Boston Scientific was accused of racketeering in a federal court in January, 2016. The complaint filed by Teresa L. Stevens, accused the company of smuggling counterfeit, adulterated polypropylene resin from China and using it in place of the approved Marlex polypropylene.
According to Boston Scientific, approximately 55,000 women are implanted annually with the Marlex HGX-303-1 pelvic mesh implant. The Stevens lawsuit claims that Boston Scientific began running out of the mesh because Philips Sumika Polypropylene Company of LaPorte, Texas, discontinued sales of the product. The Stevens’ Complaint claims that Boston Scientific was “acting like a drug dealer,” smuggling the counterfeit polypropylene from China into Belgium, and finally, into the United States, from June 2011 to the end of 2012. The Plaintiff’s claims were made under racketeering laws established to convict the mafia, Racketeer Influenced and Corrupt Organizations Act (RICO), among others.
JUDGE DEFERS COUNTER MESH ISSUE TO FDA
Judge Joseph Goodwin, the West Virginia Judge overseeing tens of thousands of mesh cases in the Federal multidistrict court, deferred to the FDA, stating that it was in a better position to determine whether the mesh device was in compliance with the FDA’s standards. The issue of the counterfeit mesh will be on hold until no later than May 1, 2016, at which time the FDA and the plaintiff’s attorney must file an updated status report.
FAILED FDA 510 (K) PROCESS
This case is indicative of the lengths that today’s drug and medical device manufacturers and distributors will go to make profits. The FDA is failing in its duty to maintain the safety of the American public. The 510(k) approval process is the loophole through which companies slip unsafe products. Our law firm is dedicated to making these companies accountable for their actions. Please call us if you have any questions about this or any other medical device or drug topic at (800) 748-7115.