Boston Scientific Faces New Legal Woes Over Tainted Vaginal Mesh
01/16/2016 - Medical device manufacturing giant, Boston Scientific, is facing a new scandal on an epic scale. The vaginal mesh manufacturer is accused of running an international conspiracy that sold defective vaginal surgical mesh, made of counterfeit supplies it smuggled in from China. The suit alleges that after Boston Scientific lost its U.S. supplier of the synthetic resin used in the mesh production, it bought unverified and substandard material from a known counterfeiter in China. Boston Scientific purportedly went to great lengths to avoid detection by U.S. and Chinese authorities and to hide multiple overseas shipments.
Boston Scientific and a Chinese company, which allegedly sold the inferior material and assisted in the smuggling operation, are being sued under the Racketeering and Corrupt Organizations Act (RICO). The RICO statute is typically used to target criminal organizations so the use in a civil case is ground breaking. The suit requests the court to immediately shut down vaginal mesh sales from the company. The suit alleges that the counterfeit mesh contains dangerous selenium, which could be harmful to patients implanted with the mesh.
Transvaginal mesh is currently facing high scrutiny by courts across the country and is now considered a high-risk procedure by the FDA. Transvaginal surgical mesh is a polypropylene-based product implanted in females to shore up sagging pelvic organs, such as the bladder, uterus and bowels, and also to treat incontinence. Tens of thousands of women have complained about serious complication resulting from the mesh eroding through the stitched tissue and requiring painful removal surgeries. Mesh manufacturers are currently facing more than 75,000 lawsuits stemming from these mesh- related injuries.
In 2005, Chevron Phillips Chemical Company stopped selling its polypropylene resin for surgical mesh indicating it should not be used in medical device, “involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” Boston Scientific disregarded these warning and sought another source for the resin pellets, known as Marlex, the only product approved by the FDA. There was no other US supplier for Marlex, so Boston Scientific concocted a scheme to smuggle nearly 35,000 pounds of the material from China, without verifying or fully testing all of the contents, the suit says.
The materials came form EMAI Raw Materials Inc., in Guangzhou, China, which claimed it was Marlex that it had previously purchased from Chevron Phillips and had in storage. Phillips later said the lot numbers on the EMAI bags were bogus. Allegedly, despite this knowledge, Boston Scientific purchased the resin and arranged to have it smuggled out of China. It claimed the product was made in China, thereby avoiding certain paperwork in China; but then advised U.S. officials the material was authentic Phillips Marlex.
According to the lawsuit, tests show significant differences between the Chinese resin and certified Phillips Marlex. Boston Scientific knowingly used the material in the mesh production without notifying the FDA in violation of FDA requirements, and knowingly marketed the devices as being manufactured with authentic material approved by the FDA. The RICO suit comes the same month the FDA announced stricter regulations for surgical mesh, reclassifying the mesh from a Class II to a Class III high-risk device.
Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who was injured by a transvaginal mesh device including, but not limited to Ethicon’s’ Prolift, Boston Scientific’s Pinnacle and Uphold, American Medical Systems’ Elevate, Apogee and Perigee, C.R. Bard’s Avaulta and Pelvilace products, Caldera Medical’s Ascend, and other products manufactured by Mentor and Tyco Covidien by calling or by going to www.ennislaw.com and completing an online case evaluation form.