and companies to do this. If they had been truthful and honest to their work and profession, more women might have not had to suffer , but they kept covering it up, from the FDA, TO doctors, companies people lying, now courts , judges , and attorneys,because of political favors and more, Wasn’t it told how the companies paid for some to meet on luxury vacations with families , what else not just in the billions all involved made, kick backs. where politicians and more gave money to the companies and the companies supported them in campaigns. . So, greedy, that they stop the truth from being told.

    What has happened to their vows of oath to americans, those that they are suppose to be truthful with? What about these juries , hand picked , what has happened in america that laws have been put into place , where we have those of organizations, lobbist, and more, like organized crimes of rich and famous, that they can get those to do their dirty work, for money? Even cover these things up and not see the crimes. I know exactly who were slamming phones down to me as I was wanting to know what was happening to me, that doctors and nurses had attitudes with me, lied in reports and lied to me face , some even saying they talked with me and they did not, these bills went to insurance companies that want part of settlements of those people , they need to take back all money lying doctors made , lying to women and treating them lower than animals.

    THE STATE WANTS THEIR PART FOR5 WHAT? the politicians that got kick backs from these companies that they supported and gave money to, so they have that money to smile in front of cameras saying they have money to look good at also lying where their money comes from.

    THEY EXPECT THESE WOMEN TO SAT ISN’T THAT NICE, AFTER ALL THAT GOT RICH, they have no conscious for sure. THE GOOD NEWS: THANK GOD , THAT WE DO NOT UNDERSTAND EVIL WAYS OF THOSE THAT FOR GREED AND POWER COVER UP AND LIE THEIR EVIL WAYS TO BEING RICH. WHAT THEY ARE WANTING TO SETTLE WITH WOMEN IS NOTHING COMPARED TO WHAT THEY HAVE SUFFERED AND WILL SUFFER FOR THE REST OF THEIR LIFE.

    I know nom judge would say what they offer , after all those that got rich off of mesh is even close to what the women have to face for the rest of their life,. NOT UNLESS THEY TOO ARE GUILTY FOR TAKING MONEY TO COVER FOR EVIL PEOPLE , TRUTH SETS PEOPLE FREE, ANDE JUSTICE SERVED, LIES BIND.

    THEY ARE DENYING WOMEN ANY TIME TO USE ANY MONEY TO ENJOY LIFE IN ANYWAY, THEY WANT TO TAKE THAT TOO. AFTER THEIR LIFE HAS STOPPED THE WAY THEY KNEW BEFORE MESH. weak and old before their time.

    HOW WOULD THEY LIKE IT IF SOMEONE LIED TO THEM AND DID THIS TO THEM, BELIEVE ME THEY WOULD KNOW FIGHTING INFECTIONS WHY WOMEN SAY STANDING TO LONG SITTING TO LONG BRINGS MORE PAIN, UNLESS THEY JUST STAY LAYING IN BED , THAT WOULD CUT THEIR LIFE SHORTER, TO JUST LAY THEIR AND DIE. KEEP MOVING LADIES, DO NOT GIVE UP. that’s what they want.

  5. pam says:

    I misspelled some words , a mistake what these companies and doctors and more did in mesh , they knew. NOT A MISTAKE WITH THEIR LIES.

  6. Holly says:

    I have a case filed.Is there any update on the status of any settlements

    • Jane Akre says:

      Aside from the AMS and perhaps Coloplast (rumored, not confirmed) there are no settlements is my understanding.

  7. Carmel Berry says:

    As always- we hear it here first! Thanks Jane. x

  8. Annie says:

    To cry every day because doing normal things that hurt is not fair. I had a life before this mesh and now I feel very alone. I have to see four different doctors on a regular basis is that normal ? No its not. Urologist , Gyn, neurologist pain management Doctor oh and physical therapy plus now I’m going to go to pelvic floor physical therapy. I can’t stand for long it pokes me I feel it. My pain is real. I just found out I’m going to have a translabial ultrasound my Gyn is ordering it but he said he doesn’t even know if they do them in my area. That means another far from home trip. I’m so terrified it stresses me out . I panic thinking OK this Specialty Urology Department says OK we can remove only part of your mesh because his partner tried to remove the arms from the groin from a lady and she practically bled to death. Boy that sure makes me terrified

  9. Richard Howden says:

    Does anybody else find it interesting that big pharmaceuticals companies are putting together ‘war chests’ in preparation of litigation? And it is reported in Financial reports? There are 10’s of thousands of pending lawsuits by women( and men) that have been implanted by a supposed ‘safe’ product and still the FDA will not go beyond a worthless ‘Alert’. As far as I can tell an ‘Alert’ does nothing for the people that have been impacted by mesh but does everything to protect the manufacturer. When are we going to have a Congressman/women or a Senator speak up for us? The status quo continues as more mesh is installed daily. If the manufacturers can put ‘war chests’ together, recognized by their share holders and financial publications, that alone should alert our Representatives that something is wrong. I have contacted my Senator and Congressman without a reply. I contacted my Attorney General concerning the Lawsuits by some States concerning faulty Mesh and Hip replacements. I asked them if they were aware of the amount of monies expended by the State in medical costs for these faulty products. I asked if the State of Colorado was going to participate in the Lawsuit against J&J and Ethicon. I was referred to the FDA! We need a public figure to champion our cause and be our spokesperson to the American people. We as a group cannot continue being called pain medication addicts, hypochondriacs or mental cases by the same people that manufactured or put Mesh in us.

  10. Sharon Bearden says:

    The really bad days which are morethan the good days. I cry then I get so really mad. I think of my Grandchildren and I can’t do much for them or with them.

  11. Sandy says:

    I don’t understand so is this saying AMS has come to a settlement? I am a AMS victum but I have heard nothing! In fact I have to go to my doctor on Monday because of chronic pain and I think he’s going to take me off work. But it sounds like that won’t matter now. I tried to read the legal jargon and it said something about your condition as of May 2013 is what they will go by. What the hell? Am I wrong please tell me I am. My attorney isn’t saying anything to me. Can someone help me here. I am going to lose my job because I can’t work anymore! Someone please explain this to me!!!

  12. cruci says:

    From that amount can somebody tell me about how much each person would get?

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