By Adam Klasfeld
BROOKLYN, N.Y. (CN) — A woman claims in court that pharmaceutical giant Boston Scientific padded its $120 million yearly revenue on transvaginal mesh products by smuggling counterfeit plastics out of China.
Pelvic mesh product manufacturers have faced increasing regulatory clampdown this year after the Food and Drug Administration reclassified them from “moderate risk” medical devices to “high risk” devices.
More than 1,550 lawsuits have been filed related to the product, including one from California’s Attorney General Kamala Harris, who sued Johnson & Johnson and Ethicon in May.
These complaints typically focus on complications – such as sexual dysfunction or permanent disfigurement – that can arise when pelvic mesh implants are used to treat pelvic floor conditions such as stress urinary incontinence and pelvic organ prolapse.
But the latest class-action lawsuit against the Massachusetts-based Boston Scientific Corp. goes beyond the typical allegations.
In her lawsuit filed Monday with a federal judge in the Eastern District of New York, New Yorker Frances Peel Hennington complained not only of the stress urinary incontinence she now suffers, but she also claims Boston Scientific’s corporate practices amount to racketeering.
Boston Scientific’s problems began in 2010, when the company started running out of Marlex, a plastic invented by two chemists from the Philips Petroleum Company, according to the lawsuit.
“After failing to convince the manufacturer, Phillips, to sell it any more Marlex, BSC made the fateful decision to smuggle counterfeit Marlex out of China,” the 89-page lawsuit states.
Though Phillips is not accused of wrongdoing, four other companies appearing in the lawsuit are: EMAI Plastic Raw Material Co. Ltd., Proxy Biomedical Ltd., Luxilon Industries NV, and Shenzhen YFL International Logistics Ltd.
If Hennington succeeds at trial, her damages would be tripled under the Racketeer Influenced and Corrupt Organizations Act. Her lawsuit charges 13 counts, including violations of federal anti-racketeering law, strict liability, negligence, fraud, unjust enrichment and breach of warranty.
She is represented by Houston-based attorney J. Steve Mostyn.
In a statement, Boston Scientific’s spokeswoman Kelly Leadem said allegations like these are not new.
“Like Mostyn’s other allegations on this matter, we believe this case is without merit,” Leadem said. “We stand behind our products, the materials used in those products and our commitment to women’s health.”