Image, Linda Nylind for The Guardian

Image, Linda Nylind for The Guardian

Mesh Medical Device News Desk, April 20, 2016~ Twelve years ago today a grandmother was implanted with a Caldera Medical pelvic mesh used to treat incontinence, which she says she didn’t have.

Today she is urging a quiet revolution that threatens to implode the $11.7 million settlement the privately-held company has offered to get out of the domestic pelvic mesh business and end contentious mesh litigation with a looming April 25 deadline to object.

They entered our marriage, they mutilated my beloved wife. They never gave us a choice. I will never make love to her again. I watch her fade. I listen at night to her cry.  If this was the mutilation of American Men, the nation would be outraged.  Where are the leaders who can help us? 

They are all greedy, evil bastards who invented these devices and implanted so many helpless women. They are responsible for the slow death of my wife. ~ Husband of transvaginal mesh-injured woman

 

On October 14,  2003, Caldera Medical Inc. of Agoura Hills, California began introducing its product line of mesh to treat incontinence and pelvic organ prolapse in women.  Six months later, “Samantha” became one of its first recipients.building

Without knowing it, she was implanted with the T-Sling, a polypropylene mesh that did not yet have Food and Drug Administration (FDA) approval. She was implanted by a co-inventor of the implantation of the T-Sling mesh procedure, which he never disclosed.

It would be another 22 months before the T-Sling was approved for sale under the FDA’s 510(k) approval process.

Mesh News Desk’s editor knows “Samantha” (not her real name) who is represented and was advised not to go public at this time.

The Settlement

In February, the news hit Samantha hard. Caldera Medical announced an $11.75 million settlement for 2,100 women who had received Caldera pelvic mesh products. There would be no opt-out, no other options. Caldera said the $11.75 represents “virtually all of Caldera’s funds” which was whittled down from a $25 million insurance coverage provided by Federal Insurance Company, a subsidiary of the Chubb Group of Insurance Companies.caldera logo

Litigation between Federal and Caldera over the company’s remaining assets and coverage show the insurance coverage policy covered four years only from 2008 to 2012. See the document here.

Plaintiffs allege Caldera knew or should have known that its pelvic mesh products caused mesh erosion, infection, mesh contraction, scar tissue, dyspareunia, chronic pain and nerve damage, among other injuries.

Caldera denies any wrongdoing.

The company told women in a press release, take it or leave it. The average settlement would amount to roughly $5,000 per woman. The claimant release form would ensure confidentiality about the settlement.  If you opt-out you will not be able to sue Caldera.

Image from foreclosure fraud

Image from foreclosure fraud

Just Say No 

Samantha didn’t hesitate in saying no, partially because she was implanted in years before the insurance coverage claims to have been in effect. How could her claim be buried in with other policy years covered by Federal/Chubb Insurance?

Bringing her in with the other Caldera women would only lower the dollars available for everyone, she reasoned. Samantha suspected insurance fraud.

Introducers, Caldera

Introducers, Caldera

No American company can offer a settlement to women when it only had four years of insurance, not 14 years during which time the mesh was sold.  I believe there is a complex set of general liability policies that are accessible in additional litigation and the class action fails to produce discovery for all resources that could be available to Caldera victims,” she says.

Samantha learned those general liability policies would extend to the co-inventors of the Caldera mesh devices. They enjoy the shield of insurance, which protects their intellectual property – the creation of the mesh kit, the trocars, introducers, and the implantation method directions. None of that insurance was being tapped. There were at least four companies that shared the royalties for these tools and directions covered by at least 11 different patents so it stood to reason they should also share responsibility to women who were injured by those tools and implant directions.

Samantha followed the money trail. Many companies are affiliated. She found just last year, for example, American Medical Systems asked Caldera’s insurer to cover its litigation costs because Caldera medical pelvic mesh products were manufactured under a licensing agreement with AMS.   See the link here.   Samantha found intellectual property patent law specifically lists the inventor as having liability, therefore insurance coverage.

Samantha is now stirring the pot connecting with other Caldera implanted women on social media with this additional information.

They include:

  • One Caldera woman has been implanted with the T-Sling and is inoperable. The mesh sling is embedded in an SI joint and causes her mesh-related back and hip injuries, chronic infections and a general collapse of her health. An inventing physician caused her harm and she contends she was a human experiment and the inventors and at least three additional manufacturers should be held accountable for Caldera Medical victims.

  • A woman on the west coast, also implanted by an inventing physician, has had care both in the U.S. and Mexico. She and her husband have spent over a $100,000 plus her insurance on her care and she’s been told the mesh cannot be removed. Her life-altering injuries are numerous and she too believes the physician who implanted her should be held accountable because she was never told he was benefiting financially from his device he was putting in her body.

  • A 39-year-old woman has life-altering injuries, multiple surgeries, and is now facing mesh migrating into her colon. She is seeking a second opinion, not necessarily another surgery which has been suggested. This woman was also implanted by a co-inventor, without her knowledge of his conflict of interest.

  • A woman in Kentucky still is suffering after partial mesh removal and she has infections and cannot wear her pacemaker because of the chronic infections. She has had to downsize her home to endure the cost of this catastrophic health injury she says was caused by Caldera Medical, Inc. and those who inventing their devices and shared research.

  • Another woman, a 31-year-old mother, has had over 20 surgeries and she cannot void. Instead she must self-catheterize. She says she is destroyed physically and emotionally. Her father is an attorney and he is leading the fight for her justice. She says she has hope as she has been directed to leaders both in the healthcare field and legal field to gather their resources to help her gain a better quality of life and her justice.

 

She found many of Caldera’s implanted women are from the South and had no idea their implanting surgeon was also a co-inventor of the procedure who has separate insurance and legal responsibility to a patient.

patent co inventors

See the co-inventors listed in the patent for Caldera “Implants and procedures for treatment of pelvic floor disorders, July 2013,here.

“He saw me as sick, poor, he signed me up for Medicaid, then cancelled it. I never got any follow-up care,” says Samantha.   cm logo

Samantha believes there is now a way to help the more than 2,100 Caldera victims and she is encouraging women to object on the grounds there is additional insurance coverage that is being left on the table.

She and others plan to opt-out of the Caldera settlement and ask their cases be returned to Judge Joseph Goodwin, who is overseeing the federal pelvic mesh litigation, and allow him to remand all cases back to state courts.

 

“Until this litigation is fully fleshed out, and the person who has to be convinced of this is Judge Goodwin, monies will be left behind. We need Judge Goodwin to assign a special master for all manufacturers to pull all resources.  I really feel confident I’ve built the framework for insurance fraud for having constituted my own claim numbers.  If today you were hit by a car, they all partake in the injury, why would we accept an auto accident attorney who would let three cars walk away?

“I share this information so other women may have a better option to object. Print this article out and tell their attorney they are objecting because there are too many questions about other financial compensation. The policies in question in 2008 to 2012 are included in this document. “~Samantha

 

For those who do take the Caldera settlement, if they also receive government benefits, they may lose those benefits or have them reduced as a result of the additional income. Forming a Medical Needs Trust is the only way to accept monies and make them immune to a reduction in Social Security Disability or Medicaid dollars.

Meanwhile, Caldera, while claiming it is insolvent, announced plans in February to partner with IVUMed to implant one million third-world women with its pelvic mesh over the next ten years.

Background 

A cash settlement of $11.75 million has been proposed for those permanently injured by transvaginal mesh (“TVM”) devices manufactured by Caldera Medical, Inc. which includes at least 2,184 product liability claims.

The claims involve TVM marketed under the trade names T-Sling, Desara, Ascend, Hydrix, POPmesh and Vertessa. Manufacturers include Caldera, Biomedical Structures, Encision, Coloplast (on its own behalf and as successor in interest to Mpathy), Parker Hannifin and J-PAC LLC .

Allegations against Caldera include negligence, failure to warn of the defects of its TVM devices, the defective design of its TVM devices, breach of express warranties, deceit by concealment, negligent misrepresentation, fraud, and loss of consortium, among other charges.

Desara mesh, Caldera

Desara mesh, Caldera

Filing Deadlines

Women face an April 25, 2016 deadline to object to the settlement. Attorneys for injured women who have not joined the class action must file a request to appear by April 26, 2016 to participate in the final approval hearing which is scheduled before US District Judge Stephen V. Wilson for a final hearing on June 13 in Los Angeles where individuals can ask to speak in court about the fairness of the settlement.

Claim forms must be submitted by May 2, 2016.

Disallowing one’s access to a trial by jury appears to be a violation of one’s Seventh Amendment rights to federal trial.

The Caldera case is not involved in multidistrict litigation  in West Virginia federal court which involve mesh makers C. R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic. Link here.

In summary Samantha strongly urges women learn of their rights.

Pen drawing, Wellcome Trust, WikiCommons

Pen drawing, Wellcome Trust, WikiCommons

“The limited settlement chosen so far is an insult and victims and their families expect more. Every avenue to recover funds will be investigated. Women are brave and their families are braver.

We will not allow our daughters and granddaughters to be implant victims in the 21st century because these companies survive an anemic MDL process and we are left with nothing.”

 

 

LEARN MORE:

Federal Insurance v. Caldera Medical, U.S.D.C., Central District of California Case No. 2:15- cv-00393.
https://www.unitedstatescourts.org/federal/cacd/608750/1-0.html 

AMS and Caldera licensing agreement in Order Denying Transfer, August 7, 2015
http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2325-Order_Denying_Transfer-07-15.pdf


Notice of Proposed Class Action Settlement
http://settlement-alliance.com/assets/Claims-Notice-Counsel_CALDERA.pdf
 

More information is available at www.calderaclaims.com. 

Mesh Medical Device News Desk, February 22, 2016, Caldera Medical – Take $11.7 Mill Mesh Settlement or Nothing!
https://www.meshmedicaldevicenewsdesk.com/caldera-medical-take-11-5-mill-mesh-settlement-or-nothing/

IVUmed
http://www.ivumed.org/

Caldera – Launch of the Desara, August 2013
http://www.businesswire.com/news/home/20131015006880/en/Caldera-Medical-Introduce-Products-American-Urogynecologic-Society#.VZGZ8flVhBc

Mesh News Desk, Caldera Medical among 33 mesh manufacturers to follow-up on complications. See story here:
http://meshmedicaldevicenewsdesk.com/mesh-makers-who-received-fda-letter-requiring-follow-up-tests

Chubb Insurance Group
http://www.chubb.com/businesses/cci/chubb15596.html