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J&J PROSIMA Pelvic Mesh Case Goes to the Jury!

cropped prosimaMND, October 2, 2015 ~ About 3 pm Central Time, the case of Cavness v. Ethicon rested  and went to a Dallas jury for deliberation.  (Carol Cavness v. Kowalczyk et al., case # DC-14-04220).

**Late Word** The jury was dismissed 5:51 EST saying they needed more time. They were hungry and tired!  Monday they will continue deliberations! 

The 12 jurors will have to decide if the Prosima pelvic mesh, used to treat pelvic organ prolapse, is defective in its design and its manufacture and if the manufacturer, J&J’s Ethicon division,  failed to inform the end user doctors about its dangers, that is, whether it was also defective in its instructions.

Previous trials have resulted in $15.87 million in judgments against Johnson & Johnson, which makes the Prosima.  J&J has vowed to continue to try these cases rather than settle, as three other mesh makers have begun doing.

Jurors, art by Akre

Jurors, art by Akre

JURY INSTRUCTIONS Gavel 500

Before Judge Molberg this morning, both sides discussed jury instructions. Among the 20 or so questions for the jury to consider, the Defense wanted to change some of the language.  Defense suggested to Judge Molberg the instructions should say the Prosima is an unavoidably unsafe product because it is implanted surgically.  That suggestion was overruled.

Defense wanted the jury to be told the manufacturer does not have a duty to warn the patient about the rate of severity of adverse events because the device is a prescription device. That was overruled.

Also Defense wanted the jury to consider when there is reasonable disagreement in the scientific community, it should not representat a liability for the manufacturer. That too was overruled.

Judge Ken Molberg, 95th Judicial District, TX

Judge Ken Molberg, 95th Judicial District, TX

BACKGROUND

The case began Monday, September 2 in the 95th Judicial District Court of Dallas County before Judge Ken Molberg who has presided over two other pelvic mesh cases, both of which resulted in jury awards for the plaintiff.

In the case of Linda Batiste, her case against Ethicon over its TVT-O, the jury found the mesh to be defective and awarded her $1.2 million.  In the case of Maria Salazar, the jury found for Ms. Salazar and awarded her $74 million over her Boston Scientific pelvic mesh. That amount was later reduced to half due to a state caps on jury awards.

Friday verdicts are not uncommon and at this writing everyone is sitting in the courtroom waiting.

Cavness is represented by Tim Goss and Richard  Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.

Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kathleen Gallagher of Beck Redden LLP.

Thanks goes out to Courtroom View Network for access to a live feed in the courtroom proceedings. 

 

31 Comments

  1. Pam says:

    As always, thanks Jane!! You keep us all informed of such vital aspects of our lives in an otherwise hopeless state!! Each document, & interview that’s uncovered you’re always reporting, & again Thanks for the superb job that you do!!

    Prayers for Mrs.Cavness & the jury to impose judgement against J&J!!

  2. Mesh Nightmare says:

    Praying this jury will send a clear message to Johnson & Johnson/Ethicon that the time has come for them to concede.

  3. Anonymous Anonymous says:

    Yes as usual thanks again Jane:

    Just hoping the Jury goes in Mrs Cavness favour and praying if so that J & J might come a little closer to seeing that they have to settle all cases involved to end this Mesh nightmare as this just can not keep going on like this surely they must see this by now.

  4. Linda says:

    I don’t think this doctor knew the dangers. Her we are 3 years after the second FDA warning and doctors don’t know. They put stuff in our bodies and base it on the words from a salesman. It’s a scary time in our medical world. Positive energy to the jury!! They don’t have any idea how many of us exist either.

    • Jane Akre says:

      True. They were not told about the scope of mesh lawsuits… in excess of 100.000 cases And growing!

      • Bejah Blue says:

        My goodness, just the other day it was 80,000! Where do we go from here. Sometimes I wonder what the point is. These defendant corporations are just going to manipulate the courts in whatever ways necessary to ensure a favorable outcome for themselves. They do not care what this costs the justice system, the American taxpayer, and the economy of the nation. Soon will attorneys stop taking cases because the cost benefit analyses are just too far off to make representation of clients sensible. Then what? It is time for criminal prosecution. It is time for Johnson & Johnson to be forced apart. This has to end.

        Bejah

  5. stopmeshimplants says:

    Many thanks to Jane for your excellent reporting of the facts in this case. My prayers go to Ms. Cavness, her family and her attorney’s for representing and supporting her throughout this trial. I am also praying for justice from these jurors and am hopeful they understand the seriousness of Carol’s life long pain issues and award her huge monies accordingly. Only then will J & J begin to realize we the injured are not going away and will fight to get our stories out there with these trials. Big phamas are going to lose and our stories will be told. I have to believe that!

  6. guest says:

    Defense wanted the jury to be told the manufacturer does not have a duty to warn the patient about the rate of severity of adverse events because the device is a prescription device. That was overruled.

    ” because the device is a prescription device”-

    That is the most asinine statement I have ever heard. How can you ask for such nonsense as the manufacture of your own product, then say because it was a prescription which was written for your own product, that you are not responsible for the adverse effects?

    stupid request..

    • Bejah Blue says:

      It is called linguistic manipulation in some circles. Language can be a very powerful tool and a very dangerous weapon. JnJ will do just about anything, not just to protect perceived assets and markets but this sort of pathological personality that is JnJ must also win, to protect and expand its egoistic empire building vision. That is one of the things it feeds on. We must all understand what we are dealing with.

      Bejah

    • Bejah Blue says:

      And if my memory serves me well certain manufacturer’s are now blaming the implanting physicians, deflecting blame from themselves it would seem, but I promised to be kind and I must take care about what I say for fear Jane will be criticized because of something I said in a particularly emotional moment.

      It is hard to be civil sometimes in the face of such evil. Who can we trust? What of freedom of speech, where are the barbed wire fences around that civil liberty I sometimes wonder. We know we can trust Jane because she has been through the fire and remains standing but what of some of the visitors to the site and others? Do we not have the right to be critical when something seems out of balance? In life, sometimes people sell others out, and neither doctors or lawyers or Indian chiefs are immune from suspicion. Sometimes people sell each other out. especially where a lot of money is in play.

      There are moments when I am tired of being kind, civil, respectful, and always giving others the benefit of the doubt.. When you have been run over by a truck and left to die in the road kindness is not your first impulse although it is the most civil perhaps. Women are by nature relatively kind, sometimes too kind, too forgiving, too willing to compromise and too easily manipulated. I do not wish to be unkind and it is not my nature but surely there are times when it is understandable, and times when the innocent are unfairly criticized. I guess it comes with the territory. Ultimately, freedom of speech must be protected over the feelings of any individual who may be on occasion, unfairly criticized or offended. If I have been guilty of that I am truly sorry.

      Bejah

  7. anony says:

    -As most people know by life’s lessons, it is easier to tell the truth than to hide all the darkness, which will come to light, eventually.

    No matter which way the jury goes, the plaintiff won this case based on how the evidence was submitted and lack of any responsibility at all from the defendants. The plaintiffs legal team did an amazing and outstanding job, and no client could ask for anything more or better than what they presented.

    I for one, struggle to understand how so little is allowed into evidence or allowed to brought to the jury’s attention, but the plaintiff attorneys did well with everything they had to offer. IMHO

    • Emmie says:

      I taped Oprah’s “Super Soul Sunday” that aired tonight and just finished watching the show. I will watch it again tomorrow. The show had so many wise words.

      Oprah’s guest was Dr.Brene Brown and the subject was her new book, “Rising Strong”.

      I felt there many comments that can be related back to our our struggle with the mesh mesh. We need to” Dare Greatly” which the title of another book Brene wrote.

      Here are a few comments that touched me:

      “The soul of the work is the willingness to show up and let ourselves be fully seen and heard.”

      I think the strength we need is in our numbers and together we must be heard and seen.

      “Vulnerability is best measure of courage.”

      “The body keeps score and it always win.”

      We cannot ignore the cry of our bodies. We need to listen to what our bodies are saying to us.

      Pharmaceutical companies cannot ignore the 1000’s of women whom they have hurt.

      “All are tied to each other. Our humanness (sp?) bring us together.”

      Part of manifesto found on page 267 of book “Rising Strong”.

      This is what I heard Oprah read and wrote what I heard.

      “We are the authors of our lives. We write our own daring ending. We craft love from heartbreak. Compassion from shame. Grace from disappointment. Courage from failure. SHOWING UP IS OUR POWER. Story is our way home. TRUTH IS OUR SONG. WE ARE THE BRAVE AND THE BROKEN HEARTED. WE ARE RISING STRONG.”

      I am not in any way promoting this book even though it is my plan to read it. I am writing the words that inspired me.

      Dr. Brene Brown is a social scientist. I wrote all the words of the quotes and I understand some may construe some of Brene’s words. This was not my intention.

      Jane bravely took the lead for us and without her reporting we would be in the dark. I thank you Jane for standing up and keeping us informed. Our strength is in our numbers and sadly in the pain of our injuries. Our tragic stories need to be heard loudly with a echo effect that cannot be ignored!!!

      Donald Trump…Oprah…Dr. Phil…Dr. Brene Brown any major public media.

      Please help tell our stories. Pharmaceutical companies cannot get away with thinking they are above the laws.

      PHARMACEUTICAL COMPANIES HURT VICTIMS OF BLADDER MESH SLINGS.

      PLEASE HEAR OUR VOICES LOUD AND CLEAR.

      Praying the jury sees the truth and gives a verdict in favor of Carol.

      Praying and thinking of you Carol. As Bejah commented in another post, a win for you is a win for all of us. Please God, bless us all.

      • Emmie says:

        Sorry for being so long winded and wordy.

      • Bejah Blue says:

        That was really beautiful Emmie, thank you. I really like to watch Oprah’s Super Soul Sundays, one of the best things she’s done. You can see so clearly how she has evolved over the years. Sorry for late reply, I am trying to catch up, keep up. When we heard of Cavness verdict it really shut me down for awhile. Sometimes longwindedness is a good thing!

        Bejah

    • Bejah Blue says:

      Thanks Anony for reminding us that “winning” has many definitions and perhaps dimensions…it seems also that it can be a process and not something black and white or something that is decided in a moment.

      We know our truths to be self evident just as we know in our souls of our inalienable right to be free. NOTHING can change that.

      I expect the research that proves the toxicity of this material and the devastating, life altering impact of the substances which leach out of it as time passes will come out of Europe and NOT the United States, just as the initial findings many years ago now came out of European studies. America seems to be doing very little to help us, the women and men who have, by the thousands, just in this country, been so deeply damaged by this polypropylene.

      That is not to say that life damaging materials have not also been produced in Europe as exemplified by Bayer, for example. Boycotting Bayer is a good idea. As many of your know their most recent money making scheme involves a way to make women sterile (How appropriate).

      And we thought the Nazis were gone. Many of them were of course brought to America at the end of WWII and granted all the freedoms and rights of citizenship because of their special skills and high level of intelligence, many to work for the military. The face of that evil has changed but it is still existent. Beware of Fascism and its many guises. They would have you believe these are the ragings of a madwoman but that is just what they want you to believe, it is not the truth. GOD tells us that the greatest trick of the nexus of evil is to cause us to believe that it does not exist.

      On a lighter note, I have somehow survived a terrible night with no pain medication, taking too much of other medications and sleep medication but I am still alive. I did not even care if the combination of medications might kill me, such was the pain. I realize that I would seriously consider suicide if there were no pain medication that could help me. This morning by about 10am I will have my pain medication again. It has been a terrible three days but it has also been a good learning experience. I will never again let my script lapse, for example.

      A neighbor who has worked with the dying said that two of the signs that life is fading are a loss of appetite and sleeping a lot and I, like many of you I expect, experience these to some degree. I also am sometimes so chilled as if from deep within, and then suddenly I will feel overheated. I feel my body is out of control, way out of balance.

      But I know that those who have caused all of our suffering will be brought to justice by a court they can not control, a court they do not even know exists.

      Bejah

    • Bejah Blue says:

      Important documents were not introduced, the jury was not properly educated, and tell me how many expert witnesses did the plaintiff’s counsel call upon? Someone else mentioned that the case was NOT ready for trial. I must disagree with you even though my knowledge of the law is minimal.

      Bejah

  8. guest says:

    Please know, You are not alone ma’am.

    Please Copy & Paste to view.

    https://www.youtube.com/watch?v=ybcrIO-I7ho

  9. Dawn says:

    How many cars brakes have to fail before there is a recall ???

  10. K says:

    Jane, do you think the judges especially Judge Goodwin visits this site?

  11. Janet Yellen says:

    Do the doctors (presumed learned experts directly responsible for the patients) involved get sued as part of this? After all, the doctors make the crucial equipment choices/recommendations.

    Or does the FDA clearance-to-market absolve them of most of that responsibility?

    What effect does a result in such a lawsuit have on an action against the manufacturer, if any?

    Or are patients (i.e. law firms) only going after the companies because they have the deep pockets (and can’t sue the FDA)?

    • Jane Akre says:

      The doctor in this trial and many others is being sued as well. She should have known that the mexh carried risks which she did not relay to the patient. The FDA only cleared the product to market it, not based on safety, so no the doctor is not immune from prosecution as they are with drugs. The manufacturer will count the wins and losses and do a calculation based on what it will cost them to continue with litigation. Usually they offer a settlement. It is the only way that consumers can speak to manufacturers until they start filing criminal charge which will result in prison time for executives. Many feel that is the way to go. Your last question is insulting.

      • Janet Yellen says:

        Thanks for the response.

        Criminal charges, while significantly more difficult to prove, will be a much more effective deterrent to companies than what is in effect today, IMO.

        The FDA clearance to market 510(k) is based on proof of equivalence to a previously marketed (and considered safe) medical device, so there is a safety component that the government agency is considering.

        As to your last statement, there’s no need to get sanctimonious.

        Not knowing whether the cases were only against the companies, since that is all that is generally referred to on the website and in most news articles, it would be legitimate to ask why only bring action against the companies. And since the law firms typically take 33-40% of settlement monies, cases that would result in payouts less than the work to cover just the initial filing costs (for instance) would logically not make sense, unless of course this is all pro bono work.

        • Jane Akre says:

          However consider when the FDA removed a medical device from market such as the ProteGen for being substantially unsafe, all of the devices cleared on that predicate remain on the market. What assurance of safety is that? Why not a re-review of ALL of the devices that pointed to the ProteGen, for example, as “substantially equivalent”? The FDA does not do that.
          My statement was based on the effective PR of companies that have the public believing this is a lawyer generated issue when in fact it is not. There are 83,485 cases filed in ONE MDL, the most in any other mass tort. There is a growing body count and this has been called a dark chapter in women’s health. Still no widespread media coverage of the issue….. unlike Vioxx, breast implants, thalidomide…. So I believe the PR has been very effective ( I’ve even heard that from one doctor.)… so yes, when I hear “deep pockets” of the defendants as a reason for this litigation, it hits a nerve. The media should be ashamed in my opinion.

          • Bejah Blue says:

            Well stated Jane, ever consider law school? 🙂

            PS You are not answering any of my email because:

            1. I am a wordy birdy

            2. You do always have a few things on your plate

            3. I forget…my mind is going…but I just remembered one thing…OK to give Addison my personal email.

            Bejah

          • Jane Akre says:

            I just spent a week moving and still have no wi fi…. nothing personal.

      • Bejah Blue says:

        Criminal charges…yes let’t start talking about criminal charges.

        Although the last question posed by Janet was “insulting” it must be said that law firms choose to focus on manufacturer’s for that very reason, because not only is that where the ultimate responsibility is, it is also where the money is. I do not mean to support Janet who seems to think deeply wounded plaintiffs would simply look for as much money as they could get…when you are in unbearable pain and you know this thing is killing you and you are not sure how many months or years you will live, big bags of money are not your principal concern and concern about addressing medical needs for whatever is left of your life of pain is best addressed by a life plan that is enclosed in settlement documents, and it is certainly the most civilized option. I would be interested in hearing Janet explain his or her reasoning.

        Bejah

      • Bejah Blue says:

        What I really want for Christmas, if I live that long, is for just one physician to step out into the light of day and admit they were paid under the table by one of the defendants to implant a woman who was not informed about risk or exactly what was being done to her, and for whom non surgical options were viable and more appropriate. Just one doctor, or failing that just one FDA employee in the Devices section who will testify that they overheard certain conversations between JnJ and an FDA employee who was in a position to prevent a level III advisory from moving forward after the cozy little tea party called by Johnson & Johnson. It is as if they know we know the truth but they also know there is ultimately nothing we or anyone else can do about it. It is as if they may lose a few battles or even more than a few but it does not matter because they believe they have already won the war. Sometimes the ego obsessed trip themselves up. Perhaps that will be the case in this matter. But how many smoking guns would it take to bring down the beast that is Johnson & Johnson?

        Has anyone written to Jennifer Anison (Do not know spelling of her name, sorry fans) to tell her Johnson & Johnson is paying her to advertise its product so well? We really should do that. I wonder if she knows. I wonder if she cares, don’t know her politics, etc. One high profile person like that who would do a 360 on them could help a lot. I will do a first cut if anyone thinks it would be worth trying. I will need an address, FAX not advisable in this situation.

        Bejah

  12. Ron Miller says:

    This is a good article and there are a lot of interesting comments here.

    Unfortunately, this was not the outcome plaintiffs were hoping for but many juries have spoken loud and clear that these medical device manufacturers are on the wrong side of these cases.

    • Bejah Blue says:

      Amen. Thank you Ron. We must look at the big picture and learn from this. It is an opportunity to learn more about the great adversary, study strategies on both sides, and not waste too much time grieving for Ms. “C”. I’ll bet she would encourage us to remember the old adage “Don’t get mad, get even”. Or how about this…the best revenge is a good offense? The constant deep worry for me is that we do not seem to have the support of the FDA whom I raged at this morning. They seem to have forgotten who they work for.

      Bejah

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