Boston Scientific ($BSX) is facing more legal pushback over defective vaginal mesh devices, but this time, it's not from women who claim injuries or serious side effects from the products. A Houston-based law firm is cracking down on the company for allegedly smuggling mesh materials out of China and putting women at risk for serious side effects.
Mostyn Law filed a suit in a federal court in West Virginia against Boston Scientific and three other companies, claiming that Boston Scientific ran an "international conspiracy" and racketeering operation to get counterfeit supplies for its mesh devices, the firm said in a statement. Mostyn is asking the court to immediately ban Boston Scientific from selling any mesh products that contain the material.
After Boston Scientific lost its mesh supplier in the U.S., the company bought "unverified, substandard material from a known counterfeiter in China," the company said in a statement, "at times acting like a drug dealer" to cover up multiple overseas shipments. Mostyn's suit is also seeking unspecified damages for thousands of women who got a Boston Scientific mesh implant after September 2012. And according to the firm's calculations, that's as many as 55,000 women a year.
"Boston Scientific knowingly sold a product that put women's health and their lives at risk. It conspired with questionable suppliers in China to get material that it couldn't get in the U.S. and went to great lengths to hide it," Amber Mostyn, head attorney at the firm, said in a statement.
Plus, the materials found in the counterfeit mesh could present harm to patients, Mostyn said in a statement. The firm's "latest scientific tests conclude their counterfeit mesh product contains dangerous selenium," Mostyn said. And the firm will meet Boston Scientific "anywhere and anytime to work together and get this dangerous counterfeit medical device off the market," she added, urging the company to turn over internal documents related to its supply transactions. "It is time for this company to do the right thing."
Boston Scientific is denying Mostyn's claims, saying that "patient safety is of the utmost important, and we dedicate significant resources to deliver safe, high-quality products," spokesman Tom Keppeler told The Boston Globe in a statement. "We don't believe the case has merit and intend to vigorously defend these claims."
The latest action adds to Boston Scientific's vaginal mesh woes. The company faces more than 20,000 claims related to vaginal mesh implants in U.S. state and federal courts, including cases consolidated before U.S. District Judge Joseph Goodwin in West Virginia.
In May, the company was ordered to fork over $100 million to a woman who claimed that Boston Scientific's vaginal mesh products caused her undue pain and suffering. The order came a month after the Marlborough, MA-based company agreed to shell out $119 million to resolve about 3,000 suits over the devices.
Mostyn's suit comes as the FDA ramps up its oversight of transvaginal mesh devices amid growing safety concerns. Earlier this month, the agency said it would reclassify surgical transvaginal mesh devices for pelvic organ prolapse (POP) from Class II to Class III, its most serious designation, and would require a premarket approval (PMA) application from manufacturers before signing off on related products.
Heightened scrutiny could spell out more trouble for Boston Scientific, which has a lot on the line with its mesh products. The company earned more than half a billion dollars in revenue in 2014 from mesh and other urology and women's health products, the Boston Globe points out, and additional legal action could put a dent in those spoils.
- read the statement
- get more from Mostyn
- here's the Boston Globe story