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| Boston Scientific's Marlborough, MA-based corporate headquarters--Courtesy of Boston Scientific |
Boston Scientific ($BSX) is facing more pushback in its legal saga over vaginal mesh implants. Federal prosecutors are convening a grand jury to consider evidence that the company used defective counterfeit raw materials from China for its devices.
A grand jury in Charleston, WV, has sent out multiple subpoenas recently seeking documents about Boston Scientific's purchase of a type of synthetic resin used in mesh implants, The Boston Globe reports. Investigators in the U.S. Department of Justice (DOJ) want to see if the Marlborough, MA-based company knowingly got substandard resins from China that were cloaked in materials approved by regulators, and then sold them to healthcare providers.
Allegations against the company regarding counterfeit mesh products cropped up earlier this year. In January, a Houston-based law firm accused Boston Scientific of allegedly smuggling materials out of China to use in its mesh devices.
Mostyn Law in a suit filed in a West Virginia federal court said that Boston Scientific ran an "international conspiracy" and racketeering operation to get counterfeit supplies for its mesh devices. The company bought "unverified, substandard material from a known counterfeiter" in China, "at times acting like a drug dealer" to cover up multiple overseas shipments, the firm said at the time.
Now, Mostyn Law is seeking unspecified damages for thousands of women who got a Boston Scientific mesh implant after September 2012. According to the firm's tally, that number comes to as many as 55,000 women a year.
Boston Scientific said that it's working with regulators to clear up the issue. The company has voluntarily handed over information requested by the DOJ, spokeswoman Kelly Leadem told FierceMedicalDevices in an email. Boston Scientific hasn't gotten a subpoena, she said, although the company in a recent regulatory filing revealed that the U.S. attorney's office in West Virginia was reviewing claims of defective mesh resin.
"We will continue to cooperate with those organizations that have requested accurate information about the allegations and are confident they will be disproved," Leadem said.
Boston Scientific is also defending its product's safety. The company "does not use 'counterfeit' or 'adulterated' materials in our medical devices," Leadem said. And Boston Scientific has a "robust quality system and dedication to patient safety," she told the Globe. "We stand behind our products, the materials used in those products and our commitment to women's health."
Still, the latest news does little to detract from Boston Scientific's problems related to vaginal mesh devices. Earlier this month, the FDA said that it was looking into allegations that substandard materials were used in the company's urogynecologic surgical mesh. The agency stopped short of recommending that the implants be removed, though, because "available data do not suggest any decreased benefit associated with the device," it said, as quoted by the Globe.
Meanwhile, Boston Scientific faces a swath of lawsuits over claims that its vaginal mesh products caused health problems in women. In 2015, the company paid $119 million to settle 3,000 suits. But Boston Scientific still is dealing with thousands of other cases, which are consolidated before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.
- read the Boston Globe story
- here's Boston Scientific's 10-K