Knowing the Food and Drug Administration has the ability to issue a recall, Steve and Amber Mostyn of Mostyn Law have done what no other has. On March 31, 2016, Mostyn Law filed a Citizen’s Petition on behalf of Teresa Stevens, a victim of counterfeit transvaginal mesh. The petition seeks an immediate Class I recall of the Boston Scientific products, requests to quarantine the Chinese resin so no future products would be made from it, and asks the Food and Drug Administration (FDA) to seek out the source of the raw material.
On April 1, the FDA issued a safety statement agreeing to let Boston Scientific investigate the safety and effectiveness of the its own products, while acknowledging Boston Scientific’s urogynecologic surgical mesh “may” contain counterfeit raw material.
“Sort of like asking a drug dealer to determine if the cocaine he was caught selling was really cocaine,” says Steve Mostyn. “I believe we will find there is no consistency in the product at all. With that province, a garbage dump for all sorts of industrial plastics, the FDA is not acting on behalf of the public and is abrogating its duty to public health and safety by giving Boston Scientific a pass.”
In an April letter to FDA commissioner Dr. Robert Califf and Health and Human Services Secretary Sylvia Mathews Burwell, Amber Mostyn urged the FDA to step up its investigation into criminal conduct and not allow Boston Scientific to simply compare new mesh implants to old ones.
“Does the FDA believe equivalence is a defense to trafficking of counterfeit raw material in violation of 18 U.S.C. § 2320 (Trademark Counterfeiting Act),” Mrs. Mostyn question in the letter.
Largely due to the new revelations uncovered by Mostyn Law, federal prosecutors have now impaneled a grand jury to launch a criminal investigation into charges of fraudulent activity by Boston Scientific.
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 fine for a company.
The grand jury in Charleston, W.Va., has sent out multiple subpoenas in recent months, one of which was obtained by the Boston Globe.
The investigation will determine whether Boston Scientific engaged in deceptive trade practices by receiving the substandard materials, which it fraudulently sold to health care providers and ultimately implanted in unsuspecting women, like Teresa Stevens.
Boston Scientific, responding to an inquiry by the Globe, denied it uses counterfeit or adulterated materials in its medical devices.
“Boston Scientific has a robust quality system and dedication to patient safety. We stand behind out products, the materials used in those products and our commitment to women’s health,” said a spokesperson.
In the latest turn, on May 5th, in the court overseeing transvaginal mesh medical products cases in California, Judge William F. Highberger denied Boston Science’s motion to bring a halt to future discovery into the Chinese resin issue. Additional depositions and discovery will be conducted of Boston Scientific’s current and former employees, people in the know.
Judge Highberger ruled, “If the product is equivalent chemically but counterfeit in terms of its actual producer source, that raises legitimate questions as to why a manufacturer of products intended for human implantation would resort to such ruses to obtain needed raw material. Plaintiffs so far ‘have made a sufficient showing that it has a reasonable potential for relevance, at least as to the issue of punitive damages.’”
Steve Mostyn says in many ways the story of the entire mesh mishap is just beginning to be told. Mostyn Law has identified 10 prior manufacturers from 2003 to 2010 who refused to sell polypropylene (PP) for use in implants. But, why did those manufacturers shy away from the transvaginal mesh business?
“The reality is you must have this fundamental information before you can evaluate the cases. We have found many things that do not relate to China but are highly relevant and we are now on a systematic review of all ten million pages and have requested additional documentation to fill in the holes,” says Steve Mostyn.
The implications for all manufacturers in the mesh mess are huge. “It was a straight up experiment,” Steve Mostyn adds. “That’s the core of it. I think synthetic polypropylene meshes for vaginal use should be off the market. Period.”