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Johnson & Johnson/Ethicon Transvaginal Mesh Implant
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Bellwether Case in Transvaginal Mesh Multidistrict Litigation Settled

Mar 13, 2015

Johnson & Johnson subsidiary Ethicon Inc. has settled a bellwether case in multidistrict litigation over transvaginal mesh injuries on the fifth day of the trial.

Matthew Johnson, a spokesman for Ethicon, said the company and the plaintiff had reached a settlement to resolve her case, but he did not provide any details of the settlement, Law360 reports.

In court documents, the woman alleged she suffered inflammation, chronic pain, and other complications because of the Ethicon transvaginal mesh device she had implanted. She had four subsequent surgeries to remove and revise the mesh, according to Law360.

Transvaginal mesh devices are used to treat pelvic organ prolapse and stress urinary incontinence. But tens of thousands of women have sued mesh makers over injuries and complications. These include mesh erosion through the vagina (also called exposure, extrusion, or protrusion), infections, pain, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. The case just settled is one in the seven MDLs involving transvaginal mesh overseen by U.S. District Judge Joseph R. Goodwin.

In recent months, pelvic mesh manufacturers have been hit with large awards over their mesh devices. A plaintiff was awarded $3.3 million in September in a suit over Ethicon’s TVT-O transvaginal sling. The jury found in her favor on all counts, including strict liability, design defect, failure to warn, and negligence, Law360 reports. Boston Scientific Corp. was hit with a $73 million verdict in September. A Texas state jury found the company’s Obtryx transvaginal sling was defectively designed and caused severe injuries. In January a West Virginia judge refused to dismantle a $2 million verdict against C.R. Bard Inc., though the company claimed there was insufficient evidence to justify the verdict. Just last week a California jury returned a $5.7 million verdict against Ethicon in a suit over the TVT-Abbrevo, a device for treating urinary incontinence.

Though the Food and Drug Administration (FDA) has rejected a call for a total ban on pelvic mesh devices, the agency is considering reclassifying pelvic mesh devices into Class III, the highest risk category. Devices in Class III are subjected to stricter regulatory control.

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