Will Caldera Medical Ever Settle its Mesh Claims?

Jane Akre
January 4, 2017

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. See the 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.


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 world 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.”


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


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.


Here is Judge Stephen v Wilson’s court, 2:15-cv-00393

Mesh News Desk coverage, Feb 2016

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