By Priyanka Dayal McCluskey GLOBE STAFF JANUARY 14, 2016
A Houston law firm has filed a suit accusing the medical device maker Boston Scientific Corp. of selling defective vaginal mesh implants made from materials smuggled from China, and putting the health of thousands of women at risk.
The lawsuit, filed in federal court in West Virginia, claims the Marlborough company ran “an international conspiracy” and racketeering scheme to sell defective vaginal mesh, used to treat urinary incontinence and other pelvic organ problems, and asks the court to stop sales of the product. Boston Scientific denies the claims.
The allegations from Mostyn Law are the latest legal challenge to Boston Scientific, which already faces some 30,000 lawsuits for its controversial vaginal mesh products. Last year the company paid $119 million to settle about 3,000 of these cases.
The new suit alleges that after losing its US supplier of synthetic resin to produce mesh, Boston Scientific bought substandard material from a known counterfeiter in China, at times “acting like a drug dealer” to hide shipments and avoid being caught by US and Chinese authorities.
Boston Scientific issued a statement refuting the lawsuit’s claims.
“At Boston Scientific, patient safety is of the utmost importance, and we dedicate significant resources to deliver safe, high-quality products,” spokesman Tom Keppeler said. “We don’t believe the case has merit and intend to vigorously defend these claims.”
The suit, which seeks class-action status, asks for unspecified damages for as many as 55,000 women a year who received the mesh product since September 2012.
Amber Mostyn, a lawyer bringing the suit, said in a interview that Boston Scientific essentially used an untested and unapproved plastic product from China to make its mesh implants, and concealed this fact from authorities.
“They knew they could not verify the authenticity of this plastic resin that they found in a warehouse in China from a known counterfeiter,” Mostyn said. “They bought it anyway and have been implanting it potentially into tens of thousands of women.”
Whether the material from China specifically harmed women is unclear. “It hasn’t been tested. We don’t know what’s in it,” Mostyn said.
In the past, patients have blamed vaginal mesh products for causing a variety of distressing symptoms, including severe pain, bleeding, urinary problems, and pain during sex.
Vaginal mesh can be implanted to treat women who have lost bladder control, and those whose pelvic organs have prolapsed, or fallen out of place. Boston Scientific earned more than half a billion dollars in revenue from selling mesh and other urology and women’s health products in 2014.
The company’s shares rose about 3 percent Thursday, closing at $18.16.