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Boston Scientific Transvaginal Mesh Implant
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New Rules for Evidence Collection in Transvaginal Mesh Lawsuits

Aug 29, 2014

The federal court overseeing the consolidated lawsuits involving allegations of injuries to women caused by implanted vaginal mesh devices manufactured by C.R. Bard, Inc. has issued a new order providing “a protocol for the collection, preservation, storage, and division” of materials produced in discovery.

In Evidence Protocol Order (Pretrial Order # 136), filed August 18, the multidistrict litigation (MDL) court overseeing mesh lawsuits against C.R. Bard (In re: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation; Case 2:10-md-02187, the U.S. District Court for the Southern District of West Virginia, Charleston Division), the court wrote: “Discovery in this proceeding may involve the collection, division, storage, preservation, and production of biomaterials evidence for which special handling, division, storage, and preservation would be warranted.” The parties to the MDL petitioned the court to enter an “evidence preservation protocol order,” which will apply to all current and future actions in the consolidated lawsuits.

The intent is “that all Material that has not previously been analyzed or tested . . .be preserved in a manner that permits the Parties equal access to and analysis of the Material,” the order states. The parties will not interfere with or circumvent the analysis and preservation of materials sent by any of the treating physicians. Once the pre-trial proceedings detailed in the order, have been completed, the cases will be transferred back to the appropriate federal district.

The lawsuits have arisen from the injuries and side effects many transvaginal mesh recipients attribute to the devices. These include mesh erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection bleeding, pain during sexual intercourse, organ perforation, and urinary problems. Lawsuits have been filed against mesh makers including C.R. Bard, Boston Scientific, and Ethicon (a division of Johnson & Johnson).

The Food and Drug Administration (FDA) recently rejected a call for a total ban on transvaginal mesh, but the agency issued a draft reclassification proposal that would move the devices to Class III, a more restricted category, with proposed premarket approval (PMA) requirements. By FDA definition, Class III devices are generally the highest risk devices and are therefore subject to the highest level of regulatory control.

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