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Cavness v. Ethicon – First Jury Vote for Ethicon 10-2, Mesh Not Defectively Designed

cropped prosimaMesh News Desk, October 5, 2015 ~ In its second day of deliberations, the 12-member jury in Cavness v. Kowalczyk (et al., case # DC-14-04220) decided for the Defendant Johnson & Johnson, 10-2.  

In doing so, jurors found the Prosima pelvic mesh, made by Ethicon (J&J) is not defective in its design and in its instructions to doctors, the end users.

This is the first trial win for Johnson & Johnson after suffering $21.5 million in losses in four previous pelvic mesh trials.

Heated debate in the Cavness jury room resulted from confusion about the questions jurors had to answer about Design Defect of the Prosima pelvic mesh, and whether the Instructions to doctors were defective or inadequate.

Jurors told patient advocate, Joleen Chambers, the questions were “too legalese” for them and they were unclear how the questions related to the evidence shown in the case.  The female jury foreman, who reportedly took 100 pages of notes, and another woman voted for Ms. Cavness. The other jurors voted ‘No’ to both questions.

Plaintiff, Carol Cavnes, 60, broke down in the courtroom and was ushered out.  The two female jurors reportedly were also crying.

Gavel 500

JURY QUESTIONS

[Jurors are invited to contact this editor, Janeakre@meshnewsdesk.com to share their story]

Chambers says jurors told her if one word was changed it would have changed the whole thing. Friday jurors were convinced they would render a quick decision in favor of the  Plaintiff, but that reportedly changed when they saw the jury questions, which they say, did not coincide with what they heard at trial.

Defense teams typically bring in lawyers specifically to write jury instructions at the end of trial. That reportedly happened here and the revised questions did not receive specific approval from Judge Molberg before going to the jury.

At trial, jurors heard about the injuries Ms. Cavness suffered and what the company knew prior to marketing Prosima.

Defense had asked for specific language in the two jury questions. Once Judge Molberg realized that, he spoke to the jury this morning asking them to change their thoughts about the definition of “Proximate Cause” to let jurors know they could find for the Plaintiff based on causation.

Molberg defined that as the cause which was a substantial factor in bringing about an injury and without such cause the injury would not have occurred.  

Judge Ken Molberg, 95th Judicial District, TX

Judge Ken Molberg, 95th Judicial District, TX

“In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company, using ordinary care, would have foreseen the injury or some similar injury might reasonably result there from. There may be more than one proximate cause of an injury,” he said.

Around 11 am Central Time, Judge Molberg told jurors if they had answered either question, they should re-deliberate using the definition he just gave “because it is the proper legal definition.”  That was all he could say to them about legal theory.

One male juror told Chambers the deliberations were very difficult. He said he learned a lot about female anatomy quickly. He learned you can have an injury and it could reappear later.  He too said the language in the question made no sense given what they were told during trial.

Day 5 Carey study on posterior repair prosima prototypeDESIGN DEFECT 

Other pelvic mesh trials have focused on the polypropylene material used to form the woven plastic and how the resin makers specifically warned against using the raw polypropylene resin for use in implantable medical devices. The Material Safety Data Sheet, which contains the warning, was not presented in this trial.

This is the first trial win for J&J and its Ethicon division, maker of pelvic mesh implants.

On Friday, the Plaintiffs asked for $9.5 million in actual damages against J&J plus punitive damage awards.

Judge Ken Molberg, who had a previous appointment, had to leave while the jury deliberated today.

Judge Emily Tobolosky told the court the jury wanted to deliver a statement along with the verdict. Attorneys for Plaintiff Cavness did not want to hear the statement while the Defendant’s lawyers had no problem with the statement, which was not disclosed.

The jury decision came back just about 4 pm Central Time.

 

BACKGROUND

The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Four cases that have gone to trial include Linda Batiste ($1.2 million) Jo Huskey ($3.57 million), Linda Gross ($11.1 million) and Coleen Perry ($5.7 million).  The Carolyn Lewis case was dismissed after Judge Joseph Goodwin granted J&J a directed verdict last year.

Other cases naming Ethicon/ J&J have settled including Budke and Wicker, as well as a few cases in Missouri.

So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.

At this writing, J&J faces 28,960 cases filed in multidistrict litigation in federal court in Charleston, WV. Thousands of other cases are filed in state courts and around the world. J&J has vowed to take the pelvic mesh litigation to trial rather than settle, as several other manufactures have begun doing.

Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint.   Instead the company called the mesh “safe and effective” in its marketing efforts.

“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.

The Plaintiff’s complaint says implanting physician, Dr. Kowalczyk, failed to disclose the risks associated with the implantation and instead recommended it as a safe and effective.

Cavness was seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages were allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.

The suit also included claims against the physician who implanted the mesh in Cavness, Teresa Kowalczyk.  The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.

THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THIS AND OTHER TRIALS!

David Matthews, Attorney for Cavness

David Matthews, Attorney for Cavness

Postscript * David Matthews of the Matthews law firm tells Mesh News Desk “This is a devastating loss and we are going to pursue all remedies on behalf of Carol Cavness. This story is not over.”  

100 Comments

  1. stopmeshimplants says:

    Unbelievably devastating news!

  2. anonymous says:

    There are no words

  3. Matteo says:

    Thanks for your hard work Jane. Why the exclamation point? It is cruel, fooled me into thinking poor Carol had won. My heart is broken for her. Whatever did they tell that jury? Jurisprudence is broke in the country. I heard the first jury vote was 9-3 for the plaintiff. What happened?

  4. Suzanne McClain says:

    My heart is absolutely shattered for Carol Cavness and her family. It sickens me how language can be used far above that of the layman, or evidence withheld in jury trials, to affect a certain outcome. It happens all the time, and until the criminal justice system is corrected, it will continue. SAD< SAD< SAD!

  5. Pam says:

    Ms. Cavness should have testified! ! It really hurt this case by her not testifying, & given the chance to state that she’d rather live the life she once knew & had prior to MESH!!!

    The pain & discomfort from prolapse is absolutely NOTHING compared to MESH!! Nor will she ever be the same!!!

    I’m so heart broken for her, & can not imagine having to know that these Pharma can do this & get away with it!!

    My prayers go out to Ms. Cavness & her family! !

  6. John says:

    It seems to me that the jury shop do be asking questions instead of having to answer them and that the judge should have previously reviewed anything given to the jury insure that it was not too “legalese” , it J&J would have lost they would have wasted no time at all in filing an appeal. Does Ms. Cavness get to file an appeal? If not, how effen fair is that??

    • Jane Akre says:

      yes….she does.

    • Pam says:

      Most attorneys are not willing to file appeals due to the costs & usually it’s the defense in these types of cases willing to spend that amount. Someone like J&J will even spend more to file an appeal to avoid having the loss of the negative feedback on their dangerous MESH!!! It’s not about the money in that courtroom, but all about their image!!!

  7. toni says:

    How this could happen in this country is beyond belief. There is no justice its the have and have not. They will continue to get away with harming the very people they say they are working for. How are we to go on believing in a broken system.

  8. Aaron Leigh says:

    I’m stunned. I guess if they couldn’t win on fact; they relied on doing their best to confuse the jury with legalese. 🙁 I feel sick to my stomach. When these jurors are no longer quarantined and are able to read about the international disaster and how many lives and families have been ruined, I bet they are going to have a hard time with their decision today.

  9. guest says:

    I’m done. Not coming back here. Women are going to die by the thousands in the next few years. No one cares.

    Thanks Jane for caring so much and for offering this forum. This proves there is no way for the poor people or little people with no power or money to face off against corporate giants and doctors.

    Good luck to all of the mesh victims. Very sad it had to end this way.

    • Jane Akre says:

      Don’t forget this is the same court that saw a $73 million verdict against Boston Scientific….

    • Bejah Blue says:

      Please don’t leave. We value your comments. When someone says that I begin to feel it will all fall apart and all of us will be set adrift. Even when all hope is lost, have you noticed it rises again. Hope can never be destroyed. It is eternal. Please stay, bear witness.

      Bejah

  10. Hal Lewis says:

    Horrible verdict.

    This kind of “jury confusion” is exactly what J&J is counting on to help them win cases.

    And in reality… it’s why a settlement that puts money in everyone’s pocket is a better overall outcome that seeing some victims compensated and others devastated.

    Then again… J&J hasn’t even tried to offer a reasonable settlement yet.

  11. kitty says:

    I never had pain with prolapse. Just bulging organs out of thVJJ. No.pain. organ pessing and sqeezing the urine out of the bladder. WHAT A fraud

    • Pam says:

      I would agree Kitty. I do not have prolapse, but I’m sure with what injury she did prior to her implant 3 days before…..her pain with MESH was far worse! I’m. Certain the defense used the Proximate Cause just for that factor, & in this case it was unfortunately in their favor.

      Sadly, it’ll take a lot of money to file an appeal, & most attorneys are not willing to do that for plaintiffs cases usually a defense.

  12. ugh…to put it mildly….. I do hope Ms.Cavness files an appeal, from what I read she should have grounds….. any lawyers want to comment? please do ….

  13. Laura Henze Rusell says:

    This decision is a travesty. We need to focus on the big picture and update all device regulations to put patient safety first, and add larger and longer clinical trials with basket studies, written informed consent, prescreening each patient for biocompatibility, robust monitoring reporting and post-market surveillance, and repeal of federal preemption. Please sign the petition for Medical and Dental Device Safety Urgent Reform: MEDDSURGE http://www.petition2congress.com/18325/medical-dental-device-safety-urgent-reform-meddsurge/.

    • Anonymous says:

      In hindsight this would have been a great idea for the manufacturers to do and should be used for future medical devices. What I don’t understand is how this is going to help find a resolution for the problem we are already in?

      Please reply

  14. anna says:

    Looking at that judge doesn’t surprise the outcome. He just reminds me of a crooket politician who just got his hand on the golden egg. How coinsidential to have to be specific about a juror question just before deliberation. I am so sorry for Ms. Caveness, just remember they still have to explain why so many othe r women including myself with no other medical history are suffering from their damaged products. Its a big battle for them, their money, and their image will be exausted before this is final. It might not be in my lifetime but, my children or my grandchildrend will see it. I GARANTEE THIS

  15. Greg Vign says:

    Specific causation requires specific source of pain. Any implantable device can cause pain. What specifically did this device do to this plaintiff. Wasn’t trial ready from a medical standpoint or a legal standpoint.

    • Anonymous says:

      Greg,

      In court, you get one bite of the Apple. One opportunity to present your case. There has to be a gross injustice, done by the court, in order to get an appeal granted by the Supreme Court of Appeals. An appeal seldom happens. It’s like telling a judge he doesn’t know how to interpret law.

      We, as plaintiffs, need to find that gross injustice to have an appeal granted. In my opinion, the jury needed to see the material safety data sheet, that stated the mesh was made out of raw polypropylene resin (plastic). The important thing is plastic should never be put in the human body according to the FDA and the company that made the plastic.

      Not letting the jury see the material safety data sheet doesn’t seem like fault of the court. The plaintiff’s attorney needed this entered as evidence but did not get that done.

      • Greg Vign says:

        You are right but explaining how the foreign body response causes traction on nearby nerves after you have diagnosed specific nerve damage takes care of specific causation. Same thing with muscle damage. Work backwards from the injury to the cause. Pain unclassified doesn’t lead to specific causation.

        • Bejah Blue says:

          Is it not true that where pain “presents” is not necessarily where the source of the pain is centered. If so, it would seem that this supports the assertion that diagnoses (Correct and thorough diagnoses) is critical in what decisions are made subsequent to that.

          What worries me is that something may be missed so having consultations with various specialists (Not just one’s OB/GYN, or Urologist/Urogynecologist) and even getting a second and confirming opinion may be warranted.

          We may then face the specter of insurance companies that will not pay for a second opinion leaving us to pay ourselves.

          If a nodule has been found on our kidney or liver and our health insurance company refuses to pay for further investigation, and if we then develop a cancer even if it is caused by the degradation of the polypropelene we bear the burden of proof and can not prove the causal link or find the insurance company responsible even if blood tests were done and suspect but ignored. It seems like we can not even save ourselves, no matter how hard we try, how well informed we try to be. That is one reason why we must retain copies of all tests, etc. and if a certain blood or other test was not ordered and should have been we can then go to the physician and demand that the test be done.

          If we are 60 and retired we are done, useless, in a nation and a world where resources are increasingly limited. And how hard are any doctors going to try to save us? There are 8 billion people on the planet. I increasingly see signs that the world wants to get rid of us. This population has to fight even harder for equal treatment where medical care is concerned and coincidentally this is the largest population of mesh wounded as well.

          Johnson & Johnson is drooling at the thought of how much money they are going to make from all the “Baby boomers” yet to be implanted and who is going to stop them?

          Bejah

          • anonymous says:

            One of my fears is that someday I could be in an accident oe unconscience and I might need surgery who’s to speak up for me and tell them no mesh to be put into me whatsoever I don’t fear dying I don’t fear people getting rid of me because I’m old actually I’m looking forward to heaven when there’s always love and acceptance and no hurt or tears but I am angry at all these companies for taking my life away when I still I’m breathing the sad part is no one cares except for those who have been through this and maybe Jane I see attorneys getting rich having good paydays I mean if you have 20 or 30 cases at your law firm and even if you only get them $300,000 each you’re going to be rolling in the dough while your clients become indigent I pray for God to come back for Jesus to show his face again on this earth for I know then my stress my struggle my depression will be gone and all I know is that I will live in glorious heaven forever so AMS, J&J, BARD and all the rest of you you may win this war on this earth but the day is going to come when you have to stand before Almighty God and giving an accounting for what you did he will show you no mercy at that time just remember that every night that you go to sleep the god knows everything you’ve done and you will have to account for it as we all wI’ll I know where I’m going do you the people who work for J & J, AMS,BARD ETC…? The time is coming close when Jesus will come back so you better get right with yourself in the world right now!!!!

          • Bejah Blue says:

            Anonymous,

            I too think now more of Heaven than of this life which is over at least as it was.

            The defendant corporations are faithless and do not realize what awaits them. They think that faith is a delusion of the intellectually challenged. They probably attend some religious services in their respective communities seeing it as a social requirement and opportunity to network.

            Those that fear that the soul lives on after death but will never know the scientific proof they demand, may think that the worst that could happen to them would be that they would be forgiven. I would remind these individuals that a supreme being that would favor forgiveness would find some sins unforgivable and so destroy the soul of that individual by absorbing it back into the GODHEAD resulting in death of the individual soul.

            Those who support the defendant corporations in some capacity may feel they are just doing their jobs, doing what they have been told to do or contracted to do and so will be forgiven but not so, their souls will be required to, as we understand it, pay for what they have done, and will be held accountable. They will likely be forced to be reborn, according to many religious traditions, into a body that will suffer as those have suffered who were victims of their evil work. There is no way out for those who have caused others to suffer. GOD knows who the faithless are.

            Bejah

    • anonymous says:

      Mr. Vigna,

      Can you elaborate? Was it shown Ms. Cavness’ implant eroded one or more times, with other complications? Can you share what you think was missing? We don’t understand because it seemed like a good case for the plaintiffs.

      • Greg Vigna says:

        This lawsuit wasn’t about erosion which is a known risk of this device. It was about pain and disability from the pain. Any implantable device we know anywhere in the body can cause pain. We need to know why this device caused her pain. That goes to the specific anatomic basis of her pain (which wasn’t determined), which is supported by targeted treatment for those pain generators that provide ‘some’ relief, that supports the life care plan, which ultimately supports the argument why this device specifically caused her pain.

        I have encouraged women to seek help by providers who understand these concepts to afford improvement in their health, but also to support a catastrophic claim.

        • Jane Akre says:

          She along with Linda Gross had life care plans. Very important… in Linda’s case it made a difference.

          • Greg Vigna says:

            Linda Gross had a diagnosis of why she was in tremendous pain and the shows why the device was defective.

          • Jane Akre says:

            Her trial did not result in a defective product conclusion, however hers is the largest win against Ethicon so far, $11.1 million. consider though, they still have not received anything in that the appeal is still in the works AND she is still seriously injured.

          • Barb says:

            Thank you Jane I also thought she did have a life care plan I remember reading a doctor stating how much it would cost for her life time of health care! Am I wrong by saying before trial don’t clients usually work with the clients to make sure they are prepared, letting them know how grueling the defense will be, how to answere such questions versus say I dont know or I dont remember?? Your case is only as good as your attorney’s have prepared you, has all evidence shown as exibits and approved from the judge and defense. Are these judges not following the golden rule for allowing the Plantiffs to bring in as much evidence they need to prove their case, they should be allowed to let the jurors know all information about these devices, how many injured woman there are the FDA warnings, and bring up what exact injuries has already been proven? Does it really matter that someone has a record or that they smoke or divorced!! I hope that these cases being picked for trial are not being based on age however I have a feeling that could be played out by the defense as well!!

          • Jane Akre says:

            If all of the evidence was produced these trials would take years…

        • anonymous says:

          Thanks Mr. Vigna. It’s our understanding now that placement, erosion, contraction, and revisions can lead to damaged nerves, organs and muscles. The damage often causes serious pain and complication. Erosion might be listed in most IFU’s but was anyone informed on what can come of it? I think most were not. Printing “erosion” and letting doctors and patients think it’s an easy fix or something that doesn’t lead to significant morbidity isn’t ok.

          • anonymous says:

            What I’m trying to say is some were told erosion is a possibility without mention of reoccurence or what could come of it (permanent pain, spousal injury, damage to nerves, tissue or organs). And many weren’t informed on contraction, mesh bunching, how these can damage nerves. Some were told the products could just be removed if problematic. No mention of difficulty or impossibility. There was a responsibility to list more and explain what could come of the few named complications and how to safely remove.

          • Bejah Blue says:

            And so we must make sure we are informed, we educate ourselves so that we can be our own best advocate and demand what our conditions truly require, and watch for inaccurate medical records which are far more prevalent than we realize, intentionally and unintentionally altered by doctors and hospitals to neutralize any potential litigation by patients in the future and protect medical facilities and healthcare providers from patients who discover that malpractice is involved. They increasingly try to force us to sign documents at the outset stating that under no circumstances will we attempt litigation. When I am asked to sign those I print under the signature that I am signing under duress (Meaning that you were forced to sign or not be seen by the physician).

            I would like to know why it is said that medical malpractice cases are very difficult to win.

            Bejah

          • Jane Akre says:

            It is difficult to find doctors who will testify against other doctors especially in the same area of the country. Also, if something is a “standard of care” who is to say it is not right? Just some of my thoughts.

  16. To clarify, after the verdict, the jury was invited back to the courtroom to speak openly to both sets of lawyers about their thoughts. As an observer, I was allowed to be in the room and the comments from the jurors were given to all present, not to me specifically. My take-away is that PREVENTION of harm is key because of the pitfalls of our judicial system. If this had been a criminal trial, the jurors could have been sequestered. It is my impression from the jurors remarks that the decision would have been quite different if they had not been allowed to have the weekend interfere with their deliberations and Judge Molberg present to the verdict end. With all the money involved in this case, it would be quite easy to influence jurors. They were admittedly confused and that impacted the plaintiff’s life catastrophically.

    • Anonymous says:

      If most of the jurors said, after the trial, they were confused, is that enough to ask for an appeal?

      • Jane Akre says:

        Yes, there was plenty of confusion there if the judge had to reissue the definition of the basis of what they were to decide… one would think.

      • Barb says:

        Could that also come under a hung jury?? Something happened, when it was 9-3 then suddenly changed!! We will never know. If the judge wanted her to pin point where her pain was the pain that we suffer is not just in one place it is vaginally, bladder, lower back, right to left, many all in front of lower stomach in the pelvic area it clearly is not in just one place!

        I know that hung jury is when jurors just can’t come to a decision and thank you to the juror who has insighted us on this trial I wonder how many jurors now have done research and has found out exactly what has been proven. It appeared to me that the doctor who did do her surgery was getting a little friendly with the salesmen I think he was doing what he needed to get her on board and if I ever found out some sales person pushing for these products was in the OR while having one of my surgeries you can bet I would be causing a stink!!

        • Bejah Blue says:

          Barb, What happened to cause the vote to change do dramatically? I tell you SATAN entered the room. With regard to the salesman being present in the surgery suite during a procedure….evidently it happens all the time. They do not tell us but especially with devices it happens a lot. What about our privacy, our right to know, and all that crap the hospital puts in its little happy patient booklets about treating us with respect? All lies, all PR. Call the facility where you were implanted and ask them if there was a salesman in the surgery suite. They do not state this in the surgery report either. I feel just like you do about this I am certain.

          Bejah

          • Barb says:

            Thank you Bejah Blue!! Our bodies has been exposed in so many different ways and we do still do have modesty!! I feel with having to go see so many specialist, alway’s having more then one person in the room whom we expose our intimate parts to is so belittling to us a woman our bodies have had more exposure then ever having the mesh! I would love to call the hospital or maybe it would state in our operative report IDK I feel we may as well be just audition for a magazine for the world to see!! Just reliving and remembering all the examines, test ect believe it or not I know every time I have an appointment my face is cherry red, however I will say that having a woman surgeon is much easier for me personally. Nothing wrong with male doctors I have had some whom understood my feelings and are/were better then some female doctor’s!! I know there are so many complications associated with the mesh devices I wish there was a list compiled for us to know what these woman who have gone to court have. So what is the worst complication, mesh erosion or still having these products inside our bodies with all the chemicals which still unknowingly is doing to our bodies??

    • Laura Henze Russell says:

      Joleen,

      Do you think jury selection was an issue? Were there only two women? That sounds like a recipe for bias from the start, and not a jury of one’s peers.

  17. Tambrea says:

    WTF! Have this product put in you and live with the pain and life changing circumstances! It is evil,! It is pain, it is living HELL!

  18. kitty says:

    Do u think the jury got confused with who was being sued?

  19. Anonymous says:

    I’ll try to make this simple, I have three questions.

    1)Why was the material safety data sheet not introduced to the jury?

    2)Does that sheet say that the mesh was made out of raw propylene resin?

    3)Does the manufacturer of the propylene resin (plastic) say not to put it in a human body permanently or temporary.

    • Jane Akre says:

      Dont know why it wasnt introduced- that is armchair hindsite observation on my part.
      The MSDS is issued by the resin maker- it is intended for all those who work with the material and is required under OSHA. Please look up on the Search Bar and you will see what one looks like
      yes to number 3. thats exactly what it says.

      • Jane Akre says:

        A MSDS was introduced in the Cisson case for a Bard mesh… Marlex. Also made of polypropylene… Here it is

        https://www.meshmedicaldevicenewsdesk.com/wp-content/uploads/2013/12/Bard-Exhibits-200-1-Marlex-Mesh-MSDS-10-pages-20113073699.pdf

      • anonymous says:

        Hi Jane. My parents even had those same questions. The mesh implants are made of the same material, so the MSDS would apply to all vs. some, right? We thought displaying the material safety data sheet would be important in every trial and difficult for judges and juries to disregard. Is it more likely the plaintiff attorneys were unaware or chose not to present or that the judge didn’t allow? Some being allowed to submit while others aren’t doesn’t seem lawful. Hopefully we missed something and this isn’t the case.

        • Jane Akre says:

          Other trials have uncovered the same sheet on Ethicon Prolene. It is shocking when you see it the first time. how can a company implant materials when it clearly says Not to.

          • Janet Yellen says:

            I would advise not to get too hung up on the MSDS sheet like it was a smoking gun.

            The MSDS from the raw mat’l vendor contains a lot of CYA aspects. In the case of polyproylene, like many other plastics ROUTINELY used in medical devices (e.g. the vast majority of hernia mesh materials are: Polypropylene, Polyester and ePTFE *per http://www.ncbi.nlm.nih.gov, used at rate of maybe 2000 PER DAY), the vendor does not know or control how the polypro pellets will be molded, formed, treated/stored, or used after they let it out of their hands, so the responsibility for implantation use and testing falls on the device maker.

            And it is worth noting that this material, like others, does have disadvantages that can occur such as adhesion and infection, among other things, so it is not the ideal choice – WHICH DOES NOT EXIST for hernia meshes – all materials have some risk. It may have been a poor choice for this transvaginal mesh application, or it could be the design is at fault instead and the material is the best choice available at this time, or a combination of the two.

            Initial testing (i.e. was it adequate) and follow-up on incidents (e.g. when did the company know there were issues and what changes were made, including product recalls or suspension of sales if indicated) would be more indicative of company malfeasance in my view. The FDA often changes device classification, or raises the bar significantly on clearance, once something like this is known. Unfortunately, as Jane alluded to in other comments, the failures were not widely publicized or investigated for awhile, so far too many patients were affected by this new procedure/device.

          • Jane Akre says:

            Janet- Another concern is the inconsistency I would imagine in the raw resin formulations. If pp is used for fishing line and pelvic mesh, what assurances are imposed during the manufacturing process for creating a product that would be safe, consistent, biocompatible, etc. ? Might that partially explain the range of those affected?

          • Janet Yellen says:

            Jane,

            Inconsistency in material is a genuine concern, but usually as an isolated occurrence across a lot or lots of material and the devices produced therefrom. Device manufacturers, especially experienced ones like those involved, do a lot to ensure consistency of raw material and process. Here we would have three major players making the same mistake on a relatively common material. Given the widespread effect, plus the nerve issues referred to below, I would lean more towards design inadequacy (including choice of material possibly), either to allow the delivery method, or just not taking into account factors that came out in the long term use.

          • Jane Akre says:

            Thanks, design worked well in a hemi pelvis but in the real world… not so much!

          • Anonymous says:

            If the MSDS isn’t that big of a deal why does it seem like C.R. Bard’s CEO created a 3RD company, just so the materials could be sent there? Wasn’t there some E-mails being passed around by Bard that can support my theory?

          • Barb says:

            Jane is this the same plastic all manufacturers used in their product???

          • Jane Akre says:

            Basically polypropylene, also known as PP, same material in most meshes unless they area biologic composite (still with PP) or totally biologic.

  20. Janis Urban says:

    Judge Goodwin was correct in his remarks stating there are some of the best Attorneys in the Country representing both sides. Was there any comments from the Plaintiffs Attorney. I’m sure there was some nail biting going on. Instructions to the Jurors and the confusion the Jurors had throughout their deliberations confuse me. How were they permitted to make any verdict? So how does the Appeal process work?

  21. kitty says:

    .First off thank you Jane for report and thank you Joleen Chambers for being there. Some of us older ones may not make it. MEDICARE IS SLASHING HEALTHCARE TO SENIORS. A friend oh ours is wearing an external AEĎ because Medicare will not pay for an I ternal pacemaker for 3 months. They want him to die. So the death panels that were mentioned in the 2008 election are so true.

    • Jane Akre says:

      Insurance has always decided what is covered and what is not…. no death panels, just fiscal decisions made by large corporations.

      • Janet Yellen says:

        I agree with Jane that “Death Panels” are not at play, however:

        From what Kitty says, it appears it is the government that is deciding here (Medicare), not private insurance companies.

        There are financial limits to what makes sense given that funds are not unlimited. For example, should Medicare or private insurance spend maybe a million dollars to prolong a cancer patient’s life by two weeks to two months when that money could cure 15 Hep C patients?

        There are also physical limitations and trade-offs. The chance of death in an open heart surgery or just pacemaker implantation on a patient at 15% heart function, advanced age, other organ deterioration may be high (and if the patient does die, you know there’s a certain percentage who would be suing the doctor and hospital for trying).

  22. kitty says:

    I am wondering if the plaintiffs attorneys had any input to the jury instruction. Why did they allow this travesty? Jane please do not leave us.

    • Jane Akre says:

      More questions need to be answered. Jury instruction are an art… that’s why both sides bring in experts to craft the questions just so. I’ve seen it with my own case. It seems trivial but it is not. Jurors- if you want to talk janeakre@meshnewsdesk.com You can remain anonymous but I would have to verify you are an actual juror. thank you.

    • Bejah Blue says:

      Kitty, Why would you think that Jane would “leave” us? I do not understand.

      Bejah

  23. kitty says:

    Hopefully there will be lesson learned from this trial. ANATOMY 101 needed for jury. Charts pictures— graphics are needed to instruct and teach. A woman’s pelvis is QUIET after cessation of menses and at menopause. Prolapse is not painful.

  24. Maria Garcia says:

    I knew this was going to happen because not one case has focused on the real source of the “Defective Design” responsible for the pain all of us have. My doctor is a Urogynecologist and what he said to me about the cause of my pain and why it’s not the focus in the trials of any brand is beyond comprehension. Every case keeps trying to prove the point of deception, material or the doctors skill yet the elephant goes unmentioned. The long term or lifetime pain issue is nerve damage and inflammation caused by a defective design. My doctor said that the arms of the mesh connect in locations which directly damaged nerves and pass through muscle creating additional pain. I went in for bladder support and now I have lifetime incontinence because of nerve damage from the PROPER installation of this manufactured product by Johnson & Johnson Ethicon Division. That is the “Defective Design” that should be focused on because of the nerve damage and never ending inflammation. What if you set aside the auto immune issues, particles, laser cut versus mechanical, light or heavy mesh and brand name, what is causing the primary pain…NERVES ARE THE REAL PROBLEM. Once disturbed by mounting arms the damage never stops or settles down and this is easy to prove. This damage is well known and documented by neurologist specialists that work closely with urogynecologists that specialize in mesh removal. There are many doctors like mine that say the mesh argument is secondary to the real root cause…nerve damage and inflammation. There are to many lawyers focusing on recycling the same old arguments that have equal amounts of experts on both sides. The human anatomy is the same for every woman and it would be a check mate in court for a nerve specialist to show the “REAL DEFECTIVE DESIGN” of placement and encroachment upon nerve bundles. This is something a jury could hear, see and understand. The mesh material and all of the factual evidence can be a reinforcement to the real root cause of “NERVE DAMAGE” by defective design. How is the material brought into the body? How is the device attached? Where are the nerves in relation to the mounting positions? Were muscles pierced in order to arrive at the desired mounting position? The lawyers need to hit Ethicon on two fronts working towards the middle and there will never be a day in court like this again. There are a few nationally known nerve specialists which their specialty is nerve damage from vaginal mesh products. There is one in Sugarland Texas Dr. Charles A Popeney DO

    and five or so others around the country. Cross Country bike riders have similar nerve damage from their seats pushing on the pudendal nerve. I know if the attention was switched to actual scientific causation of nerve pain as the primary defense for defective design, the added mesh evidence would be the knockout punch.

    • Greg Vigna says:

      Well said. Specific causation from the defective design needs a specific diagnosis. If it is muscle/spasm then it needs specific treatment which supports the life care plan and supports the reasons why it is defectively designed as a cause of muscle/spasm pain and disability.

      It it is nerve damage that the discussion must focus on the defective design why it places the nerves of the pelvis in peril.

      By targeted diagnosis supports the life care plan and supports specific causation. Everyone knows that any implantable device can cause pain, but need the specific diagnosis to target why these devices are defectively designed.

    • anonymous says:

      Let’s face it ladies even if she would have won she probably would have never seen the money they will hold it up in appeals for as long as they can and most of us will die before we see any money if we don’t take the lousy settlements that they’re offering and I do mean lousy and then on top of that and don’t get me wrong many attorneys deserve to be paid well but almost half of what we get we are the one suffering we are the ones who have to try to live the rest of our lives by not being able to work dealing with doctors all the time dealing with disabilities pain muscle spasms you name it and in the end we will walk away with nothing little or nothing in the way of monetary compensation and it makes me sick I was recently offered a settlement and I said no why because when everything was said and done I walk away with about $20,000 and I have suffered too long too hard to accept that settlement all of this makes me just so sick some days I just want to give up and say Lord take me home right now I really AM sick of the whole circus can someone just step up and say I will do the right thing I will pay you for your disability your lost wages your medical costs and compensate you for all the pain and agony you going to have to go through with the rest of your life which will be cut short because of all the narcotic pain medication surgeries and everything else I’ve been through that is why my body is still rebelling to this day with all kinds of rashes and infections day after day what the hell is wrong with these people!!! I just want to give up I really do because no one is hearing us very few attorneys want to fight for the way we need to be fought for they’re just waiting for their payday so they can go out and buy a new car whatever and do very little in the way of actually fighting for their client the way they should with blood in their eyes I don’t believe there’s any hope for any of us I’m just sick of all of this excuse me for the rant but I’m just sick to death of all this and I won’t even start on the doctors who do not want to treat most patients because they are after all MESH patience and they are a liability

      • tammy says:

        You got that right how can you fight the goverment an win dah.!!!!!

      • Barb says:

        ANONYMOUS may I ask if you have AMS??? That’s what your settlement appears to be from!! I have AMS and I have gotten very demanding and told them I will fight to get a fair settlement and it’s not a million!! I remind them they do work for me and I deserve answere’s! After 4 surgeries, sepsis more and more infections, no intimacy, not being able to drive at times, all my time consumed with doctor’s, my surgeon saying due to several mesh complications I will never be 100%, pain management, faucet injections, blocks, still sever SUI, organ prolapse that I did not have prior to, dropped bladder, cystitis. liver issues never had before until 7 months ago, thyroid issues although I don’t believe is caused by mesh, needing surgery for SUI, rectocele/cystocele prolapse grade 2 and still have 2 defective devices that I;m told since it’s been there since 2008 unlikely able to remove, and mesh erosion! They did on July 17 2015 laproscoy, hysterscopy, bladder distention, another cystocopy and the mesh that was eroded in my uterous the doctor spread other organs to see if more erosion found some in my bladder she could only cut away what she could see not to mention the depression but was already diagnosed with, the emotional and mental anguish that we all have been through and having sepsis which is an infection in the blood stream you know it also is going through my all internal organs!! So the 4th will not be in my packet I will have to file for more money and since my surgeon cannot put a date of when the other surgeries will take place nor does she know how many more and that doesn’t include surgeries for more mesh erosion!! I did find out that they will not be taking any moneys out of the monies i will receive for future surgeries I still do not know what injuries they will associate with the mesh!! WHY WE ARE NOT ENTITLED TO PAIN AND SUFFERING> Didn’t Judge Goodwin in one article I read Please be fair for these woman and what they have suffered. Wonder what he would do if I wrote him a letter on the damages we all have!! I already informed the paralegal I”M NOT SETTLING for pennies after what they knew, and why can’t those who don’t go to court and these devices have already been proven defective, what about us not properly informed I wasen’t………………

    • Janet Yellen says:

      Excellent discussion point.

  25. Gg says:

    This makes me feel so discouraged. I have had 2 of J & J’s horrible products implanted, eroded, removed, etc..total of 12 surgeries, 4 products.left me not even classifIable as a woman. I’m left wondering if there will ever be any compensation for all of my pain & disfigurement.

  26. Laura Begley says:

    Sounds to me like someone is getting paid off …….its all a conspiracy!!!

  27. Disgusted says:

    Unbelievable. It makes my heart sick. That poor woman and family. The jury should have been upfront as soon as they knew they didn’t understand and asked the questions, instead they guessed. I think Greg Vigna has a good point. There could of been confusion due to preexisting pain and it was not explained that the pain was much worse after. Because we are living through it, we KNOW what they are talking about. The jury however does not and they have to go with what is presented. I don’t understand why the use of materials that didn’t meet the MSDS wasn’t shown. I wonder if the jury was confused about how much the implanting Dr. played into their decision. The Dr. was the one who was accused of not giving the information and as far as I can tell, he wasn’t being tried. What really irks me is Dr.’s are testifying to two very different opinions. One says it causes all these damages and another pretty much denies everything he is saying. How do the jurors know who is telling the truth? Both sides say that they have the reports that conclude this. If you look at the the science articles on the web it is completely confusing. Some say mesh removal is doable. We know it isn’t true. There should be standards for these science studies by an independent source. Smoke and mirrors and very little science. What about evidence based science?? I hope she gets an appeal and wins.

    I wish the jury could just stand one day in our shoes – that would be very telling.

    • Anonymous says:

      Even with a straight forward case, you are in for a LONG and intrusive legal journey as I speak from my own personal experience. And at the end, you are left with the physical and psychological scars.

      However, with that said, I do not regret speaking up for myself and making my voice heard. Anyone seeking assistance, keep in mind your STATUE OF LIMITATIONS IS KEY and will expire so you must reasonably demonstrate even after that period expired that you knew something was wrong and started seeking help.

      SO I SAY TO ALL MESH VICTIMS, SEEK MEDICAL TREATMENT, ASK QUESTIONS, and IF YOUR STILL SUFFERING, SEEK LEGAL HELP ASAP!

      My prayers and thoughts are with everyone.

  28. PLC says:

    Are the 29 other cases still a go in court for November 2, 2015 ?

    J&J will be prepared to win this trial using the best lawyers they have.

    A lot at stake here for this many cases tried at once.

    • K says:

      Trial has been moved to December I think the 6th but I’m sure it will get moved back again!

      • Jane Akre says:

        Jury selection December 4,,, trial begins the 7th Monday. Charleston WV. 39 plaintiffs tried in one case against Ethicon TVT.

    • Bejah Blue says:

      The defendants want to wear us down and leave us both physically and emotionally brutalized. Please do not let them get away with it. Stay strong and focused. Runners say they run through the pain and that is what we must do. The defendants want us to wear out, give up, crawl off and die but we have a choice so choose life for all of us.

      Bejah

  29. kitty says:

    A large graphic of the female pelvis with all the ligament and nerve connections should be used as instruction to lay persons

  30. Kitty says:

    The verdict was so upsetting. Last night I had the worst nightmare of my life.

    A man that I have known all my life turned on me in the worst way one could imagine. I was on the steps and trying to get out and called “Help Police” but the words could not get out—his face turned green and black and the eyes were like a monster. He threatened me with harm if I called out anymore for the police. The face was far more grotesque than Jade’s Mesh Horror face. I’m sorry if I upset anyone. Please somebody appeal for Ms Cavness.

  31. mesh injured nurse says:

    As a severly mesh injured nurse, I am beyond flabber-gasted that a few words could make such a completely unfair, prejudiced, and skewed turnaround in this case. I am completely disgusted with our medical and legal systems. Patient safety seems to be the last concern on everybody’s minds when it comes to bringing these products to market!

    My heart goes out to Ms. Carol Cavness, for both her physical and her emotional injuries.

  32. Mamohio says:

    I think her lawyers failed her and they should def appeal. If not I hats to see the turn out in Dec in West Virginia for the 13 or so plaintiffs being grouped together because of the same mesh and the same Dr who put it in. I hope the lawyers getting ready for the trial in Dec learnedly something from this. And what’s with the Judge leaving early before the verdict. Did he already know the outcome. I would also tell the Plaintiffs attorneys to have their shit together and ready to fight for a win covering all aspects of questioning and educating the jurors. Seeing how they are getting 40% of our settlements if we even when. Women please don’t give up just because of this trial. Look at how many J & J has lost. Keep writing to News program’s politicians, Daytime talk shows, 20/20, 60 min. Everybody and anybody. There is also a National Broadcasting Association I just saw on TV today that is asking for stories to keel their program alive. Check it out and they may be hungry enough to break open this travesty happening to women all over the world. GIVING UP MEANS GIVING IN AND WE HAVE NOTHING TO LOSE.

    • K says:

      You are right the attorneys better be ready December 7th and it is 37 cases being tried at one time. With this one win they will probably now offer a settlement before December and it will probably be pennies. They wanted this win for that reason!

  33. Karen says:

    Yeah with 313 billion dollars and the facts. Alex Gorsky can pay for who every he wants . All attorneys and judges take money under the table . Why would any jury help a company that butchers women and found it OK . There’s a lot of money , a lot . Nothing surprises me at this point . Billion of dollars and our settlements are only 5 million if that . No money for medical . Women losing family and homes for what . Billionaires sit and watch and laugh as if this is a game show . These people invest in vaginal mesh like we are not important not even human . One day soon we women will comes together like we were before and no one will be able to hurt and slaughter, us again . And get away with it .

  34. kitty says:

    Karen. That is a very uplifting post and we will get stronger.

  35. Janet Yellen says:

    Based on this statement in the summary article:

    “Defense teams typically bring in lawyers specifically to write jury instructions at the end of trial. That reportedly happened here and the revised questions did not receive specific approval from Judge Molberg before going to the jury.”

    It does beg the question of why the plaintiff’s attorneys did not have similar input or ability to at least raise the issue with the judge as to how the jury instructions were worded BEFORE they went to the jury. Could be the defendant’s lawyers were just more thorough or crafty.

    Odd too that Judge Molberg evidently neglected to thoroughly review the definitions/instructions before it went to the jury. Not being a lawyer, I don’t know how common such post facto changes are. Could possibly be worth noting in any appeal, considering the jury could have decided Friday before said correction took place.

    • Bejah Blue says:

      Or perhaps the plaintiffs counsel was either incompetent or was paid off.

      Bejah

      • Jane Akre says:

        Bejah please be kind. It takes hundreds of thousands of dollars to bring one mesh case to trial, upward of one million in some cases. Plaintiffs’ attorneys are in it to win. They are not passing cases around on paper but trial attorneys work hard and fight hard. It is grueling work. At the end of the day, they are all you have to confront the Defendant unless you want to go Pro Se, which is not advised…..if you watched the trial, there was solid evidence presented to the jury. Consider Dallas is a very conservative venue as well which may be an additional factor not being discussed. Please be kind to the folks who are helping.

        • Bejah Blue says:

          OK Jane, but there is a reason why people have come to distrust attorneys in general and failing to produce basic pieces of evidence in such a case are hard to understand in view of that. Cases that are not trial ready, especially when the stakes are so high, should not be brought to trial until they are ready which begs the question, why are they?

          Bejah

          • Jane Akre says:

            You must understand that the case was trial ready.. Ms. Cavness was a defense pick for whatever reasons they thought she would not play well to a jury. Again, it’s easy to blame lawyers but going to trial is a crap shoot. If any lawyer tells you differently, run don’t walk!

  36. Janis Urban says:

    It all seems to boil down to if it was what they call a “defense pick” Bellwether. Luck of the draw. JNJ got the better draw. Be better prepared to play your hand. JNJ did. She didn’t have the Mesh in that long and not to remember details is confusing to me. I remember how I felt the moment I woke Up from surgery. I knew something was wrong..My body was screaming at me. Get this out of me. No one listened, they couldn’t wait to get me out of there. They finally shoved a Cath in me drained my overflowing bladder, threw some supplies at me and sent me home after 8 hours. Shortly after getting home I couldn’t walk, stand up straight, sit or lay down, I crawled around on my hands and knees for over a week. I screamed at the implant surgeon for a year and half. What did you do to me. You ruined my life. Everyone in his office heard by complaints and were told they had a part in this destruction of my body& life. We all have such horror stories and it never ends. So sorry that the verdict went to the defendants. Lessons learned!! Thank you everyone!!

    • Bejah Blue says:

      This is a woman who was obviously traumatized, would not even testify in person, and one of the many impacts of trauma is forgetfulness, anxiety, depression, all of it causes memory issues. She was not prepared for trial, not coached, not ready. I would forget things and suffer the symptoms of a profound anxiety attack. Let’s remember to be kind to the victim and not blame her. We are very good as a society at blaming the victim and as women we should be acutely aware of that. I used up all my kindness for the victim.

      Bejah

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