McFarland Pelvic Mesh Case, Plaintiff Wraps

//McFarland Pelvic Mesh Case, Plaintiff Wraps

McFarland Pelvic Mesh Case, Plaintiff Wraps

TVT-O from beckenbodenzentrummuenster.de

Mesh Medical Device News Desk, September 10, 2018 ~ The McFarland pelvic mesh trial is the seventh product liability case brought against Johnson & Johnson (Ethicon) in the Philadelphia Court of Common Pleas, over its allegedly defective pelvic meshes. 

It should wrap up next week.

Lawyers for McFarland plan to rest their case today, with the defective design product liability case turning over to the defense version of the facts.

It has been busy two weeks for the plaintiff. Tracie Palmer of the Philadelphia law firm of Kline Specter is the lead counsel.  Ms. McFarland’s trial began August 27th and is being heard in the Philadelphia Court of Common Pleas before Judge Arnold L. New [1307-01577].

The court is a favorable venue for the vast majority of pelvic mesh cases heard there so far.

On or about April 3, 2008 Ms. McFarland, 67, was implanted with Gynecare TVT-O by Dr. Liang R. Bartkowiak, MD at Altoona Hospital Campus – Main in Altoona, Pennsylvania.

Traci Palmer, Kline Specter

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 case revolves around design defect, strict liability and negligence.

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.

Susan and Patrick McFarland are from Altoona, Pennsylvania.

 

Dr. Eric Rovner, YouTube AUA TV

DOCTOR EXPERTS

The videotaped depositions of Dr. Charles Nager and Dr. Eric Rovner were played for the jury by McFarland’s attorneys.

There are two doctors representing AUGS (American Urogynecologic Society) and SUFU (Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction) who wrote the medical society Position Statements on the mid-urethral sling (MUS) calling it the “Gold Standard.”

Charles Nager, M.D. is urogynecologist at UC San Diego in the AUGS, and past president of AUGS 2013-2014

See Frequently asked questions statement from Nager here.

The Position Statement on MUS AUGS/ SUFU (here) January 3, 2014, and was crafted to be used in mesh lawsuits.

Here is the Feb. 2018 version again repeating the gold standard assurances that polypropylene mesh mid-urethral slings are the standard of care and are safe and effective treatment for SUI.

The AUGS PFD (Pelvic Floors Disorders) Research Foundation 2017 Annual Report shows  support of 44% from corporate partners, the makers of the polyproyolene pelvic mesh.

Dr. M. Tom Margolis, from The Bleeding Edge documentary, Netflix

Dr. M. Tom Margolis was in the courtroom as a medical expert for the plaintiff.

Dr. Margolis has been one of the top critics of synthetic transvaginal mesh.  The San Francisco Bay area urogynecologist believes it should be pulled off the market largely because transvaginal surgery is contaminated by passage through the vagina, a clean-contaminated field, which begins the cascading effects of infection.

Dr. Margolis is known for appearing as an expert witness on behalf of plaintiffs on at least a dozen trials.  His expression, “the more mesh, the more mess,” is often repeated by the injured community and even in trial.

He has called polypropylene mesh the biggest crime against women in history and “evidence-based genital mutilation.”

At his clinic in the Bay Area of San Francisco, Bay Area Pelvic Surgery, in Burlingame, California, he performs an average of 10 major surgical procedures a week. Much of his practice at involves removing synthetic mesh from patients who have suffered numerous complications.

He adds that in the last 15 years the increasing number of baby boomers, availability of cheap polypropylene (synthetic) materials, a push by insurance companies for outpatient procedures and the added profit paid to physicians, has made synthetic sling procedures very popular.

Dr. Bruce Rosenzweig, medical expert mesh cases

Also involved was the videotaped testimony of Dr. Bruce Rosenzweig, a medical expert from Rush University in Chicago, who removes problematic mesh and who has testified at many trials.  In the Huskey v. Ethicon trial in Charleston, WV, he told jurors the placement of the TVT-O in the adductor muscles can irritate the obturator nerve resulting in pain.  He also said that the heavyweight, laser-cut mesh in the TVT-O led to mesh shrinkage and contraction and foreign body response near muscles and nerves – all contributing to pain.

Piet Hinoul, Ethicon from Linda Gross trial

Jurors listened to a videotape of Dr. Piet Hinoul, VP of Medical Affairs, Ethicon. He has been the designated corporate representative in all of the trials so far against the healthcare giant. It was his job to contact key opinion leaders and have them test and promote meshes as they were launched.

Dr. Meng Chen, of Ethicon was in charge of customer complaints, and listened to the adverse event reports coming into the company.  She had made executives aware of the complaints and complications saying in a deposition used in the Huskey trial”These complications are not transitory,”  yet the company did not make changes to the IFU (Instructions for Use).

Laura Angelini, VP Marketing Ethicon

Dr. Jorge Holste, a scientist with Ethicon has testified in previous trials that heavyweight meshes increase complications and Ethicon’s Prolene polypropylene mesh is considered a heavyweight, dense mesh.

Laura Angelini, was a VP of Marketing for Ethicon who helped bring Prolift onto the market.

 

DEFECTS WITH TVT-O

The Jo Huskey trial in Charleston, WV alleged there were six defects with the TVT-O. They include:

* It’s made with Prolene mesh
* Prolene mesh undergoes oxidative degradation
* Prolene mesh shrinks
* Prolene mesh deforms
* Prolene mesh is too heavy and causes chronic foreign body reaction
* Prolene mesh is placed in the obturator space
* Prolene mesh was
laser cut

 

THE DEFENSE

Elizabeth Mueller, Urogyn Medical Expert for Defense

The defense is calling Dr. Robert Rogers, Dr. Liz Mueller, a urogynecologist from Illinois, and Ethicon engineer Katrin Elbert. In 2004, Ethicon did internal testing of the laser cut mesh and stretched it 20 percent and found it was three times stiffer than the mechanically cut mesh, she had testified in the Perry trial.

There was no discussion of the U.S. Food and Drug Administration’s clearance of mesh onto the market. The 510(k) is a fast-track system that requires little of manufacturers other than to name a predicate that is substantially similar to their device.

The case should wrap up by the middle of next week.

Traci Palmer, Kline Specter

 

Philadelphia Court of Common Pleas

THE PHILADELPHIA COURT OF COMMON PLEAS

In September 2017, lead counsel Tracie Palmer,  along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon.

Of the six cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case.

 

Others include:

Hammons $12.5 million (Prolift), Dec. 2015

Carlino $13.5 million; (TVT), Feb 2016

Engleman $20 million, (TVT-S), April 2017

Beltz $2.16 million (Prolift), May 2017

Ebaugh $57 million (TVT and TVT-S), September 2017

The only favorable verdict for Ethicon was the Atkins case in June of 2017 (TVT-Secur). A new trial has been ordered in that case.

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By | 2018-09-14T16:35:08+00:00 September 10th, 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.

19 Comments

  1. Mamyg September 10, 2018 at 8:39 pm - Reply

    I cant Wait to hear the outcome of this trial as I was Implanted in 2005. It’s seems hard for me to find others who have had and still have some mesh remaining for this many years.

    • Jane Akre September 10, 2018 at 9:37 pm - Reply

      Unfortunately there re many. I’m sorry. Can you have it removed if it is causing problems?

    • Amanda September 11, 2018 at 1:41 am - Reply

      Mine since 2006

  2. Sue September 10, 2018 at 10:03 pm - Reply

    My dr told me there was no way I could have the remainder removed cause I would bleed to death. So I continue to take an antibiotic daily, had many tests!!

    • Jane Akre September 11, 2018 at 12:03 am - Reply

      Sue- Have you had another evaluation by a mesh removal expert? There are a few and I would hat to think that s\a doctor, not experienced in removals is giving you this advice. If you’d like, let me know where you live and whether you can travel. I have a doctor director to share… Please have at least one more opinion…. janeakre@meshnewsdesk.com

  3. Tony September 11, 2018 at 9:07 am - Reply

    This is a very interesting article. Thanks for posting this information.

  4. Liz September 11, 2018 at 3:08 pm - Reply

    I was told the same thing, that I could bleed to death. It was a Dr. in Ct. who told me that. I went to another specialist in Boston who confirmed the same thing. He Insisted I do Botox injections. Needles to say I still live with pain. No Botox!!!!! I have remaining mesh from a sling in 2000 which only was able to remove 80 percent and a full sling put in 2013 after I specifically asked for no mesh. I have spoken to the office of Dr Veronikis in St Louis and plan surgery removal again, in Spring of 2019. Apprehensive but can’t live this way!

    • Jane Akre September 11, 2018 at 3:12 pm - Reply

      Depends on the mesh,…I”m told a TVT is far easier to get out than a Prolift, but it depends on many things. REmember- a doctor does NOT want to face a medical malpractice lawsuit so touching you can get him/her in big trouble. Many docs simply turn away mesh women…. you all know this I’m sure.

  5. Onewhodoesknow September 11, 2018 at 3:34 pm - Reply

    Had mine put in 2006. Dr Raz of UCLA removed all of it 7 years later. I had so many Doctors tell me it can’t be removed, get pain injections. I just did not believe that there was not a Doctor out there that could not help me.

    Well Dr. Raz did! I had TVT-O and it is all gone. I never had a bladder infection again. He gave me back my life.
    So do not listen to Doctors who have no idea what they are talking about.

    • Jane Akre September 11, 2018 at 4:27 pm - Reply

      So glad you sought and found relief! Thank you for commenting.

  6. Mindy September 11, 2018 at 5:37 pm - Reply

    By no means, I am upset about these cases being awarded millions of dollars, but my question would be that if they happen to get each what they are awarded and rightfully all of us who suffer with mesh should get, then where does that leave the rest of us who were not picked to go to trial? I think each victim should be able to recieve more than a few thousand dollars each and not just a handful of mesh injured receive almost 100 million because they were ones picked to go to trial!
    There should be a productive and equal way of having J&J pay all of their victims a fair share of funds. I read over and over how so many women are still suffering so much and can’t even get decent compensation for their settlement!! It’s just a shame how this MDL has played out! I have been meshed injured since 2007 with many surgeries, pain, bladder issues still, and now my attorney tells me I may not even be a part of this wave simply because I had to turn down my first offer because I knew I would need another surgery! So now, I have to keep waiting and waiting and waiting! Then I am only offered a certain dollar amount for each surgery! I don’t even get to be compensated for pain and suffering for myself, husband, or kids that had to endure my suffering while growing up during the time all this happened to their mother! Like i said I’m not bashing women that did go before a jury and awarded millions but then if J&J has to pay them millions where does that leave money enough for all other women who couldn’t go to trial???

    • Jane Akre September 11, 2018 at 11:52 pm - Reply

      Don’t worry about J&J running out of money, there is more than enough there to compensate mesh implanted adequately….$76 billion a year company…..Your manufacturer wants to pay you less is the bottom line. And apparently they can do just that!

  7. Liz September 14, 2018 at 2:02 am - Reply

    Mindy don’t be intimidated with your lawyer speak up! Let them know you need more. Don’t
    sign anything tell them to ask more. Let them work.for you.

  8. Still Standing September 14, 2018 at 12:27 pm - Reply

    This MDL doesnt work that way..The manufacturers are settling cases with individual law firms. They have set the tiers for compensation , they look at your medical records and count your surgeries and that is the amount you will get. The attorneys have to deliver 95% of their clients to sign settlement agreements and then the settlement process begins. There is no money for pain and suffering. They are not admitting that their products cause harm in any way. And, because most cases dont go to trial, settling with plaintiffs is just part of doing business. Each manufacturer has different compensation tiers. I know the tier structures for Bard and Coloplast, and AMS. They are very different in the amounts they award and whether they pay anything for product in place. You do not have to settle, but if you find yoursef in the 5% that refused settlement, you will need to find another attorney because law firms appear to drop clients that dont settle. You could be called in for a settlement negotiation meeting with the judge, your attorney and defense attorneys. You do have a right to say no then get a different attorney. I think Jane has a list of attorneys who are still taking new mesh clients. If they feel that your case has value, they may take your case. I doubt that any of them would consider it if you are in the lower tier bracket. It is frustrating and you do need to have a frank conversation with your law firm.. just remember that they dont have much leeway to negotiate individual awards outside of the tier structure.

    • Jane Akre September 14, 2018 at 2:34 pm - Reply

      All of that is true. If the manufacturer does not want to pay on your case, how can the law firm force it? Ethicon is particularly stubborn it would seem in payouts, instead playing the watch and wait game hoping you give up or give out first. It is a cruel, sociopathic business model for sure by a company which claims it “Puts Patients First.”
      .

  9. Phyllis R September 18, 2018 at 10:56 am - Reply

    I had Aris TOT by Mentor put in in 2006.I have developed an autoimmune desease 10 years ago and have suffered with fecal incontenence for the last 5 years.I also have pain in my hips.
    My question is since I didn’t have a reversal can I still be compensated?

    • Jane Akre September 18, 2018 at 11:53 am - Reply

      Do you have a lawsuit filed? What does your lawyer say? Generally the criteria for compensation is removal or revision…. however it is entirely up to your law firm if it wants to seek compensation based on the autoimmune disease….would you consider a revision? That would take some advocating on your behalf by the firm. The longer we wait, the more things will be associated with harm from mesh.

  10. Wern October 3, 2018 at 2:19 pm - Reply

    Hi Jane. I have gone through as much misery as many others have. I had my Ethicon TVT placed in 2007 and upon waking up from anesthesia I had excruciating pain and it has stayed with me for years now. I had a revision in 2012 which it was revealed it was put in incorrectly. Permanent damage has been done and I receive Botox injections and bladder overdestentions every 3 months and probable will for the remainder. I went through the MDL process and was given a settlement in the second tier group but decided to reject it as it would not begin to repay what medical costs I have paid for now nor for future care.
    I know it’s a long shot but could you give me names of law firms who are still taking clients. I don’t have much more to lose.
    I can’t thank you enough for you time and dedication to this horrible mess so many of us women are faced with daily. You are my hero.

    • Jane Akre October 3, 2018 at 2:33 pm - Reply

      That’s the problem , if you have rejected a settlement, and you are not devastatingly injured, a new law firm might think you will reject a second offer. But that’s for your conversation with them. Try Mazie Slater in New Jersey, Wagstaff Cartmell in Kansas City, Ed Wallace, Wexler Wallace, Sheila Bossier, Greg Vigna, Joe Saunders of Pinellas Park, FL. Kline Specter in Philadelphia. I’m sure there are a few others but that’s what I have off the top of my head and the above may not be currently involved in this litigation.

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