Mesh Medical Device News Desk, November 16, 2016 ~ RICO lawsuit filed naming Boston Scientific alleges fraudulent activities involving Chinese smuggled pelvic mesh.
A newly filed lawsuit accused Boston Scientific Corp. (BSC), maker of transvaginal mesh, with racketeering activity and trafficking in counterfeit goods, specifically transvaginal pelvic mesh.
Frances Peel Hennington filed her lawsuit Monday in the Eastern District of New York and will head the class action.
In the 89-page complaint, Hennington says the company began sourcing counterfeit Marlex out of China from known counterfeiters and substituted the Chinese version with known elevated levels of selenium. Its know known what other toxins are included in the counterfeit Marlex and the effects it may have on the body.
What resulted is outlined in the 13 counts - violation of federal anti-racketeering law, negligence, strict liability, unjust enrichment and breach of warranty, all elements of organized crime.
Under a Racketeer Influenced and Corrupt Organizations Act (RICO) lawsuit, damages could be tripled.
In a statement, Boston Scientific’s spokeswoman Kelly Leadem tells Courthouse News 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.”
Advantage Fix mesh, BSC
Hennington was implanted with Boston Scientific’s Advantage Fit Sling System on October 17, 2014, to treat stress urinary incontinence. She claims to suffer from pain, bleeding, painful intercourse, a return incontinence, infections and punctured organs.
The mesh and unknown toxins degrade in the body, according to the complaint.
Both women are represented by Mostyn Law of Houston.
BSC makes its transvaginal mesh implants from Marlex HGX-030-01, a polymer, propylene that was cleared for marketing under the Food and Drug Administrations 510(k) clearance process. The company is required to use the proprietary formula of Marlex that was cleared by the federal agency.
If a different material is substituted, regulatory policy requires a new 510(k) application be submitted.
That did not happen.
According to the complaint, Chevron and Phillips Sumika of Pasadena, Texas made the Marlex used in pelvic mesh which was transported in raw pellet form. In 2011 BSC allegedly ran out of its Marlex at the same time Phillips refused to sell any more of the material of BSC because that polymer carries a warning it is not to be used for implantable medical devices.
In June 2011 through the fall of 2012, internal court documents show BSC decided to smuggle counterfeit and less expensive Marlex out of China. The raw Marlex resin pellets were sent to Luxilon to produce counterfeit Marlex filament fibers then forwarded to Proxy to make counterfeit mesh, enough to make 25-years of pelvic mesh products.
BSC corporate executives exchanged emails showing they were aware of the fraud, according to discovery in the case. The company purchased a total of 37,400 pounds of fake Marlex from China, specifically EMAI, says the complaint.
Yimao Plastic Molding, Guangdong Province, China
The plaintiff and other class members were implanted with mesh made of the counterfeit material, says the complaint. The substitute resin has been shown to contain excessive levels of selenium, an oxidant that attacks polypropylene. See a background story here.
Named defendants in the “scheme to defraud” are EMAI Plastic Raw Materials, Co a/k/a Yi Mai Plastic Raw Materials, Co, a foreign corporation organized under the laws of China and based in Guangzhou. Proxy Biomedical Limited of Ireland is another defendant. Proxy is accused of participating in the fraud as is Luxilon Industries, incorporated under Belgium law; Cambridge Polymer Group, based in Charleston, Massachusetts; and Shenzhen YFL International Logistics are also named.
BSC currently is facing more than 24,000 defective product lawsuits filed in federal court in Charleston, West Virginia. BSC generates about $120 million a year in revenue from the sale of its transvaginal mesh products. About 55,000 women receive a BSC mesh implant every year. ##
Read the Complaint here: