McFarland v. Ethicon Makes TVT-O Design the Focus in Philadelphia Pelvic Mesh Case

//McFarland v. Ethicon Makes TVT-O Design the Focus in Philadelphia Pelvic Mesh Case

McFarland v. Ethicon Makes TVT-O Design the Focus in Philadelphia Pelvic Mesh Case

TVT-O from

Mesh Medical Device News Desk, August 21, 2018 ~ Four new pelvic mesh lawsuits will be heard in the coming months after a long lapse with no trial action.  The Philadelphia Court of Common Pleas is the next venue.

Monday, August 27, is the opening day of a jury trial in the case of  McFarland v Ethicon, [1307-01577 Mcfarland Etal v Ethicon Women’s Health and Urology],. Ethicon is the medical device division of Johnson & Johnson and maker of the TVT-O.

Jury selection was last week and McFarland will be the 8th case heard in the Philadelphia Court of Common Pleas.  All but one has yielded multi-million dollar compensation verdicts in the plaintiffs’ favor. Kline Specter of Philadelphia is representing Ms. McFarland.

Image: Tracie Palmer, attorney for Kline Specter

On or about April 3, 2008 Ms. McFarland was implanted with Gynecare TVT-O by Dr. Liang R. Bartkowiak, MD at Altoona Hospital Campus – Main in Altoona, Pennsylvania. TVT-O stands for tension-free vaginal tape-obturator, referring to the obturator space through which the polypropylene mesh is woven.

See Dr. Bartkowiak, on Dollars for Doctors, a ProPublic Project.   See the Vitals Reviews here. 

Dr. Liang Bartkowiak, MD

Ms. McFarland has undergone one revision surgery.

As a result of the surgeries she, “has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including but not limited to, obligations for medical services and expenses.”

The action names Ethicon, Inc. Ethicon Women’s Health and Urology of Ethicon, Inc. and Secant Medical, a corporation located in Perkasie, PA in business jointly with Defendant Prodesco, Inc. the venue is correct in that plaintiff and defendants live and/or have business in the state of Pennsylvania.

Traci Palmer, Kline Specter

The Complaint says J&J knew that its disclosures to the FDA were and are not complete and are misleading and that their pelvic mesh products “were and are causing numerous patients severe injuries and complication like those suffered …” by the plaintiff.

J&J “suppressed this information, and failed to accurately and completely disseminate or share this and other critical information with the FDA, health care providers, or the patients. “

In January 2012, the FDA ordered the Defendants to conduct randomized, controlled clinical testing of the pelvic mesh products and by June 2012 many defendants announced they were withdrawing some and or all of the pelvic mesh products from the market and would not be conducting randomized, controlled clinical testing ordered by the FDA.

“As of the date of the filing of this Complaint, neither the J&J Defendants nor the Secant Defendants have ever begun or  completed any of the randomized, controlled clinical testing ordered by the FDA.”

The Complaint lists – defective manufacture and design; failure to warn; negligence; common law fraud; negligent misrepresentation; negligent infliction of emotional distress; breach of express warranty; breach of implied warranty; violation of consumer protection law; gross negligence; loss of consortium;  signed by Lee Balefsky, on July 10, 2013.

Tracie Palmer will be the lead counsel. In September 2017, she along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon. Of the seven cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case in pelvic mesh litigation in that venue.

Two other product liability trials involving Ethicon’s TVT-O have concluded it was defectively designed. They include Jo Huskey v. Ethicon ($3.27 Million) in September 2014 (here), and Linda Batiste v. Ethicon, ($1.2 million) in a Dallas court in April 2014 (here).

In the Huskey trial, it was argued that the heavyweight laser-cut mesh led to mesh shrinkage and contraction and foreign body response near muscles and nerves, all contributing to pain.


Gynecare no longer exists. Gynecare, Inc. was merged out of existence and into Ethicon, Inc. on January 3, 2000. Ethicon supplies Secant with spools of PROLENE polypropylene filament which it knits to produce large rolls of mesh per specifications.

J&J’s Prolene Mesh

According to filings in the McFarland docket, defendant, Ethicon, has been busy trying to eliminate experts on behalf of McFarland.

Among them is Dr. Bruce Rosenzweig, a urogynecologist from Chicago and expert witness for the plaintiff, as is regulatory expert, Peggy Pence, PhD.  Dr. Uwe Klinge, an expert on mesh after its removed from the body, has appeared at other trials and submitted an expert report in McFarland as has Vladimir Iakovlev, MD, who heads a hernia explant lab in Toronto, and the Mayo Clinics’ Dr. Daniel Elliott.

The motion to exclude Dr. Klinge was denied as was the defense motion to exclude Dr. Pence. The defense motion to exclude Dr. Iakovlev MD was denied as well.

Besides the Ella Ebaugh case, other cases heard in the Philadelphia court include the Atkins’ case on the TVT-Secur which yielded zero for Ms. Atkins; Ms. Beltz was awarded $2.16 million; Ms. Engleman was a $20 million verdict for the plaintiff;  Ms. Carlino $13.5 million; and Ms. Hammons $12.5 million.



In November in the same court the case of Emmett v Ethicon will be heard. 1307-01495  Emmett Etal vs Ethicon Women’s Health and Urology, Trial date: November 19, 2018. See docket here. 

In Bergen County, New Jersey, two trials will be heard in Superior Court there with attorney Adam Slater representing the plaintiffs.

Oct 1, Catherine Burns v. Ethicon – Prolift Anterior and TVT-O,  013723-14, filed 2/2/2010

Oct 22, Sandra and Ernest Rios v. Bard – Avaulta Solo Anterior, 018689-14, filed 5/5/2014.


Mesh Trials so far


By |2018-09-10T15:40:22+00:00August 21st, 2018|News|19 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. Pat August 24, 2018 at 3:31 pm - Reply

    My attorney has asked me to settle. Way less than others. I’m shocked they would insult me like this. Do you have any suggestions. My pain will never stop. I have been in pain since 2006. I’m scared to allow anyone to touch me with the horror stories I heard. My mesh has attached. Please help with any advice.

    • Jane Akre August 27, 2018 at 10:11 am - Reply

      There are many considerations to whether or not you settle… among them, could you do better at trial, and then, who will take your case? There has been a mass abandonment of attorneys willing to take these cases forward. Why then did you take them on, one could ask!? So if you have had a few revisions, if yours is a clean case, meaning not a lot of liens, if your law firm is willing to let you go or will for a small sum, if you have catastrophic injuries that require a lifetime of case, all of these things make yours a better case for a new lawyer. It will never be enough to care for you….however. That’s just the way these settlements are going. Blame the manufacturers… for many injured patients, they do not take responsibility, continue to use the products, blame the victim, insult them with low offers, then drag out even paying that. That’s the way this is going! and I’m sorry.

    • Still Standing August 27, 2018 at 1:04 pm - Reply

      So do you have mesh in place with no further treatment. If so, payouts are low.

    • donotknow August 27, 2018 at 4:03 pm - Reply

      Pat go out to Dr Raz at UCLA and have him decide. Mine was attached to my hip bone as well and he got it all out. I feel so much better. I did have to have a 2nd surgery as the mesh did shrink the vaginal area and UCLA did fix that as well.
      You do have to wait a year to see Dr Raz but it is worth it.
      As for the cost to get there you can get low rate airline tickets, Tiverton house UCLA does have a form for low income people to pay a small amount or none to stay there. You need to do the research like all of us did. Pick up the phone and start making calls.
      Good luck.

  2. jenni August 27, 2018 at 3:34 am - Reply

    I need assistance with filing a case or becoming part of this class action. I had mesh implanted Oct 2016. I’ve been a mess ever sense. 9 months ago I was admitted into the hospital for a emegery blood transfusions. I was losing blood as my blood count dropped to 6..7. Am gonna stop here. Please someone contact me. I have difficulty reading and writing. All of this that ive been experiencing is so wrong and am so tired of it. I don’t know what to do or where to go for help. The surgeon is ignoring my calls. Please contact me

    • Jane Akre August 27, 2018 at 9:56 am - Reply

      So sorry that surgeon is ignoring your calls…..Do you know what kind of mesh you have? Transvaginally placed? Or hernia mesh? All of this is important to know. here are only a few pelvic mesh lawyers left litigating cases….I will send you the story.

    • Still Standing August 27, 2018 at 1:02 pm - Reply

      There are limitations on long you have to file a personal injury lawsuit. This is important because most states have 2-3 years. Some of us got through by certifying that we did not know mesh was causing our problems and the statute of limitations started from the time we knew. If you have already documented in a medical chart that you knew sooner, then it will be a hard argument to make. Mine was interesting. I was implanted in Kansas, which has a 2-year statute, but actually resided in Missouri, which has a 5 year. My attorneys argued that I should be given the rights conferred by the state I live in. So, if you were implanted in October of 2016, you need to get an attorney before then if your state has a two year limit. Attorneys in the MDL were able to argue this technicality because they were bringing so many cases to resolution. Now that the MDL is closed to new filing, your case will be filed in state court. Before you call an attorney, get you hospital records and find the inventory number and manufacturer of your mesh. They will ask you that information on the initial can bee filed in your home state or state where corporation has primary presence. I hope this info help you find representation.. it is troubling your surgeon isn’t taking this seriously. Have you had any intervention for pain? Partial excision of eroded mesh, baclofen suppositories, physical therapy…those are important steps.

      • Jane Akre August 27, 2018 at 1:07 pm - Reply

        Good information about the SOL Still….. thank you!!!

  3. donotknow August 27, 2018 at 3:57 pm - Reply

    I did not know the mesh was causing the problem as I had several other surgeries when I had the TVT-O implanted. . So It was a backtrack for years trying to find out what was causing the pain. No doctor could figure it out. It was 6 years later and When I saw the advertisement on TV with all the symptoms it clicked. I got my medical records and then contacted an Attorney. That was when the statue of limitation started. When I knew.

  4. Jane August 27, 2018 at 8:22 pm - Reply

    When is my day in Philly court going to happen?Been 5 yrs. Did depo. Tired of waiting. I know my attorney interview my Dr last week.

    • Jane Akre August 28, 2018 at 3:54 pm - Reply

      Are you scheduled for trial? here is the docket for the pelvic mesh cases in Philadelphia…

    • donotknow August 28, 2018 at 6:42 pm - Reply

      Ask your attorney what is happening.

      I am in a Wave below 7 ,did a depo and got a letter just a few weeks ago from a different law firm dealing with a settlement and how they are going to take a share of my attorney’s pay out.(Part of the 40 percent) so it will not cost me any more.

      They said to give them time as the Settlement Master has to go through medical records to see what tier I would be in.
      So I guess no court for me. I had 4 surgeries,including the original and vaginal physical therapy

      Worried because my insurance company has a lien and that will be hefty.

      • Still Standing August 29, 2018 at 2:28 am - Reply

        donorknow, the Special Master will negotiate a payback to your insurance company. You will not be on the hook for everything they have paid. Actually, they should not get anything if you were paying for private insurance, but they do. There are loopholes they have been able to go through with subrogation. Generally, the original surgery doesn’t count and the vaginal physical therapy will not be considered on the tier calculations but each company is a bit different in what they count and what they pay for each tier. If you did a deposition, you will have higher case costs in addition to your 40%. If you have not signed your papers, make sure you ask them to share the costs of the MDL common fund with you. It doesnt hurt to ask and ask them to give you the estimated case costs incurred thus far.

        • Jane Akre August 29, 2018 at 10:08 am - Reply

          Excellent advice. Thank you Still!

  5. donotknow August 30, 2018 at 6:44 pm - Reply

    Still Standing; Thanks, I did a deposition and I did a get a ball park figure on what my private insurance company wants back.

    I did not know vaginal therapy would not count. I hope the insurance company does not try and get that money back.

    Again thanks for your info. Now I wait.

    • Still Standing September 3, 2018 at 3:12 am - Reply

      Do not know, I just want to make sure you understand there is a difference between what your insurance takes back ( called subrogation) and what your case costs are. 25% of your award will be held back for insurance leins and other payouts the creditors have the right to claim. Even past bankruptcies you might have entered can make a claim on your settlement. . The Special Master will then negotiate your payback to these entities. Your case costs are completely different. These costs are above the 40% your attorney will get. They can cover court filing fees, costs of depositions, including travel expenses, document copy costs, and even time spent by law firm staff in phone calls with you, especially if that is frequent. Your firm should provide you with a breakdown of their costs so that you can get a better understanding of the net award you will receive.

  6. Anon October 5, 2018 at 10:21 am - Reply

    Any word concerning the Catherine Burns v. Ethicon trial? Did the trial begin on Monday? I absolutely love Adam Slater’s compassion shown toward his clients…he distinctly, unquestionably understands the seriousness of the circumstances that (mesh victims) have inherited.

    • Jane Akre October 6, 2018 at 8:04 am - Reply

      Sorry- Burns settled before trial.!!!!! I forgot to tell you….

  7. Anon October 6, 2018 at 1:50 pm - Reply

    Thank You Jane! After the McGinnis verdict…we will see more of his clients cases settling before trial. Adam’s heart is in this war with us.

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