Judge Approves $12 Million Settlement in Caldera Transvaginal Mesh Claims

Jane Akre
January 31, 2017

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, 2016

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. ###

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