Class Action Accuses Boston Scientific of Racketeering and Fraud Over Counterfeit Pelvic Mesh

//Class Action Accuses Boston Scientific of Racketeering and Fraud Over Counterfeit Pelvic Mesh

Class Action Accuses Boston Scientific of Racketeering and Fraud Over Counterfeit Pelvic Mesh

Polypropylene resin

Polypropylene resin

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.”

THE COMPLAINT

Advantage Fix mesh, BSC

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.

Her complaint echoes the RICO (Racketeer Influenced and Corrupt Organizations Act) case filed by Teresa Stevens against Boston Scientific.

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

Yimao Plastic Molding, Guangdong Province, China

THE HARM

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.  ##

LEARN MORE:

Read the Complaint here:
http://www2.courthousenews.com/wp-content/uploads/2016/11/Boston-Scientific.pdf

 

 

By | 2016-11-22T20:13:43+00:00 November 16th, 2016|News|9 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

9 Comments

  1. Kitty November 16, 2016 at 1:23 pm - Reply

    China sells rat meat. I am a bigot. I do love Black people and Jews.

  2. janet H November 18, 2016 at 8:58 am - Reply

    This does not surprise most of us at all. We always knew what they did was criminal. I say lock them all up!
    Thank you Mostlyn Law firm for filing the Ricco lawsuit.

  3. Sea November 23, 2016 at 8:56 am - Reply

    Hard to read this …but so grateful for your endless reporting the truth ….Thank you Jane ….Hanging in there along with all the other sisters of this mesh mess ….

  4. Lorie M December 3, 2016 at 12:36 am - Reply

    When is this going to be over? I’m still paying Hospital bills from partical mesh removal,scaring and bowel obstructions and 5 hospital stays!y

  5. tiffany December 16, 2016 at 9:51 pm - Reply

    After having my young life ruined from Boston scientific an years of pain an agony my lawsuit was apparently sold or traded an the new firm says they settled an want to offer me 5k are you kidding??? Of course I declined anyone actually have a good lawyer for me I have proven bs faulty product an pain email me atchadirl28@gmail.com

    • Jane Akre December 17, 2016 at 11:30 am - Reply

      You will have to fire that attorney before any other will talk to you.

  6. Nancy T December 30, 2016 at 12:04 am - Reply

    I’m with the Mostyn law firm, as a client. Boston Scientific is what I was implanted with. Has anyone got any settlement news? I was told I won my case in front of a jury in 2015. And I still haven’t heard of an amount. Anyone else with Mostyn?

    • David S January 4, 2017 at 7:54 am - Reply

      My wife is still waiting for news from Mostlyn law firm. Haven’t heard anything and my wife still dealing with the pain.

      • Gwyn February 19, 2017 at 7:28 pm - Reply

        I just had the bsc mesh implant fully extracted in October. Mine was implanted at the end of 2012. I just received a ridiculous settlement offer from Boston scientific which I have declined. I’ll be looking for a new lawyer

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