Attorneys representing women who were permanently injured by transvaginal mesh (“TVM”) devices manufactured by Caldera Medical, Inc. have proposed a cash settlement fund of $11.75 million for more than 2,000 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.
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 on June 13 in Los Angeles. To obtain
any payments parties must join the settlement class and submit a claim form by May 2.
The case is Federal Insurance Company v. Caldera Medical, Inc., U.S.D.C., Central District of California Case No. 2:15- cv-00393. David Bricker of Waters Kraus & Paul of Los Angeles is the class counsel.
Note that this case is separate from several multidistrict litigation dockets in West Virginia federal court involving C. R. Bard, Inc., American Medical Systems, Inc., Boston Scientific Corp., Ethicon, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.
Plaintiffs allege Caldera knew or should have known that the TVM devices created an increased risk of serious personal injury, including mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia (pain during sexual intercourse), blood loss, neuropathic and other acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and, prolapse of organs.
Level of Injury
Payments will be based on the injury level:
- Level 1: Device only (no complication).
- Level 2: Documented complications related to a Caldera Transvaginal Mesh Product.
- Level 3: One revision or explant surgery under general anesthesia related to a Caldera Transvaginal Mesh Product.
- Level 4: Two revisions or explant surgeries under general anesthesia related to a Caldera Transvaginal Mesh Product.
- Level 5: Three or more revisions or explant surgeries under general anesthesia related to a Caldera Transvaginal Mesh Product.
More information is available at www.calderaclaims.com.
The $11.75 million being paid into the settlement fund represents virtually all of Caldera’s funds. The company claims that the only assets it has to pay Transvaginal Mesh Medical Product Claims are the proceeds of insurance policies issued by Federal Insurance Company. Caldera denies any wrongdoing.
The court will decide whether to approve the settlement and whether to certify the settlement class at final approval hearing on June 13.