Court Approves $12.5M Caldera Transvaginal Mesh Settlement

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Caldera to Pay $12.5M to Settle 4,000 Pelvic Mesh Lawsuits

A California judge has approved a $12.5 million class action settlement to resolve 4,000 lawsuits filed over Caldera pelvic mesh implants. As with other injury claims filed over pelvic mesh, also known as transvaginal mesh, plaintiffs allege that the device is defective and caused complications such as pain, bleeding, infection, and the need for surgical removal. Transvaginal mesh implants are used to treat pelvic organ prolapse and stress urinary incontinence.

The transvaginal mesh lawyers at Parker Waichman LLP are well-versed in pelvic mesh litigation. The firm, which has decades of experience in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh lawsuit.

According to court records, Judge Stephen V. Wilson of the U.S. District Court for the Central District of California gave final approval for the settlement on Jan. 31, 2017. Judge Wilson noted that the medical device litigation against Caldera totals roughly $100 million. However, the company’s insurance policies only have $12.5 million remaining. Previously, he rejected the settlement because he was not certain of whether a limited fund settlement had been obtained under federal case law, court records state. He gave final approval for the settlement after Caldera hired an economist demonstrating that the company has no current income. The economist also said the company had a negative liquidation value, stating that these factors would not obtain more compensation for plaintiffs.

Caldera’s transvaginal mesh device is used to treat pelvic organ prolapse and stress urinary incontinence, two conditions that become more common among women who have given birth. Pelvic organ prolapse is when the organs of the pelvis fall, or prolapse, from their usual place and stress urinary incontinence is the involuntary release of urine during normal, everyday activities.

Pelvic mesh lawsuits against Caldera were centralized in Los Angeles. In addition to product liability lawsuits, Caldera also faced a lawsuit from its insurer, Federal Insurance Co. The insurance company requested a declaratory judgment and a settlement was negotiated.

Initially, insurance coverage totaled $35 million. Following defense costs, personal injury plaintiffs are left with only $12.5 million.

Transvaginal Mesh Lawsuit Background

Transvaginal mesh is designed to provide support to sagging pelvic organs and muscles. However, the devices have become controversial following thousands of personal injury lawsuits and safety concerns. Several different device makers, including Ethicon, Boston Scientific, Endo Pharmaceuticals, Coloplast, and C.R. Bard, have faced substantial pelvic mesh litigation. This has resulted in significant verdicts as well as settlements.

Pelvic mesh lawsuits have resulted in several transvaginal mesh multidistrict litigations (MDLs) in West Virginia before Judge Joseph Goodwin. These mass torts are created when there are a growing number of lawsuits with the same questions of fact; the goal is to make the litigation move along more quickly and efficiently.

Safety advocates and plaintiffs point out that transvaginal mesh implants were approved through 510(k). This fast-track approval process circumvents the need for clinical testing, as manufacturers are only required to prove that new products are “substantially equivalent” to a previously approved device. 510(k) is not intended for high-risk devices.

In 2016, the U.S. Food and Drug Administration (FDA) reclassified transvaginal mesh as “high-risk”, meaning they can no longer be approved through 510(k). Pelvic mesh implants must now be approved through premarket approval (PMA), a stricter process where device makers must submit clinical data showing their products are safe and effective before obtaining approval.

The FDA has issued warnings involving transvaginal mesh in the past, once in 2008 and again in 2011. In 2008, regulators initially said that complications associated with transvaginal mesh were serious, but rare. The most common injuries reported with pelvic mesh, the agency said, included:

• Mesh erosion
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse
• Incontinence

Additionally, there were also reports of bowel, bladder, and blood vessel perforation in some women.

The FDA released an update on pelvic mesh risks in 2011. The agency announced that, contrary to its previous communication, complications associated with transvaginal mesh are “not rare”. The FDA also said there is insufficient evidence to support the benefits of pelvic mesh in patients with pelvic organ prolapse compared to other non-mesh methods. The use of transvaginal mesh in these patients may present additional risks.

Filing a Transvaginal Mesh Lawsuit

If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).