Settlement Reportedly Reached in Thousands of Covidien Transvaginal Mesh Cases

A court filing made on Tuesday in West Virginia federal court indicates that Covidien has reached a settlement that may cover more than 11,000 transvaginal mesh cases involving claims that the devices caused injuries and complications for the recipients.

The court filing did not disclose the settlement amount or indicate the number of cases that would be resolved under the confidential agreement, Reuters reports. But as of June 1, Covidien mesh products are involved in about 11,300 filed and unfiled claims. The device maker Medtronic acquired Covidien last year for $42.9 billion in cash and stock. A recent Medtronic filing with the Securities and Exchange Commission (SEC) included the 11,300 estimate of Covidien transvaginal mesh cases. The filing also reports that two Covidien subsidiaries supplied mesh products to another medical-device manufacturer. Covidien is indemnifying that company in some of the cases it faces. But Covidien believes that company is responsible for indemnifying it for claims over the devices’ promotion and marketing. C.R. Bard has identified Covidien units as its suppliers for some mesh products. Bard believes Covidien is responsible for defending or indemnifying it in approximately half of the more than 14,000 claims it faces, according to Reuters.

The Food and Drug Administration (FDA) explains that transvaginal mesh devices are implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The devices provide support to weakened or damaged pelvic walls. But tens of thousands of women have sued device manufacturers over painful and sometimes permanent injuries and complications they have suffered after implantation of the devices. These include erosion of the mesh through the vagina (also called exposure, extrusion, or protrusion), pain, infections, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Many women have undergone additional surgery to remove the mesh or repair organ damage. In some instances, though, the mesh was embedded in the woman’s organs in a way that made complete removal impossible.

An estimated 100,000 lawsuits filed in state and federal courts against mesh device manufacturers allege that poor design, substandard materials, and inadequate testing led to the injuries and complications recipients suffered. A number of the cases were organized into seven multidistrict litigations (MDLs) overseen by U.S. District Judge Joseph R. Goodwin. Centralizing similar lawsuits before one judge makes pre-trial proceedings more efficient.

A 2011 FDA safety communication identified serious safety and effectiveness concerns with the devices and said complications linked to transvaginal mesh implants are “not rare.” The agency warned that in some cases transvaginal mesh devices may be more harmful than alternative methods for treating pelvic organ prolapse. The FDA is considering reclassifying transvaginal mesh devices from Class II (moderate risk) to Class III (high risk) and requiring manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

The Covidien settlement is not the first transvaginal mesh settlement. In 2014, Endo’s American Medical Systems set aside $1.6 billion to settle about 40,000 filed and unfiled claims, Reuters reports.

 

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