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Judge’s Order to Boston Sci – DO NOT Destroy Chinese Pelvic Mesh or Docs!

Yimao Plastic Molding, Guangdong Province, China

Yimao Plastic Molding, Guangdong Province, China

MND, Feb 16, 2016 ~ In a move reminiscent of the document destruction by Johnson & Johnson, a Texas state district judge has ordered Boston Scientific Co. not to destroy any documents or materials pertaining to the Chinese mesh the company smuggled from China.

Harris Co. District Court Judge Jaclanel McFarland ordered the company not to dispose of or alter any supplies of polypropylene (PP) resin sitting in an Indiana warehouse that allegedly was smuggled in from China without any regulatory oversight.

Boston Scientific (BSX) turned to an unknown Chinese supplier after its source of U.S. – made PP known as Marlex, refused to supply BSX with the raw resin.  Supplier, Chevron Phillips, had learned the resin was to be used for mesh medical devices that would be permanently implanted in the human body, in violation of its own direction that specify the resin was NOT to be used for implantable medical devices.

Bard Marlex Mesh MSDS

Bard Marlex Mesh MSDS

Chevron and Phillips Sumika of LaPorte, Texas (which has since moved to Saudi Arabia) manufactured Marlex HGX-030-01, the specific polypropylene, which is the basis for FDA clearance of the BSX product. Any new formulation requires the company to reapply to the FDA for clearance to sell its medical device.

Mostyn Law of Houston filed a federal racketeering lawsuit last month accusing the company of conspiring with a Chinese supplier to import 34,000 pounds of a counterfeit Marlex which “contains high levels of toxic selenium,” says the law firm in a news release.  “And if Boston Scientific won’t do the right thing, the FDA should make them do it without delay,” says Amber Mostyn.

Included in the order is the destruction of any of the following- shipping orders, customs forms, and communications with suppliers.

The federal lawsuit filed by Mostyn law is the first to invoke the Racketeering and Corrupt Organizations Act (RICO), which is traditionally used in organized criminal activity.

The case is styled Stevens v. Boston Scientific Corp., et. al., 2:16-0265, U.S. District Court, Southern District of West Virginia.

Steve and Amber Mostyn

Steve and Amber Mostyn

It echoes the order placed and violated by Johnson & Johnson which was found to have destroy hundreds of thousands of pages of documents pertaining to transvaginal mesh that were under a litigation hold.  Besides a reprimand from the court, Magistrate Cheryl Eifert, there has been no sanctions against J&J. See background story from Mesh News Desk here and here.

The firm hopes to turn the RICO action into a class action on behalf of those women implanted with the counterfeit made resin.

With Boston Scientific using about 3,000 to 4,000 pounds of resin a year, Steve Mostyn believes that leaves thousands of pounds sitting in a warehouse.

“Who knows how it’s stored. They transported it in brown paper sacks. I don’t know if the warehouse is climate controlled, rodent or insect controlled. If the shelf life of Marlex is ten years there is no way to assume when it was made,” Steve Mostyn tells Mesh News Desk.

Mostyn is concerned hundreds of his clients may have been implanted with the mesh made from Chinese Marlex resin.

Last month, U.S. District Judge Joseph Goodwin, who is overseeing the multidistrict litigation concerning transvaginal mesh litigation, directed the plaintiff to take the counterfeit mesh controversy to the Food and Drug Administration (FDA) for the agency to determine whether the counterfeit mesh poses a problem for use in vaginal implants.  See the story here. 

Plastic toys made in Guangdong province

Plastic toys made in Guangdong province

Internal company documents that show the extent of the conspiracy remain confidential and Judge Goodwin, who retained jurisdiction over the case, has the authority to release them to the public. Those documents were generated between 2011 and 2012, the years that the alleged smuggling of 34,000 pounds of material were brought into the U.S. without any oversight by EMAI Plastic Raw.

Mostyn tells Mesh News Desk they now believe that was fake company with an address to a storefront in Guangdong Province, China’s hub for manufacturing plastic toys. The province was called the world’s largest electronics waste dump, according to a 2015 Reuters story here.

LEARN MORE:

Mostyn Law Press Release Release

http://www.prnewswire.com/news-releases/mostyn-law-wins-court-order-barring-boston-scientific-from-destroying-evidence-300214064.html

 

58 Comments

  1. Debi says:

    OMG!!!!! I dont know how to feel about this. I am so happy about the courts moving so fast on the RICO charges, but I am sick to my stomach about the thought that this plastic is in us and no one gave a damn about the women they were hurting. What has this world come to? It’s sad

    • Lee Festerman says:

      My family is very upset with the doctor that put this in to my wife I am so happy to hear that that judge Goodwin is taking care of this matter for my family. It looks like he’s the only one that cares for the women in country. Thank you God for this great man.

  2. Emmie says:

    Jane:

    Thank you for the update.

    What is happening with J&J destruction of documents?

    Are their actions going without any punishment?

  3. Don't give up! says:

    That’s insane holy crap I’m hoping other pharmaceutical companies didn’t do this for the sake of thousands of other mesh injured,sad so very sad.

  4. Louise says:

    Having all these proofs, why don’t Judges, tell Boston Scientific to pay right now, all American and Canadian women, without wasting money in courts and trials, and be DONE with it…A lot of us will be DEAD by then…What other proofs do they need, Jesus…Women need to get their compensations, NOW…

  5. V. Smith says:

    This also proves that the resin Marlix made by chevron that it was not safe to use in humans. Why is BS not held responsible?

  6. Janis Urban says:

    Why wouldn’t all of Boston Scientific Pelvic Mesh Kits be defective if they are made from this raw resin not to be used or implanted in human bodies. One would think it is an open and shut case? Poisoning Humans a Criminal Act? They just sentenced the man responsible for distributing salmonella tainted peanuts to prison?

  7. Toni says:

    I can’t believe this whole mesh mess is not on national news. How are they getting away with this stuff and not being exposed for their criminal acts. Shredding evidence using propelene they were knowingly using when warned not to

    Then getting substandard products from China that have no control of standards in manufacturing. Wow so much corruption from companies that care. Lol care about money not people’s lives and health

  8. Idlewild says:

    So will we be informed if we were in fact implanted with mesh from China? Any idea which kits? This is so disturbing… I feel sick. How are they getting away with this?

    • Jane Akre says:

      What year was your Boston Scientific mesh made? After 2011? Your law firm may want to contact Mostyn law to see if you can be included in their actin…. I’m not a lawyer so talk to yours.

  9. Becky says:

    Where was J&J mesh manufactured?

    • Jane Akre says:

      Here is a story with more
      http://meshmedicaldevicenewsdesk.com/commentary-one-hand-tied-behind-their-back

      It says: “Dr. Klinge did appear on the stand Thursday, February 13 but jurors did not hear that the largest maker of polypropylene in the country is in Kenovah, They also did not hear from Dr. Klinge’s Expert Report (Doc #132) that the compounding resin hasn’t changed much since hernia mesh was first made.

      “Ethicon’s use of polypropylene as a suture material dates to the late 1960’s when it began purchasing polypropylene resin for its Prolene sutures from the Montecatini Company at their Novamant Plant in Kenovah, West Virginia. The mixing and compounding of the resin has not changed since that time – same composition; same molecular weight; and same molecular weight distribution. The individual component additives to the resin are Santonox (antioxidant); calcium stearate (lubricant); dilauralthiodipropionate (antioxidant); Procol LA-10 (lubricant); and CPC pigment (colorant to enhance visibility). After the extruded resin material leaves. the compounder in pellets for shipping to Ethicon.”

      The West Virginia-based Braskem America’s Neal Plant was purchased from Sunoco in 2010 and makes 70 different types of PP. 1.4 million lb/day in this 24 hour operation.”

  10. K says:

    Jane, have you sent a press release out to all major media on this?

  11. K says:

    I dont believe for one second that if they did a full blown investigation that would find J&J did something very similar. Everyone in their company should be questioned. Someone knows the truth!!!! Put the pressure on them! Not smart to push and push a group of hurting women. Does Lana’s Ricco case include similar alligations toward J&J?

  12. Angry says:

    Sure hope that once this is proved in court that the use of counterfeit plastics become headline news but won’t hold my breath. Doing my part by relentlessly sending emails and phone calls to the major media. Do I get call backs? Hell No but I refuse to stop trying. Jane as always I can not Thank You enough!

  13. K says:

    Can some explain this to me? This whole thing is illegal how can Judge Goodwin let the FDA decide Boston Scientifics fate in this? He wants them to decide if this train caused a problem? Are you kidding me???? Why didn’t he deal with it?

    • K says:

      Resin not train.

    • Jane Akre says:

      My thought- He is not an expert in the field of mesh regulations…. how does he know the formulation the FDA considered to give a 510(k) approval? How does he have access to the labs to test the BS mesh? He doesn’t know what selenium tainted mesh might result in. Does the FDA have these answers?

    • Still Standing says:

      I think this was a procedural event. The plaintiff filed in Judge Goodwins court, probably knowing it would get sent to the FDA regulatory venue. I dont think he was trying to avoid making the decision, but instead remanded it to the appropriate court. Judges determine what court should hear cases….as in mesh cases, federal judges determined that an MDL would be the best, cheapest and most streamlined way to hear pretrial motions and discovery for mesh, so cases filed re mesh were dumped into this one court. Unfortunately, just the sheer number of cases filed has made it very complicated and definitely less streamlined. Theoretically looks good, practically not so good.

      • Meshie says:

        http://www.wvsd.uscourts.gov/sites/default/files/opinions/2-16-cv-00265.pdf maybe if this links works you can read it yourself. I am going to step out here and offer an observation. Judge Goodwin is doing all he can to move these forward. I really think calling him dishonest and taking bribes is terrible.

        I know we all have our opinions, but hey, if your going to say these things about someone overseeing in excess of 90,000 cases and all the other cases he still has to deal with that are not this MDL then you need to start casting stones at the state court JUDGES also that are not in W. VA. My case is in a state court and has been there for 5 years.

        How much are you paying your attorney ( that you have spoken to once or twice in the last how many years). Maybe we should ask this same judge to reduce the amount of what we are paying them since this is dragging on so long.( I think somewhere by law that can happen)

        How do we not know that the Attorney’s are going to get a kick back or they are stalling just to make more money…

        Conspiracy theories abound!!!!!

        I will be glad when the mesh is officially listed as an autoimmune inhibitor.

        Off my soapbox now!

  14. kitty says:

    There is a Dr. In the Midwest tjat is now in prison for using spinal appliances that we’re imported from China. I believe his name is Dr. White.

  15. Dorothy Carpenter says:

    Did anyone notice that Chevron and Phillips Sumika of LaPorte, Texas, the polypropylene Company who wouldn’t sell there product for implantation in the human body has moved to Saudi Arabia. Even though they appear to be honest, they may be jumping ship while they can. Sounds fishy to me.

  16. anna says:

    I think the FDA is working on saving their and their corporations a……. forget about ours. Tell me they don’t have enough evidence to reclassified TVT.

  17. sandy says:

    Fact is, the PP mesh should NOT be implanted regardless of where it is manufactured. BSX and other companies obtained the mesh knowing it was harmful. Some companies made dummy corporations to buy mesh when the manufacturer refused to sell it when they learned it was being used for POP and SUI treatments. ALL of these companies have MANY, MANY lawsuits, not just for MESH, and they knowingly produce harmful products. It’s a shame…

  18. sandy says:

    JNJ was ordered not to destroy records, yet they did and a judge determined they didn’t do it on purpose! And it can’t be mentioned in some of the trials they did destroy records…

  19. Gigi says:

    I sure hope judge goodwin stops dragging his feet on this.

    If after the next court appearance the judge denand cases resume I WILL ALSO HOLD HIM RESPONSIBLE

    • Meshie says:

      If you want to start reading the opinions and briefs that are written (http://www.wvsd.uscourts.gov) by the Judge’s in the MDL’s … Judge Goodwin just denied a delay in a case starting tomorrow.. Again, maybe we all need to light the fire under our Attorney’s and let’s start holding them RESPONSIBLE

      Oh by the way when you figure out a way to hold him (Judge Goodwin) RESPONSIBLE let us all know..okay?

      • meshie says:

        Bellwether Trials

        Updated 2/18/2015

        Wise, et al. v. C. R. Bard, Inc., (2:12-cv-01378), scheduled to begin trial on February 18, 2015, has settled.

        mute point it settled

        • anonymous says:

          Does another trial begin today, February 18, 2016? I think the Wise case settled in February of 2015 (year ago today).

        • meshie says:

          Hey … I have been doing so much reading and dang it the years have just run together..lol we are in 2016,, Jane you are more then welcome to delete the above and this… thanks

  20. jim says:

    Makes one believe The Hon Judge Goodwin is bought and payed for by the large mesh makers

  21. sandy says:

    It was mentioned in the latest Philadelphia court trial but was not allowed in some previous trails. Not to say it won’t be allowed in all trials going forward, who knows.

  22. Toni says:

    Why were you brought up in a trial ? Was it defence derogatory or for the plaintiffs side. It doesn’t sound like it hurt either way we all win if we get a positive verdict.

  23. Debi says:

    Jim,

    That was a very unfair statement about Judge Goodwin. He has to follow the rules of the law, he doesn’t change the court dates because he wants to. A law suit is not governed under the ” speedy trial ” law, we are all under stress and wondering if or when this is going to be over, BUT that doesn’t give anyone the right to blame or defame others.

    Please everyone stop the false statements, they just stir the s—t pot and does nothing for us. Remember our words are the reason Jane is unable to get the live news feeds. Don’t put her in that position again.

    • Jane Akre says:

      I fully endorse everyone’s right to speak up and out as long as we are not profane and don’t generalize. That unfortunate incident should not reflect on your future conduct… as long as you are civil. And, unless you have personally spoken with Judge Goodwin, your speculation is just that….please state it as such…. thank you.

    • anna says:

      Everybody is trying to understand this cases. But, its hard to except the fact that some Judges, have clear documentations, of J&J destruction of documents, and make the decision not to allow it as evidence in the trials. In addition to the damage their product caused in our bodies, this information could have a great impact on the jurors. I know they are all very bright, otherwise, they would not be sitting were they are. So why are some allowing it, and others aren’t? Is it fair for the women who have lost cases because, pertinent information are not enter as evidence to their trials..

  24. jim says:

    I am sorry for the strong words I spoke yesterday.They were ill advised and too early we will all know more after a few more cases in the mdl courts.After reading about the Edwards case I could not hold myself back.My wife and I like most everyone on here have gone through terrible times 8 hospital trips and 5 operations in the last 12 months lost our car our house has been foreclosed on and trying to raise two grandchildren.After reading the Edwards case and the judge not allowing any evidence for the plantiff what do you think.Bottom line device is defective and made from materials not supposed to be in the human body case closed.

  25. kitty says:

    It’s OK Jim. I too have said things that I needed to apologize for.

  26. janet says:

    It does not matter

    The crap is bad they did it they know they did. They decided y ok play God with our lives.. this company needs to make it right for everyone

    They need to pay out good settlements and let us try to fix what they destroyed. .r it might kill us..judges need to have them stop playing with our lives and pay up .. and nit these little 20 to 40 ,60 thousand settlements they lied and cheated us from our health …

  27. Jeanine says:

    I am like you all, tired of waiting for Boston Scientific to settle and admit guilt. They are causing more harm to us everyday they delay. So any people have lost so much and I pray everyday for resolution. I am in need of medical help which i cannot afford even with insurance. So I can’t even get more documentation for my case. We just don’t make enough with my hubby going through chemo for stage 4 cancer and he is trying to work still.

    Has anyone else developed severe body pain that a doctor has blamed the mesh for? I am in excruciating pain every day, barely able to function for a lot of activities and I wonder if this is from the poison from the resin?

    Is there an online support group that anyone has heard of?

    Thanks for listening. I am so sorry you are all going through the pain and suffering this has caused. I will keep you all in my prayers.

    • Still Standing says:

      Jeanine…Im so sorry for your pain and the difficulty of getting adequate medical care. I know just words cant comfort you enough but please know that you and your pain are in my heart and the hearts of women with mesh everywhere. We have to hold each other because most of the world doesnt know how. It is hard to feel out of options, and even more to feel that there is no hope. The added stress of caring for your husbnad must be overwhelming. Try to grab out and take hope wherever you can. Its out there , sometimes out of sight, but still there, in the shadows of our pain.

      I, too, developed joint and body pain. Have you ever heard of myofascial pain? I have a link here below. It is a painful muscle pain where trigger points develop over muscle groups, often not in the same muscle group that experienced the trauma. As you brace and hold in because of your pain, your muscles become shorter and even more inflammed and painful..it becomes a diagnosis itself. Women seem to develop more myofascial pain than men. This is especially true in the pelvic area. I dont know what your surgery was for, but more than likely, you had some muscle tightening before the surgery as a natural result of prolapse or SUI. The surgery then just added additional trauma, then the post mesh pain reinforeces it. You have so much stress that you more than likely stay in that fight or flight mode, and the pain just feeds off itself. It is important to become aware of your pain in the context of your day. When does it hurt most? Are you sleeping…if not, that is a major trigger. Can you carve any time out of your day for self care. My doctor told me to rest one hour for every two hours up. That is hard to find the time, but so necessary in order to start relaxing those tight muscles. I recommend a pain diary to the pain patients I work with, just to help connect the dots about when you hurt, where you hurt through the day. I could write forever here, but I am absolutely willing to volunteer to do some phone call pain counseling for you if you would like. It is my mission and part of my coping to teach others about managing pain. Jane has my email and phone numbef and she can give it to you and we can have a phone chat if you think it could help you. Here is the link about myofascial pain: https://my.clevelandclinic.org/health/diseases_conditions/hic_Myofascial_Pain_Syndrome

      Additionally, pain is caused by inflammation. I see an integrated health MD who has tested me for many inflammation markers and he does believe the mesh has caused my immune system to go into high gear, a natural thing for it to do as it recognizes the mesh as a foreign body and tries to get rid of it. This has triggered many food sensitivities and just overall inflammation. I am following an anti-inflammatory diet which has been helpful. Dairy and sugar are two things that drive inflammation. And, of course, when we hurt, we want comfort food, which could be sweets, ice cream, the good stuff, but it can really up your pain.

      I hope so much that you are able to resolve your legal claim. Dont hold out for an admission of guilt, though, because more than likely at this point, decisions are probably led more from their insurance companies than the actual corporations who sold the mesh.mesh. They have a lot to lose. Most business liability insurance prevents the company from admitting guilt. They could forfeit their insurance benefit if they do. Settlements occur without an admission of guilt on the corporation. That is why even in the face of damaging facts, they continue to maintain their innocence. Insurers are kind of the silent elephant in the room that can actually drive the litigation.

      I hope to hear from you, Jeanine. There is the hope of better days.

      • Jane Akre says:

        Careful of Cleveland Clinic,,, they are NOT a leader in dealing with mesh complications.

        • Still Standing says:

          The same info is available vie webmd, and other online sources about pain. I didnt pick them specifically. However, I had my most crucial explant surgery at Cleveland Clinic. It was a brutal surgery that required cutting around delicate organs and tissue and to finding and dissecting out a cut arm that had migrated far from where it was placed. I had multiple blood transfusions and blood clots but a few years later, I can point to that surgery as the one that turned the corner for me. My treating urgyn and my physician at Cleveland had extensive talks and I felt that I was in capable hands there. I was able to get all but about 15% of the mesh removed with this surgery plus others before and after. So, I guess there are positive and negative experiences anywhere we would go. I almost didnt go to Cleveland because I searched and found negative comments about them, but I trusted my treating doc to advise me and it has benefitted me personally. I do realize, of course, that many doctors dont earn that kind of trust and it would be a harder decision to make. Just as one mesh experience doesnt fit all women, there are doctors who can help one patient but not the next.

      • Jeanine says:

        Still Standing,

        Than you so much for your encouraging response. Yes it is almost impossible to get completely through a day. Work and home is all we do now and that in itself is very trying for both of us. But we do it because we have no choice. I will check out the link and get a better understanding of this pain and maybe can get some kind of help for that. I am scheduled for Botox injections in my bladder. They didn’t work last time, but this time I am getting a double dose so that in itself has risks of not being able to go at all therefore I would have to self cath until who knows when, but I can’t keep going like I am now. The progression of problems are amazingly fast. I wish you all the best and will keep you in my prayers.

        • Still Standing says:

          I had to self cath for a period of time. It was a tremendous emotional hurdle, but turned out to be not as bad as I thought it would be. Once my bladder started functioning better, I was able to discontinue that fun pasttime. Amazing what we are able to adapt to…we have to dig very deep but there is a well of resilience inside all of us. Very hard to tap in to, but I believe it is there.

      • Bejah Blue says:

        SS, You are such a treasure.

        Bejah

  28. annonynous says:

    So,Johnson and Johnson destroyed their paper trail,and got away with it,how do we know if they too weren’t using this? I’m in disbelief that these companies continue to feel they aren’t responsible for what has happened to the victims. Fda and judges seems to ignore the fact that victims from across the country with different manufacturers and drs have suffered. It is not a specific area of the country,or Dr, or even one manufacturer. Come on these manufacturers have probably all users this crap and we were the guinea pigs…

  29. […] because any resin product from China, where there are no regulations, might be tainted with toxins incompatible with the human body, […]

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