Plaintiff Teresa Stevens had sought RICO charges against Boston Scientific for its alleged smuggling of counterfeit resin out of China for use in transvaginal mesh. For now, a judge has given FDA jurisdiction over the case.
A federal judge in West Virginia has handed an alleged class-action racketeering lawsuit filed against Boston Scientific to FDA. The judge also rejected a request for a temporary restraining order against Boston Scientific to halt sales of its surgical mesh products on the grounds that the company was not notified of the application for the order.
The allegations of the recent lawsuit sounded like something out of a movie. Plaintiff Teresa Stevens had alleged that Boston Scientific had managed to get clearance for a range of vaginal mesh products made of a resin, Marlex HGX-030-1, not intended for use in permanent implants.
The MSDS for the material warns: "Medical Application Caution: Do not use this Chevron Phillips Chemical material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues."
The legal complaint states that after the maker of the material, Chevron Phillips stopped selling the Marlex grade to Boston Scientific in 2005, the company hatched a plan to smuggle a counterfeit version of it from China.
"Our efforts to get justice for women who have been harmed by Boston Scientific's dangerous surgical mesh are far from over," said Amber Mostyn of Mostyn Law, an attorney who represents the plaintiff in the case. "The court has given the FDA an opportunity to act, but retained jurisdiction over the lawsuit while the FDA investigates," she said in prepared remarks.
Mostyn declared that Boston Scientific's mesh "harms tens of thousands of women with counterfeit plastic that contains high levels of toxic selenium" and called for the company to remove its mesh products from the market and to release documents related to the mesh to the public.
Mostyn has also filed to make public many of the documents crucial to the case, which the firm contends detailed a smuggling plan to obtain counterfeit resin from China and hide it from the public.
The ability of U.S. courts to find that drugs and devices are not safe or effective has become more difficult following the Bush appointment of Dan Troy as chief counsel to the Food and Drug Administration in 2001. Troy had argued that when the FDA decides that a drug or device is safe and effective, that preempts courts' ability to rule otherwise.
In its response to the complaint, Boston Scientific also took issue with how many of the documents cited by the plaintiff were confidential: "Plaintiff's lawyers should have followed the procedure laid out in the Stipulated Protective Order for utilizing 'Confidential documents.'" It continues: "Instead, in an apparent publicity stunt intended to draw attention to the Complaint, Plaintiff's lawyers simply incorporated the contents of Confidential documents into their filings, and attached a number of the Confidential documents to the Complaint and motion papers, and then moved in this action to declassify them."
A similar RICO case filed against Johnson & Johnson in a Florida district court last year lists the FDA as a co-defendant.
While polypropylene has become one of the most commonly used materials for surgical meshes, the material has become somewhat controversial for medical applications as some research indicates that it is not inert.