Caldera Transvaginal Mesh Update: Individuals Treated Unfairly for No Reason Grounded in Rationality or Fairness

//Caldera Transvaginal Mesh Update: Individuals Treated Unfairly for No Reason Grounded in Rationality or Fairness

Caldera Transvaginal Mesh Update: Individuals Treated Unfairly for No Reason Grounded in Rationality or Fairness

Image from The Guardian

Mesh Medical Device News Desk, January 14, 2017~  This writer, implanted with Caldera Medical’s transvaginal mesh, is one of 4,000 facing litigation against Caldera which has yet to offer a rational settlement, she says in this Op-Ed. She wishes to remain anonymous because she is involved in litigation.  

This opinion does not necessarily reflect the opinions of Mesh News Desk. 

Stop it! MDLs make up nearly half of the federal civil docket. It is a serious failure of our individual rights.

Every woman harmed by Caldera Medical, Inc. transvaginal mesh implants have separate causations; some had no informed consent, some never knew of the implant placement, and were given different information from surgeons and hospitals and their staffs. Causation lies in the manufacturers, surgeon, staff and physicians, and facility whom purchased and marketed these devices, implanted these devices and brought to market these devices with multiple manufacturers. Each woman has a unique version of how she was harmed.

Your tier systems you agreed upon, they are not fair or rational.


The problem is that the plaintiff lawyers making many of the decisions in an MDL (usually adorned with the regal title of “the plaintiff steering committee”) do not represent all the plaintiffs.

Stop it. It is an ugly problem and if MDL attorneys have not been told by a client who sues you and wins; it is legal malpractice. Mass Tort attorneys have hurt us. We may never recover. You have reared your ugly heads to steal from us as Americans the most sacred of trusts:

  1. The right to trial by jury.

  2. Our right to protect our bodies from the medical battery.

  3. The right to have our marriages protected; these transvaginal mesh devices destroy our bodies, our marriages, our professions on a scale never before seen in America.

Individuals get treated as an aggregate, and some make out better than others for no reason grounded in rationality or fairness and others left with nothing.  MDL plaintiff lawyers steer more dollars toward their cases than others; take the gentlemen’s agreement in the Caldera Medical Inc. class action and the deliberate unwillingness to litigate our cause and obtain our damages from American Medical Systems whose novel surgical tools are part of the Caldera Medical, Inc kits.

The MDL statute was developed as a judge-centric model – its framers intended that judges would wrestle control of cases from the litigants and guide the litigation to a conclusion that would relieve the federal courts of potentially crushing caseloads.

Well, MDLs fail. They fail us all. We do not care about case loads. We want fairness! We want our trials in our communities. We want our jury of 12 to hear about all the parties involved who destroyed us. We want fairness!

What’s the solution?  As an injured woman, I point with favor to the judge in the World Trade Center Disaster Site Litigation who expressed the view that a proposed settlement was not enough.  That judge, according to the authors, based his authority to reject the settlement on a quasi-class action theory created by Judge Weinstein the Zyprexa MDL.

The WTC judge acted as an “information intermediary.” Once he put it out there that the settlement was, by his lights, unfair, it was not possible to cram the settlement down the throats of plaintiffs.

from Whistleblower Law insights

I hope MDL attorneys do read this site and take pause as to the harm we are suffering because we as individual Americans are not being treated fairly. In the 21st century with life science policies and biomedicine, the strong interest is in settling cases, not fairness. WE WANT FAIRNESS!

The system must now be subordinate to the rights of the individual American who suffers life altering harm through the implantation of surgical mesh.

PLEASE do not approve settlements that are unfair to plaintiffs.  MDL litigation thrives on the concept “Settlement is good.”  When you are harmed as we are in such a personal and intimate way, where most of us will never make love to our spouses again; we believe a jury verdict in our State courts is justice.

I am a Grandmother; I do not want to see American granddaughters and great-granddaughters be implanted.

Until surgeons, facilities and executives are found in State courts to be responsible for our harm along with the manufacturers we will not have been treated fairly.

Not All Settlements are Good. Some are neatly wrapped gentlemen’s agreements that leave our lives, our marriages, our health and our hope trampled on the floor of justice. 

By | 2017-01-20T03:50:42+00:00 January 14th, 2017|Op-Ed|14 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Still Standing January 14, 2017 at 7:48 pm - Reply

    This was a good article and you did a wonderful job laying out your very valid points. Unfortunately, civil cases are very different from criminal cases and criminal prosecutors have to have rock solid irreutable evidence and lots of money to prosecute criminals on behalf of the government. . Not much has happened on charging people up and down the mesh supply chain for crimes apart from a federal RICO motion. I agree that state civil trials would probably be the most fair to mesh women , but who is going to pay for them? The primary reason that MDLs were originally set up was to share the huge costs of discovery, getting the evidence. Paying for expert testimony, filing motions, and other case costs. Very few single law firms have the financial ability to uncover all of the medical evidence needed to mount a single case that results in a positive judgement in a local or state civil mesh jury trial. Some Medical experts who were deposed in this MDL charged $1500 per HOUR not to mention the huge costs of court reporters and videographers, travel, lodging, etc. That isnt $1500/hour for being in court, but $1500 for all their pretrial preparation as well. Since personal injury attorneys work on a percentage of the settlement or judgment and they get nothing unless the plaintiff gets an award, that means they would have to front all the money for possibly years unless the plaintiff hired the attorney and agreed to pay for all of these costs as they were incurred. How many mesh women can do this? Adding hospitals and doctors to a civil suit against mesh manufacturers would expand those case costs out of control, not to mention adding the burden of proving that all of them willfully caused damage. The full burden of proof of damages rests entirely on the plaintiff.

    I agree that the mesh MDLs are a mess, but I think we need to be cautious when pointing the finger of blame at the plaintiff attorneys. Agreed that they get a good payoff from settlements in the end, but what attorney can represent us for free? It would be nice if some would just do this out of an abundance of generosity, but that isnt realistic. There is also plenty of blame to cast on the defendant’s attorneys ( or their insurance company’s attorney) as well. They legally file motion after motion to put up roaddblocks and drag out the cases. The judge cant stop this as long as they follow the law.

    Im also a grandmother of two amazing little girls. I want to protect them from all the unfairness in the world, but that is impossible. They will face unfairness across their entire lives. They are biracial and I know that there will be times that they will be unfairly treated by ignorant people. I cant prevent this, but I can teach them how to stand tall when they get treated badly, I can show them and my daughter and daughter-in-law a strength I never even knew I had until mesh knocked me over. I came close to killing myself several times so passing on this lesson of resiliency in the face of unfairness is something I take seriously every day. Some days I’m not the best teacher, but here I am, 8 years later celebrating that my 1yr old granddaughter took her first steps today and that my 7 year old granddaughter absolutely loves math and rattles off multiplication tables like a high schooler. They need their grammy, even a mesh damaged one, to show them that living is beautiful even though it is unfair. I have to remind myself of this truth from time to time. No judge or jury can ever make this fair at all.

    • Anon January 15, 2017 at 7:06 am - Reply

      I personally agree totally with what Caldera mesh victim had to say. All of our stories, experiences are different, i. e. background, socioeconomic status, sociocultural factors. The ugly truth is…………….we (the victims) will have to live with the horrible effects of mesh for the rest of our lives. The MDL Judges, the attorneys, the surgeons, the physicians are free to go on in a couple of years from now, put this nightmare out of their minds and live a healthy, financially stable life. WE (MESH VICTIMS) WILL NEVER HAVE THAT FREEDOM DUE NO FAULT OF OUR OWN.
      We are not privy to all that goes on behind the scenes, not even close. I just recently learned that some law firms finance some of their clients mesh surgery. Their is INJUSTICE and a lack of FAIRNES being practiced from everyone involved in this mesh mess except the MESH VICTIMS.

  2. Patient Advocate January 15, 2017 at 9:03 am - Reply

    Thank you for your response. We all are injured. Many are grandparents. We do have the highest obligation as to teach our grandkids to live life well.

    Caldera victims are the only mesh victims placed in an NON-OPT out class action. MDL attorneys did it by gentlemen’s agreement. Never allowing one bellwether case to be brought to trial for Caldera victims. They have known for some time of the American Medical Systems novel surgical instruments involved.

    Our injuries occurred due to a patent method, surgical tools, and the mesh. There are many solvent partners who could pay us. Instead, it now averages $2733 per victim. There are tiers that are mythical through gentlemen’s agreement. Under the life science policies, Caldera victims are limited to $50,000 to $75,000 each and then there is a general liability for the company. Furtheremore, American Medical Systems Inc. has life science policies and general liability policies that apply to us. Additionally, Johnson and Johnson’s patent method is included in Caldera Medical Inc. litigation targets for recovery.

    Additionally, Caldera Medical Inc. is a privately held company with private stockholders. Those stockholders include surgeons. Surgeons we are not allowed to know. Not once has the MDL lawyers subpoenaed and made public those individuals who brought these devices to market. Caldera Medical Inc. CEO and others should be held accountable like Enron CEO.

    In 2001 it employed 20,000 employees Fortune magazine named it “America Most Innovative Company” for six consecutive years. It did so through institutionalization, systematic, and creatively planned accounting fraud. The CEO went to jail. Caldera Medical, Inc. has repeatedly cried, “Wolf, we are insolvent” while still bringing new products to market and seeking to help implant 1 million third world women with their products. ” As one of their victims, I hope the Mesh Litigation specialist one day hold Caldera Medical, Inc. to the Enron standard. A mesh CEO in handcuffs might sober this nation’s biomedical companies to do no harm.

    My injuries happened at Healthsouth, Birmingham, Alabama. I was implanted two years before the device was on the FDA radar, I was not a clinical trial. I was used as an unethical human experiment. There are women like me implanted in the early stages of pre-development within each manufacturers spectrum of the invention of their devices. No tier system address us. If it did their predevelopment, unethical tactics would be brought to light and maybe new devices would not be brought to market to hurt Americans. Thank you Still Standing for surviving. This is a hard life for us all.

    • Jane Akre January 15, 2017 at 5:14 pm - Reply

      You are so right Patient- How can you be prevented from your Seventh Amendment right to access to the courts……

      • Kitty January 15, 2017 at 10:06 pm - Reply


    • Still standing January 15, 2017 at 6:16 pm - Reply

      What an eye opening post, patient advocate. You are right, Caldera needs to face harsh punishment. What can I do to help? I can make calls, contact federal level people. Claire McCaskill, US Senator from Missouri may just be one person who would listen to your story. She is front center on shutting down website that sex traffic underage girls. Her husband owns nursing homes, so she may have some awareness of and empathy for your story.. Im really sorry that I didnt understand how Caldera women are in such limbo They DID use you all terribly. You deserve to be heard and compensated. I did contact three different physiciansabout the 1million mesh kits going to third world countries. The reply I got from DC is that they are not supplying mesh transvaginal mesh kits, “just” bladder slings. I asked them to take a look at the comments posted here about bladder slings. I had quite a conversation with a physician who teaches at Harvard about that. It makes me sick. Unfortunately, the three physicians I was connected with were all men and they stand by the bladder sling is ok point of view. Please, advocate, I am really offering to help you in your effort. Let me know what I can do.

      • Patient Advocate January 16, 2017 at 5:21 pm - Reply

        Please send Jane your contact info and will call you.

        • Still standing January 17, 2017 at 9:34 pm - Reply

          Jane has it . Look forward to talking with you.

      • michele January 24, 2017 at 1:30 pm - Reply

        My name is Michele and I was implanted with a Caldera t-sling in 2006 in Tennessee. My bladder sling eroded into my urethra and caused a fistula among many other medical problems. I get so upset every time I hear these doctors say that the bladder sling isn’t the problem. I can personally tell them that it does and have the proof and scars to show it. Thank God I was directed to a doctor that was able to help me….well as much as she could professionally help. I am so disgusted and angry and dumbfounded that this is allowed to happen to women everyday. Just when I think it can’t get any worse, surprise!!! How is this even legal on any grounds? Why aren’t the news, media, investigative reporters, or even members of the health organization getting involved in this? I hear about stories and recalls on the news everyday that come nowhere in comparison to the injustice that is being done to all of the victims of pelvic mesh. You would think that someone, some reporter or someone with some “pull” would be interested in helping us. The law firms have done nothing but taken advantage of our pain and suffering and from what I have seen Jane’s MeshNewsDesk is the only forum in which we have a voice. I just can’t wrap my head around how any of this could have happened and continues to happen. It is a total disgrace that we live in this country that is supposed to be the best country on Earth with the best doctors, lawyers, congressmen, lawmakers, and so on, but yet we are treated no better than women in third world countries!! There has to be something we can do to get justice. The FDA is a total joke and the fact that they are allowing this product to continue to be implanted in women is beyond disgraceful, beyond degrading, and beyond any women’s rights. The justice system has failed us, the health organization has failed us, and the men and women in congress have failed us. I refuse to believe that this country I live in has become so money hungry and greedy that a woman’s basic rights to fair treatment, good healthcare, and just basic decency can be so crudely ignored. I want to do something, anything, but I don’t know where to begin. Please someone, anyone, help us!!!!

      • Cara March 2, 2017 at 11:27 am - Reply

        I am curious at to whether you ever contacted Clare McCaskill?

    • michele February 21, 2017 at 12:23 pm - Reply

      Patient Advocate could you please contact me. I would really like to speak with you about this Caldera mess. I have spoken with Jane about my situation with Caldera and she has my contact information. I am particularly interested in what you have to say about the time frame before 2008 when Caldera had or rather did not have Chubbs insurance. I was implanted in 2006 and have several questions in regards to this. I am beyond disgusted at how this has played out and I refuse to just let it end this way. I have contacted someone who may be able to help but I really need more information to give and I feel as though you are the one person that can provide that. Please get in touch either by email or phone. I do look forward to hearing from you.

  3. Edith January 15, 2017 at 6:44 pm - Reply

    I can point my finger at attorneys that are doing nothing but expecting outrageous payments for doing nothing!!! My life was destroyed because I was not informed and didn’t give consent…. I have fought so hard to still be here for my grandsons….. Why should attorneys be paid and not the victims?? My attorney dropped me as a client because I refused to sign into the Caldera agreement..

  4. Diva64 January 16, 2017 at 1:12 am - Reply

    I have hoped to see this through not to let the MANUFACTURES have a winning score walk away with a grin on their face but since Mesh gave me lupus
    It does effects 2/3 of the patients hearts. I hope to get through this but get a,lot of chest pain maybe clots may be pericarditis idk, I only have one doctor left I can go to can’t afford all the needed doctors.So my autoimmune specialist is it. Since MS Hopes is working with Dr Raz at UCLA I will try to keep that appointment his notes alone may may them drop the tier idea. Many mesh sisters don’t even know all their problems. For being unable to financially go to the various needed doctors. I spoke to my attorneys office a week or so ago ,this time not a assist, nor PA, an attorney called as she was naming conditions she left out kidney failure I have been so sick I didn’t correct her. But know I will have a have a chance when and if papers ever arrive in the mail. NO we are not tiers even inmates get the opportunity to go before a hearing view every so often to update them on their progress shouldn’t we the injured party we allowed to ptesent our story and what this has done to out lives and how the insurance company and FDA doesn’t deserve more than we walk away with ,they didn’t suffer a bit.and well not suffer. We have to be United .

    • Patient Advocate January 17, 2017 at 4:55 am - Reply

      Klebsiella pneumonia, Enterobacter cloacae and other infections caused by the mesh in the vagina migrate to the heart and lung. I have Enterobacter cloacae infection. Bladder wall abscess following mid urethral sling procedure is common. Enterobacter Kobe is the species of the Enterobacter cloacae complex, These types of infections are systemic. Your pelvic core infections open your heart and lungs to long term damage through the migration of the infection. I am sorry for you injuries and suffering. All we can do is battle one symptom at a time. It is very hard. In April I will have been implanted 13 years. It cannot be removed. These infections are a constant battle. Stay as well as you can. Be kind to yourself.

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