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Caldera's Transvaginal Mesh and $12.5 Million Settlement

Mar 9, 2017
Caldera's Transvaginal Mesh and $12.5 Million Settlement

A $12.5 million settlement to be shared by approximately 4,000 plaintiffs has been approved by United States District Judge Stephen V. Wilson of the U.S. District Court for the Central District of California. The plaintiffs had brought lawsuits over Caldera Medical Inc.'s allegedly defective transvaginal pelvic mesh.

The settlement amount is seen as minimal. The $620,020 in fees recovered by plaintiff attorneys is less than six percent of the settlement fund and is the result of the availability of Caldera's insurance policies.

Caldera's Financial Status

The medical device litigation is estimated at $100 million, but only $12.5 million is left from the company's insurance policies, according to the judge. The judge had initially rejected the settlement as he was not convinced that a limited fund settlement had been confirmed under federal case law. The judge said an economist hired by Caldera showed the firm has no current income and has a negative liquidation value that would not afford more money for the plaintiffs.

Dr. Joseph Tanimura Ph.D., J.D. is an expert who upon request of the parties involved, conducted a liquidation analysis and found that liquidation of Caldera would not raise additional funds. Caldera's current labilities totaled $3.6 million and the book value of its assets was $2.9 million. Most of that would sell for significantly less in the case of a forced liquidation. Dr. Tanimura ascertained that a liquidation of Caldera would produce a value of negative $3 million. The California federal judge granted final approval to a compulsory class settlement to provide $12.5 million for pro rata (in proportion) awards to some 4,000 claimants.

Initially Caldera had $20 million in coverage, but after paying for its defense costs, only $12.5 was remaining. One million dollars will be held to cover the costs of the class notice and settlement application.

Purpose of the Transvaginal Mesh Device

Caldera Medical manufactured transvaginal mesh devices. The medical device, also known as pelvic mesh, is surgically implanted in women to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Lawsuits were brought against Caldera by plaintiffs over allegations that the transvaginal mesh devices caused them infection, bleeding, severe pain, erosion of internal bodily tissue, dyspareunia (difficult or painful sexual intercourse), painful scarring, as well as other injuries. Plaintiffs also maintained that these adverse reactions required surgical removal of the device.

Transvaginal mesh devices made by Caldera are known by the trade names T-Sling, Desara, Ascend, Hydrix, POPmesh, and Vertessa. The lawsuits against Caldera were centralized in the California Superior, Los Angeles County Court. The national personal injury law firm Parker Waichman LLP has extensive experience in medical device litigation. Attorneys at the firm are available to answer any questions about filing a transvaginal mesh lawsuit.

Transvaginal Mesh Warnings Issued by FDA

Transvaginal Mesh Warnings Issued by FDA

The U.S. Food and Drug Administration (FDA) issued warnings about transvaginal mesh implants in 2008 and 2011. In 2011, the federal agency changed its prior notice to indicate that complications linked to transvaginal mesh were "not rare," and indicated that transvaginal mesh does not seem to have any clear benefits for patients diagnosed with POP when compared to non-mesh methods.

The FDA indicated the most common injuries reported due to use of the transvaginal mesh are: infection, incontinence, pain, mesh erosion, recurrence of prolapse, and urinary problems. Women also reported injuries including perforation of the bowels, bladder, and blood vessels connected to the implantation of transvaginal mesh devices.

Over time, the transvaginal mesh has failed in a number of ways, often eroding through the vaginal wall or skin. This has caused incredible amounts of pain and alters women's lives who suffer from a malfunctioning transvaginal mesh. Women have described their pain including an inability to sit, stand, or lay in a position for more than a few minutes at a time.

A number of plaintiffs noted that the transvaginal mesh devices had been approved through the FDA's 510(k) fast-track process. The 510(k) allows device manufacturers to bring devices to market without the normal, stringent clinical testing for safety and efficacy. The new device has only to show that it is "substantially equivalent" to a previously FDA approved medical device, even if that product has been voluntarily recalled.

The FDA handled these concerns by reclassifying transvaginal mesh from a moderate-risk device to a high-risk device. This means that transvaginal mesh device manufacturers have to go through the FDA's more rigorous pre-market approval process and submit data proving their devices are safe and effective.

Advice and Information for Transvaginal Mesh Recipients

If you or someone you know suffered injuries regarding the use of transvaginal mesh implants, you may have valuable legal rights. The transvaginal mesh attorneys at Parker Waichman offer free, no-obligation case evaluations. We urge you to contact at 1-800-YOURLAWYER (1-800-968-7529).


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