A federal probe into allegations that Boston Scientific (NYSE:BSX) used counterfeit resin to make pelvic mesh products has reportedly convened a grand jury in West Virginia that’s already sent out several subpoenas.
The accusations 1st surfaced in January with the filing of a purported class-action racketeering lawsuit in the U.S. District Court for Southern West Virginia, the venue for multi-district litigation against a clutch of companies over their respective mesh products for treating female urinary incontinence and pelvic organ prolapse.
Plaintiff Teresa Stevens alleged that Marlborough, Mass.-based Boston Scientific conspired with subsidiaries in Belgium and Ireland to use the counterfeit resin to make the Advantage mesh used in all of its pelvic mesh products after its original supplier allegedly refused to continue providing the product because it’s not supposed to be implanted in humans. Lawyers for Stevens later petitioned the FDA to ban the medical device maker’s pelvic mesh products made with the allegedly impure resin.
The subpoenas sent by the grand jury in the Mountain State seek documents related to the purchase of the resin, 2 unnamed sources told the Boston Globe.
“Among other things, 1 of the people said, investigators are examining whether the Marlborough medical device company engaged in deceptive trade practices by knowingly receiving substandard resins from China in packaging from a vendor whose materials had been approved by federal regulators, and whether it fraudulently sold defective products to health care providers,” the newspaper reported.
Boston Scientific spokeswoman Kelly Leadem told MassDevice.com in March that the company “does not use counterfeit or adulterated materials in our medical devices.”
“The company rejects the contrary allegations in the petition” filed by Stevens’s lawyers, Leadem told us. Boston Scientific has not received a subpoena but is cooperating with the U.S. Justice Dept., she told the Globe.
In a statement released April 1 after the FDA revealed that it too is investigating the matter, the company said it’s dedicated to patient safety and backs that up with a robust quality system.
“Changing suppliers of raw materials is not unusual for medical device companies, and when Boston Scientific makes such a change, we follow the processes required by our quality system,” Boston Scientific said. “In 2011, we located a new supplier of Marlex resin. Upon doing so, we put samples of the resin through a rigorous battery of tests to demonstrate equivalency. In addition, we conducted extensive mechanical tests to ensure that our mesh products manufactured with the newly sourced material met product specifications.
“We have the highest confidence in the safety of our mesh devices. We have shared our test data with the FDA, and are fully cooperating with the agency’s requests for information as part of our ongoing discussions. Additionally, we have offered to conduct further biocompatibility and chemical characterization testing to complement the results from existing tests. This entire process is expected to take several months, depending on the individual tests,” the company said.