*Just In* Wave 7 Ethicon Trial Postponed Until Next Year

//*Just In* Wave 7 Ethicon Trial Postponed Until Next Year

*Just In* Wave 7 Ethicon Trial Postponed Until Next Year

Mesh Medical Device News Desk, August 13, 2018 ~ It was set to start tomorrow, but the mass trial of more than 100 plaintiffs has been reset as thousands of cases are purged from the Ethicon docket.


Image: Wave, WikiCommons

You’ve heard the term – a “Wave” of cases  – that were set to begin Tuesday, August 14, 2018 where multiple plaintiffs, more than 100 at one time, all women from West Virginia who had suffered from TVT mesh implants, were to have their case against Ethicon ( J&J) heard in one mass trial.

The Wave is off as the court goes through a purging of cases in an attempt to have it dissolved.

Last May, it was announced that the Wave would be heard before Judge Joseph Goodwin. At the time he was  overseeing more than 100,000 pelvic mesh cases before him representing seven mesh makers consolidated in one multidistrict litigation (MDL).

Judge Joseph Goodwin

Since then, Ethicon asked, and Judge Goodwin agreed to clear the docket of non–revision TVT meshes, of women who have not had any surgical removals of Ethicon meshes from the TVT family (tension-free vaginal tape) family.  That includes TVT Retropubic, or Abdominal,  TVT Obturator, TVT Abbrevo, TVT Exact.

Four devices which are no longer marketed are also included such as Prolift, Prolift +M, Prosima and TVT-Secur.  The TVT family also includes Gynemesh PS and Prolene, the proprietary name of Ethicon (J&J’s) polypropylene mesh.

See MND on what Ethicon was granted here.

Judge Goodwin has been busy removing those cases from the So. District of WV docket as law firms announce they have reached settlement with Ethicon on  behalf of their clients.

Between dismissals and settlements, the 100 woman caseload of Wave 7 is now whittled down to one.

Dr. David Afram, MD, YouTube

Sutphin v. Ethicon is scheduled to be heard April 22, 2019, before Judge Goodwin in Charleston, WV.


The West Virginia plaintiff was implanted with a TVT February 24, 2009 at Logan Regional Hospital in Logan, West Virginia by Dr. David Afram, MD, who now practices in Virginia.

The attorney on the complaint is Lee Balefsky and Michelle Tiger from Kline & Specter, while Kila Baldwin has tried many cases for the Philadelphia-based law firm.



Filed this month in the Sutphin (2:14-cv-01379) case, Defendant Ethicon has objected to Plaintiff wanting to exclude the FDA 510(k) evidence.

Plaintiff says the defendants now attempt to introduce additional arguments that the 510(k) clearance of mesh means it is, “FDA cleared, safe and effective,” and without risk.

Kila Baldwin, the attorney for Sutphin, says the defendant has “cherry picked” from FDA language, “from case law and FDA determinations, made blanket assumptions, and have fully ignored the conclusions made both by the Courts and the FDA.”

The FDA’s 510(k) clearance to sell is not the same as a premarket approval or PMA which drugs must undergo.

Even the U.S. Supreme Court has acknowledged” “The 510(k) notification process is by no means comparable to the premarket approval process; in contract to the 1200 hours necessary to complete a premarket approval review, the 510(k) review is completed in an average of only 20 hours.”

Kila Baldwin, Kline Specter

To introduce the regulatory language by the FDA could be considered an attempt to go down the rabbit hole of FDA regulatory jargon, sure to take up time before a jury and serve to confuse and obfuscate exploration of the defective nature of the polypropylene mesh implant, used to treat incontinence.

Defendant corporations have tried, unsuccessfully in the past, to introduce the 510(k) issue.

Baldwin writes,  “To ask this Court to now provide jury instructions implicitly stating that the FDA has determined that the TVT-O is safe and effective and/or that Defendants acted with “due care” because it is a Class II device, without mentioning the FDA’s litany of concern over the Device’s safety and efficacy is misleading and preposterous. “

Filed last March 5, 2018 was a defendant’s motion to exclude Peggy Pence, Ph.D from the Wave 7 trials.

As many readers are aware, Dr. Pence has testified about the FDA regulatory process, and is considered an expert in how drugs and devices are brought to market, development, regulatory affairs and labeling standards.  Judge Goodwin said the expert opinions expressed early on in this MDL are identical to those offered today.

Dr. Peggy Pence, Courtesy CVN


The court attached similar rulings from a 2016 Memorandum Opinion and Order ECF 2075 on Peggy Pence:

Denied – Ethicons’ challenge of Dr. Pence and her 40 years of accumulated knowledge about the adequacy of the IFU, Instructions for use.

Denied- The use of Dr. Pence to testify about premarket testing of medical devices.

“Accordingly, the court will refrain from engaging the extremely inefficient practice of continuously reexamining the qualifications, reliability, and relevance of dozens of experts and their numerous opinions.”  Challenges to experts, known as Daubert challenges, not previously addressed to the court are reserved for trial, says Judge Goodwin writing August 7, 2018.  ###

By |2018-08-21T18:11:57+00:00August 13th, 2018|News|29 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. HJ August 14, 2018 at 1:06 pm - Reply

    JUst a comment how it seems the drug companies hold out till you either give up or die….

  2. Anonomous August 14, 2018 at 5:25 pm - Reply

    Ethicon is milking the court the justice system the judges the US the doctors integrity and politicians all their puppets. Let’s get on with this. None of us who suffered will ever truely see justice just a parade of BS. Again how is this justice. Just wideling down till we all die or go away.

  3. Anonomous August 14, 2018 at 5:28 pm - Reply

    Goodwin not working for the people just helping the defendents loose little to pay for a lifetime sentence they gave us when they implanted us with this garbage.

    • Jane Akre August 14, 2018 at 5:38 pm - Reply

      What else can he do? Corporations know they have the upper hand when it comes to waiting you out and they use it. He can’t get blood from a rock…..Stop buying J&J products!!!

  4. sue August 14, 2018 at 6:26 pm - Reply

    I hope this doesn’t happen in the New Jersey Court too!

  5. Anonomous August 16, 2018 at 5:09 pm - Reply

    I’m in New Jersey courts they are not moving at all or barely. It would be good to see some kind of movement. I was implanted at 40 now I’m 53 and been through hell. I’ve had 4 surgery revisions last one got 85 percent best I can do without doing more damage or dying. I lost my career almost lost my home I’ve own for 23 years. But I sit and wait. Be dead before I see a dime. But won’t settle I just assume die before I let them get away with this crap for pennies. Working again but no insurance so even if I need a doctor which I don’t trust anymore I’m not going unless it’s absolutely needed because all they do is mess me up worse. This country needs reformed with these pharma company running our government.

  6. Anonymous August 18, 2018 at 11:39 am - Reply

    There really is no hope for us. They either drag it out until you give in and give up or they quit on you. It’s better to just walk away and try to regain your life then to keep fighting because in the end we all are going to lose no matter what. Yes there were a few people who are lucky enough to get millions for what happened to them but the majority will walk away with nothing. This was not about helping the plaintiff this was about attorneys making a lot of money off of injured women. I fought for over 7 years and I finally just had to give up because the attorneys were washing their hands of the whole deal. There is nothing that anyone can say that will never make me understand this. I was promised that he would fight until we went to court and yet he quit anyways. The mdl is the worst thing that could have ever happened to a person. The amount that we have to pay the attorney’s is Ludacris and outrageous. I hope there’s a special place in hell for any attorney who sold out or who walked away. And I hope there’s a special place in hell for judge Goodwin giving into the defendants time and time again. As a woman I feel defeated and broken and nothing will ever undo this. Whatever life I have left I will live in pain the rest of my days. And to the manufacturers I hope something equally or greater happens to each and everyone of you and you live in pain and misery the rest of your days.

    • Jane Akre August 19, 2018 at 12:17 pm - Reply

      Anonymous- I feel as though you are directing your anger at everyone BUT the manufacturer who did this in the first place. They are the ones who sold a defective product that forever changed your life and did so by using every regulatory loophole for safety. The FDA allows that under the current regulations. Let’s not forget, they are the entity that is holding out and not offering you the dollars you deserve. What else can the judge or your lawyer do – force them to give you more money?

    • V August 19, 2018 at 1:01 pm - Reply

      There is always hope. Don’t give up!

      • Jane Akre August 19, 2018 at 2:31 pm - Reply

        Speaking of Hope- what would you like to see – ideally!?

  7. Kissitgoodby August 19, 2018 at 12:52 pm - Reply

    Filing a civil lawsuit is like… being gang raped and bullied into remaining silent. This is a statement that I read on another site and I began to meditate on and analyze the meaning behind the words. Suitable Analogy! Those words does have a reasonable amount of truth when related to this MDL process. Every player in this process has taken something precious away from us that we will never be able to regain or ever fully reclaim or recover. The process began when our doctors, not knowing all the facts, (destroyed evidence) implanted us with this horrible mesh and so on.

  8. V August 19, 2018 at 2:21 pm - Reply

    It is a disgrace when this process become a game to some (attorneys). This is not a game to ones that has lost their lives and everything that the word (lives) entail.

  9. anonymous August 20, 2018 at 10:42 am - Reply

    Exactly V and Kissitgoodby. I think if a client wants to go to court the attorney should go to court. It is the risk some of us were willing to take but the attorneys are forcing us to take a settlement or take nothing. I wanted to bring to like what has happened to all of the destroyed women involved in this. I think all the people involved from the manufacturers to the attorneys and the judge should be held accountable for their actions. I am not the only person who has been told take the settlement or we quit. There have been to many women who have been forced to settle. Ya maybe we would have walked away with nothing but at least one more story would have gotten out. I know of to many women who have been told that their attorneys are walking away when they still wanted to go to court. What a shame. Where is the integrity of these people? What happened to if you want to go to court we will. My doctor knew there were issues and still implanted me. The lies are unbelievable. I have been told by doctors and nurses they don’t know how to help mesh women completely. There will always be pain for some women. I wish the judge, the manufactures, the attorneys and anyone who defends mesh would have to live with the pain that we live with. I wish they had to live like we do after our lives have been destroyed by surgeries, infections, disability and pain. Never knowing from one day to the next what your body will be doing. Not knowing how you will pay all the medical bills and trying to survive on a disability payment. Your life destroyed in the prime of your life. Left to struggle just to keep a roof over your head. I will never trust a doctor or a attorney and certainty not the FDA. I am directing my anger at people who just as soon walk away because they want to go on to the next big lawsuit. Who cares now for all the women who’s lives have been destroyed? Who pays their bills? Who sits with them while they cry in pain or takes them to their doctors visit? I think giving the defendants more time and then more time and then more time is criminal! Women are suffering out here!They need hope and a chance to go to court and have their day. Unfortunately most of us will never get that. To many still don’t understand what mesh has done to our lives. Why do some get millions and others get almost nothing. Yes more money would help women to manage the rest of their lives easier. But none of the people involved really care about the women. They just care about paying the least and getting out as soon as they can. Just like the lady on the east coast (and Jane you know who I mean) that almost died again because of an operation she had to have because of mesh! No one really cares. She has been told also to settle or get nothing. How is this fair? I have been told all the injustice done to us will not go unpunished I can only pray this is true. I can not believe that this is happening in the United States but it is just another example of our crumbling country and the progressive decay of our moral consciousness.

    • Still Standing August 20, 2018 at 5:15 pm - Reply

      I imagine that you could hire an attorney to move your case to court if you willing to pay them by the hour. Just hire them outright, no contingency. There are many reasons a case is not a good gamble in trial. Everything you have ever done will be brought up as evidence. Remember, a trial defendant does not have to prove anything. The plaintiff has to prove their complaint t. Sounds easy but it is t. It takes hundreds of thousands of dollars to take a case to trial. If the attorney sees problems in your case, they certainly are t going to risk everything to pay for your case with no surety they will receive a dime..I just don’t get how much the attorney’s are so vilified here. Or the judge….he is impartial . He can’t let the personal stories sway his promise to follow the law as it stands. I image the defendants also think Judge Goodwin partial to the women. Go back and reAd all of his orders and see if his rulings have favored one over the other.

      • Jane Akre August 20, 2018 at 8:51 pm - Reply

        Your attorney can set Motions in Limine that will prevent past items from coming up if they can get the other side to agree. Both sides generally want some things NOT to be mentioned. Some of the attorneys have displayed very bad behavior toward their clients so I get it. Not calling them for a year, when they want them to settle they say things like “no one will want your case” and “this is the best you will get”…. which may or may not be true. (in many cases it isn’t). There are really no easy answers here. I applaud the lawyers who are committed to taking cases forward to trial on behalf of their clients. There are a few but the majority thought this litigation would be far easier than it turned out to be…..just my opinion a a non-lawyer…anyone else is invited to share their opinions.

        • Still Standing August 21, 2018 at 2:20 am - Reply

          Motions in Limine only pertain to exclusions of information the jury hears. In depositions, every single thing is fair game as is everything in discovery. There is not a judge present. The defendant can ask any question it wants to and you have to answer and they go to the throat to throw plaintiffs off guard. Depositions give your attorney an idea of how you might do in court, and it also shows the defendant how you will do in court.all parties get some understanding of the strengths and weaknesses in a case. Many women here think that their court trial would give them the opportunity to tell their whole story to sympathetic ears and that just isnt what happens. You only answer questions and only questions that either your attorney or the defendant attorney thinks is relevant to winning the case. You dont tell a story from when mesh was implanted to present. You answer questions as sucinctly and as accurately as you can. You dont add any details outside the specific answers to specific questions

          • S August 21, 2018 at 6:03 pm

            The ultimate goal for a trial is to hopefully balance the scales of justice. Marketing and selling a defective product for material gain is a civil crime, a horrible injustice. These pharmaceutical giants should be held accountable by our justice system to pay for the damages that their products has caused. Our stories or parts of our stories are needed to paint a complete picture. I feel that a trial is just closure that is needed by some to move on.

  10. anonymous August 20, 2018 at 10:58 am - Reply

    P.S. What I would like to see is a higher payout for those who have been seriously hurt. I would like to see attorneys fee’s capped at a lower amount. Something like 33% or less. Some attorneys are getting more than the people hurt! I would like to see the manufacturers paying for all medical expenses related to mesh injuries, not the injured. That is why we have to pay the insurance companies back because they feel the manufactures should have to pay this. It should not come out of our settlements!! Finally I would like to see the MDL process done away with and the FDA completely redone. Not just the approval process but a complete investigation of the entire department. We must do something or this will continue to happen with the next gold standard BS that they put on the market. People should be fired!
    Yes I know maybe they would go bankrupt. But maybe then the manufactures would think many times before the put this garbage on the market not caring about who it hurts just how much money they can make off of it. It is a money game not a we care that you are suffering game. But with the money that is flying around none of this will ever happen. The rich will get richer and the poor will continue to struggle. As I said the moral character of this country is going down fast and will continue to. You may not agree with me but then you haven’t walked a mile in my shoes either. I have already wrote my obituary because health problems keep coming and I am tired of fighting them. I pray for relief from the pain and infections and day to day struggle just to survive. Thank you to all the manufactures who don’t give a damn and to all the attorneys who quit on their clients. My death will be listed as death due to mesh complications.

    • Jane Akre August 20, 2018 at 1:03 pm - Reply

      Have you filed your adverse event report with the FDA? I know it sounds like a black hole, but if everyone did it, there would be thousands and the agency would have to listen. Please don’t give up on doing that.

  11. Confused August 21, 2018 at 12:17 pm - Reply

    There are trials going on all over this country fighting Ethicon, J & J over their defective products including mesh, we just get a minute part of the picture here. This MDL process has harmed most of us by holding our cases hostage for years. Just type in the originating district where you case originally came from, many cases that were filed this year is headed to court. Widen your search for answers… you will be surprised. Some in our justice system are rotten.

    • Jane Akre August 21, 2018 at 12:56 pm - Reply

      Confused- you are confusing me. Where are you getting all of this information about other trials being held of newly filed cases? I don’t believe that is accurate but am welcoming being proven wrong. You can always check the other websites dedicated to covering this issue – what are they again?

  12. Confused August 21, 2018 at 1:10 pm - Reply

    Sorry Jane! My comment wasn’t meant to direct ones away from your website. You are dedicated, have been from the start to mesh victims. Thank You!

    • Jane Akre August 21, 2018 at 4:59 pm - Reply

      Again, where are you getting info about others getting to trial sooner? There haven’t been any trials that i”m aware of but I could have missed some…. pls advise. thank you!

  13. Alice August 21, 2018 at 2:51 pm - Reply

    Just got offered a very paltry settlement. Under 10k. No way it compensates for the lifetime sentence I have now of almost complete incontinence and pain. Plus doctors lying about whether or not it was ever removed. Doc says it was “cut loose”, records say it was removed. Lots of conflicting statements. Anyone else been offered a settlement?

    • Jane Akre August 21, 2018 at 4:56 pm - Reply

      A cut loose generally means the surgeon went in and released the tension, in some cases, just cut it in the middle, that is hardly a removal….it generally indicates that surgeon had no idea what he/she was doing. That is just my opinion.

  14. Confused August 21, 2018 at 5:40 pm - Reply


    • Jane Akre August 21, 2018 at 6:01 pm - Reply

      Thanks, do you have any names of cases?

  15. SOS August 26, 2018 at 9:52 am - Reply

    I signed papers over a year ago to receive my settlement and am still waiting to see anything. I call the lawyers office and they say they are waiting on the manufacurer, shouldnt there be a time limit of when they need to pay the settlement?

    • Jane Akre August 26, 2018 at 9:47 pm - Reply

      Unfortunately the manufacturers appear to be in no hurry to make your life any easier…. shame on them. Do you know how much you are receiving?

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