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Judge Orders ProteGen Documents in Vaginal Mesh MDL

December 7, 2012 — Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia is currently presiding over a litigation of unprecedented scale. Nearly 8,000 vaginal mesh lawsuits have been separated into four Multi-District Litigations (MDLs) against five manufacturers, and billions of dollars are on the line. Given the size of the litigation, it is moving along surprisingly quickly — Judge Goodwin has ordered expedient production of documents, taking little sympathy for the defense’s arguments of “burden.”

Judge Goodwin has ordered Boston Scientific to turn over documents related to the ProteGen vaginal sling. Evidence gathered from these documents will likely form a foundational argument — namely, that the manufacturers should have been aware of the risks associated with vaginal mesh.

The ProteGen was recalled in 1998, just two years after gaining approval from the FDA. The recall was issued because the ProteGen was linked to devastating complications — infection, erosion, chronic pain, difficult revision surgeries, and more.

Despite the known safety hazards associated with the ProteGen, just a few years later, several manufacutrers submitted 510(k) applications for new devices that were based on the ProteGen design. Under the 510(k) system, manufacturers of new devices can avoid conducting safety studies so long as their device is “substantially equivalent” to another approved device. Unsurprisingly, many of the new devices had the same devastating complications as the ProteGen.

Judge Goodwin has also ordered that American Medical Systems must turn over foreign documents. In the order, Judge Goodwin wrote:

“The human body’s reaction to implantation of pelvic repair products does not depend on the patient’s nationality, race or native language; adverse reports from France, India, South Africa, Brazil, or Australia are as relevant as those from the United States. Medical research on the efficacy of such products is relevant whether it is written in Greek or English.”

If the production of documents continues without delay, it is likely that lawyers will be ready to prepare their cases for trial before long. By the end of next year, more than 10,000 vaginal mesh lawsuits are expected to be filed.

Do I have a Vaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting vaginal mesh induced injury cases in all 50 states. If you or somebody you know has been injured by vaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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