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January Opening Statements in Gynecare NJ Trial

December 4, 2012 ~January 10, 2013 is the date set for opening statements in the next trial of a mesh implant patient.

The plaintiff, Linda Gross, of Watertown, South Dakota, accused Gynecare, a division of Johnson & Johnson, of negligence and defective product design.

The Honorable Carol E. Higbee of Superior Court of New Jersey on November 30 signed an order for a pre-trial schedule in the case of Gross v. Ethicon, Inc. et al. Ethicon is the division within J & J that makes Gynecare vaginal mesh.

By December 7, both sides must agree on questions to be submitted to the jury. A December 11, case management conference is scheduled. All papers opposing pre-trial motions needs to be submitted by December 21. Oral arguments on pre-trial motions are set for January 3-4, 2013. Jurors should be selected by January 9, 2013. After opening arguments on the 10th, witness testimony is set to begin on January 14, 2013.

Here is the Case Management Order.

Gross is one of 1,870 women (as of November 30) suing Gynecare (J&J) in the Atlantic City, NJ court. See the case list here.

ABC News reported in September 2011 on the Gross case here. Her Gynecare mesh was implanted in 2006 to relieve bloating, constipation and pelvic organ prolapse. She received the Gynecare Prolift, which last June, Ethicon announced it would discontinue selling along with three other meshes over the next 12 months. See story here.

An Ethicon spokesman insisted it was not a product recall.

“We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”

Gross accuses the company of urinary complications, constant pain and swelling in her body as it tries to reject the mesh. Twelve removal operations have been a failure and she is still in pain, still has mesh and her body is still swollen, reports ABC News.  Her doctor reportedly told her the Prolift device was safe and low-risk. He allegedly did not tell her Prolift had been allowed on the market with no clinical trials or checks for safety and efficacy.

“It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Gross told ABCNews.com. “I wouldn’t wish this on anyone.”

Her attorney, Adam Slater, told ABC News that, “the whole concept of the 510 (k) process should be scrapped,” adding that the doctor who created the product even said there needed to be more studies.

The FDA found about 4,000 mesh-related complications that were reported to the agency between 2008 and 2010. Of those complications about 35 percent involved mesh erosion into other organs and tissues. Other complications include pain, infection and bleeding.

You may recall that Johnson & Johnson launched the Prolift without any FDA approval in 2005. When the agency discovered the mesh was on the market and the company had not alerted the agency, it approved the Prolift in 2008.

Gross had her mesh implant two years before the FDA’s first warning issued in October 2008. The second more strongly worded Safety Notification was posted in July 2011.

13 Comments

  1. anurse says:

    Prayers and best wishes to Linda Gross in her trial. Linda is speaking out, not only for herself, but for thousands of severely injured women all over the world. Stay strong Linda.

  2. mesh sufferer says:

    Stay strong Linda Gross!!! I am suffering right along with you. It is a sin that the Gynecare mesh is still being put into womens bodies. It is very low of J&J to only warn so they are not sued further;yet they continue to make their money in having this awful mesh put into others bodies.

    • Linda mclaughlin says:

      hi linda i am in same situation as you .had mesh implanted in body 3 and half years ago like you 9 0ps later and still suffering.it is so hard but helps to know you are not in this alone.good luck

  3. Betty says:

    Hold strong Linda. From what I understand they (the opposition) can get pretty nasty. Stay strong and remember they are the liars as 10’s of thousands can attest. We’re behind you. This is such an emotional issue and affects us as women at the core of our being. I’m praying for the truth to come out and for vindication – although they can never cover what has been done to you – I hope they feel it!

  4. DebC says:

    wow. There are “1,870 women (as of November 30) suing Gynecare (J&J) in the Atlantic City, NJ court.”??

    1,870?… just for Gynecare in NJ?? That’s amazing…. and yet – it seems so many of who have mesh complications are told we are “the only one”. ?!?

    Best of luck to Linda Gross. It sounds like she has been through hell and back already.

  5. Dawn says:

    Linda, May God hold you in his hands throughout this process… So many are following in your footsteps … Lord help those in charge to see the pain and suffering MESH has caused and is still causing.. The madness needs to stop and those that have been tormented need to be compensated. Prayer for you Linda.

  6. Jane Akre says:

    Opening arguments Thursday!

  7. suffering in silence says:

    Oh thank goodness some peoples trials have begun and thank you for posting this. I now know Gynocare is a division of Ethicon because all I ever see is suings of Ethicon and Bard which may all be J&J companies. I had no idea of that and am so glad to here it and wish all the luck to those in this trial for when courts go underway they tend to blame us for the injuries thier products caused and call us liers when all we want is for someone to be held responsable or atleast I do. Money helps but it will never give us our lives back so the best part of a trial and not just a settlement is that everyone hears of it and than can know what serious issues these products cause for women of all ages including myself which had mine in June 2012 and immediatly had issues which linger and worsen each day to the point of not knowing if i shall wake each day or not. Good for Gross and all those others in this case!!!! My prayers go to them for victory.

  8. Renee Cook says:

    Stay strong Linda Gross!!! It’s amazing what she is doing for all of us, she’s speaking out for the woman that cant… The artical said that J&J was stopping all sales and production on all Gynecare mesh but it only listed four of the meshes? The Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and the Gynecare Prolift + M ! Im confused because I have the Gynecare TVT Prolene model #810041b and it’s not on the list to be recalled? I think all the Gynecare TVT meshes need to be recalled! God bless Linda Gross… Everyone who is suffering with this GOD AWFUL MESH please don’t give up!!!

    • Jane Akre says:

      Renee-Prolene is the same mesh that the Prolift used, just reconfigured into a precut kit. So it’s the same basic mesh material. They don’t call it a recall, but taken off the market for financial reasons. If you have a law firm they can direct you but don’t give up. Prolene is the hernia mesh PS (prolene soft) that they reconfigured for vaginal mesh, but its the same product used for hernias, prolene for vaginal and Prolift.

      • Renee Cook says:

        Hi Jane,

        Thanks for the information but the mesh I had implanted was the Gynecare TVT Prolene. But it wasn’t listed among the other meshes that were taken off the market like Prolift, Prolift +M,

        TVT Secure and the Prosima. So do you know for sure if the Gynecare TVT Prolene lot # 810041b is among the other meshes that was discontinued?

        Any information would help because I’ve looked around and I haven’t found it yet. Thanks for all your help Jane.

        • Jane Akre says:

          I believe the TVT is still on the market… only the four you mentioned were voluntarily taken off the market last year… but worth giving it a second look. I believe it’s still on their website…

  9. I too am on the docket filed 12/18/12. Who knows how long before it is heard. Had a complete hysterectomy including Prolift I and II in May 2010. At my six week checkup, mesh had already eroded thru the vaginal wall. Doctor cut it away in the office, sent me home with estrogen creme and pain killers and said see ya in two weeks. Nothing changed in two weeks. There was a hole the size of a quarter in the vaginal wall. In July they opted to use a porcine graft on the hole. After 5 months of going every 2 weeks and using tons of estrogen creme, the doctor wanted to do another graft. I refused. I could not take the feeling of this foreign material in my guts any more. Went to the Women’ Pelvic Health Center in Houston, got a second opinion, had all mesh removed that was possible. To this day, my guts still feel like they are on fire. It is like someone injected insulation under your skin. I can only stand for about 20 min, sit about and hour. Other wise I am laying flat on my back for relief. It is a horrible invasive procedure. No woman should go through this. Sadly, I found out that the prolapse I was experiencing could have been corrected without the use of this magic mesh.

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