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Cardenas Trial v. Boston Scientific Omitted Material Safety Data

Prolene Mesh 300According to this article in Lawyers and Settlements, lawyers for Maria Cardenas (Cardenas v. Boston Scientific) were not allowed to introduce to the jury the Material Safety Data Sheet.  The MSDS, you’ll recall from other trials, is a breakdown of the raw material that comes from oil companies,  Phillips or Sunoco, that goes into the raw resin material that eventually is spun into pelvic mesh.

See the Donna Cisson trial here:

http://meshmedicaldevicenewsdesk.com/latest-in-the-litigation-concerning-mesh-and-medical-devices/c-r-bard-transvaginal-mesh-case-week-2-bard-avaulta-never-studied-in-humans/

Twice now the MSDS has been introduced into evidence and twice the jury has seen that the supplier adds a disclaimer that the resin is not to be made into implantable medical devices.   That might make all the difference for a jury to see.

Here is the Lawyers and Settlements story:

http://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/tvt-sling-transvaginal-mesh-24-20069.html#.VBX0RmPE4R9

 

13 Comments

  1. msm says:

    Perhaps an attorney or court official would like to weigh in on why there is such a vast difference in admission of evidence between courts? Comparing the trials in Massachusetts, Texas, and West Virginia, there are significant differences resulting in significantly different verdicts and awards. I realize that some of the cases are having to follow laws of other states (especially cases in an MDL), but a lot of the decisions seem to up to the judge. Why such different decisions? Are there legal precedents that apply? Does it depend on the presentation by the attorneys to the court? Is it the result of compromises made in pre-trial proceedings? Please educate me on this.

  2. msm says:

    Now I am even MORE confused.

    The article referenced from “lawyersandsettlements” states:

    “Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI) are two conditions that are commonly treated with transvaginal mesh inserted laparoscopically through a small incision and deployed inside the abdomen by a surgeon guided by a small camera.”

    I think they have the wrong procedure.

    • Jane Akre says:

      msm I didn’t see that…. I believe you are right… it is commonly done transvaginally…some women are having polypropylene put in laparoscopically though as sort of a skirt around the warning on a transvaginal approach. A surgeon might be able to answer that… good question for an “As the Surgeon” section! Thank you.

      • msm says:

        I believe (my opinion) that the laproscopic approach has the least risk of infection because there is a sterile field as opposed to the vaginal approach. However, the manufacturers will not promote this because

        A) they would have to admit that the vaginal approach has a greater risk of infection so there is a better alternative.

        B) the 22-minute procedure goes out the window and there goes their greatest selling point.

        No more “Gold standard”.

        C) laproscopic approach requires more training and equipment and they cannot be bothered with it.

        Of course, the end result is still mesh in the body. But at least it wouldn’t already be infected when it starts eroding into everything around it.

    • Kitty says:

      msm–I just went to that read and it is no longer available—they must have DELETED IT.. I smell a Rat–as in the dead rats that were euthanized after implant ie Jennifer Mercuri #300-58

  3. msm says:

    Kitty, the link is dead on this site. You have to cut and paste it gov to the site. Clicking on it won’t work.

    http://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/tvt-sling-transvaginal-mesh-24-20069.html#.VBX0RmPE4R9

  4. msm says:

    OK. That was confusing. Sorry. What I meant was if you click on the link in the story, it is dead because there is a link “behind” that is dead.(Jane might want to fix that)

    Click on the actual URL I have in the comment above, and it will take you there.

  5. Dean says:

    So it’s very possible Cardenas could have a retrial due to this evidence it’s not right you can use evidence in one court room and not in another court room especially if it’s about the same issue what’s really going on here this isn’t right even if it’s different jurisdictions or not.

  6. Kitty says:

    What I read was that transvaginal mesh was placed laproscopically thru the abdoman. TRANSvaginal—means via the vagina. This was an error in this report——the way I see it. How can one go thru (trans) the vagina and then thru the abdoman. This reminds me of the Kennedy assasination —-how the bullet made a U turn in mid air.

  7. msm says:

    Food for thought….if TVT for SUI is the “gold standard”, why are the mnaufactures losing business in their women’s health divisions? One could claim that docs are shying away because of lawsuits. However, if mesh mid-urethral slings are still the best treatment available, wouldn’t docs continue to use them at at least the same rate as before the lawsuits multiplied to current numbers? If docs truly believe that TVT is a safe product that will improve the quality of life of their patients, why would sales drop? Is it just because docs are afraid of lawsuits? It’s the manufacturers who are the target of the majority of the lawsuits. Or…..just a random thought…. have docs begun to question the safety of mesh in general and are looking to exhaust all other options before considering mesh AND are then discussing it with their patients honestly? I believe the latter.

    Yes, there are some docs with loud voices on prominent platforms with impressive credentials who tout mesh mid-urethral tape as the “gold standard” of care. But how many docs are using them. What are the numbers. Have sales remained the same? Increased due to all of the new products? Decreased to the point of financial loses in those divisions requiring layoffs of sales reps? Is this why Endo is trying to sell AMS for a billion less than they bought it for three years ago? Are others considering reducing the product line of mesh products overall? While manufacturers may demonstrate financial stability you can bet it is not because of their women’s health or pelvic health divisions. Just food for thought and discussion.

  8. Summer says:

    Has anyone thought about contacting Michael Moore who does the documentary

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