What is the class action lawsuit about?
On January 12, 2016, Mostyn Law, headed by Steve and Amber Mostyn, filed the suit against Boston Scientific Corporation, EMAI Plastic Raw Material Co, LTD, Proxy Biomedical Limited and Luxilon Industries NV under the Racketeering and Corrupt Organizations Act (RICO) on behalf of women who have suffered severe discomfort, bleeding, infections, painful intercourse, urinary problems and other complications due to unsafe transvaginal mesh implants.
What is the complaint?
The lawsuit alleges that Boston Scientific, EMAI, Proxy, and Luxilon engaged in an international conspiracy to sell defective vaginal surgical mesh, made of counterfeit resin Boston Scientific smuggled from China.
Who is the plaintiff in the case?
The lead plaintiff who brought the individual complaint is Teresa Stevens, a 46-year-old grandmother from Lincoln County, West Virginia. Stevens had a transvaginal mesh implant procedure in October 2014 and has since suffered physical pain, bladder infections, and other complications due to the medical device.
Mostyn law has also organized a class action lawsuit against EMAI, Proxy, and Luxilon on behalf of thousands of women who have received a Boston Scientific transvaginal mesh products after September 2012 and who have suffered complications due to their plastic mesh implants.
Is this the first time legal action has been brought against Boston Scientific due to its transvaginal mesh products?
Boston Scientific is one of six major manufacturers that have been named in lawsuits filed by more than 70,000 women injured by surgical mesh implants. Specifically, Boston Scientific previously disclosed that some 15,000 cases involving its pelvic mesh products have been filed against the company.
How is this suit different from previous transvaginal mesh cases?
The RICO lawsuit is the first to implicate Boston Scientific in an international conspiracy to import counterfeit plastic resin for transvaginal mesh.
What is transvaginal mesh used for?
Transvaginal mesh is a medical device used along with surgical stitches to shore up sagging pelvic organs, such as the bladder, uterus and bowels, and to treat incontinence, which can occur as a result of age and childbirth.
The Food and Drug Administration now considers transvaginal mesh surgery a high-risk procedure.
What is the mesh product made out of?
Transvaginal mesh is often a polypropylene-based product, a form of plastic. Specifically, “Advantage mesh,” which Boston Scientific uses for all of its transvaginal mesh products, is made from Marlex HGX-030-01 (also called resin). This is a specific and unique polypropylene and was cleared by the FDA for use in 2004 under its abbreviated 510(k) approval process.
If Boston Scientific uses any product other than Marlex HGX-030-01 to form its mesh, the product would not be considered “Advantage mesh” and therefore would not be approved by the FDA.
Who supplies Boston Scientific with Marlex HGX-030-01?
Chevron and Phillips/Sumika (Phillips) manufactured and trademarked Marlex HGX-030-01 and sold the product to Boston Scientific in its raw form in pellets.
In 2005 Phillips concluded that its Marlex resin was unsafe for medical applications involving “permanent implantation in the human body or permanent contact with internal body fluids or tissues.” Shortly after, Phillips allegedly discontinued its business relationship with Boston Scientific.
After loosing Phillips as its primary Marlex supplier, what did Boston Scientific do next?
Boston Scientific allegedly began a global hunt to find another source for the resin pellets and later discovered EMAI Plastic Raw Material Inc., who offered to sell what it purported to be authentic Marlex from Phillips.
Between August 2011 and August 2012, Boston Scientific allegedly purchased 37,400 pounds of EMAI Marlex and smuggled the resin pellets out of China and into Belgium and the United States without verifying or fully testing the product.
The lawsuit alleges that EMAI was unable to provide documentation showing the purchased product was authentic Phillips’ Marlex. Phillips allegedly later claimed the lot number shown on one of the purchased EMAI resin bags was bogus.
How were Proxy and Luxilon involved?
These mesh component manufacturers allegedly tested and manufactured the counterfeit Chinese Marlex. Luxilon, based in Antwerp, Belgium, allegedly manufactured mesh fibers using the counterfeit Marlex. Meanwhile, Proxy, based in Galway, Ireland, allegedly wove mesh sheets using the filament that was manufactured with the counterfeit Marlex.
How does Mostyn Law know the EMAI resin is not the same product as the FDA approved Phillips Marlex?
The lawsuit claims that performance tests conducted by Proxy and Luxilon showed significant differences between the Chinese Marlex and certified Phillips Marlex. Yet despite having prior knowledge of such, Boston Scientific allegedly proceeded with the production of the transvaginal mesh. This is direct conflict with FDA regulations, which require device manufacturers to re-apply for clearance when any material is changed in a permanent implant device.
According to the lawsuit, Boston Scientific allegedly failed to later re-apply for FDA clearance, and instead “deceptively promoted, marketed, packaged, labeled, sold and distributed this mesh as being manufactured with authentic Marlex and approved by the FDA.”