Judge Orders ProteGen Documents in Vaginal Mesh MDL

December 7, 2012 — The production of documents in the vaginal mesh litigation is moving along at a rapid pace, which is surprising given its size. It is unprecedented for such a large litigation to be centralized in one federal court before one federal judge — Judge Joseph Goodwin is overseeing nearly 8,000 vaginal mesh lawsuits split into four Multi-District Litigations (MDL), involving 5 manufacturers and billions of dollars in damages.

Two weeks ago, Judge Goodwin ordered Boston Scientific to release documents related to the ProteGen sling, one of the original hernia meshes to be used in the repair of Stress Urinary Incontinence (SUI). The ProteGen was approved in 1996, but it was recalled two years later, after it was linked to devastating complications.

After the ProteGen was recalled for safety concerns, several manufacturers submitted 510(k) approval applications for new vaginal mesh designs that were “substantially equivalent” to the ProteGen. Under the 510(k) system, manufacturers of similar devices do not need to conduct new safety studies. The FDA approved these devices because Boston Scientific voluntarily recalled the ProteGen. The new vaginal meshes had many of the same safety problems as the ProteGen.

Judge Goodwin has also ordered American Medical Systems (manufacturer of the Elevate, Perigree, Apogee, and other vaginal meshes) to turn over foreign documents. In the order, he 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 court continues to issue orders pressing manufacturers to turn over documents, it is possible that the first trial dates will be scheduled soon. It is expected that more than 10,000 vaginal mesh lawsuits will be filed by the end of next year.

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