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Boston Scientific Pinnacle Pelvic Mesh Verdict Overturned, Plaintiff Wins New Trial

Pinnacle Pelvic Floor Repair kit

Pinnacle Pelvic Floor Repair kit

Mesh Medical Device News Desk, September 14, 2016 ~ Plaintiff wins a new trial as Boston Scientific Pelvic Mesh Lawsuit is Overturned.

A decision by a Massachusetts Appeals Court means a mesh-injured woman from Ohio will win a new trial against Boston Scientific over her Pinnacle Pelvic Floor Repair Kit pelvic mesh implant she claims caused her injuries.

Yesterday, the court overturned the 2014 verdict against Diane Albright.

The jury in  her 2014 trial in Massachusetts had concluded her Pinnacle pelvic mesh was not defective and the warnings to her doctor were adequate.

Fidelma Fitzpatrick, Motley Rice

Fidelma Fitzpatrick, Motley Rice

See the Mesh News Desk background story here and after the verdict here.   Albright was represented by Fidelma Fitzpatrick of Motley Rice.

Lawyers for Albright immediately filed an appeal.

Judge Diane M. Kottmyer

Judge Diane M. Kottmyer

The appeals court agreed – key evidence was omitted from the 2014 trial by Judge Kottmyer.

The judge withheld from jurors the Material Safety Data Sheet (MSDS), that is a document that gives detailed information about a chemical, its properties, safety, and environmental hazards. It is designed to keep workers who handle such materials safe and is required by OSHA, the Occupational Safety and Health Administration.

It has been one of the most compelling pieces of evidence plaintiffs’ attorneys have shown at trial for several different types of mesh, all made of the polymer, polypropylene.

The MSDS said that devices made from polypropylene resin are “not suitable for permanent implantation.” Pinnacle, made from polypropylene, is a permanently implanted pelvic mesh.

Judge Kottmyer also did not let jurors see two letters from the Food and Drug Administration (FDA) that ordered post approval surveillance of Pinnacle.  Instead, Boston Scientific took Pinnacle off the market in a voluntary recall in May 2011, three years after it was launched.

While the jury knew that the produce was cleared, the Plaintiffs were not allowed to present evidence about what was wrong with that 510(k) application process, a process that clears mesh for sale and not based on safety. That left the jury with the impression that the product was “legal” even though the Plaintiff vigorously argued that the product was not safe and was not effective.

According to court documents printed in MassDevice:

“We conclude that the MSDS caution was relevant, material evidence admissible for the limited purpose of showing that [Boston Scientific Corp.], which had received the MSDS well before 2009, had notice or knowledge of the content of the caution,” Justice Gary Katzmann wrote. “When considered solely for the purpose of demonstrating notice or the extent of BSC’s knowledge, the caution was not hearsay.

“We conclude that, in the unique context of this lengthy trial, Albright ought to have been allowed to use the letters for the limited purpose of cross-examining BSC’s witnesses, who had testified, without qualification, that the Pinnacle device was safe as of the time of trial. Such a limited use, to show bias or to rebut the witness’s opinion testimony, would be reasonable cross-examination,” Katzmann wrote.

“We add that the judge would have been well within her discretion to exclude all reference to the 510(k) clearance because of its potential to mislead the jury and confuse the issues. However, having permitted BSC to invoke the 510(k) clearance, it was error to preclude Albright from using the later-in-time (2012) letters in cross-examination of BSC experts or employees, who had addressed the FDA clearance, to rebut BSC’s claim that its product was, in essence, ‘cleared’ as a safe device,” he weot.

47 Comments

  1. Lori says:

    I also have suffered and continue to suffer from B.S. Pinnacle Mesh for POP as well as J&L, E.. 3 Ehticon, 3 mesh were implanted in me. It should be criminal.. These companies are as a murderer, but much more cunning and cruel.

  2. Anon says:

    Hugh win for mesh victims. So encouraging for ones that continues to fight for what they deserve.

  3. Sea says:

    HURRAY >>>>>>

  4. jan says:

    Why is it that these manufacturers keep putting us through HELL
    they know what they have done they have altered our bodies injured us to were we will never be the same
    Boston scientific had bragged having 185 Billion to fight against us the injured women there device had altered us.. instead of taking that money and settling some of there cases.. they know they have lied they gave basically murdered us we will never be the women we were before these inplants.. but yet they want to keep injuring us .. this is so sad we have pain severe pain everyday along with other issues that will never be resolved because of there Greed for more money…when will these judges make these manufacturers do what’s right for us the injured. .

  5. Pat says:

    Let’s hope she gets justice this time.

  6. Linda says:

    Good News someone that believes actual evidence needs to be presented to the Jury. Does this mean we might be making some progress?
    I have a question. Has anyone had dental work with a dental dam over their mouth and then broken out in blisters? It was non latex. 4 weeks later with oral and topical steroids can’t get rid of them

    • Linda, I developed mouth ulcers shortly after the mesh and would get a terrible flare up whenever I had mesh erosion. I have since been diagnosed with a very severe form of erosive lichen planus…vaginal and oral. It is an auto immune disease. It can be confirmed using a specific staining of a biopsy. Getting ready to start taking cyclosporin, an immunosuppressant. Not happy about that but like you, cant seem to get rif of ulcerations.

  7. Hope Pagano says:

    What is the chemical they are referring to in your article?

  8. Terri says:

    Thank you, God!

  9. carolyn says:

    I brought this msds issue up with the therapeutic goods administration in australia a few weeks and their response was that polypropylene has been used as implants for many years and the msds are all approved for mesh because of certain formulations that make them safe.
    Yeah right tga. We believe you – not.

    • Jane Akre says:

      Certain formulations that make them perfect for fishing line or transvaginal mesh. They need to see these. it specifically says not for implantation

  10. carolyn says:

    Dear Cheryl (TGA),

    Pelvic mesh is made of polypropylene.

    This Material Data Safety Sheet states that polypropylene is not safe for permanent implantation in the body. Why then have these devices been approved for safe use to implant as a permanent device in women?

    Can you please explain this to me?
    ________________________________________
    Hello Caz

    Many different types of plastic, including polypropylene are used in implantable devices, for example heart valves, sutures and stents, and have been for many years.
    Polypropylene, as with all plastics, is produced by many different manufacturers for many different purposes including medical use. This results in different types of polypropylene, depending on its ingredients and processing methods and intended use. Each manufacturer produces a material safety data sheet (MSDS) for each type of polypropylene it supplies. You provided one such example of a MSDS for a type of polypropylene that was not intended for implantable devices. Manufacturers of polypropylene that is intended for implantable use have their own MSDS for this type of product.

    Kind Regards

    Cheryl
    _____________________________
    Dear Cheryl,

    Are you able to please provide me with the MSDS for every registered transvaginal mesh product on the ARTG?

  11. stopmeshimplants says:

    This is wonderful news! Thank you for this important update. I truly believe all of this mesh mess will come out to the public and people will finally understand our cry for help. I don’t know when, but it is going to happen. Thank you, Jane.

  12. Absolutely wonderful news. Justice served

  13. Jimmy says:

    Jane does this put pressure on every mesh maker or does it just affect bostin scientific. To start settling

    • Jane Akre says:

      No way of knowing but common sense tells us it is not good news for Boston Sci…..

    • Jimmy says:

      My mother just keeps hearing from her lawyer thst it will be done this year. But she is through ethicon. And her lawyer didnt even know that mesh causes back pain. It just has her concerned that she isn’t being represented very well. And she is going in for more back injections and another major surjery to try and remove the mesh. All of these surjery have totaled up to close to 20. She is just very worried that she wont be treated fairly through the settlement process

      • Jane Akre says:

        Does your lawyer have all of her medical records? have you kept a copy in case you change lawyers? Is her law firm partnering with another that is negotiating with J&J? If they are not planning to settle, are they planning to work her up for trial? Do they have any history of settling with J&J? What exactly are they doing that they expect to be paid 40%?

        • Jimmy says:

          Yes she has beef faxing every back surgery/ injections to them. Has been seeing a pain specialist also with a back specialist. Cant get an answer if they ate working with another lawfirm to settle. And has had 8 surgeries to work with just the mesh not her back. My mother isnt over 60 and is walking with a walker and probably heafing for a wheelchair. If the next mesh surgery doesnt work she is going to have to self catheter the rest of her life. She cant even pick up her grandchildren or go to a school function without wetting herself. Her lawyer sent her a paper saying no need to call anymore and to just fax the paperwork. I feel like my mother isnt getting the attention her case deserves or needs. Its very frustrating. And they haven’t sent all of her paperwork to us yet. I fear that she is going to be pushed into a settlement agreement with no choice of her own. Is there anyway we can get more answers

          • Kitty says:

            Hi Jimmy… I dont think there is research on The back issue. I think if I woman has a very weakened pelvis..there is a propensity for the spinal column to prolapse and cause pain and slipped disks.

          • What the hell does that mean?? No need to call? You have got to be kidding. How long has your mom been with this firm? Has she done a plaintiff fact sheet yet? Tell them you will not just sign and FAX any document without going over it by phone with someone in the office. i just cant believe what some firms are NOT doing. It s not right on any level. Your mom is their client. The firm is required to maintain appropriate communication with their clients, to engage them in the case and to operate with transparency. Now, go contact the firm, politely but firmly tell them you have significant concerns about her case. If they do not return call with a person qualified to discuss your case, call the state bar association ,whatever state the attorney is practicing in, and ask for their assistance in getting your lawyer to inform you. Register a formal,complaint if you can. They owe this much to you AT THE VERY LEAST.

          • Jane Akre says:

            Thank you Still. It is outrageous….. one could get the impression some firms just want to “clear their inventory” of mesh cases, a term I have heard.

          • Jan says:

            My firm has not contacted me but one time since the first filing
            T h ey never give updates they do not even call to ask questions regarding doctors. . I take it in my hands I have sent all medical records ftom every doctor I have seen surgery information . I have to contact them I phoned them 3 weeks before my surgery in July and they still have not contacted me asking anything
            I had to explain the anxiety that is affecting my heart spent 3 days in the cardiac unit
            They just want there 40%

          • Jane Akre says:

            I’m sorry but that is not acceptable behavior.. I don’t know who they are but really it is not! Care to name them?

      • Kitty says:

        Jimmy..so sorry to hear of ur Mom. Be careful of who does this surgery…it could lead to further damage. I believe there is correlation between mesh implant and spondolethesis.

  14. ANNE says:

    This should be done with all the mesh trial, also the Judges should stop rescheduling cases. It’s time to stop siding with this defense attorneys, in which by dragging cases are making themselves rich with the money that most injured women should get.

  15. Linda says:

    Called attorney today and updated all places they need to get records. If your name is not on the list of trials, then it was not selected. Ladies keep your records up to date so your attorney can track your case on-going. I assembled a very large binder of my copies. I put them in chronological order and divided them by the doctor I saw. You want to have your personal copy. This is also helpful if you are following up with different specialist. This way they can track what you have been through, tried, works, does not work and why the pain continues despite attempts to correct. It really shocked me when I started putting it in order. So many visits, so many UTI lab reports and bacterial infections, x-rays, MRI’s, suffering. Be prepared the whole process triggers a lot of negative emotions. Jane, if possible can you give my number to still standing.

    • Jan says:

      How do we find that out

      • Jane Akre says:

        Have you even seen your complaint? Do you have a case number? Have you made sure it was filed? Do you have any contact person at the firm? I can look it up if you have a number… it should be on some document.

        • Here is an article about attorney client relationship expectations. It appears that there are some who are representing mesh women who are not following the American Bar Association guidelines. Insist on your rights as a client to be treated professionally and ethically. Maybe this is a topic that we can bring to light to the legal profession. Jane, I would be interested in doing a questionnair of the readers about the quality of legal representation they have had. Could be an eye opener. If you will publish it, I will set up a quantifiable survey that we can submit to the American bar association. Go to the link below to see how you SHOULD be treated.

          http://www.americanbar.org/content/newsletter/publications/gp_solo_magazine_home/gp_solo_magazine_index/2008_jan_feb_clientcommunication.html

        • Jan says:

          Yes it is filed in west Virginia
          It was first filed in texas

        • Jan says:

          I spoke with an attorney 2 yrs ago there I had to insist hard
          She phoned me about 8pm if I remember correctly
          Her response to everything wad they have no money.
          We will never see anything. . Thats the truth I did not like her at all.. she stated before they ever get to my case Boston scientific would be in bankruptcy

          • Jane Akre says:

            Doubtful. BSC is taking care of itself and won’t let that happen.

          • Jan, you need to ask your attorney who told you they would run out of money and you would not see any why they took your case. Just cant imagine they would tell you that. I cant believe the totally unethical legal representation I have seen talked about on this site. Even them telling you that you would be able to take a vacation, invest money was not appropriate either. They should not have promised you something they could not guarantee. They should have told you they would fight hard to protect your interests while giving you honest communication about the litigation process. You have a right to be angry with this process.

          • Jane Akre says:

            Agreed. I’ve heard more than once, This is a million dollar case, in order to get women to sign on. Then only to cease communication and not deliver. Anytime a law firm makes promises like that, find the nearest door!!!! (in my opinion)

  16. Looking forward to talking with you Linda when I get your number or you get my number from Jane. Are your attornies not pulling your records automatically. I signed a HIPPA release, the attorney contracts with a health records firm, then that firm pulls everything out there regarding my health. Believe me,the defense gets all of it. At my deposition, they had my records back when I was in college going forward. Every single thing, regardless of what connection it had to the case. It is a form of intimidation for them to reveal early in the deposition that they know what happened to you almost 50 years ago. They also brought up my children and they had information about where they lived,where they went to school, where they were employed… Yes, they know it all.

  17. Linda says:

    No when I called yesterday the only record they updated were from my Psych therapist. They had not sought my removal report or reconstruction reports from UCLA. I also saw a gastro recently who did some pretty gross tests to figure out why I cannot go without using the laxative. Of course it all ends up with no answers, but they still should have the records. They have not requested anything. I am guessing if settlements are approached it will be based on records. Like always we have to follow up on every thing. I am going to mail them copies because who knows if they will be requested or not. I called because I was worried when my name was not on the filed list. I had a letter from them 3 years ago with a filed number. I thought I better call. Now I have a legal section in my binder and I make a note when I call and who I spoke with. It’s just all exhausting. They hope we will wear out and give up. It seems the attorneys are getting tired. I can’t say I blame them because they have worked hard and everything is put on hold or appealed. We have to encourage each other to continue forward. We will not go down without a voice!!

    • j williams says:

      Linda,
      I too had the same problem not being able to have a bowel movement without taking a very strong laxative. It wasn’t until I had the mesh removed that I was able to have bowel movements again?

  18. Linda says:

    They can pull what they want. The truth is I want my day in court. I really want to attend a trial. I see the corporations just like any other perpetrator. I’m sure they try everything to avoid discussing the real facts. Perpetrators always try to turn it around and place the blame on you. Unfortunately there tactics work a lot of the time. Just like shutting Jane out of the trial. I will go down kicking and screaming.

    • Jan says:

      I really do not know ladies is it good are not
      The trials for Boston scientific have had good outcomes. . These ladies win millions and we are stuck with offers of pennies.
      Is that justice, Is it fair?
      I am happy for them but then we, the low women on the totem pole, lose.
      I want these manufacturers to be fair, I am not out for blood
      But I can not take care of myself or my medical for pennies.
      My attorneys office when I first hired them stated we want you women to be able to invest your money to help in income.. we want you to take a vacation because we have been through so much. . Well how in the HELL do u invest pennies and be able to take a breath on a vacation and say that part us over an try to conquer your health issues knowing we can not afford to live
      I have listed everything. I want them to be honest
      I would still be at my wonderful job making great money enjoying my life and children’s and grandchildren lives.
      I cannot enjoy any of my life because of my health and the pain is greater than I.
      Why can’t these manufacturers just be honest and do what’s right
      Boston Scientific had 185 BILLION to fight us would it not be in there best interest and there company’s interstate to do what’s right by us.. it would show them being a passionate company….but instead they would rather put us through more hell.
      I am pleading with Boston Scientific to do what is right by all, not a few.

      • Jane Akre says:

        I so hope someone with BSC sees your words Jan and feels what you are going through. I’m so sorry.

      • Barb says:

        What kind of attorney firm talks with their clients in this form of speech?? I have never had issues with my attorneys. remember they work for us, demand, be a huge advocate, get answere’s!! BTW for you all who are/have signed a paper for your attorney firms to get all medical records it takes longer. Please do it yourself, I did and alway’s keep copies and the amount of money they will charge you is going to be several hundred or thousands that will be deducted from any settlement.

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