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Women implanted with a Caldera Medical pelvic mesh product have until May 2, 2016 to submit a claim to a limited settlement that is being offered by the company. A cash settlement fund of $11.75 million is intended to settle thousands of defective product claims over the Caldera pelvic mesh products.
The settlement was just announced by The Settlement Alliance of Southlake, Texas which is the claims administrator. It was reached by the Federal Insurance (a subsidiary of Chubb Insurance Group here) interpleader and the Levin Simes law firm.
See it here.
Why the settlement for the Agoura Hills, California company?
Basically, Caldera Medical claims it is insolvent. At the same time, it admits it did nothing wrong in launching its brand of pelvic mesh.
“The claimants assert that Caldera manufactured, marketed, sold, and distributed TVM devices that it knew or should have known were hazardous and dangerous to patients who were implanted with them. Caldera denied and continues to deny that it did anything wrong. The principle reasons for the Class Settlement are to maximize the share of Caldera’s limited resources that are paid to claimants, and to eliminate the expense, uncertainty and risk of further litigation.”
“Attorneys for claimants have investigated the facts and applicable law regarding the Transvaginal Mesh Medical Product Claims against Caldera and Caldera’s defenses. The attorneys also have pursued extensive litigation, including litigation relating to the actions entitled In Re Transvaginal Mesh Litigation, Los Angeles Superior Court Case No.: JCCP 4733 (the “JCCP Action”) and Federal Insurance Company v. Caldera Medical, Inc., U.S.D.C., Central District of California Case No. 2:15-cv-00393 (the “Interpleader Action”). In connection with the Interpleader Action, representatives for the Settlement Class, Caldera, and Caldera’s insurance company, Federal Insurance Company, engaged in lengthy negotiations and mediation.”
Caldera says the $11.75 million fund represents “virtually all of Caldera’s funds." That comes to about $5,000 per claimant if there are an estimated 2,200 women implanted who have filed claims.
If you choose not to participate in the settlement you are forbidden from receiving any dollars or from even be a party to any lawsuit against Caldera in this case.
This is a Non-Opt Out settlement class, says the notice.
“You can tell the Court that you don’t agree with the Settlement or some part of it.”
The Court will hold a hearing, called the “Final Approval Hearing,” to decide whether to approve the Settlement and Class Counsel’s requests for fees and expenses. You may attend, but do not have to do so. You may be able to speak if you do not have an attorney. But you must request permission to speak at the Final Approval Hearing.
Signing the agreement releases Caldera from any future claims by the plaintiff or her estate. There is no admission of liability.
Caldera develops and markets surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) including the T-Sling®, Desara®, Ascend®, Hydrix®, POPmesh®, and Vertessa®.
Caldera is a manufacturer often linked as a co-defendant with American Medical Systems litigation over pelvic mesh. See case here.
Earlier this month, Caldera Medical announced it was partnering with IVUmed to:
“eradicate the incapacitation and suffering of women with Stress Urinary Incontinence (SUI) and pelvic organ prolapse (POP). The two companies will go into third would countries and make quality urological care available to people worldwide.”
In other words, it is exporting its mesh products to Vietnam, Rwanda, Senegal among other countries and train local doctors on the use of its mesh products.
IVUmed will coordinate the “humanitarian “ trips and train local surgeons in workshops using American doctors as preceptors/trainers. See the news release here.
Its Desara Sling (for SUI) is still on the market used for the treatment of SUI and Vertessa Lite (for POP) is used in abdominal sacrocolpopexy procedures to treat POP.
Caldera Medical launched the Desara SL, Mini and Blue at the American Urogynecologic Society meeting in October 2013. See press release here.
The Desara products can be placed with multiple approaches including transvaginally, suprapubic, and transobturator. #
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
