Mesh News Desk, January 15, 2016 ~ This week the Mostyn law firm of Houston filed a federal racketeering lawsuit against Boston Scientific, the transvaginal mesh manufacturer already the focus of thousands of pelvic mesh actions in federal court in West Virginia.
The charge – Boston Scientific (BSX) knowingly smuggled and used counterfeit material from China to make vaginal mesh implants.
According to the complaint, BSX was involved in a “scheme” to defraud regulators in both China and the U.S. The Massachusetts-based company could face criminal charges if the allegations are proven.
Reportedly when the BSX supplier of polypropylene resin used to make pelvic mesh, Chevron Phillips, stopped selling it to the company, it turned to China, smuggling into the U.S. 15 tons without verifying its contents.
The complaint says the resin the company purchased was unverified, substandard material from a known counterfeiter and the company “acted like a drug dealer” to hide overseas shipments from regulators in both China and the U.S. This reportedly occurred between June 2011 and the fall of 2012.
Amber Mostyn of the law firm says their goal is to try and stop the sale of transvaginal mesh implants made by Boston Scientific. They are seeking class action status. Mostyn told CNN Money BSX could still be using the counterfeit resin to make mesh implants.
Boston Scientfic issued a statement to MND saying, “At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products. We don’t believe the case has merit and intend to vigorously defend these claims.”
The RICO action was filed in District Court in the Southern District of West Virginia before Judge Joseph Goodwin. The RICO (Racketeering and Corrupt Organizations Act) suit was filed as a class action on behalf of women who have been harmed by the Boston Scientific mesh. Lead plaintiff, Teresa Stevens is from West Virginia and the firm is seeking others to add to the action.
Stevens was reportedly implanted in 2014 with Chinese grade Marlex mesh – the Obtryx-Halo Urethral Sling System. The case is Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia (Charleston).
Chinese supplier, EMAI Plastics Raw Materials Inc. is also named in the action. The company is reported to be a “known counterfeiter of plastic products,” based in Guangzhou, China.
The emails that led to this discovery are under court seal unless Judge Goodwin orders them released. BSX subsidiaries, Proxy Biomedical Limited of Galway, Ireland and Luxilon Industries NV of Belgium are also named in the action as participants in the fraud.
The Chinese grade Marlex mesh, the proprietary name for the company’s mesh product, is reported to be inferior to mesh made in the U.S. The counterfeit mesh resin was said to have been divided into 500 bags and shipped in three different small shipments to evade customs agents.
Though discovery has occurred between the seven defendant companies and plaintiffs who have filed 100,000 defective product lawsuits over pelvic mesh, this action is ground breaking because it is the first to accuse a manufacturer of engaging in an international conspiracy.
“We have asked for the court to shut down sales from this company and to protect women from the pain and suffering that can result from this dangerous product,” said attorney Amber Mostyn. She said Boston Scientific put profits ahead of health concerns, calling the company’s disrespect for women “disgusting and appalling.”
Boston Scientific is currently facing 19,767 lawsuits filed before Judge Goodwin in federal multidistrict litigation convened in Charleston, WV. #
Read the Complaint
Mostyn news release
Mass Device, January 15, 2016“