In a federal class action lawsuit filed on January 12, 2016 in the U.S. District Court for the Southern District of West Virginia, the plaintiff alleges that Boston Scientific Corporation (“Boston Scientific”) knowingly imported counterfeit raw materials from China that it used in its manufacture of transvaginal mesh that was used in women to surgically treat pelvic organ prolapse and incontinence.
On average, 55,000 women in the United States receive transvaginal mesh manufactured by Boston Scientific annually, which contributes $120,000,000 to Boston Scientific’s annual revenues. Boston Scientific’s Advantage mesh is used in all of its transvaginal mesh products, which is made using Marlex HGX-030-1, which is a specific and unique polypropylene resin approved by the FDA that comes in pellet form and is manufactured by a joint venture between Chevron and Phillips/Sumika (“Phillips”). The FDA approved only the trademarked Marlex HGX-030-1 in Boston Scientific’s manufacturing of its Advantage mesh.
The plaintiff alleges that in 2005, Phillips terminated its contract with Boston Scientific to supply it with Marlex HGX-030-1 because the product was not intended for use in permanently implanted products (transvaginal mesh is intended to be permanently implanted in patients); Phillips limited Boston Scientific to purchase an additional 4,000 pounds of the resin during 2005.
The plaintiff alleges that in 2011, Boston Scientific began running out of Marlex HGX-030-1, expecting to run out of the raw material in August or September 2012, and was unable to convince Phillips to sell it more Marlex HGX-030-1. Fearing loss of substantial revenue, the plaintiff alleges that Boston Scientific smuggled 34,000 pounds of counterfeit Marlex pellets from China between June 2011 and the Fall of 2012 that were subjected to a manufacturing process in Belgium and then Ireland before being brought into the United States where the manufacturing process was completed in Indiana. The plaintiff alleges that Boston Scientific intended the 34,000 pounds (618 bags) of counterfeit Marlex to last it 25 years.
The Chinese manufacturer of the alleged counterfeit Marlex pellets was EMAI Plastic Raw Materials, Inc. (“EMAI”), which is also a named defendant, that the plaintiff alleges is a known manufacturer of counterfeit plastic products. EMAI allegedly certified that the Marlex that it sold to Boston Scientific was authentic Marlex HGX-030-1 manufactured by Phillips, but EMAI was never able to provide documentation to Boston Scientific to prove that the designated Marlex HGX-030-1 that it supplied was authentic (Phillips even confirmed that the lot number of the EMAI Marlex resin that it supplied to Boston Scientific was not a Phillips lot number). The plaintif alleges that Boston Scientific did not advise EMAI of its intention of using the counterfeit Marlex in mesh used for human implantation.
The plaintiff supports the RICO allegations by alleging that the defendants, including Boston Scientific, had a common goal and purpose of smuggling adulterated and/or counterfeit Marlex out of China, circumvent the import/export laws of China and the United States to “pass” the counterfeit mesh as authentic Marlex, and to avoid the scrutiny of the FDA and the termination of Boston Scientific’s mesh sales to the plaintiff and other class members that generated massive profits for the defendants.
The plaintiff’s 59-page, seven-count Complaint seeks lass-action status, treble damages under the federal RICO law, a temporary restraining order, temporary injunction, and permanent injunction against the defendants, and statutory, compensatory, and punitive damages from the defendants.
If the plaintiff is successful in her federal RICO lawsuit filed against Boston Scientific, EMAI, and others, it may be an open window into the motives and ethics of pharmaceutical and medical device manufacturers, and the extent to which they may voluntarily choose to circumvent laws and regulations that are intended to protect unsuspecting patients and the public, in order to market their products and protect their profits.
If you or a family member were implanted with transvaginal mesh or other surgical mesh and suffered complications, injuries, or chronic pain afterwards, you should find a mesh claim lawyer in your U.S. state who may investigate your surgical mesh claim for you and represent you in a claim against the manufacturer, distributor, and/or supplier of the surgical mesh, if appropriate.
Turn to us when you don’t know where to turn.