January 15, 2016 — A class action racketeering lawsuit has accused Boston Scientific of illegally smuggling counterfeit resin for vaginal mesh out of China “like a drug deal,” attorneys allege.
Boston Scientific had approval from the FDA to use Marlex polypropylene resin in the Advantage Fix and Lynx vaginal mesh products. In 2005, the resin supplier stopped selling Marlex to Boston Scientific and warned that it should not be used in permanent implants because it was not compatible with human tissue.
The lawsuit alleges that Boston Scientific then “smuggle[d] 15 tons of the material from China without verifying or fully testing the contents,” MassDevice reports.
From June 2011 though the fall of 2012, Boston Scientific allegedly bought 34,000 pounds of polypropylene resin from a Chinese firm with counterfeit labels. The resin was split into five separate shipments and processed in Belgium and Ireland before final fabrication in the United States.
The primary goal of the lawsuit is to get an injunction that would stop sales of Boston Scientific’s vaginal mesh. It is also seeking class action status that could include thousands of women, attorneys said.
Plaintiff Teresa Stevens alleges that Boston Scientific “concocted a scheme” to deceive regulators and get counterfeit materials from China, according to CNN Money. The case was filed in West Virginia federal court, where more than 70,000 civil lawsuits have been consolidated against seven medical device manufacturers. About 30,000 of those cases are pending against Boston Scientific in state and federal court.
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