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Caldera Final Pelvic Mesh Settlement Deadline Facing Opposition

Image, Linda Nylind for The Guardian

Image, Linda Nylind for The Guardian

Mesh News Desk, June 10, 2016 ~ Editor’s Note: We’ve called her “Samantha” and at the present time she, along with a few other women, are attempting to opt out of a mandated pelvic mesh settlement offered by mesh manufacturer, Caldera Medical.  

You may recall in February, Agoura Hills, California based – Caldera Medical, said it was insolvent, had about $25 million in insurance coverage to settle defective product claims by 2,184 Caldera mesh-injured women.  Take it or leave it, no opt-out.  See the story here. 

Half of that money has already gone to cover litigation costs between Caldera and its insurance carrier, Federal, a subsidiary of the giant Chubb Limited Insurance Company. See the complaint here.

 

Robert Kaplan

Robert Kaplan

It’s not surprising the money went so fast. For example, the mediator in the case, Robert Kaplan, charges $1,000 an hour, $10,000 a day.

 

“If litigation continues, the Policies will be swiftly exhausted, Caldera will be forced into bankruptcy, and most or all of the claimants will receive nothing,”  Caldera claims in the May 16, 2016, Joint Motion for Final Settlement and Approval of Class Certification.

 

The agreement, if signed by women injured with Caldera pelvic mesh, will provide the injured claimants with approximately $2,000 per individual. They will be required to sign a non-disclosure agreement and forever be forbidden from seeking any future damage claims against Caldera Medical.  Caldera will admit no fault.

When Caldera Medical announced it was insolvent earlier this year and had no cash on hand or liquid funds to contribute to a settlement, it laid out its plans for the future. The company will form a partnership with IVUMed to implant one million women in third world countries with its pelvic mesh.

The URL for the announcement indicates it has federal subsidy (Affordable Care Act) grant support.  See the link here.  See the story here.

Now a little over $11.75 million in insurance dollars is left for the injured women, which has now grown to 4,000 claimants in the last couple of months. Each woman will receive less than previously predicted.  

 

FINAL APPROVAL HEARING

On Monday, June 13, a District Court in Los Angeles will hold the “Final Approval Hearing,” to decide whether to approve the Settlement and Class Counsel’s requests for fees and expenses. Caldera claimants may attend, but do not have to. They may be able to speak if they do not have an attorney present but must request permission to speak at the hearing. (See the Los Angeles Court location at the bottom of this story).

So far, there are 47 objections filed.   Samantha is mentioned along with several other women.  She is filing her objections Pro Se, or without an attorney. Thirty-seven objections were filed by the law firm, Kline & Specter, of Philadelphia, and by the Mazie Slater law firm of New Jersey.  

Kline & Specter objects that claimants should be allowed to opt out “and have their day in Court.” (Never mind that “no opt-out” it is a violation of ones Seventh Amendment right to seek redress in a court of law.) Besides, some women, Samantha to name just one, were implanted outside of Caldera’s insurance coverage between 2008 to 2011.

Technically these women should be able to opt out of the final agreement, the law firm argues. Chubb says the coverage was retroactive.

Samantha filed an objection too. She was implanted with a Caldera T-sling 22 months before it was FDA approved for sale under the FDA’s 510(k) process, and years before there was any insurance coverage. In other words, it was not even on the radar of the FDA.  Because of that, she calls the procedure she underwent “experimental.”

Chubb, in reading Samantha’s objection, refers to it in the Joint Motion as a “misunderstanding.”

Samantha suggests that our daughters may be facing hysterectomy in the future, this is the darkest time in American urogynecologic history. This litigation is about more than a defective mesh fabric, it’s also about the implanting method and about female genital mutilation.  The health effects are similar – recurrent infections, difficulty urinating and passing menstrual flow, chronic pain, the development of cysts, an inability to get pregnant, complications during childbirth, and fatal bleeding..

Samantha has complained to Chubb that all mesh makers who colluded to share patents for the implant method are implicated and should share responsibility.

 

TRANSOBTURATOR SURGICAL MESH IMPLANT METHOD  – SHARING PATENTS

This is where it gets a bit complicated but it is a layer that has not been addressed so far. Until 1999, medical procedures could not be patented. But the method of placing  most transvaginal tape-obturator is patented and shared by TVT-O manufacturers. It is considered Intellectual Property. The Transobturator Surgical Mesh Implant Intellectual Property Medical Method, is how the TVT-O was brought to market, regardless of the company.

Samantha calls it a failed procedure which implicates all of the companies which Chubb insures because they have an interlocking patent history and all share financial gain from the method.

Here’s how it works.  First, Mentor infringed on Ethicon/Johnson & Johnson on their patent – US6638210. September 26, 2001.

Infringe means a manufacturer uses an invention that is owned by patent by another entity without obtaining permission.  The infringing party is liable to the owner of the patent for all profits made from the use of that invention.   They can enter into a licensing agreement to share profits. In December, 2008, J&J acquired Mentor for about $1.07 billion.

 

1. 211 drawing.png

US6638211 Patent

US6638211 Mar 5, 2002 Oct 28, 2003 became the patent for Mentor Corporation’s method for treating urinary incontinence in women and implantable device intended to correct urinary incontinence.

American Medical Systems (AMS)  infringed upon Mentor through their US6911003 March 3, 2003. On June 28, 2005, AMS Research Corporation Transobturator surgical articles and methods and Caldera Medical, Inc. infringed upon American Medical Systems, Inc.  Implants and procedures for treatment of pelvic floor disorders,  US 8480558 B2, created by Francois Blaudeau, Vice President of Caldera Medical, Sandra Muhlfeld, CEO of Caldera Medical, Inc. Bryon Merade and others.

US08480558-20130709-D00000.png

This is the patent Samantha fell under in April 2004, when she was implanted by one of the coinventors of the Caldera implant method who shared in its patent and profits. Women with hysterectomies, had no uterus and it is core element of the entire patent process to place the tape between the uterus and vagina. This is why in many women the device migrates and does not remain in place, due to placing in women with no uterus.

The internal obturator muscle, obturator internus muscle originates on the medial surface of the obturator membrane, the ischium near the membrane, and the rim of the pubis. It exits the pelvic cavity through the lesser sciatic foramen. The internal obturator is situated partly within the lesser pelvis, and partly at the back of the hip-joint.

There are eight incisions, entry and exit woulds which result in the Sciatic and pudendal internal damage, all from the patented implant method.  “This is how the harm occurs,” Samantha say and its profound and life-altering.Sciatic-nerve-and-piriformis-muscle-300x287.jpg

US06911003-20050628-D00000.png
US06911003-20050628-D00002.png

Patent US6911003 B2

 

Samantha writes in her recent claim to Chubb, “There really seems to be a blindness to Chubb, not believing that eventually this is going to grow into numerous claims for Chubb insured Transobturator Surgical Mesh Implant Intellectual Property Medical Method Harm. There are now women years after removal having  urethral  and rectal diverticulums due to the mesh migration, embedding and erosion. This IP Method is a multi party claim. The fraud, is Chubb knows their is more than one party they insure who are collectively at fault for this harm.”

The Chubb insurance policy says there could be upward of $5 million to $10 million per occurrence for damage from TVT-O products. However they contend all 4,000 claimants are one occurance.

She and the other women want an Emergency Motion to Stay Due to a Criminal Investigation,  which could include insurance fraud, human rights violations, experimental procedures, and Stark’s  Law violations where an implanting physician has an ownership of the product.

 

SO WHAT YOU CAN DO – A MOTION TO STAY

A Motion to Stay the Caldera Final Approval would allow time for the Attorneys General of both Washington State and California to conduct an investigation, civil and perhaps criminal, says Samantha.  

Recently, Attorneys General in both Washington State and California filed civil lawsuits against Johnson & Johnson for deceptive marketing of surgical mesh products. California AG Kamala Harris said other defendants may be added, who also deserve to be charged with consumer fraud. See the California complaint here. See the Washington State complaint here.  

 

Here is a letter suggested by Samantha. 

Dear Attorney General Kamala Harris and Attorney General Bob Ferguson:

I have had life altering injuries due to the Deceptive Marketing of Surgical Mesh Products of Caldera Medical, Inc.

AG Harris said she will be adding future defendants who also committed consumer fraud. J&J is the first medical device company. This is a request to make Caldera the second device company for people who are injured in the state. Boston Scientific, J&J, Caldera, Bard, Cook all brought the transobuturator surgical mesh to market.  All are implicated through their shared financial gains for these patents and should be added to the AG complaints.

Chubb insures all parties for these patents and they pretend these general, overlapping life science policies do not exist.  The first 8 incisions and the entire entry wounds which result in Sciatic and Pudendal Internal damage is all Intellectual Patent Medical Method harm, brought to market by these four major device manufacturers. The damage and harm is profound and life-altering.

They are also tied to Johnson and Johnson through the Deceptive Marketing of Transobturator Surgical Mesh Implant Method.  The US6638211 Patent ties Johnson, Mentor Worldwide L.L.C., Ethicon, American Medical Systems, Inc. and Caldera Medical, Inc. together as this Intellectual property of the first eight medical methods are necessary for all of these companies products to implant these devices.

Methods and devices for placing the implants do not minimize trauma to the pelvic floor and do not provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions. I have sexual harm and bodily harm. It is undeniable that Johnson and Johnson, Mentor Worldwide L.L.C., Ethicon, American Medical Systems, Inc. and Caldera Medical, Inc. are all responsible for the injuries suffered by Caldera Medical, Inc.’s victims.

Although I am writing from a different State (if applicable), you need to add Caldera Medical Inc to your lawsuit and investigation because of the injured women in California and Washington State.

The Transobturator Surgical Mesh Implant Intellectual Property Medical Method claims that the methods and devices for placing the implants minimize trauma to the pelvic floor and provide well-anchored support to pelvic organs without interfering with sexual or other bodily functions. I confirm they do not and cause sexual function harm and bodily function harm.

 

Signed,

Contact Information for Washington State AG, Bob Ferguson
Attorney General of Washington
Consumer Protection Division
800 Fifth Avenue, Suite 2000
Seattle, WA 98104-3188
(206) 464-7745
Contact Information for California AG, Kamala D. Harris
Attorney General of California
600 West Broadway, Suite 1800
San Diego, CA 92101
(619) 645-2001
Deputy AG Jinsook Ohta
jinsook.ohta@doj.ca.gov
FINAL APPROVAL MEETING,  Monday, June 13, 1:30 PM

U.S District Court, Central District of California
312 North Spring Street,
Courtroom 6
Los Angeles, CA 90012
before the Honorable Stephen V. Wilson 
Case No. 2:15-cv-00393-SVW-PJW
1:30 PM Pacific time

 

32 Comments

  1. Katharine says:

    I have had for surgeries for pain and to remove Caldera mesh

  2. Katharine says:

    Was wondering what happened today in court

  3. Toni says:

    This whole thing is such a mess. All of these companies need to be publicly exposed. There is a show called Vice that uncovers alot of subjects that are controversial maybe Jane can contact them and get this whole thing exposed for what it is. We have been duped into being human experiments for the pharma and FDA and government are allowing it to happen. Wish Hilary had mesh implant so she would expose them instead of taking money from the pharma giants . When will the truth be exposed mainstream buying our silence is not helping stop this madness .

  4. Mary Pat says:

    Any news on court decision?

    • Jane Akre says:

      The court has 90 days to decide on the Caldera final approval. We know that some of Samanthas objections were entered into the court record. Quite a few actually. Any of you who had your lawyers raise objections were entered in the proceedings as well.

  5. Karen says:

    I filed many objections… I know for sure one was heard…

  6. Melissa d says:

    I thought the case was over

    • Jane Akre says:

      Not yet….. lawyers are going for the final approval to the settlement but the dollars are so small it hardly seems worth it to many.

      • Melissa d says:

        Wow I heard different the judge already agreed on Monday to the settlement. The only people who aren’t receiving much are women with minimal injuries

  7. Kathy Mc says:

    I have mesh/bladder sling in2012 here I Pensacola FL 3 revisions Also I’m in such pain every day an night I urge all women I meet please don’t have this done I’m down to 100lbs also I’m now just waiting to die I’m so tired of the suffering

    • Still Standing says:

      Kathy, please make yourself eat. Mesh can actually interfere with the hunger messages that your brain
      interprets, creating a medically induced anorexia. You have to make yourself eat, not just calories, but calories that matter. Poor nutrition leads to poor muscle maintenance and muscle building, both integral to being able to get better. Muscle health also contributes to how our muscles relax and contract. Pelvic hypertonic muscles cause pain. It is all so interconnected. We should all try for about 60 grams of protein daily. That is a lot and I fall short many days, but it is a goal we should aim for. High protein found in eggs, lean meat, nuts, yogurt ( watch out for lots of added sugar), etc. Kathy, it is hard to be optimistic in the face of such pain, and there are days we dont want to live. There is a big difference in wanting to die and not wanting to live. A big difference. Please allow yourself to care for you…ease your suffering any way you can. Be self compassionate and take in what you need physically and emotionally. I truly care…we all care. You can fall into that safety net whenever you need to.

  8. Jan says:

    Kathy Mc
    I’m sorry to hear that you are suffering so much. Have you considered full removal of the mesh?
    The revisions seem to make things worst.

  9. Becky says:

    I refused to sigh their agreement.What is my next step……Besides the media and or every powerful women I can think of??? I have a letter already drafted….

  10. Rebecca L says:

    Does this mean that there will be funding set aside for Caldera implants that need to be removed once the State sues them?

    • Jane Akre says:

      Caldera claims it is insolvent….. the dollars offered are barely worth mentioning… coffee money. Unless they can find more money, that appears to be all thats offered.

  11. Ammie val says:

    You know what amazes me!!!! Really no one cares. The judge, lawyers, Dr’s and Caldera. They really don’t care. I’m the one in pain not them. I have Dr. bills from HELL. Not them. I read all the paperwork that was sent to me 4 months ago. There was more in that paperwork about how much the lawyers were getting than what people like us could get. The company that will look at ever ones case to decide how much to pay you is getting $500.000. This is a joke. I called my Lawyers office on 06/14/2016. I was told that the judge wanted to see if Caldera had any other assents that could be sold. WHO REALLY KNOWS!!!

    • Jane Akre says:

      You are offered $500 !????? Is that before or after legal fees? What is your next step….. do you need to get in contact with Samantha?

      https://www.meshmedicaldevicenewsdesk.com/caldera-final-appeal-deadline-facing-opposition/

      • Margret says:

        That doesn’t even sound right. No offense but the information about the case clearly stated women with little to no injuries will not receive much. I’m not siding with caldera but it was already stated plenty of times what women could potentially receive. Highly doubt majority of the women are getting 500.00 the case goes by tiers .

        • Jane Akre says:

          Caldera is different. It claims it is insolvent. Read the stories. Most women are getting from Caldera is a little over $2,000.

          • Margret says:

            Most of these stories don’t seem to make sense . Especially when the paperwork clearly stated if this was a regular class action then yes 2,000 dollars would be the amount everyone gets but it goes by tiers which are the injuries and surgery women have had because of calderas mesh devices so no everyone is not receiving 2000 dollars

          • Jane Akre says:

            Margaret- with all due respect. please read the numbers. They don’t lie. This is a settlement by a company that says it’s broke. It’s been spending $$ on lawyers and mediators with very little left for the women. Put Caldera in the search bar and read about it. …

          • Margret says:

            Not trying to be rude but once again the paper clearly states women with serious injuries or have had surgery will receive the most unless you know every woman who is involved in this case then I’ll gladly accept what you say but when actual court documents stated exactly what I have already stated I tend to believe court documents. Majority of the women dropped out majority of those women probably didn’t file complaints or have surgery so of course they won’t receive much this isn’t a regular class action everyone is not receiving 2000 dollars

          • Jane Akre says:

            I wish you luck with your Caldera claim. Please write back so others can learn if there is some loophole they too can make use of when it comes to Caldera…

      • Ammie va says:

        No, The company that will look at ever ones case to decide how much to pay you is getting $500.000. It is in the Legal documents. I will be lucky if I see $4000 from what the paperwork I got from my lawyer said. I have had 4 surgeries to repair. I just don’t understand any of this.

        • Margret says:

          The attorneys all together are getting only 670,020 plus the 500,000 is going in reserve for future cases against caldera. That’s not even a fraction of the whole amount left over . Highly doubt someone with four surgeries will only get 4000 that sounds silly. Especially when majority of the women dropped out those documents are from may it thoroughly went into detail how much those attorneys are getting which is once again 670,020 that’s it.

  12. Ammie va says:

    Problem is, Caldera has no money. The $11.5 million is for the lawyers and the clients. The Lawyers will walk away with more money than the clients. If you go to Caldera settlement you can read all the legal paperwork from the hearing which is the same paperwork that was sent to me. The big fight right now is how much to pay the lawyers( all 15 of them) They are going to get paid. It shows what they are asking for and it more then I will ever see.

  13. Ammie va says:

    The company that will look at ever ones case to decide how much to pay ARE getting $500.000. That is what they are charging for their services to the courts.

  14. Margret says:

    Did you have surgeries under general anesthesia? Or did you just have regular procedures done? If your attorney thought those counted they didn’t the real forms from caldera said you had to be under general anesthesia for that procedure to even count .

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