Judge Denies Directed Verdict and Punitives in Federal J&J Trial

//Judge Denies Directed Verdict and Punitives in Federal J&J Trial

Judge Denies Directed Verdict and Punitives in Federal J&J Trial

Christy Jones, Dave Thomas, atnys for J&J

Christy Jones, Dave Thomas, attnys for J&J

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.

Plaintiffs Rest their Case

As the plaintiffs rested their case in this defective product trial against Johnson & Johnson and its polypropylene pelvic mesh, the defense immediately launched an attempt to end the case in its favor.

That is the same thing lawyers for the healthcare giant were granted last February in Lewis v. Ethicon, another pelvic mesh case also tried before Judge Joseph Goodwin in the same Charleston, WV courtroom.

This time the motion failed.

Judge Goodwin did grant a  J&J request to disallow punitive damages in the ongoing trial.

Dave Thomas, an attorney for Ethicon, a division of J&J that makes medical devices, argued the plaintiffs have not shown any adverse event warning to the doctors contained in the product label would have changed the treatment of Mrs. Huskey.

Jo Huskey, 54, received J&J’s TVT-O pelvic mesh sling in February of 2011. She has since experienced chronic pelvic pain despite the fact she’s had two partial removals. Her implanting physician, Dr. Gretchen Byrkit had told jurors if there was a contraindication that active women (such as Huskey) should not receive a pelvic implant, she might not have used the TVT-O.

TVT-O from TVT Meshed Up, UK

TVT-O from TVT Meshed Up, UK

The case hinges on whether there were adequate warnings to her physician as to the dangers and potential risks of the device. The plaintiffs must also show, by the preponderance of the evidence, that the TVT-O is defective in its design and manufacture.

Thomas argued that federal preemption should be the basis of granting J&J a favorable ruling.  I’ve already ruled on that, said Judge Goodwin.

J&J had argued its mesh had been approved by the U.S. Food and Drug Administration (FDA) therefore could not be the basis of a defective product claim. Prolene filaments had FDA approval decades ago, but a thread is not the same as a new device, Judge Goodwin had ruled.


Dave Thomas, attorney J&J

Dave Thomas, attorney J&J

Then in an impassioned plea Thomas argued the product label contained adequate warnings about the product – warnings about the potential for infection, nerve damage, the puncturing of vessels and nerves and of scarring.


Judge Goodwin asked Thomas if he drew a distinction between warning of pain and warning of chronic pain. “Its well known,” said Thomas, “And Dr. Bykrit (implanting physician) was well aware of that risk and that means we don’t have to warn what she already knows.”

Thomas blamed the second attempt to remove the pelvic mesh on a physician, and that, he said, was what actually caused scarring and therefore Mrs. Huskey’s pain.

The case will continue on Tuesday after the holiday break with the defense telling jurors why the polypropylene pelvic mesh implant is not defective and how the company reveals all potential risks to doctors in its product labels, also known as the IFU (instructions for use).  ##


By | 2014-08-29T15:35:33+00:00 August 29th, 2014|News|32 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.


  1. Jane August 29, 2014 at 7:56 pm - Reply

    I’m on pins and needles here. I have the very same problem. I am getting PT for trigger point pain.

    I have nerve pain every night. I have not had a surgery to remove the mesh nor did I have

    an accident like Huskey. My tape broke twice during surgery. I have BS sling. Nerve pain started

    immediately after surgery.

  2. Nonie Wideman August 29, 2014 at 8:01 pm - Reply

    at least the judge did not allow a directed verdict this time …. will be sitting on pins and needles waiting for the verdict from the jury …. in my opinion there is not enough mention of all the risks or seriousness of the risks, no mention that PP is not inert, no mention that FBR may not be transitory for many women….. there is no mention of the effects of autoimmune disruption, only hints, as in those with underlying autoimmune issues are not good candidates for mesh implantation…… furthermore how many physicians understand the difference between cleared for use by the FDA and approved for use by the FDA? How many physicians like patients realize that the permanent intended implant materials did not go through the testing at a level three that would test for toxicity,degradation, etc ? Who in their right mind would think a material to be placed in a human body to mix with body tissue and be integrated into tissue would not have been tested at the appropriate level to assure benefit over risk? The FDA needs to be overhauled and those with conflict of interest ( in bed with manufacturers) tossed out….. I pray the jury sides with the plaintiff……

    • Jackie August 30, 2014 at 3:33 pm - Reply

      Seriously?!!! They consider their so called ‘warning’ a full & accurate warning?! I’m appalled at what these mesh makers get away with! AND the FACT that jury is NOT informed of the way this mesh bypassed its way to FDA approval!! I am still baffled beyond belief how this explanation is NOT allowed in court. To me, it makes all the difference in the reason WHY it has so-called FDA approval! I would NEVER consider this FDA APPROVED once informed of the way mesh companies got their TOXIC material approved and in our bodies!

  3. Kim August 29, 2014 at 9:26 pm - Reply

    Sitting on pins and needles won’t be any different than what I already do but this is such bull.

  4. Tambrea August 29, 2014 at 10:48 pm - Reply

    In pain as I tell you J&J hurts women! Was not told the adverse effect by my Dr! Was not told all the information, at all because they did not know, or did not care! They just wanted to profit fro the Dr’s that are still in denial!!!!!!!!!!

  5. Doris August 29, 2014 at 11:00 pm - Reply

    We are all out raged over these judges allowing these companies getting away with murder !!! Why in the Hell does anyone think that thousands and thousands of women from all across the globe came together while never meeting one another and started making up all the exact same symptoms , and for the life of me I can’t understand how 12 jurors could look at the evidence that over 60.000.00 women are screaming out in so much pain some even taking their own lives because the pain is overwhelming and No Doctor’s have the balls to stand up and tell just how much damage the mesh has done to the patients because they are afraid of being brought into the courtroom and be made to tell the truth , Enough is enough this is bullshit if this happen to men only then they would have done reached a multi million dollar settlements, but because we are woman it seem that we all just have PMS AND MUST BE OUT OF OUR MIND !! ,, Can anyone tell me why or how can a judge order a direct verdict when the companies who lost millions in verdicts can file appeal after appeal, The first case that mesh victim should have never been chosen to have her case heard in the bell weather trials when she had so many other heath problems but I don’t know how in the hell any jury can find on the behalf of the companies because they have had document after documents have proven to have been destroyed to cover up the proof that these companies knew what this stuff was going to do to us but they still choose to kill a few women in order to make a profit of billions of dollars and we have got to get our voices heard at any cost, It’s not about money any more because I am pretty sure most of us will not live to enjoy and money or to crippled to do anything but laying on a couch or bed and pray dear God please HELP ME !!! PLEASE GIVE ME MY LIFE BACK !!! But don’t let this one verdict sit us back if anything it just shows us that we must come together and show as one voice one mother, one wife, one sister, one lover, and show we are not the weaker sexes !! and we will NOT STAND ALONE ANYMORE !!!!! We did not ask for this and we don’t deserve to be treated like trash !!!! any longer, and I also feel that NO CASES should be trialed in the state where they company main headquarters are located because those companies have hundreds of employee’s and their taxes are paid in that state, so I don’t see how anyone can get a fair trial because the town people will not go against the butter to their bread and the judges are the same and at the bottom lines is never bite the hand that feeds you !!!!

  6. Ginger August 29, 2014 at 11:30 pm - Reply

    Doris that is why J&J is willing to go to court they destroyed all the evidance…. they nothing to loose…

    • Jane Akre August 30, 2014 at 10:57 am - Reply

      Hello- And there have been no sanctions for doing so. One has to wonder if other mesh makers have noted that and also destroyed documents. Why not? If there is no downside, it would be tempting.

    • Jane Akre September 1, 2014 at 11:13 am - Reply

      Ginger you are right and that will NOT be entered into evidence in this case…. What is missing? Why can’t the jurors hear that?

  7. J.C. August 29, 2014 at 11:56 pm - Reply

    Most women attempt multiple surgeries to have the mesh removed, but they are intended to be a permanent implant, one that never underwent Food and Drug Administration approval for safety and efficacy.

    That information is excluded from these trials as is the number of claims filed around the country.

    And yet J&J is allowed to say: J&J had argued its mesh had been approved by the U.S. Food and Drug Administration (FDA) therefore could not be the basis of a defective product claim. Prolene filaments had FDA approval decades ago, but a thread is not the same as a new device, Judge Goodwin had ruled. Where is the fairness in all of this? And when they ask how much a doctor has been paid to be a witness, doesn’t J&J pay expert witnesses to testify on their behalf?

    • Jane Akre August 30, 2014 at 10:56 am - Reply

      Hello– Both sides routinely point out how much the other side pays its experts… It is usually the same, about $500 an hour and thousands of dollars to appear on the stand per day. That is calculated by what they would otherwise make in their regular professional capacity. If both sides point it out, hopefully it becomes neither a negative or positive… just a fact of life..~ ja

  8. kristine August 29, 2014 at 11:57 pm - Reply

    I have mesh damage and I get sick and throw up every time I read about how nothing is being done. I can’t stand knowing I’m walking around with a product in my body that’s making me sick . I’m not well and I’m getting worse. Someone needs to be held accountable . I did my last will and testimony. I did an advanced directive. I’m 43 and I was normally healthy and very active. I can’t live my life . I’m terrified. F… mesh and who ever thought it was OK to put in our body. May god give me and other women just a little longer in life. I’m having bad terrifying breathing episodes. I stop breathing and can’t swallow. This is not normal. I’ve been in the hospital two times this month with infection. I saw my life flashing before my own eyes. I have nerve damage . Trouble walking trouble sitting. I can’t drive half the time. I’m not eating . I’m not sleeping. I cry constantly. I will die before I get the help I need . I won’t see my grandsons grow up. I won’t see my youngest daughter get married. I know my body and it can’t hold up. Good luck with this trial huskey you deserve all the money you can get .

    • Barbara August 30, 2014 at 2:49 am - Reply


  9. msm August 30, 2014 at 8:00 am - Reply

    Does anyone know if it is true that the majority of the cases are women who have mesh but have not yet had significant treatment? We all know it is just a matter of time and many may need more treatment right now than they are currently getting.

    The attorneys on both sides have reviewed cases in selecting bellwethers and the judge has also reviewed the facts of the cases selected and decided what to try. I am sure all parties have discussed this in there meetings when deciding what to settle and what to try. Is this perception that most cases involve minor or no injury that is causing this health crisis not to be taken seriously?

    These women and thousands more will suffer or are suffering in silence leading to hundreds of thousands of cases in the future. This is the tip of the iceberg. Dr. Blavais knows this as do many more but they are not being listened to or are too intimidated to speak out. It floors me that in a country that is supposed to be progressive would not see how this health crisis will progress without governmental intervention.

    I believe that anyone who has polypropylene implanted will have some physical reaction. If it is one suture, maybe the reaction is small and goes unnoticed. If it is mesh consisting of concentrated polypropylene mimicking thousand of sutures, the reaction is or will be undeniable. How many men and women are suffering pain and other health issues related to mesh who were never rold that mesh was used? This material in any from does not need to be in the human body.

    One “expert” defense witness testified he conducted a “study” that consisted of implanting the material under the skin of animals. How does that compare to implanting the material inside the body around delicate mobile tissues? Everyday and all day with every move , I am reminded of the pain so many will suffer unnecessarily.

  10. PLC August 30, 2014 at 8:21 am - Reply

    I am also a little confused why there are certain cases only 3 years after surgery going before the courts. These poor women have only dipped their toes in what’s ahead. The jurors have no idea of what’s yet to come.

    10 years later I can tell you first hand, the symptoms, side affects, surgeries, illness and the path of destruction it leaves, never ends.

    Mesh is a life sentence.

    • Jane Akre August 30, 2014 at 10:50 am - Reply

      Hello— Judge Goodwin wanted cases from women ages 40 through 60,,, and I believe he wanted no more than two post-op surgical procedures… will check on that. Of course this criteria leaves out many other women. Many cases are potentially able to go to trial but in the end each side gets to select some…..sort of an inexact science.

      • Jane R. August 30, 2014 at 11:51 am - Reply

        My surgery was in 2008. I have mesh erosion. My uro gyn has offered to operate.

        The attorneys want me to have surgery. I have delayed it because of the

        nerve damage in my leg. Obviously if the mesh becomes infected or punctures

        an organ I will have to have surgery. So it’s kinda like being a sitting duck.

        And I’m sure I’m not the only one. Who knows what the future will be for these

        implants but it doesn’t look good to me.

        I currently receive PT for the nerve damage. I am also going to get PT for

        the lymphedema starting next month.

        My medical bills are over 10,000 this year with my copays of 3,000.

        I didn’t have insurance for over a year in 2012-2013 and couldn’t see my doctors.

        Applied for SSDI and was denied because I didn’t go to the doctor.

        Now that I finally am getting the tests, I might have a chance at SSDI. But

        I can’t work because of the nerve leg pain I get daily.

        I have sold every thing of value I own to get the lights on. Just antiques

        my family had. Nothing of huge value but enough to help.

        This is how I’ve been living for 3 years.

      • Pam August 30, 2014 at 4:04 pm - Reply

        How do we find out the selection process for Judge Goodwin?? I’ve researched allover and can NOT find anything with how these cases are revewed, taken to court, or anything like that

        • msm August 30, 2014 at 4:54 pm - Reply


          These are the orders from the judge to the attorneys. Pay particular attention to docket control, bellwether cases, discovery pool, etc. Can’t remember but the process is addressed in the orders.

        • Jane Akre September 1, 2014 at 11:16 am - Reply

          I believe that happens in pretrial conferences that is not public.

  11. Dean August 30, 2014 at 3:25 pm - Reply

    Just wondering are they showing any pictures of the mesh that has been taken out when Dr Razz took my wife’s out he had it in a container and I took a couple of pictures on my phone and sent them to our lawyer it looks disgusting you can clearly see it had deteariated in her body

    • Jane Akre September 1, 2014 at 11:17 am - Reply

      Good point Dean- we’ve not seen any pictures of explanted mesh in this trial….. they did argue and were allowed to show the mesh before it went in. they were allowed to show the video of a surgery, that is something new. but you would think for comparison, an explant might be helpful for the jury to understand what happens in the body. It is a fact afterall!

  12. Disgusted August 31, 2014 at 2:43 pm - Reply

    This is just unbelievable and making me so sick. What is happening is criminal – where else would any group or even corporation cause so much pain, both physical and emotional – devastation to marriages, families and communities – but the medical field? Automobiles are under so much more scrutiny, they try to cover-up but it comes out. The piper is paid. Not so with the pharmaceuticals, they have been doing this for years, even before mesh. As had been said “dog food faces much more accountability than mesh”. I do not understand how the Judge could rule that punitive damages are out. If they are shown to have a defective product why can’t they be punished for what they already knew, especially in light of destroying so much evidence? It is a crime to destroy any persons life – depraved indifference. They knew this was permanent and they are passing (the buck) their responsibilities to the Dr.’s. They’ll sell to anyone, it doesn’t matter if you’re qualified. How does this go along with their credo? WHO, in their right mind, would allow an implant for incontinence if they knew that it would not only cost them their lives as they knew them, but it would also cause a permanent living in pain and torture for the rest of their lives? Can anyone really believe that any of us would have chosen permanent, life altering pain over incontinence??? Saying the issue came from the Dr. removing the mesh and not the mesh is as low as it gets. Leaving mesh in place does not stop the pain, organ damage, or even erosion. The belief that it stays in one place has been shown over and over to be a straight out lie. Ladies, if you can at all – get it out in one piece, that is the best chance for wholeness. Also, do not do PT or anything that is really physical until it is out. PT can increase pain while the mesh is still in. Of course that is my opinion, but I’ve lived with this for a long time and have many mesh injured friends. We learned a lot the hard way. I am happy that Judge Goodwin has caught on to the difference between permanent pain and transitory pain. Pray he will get the whole picture. Pray the jury will read between the lines. Healing and blessings to us all.

    • Jane Akre September 1, 2014 at 11:08 am - Reply

      AND cars have VIN numbers to track problems. Medical devices that are permanently implanted in our bodies do not. Does this make sense??

  13. Jan Urban August 31, 2014 at 4:42 pm - Reply

    Feeling scared and hopeless today. The court proceedings appear slanting towards J & J once again. It feels as if I’ve been surgically maimed all over again. I am going for exploratory surgery 9/1514. Doctor feels there are to many issues going on with me that he can’t get a handle on a specific one. Sound familiar? Anyways, I’ll try and keep the faith. Jan Urban

    • Kitty September 2, 2014 at 4:13 pm - Reply

      To Jan Urban: Please keep us informed on the exploratory. I had a quiet pelvis for many years—but then something happened and it feels like cancer——-but it isn’t——– and there is no answer

      If it isn’t the mesh—– what is it?

  14. Sandy September 1, 2014 at 10:27 am - Reply

    I don’t understand a lot of the legal jargon but here’s my question— are they trying to say it was the doctors fault that we recieved damage??? If so that’s kind of throwing the doctors under the bus. And here’s the other thing the time limit on sueing the doctors has passed for most of us!!! So then we are just told to bad your life has been destroyed and we just have to learn to live with it!! OMG!!! I don’t know how much more of this I can take and at the rate of trials and settlements I will never live to see a settlement if I would get one. Every day I lose a little more hope! THIS IS SO WRONG ON SO MANY LEVELS I AM SICK TO DEATH OF IT. AS SOMEONE WHO HAS HAD MANY TREATMENTS I AM SICK OF DOCTORS AND HOSPITALS!!!! I face a future of unknown health issues and more surgeries. I don’t understand in the UNITED STATES how this can happen or be allowed.

    • Jane Akre September 1, 2014 at 11:05 am - Reply

      Sandy- I’m not a lawyer but the failure to warn goes directly to the doctor! He/she is the end user of the product. it is their responsibility to warn the patient…. so the directions in the form of a product label (IFU-Instructions for use) must be adequate so the doctors knows ALL of the potential problems with the mesh… Everything… hope that helps!

    • Jane Akre September 1, 2014 at 8:09 pm - Reply

      Here is the IFU….
      click on tVT-O

  15. Sandy September 1, 2014 at 3:29 pm - Reply

    Does any of the information advise patients/doctors that there could be nerve, muscle, bladder etc…. Damage done. I think the design is defective because of the placement of where the barbs they put in me had to go. I am not a doctor but had they told me it goes close to a nerve that could affect me as it has I would have never agreed to this. No one warned me. I never had anyone point this stuff out to me directly. I still think in my case AMS failed to advise me of the dangers and made me a cripple!!!!

  16. Anonymous September 2, 2014 at 11:18 am - Reply

    They destroyed evidence, bypassed the FDA and are using the fact that it was FDA approved in closing?

    Desperate much?

    It makes me sick to my stomach as my life is ruined and I truly think the mesh caused long term effects-none of us realize yet. Thousands of women reporting the same thing.

    The other point the plaintiffs lawyers *MAY* be missing aside from the supposed bogus warnings. Is, that NEVER was I told that the TVT Mesh could not be removed in the same facet it was put in. I felt as if the doctor that put in my mesh was taking a crap shoot guess when he referred me to Duke Hospital. Hoping they could remove the mesh. Never was it explained to me the overall risks. Let’s say the implanting mesh doctors office suddenly put a pamphlet in the far let corner of the waiting room somewhere. This constitutes as a warning-even if they had done it? I was never given a pamphlet nor told anything about it other than it was mesh and the ‘gold standard’ and I would stop leaking urine every time I laughed or coughed. I woke up to having a complete hysterectomy with the edema being the same today as the day after surgery. My stomach and lower pelvic are grotesquely inflamed . Even AFTER mesh removal. I quite quickly put on weight to be the same as when I was pregnant. Why am I still grotesquely bloated?Why have I suffered with odd ailments ever since? IBS, heartburn,burping, overall constant sick feeling? It is not just side effects of all the pain meds they used to cover up the pain from hell. Why did I wake up with a low grade fever with the mesh still in, every single day?

    I hereby challenge, any Ethicon female lawyer to have the TVT mesh put in. And after their hell .Tell me what it feels like to have this mesh entangled around THEIR lower pelvic muscle. And even, how they feel after many surgeries of removal. Ask this very same lady lawyer for J&J Ethicon; if even 5.5 million dollars was enough for them to go on disability, loose any active hobbies, their sex life, their spouses? Or just daily life: walking to the bathroom with pain gyrating down their thigh and pain that morphine would not touch when their hellish mesh was in THEIR body.

    Who coached these docs to say it was the gold standard? Also, never was I opted not told that plan A: putting in the mesh plan B- stitching up my bladder or medication or any other options. I was told this the TVT mesh was the ‘gold standard.’ That alone is very deceiving!

    ALSO: Who exactly trained any gyno/urogyno in TVT mesh placement surgery? How is it specialty hospitals and doctors in the urogyno field know how to remove the mesh (maybe) and the implanting doctors are clueless? Do any of the implanting doctors have any vested interest in these mesh products? Stock options? Patent monies? I am guessing it must be MONEY because I have had my implanting doc(s) and other gynos defend this crap they call TVT mesh; EVEN AS THEY WERE INJECTING my lower pelvic trigger spot(s) with steroids that hurt like the ever loving dickens in itself. Yet providing a camouflauge of pain easement until full mesh removal?

    If the TVT mesh is safe— why does pain continue even after removal? Obvious no-brainer answer is, permanent damage was caused. What else 20-30 years down the road will happen as chronic pain in the pelvic floor eases but as I have been told by a doc and a PT. It will never go away.

    The Gross case verdict amount of award is peanuts to this company. It is what they pay in advertising in a few hours. Yet J&J is trying to blame the doctors now? Most of the implanting docs are defending J&J’s rotten mesh. The question remains will the doctors cease the dog and pony show when the finger is pointed at them? I doubt it as they laugh all the way to the bank. One of mesh survivors needs to sue the implanting doc’s as well— and see how far they will go— to lie for the mesh makers.

    My thoughts and prayers to each and every person going through this hellish nightmare.

    I literally, feel your pain. Please excuse typos/misspellings I typed very quickly.

  17. Disgusted September 2, 2014 at 2:17 pm - Reply

    I thought of this later on; Did anyone catch what the defense lawyer stated? That they did not need to put in the IFU that pain would be permanent because it is a well known fact and the Dr.’s know it. That is a very telling statement. I hope the jury catches it.

    “Judge Goodwin asked Thomas if he drew a distinction between warning of pain and warning of chronic pain. “Its well known,” said Thomas, “And Dr. Bykrit (implanting physician) was well aware of that risk and that means we don’t have to warn what she already knows.” ‘ TAKEN FROM JANE’S ARTICLE ABOVE.

    Am I missing something??? They know it has the potential to destroy a person’s life and it’s still worth putting in? The defense’s lawyer made this statement. INCREDULOUS!!!

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