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Engleman Trial Against J&J Pelvic Mesh Begins Today

Philadelphia Court of Common Pleas

Mesh Medical Device News Desk, April 10, 2017 ~ It’s been 14 months since the last product liability trial naming a mesh manufacturer.

In this case, Ms. M. Engleman was implanted with two pelvic meshes made by Ethicon, the division of Johnson & Johnson.

Jury selection begins today. 

An army of eight law firms has converged in this Philadelphia courtroom to hear the first defective product case against Johnson & Johnson pelvic mesh in 14 months.

The case, Engleman v. Gynecare ( No. 140305384) will be heard before The Honorable Arnold New in the Philadelphia Court of Common Pleas, the same court that delivered two overwhelming jury verdicts against J&J  in December 2015 and again in February 2016.

TVT Secur, Megamed Service, RU

Ms. Engleman was implanted with the TVT-Secur (TVT-S) and the TVT in 2007 and 2008, in two separate Philadelphia hospitals. Her implanting doctors are not named in the action, Dr. Gregory Bolton and Dr. Joseph Montella.

In mid 2012, Johnson & Johnson quietly removed four troublesome meshes from the market citing business reasons. TVT- Secur was among them. See the Mesh News Desk story here.

The plaintiff has filed 15 claims against Ethicon including defective design, failure to warn, negligence, breach of warranty and violation of consumer laws, among others. She is seeking punitive damages.

Also named as defendants are in the case are Johnson & Johnson, Ethicon Inc, Ethicon Women’s Health and Urology, a division of Ethicon Inc.  Gynecare is a division of Ethicon. See the court docket here.

If previous cases heard in this court are an indication, punitive damages could be huge and drive the defendant one step closer to mass settlements, which it has so far rejected.

In the Carlino case, also heart in this Philadelphia court in February 2016, the jury awarded Sharon Carlino $13.5 million finding her TVT mesh was defective. The award includes $3.25 million in compensatory damages for her pain and suffering, $250,000 for loss of consortium to Mr. Carlino and $10 million in punitive damages.

See Mesh News Desk on the Carlino verdict here.

Patricia Hammons was awarded $12.5 million in December 2015 after jurors listened to her case against the J&J and its Prolift mesh to treat pelvic organ prolapse (POP).  The award included $5.5 million in compensatory damages and $7 million in punitive damages. J&J has quietly removed Prolift from the market.

See Mesh News Desk on the Hammons trial here.

Christy Jones, Butler Snow for J&J

The defense team is led by Butler Snow firm of Ridgeland, Mississippi.

It has filed to limit the expert testimony of Dr. Uwe Klinge who has been an expert in other Ethicon cases. Dr. Klinge is a former hernia surgeon from Germany who has used Ethicon’s Prolene mesh in hernia repair. He has also collected explanted meshes that have failed.

Defense argues he has not treated stress urinary incontinence (SUI) and never used the TVT-Secur in his practice.

Dr. Uwe Klinge

In suggesting an alternative design, Dr. Klinge says the PVDF mesh or larger-pore like Ultrapro would have been a safer treatment for SUI, however, defense argues the PVDF is not cleared for use in the U.S.

Dr. Klinge will testify, as he has in both the Gross case and the Huskey case, that Prolene will degrade, fray and lose particles but Ms. Engleman has not provided any evidence that occurred in her case, says the defense.

Plaintiff’s Motion in Limine No. 6 is written to exclude information about the FDA to the jury, including that the TVT-S was submitted to the FDA August 30, 2005 to be marketed under the 510(k) clearance, a short-cut fast-track way to get to market, and that the FDA never pursued an enforcement action against TVT-Secur.

Defense argues that under New Jersey law (the Plaintiff is from New Jersey), a device maker’s compliance with FDA regulations indicates Ethicon acted reasonably in designing TVT-Secur and warning about its risks.   Defense wants this information before a jury.

Under New Jersey law, a product manufacturer is not liable for harm caused by a failure to warn if the product contains an adequate warning or instruction. Complying with FDA requirements presumes one has an adequate label.

Ben Anderson, Anderson Law

Attorneys for the plaintiff are Ben Anderson, Bryan Aylstock, Lee Balefsky and Stark and Stark.   Representing Ethicon are Butler Snow, Drinker Biddle & Reath, Tucker Ellis and Combs & Spann.

There are dozens of defective product cases naming mesh manufacturers filed in the Philadelphia Court of Common Pleas that are being readied for trial.

In multidistrict litigation in federal court in Charleston, WV, J&J is facing more than 38,000 cases with another 9,000 filed in a state MDL in New Jersey, more lawsuits than any other mesh maker. ###

 

 

 

 

37 Comments

  1. Tina g says:

    Pray for these woman but most of us will be lucky enough to get anything. Still waiting. All they say is soon ….

  2. Kathy J says:

    I am hearing rgat if you have not had second surgery to remove the mesh – that youreceipt case is probably worth nothing! My Urogynocologist wants me to have it removed but I am scared to death after reading some of the horror stories!! Sex life is almost non existent pain peeing myself daily- the thought of things becoming much worse does nothing for me! And all my attorney office says no news! I have great attorneys but it has been years since my case was filed in New Jersey! Very frustrating!

    • tiredofwaiting says:

      You have just posted the story of my life. I am terrified of having a second surgery. I’m afraid of the months of recovery, the possibility of severe infection……….. I don’t know what to do.

    • Karen says:

      Kathy, I had the mesh removed a year ago and am now having reconstruction surgery again the end of the month. It has been a LONG recovery, but well worth it. I have an excellent Urogynecologist. It’s not 100%, but the constant pain has been less since having it removed and I am optimistic that my Quality of Life will be improved when it’s all said and done. I have heard stories as well, but if you seek out a qualified Dr., I think it is worth it.

  3. Kitty says:

    Kathy…do u consider your implant your 1st surgery?

  4. Linda says:

    Kathy
    I understand your fear but my experience isthat although removal does not fix it all, I am much better after removal. I was on antibiotics for 10 straight months prior to removal. No antibiotics since removal. I have less abdominal swelling. Less pain but still get my butt and back if I don’t monitor my activity. I still have spasms but I can now have a bowel movement. I could not with the mesh in. I highly suggest you speak with women that have had removal. I would not have made it without removal. It is a long recovery and had to have reconstruction a year after removal but I would stikk go through it again. I went barely surviving from pain to a moderate quality of life. I can work and on the weekend ,in the earlier part of the day I can do a few things like go to breakfast, a trip to home depot, take a walk. Before removal I could not do anything but work and that was extremely difficult and truthfully I was ready to give up on life. There was no quality.

  5. glenda m says:

    WHY DON’T WE ORGANIZE A BOYCOTT OF jOHNSON&jOHNSON SINCE THEY ARE DRAGGING THEIR FEET IN THE LITIGATION

    • Kitty says:

      How will we do that?

    • Angeka says:

      I am disabled I have Lupus. I also have the ethicon mesh implant. J&J has offered settlements into three tiers. I’m on the last one with the least money! I will be lucky to come out with 3000.00 after all is said and done. I have not signed the paper nor did I get it notarized. I want my Atty to sue but he says too late I already accepted the settlement which I do not recall signing any paper accepting. I sincerely want my lawyers to try my case.

      • Angeka says:

        I have had 2 revisions to remove 3 inches of the 10 inch mesh implant. Only 7 more to go! I want it out and gone. I guess we have all been thru the same thing. The constant pain, constant UTI’s, etc…I feel like I have an alien inside of me. I want it gone! There has to be something else. I mean what did they use in the 60’s for hernia repair?

      • Jane Akre says:

        Dont sign for 3,000, puts your lawyer in a spot doesn’t? They can drop you. If you are in the top tier a real trial lawyer can pick you up. No promises but some firms are hanging in there and won’t settle for peanuts!

      • Toni says:

        Angeka so disabled lupus seems like I’ve heard of a lot of women on here with lupus. Anyway my question is how many revision surgeries have you had? I would never settle for 3000 or even 30 k after what I’ve been through and continue to go through. I hope your lawyer will truely fight for you. I don’t get it how these lawyers that are supposed to be fighting for us think it’s ok to practicly force us to take this kind of B’S. We have suffered And what does how many surgeries have to do with our suffering. I’ve personally had 4 but the suffering in between was just as bad as recovery.

      • Terri says:

        I’ve had several surgeries, and I’m still not sure what level tier I’m on. How do you find out?

        • Jane Akre says:

          Please ask your law firm. It’s the least they can provide. Ask to speak to someone with legal training, not an entry level employee.

      • Still Standing says:

        Angeka, all women want their attorney to take the case to trial. The harsh truth here is that it is very expensive to take a case to trial (thousands and thousands of dollars a day) and most firms cannot afford to do that on a contingency basis. They could invest a lot of money and get nothing back. Even if they win, years of appeals will delay their debt recovery. They borrow money to fund these cases. They pay interest ( most will charge that back to you), but if you are looking at a settlement that nets you $3000, your attorney sees a case they can’t afford to take to trial.it is their money they are fronting. They still have to pay their staff, their rent, and they do need to have some money to live on. One big loss could sink a small firm. They unfortunately have to look at the financial risk invovled and most are seeing that million dollar payouts are few. They have to look at the particulars of your case. How strong is it? Did you have any preexisting physical or mental health issues? Do you smoke? Are you overweight? Were you physically active before the mesh? Have you made negative public comments online? Defense is expert in uncovering digital footprints. Have you posted pictures of yourself out and about on social media? Do your medical records show that you have been in compliance with everything your treating doctor asks you to do? Can you deliver compelling testimony at your trial?

        Believe me, they look at everything because the defense will be looking at EVERYTHNG in your files. They will have access to all of them. At my deposition, they had many dozens of cardboard file boxes with every single medical record from the time I was 18. I’m almost 66. Five of my physicians were deposed. They all charged $1500/hour, not just for the actual deposition, but for “reviewing” the case before the deposition. My attorneys had to fly to Cleveland, Ohio, Los Angeles, California, and Kansas City for physician depositions. Each one costs $15,000 + when all was said and done. That is significant. Then, your personal deposition will cost thousands. Plus, at a trial, you have to be there physically. Will they have to front your travel costs, your lodging and meals plus their own per diem costs for perhaps weeks? Court reporters and videographers charge a LOT of money as well.

        This does not mean that i think you should settle for a small amount or that I think what is happening is right.
        It isn’t. I’m just trying to give you a realistic view of wht is happening in the mesh MDL Hell hole. Jane is right. If you are in the highest tier, you may find someone to carry you further past your original settlement offer. That is doubtful if you are in a lower tier.

        • Kitty says:

          SS your pragmatism amazes me. For 3K…I would blow the GAG order and scream from the roof tops. Have you not heard? “Hell hath no fury like a woman scorned”

          • Still standing says:

            Well, the opposite of pragmatism is idealism. We know this is not a perfect world scenario. There comes a time when we have to reconcile idealistic expectations ( Defendants doing the “right” thing ethically) with what is really happening with this MDL, which is not even close to ideal.

    • Angie says:

      I am in. Have you signed your blue papers yet and had them notarized? I don’t want to accept that offer. It’s just a slap in the face is what it is. For me part of the problem is not telling me the percentage of rejection for a patient with Lupus/RA, u name most of the connective tissue diseases that go along with that and you will see I’m fighting a losing battle as is! Then they put something in me that was not properly tested. If they only knew the pain, and humiliation of it all! I mean peeing in the bed at 53 years old is enough to make you want to throw on the towel.

  6. Sharon says:

    I hope many of you are planning on attending the J&J stockholder meeting in protest organized by MAM. It is not enough to just complain. You must show up and be heard. As for pain being a reason it should not be. We are all in pain. Please show up and be heard.

    • Amy B says:

      When and where is this i have had to have not only 2, but 3 surgerys and have to take meds the rest of my life just to go to the bathroom right… I am tired of hearing hurry up and wait.

  7. Angie says:

    I would like to go. Where is it?

  8. Jimmy says:

    Any word on hiw this trial came out???

  9. anon says:

    I have posted some of this before, but will again.

    Ladies,

    If you have not had the mesh removal surgery, before you do, pick your mesh removal doctor wisely. How you do after depends on the care you receive from that dr.

    i wish I could go see Dr. Raz.

    I had the mesh removed by one of the doctor’s that is a recommend on this site.

    However, I knew about them before they ever found their way over here. They are so busy they don’t have time to care or follow up on us.

    I don’t understand. I do love them and I am thankful, and I do want them to help as many women as possible, but I feel so neglected. I am a hot mess. I am worse after the removal surgery. Pain, peeing everywhere, weak, muscle spasms in my back that are horrific, and I think something happened to me during the surgery they did not tell me about. I have symptoms now that are equal to a traumatic brain injury that I did not have before, and it is causing me much o problems.

    Why not hire staff to follow up and see how us women you operate on from all over the world are doing for medical research purposes if nothing else?

    Yes, he did the removal.

    NO HE DID NOT AND DOES NOT DO ANY AFTER CARE.

    Six week checkup and your dismissed, saronota, goodbye, go away.

    PC has no idea wtf to do. ER doctor’s tell you to get out and not to come back. Yes honest to G-d I was in shock. Happened twice to me. Was so sick and told to go back to PC who had not helped me in the weeks I was so sick after the surgery.

    Pain Management is a joke and oh my g-d is so much trouble you want to die. You are so sick and in pain, and you drive miles and miles to be mistreated. All they want to do is procedures! Back and spine crap. They don’t have a PM doctor that just covers pain. It is nuts. They are all back and spine specialists. woooooooo….

    And when the PM doctors quit because of government interference , (and I have seen this happen so many times in the last 4 years) it is a nightmare starting over. Almost impossible and takes weeks and weeks to start over and get the medicine and help you so desperately need. Mesh hurts so bad. It is a terrible pain.

    Talk about being mistreated! Criminals are treated with more respect than most patients going to PM. How did it get to be like this? Six surgeries later and the last PM dr. I saw in the group ask me, why are you here? Well genius, read the file. After 3 years, you should know why.

    You get tired of repeating the same thing over and over, and that is why most of us want to give up. We are told over and over it is not related, (mesh problems) when trying to explain our conditions, when we know it is the exact reason we are so sick.

    It is horrible in this state to try and get any medicines anymore. They have stopped writing everything. It is not suppose to be like this. I look up providers and cry my heart out at what they are not writing patients anymore. There are so many sick people in pain and suffering with cancer and other diseases who are not getting the right treatment or medicines, because they keep telling us there is an epidemic. Where? How?

    Maybe street drugs. But no wonder, if they cut off all of the RX, what options do people have who have no other means to try and survive the pain?

    Why are women and patients suffering because dr’s are terrified the government is going to get them for treating real pain and other issues. Seniors, and the elderly are really suffering.

    However, after removal, you just don’t heal well. Especially if you are over 50 yoa. There are so many _x!ox!___ complications. Your body is not the same as before the mesh nightmare.

    a. make sure you are ready to face it all again. You may get more money but I warn you, if you really do not need removal, don”t get it. Only you know what you can and can not live with. Get counseling before you make this decision. It is your life.

    b. make sure you have family and friends who can do it all for you for at least 8 weeks, and maybe 12 weeks. You can’t lift anything at all, nothing for 6 weeks. No bath, (shower) no cooking, no driving. no walking, not much exercise and no getting upset.

    c. take the stool softener every day forever or you will be so sorry. every s-i-n-g-l-e day.

    d. the second you come out of surgery, scream for ice packs and place them on your v and on your butt between your cheeks. The pain is unbearable if you don’t get ice packs.

    e. The pain medicine sux. It is not enough so do not be scared to ask for more. Make sure you can take Tramadol, which is nasty, but is given to seniors and others over 50. Some dr’s alternate pain medicine and tram every two-for hours. Just scream if you are in pain. It really does hurt.

    f. make sure the hospital saves your mesh removed for evidence.

    g.make sure the hospital saves your mesh removed for evidence.

    h.make sure the hospital saves your mesh removed for evidence.

    Only you can decide if you want the removal surgery. I almost did not get mine. I wanted to die unless I got it, and now I feel like I am dying.

    On the settlements: I am not a dr or atty, but I will say this and you can cuss me, hate me, beat me up or whatever, but if your attorney offers you a settlement, you would be foolish not to take it. You are probably not going to get your day in court and most of us are too sick to go to court. You can’t last through a trial without really good doctor care. And you could die or be waiting another 10 years to get to court if that is even a reality.

    if you get something, take it and don’t look back. I don’t want you to miss out if you are aiting on a milion dollar settlment. Your attorney knows the courts, the Judges and what”s up. if you get cut loose, it will be horrific starting over with a new firm, if you can find one to take you. They will look at you as a liability instead of a team player and may fear you will turn down any settlement offers they may make to you as well.

    • Jane Akre says:

      Medical marijuana? I don’t see anyone writing about that… might that be of some help? Thank you for being so precise. Some settlements however are NOT worth the paper they are written on AND they forever foreclose you from pursuing any claim. Is that worth $5,000? I recently talked to a lawyer who said you can call another law firm even if you are represented and find out if you might get another lawyer. That is if you are in an upper tier, have nerve damage, multiple surgeries,,,,, might be worth a try? I’m compiling a list of lawyers still taking mesh cases. stay tuned!

      • Cara says:

        I am on medical marijuana for chronic regional pain syndrome from a botched dental surgery, and YES, it helps my pain from the mesh!!! I am allergic to opioids, so thank God for cannabis.

    • Still standing says:

      Im sorry you are having so much trouble with pain management. You asked why it is getting to be impossible to get pain meds and here is the reason. Opioid drug use has skyrocketed in the past few years as have opioid overdose and death. People who legitimally use pain meds have been put on the same bus as drug addicts. The government has come down very hard on physicians who over prescribe. Doctors are fearful of being investigated by the DEA and rightfully so. You will find very few emergency rooms who will prescribepain medication for anything, and if they do, it will only be for a few days.. obama administration sent a stern letter to every physician in this country last summer about following the CDC guidelines which are no more than three day supply for post surgery or acute injuryNone for chronic pain. People with cancer related pain were spared the cut. It has been a cruel process. Pain clinics are shutting their doors. A person I know who works with pain physicians says the doctors want out . There should be tighter controls on opioids, but now people cant access prescriptions and insurance does not pay for yoga classes, mindfulness classes, adequate mental health counseling, accupuncture. These have all been found to help with chronic pain, yet few can afford these interventions. It is a terrible dilema but people with pain are being overlooked and under cared for.

    • Kitty says:

      ANON. I keep reading your post. It sounds like u need a pain pump. This is horrible the way u are suffering. Maria Garcia reported several months ago about her pump. I don’t know if she is still living. She was to report back to us to let us know how she is doing. Haven’t heard

  10. Cin says:

    Anon,
    I am sorry u r going thrue all of this with all of us… i had my 10th revision and all have been with Dr Raz, And am heading for another but I no its difficult to get to Cali to see him but he does take on as many patients as he can, I never felt the pain you described after ur procedures and I believe because Dr Raz and I would hope most surgeons will not let u be in pain like that. Dr Raz is currently teaching Drs all over the US how to remove and repair, check with Urogynecologists in ur areas… I love my great and powerful RAZ

  11. Kitty says:

    Just re.reading Anon’s post. …the uro.gyn with the high AUGS credentials says “what does peroneal nerve damage have to do with your mesh? DID U SEEN THE psychiatrist from our team? I said “Yes. I saw him twice and he didn’t think I was nuts,”
    Then the Mavin (DR) said
    “Well I guess we are done here.” And I say to myself “good riddance” but all is not well. The shame and anxiety that follows after being humiliated in front of her 2 Proteges’ is not going away very well.

  12. Cathy says:

    Jane, I’m glad you brought that up. Pain management clinics are no help to us anymore. I saw the writing on the wall over a year ago and started tapering down and off of pain meds. Do your research ladies!!! Since getting off of my meds, I still have pain but all the terrible side effects are GONE. I feel better mentally (more clarity) and continue to search for ways to tame the chronic pelvic pain. Cannabis is great for inflammation, research every option available for pain. Don’t give up!

  13. Kitty says:

    ANON. I’m sorry for your pain. I have gone thru some of what u have gone thru….but I was able to run to my primary Dr to get help with my pain and anxiety. The OPIATE crackpots that are out there making $$$ with their Pain Management Clinics. They make good people that have pain into crack heads and dopers. They should be horse whipped in front of the County Hospital ER. Also I don’t use pot..but I know an older woman that has suffered for years is now pain free in Arizona using it.

    • Still standing says:

      Actually, CBD formulations are legal in all states. It is the hemp based product that has all the psychotrophic substances removed. It is important to look for good quality product, not just the lowest price. They are not all created equal. I have not tried, but know others who have found great pain relief. It can be oil based or topical applications. They can be ordered online.

  14. Liz says:

    Is there any update on this trial of Engleman in PA court?

  15. Anon says:

    I had two mesh removal surgeries at Duke Univ Hosp. Most any urogyno there can remove the mesh. My original implant of the mesh doctor called my mesh the GOLD standard. Yet when he finally admitted it was the mesh causing pain he said he couldn’t take it out.

    I had so many UTI’s before the mesh was removed no antibiotic would cure my UTI’s and other vaginal infections that only the antibiotic flagyl cured. I turned into my own researcher and advocate. I asked the Duke urogyno removal surgeon at one point if my body was rejecting the mesh. She said no. Guess what it was. After my TVT mesh was removed in two surgeries, I was still in pain but not nearly as bad. I went to physical therapy for the pelvic floor chinese medicine practice my insurance actually paid for! I was told by many docs that the plvic floor pain would NEVER go away. I can now leave my home. I am on permanent disability. I am even thinking of working from home or GASP returning to work.

    The shame and loneliness is the worst part.

    I STRONGLY suggest to anyone that they get the TVT mesh removed. I have heard about ‘the tiers’ as well. The lowest amount of settlement money tier is people that simply have the mesh in their bodies with no pain, and then people with mesh in with some pain. People with mesh in with wicked pain. And people with removal revision surgeries and most still have pain but they have quality of life.

    There are also certain LOT number of the mesh that are not as harmful to women. I have Gynecare TVT and mine was AWFUL and HAD to be removed. I had mine removed before I knew of any lawsuits.

    I am in the NJ docket for 6 years now. My NY attorney has told me that he only takes revision surgery mesh cases. He said there was a case of multiple revision surgeries and the attorney settled for peanuts. This is what is harming others. Lawyers settling for barely enough money to cover their fee.

    • Kitty says:

      It is good karma to hear Slater speak for us. God Bless you Slater…it means so much…. more than gold to have his valedation.. “God hears the cries of the poor” Also thanks to ALL for advice.

  16. Anon says:

    Also: in suffering so, so, many UTI’s when the mesh was in– and LIVING ON ANTIBIOTICS. I took renew life probiotics and did not get C-Diff. Now these types of probiotics are sold in Walgreens!!!

    It got to the point that a doc wanted me on an antibiotic low doses every day of my life as a prophylactic . Having nursing in my background I knew this was bad.

    I researched natural remedies and D- Mannose for UTI saved me. As well as tiger balm rubbed in my uppetr pelvic muscle area with Ben Gay after removal surgery. As well as my PT HAND KNEADED my surgical site pelvic area above vagina) of lumps that can be painful scar tissue.

    KNEAD your scar area like flour don’t be afraid it will help.

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