Judge Approves $12 Million Settlement in Caldera Transvaginal Mesh Claims

//Judge Approves $12 Million Settlement in Caldera Transvaginal Mesh Claims

Judge Approves $12 Million Settlement in Caldera Transvaginal Mesh Claims

Mesh Medical Device News Desk, January 31, 2017 ~ On Monday, Caldera Medical received final approval of its proposed settlement to end all of its pelvic mesh litigation.

Those women who claim permanent injuries from Caldera transvaginal mesh, will receive the smallest settlement dollars among all seven manufacturers, under $5,000. 

At a hearing Monday in  Los Angeles courtroom, California-based Caldera Medical faced bankruptcy as one option to finally resolve its 3,800 pending claims. 

After once denying the proposed Caldera Medical settlement of $11.75 million, Judge Stephen V. Wilson of U.S. District Court for the Central District of California, on  Monday agreed to the proposed settlement, ending Caldera Medical’s transvaginal mesh litigation. The monies will  be distributed to women who were implanted with one of Caldera Medicals transvaginal mesh products – the T-Sling, the Desara, Ascend, Hydrix, and the pelvic organ prolapse mesh, Vertessa.

Depending on her degree of injury, each woman will receive somewhere under $5,000 after legal fees and expenses are paid, making it among the smallest compensation settlement for the 100,000 women who claim injuries by transvaginal mesh made by seven manufacturers.

Bankruptcy was one option for California-based Caldera Medical, which has been in protracted litigation over its insurance coverage, the cost of which reduced the settlement dollars from $35 million to $11.75 million.

Caldera Medical, Aguora Hills, CA

The afternoon hearing before Judge Wilson was a renewed motion for attorney’s fees and the renewed motion for settlement approval of the Caldera class of injured women.

Dozens of women had objected to the initial offer made by Caldera Medical.

**Late Add** One women, who has pursued Caldera Medical pro se, that is without representation, Samantha, is barred from filing any future claims within the federal judiciary, per an email she received by RR Johnson, Senior Counsel Locke Lord LLP, an attorney for Federal Insurance Company.

He sent an email to Samantha, (not her real name) saying her objections were specifically mentioned to the Judge before he granted final settlement approval.  “Any and all claims that you may have had against any of the released parties, including Caldera, are now barred any released.”

 No reason was given.

“Overwhelming,” was all she had to say to Mesh News Desk.

Attorney Lee Balefsky (Kline Specter) who appeared before Judge Wilson, on behalf of  36 claimants, said Judge Wilson did not offer an opinion but it should be published shortly.

“In our  view it’s a sad day for women who have been injured by this company’s products,” ~ Lee Balefsky.

You may recall that last year Caldera Medical said it was insolvent after the litigation between Caldera and Federal Insurance (Chubb). The $11.75 would be a final offer, there were no opt-outs, no chance to go to trial for women seeking compensation due to their transvaginal mesh injuries. Take it or leave it.

Some attorneys for the women agreed to the proposal while Balefsky and others asked Caldera to be dissolved to determine its true value.

Last February, while insisting on the limited settlement, Caldera announced it was partnering with IVUMed to “eradicate the incapacitation and suffering of women with stress urinary incontinence and prolapse organ prolapse.”

The one million women who would allegedly have their suffering eradicated were from Third World countries.

Caldera promotional material at AUGS

Then in October 2016, Caldera Medical spent thousands as one sponsor of the 2016 American Urogynecologic Association (AUGS) annual meeting. One of the company directors told me there that they were fully solvent.

Where did you hear they were insolvent? she asked, “From a trial attorney,” she glared at me.

Caldera Medical says it is dedicated to “improving the quality of life for women.”

Whistleblower Image, Linda Nylind for The Guardian

Samantha, a Caldera mesh “victim” as she calls herself, said a bankruptcy would have been a good option for the company to determine its true value.

“The federal trustee could then determine the level of federal fraud between Caldera Medical and Chubb Insurance Company and American Medical System (AMS) and determine if the stockholder and the patent holders and the board of directors will also have to contribute to the damages for victims,” she said before the agreement was announced.

Samantha, like others damaged by the Caldera pelvic mesh believe that AMS should also be tapped for its insurance coverage since it provided the surgical tools used in the mesh kits that Caldera sold.

She believes all of the mass tort attorneys wanted out of this litigation so they agreed to a settlement that was not in their client’s best interest.

“If you are hit by a drunk driver, that’s what this is like. There was no informed consent. I find out who the parties are who have damaged me. I called them and was given a claim number with no investigation at all. You wouldn’t allow this in a hit-and-run. They know there are multiple policies and they know I’m outside their policies.”

She was implanted with a Caldera mesh in 2004, outside of the Caldera Medical insurance coverage period of 2008-2012. In 2004, the FDA had not cleared Caldera Medical pelvic meshes for use, in fact, the FDA had no notice Caldera pelvic mesh was being used by select doctors, according to Samantha, who was the first patient to receive a T-Sling. She says she did not sign an agreement to be part of a clinical trial.

Caldera Medical, while technically not insured at that time, claims that “tail insurance” will cover Samantha and others outside of the coverage period.  Samantha calls that insurance fraud.

“They said that’s all the money for the Caldera women and that’s not true,” she says.

Did Caldera operate for a decade without any life science or general liability insurance?

That question also has never been litigated. ###


By | 2017-02-01T10:56:37+00:00 January 31st, 2017|News|18 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. jan February 1, 2017 at 8:54 am - Reply

    So sad this is a slap in the face against alot of injured women. . It’s a statement telling the American women these manufacturers can do what ever they want to put injury on you and get buy with it.

  2. Kitty February 1, 2017 at 1:16 pm - Reply

    You know what is interesting here is that women who file claims have to pay if they were in bankruptcy. It should go both ways.

  3. Patient Advocate February 1, 2017 at 6:51 pm - Reply

    For Us All

    So, not sure what is next. But leaving Judge Wilson’s court so the appeal can begin may just be a very good thing. The ninth circuit court of appeals has one of the the nation’s largest Pro Bono Program. Now, a civil rights hopefully will find this cause worthy. Here is the history of the Pro Bono Program:

    Approximately fifty percent of all new appeals filed in the Ninth Circuit have at
    least one party who is proceeding pro se. All new pro se civil appeals (including habeas
    petitions) are reviewed at the outset by court staff for jurisdictional defects and are
    dismissed early on if no jurisdiction exists. Still others are dismissed for failure to
    prosecute or otherwise summarily disposed of during the course of the appeal. Many of
    the remaining pro se appeals (primarily those determined after the completion of
    briefing by staff and/or judges to meet the criteria set forth in 9th Cir. Rule 34-4 to be
    submitted without oral argument) are processed on the merits by staff attorneys through
    presentation to oral screening panels.
    The remaining pro se appeals (primarily those determined by staff attorneys or
    judges to warrant further briefing and/or oral argument) are reviewed for a determination
    whether counsel should be appointed. Appeals that have been initially referred or
    submitted to oral screening panels are sometimes considered to be too complex for the
    oral screening process or require further briefing and/or oral argument for some other
    reason. These appeals are “kicked” from the screening process by staff attorneys or
    oral screening panels and referred to the coordinator for inclusion in the program and
    supplemental briefing. Still other appeals are referred by motions panels or staff
    attorneys prior to the initial briefing and inventory process on the basis of a motion for
    appointment of counsel and/or a review of the district court or agency record.
    Cases selected for inclusion in the program include a broad range of legal
    issues. While a significant percentage of the cases are prisoner civil rights appeals or
    immigration petitions, many other civil cases are included, such as labor and
    employment cases, discrimination, bankruptcy, social security, Indian law, mining law,
    contract and civil forfeiture appeals. Direct criminal (and most habeas corpus) appeals
    are not included in the program because the appellants are entitled to paid counsel
    under the Criminal Justice Act and because any such appellant proceeding pro se is
    probably doing so out of choice. However, habeas corpus appeals presenting issues of
    first impression, complex issues of fact or law, or raising meritorious claims warranting
    further briefing are selected for inclusion in the program.
    Due to the complex and changeable nature of immigration law, the court has
    posted an immigration law outline on the website to assist attorneys in immigration
    cases. In addition, pro bono attorneys appointed by the court may request assistance
    from the Immigrant Legal Resource Center (ILRC), by calling 415/255-9499. (Let them
    know you are pro bono counsel for a Ninth Circuit petition for review and are seeking
    mentor assistance.) Links to both the ILRC website and the court’s “Immigration
    Outline” are on the court’s website at http://www.ca9.uscourts.gov/probono.
    In summary, program cases are generally (though not exclusively) selected after
    briefing and inventory have been completed. This allows staff to more fully evaluate the
    merits of the appeal and allows the court to assure participating counsel that only
    meritorious or otherwise deserving cases will be selected for the program. One
    rev. 01/11/12 -2-
    measure of the usefulness of the court’s pre-screening process, and of the success of
    the program generally, is that the success rate for the pro bono attorneys and law
    students participating in the program has been approximately 50% (at least partial
    reversal or other termination favorable to pro bono client) since the inception of the

    So, I continue. Samantha.

  4. Cara February 8, 2017 at 12:10 pm - Reply

    Wow.I am speechless.I haven’t even heard this news from my attorneys yet.Just out.of curiousity,I came on this site today and found out that I will get less than five grand for a product that has destroyed both mine and my husband’s life.Shame on Caldera.I am so sorry for all of the women who will find out this sad news.So much for justice.

  5. Debra February 13, 2017 at 3:06 pm - Reply

    Divorce, and all hopes of a relationship was what this company stole from me. I know that no amount of money could replace that, but 5K or under is just disgusting!

    • Elizabeth June 12, 2017 at 10:45 pm - Reply

      I am with you on what they have stolen from us as a woman and the possibility of a future stable and happy relationship with a man. I believe I am seperated and starting all over at the age of 48 because the product Caldera meliciously allowed doctors to use on our bodies . I hope and pray to God that we get more than 5K
      What iv lost and my current living situation and planning for a future has already exceeded the 5K they want to award me with. I can’t even have a decent job , I have trouble taking drug test and do you know that they do not allow you the use of a catheter . If you can product Urine without on your own you are considerate a refusal candidate there for you will not be hired at that potential job you might be seeking .
      Where is the justice ?

      • Jane Akre June 13, 2017 at 6:42 am - Reply

        I’m so sore Caldera, which has consistently been one of the worst to make it right with the people implanted with its product.

  6. Diva64 February 17, 2017 at 4:23 pm - Reply

    On the news we hear ISIS is the enemy is that Mesh spelled in a different language. And by destroying the female you end population and win a war. ,,,,,,,,
    God help us if our courts let Mesh Manufactures off at 5K. I think the Mesh Manufactures will be screaming in pain for eternity and any judge that approves such if I am reading and comprending this correctly.

  7. tina April 3, 2017 at 9:18 am - Reply

    I called my attorney last week and they told me that they did not settle. That caldera is insolvent and there is no money. That the case is over. Is that true?

    • Jane Akre April 3, 2017 at 10:00 am - Reply

      No it is not true. They are in settlement mode is my understanding. There is still to be a final distribution of the last dollars, and the company does say its insolvent, though it has reinvented inself.

      • tina April 6, 2017 at 7:08 am - Reply

        Thank you jane

      • Cara May 12, 2017 at 3:50 am - Reply

        I wonder if we can go after the reinvented company Jane.I am having a difficult time accepting that five grand will be enough for all of this agony.I am planning on seeing Dr.Raz next year to remove my mesh and may , or may not be worse off when it is removed.My attorneys(well, their paralegal-I have yet to speak to my attornies)said that Caldera is still negotiating, and that a Judge did not make a decision.What am I to believe?

        • Jane Akre May 12, 2017 at 8:24 am - Reply

          Caldera is the most horrendous story of all mesh makers. A private company, they are not accountable to the SEC, therefore do not make public filings. They were under insured, they spent half of the insurance they did have fighting their insurance company. Women with Caldera mesh basically get nothing. That is my opinion. Instead of vigorously pursuing the directors of the company personally and instead of going after the patent holders on the Caldera meshes and implant instruments, trial lawyers let them slide… …I hope I’m wrong on all this, but that is my understanding.

  8. Tina July 25, 2017 at 6:59 am - Reply

    So, caldera mesh victims get nothing or what? This is so frustrating. Somewhere else i read payments will be out by the end of the year for 1700.00. Is is that or nothing at all? Who has the answers for caldera mesh?

    • Jane Akre July 25, 2017 at 10:06 am - Reply

      Tina please put caldera in the search bar of Mesh News. There is a lot of coverage including a number of reports about Samantha, another Caldera victim. Let me know if you have trouble.

  9. Norma October 21, 2017 at 8:45 am - Reply

    Thanks for taking away my womanhood Caldera! You have destroyed so many lives and got away with it.

  10. Crystal December 31, 2017 at 12:45 pm - Reply

    This is not justice! We including myself that had Caldera are being given pennies for the lifetime sentence. What can we do? Is there anything that we can do to appeal? I have heard they claimed solvency yet creating a new mesh product with a different name that’s FDA approved. I believe it’s Desara Lite. I haven’t received one red cent to date, but I was told it would be less than 5,000. How are other women getting millions and were getting pennies? Same life sentence of infections, pain, poor quality of life! ????????????????????????????????????????????????????

    • Jane Akre December 31, 2017 at 3:59 pm - Reply

      And you only receive half of the $5,000 if its even that. I’m sorry. What can be done? Caldera, as you know, never had enough insurance to cover losses. If you are in an auto accident and you are not adequately insured, I can go after you personally. In the case of corporations, the owners are protected from such things… but you are right, there must be something more you can do….

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