MND, Feb 16, 2016 ~ In a move reminiscent of the document destruction by Johnson & Johnson, a Texas state district judge has ordered Boston Scientific Co. not to destroy any documents or materials pertaining to the Chinese mesh the company smuggled from China.
Harris Co. District Court Judge Jaclanel McFarland ordered the company not to dispose of or alter any supplies of polypropylene (PP) resin sitting in an Indiana warehouse that allegedly was smuggled in from China without any regulatory oversight.
Boston Scientific (BSX) turned to an unknown Chinese supplier after its source of U.S. – made PP known as Marlex, refused to supply BSX with the raw resin. Supplier, Chevron Phillips, had learned the resin was to be used for mesh medical devices that would be permanently implanted in the human body, in violation of its own direction that specify the resin was NOT to be used for implantable medical devices.
Chevron and Phillips Sumika of LaPorte, Texas (which has since moved to Saudi Arabia) manufactured Marlex HGX-030-01, the specific polypropylene, which is the basis for FDA clearance of the BSX product. Any new formulation requires the company to reapply to the FDA for clearance to sell its medical device.
Mostyn Law of Houston filed a federal racketeering lawsuit last month accusing the company of conspiring with a Chinese supplier to import 34,000 pounds of a counterfeit Marlex which “contains high levels of toxic selenium,” says the law firm in a news release. “And if Boston Scientific won’t do the right thing, the FDA should make them do it without delay,” says Amber Mostyn.
Included in the order is the destruction of any of the following- shipping orders, customs forms, and communications with suppliers.
The federal lawsuit filed by Mostyn law is the first to invoke the Racketeering and Corrupt Organizations Act (RICO), which is traditionally used in organized criminal activity.
The case is styled Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia.
It echoes the order placed and violated by Johnson & Johnson which was found to have destroy hundreds of thousands of pages of documents pertaining to transvaginal mesh that were under a litigation hold. Besides a reprimand from the court, Magistrate Cheryl Eifert, there has been no sanctions against J&J. See background story from Mesh News Desk here and here.
The firm hopes to turn the RICO action into a class action on behalf of those women implanted with the counterfeit made resin.
With Boston Scientific using about 3,000 to 4,000 pounds of resin a year, Steve Mostyn believes that leaves thousands of pounds sitting in a warehouse.
“Who knows how it’s stored. They transported it in brown paper sacks. I don’t know if the warehouse is climate controlled, rodent or insect controlled. If the shelf life of Marlex is ten years there is no way to assume when it was made,” Steve Mostyn tells Mesh News Desk.
Mostyn is concerned hundreds of his clients may have been implanted with the mesh made from Chinese Marlex resin.
Last month, U.S. District Judge Joseph Goodwin, who is overseeing the multidistrict litigation concerning transvaginal mesh litigation, directed the plaintiff to take the counterfeit mesh controversy to the Food and Drug Administration (FDA) for the agency to determine whether the counterfeit mesh poses a problem for use in vaginal implants. See the story here.
Internal company documents that show the extent of the conspiracy remain confidential and Judge Goodwin, who retained jurisdiction over the case, has the authority to release them to the public. Those documents were generated between 2011 and 2012, the years that the alleged smuggling of 34,000 pounds of material were brought into the U.S. without any oversight by EMAI Plastic Raw.
Mostyn tells Mesh News Desk they now believe that was fake company with an address to a storefront in Guangdong Province, China’s hub for manufacturing plastic toys. The province was called the world’s largest electronics waste dump, according to a 2015 Reuters story here.
Mostyn Law Press Release Release