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Lewis v Ethicon is Over! Judge Grants Ethicon's Motion to End Trial

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

The plaintiff’s side in the first Ethicon trial to be heard in this federal court, had six days before it rested its case. One day later, Judge Joseph Goodwin ended the bellwether trial when he granted Ethicon’s (Johnson & Johnson) Motion for Judgment as a Matter of Law.

See attached Carolyn Lewis Doc #291.

Doc #290  both filed February 18, 2014.

The brief filed Tuesday said there was insufficient evidence presented that would prove liability or defective design. The case never went before the jury for deliberations and the directed verdict came on the eve of Ethicon’s case before the jury.

Earlier Judge Goodwin had dismissed plaintiffs from both New Zealand and Canada who petitioned to have their cases moved to the Charleston, WV federal court.

Plaintiff Lewis was implanted with a TVT mesh to treat incontinence in November 2009, She told the jury of ten last week that she had had problems ever since and finally found Dr. Philippe Zimmern of Dallas to remove it. He was unable to remove it all and the arms remain behind.  She said she felt much better but was still not 100 percent.

Failure to Warn

Judge Goodwin had left the Plaintiff’s with a difficult burden to prove. He had removed from consideration one element of a defective product case, insufficient warnings. He did so because her implanting physician said she had not read the IFU since 2002.

In the first of four bellwether cases chosen against the C.R. Bard Co. Judge Goodwin had disallowed any discussion of the FDA’s 510(k) approval process that does not require clinical trials for the majority of medical devices.

In a case heard before jurors in state court in New Jersey, Ethicon revealed it did no testing on humans before the product was approved for use in the U.S. in 1998.

There are more than 15,000 cases filed against Ethicon and more than 50,000 filed together against all six manufacturers that are consolidated in this one courtroom before Judge Goodwin. The jurors were not allowed to hear about the number of cases amassed in one court.

Judge Goodwin also did not tell jurors about the mishandling of thousands of pages by Johnson & Johnson, evidence that was to be used in this case to prove the TVT was a defective product.

The Plaintiffs had asked the Court for sanctions and for favorable rulings in the pending bellwether or four selected cases to be heard before the jurors.  Judge Goodwin did not allow any evidence of the destruction of evidence, also known as spoilation, to be introduced to jurors.

Additionally lawyers for Ethicon, Christy Jones and David Thomas said that Ms Lewis did not file her cause of action July 25, 2010 more than two years after her two-year statute of limitations.

Ethicon’s Motion

In it’s motion filed February 18, Ethicon said the Plaintiff’s did not meet the legal standard for defective. The Plaintiffs filed to provide evidence that proved the TVT is unreasonably dangerous was designed and there”was a safer, feasible and equally efficacious alternative design to the TVT that was available at the time of Plaintiff’s implantation in 2009. ”

Attorneys for Lewis showed the jurors the small pore TVT mesh made of polypropylene was too heave a weight to be placed in the pelvis and with small pores caused an overgrowth of fibrotic scar tissue that contracted and entrapped nerves. Attorneys also showed jurors that a larger pore mesh existed at the time that showed less scarring and bridging.

Lewis should have filed her case sooner as any “reasonable person” would have done knowing she was not healing properly said attorneys for Ethicon. Instead she waited two years and six months before filing an action.

Jurors never learned what Ms. Lewis was told by her implanting physician Dr. Muriel Boreham and whether she even knew she had a polypropylene mesh medical device that would be a permanent implant. That information was not allowed into the case. Often women are told the pain they are experiencing is just part of the ongoing healing process and they should be patient,. Mesh News Desk has found it is common for a woman to realize her symptoms may be mesh related.

Earlier attorneys for Ethicon had suggested Ms. Lewis filed her lawsuit only after seeing advertisements by law firms for clients in transvaginal mesh litigation.

The entire issue of any punitive damages is off the table with this ruling.

Preemption

Attorneys for Ethicon say the Plaintiff’s claims are preempted because the Prolene (commercial name for Ethicon’s polypropylene) is used in suture filament which is classified under the Food and Drug Administration as a Class III medical device.  Regardless, a Class III medical device is not “approved” in the way drug’s are which is the basis for a federal preemption of a defective product action.

In the classic case of Riegel v. Metronics, the family of Charles Riegel sued medical device maker Medtronics over his faulty heart implant. In that case, the implant did receive explicit FDA premarket (PMA) approval. The Riegel case was dismissed because federal approval trumps any state court action.

In the case of polypropylene mesh, there is no explicit FDA approval for safety. The 510(k) approval is an exchange of paperwork where the manufacturer notifies the FDA it plans to sell the product.  No requirements for safety and efficacy are required.  Since there was no  PMA approval by the FDA, the preemption argument here does not appear to be directly applicable.

Evidence entered in the case also showed the amount of polypropylene that makes up a suture is miniscule in comparison to a transvaginal mesh implant, therefore making a comparison inaccurate.

More Litigation Ahead

Attorney Adam Slater who secured an $11.1 million verdict in favor of plaintiff Linda Gross in her defective product case against Ethicon told MND this afternoon “I look forward to the next trial against Johnson & Johnson.”

Slater’s Ethicon trial schedule is here.

The upcoming bellwether trial schedule for Judge Goodwin’s court is here.

Bellwether cases are selected to test legal theories before juries. More than 50,000 cases have been consolidated in one courtroom. As of today, there are 16,471 lawsuits filed against Ethicon and its family of Gynecare products, some of which have been taken off the market allegedly for business reasons. The Gynecare TVT remains on the market. 

Here is the schedule for the rest of the three Ethicon scheduled trials in this federal court.

Updated 1/29/2014

The third bellwether trial is scheduled for December 4, 2014 at 8:30 a.m. in Bellew v. Ethicon, Inc., et al.,2:13-cv-22473. If the Bellew case has settled or is otherwise not ready for trial, the Lehrer v. Ethicon, Inc., et al., 2:12-cv-08157, case will proceed to trial instead.

Updated 10/08/2013

The first bellwether trial in Lewis, et al. v. Johnson & Johnson, et al., 2:12-cv-04301, will commence on February 10, 2014 at 8:30 a.m.

The second bellwether trial is scheduled for June 23, 2014 at 8:30 a.m. in Huskey, et al. v. Ethicon, Inc., et al.,2:12-cv-05201. If the Huskey case has settled or is otherwise not ready for trial, Edwards, et al. v. Ethicon, Inc., et al., 2:12-cv-09972, case will proceed to trial instead.

Mesh News Desk

Mesh Medical Device News Desk was the only news resource in the courtroom during the Plaintiff’s case. Here are the stories what were filed.

Pre Trial – J&J Faces First Defective Transvaginal Mesh  here

Day One – Lawyers, Liars and Bridging Fibrosis  here

Day Two – Ethicon Defends TVT Transvaginal Tape Science  here

Day Three – Polypropylene Under the Microscope  here

Day Four – When Did Ethicon Know it had Problems   here

Day Five  – Ticking Time Bomb  here

 

 

 

42 Comments

  1. debc says:

    Unbelievable. So they can destroy evidence, & not only get away with it but nobody can even mention it? They weren’t allowed to mention hardly anything about anything! Wtf? They are holding it against her how long it took her to file the claim but we all know you can go to doctor after doctor & they just keep sending you to more doctors. They don’t warn you ahead of time about what could happen, & when you do have problems they blame everything but the mesh. They seem to never admit, or know, it’s the mesh until you figure it out yourself and/or its visibly coming out of places it shouldn’t be. I feel very bad for this woman& her family. 🙁 So not right.

    Thanks for reporting on this, Jane.

  2. Vicky says:

    i am horribly sickened by this, how is this possible? our lives mean nothing!! we are disposable, what a wonderful world we live in……….. I wasn’t even able to read the whole write up. I feel like a “nothing” a piece of dirt that one sweeps under the carpet then says ooops to bad you were implanted with this..

    am I angry? your darn rights I am. we mean nothing!!!

    thank you Jane for your dedication to us suffering, you are our angel without you we would know nothing.

  3. The outcome is sad but not unexpected. The points about evidence withheld would not have made the difference. The strategy of hiding behind the FDA class 3 ruling was a great play by the defense and could have only potentially been overcome by one core attack. The attack was never made ob the actual quality of the implantd devices and a timeline of quality defects from design through manufacture never clearly laid out it would appear. Until the TVM community starts looking at the core issue here the outcome of any other cases will be the same.

    The only end run now seems to be getting some type of warranty in place . I hope the various advocates and activists will pick up on that play.

  4. Suzanne McClain says:

    Makes me angry, but as I understand it Ethicon is the entity that chose this case, and I believe they chose it because the case was filed after the statute of limitations had already run out, and they knew definitively that the ruling would be in their favor.

    Ms. Lewis is from Texas, and Texas has a statute of limitations for personal injury and product liability.

    This is something to work on for another day, but the statute of limitations for personal injury due to product liability is unreasonable. When I realized I had sustained injuries due to the mesh, it was in 2008; basically, this was in its infancy. It took me nearly two years to find a lawyer to accept my case, and this was with me working on it nearly every day. I talked to dozens upon dozens of law firms, and none had even heard of this before. My diligence paid off, and I was able to get my case filed before the statute ran out in my state.

    I feel sad for C.L. Lewis, but sincerely think this is the reason Ethicon chose it as one of their Bellwether cases. These cases are supposed to set precedence, and we all know how underhanded these companies and the lawyers that protect them are. 🙁

    • Patricia Shaffer says:

      I agree

      II agree! However, I have always believed that the statute begins when the damage or problem is first known by the plaintiff. Can someone explain why that is not the law in Texas. Thank you JANE!

      • Suzanne McClain says:

        Patricia,

        That is how I understand it too, as explained to me by several attorney’s. As Jane said, Ms. Lewis was implanted with the mesh in November of 2009, and “she told the jury of ten last week that she had had problems ever since…”

        I believe, since she stated she had problems from the get-go, her statute of limitations began immediately after she was implanted.

        It is a sickening process, but again, I believe that Ethicon chose this particular case because they knew they had it in the bag, and this is one of the trials to set precedence. In choosing this particular case, they are severely limiting damages they may be ordered to pay the rest of us in the end. They are all disgusting human beings, and I hope they all rot in hell, but not before being implanted with the garbage they have so egregiously breached the trust of the masses with.

        • Patricia Shaffer says:

          Sad but true Suzanne! So many many off us knew nothing at all about what was implanted in us tho. So even if we had problems we never put two and two together. At least until the mesh started coming out of our bodies. I just hope our lawyers will fight for this group of people.

          • Amen Patricia! I was having problems and just kept blaming them on all kinds of things; never thinking it had anything to do with the mesh! Although, I knew that after my first pap smear everything started getting worse. However, I continued to be told that “everything was okay”!

      • Donna says:

        Yes…I am also confused about the statue.

        Gynecare Prolift—-December 2006

        TVT—–November 2007

        Doctor continued to tell me mesh was not my problem even though both implants failed to correct my issues and only bought me pelvic pain. Second opinion doctor tried to remove mesh in 2010…only a very small amount removed because it was embedded. Went for a third opinion 2011 and doctor agreed with second opinion.. Dealt with breast cancer and 12 inches removal of my colon in 2009. (While reasearching I found info that related the mesh to cancer????) — frightens me about the future and the unknowns about what us mesh victims might need to face.

        Filed my lawsuit in January 2012.

        So did I file to late?

        • Karen Lavandowski says:

          The whole thing makes me sick i am a mess pain everyday surgery after surgery and nothing

        • Jane Akre says:

          Donna that depends on your state. I’m not a lawyer but my understanding is some states start the clock at the time of your implant… the others when you first knew you had a problem. That is a good question for your law firm, I’m assuming you have one. ..let me know and I’ll look it up… Go to our Facebook page and I can post the answer… you can reach me at janeakre@meshnewsdesk.com I’m sorry…. ja

  5. Dawn says:

    Mesh- never properly tested

    Mesh – goes bad in Patient

    Patient – goes to see Doctor

    Doctor – No ,it’s not the mesh

    2nd Doctor- eye rolls / No , it’s not the Mesh

    3rd Doctor – head shake/ no, it’s not the mesh

    Can’t walk , sit / too much pain

    Patient- I know it’s the Mesh , I’m not listening to those Dr.’s

    Patient – do my own Internet research

    Patient – OMG !!! There are 1000’s out there just Like ME !

    Patient – Finally find a Dr. To admit mesh is eroding in vagina.

    Doctor- Have to fly to California from Illinois for complete removal.

    Commercial- see my first lawyer/ transvaginal mesh commercial .

    And yet there is a Statue of Limitations on this product ??????

    How can there be if no Dr.’s are admitting that mesh is the problem.

    The core of the problem is POLYPROPYLENE !!!! It needs to be tested before putting in human tissue.

  6. Jaramillo says:

    Wow, I can’t believe it did not make it to the jury! They raped her yet again and they sit back and enjoy it! Is this how all the cases are going to go since we have none of their records? Jane I think we need to build a state registry. Then the women that are able to can start picketing the doctors offices. If we can get a large enough group maybe the media will come. What if we gather in front of the court house of the next trial? There is an ethicon plant in my city and I would gather if I could find the other women in my state. The suits are one part of the problem but the women who are being approached by surgeons need to be made aware. I doubt that doctors are warning any differently than they did 2 years ago. Why would they, there is money to be made. There has to be a way to unite. I had removal 8/2012, reconstruction 12/13. My surgeon referred me for a catscan to determine why I am continuing to have bowel problems. Nothing found but a grapefruit size cyst in my ovary. Now another surgery b/c they are afraid it will burst. I never had ovarian cysts before. Are any other survivors experiencing this? I found some research that they can happen from trauma. We all know it’s nothing but pelvic trauma from the day it’s put in. There has to be a way to protect others. It’s to late for us, but there are so many that do not know.

  7. Barbara Vance says:

    Wow this saddens me for this mesh sister. I am shocked beyond belief.

    What does this mean for the rest of us Jane? Did this happen because

    she filed to late? Confused!

  8. Rebecca says:

    I’m with Barbara… what does this mean for the rest of us? This both pisses me off and scares the hell out of me! I have been trying for 7 years to find out what is wrong with me and almost a year to get insurance after this beast stole my life my job and left me with no insurance only a shell of my former self. How can a statute of limitations cause a judge to rule against someone who could have just as easily have been his own mother or own wife or even his daughter years down the road since there seems to be no one admitting that there is a problem and stopping this mess from being used!?! I too want to scream and yell and as a matter of fact I am horse from doing just that for a while a little earlier! The big question is if the FDA can agree that the mesh is causing all these problems and that there is even a big enough problem to issue a warning then how can a judge rule for the company that continues to use this just because there has been too much time since they “felt” she should have known there was a problem!!! hell it took me longer than 2 years to even get a copy of my op report to find out what mesh was inside me and I’m a nurse! I’m sorry and I don’t mean to offend anyone but this has just infuriated me!!! I mean for YEARS women have been tossed aside for years and taught that everything that MIGHT happen to her is simply a cross to bear because we have two XX and no Y chromosomes. We go to a doctor to talk about an embarrassing thing that most of us are taught is a hush hush taboo subject and then we are trusting of the person that was willing to listen and told us he/she could fix it. Then when we hurt afterwards we are told it is just another thing that we are just to deal with and we are simply being wimpy girls about it. I’m not even 40 but as the youngest “oops child” of older parents I know this is how my mom and others of her generation and older were taught and therefore it has been passed down that way. Then when we trust doctor after doctor that tell us we need to just deal with is or that we are crazy or hormonal we believe them because that’s what we are taught to do. Then when we finally stand up for ourselves and go talk to someone and allow them to treat us as the victims we are and tell our story so we won’t have to tell it again, we are dismissed as if we don’t matter yet again… I refuse to be quiet and I refuse to mean nothing! I don’t care how many hear me scream at the roof tops that this is unfair and we DO matter I’m going to scream until I haven’t a voice left! Ms. Lewis you are right and you do matter no matter what anyone says!!! Praying for justice if not here on Earth then in the afterlife! May God Bless you and may you finally one day be pain free and mesh free as we all I pray will be! Again I’m sorry but when will enough be enough!?!

    • Rebecca, you are awesome…I loved it when you said, “We go to a doctor to talk about an embarrassing thing that most of us are taught is a hush hush taboo subject and then we are trusting of the person that was willing to listen and told us he/she could fix it. Then when we hurt afterwards we are told it is just another thing that we are just to deal with and we are simply being wimpy girls about it.”

      It was very difficult for me to tell this “young” doctor I was pee peeing on myself and when he suggested I have this surgery and that it would “fix” my problem I was elated. We were about to get permanent custody of two of our grandchildren so I thought I was going to be “home free.” NOT!

      It wasn’t long until I was cramping, and just totally uncomfortable – no energy – and almost lifeless. Soon I went back to that young doctor and asked him if my “leaking” and other problems were related and he assured me they weren’t and gave me a script for something to help…NOT again!

      Like so many others I’ve lost my life and my grandchildren.

      I hurt for all of us. My house has gone to Hell! Like you said that Judge will either pay here or in the hereafter! Let’s just hope we will get our reward the same.

      In His Hope,

      A Southern Belle!

  9. Lsp says:

    Why did her attorney allow this case to be filed if her statue of limitation had been exceeded. Am I misunderstanding this? I would hope my attorney would let me know if I filed too late. This seems to be a waste of time and effort, for her and everyone involved. I feel for Ms. Lewis, this is a blow for all of us.

    No one understands the misery we have and are going through, I thought there was strength in numbers, and had some comfort knowing we could fight this battle together. I want to have faith in the judicial system, show me justice, and I will.

  10. Pam Sender says:

    Doesn’t surprise me, unfortunately. I have always been pessimistic about a positive outcome. We are all little people trying to get justice out of the old boys system. My husband saw what I went through and heard the stories of the other women we met in Califionia and believes that justice will prevail. I guess after going through all of the pain, side effects and surgeries, I am pessistic that anyone gives a hoot much less would like to compensate me for everything or anything I went through. Life just isn’t fair sometimes. I have learned to live with low expectations.

    • stopmeshimplants says:

      Unfortunately I believe there are many women who are just as pessimistic as you and I. You get to the point that you just don’t believe any good news will happen for any of us. If you are one where they cannot get all the mesh out, you wonder what your future holds. How much pain will I endure? What kind of long term care will I require? These lawsuits just put me over the edge with worry for all the women yet to be harmed. Every verdict or decision for the defendants gives these manufacturers permission to continue selling this awful mesh and it means more women will be tortured and their lives will be changed forever. It is such a sad, unbelievable truth. I am forever grateful for Jane and her ongoing support! She does provide that glimmer of hope that someone actually cares!

    • carol says:

      You can’t just blame men plenty of these corporate people are women. Its GREED!!!! I live with bowel problems have rectal pain. Embarassing bladder incontinence. The incontinene is worse now than when I had surgery. Went to see the same group of urologists that put it inand I was told by a female doctor that the mesh is only 85% effective. I am a nurse and I know for sure I was never told that. Then she proceeded to tell me I needed to lose weight I am 5 ‘ 5″ and 170 lbs. They won’t admit or validate my concerns. They just want to make you feel that its all in your head

      • Rebecca says:

        I too am a nurse and I worked GYN Postop and I cared for these women after surgery… I assure you I was never told that there were any complications following surgery. I feel bad for all the women that I cared for and told there quality of life would change for the better after surgery. I in fact had this TVT done because I thought the outcome was so much better. We would see the clients postop and then train them to use a catheter at home if they required one. I can only pray for all the women I lied to thinking that I was telling the truth. I pray they can forgive me. I can most definitely say that even as a nurse caring for these same women that were implanted that no one ever told me of any complications and there was no information for us to give these women when they were sent home. So if there was information to be said about postop complications it was a failure on the doctors and manufacturers parts to educate the educators. We as nurses were not given any access to the manufacturers information so if it was listed on that information sheets it was either read by doctors and ignored or it was trashed and never read. I just pray for all of us some justice! I have faith that the justice WILL come as I said before if not here on earth then in the here after!

  11. Mary Pat says:

    Jane – as painful as it is to read the words you have written today, once again I thank you from the bottom of my heart for your faithful reporting. I imagine your heart was ripped to the very core today, as was ours. Facing this injustice is heartbreaking and discouraging. Please don’t let the evil we are facing wear you down. We need you, even more than ever. Without your reports we would know nothing. We would be in the dark. This day was a great discouragement for those of us who want to educate the world about the horrors of mesh. What the enemy doesn’t realize is the strength of women united. You have united us, globally and the more injustice that we face, the angrier we get. We won’t go away. This was never about the money. Every mesh injured woman and man desires to stop the torture. We won’t give up, EVER!!!!!

    Here’s a word of encouragement for you. Last week I called Channel 13 to ask them why they weren’t reporting on the trial. The news room manager new nothing about mesh. I directed her to your web site. She was quite impressed with you and the work you are doing. She assured me that she would get some one to interview you. I also called a local station, where I live (on the opposite side of the country), and the gal I spoke with had never heard of mesh either. She was a breast cancer survivor and she has been having problems with “leaks” since her hysterectomy. I directed her to your web site. She looked at it while we were on the phone together. She thanked me for educating her. She said her doctors had recommended mesh. After speaking with me and looking at your web site, she said she will NEVER get mesh implanted in her body. Your website with your excellent journalism showed her the truth in a factual and legitimate manner. Without your web site, I probably would have sounded like a half crazed injured woman. There. You saved another woman from being victimized. I hope that encourages you. I pray that God will bless your aching heart tonight. God bless you, my friend (even though I have never met you in person, you are a true friend to every mesh injured woman who seeks you out). Much love to you! Your friend, Mary.

    • Jane Akre says:

      If you would tell me her name we could set her up with some pictures… at least get the word out locally there… thank you, every little bit helps

  12. Sherri says:

    I wonder if he would be so willing to dismiss this if one of his family members was injured by mesh! I feel really bad that she has had to go through this.

    • max says:

      SHAME ON THEM. We are not the bad guys, we are the injured ones and yet we go on suffering at the hands of these evil people. There will be battles lost but the war is a long way from over!!!

  13. Anonymous says:

    I cried reading this. I had Gynecare Mesh TVT J&J in me and it ruined my life. I went to so many doctors complaining of so many medical issues/UTI’s. Most especially the horrifying lower pelvic chronic pain. I also suffered fevers daily and as medically documented my thought of me rejecting something as t I was sick. I also had horrible infections. I went immediately to the surgeon that put the mesh in within 3-4 weeks after it was put in and many other ER docs, urologists.

    I thought I was crazy as many ER’s could not do anything for me. I was also in the ER with bizarre symptoms of belching,gas that they swore it was my gall bladder. I was fighting this before the damned commercials of lawsuits on TV. As soon as my mesh was removed with two horrifying surgeries all of the strange symptoms, fevers, infections went away. But the lower pelvic pain continued. I am in physical therapy, on disability or I would be in bed all day. It is far better now then when the mesh was in but I still cannot return to work in nursing.

    I had to go hours away at recommendation of the surgeon that put the TVT mesh in; to a very well known specialty hospital to have the mesh removed in two separate surgeries. Even after the mesh was supposedly all removed by a urogyno specialty surgeon. I am still suffering in pain and on disability.

    Am I now going to not have my case heard because of this one statute of limitations case where the person acted too late and went straight to a lawyer and not doctors? My case is well documented of ER’s and urologists in several counties and states of my lower pelvic pain. It is also documented morphine would not touch the lower pelvic pain. I have evidence that the mesh is the cause of my life being ruined. As the many times prior to removal I had to be injected with steroids into the exact lower pelvic spot of mesh. I have a urogyno documenting the removal surgery as the mesh entangled into my lower pelvic muscle.

    I am on the GROSS/NJ case list and mine is GyneCare TVT J&J Ethicon. Does this ruling harm my case?

    Someone please tell me.

  14. carol says:

    Jane I so appreciate your hard work, perserverence and hope that you provide to me daily before I discoveted this Website I truly felt alone and confused. Your Website changed that for me. So thanks for all you do and are doing.

  15. karen says:

    Thank you jane, that was very hard to read. If this was what was going to happen why did the judge use 6 days to do it? These were professional individual , some attorneys and a judge. Come on why get a jury why pay for witnesses ? The real question is WHY ? No one will never know! This is like a soap opera, and we get cancelled because the judge didn’t think we gave him enough money under the table. Let be real johnson n johnson r Hugh !!!!! They print money , they just got approved again through the FDA, so lets see how many investors we can have to the judges chambers.

  16. Linda Dodson says:

    It is very sad that this lady could not have her day in court. I still have a box full of evidence against Eticon. I personally met with the Assistant Director at the FDA office in Atlanta on February 22, 2007. I provided them with a 27-page letter of my complaint against Ethicon mesh products, along with all other mesh products manufactured by other companies. The FDA did conduct an investigation into Ethicon and they were issued citations for failure to submit adverse event reports, along with several more citations. I waited for months to read on the FDA’s website that Ethicon was issued a warning letter. However, this never happened.

    I fault the FDA as much as I do the manufacturer’s for having allowed these dangerous products to remain on the market. IF you read ALL of the rules and regulations, like I did, on how the FDA regulates medical devices, you would come to the same conclusion that I did………the FDA is not doing their job.

    I had Gynecare Gynemesh placed in me, without my knowledge and consent, on January 26, 2006. My story is on Jane’s website. Once I started reading the 100’s of adverse event reports on the FDA’s website, I could not ignore the serious complications of mesh. I believed that women were being used as guinea pigs for the Drs and manufacturer’s own greed. It took several more year’s for the FDA to issue a health notification to the Drs and hospitals about their concern of mesh products. I believe this warning was issued in the fall of 2008. It’s been a few years since I’ve reviewed all of my documents. After reading this 2008 health notification, I felt outraged that NO warning was issued to the general public. I spent a week copying and pasting all of the FDA’s adverse event reports that were posted on their website. I listed this information by the manufacturer, mesh complications, deaths, hospitalizations, repeated surgeries, disabilities, etc. I also spoke about my outrage that they continued to ignore this very serious issue. This was a 55-page letter to the FDA. One of the two female Drs that I had been corresponding with at the FDA came up to me after the FDA meeting in Maryland several years ago and told me if I had not sent the 55-page letter to them, they would not have formed a committee to investigate this issue. I told this Dr that the information I provided in this letter was the same information that they had on their own website and it was their responsibility to monitor it. At the time I was doing my own research into the FDA, they had seventeen people to monitor the adverse event reports and it was their responsibility to monitor any pattern of adverse events. To this day, I have zero trust and respect for the FDA. It is the FDA’s responsibility to protect the general public against harmful medical devices and medications.

  17. jade says:

    Jane – I would like to contact you directly. Thank you.

  18. Karen Lavandowski says:

    Would love to talk to all of you i also had this put in please i dont even care about sending my number to 10000000 people i would love to talk 862 226-7162 i found a dr who can remove alll of it yhis makes me sick to think that its happening to so many and we all just keep thinki g it would get better i would love to know how the judge would feel having this stuck in his penis???????

  19. Annie says:

    I’m laying in bed now. Suffering from AMS Mesh. This is so not fair to me or any other woman. I have been through the most awful pain and suffering since having this crap put in my body. No joke. To many infections. Pelvic pain butt pain and nerve damage. No one doctor will admit its the mesh or they do not have the knowledge to deal with mesh complications. I can’t stand up without feeling it poke me severely. My personal Gyn told me tell the specialty center your going to go to to take it out get it out now. He did a pelvic exam. I did not know the different places he was pushing on inside my vagina but he kept poking around and pushed in one extremely painful area… I practically jumped off the table. He said that is back where the mesh is placed. So yes he confirmed what I all ready knew. It is pain from mesh. I’ve been going back and forth to a hospital an hour away to their specialty doctors. Urology/ Gyn then I saw a Gyn now I’m being sent to just the urology department for a cysto and a cystography. Once done their . I will be going back to see the uro /Gyn to see a surgeon. I don’t even know if this surgeon has experience taking out the mesh. I’m scared. We as women should have a place to turn. I would like to see how these women attorney’s would react to this mesh in their bodies and see if they like how it feels. I’m not the same person anymore. I cry constantly. My husband suffers the loss of the wife he once knew. My children have to see me suffer. My son see’s me crying and says I’m so sorry this is happening to you mom….he says I love you mom this is so unfair its stressing me out to see you like this. He is 21. You see the families of this terrible damage suffer as well. Money won’t bring back who I am or was but it will help pay for my future surgeries and it will make the darn companies suffer a loss just as we have. We should all be allowed to tell our Story to a jury and to be heard. Sex is no more. Urine leakage is still happening and worse then before. Pelvic pain is horrific. God bless you all.

  20. I’m so tired of hoping! Wish I had never even contacted an attorney. Ignorance is bliss!

  21. Bejah Notrettu says:

    OK, Here is what we need to do…stop weeping. Ethicon has people (trolls) monitoring this and other websites so know that when you pour your hearts out and be careful what you say. Even though they may not know who you are as an individual it can impact how they see us as an adversary. Actually they probably see us more like Christians in Rome being fed to the lions for the entertainment of their countrymen. They think they have disemboweled us, emotionally crucificed us, left us humiliated, hopeless and our troops scattered. This is the time we need to garner more strength and determination. They think we are a population of whining old women, most of us unsophisticated and at the mercy of small town attorneys who want to be noticed, want mention made of their names in big time lawsuits, That is not the case. This is not over. It is just beginning. Remember that you have the truth and knowledge of what is just on your side and that means you have the most powerful allies. This is just one battle.

    Apart from that know that the FDA is not your friend. The FDA is owned by BIG CORPORATE AMERICA.

    I personally now believe that this judge is also biased but I am not a student of the law and he may think he is following the law and has little discretion. I wonder how much discretion he does have. Who appointed him to this role. What do we know of his background?

    I think many of us would like to understand how it is just to refuse to allow testimony to those who are clearly important witnesses, etc. How is is just to limit the time an important witness can be allowed on the stand? How is it just to refuse to allow testimony or impose sanctions on an organization that destroys thousands of pages of evidence? Show me where in the law the statements are that allow these things? In a true Democracy this would not be tolerated. So if this is no longer a Democracy what form of government is it that is masquerading as a Democracy and withholding news from the general public that the public has a right to know of and may have a far more important bearing on them than a traffic accident or local gang activity or what club a celebrity was seen visiting. Who will explain these things to me?

    My heart goes out to the plantiff and her family. I pray that you will find peace and happiness in the future and let go of the evil you have encountered.

  22. Sharon Bearden says:

    How do we as Mesh Angels form groupsinour states to get together and statnd up against the large Corporations? How do We form small groups and join forces to form large groups? This needs to go as far a Washington . To anyone that will listen?

  23. Karin says:

    What is so sad about this case is that as the bellwether it sets the stage for all that follows. What a horrible case to represent those of us suffering from mesh complications. I have read so many stories online posted by women like myself and I often think, “i could have written that myself” or “she is describing me.” I totally relate to the pain and other issues as well as being blown off by our implanting surgeons and other doctors as well. We DO seek out help from doctors and complain of our issues…. Searching for answers… Why is this happening! ? What can be done? Often not even suspecting at first it IS the mesh and often seeing multiple doctors only to be sent away frustrated and in tears… Until we find the right doctor who knows what it going on or until we give up hope and resign ourselves to a lifetime of issues and pain. But this gal didnt go to anyone? Complain of any issues? Not all women react the same to the mesh in them. Somehow they managed to secure the mildest possible case and the least likely to win. The majority of us have a medical paper trail a mile long and a history of tests, procedures and surgeries to address the problems . We are desperate to seek relief from pain. Fatigue and disfunction.

    There is nothing vague or mild about it. But they surely did just finish trying the mildest, most vague representation of what the rest of us are dealing with. It is completely unfair to those women who DO have years of pain, suffering and medical nightmares that a case such as this one should be allowed to be chosen as representative of a typical case. It most surely is not. While we are at it… Why not simply ignore the destruction of years of self incriminating documents and sweep that under rug along with it

  24. Richard Howden (AMU) says:

    As usual, Jane reports what others will not. When the FDA tells a reporter that a Mesh Victim is just disgruntled, hooked on pain meds, the pain is their head or the victim is just trying to get a law suit, the reporter will believe them. No matter how many complaints the FDA has, they are not going to admit that all Mesh is bad. This is where Jane Akre does what no other reporter will, she doesn’t believe the FDA. Bruce and I have tried to get reporters to report about our Mesh but the reporter checks with the FDA who tells them that we are just trying to make money ( or whatever) and of course they are going to believe the FDA over a malcontent. The FDA is there to “protect us” from bad drugs and medical devices. They are the benchmark and therefore cannot be refuted. We harbor distrust of the IRS, the NSA and even the DOJ but for some reason we believe the FDA in all things. Unless of course, you are a Mesh Victim. There is just too much money involved for the FDA to kill the Mesh industry. The Mesh manufacturers have more Lawyers than we have money and more money than we have Lawyers. Keep up the Good Work, Jane……..

    • jane akre says:

      Thanks Richard,,,, going up against power (Fox) and being called a “disgruntled, former” myself, I know that is tactic used to minimize individuals who may have a lot to say. The crowd will always go with the safer option so they don’t have to get involved. I guess it’s human nature. I like those who speak truth to power…. thank you!

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