Judge Joseph R. Goodwin, who is presiding over the vaginal mesh MDL that is currently taking place in the U.S. District Court for the Southern District of West Virginia, has ordered that Boston Scientific turn over documents that are related to the ProteGen vaginal sling.
The West Virginia MDL is currently existing at an unprecedented level in that it consists of nearly 8,000 lawsuits filed over vaginal mesh complications. In fact, the lawsuit is so large that it has been separated into four Multi-District Litigations that include five different manufacturers. And considering how large the MDL is, it is moving along very fast. Now that Judge Goodwin has ordered one of the defendants, Boston Scientific, to turn over documents that are related to the ProteGen vaginal sling, it is showing that Goodwin isn’t going to let this MDL drag on unnecessarily. These documents should help plaintiffs to prove that the manufacturers of vaginal mesh devices knew or should have known how dangerous their products are.
There are several other defendants named in the West Virginia MDL, which include American Medical Systems, Coloplast, Johnson & Johnson’s Ethicon and C.R. Bard. Even while the ProteGen device was proven dangerous, the other manufacturers of similar devices that were based on the ProteGen device’s design sought approval with the FDA under the agency’s 510(k) system. The 510(k) system allows for new devices that are based on similar ones to be granted approval without even conducting safety trials first. The thought process here is that if the devices are basically the same, then previous clinical trials for the original device will stand up. The problem with the FDA’s logic is that all of the devices are subject to the same complications and side effects as well.
While Judge Goodwin has ordered the domestic ProteGen documents from Boston Scientific, he is also ordering the production of foreign documents as well. In his order, 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.”