Mesh Medical Device News Desk, April 14 2016 ~ The Boston Globe reports a grand jury will determine if criminal charges should be filed against Boston Scientific (BSC) for using counterfeit raw material from China to make its vaginal mesh implant.
A grand jury in Charleston, W.V. will determine whether BSC engaged in deceptive trade practices by knowingly receiving substandard polypropylene resin from China and then sold that defective product to women and their doctors.
Multiple subpoenas have been sent out, reports the Globe, though a Boston Scientific spokeswoman says the company has not received one.
In a February 24 regulatory filing, BSC said the US attorney’s office in West Virginia was looking into the allegations of defective mesh resin.
The Houston-based Mostyn law firm in January accused the company of running an international conspiracy to sell defective mesh. The Marlborough, Massachusetts-based BSC denies that.
The lawsuit seeks class-action status on behalf of about 55,000 women who have received the pelvic mesh implants since September 2012, the date after which the Chinese-sourced polypropylene resin would have been used. The case is Teresa Stevens. V. Boston Scientific Case no. 2:16-cv-00265).
BSC is working to test its pelvic mesh implants crafted allegedly from the Chinese-sourced mesh to see if it contains high levels of selenium, a trace element that can be toxic at high levels. The firm had a Boston polymer lab test the raw resin and found it contained high levels of selenium. “As a rare and toxic element, this result is unusual and should be verified by using another technique, such as SEM-EDS,” said the report.
The Food and Drug Administration acknowledged the allegations filed in the RICO action but did not recommend that women have their mesh implants removed.
Mostyn law said when BSC lost its US supplier of raw polypropylene, it turned to a known counterfeiter in China. Mostyn says the company acted like a drug dealer then to hide 37,000 pounds of the substandard resin from customs agents in the U.S. and China.
Yesterday in a letter to the FDA and Health and Human Services, Amber Mostyn urged the FDA to pursue criminal charges with the Department of Justice and not just compare old pelvic mesh implants to new ones.
“The FDA‘s investigation should not be into the quality of the raw material, but rather the source of the raw material. Allowing the defense of equivalence undermines the public policy positions articulated in the very statutes Congress passed to prevent this type of criminal conduct.”~Amber Mostyn
Criminal penalties for smuggling counterfeit material and endangering public health can range from 20 years in prison for serious bodily harm to life in prison for death and a $15 million corporate fine.
The law firm points to documentation that was lacking in the imported material or sourced the material from two different Chinese suppliers. The low-cost material, lower than market value, was split into separate shipments and sent to different ports.
Boston Scientific reports net sales for its urology and pelvic health products were $693 million at the end of 2015, an increase of 30 percent over the prior year.
The company is facing almost 21,000 product liability lawsuits filed in multidistrict litigation, one of seven mesh manufacturers consolidated in one federal court in Charleston, WV.
Boston Globe, April 13, 2016, Grand jury convened in probe of Boston Scientific
April 12, Letter to FDA
STEVENS FINAL LETTER TO FDA (1)
Prosecuting Intellectual Property Crimes (here)
Mostyn Law Court Documents, Citizen Petition
Mesh News Desk, Jan. 15, 2016 – RICO Suit Accused Boston Scientific of Fraud in Smuggling Defective Pelvic Mesh from China
RICO Complaint Jan 12, 2016