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Will Caldera Medical Ever Settle its Mesh Claims?

Mesh Medical Device News Desk, January 3, 2016 ~ Caldera Medical’s pelvic mesh cases are apparently nowhere near being settled, despite multiple tries. Is the company insolvent or not?  Meanwhile, the approximately 3,800 women, allegedly injured by the Caldera Medical pelvic mesh products, remain in limbo. 

Caldera Medical of Agoura Hills, California announced last February that it was insolvent and because it was broke, would offer a limited settlement to women who alleged its gynecological mesh products injured them. The amount came to about $3,000 per mesh-injured woman, more or less depending on the degree of injury.

By March 2016, Caldera proposed a $11.75 million settlement for then 2,000 women. Seethe published settlement notice here.

The final approval hearing was set in June of last year in Los Angeles before U.S. District Judge Stephen V. Wilson.

Caldera Medical, Aguora Hills, CA

Caldera claimed it did not have enough medical insurance to cover injuries. The initial insurance pool of $25 million was whittled down by legal fees to pay lawyers representing Federal Insurance Company and Caldera. The issue was whether or not Caldera had insurance coverage between 2008 and 2011 and how much coverage there was.

(See 2:15-cv-00393-SVP-PWJ Federal Insurance Company v. Caldera Medical, Inc. et al United States District Court Central District of California.)

So with a pool of $11.75 million remaining, for the 2,000 to 4,000 women involved, there would be no opting out. It would be a “take it or leave it” settlement. (This was always a separate matter from multidistrict litigation centered in West Virginia with nearly 100,000 cases amassed in one federal court.)

But here we are, one year later, and the Caldera Medical settlement has not happened.

What has happened is that some of the women have filed pro se protests to the proposed settlement. See Samantha’s story on Mesh News Desk here and here.

Women wanted evidence of the actual value of the company if it were liquidated.

Attorney Lee Balefsky (Kline Specter) said last June an independent audit was the only way to determine the actual value of Caldera Medical. Balefsky and Kline Specter represented 36 women implanted with Caldera medical mesh at the time.  Caldera argued it had already produced financial records.

Kline Specter objected to the final settlement approval again this last November citing that the liquidated value expert designated by Caldera was not an expert and had worked with company employees to issue his report. See Nov 7 2016 Kline Specter Objection to Settlement

Judge Wilson asked why was Caldera still in business if they were cash poor and only had a small amount of insurance to settle claims.

Good question.

 

CALDERA CASH POOR? 

When Caldera announced it was insolvent and had only half of the original $25 million remaining to settle defective product claims, Caldera announced it was partnering with IVUMed to “eradicate the incapacitation and suffering of women with stress urinary incontinence and pelvic organ prolapse.”

In a humanitarian-sounding gesture, the company said it had plans to implant one million women in third would countries and to train doctors on the use of its mesh products.  See Mesh News Desk coverage, Feb. 2016 here.

Mesh News Desk has asked the company for an update on the IVUMed partnership but no call was returned by publishing time.

In June 2015, the company launched Vertessa Lite- a polypropylene mesh designed to be lighter, stronger and with larger pores than previous models to treat pelvic organ prolapse.  See the Mesh News Desk story here.

And as further evidence of its solvency, last October, Caldera Medical paid thousands to be a sponsor of the American Urogynecologic Association (AUGS) annual conference where a company representative told your editor that the company was fully solvent.

Caldera products include in the settlement include the T-Sling, the Desara, Ascend, Hydrix, and the pelvic organ prolapse mesh, Vertessa.

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

 

CALDERA TANGLES WITH AMS, COLOPLAST 

Just last month, American Medical Systems (AMS) lost a bid to have Caldera’s insurance cover its losses in pelvic mesh litigation.  See it here. 

AMS said Caldera made use of its novel surgical instruments for treating incontinence, but the district court decided that Federal Insurance had no duty to defend AMS because it was not insured under the Caldera Medical Policy.   The U.S. Court of Appeals for the Ninth Circuit affirmed.

In another legal entanglement, this time with the Danish company, Coloplast, Coloplast charged Caldera medical infringed on three of its patents.  The evidence was the Vertessa Lite transvaginal pelvic mesh which infringed on three Coloplast patents, according to Coloplast, which demanded a jury trial last May.  See the filing here.

Bryon Merade
Chair & CEO
Caldera Medical

 

CALDERA’S CEO NEW VENTURES

Meanwhile Caldera CEO Bryon L. Merade appears to be venturing out into other holdings.

Merade is associated with four companies according to CorporationWiki (here) – Vidamed, Inc where he is listed as the President, Caldera Medical, also the President, Auslo Holdings, a member since 2016 and Xmed Holdings LLC where he has been a member since 2016.

 

 

LEARN MORE:

Here is Judge Stephen v Wilson’s court, 2:15-cv-00393
https://www.pacermonitor.com/public/case/6642477/Federal_Insurance_Company_v_Caldera_Medical,_Inc_et_al

Mesh News Desk coverage, Feb 2016
http://www.meshmedicaldevicenewsdesk.com/caldera-medical-take-11-5-mill-mesh-settlement-or-nothing/

13 Comments

  1. Patient Advocate says:

    Excellent article. All Caldera Medical, Inc. victims have a right to file for payment through the AMS MDL. I have opened a general liability insurance claim against AMS. Each woman should contact their law firms and ask that their attorneys file AMS short forms immediately for them. This is not over.

    • Jane Akre says:

      Patient Advocate means the tool used by Caldera is patented by AMS, therefore your injuries would also fall under their insurance coverage since it was all part of the same kit….if you are a Caldera mesh recipient and need help with this… let patient advocate know.

    • Lux says:

      Patient Advocate-
      Can you contact me via email?
      I really need help because my doc implanted at least 5 mesh implants without consent or disclosure. Hoping you might be able to guide me in the right direction.
      Thanks so much-

  2. Patient Advocate says:

    Every Caldera Medical, Inc. victim should email or call:

    AMS national settlement law firm of Reisman, Karron, Green, LLP.

    Lauren Wulfe
    Lauren.Wulfe@RKGAttorneys.com
    REISMAN KARRON GREENE LLP
    T 424.252.1033
    M 310.971.7577
    F 202.480.8169

    AND

    Jill Boon
    Sr. Litigation Examiner, Claims ACE Chubb

    P O Box 42065, Phoenix AZ 85027, USA
    O 202-822-3250 M 703-627-4438 F 623-445-2276
    E jboon@chubb.com

    ACE and Chubb are now one.

    Your message is this:

    Please reference first claimant file use same general liability number associated with this claim.

    Subject: RE: 040516015665

    Dear Ms. Boon:

    Thank you for assisting me with this claim. My claim is based upon
    Patent 6911003 B2 as is the claimant of RE: 040516015665
    CLAIMS(14)
    1. A method of treating incontinence in a female patient comprising the steps of:
    a. creating a vaginal incision and a pair of pelvic incisions, each of the pair of pelvic incisions substantially aligned with the patient’s obturator foramen on opposite lateral sides of the vaginal incision and wherein both pelvic incisions lie in a straight line approximately at the level of the patient’s clitoris;
    b. providing an elongate surgical instrument comprising first and second ends and an elongate implant for treating incontinence;
    c. passing one of the ends of the instrument between the vaginal incision, through one obturator foramen, and one of the pelvic incisions;
    d. associating the implant with the instrument;
    e. using the instrument to pass the implant through the tissue between the vaginal incision and the one pelvic incision such that the implant extends between the vaginal incision, through the one obturator foramen, and one of the pelvic incisions;
    f. subsequently passing one of the ends of the instrument between the vaginal incision, through the other obturator foramen, and the other pelvic incision; and
    g. using the instrument to extend the implant between the vaginal incision, through the other obturator foramen, to the other pelvic incision such that the implant then extends from one pelvic incision to the other pelvic incision, through both obturator foramen and between the patient’s urethra and vaginal wall.
    2. The method of claim 1 wherein the incisions are made with the patient placed in a modified lithotomy position.
    3. The method of claim 1 wherein both pelvic incisions lie in a straight line that is superior to the urethral meatus.
    4. The method of claim 1 wherein the instrument passes through an obturator foramen membrane adjacent to a medial region of the obturator foramen membrane inferior to a region of the patient’s obturator foramen containing vascular and nerve structures.
    5. The method of claim 1 wherein one end of the instrument passes through an obturator foramen membrane adjacent to the patient’s lateral margins of each ischiopubic ramus on a horizontal line level with the clitoris.
    6. The method of claim 1 wherein the ends of the instrument pass from the vaginal incision through each obturator foramen to each pelvic incision.
    7. The method of claim 1 wherein at least one end of the instrument passes from at least one of the pelvic incisions through one of the obturator foramen to the vaginal incision.
    8. The method of claim 1 wherein the implant provides support for the patient’s urethra.
    9. The method of claim 1 wherein at least one end of the instrument forms a curve.
    10. The method of claim 1 wherein at least one end of the instrument comprises an eyelet to associate the instrument with the implant.
    11. The method of claim 1 wherein at least one end of the instrument is associated with the implant using a connector.
    12. The method of claim 1 wherein the implant is a sling.
    13. The method of claim 1 wherein the implant is a polypropylene sling.
    14. The method of claim 1 wherein the implant is a knitted polypropylene sling.
    DESCRIPTION
    ********
    The helical introducer, inside-out introducer, hook introducer for the transobturator procedure are instruments whose use and IP method have injured me. I expect my claim to be paid within the tier settlement structure with other AMS claimants.

    Also, forward a copy of Jane’s article and this post to your attorney. We deserve to be paid.

  3. Patient Advocate says:

    If you do this, if we the 4000 do this we open 4000 new insurance claims against American Medical Systems. The game changes when we are one voice. Our claims become evidence to Judge Wilson, the limited funds include AMS paying Caldera Medical, Inc. victims.

  4. Patient Advocate says:

    I have had an insurance claim since March 2016. Now, we all will have one.

  5. Patient Advocate says:

    I will be providing MeshNewsDesk full details tomorrow of how I opened my claim.

    It begins with calling Chubbs claim center is 18002524670

    So, check for more information tomorrow so if you are a Caldera Medical / AMS victim you open your claim against AMS’s general liability policy. The policies being litigated are the life science policies of Caldera Medical Inc. I hope this is helpful.

  6. Patient Advocate says:

    If you need additional information:
    I respectfully request that if you or your attorney wish to file against the American Medical Systems general liability policy number associated with my injuries which are similar to yours that you post here and I will contact you.
    The policies cover the interlocking relationships between more than one party who has harmed Caldera Medical, Inc. victims.
    It has to be said, “Cadaveric studies have shown that the anatomical trajectory of the TVT-O tape is strictly perineal and courses away from neighboring obturator and pudendal neurovascular structures.” This is untrue, and it is the basis for complex medical device patent litigation and insurance fraud I contend has caused my harm.
    The placement of the device(s) are blind placements, and they no more can see the placement in a cadaveric placement than in a live patient. The PNE pudendal neuralgia is life altering; women have chronic pain, and many have had falls and injured hip and need a hip replacement. The general tenant is that one must attempt complete mesh removal of the device both vaginally and abdominally with the Da Vinci Robot to relieve PNE, but that just adds more scar tissue from the removal, it removes the toxic mesh, but it leaves additional pain. If pain persists that is consistent with pudendal neuralgia, there must be a diagnostic block (Botox is used) and then pudendal neurolysis (or decompression) if the nerve is found to be entrapped in surgery. The blocks have side effects.
    The policies I have located associate a broad intellectual property portfolio of both incontinence and prolapse technologies, injuries to myself and other patients to have more than one policy coverage. The cross-license restriction relates to the ability for the companies to protect the uniqueness of their products. Well, their uniqueness of products establishes the products liability list of thier products that have injured us. The horrific patents for the trans-obturator surgical treatment of female incontinence and prolapse have harm us.

    Today, the most important issue in mesh litigation is the loss of Honorable Judge Carol E. Higbee

    http://www.pressofatlanticcity.com/obituaries/higbee-carol-e/article_416488ba-276f-5534-b807-8e43364bb10b.html

    I will be adding no further information at this time. If you or your attorney would like general liability policy information please post here.

    • Chell says:

      I would absolutely love to speak with you. I had a caldera t-sling implanted in 2006 and it eroded into my urethra causing a fistula among several other complications. I have had several surgeries to remove the mesh and repair all the damage it caused. I have no luck in finding out anything about caldera from the law firm that is supposed to be representing me and I really need to speak to someone who can help me and provide me with some sort of answers as to what I can do.

  7. Disgusted says:

    This article literally makes me feel sick. What kind of person(s) can make the claims of bankruptcy, keep their business going, injuring thousands, and then go on business as usual. And where is the accountability? Is this not a fraudulent claim (bankrupt)? All mesh companies should have individuals who made decisions to set the green light on these products going to jail. Why is it that OJ Simpson could get a criminal trial and and a civil trial? Torts are exempted from this duality, how? I would like some answers on why there are no criminal charges. My life is gone. My new friends lives are gone. We know suffering. For those in the profitable industries life goes on as usual. Each one should have to see exactly the harm they have created. I can’t believe that all those employed by the pharmaceutical companies are evil and corrupt. I believe there are some who would stand up, if they knew. If not, then it’s worse than I think it is. Thank you Jane!

  8. Patient Advocate says:

    Mesh Pain and Complications are now in the textbooks – Caldera Medical and AMS

    Why? Why is there not a national settlement fund for all victims? If you have an implant, you should simply be paid. This is prolonged suffering for the enrichment of the legal and medical systems, this is stunning section in this national textbook:

    https://books.google.com/books?id=dIYVK2CyXLgC&pg=PA90&lpg=PA90&dq=ams+and+caldera+medical&source=bl&ots=p3V_vO7q1h&sig=8sKUUImHFd1h_L1iC6-5o3XJDMM&hl=en&sa=X&ved=0ahUKEwiIvrG60L7RAhVl54MKHePKA3U4KBDoAQggMAI#v=onepage&q=ams%20and%20caldera%20medical&f=false

    I am the first T-sling implant patient. Cannot get an attorney to fight for me. I fight for myself. Here it is in the textbook that the T-Sling, recalled and the specific harm. How does this insanity ever end? Found tonight.

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