Caldera Final Pelvic Mesh Settlement Deadline Facing Opposition

June 12, 2016
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, mediator

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.


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.


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.

US Patent 6638211, Coloplast

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.

US Patent6911003B2 Astora Women's Health

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 wounds 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.

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.


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.


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

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

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