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Transvaginal mesh settlements in negotiation


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More than 54,000 federal transvaginal mesh lawsuits have been centralized before a single West Virginia court, and tens of thousands of additional cases have been filed in state courts nationwide. One of the manufacturers of the implanted medical device, which has been linked to excruciating internal injuries, has decided to settle.

Covidien LP has entered into a confidential settlement agreement with the transvaginal mesh victims “to resolve the claims related to the implantation of Covidien’s Pelvic Repair Products,” according to documents that the corporation filed June 23 at U.S. District Court for the Southern District of West Virginia, which has been the multidistrict litigation court managing thousands of similar federal lawsuits filed against seven mesh makers.

Covidien, which Medtronic acquired in January, did not disclose the number of settlements; nevertheless the corporation’s fiscal year report suggested that more than 11,000 cases may be settled. Covidien supplied mesh products to one of the principal defendants, C.R. Bard.

“Covidien currently is involved in litigation in various state and federal courts against manufacturers of pelvic mesh products alleging personal injuries resulting from the implantation of those products,” Covidien’s report reads. “Two subsidiaries of Covidien supplied pelvic mesh products to one of the manufacturers named in the litigation [Bard] and Covidien is indemnifying that manufacturer on certain claims. In addition, the Company believes that this manufacturer has an obligation to indemnify Covidien with respect to the promotion of the pelvic mesh products … Generally, complaints allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims. As of June 1, 2015, approximately 11,300 pending cases or claims were filed or estimated to be filed involving products manufactured by Covidien’s subsidiaries.”

There are about 11,000 federal transvaginal mesh lawsuits pending against Bard. As recently as April 1, that tally was about 14,500. And Bard expects Covidien to do right by Bard.

“With respect to approximately half of the filed and asserted Women’s Health Product Claims,” according to a Bard document filed with the U.S. Securities and Exchange Commission, “the company believes that two subsidiaries of Medtronic PLC (as successor in interest to Covidien PLC) (“Medtronic”), each a supplier of the company, have an obligation to defend and indemnify the company with respect to any product defect liability.”

Many transvaginal mesh victims cited in their lawsuits both the unreasonableness of the injury risk as well as the manufacturer’s omission of that risk.

For instance, as numerous mesh victims asserted in a lawsuit filed against Ethicon about three years ago at a federal court in Dallas, “Defendants omitted the risks, dangers, defects, and disadvantages of the Pelvic Mesh Products, and advertised, promoted, marketed, sold and distributed the Pelvic Mesh Products as safe medical devices when Defendants knew or should have known that the Pelvic Mesh Products were not safe for their intended purposes, and that the Pelvic Mesh Products would cause, and did cause, serious medical problems, and in some patients, including the female Plaintiffs identified herein, catastrophic injuries.”

Moreover, according to those plaintiffs, “Contrary to Defendants’ representations and marketing to the medical community and to the patients themselves, the Pelvic Mesh Products have high rates of failure, injury, and complications, fail to perform as intended, require frequent and often debilitating re-operations, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women, including the female Plaintiffs identified herein, making them defective under the law.”

The transvaginal mesh is made from a porous synthetic material. It is “permanently implanted to reinforce the weakened vaginal wall to repair pelvic organ prolapse [POP] or to support the urethra to treat urinary incontinence,” according to the FDA.

Scientific inquiry into the safety of and the injuries associated with the transvaginal mesh impelled the U.S. Food and Drug Administration to take a more aggressive approach. Strengthening its 2008 statements, the FDA issued a safety communication in July 2011 that read, in part, “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare [FDA’s boldface type, not ours]. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”

The agency cited the following transvaginal mesh complications: “…erosion through the vagina (also called exposure, extrusion or protrusion), pain, infection, bleeding, pain during sexual intercourse (dyspareunia), organ perforation, and urinary problems. There were also reports of recurrent prolapse, neuro-muscular problems, vaginal scarring/shrinkage, and emotional problems. Many of these complications require additional intervention, including medical or surgical treatment and hospitalization.”

Women are still coming forward and seeking compensation for their injuries.

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