*New* McFarland Jury Deadlock Results in Mistrial

//*New* McFarland Jury Deadlock Results in Mistrial

*New* McFarland Jury Deadlock Results in Mistrial

TVT and TVT-O, surology.com

Mesh Medical Device News Desk, September 24, 2018- After four days of deliberation, jurors in the trasnsvaginal mesh case of Susan McFarland v. healthcare giant Johnson & Johnson (Ethicon) ended in a deadlocked jury.

Judge Michael Erdos had no option but to call for a mistrial.

McFarland v Ethicon [1307-01577] opened August 27 in the Philadelphia Court of Common Pleas.

Jurors had before them an option to declare that Ethicon negligently designed the TVT-O (tension free vaginal mesh-obturator- see graphic) polypropylene transvaginal mesh. They were also given the option to award punitive damages.

TVT-O is part of the Ethicon family of meshes and designed to support the urethra and treat incontinence. It is also the most controversial mesh still on the market, according to doctors who used to use it.

*NEW ADD* JURY MAKEUP

Philadelphia Court of Common Pleas

The jury make up in McFarland v. Ethicon was 3 men and 9 women.

Of the men- one was younger and two older.  Of the women- three were younger and six were middle age or older.
A verdict required 10 of the 12 jurors to agree.  They agreed on the first two questions which were statute of limitations and negligent design. There were two holdouts on whether the mesh was the cause of her injury and two others changed to join the two holdouts on causation.

The primary defense was that Ms. McFarland’s injuries were caused by age and menopause-related vaginal atrophy. That really came down to a battle of the experts and the plaintiff’s testimony.

*New Add Plaintiffs’ attorney Tracie Palmer tells MND:

Traci Palmer, Kline Specter

“Johnson & Johnson and Ethicon relied heavily on the fact that the TVT-O, as well as its predecessor, the TVT, are still on the market to bolster their claim that the TVT-O is safe for women. Nonetheless, the jury saw through their defense and found that Ethicon failed to use due care and that the TVT-O was negligently designed.”

“We look forward to trying the case again in Philadelphia and proving that the negligently designed TVT-O caused Mrs. McFarland’s injuries. “

Defense attorney Melissa A. Merk of Drinker Biddle & Reath LLP asked the court to grant a mistrial in a September 24 letter to Judge Michael Erdos.

Melissa Merk, Drinker Biddle & Reath

“A jury’s failure to agree deprives any of the interim steps of finality,” as there is no splitting of claims, she writes.

On September 18, defense had asked for a directed verdict on the negligent design-defect claim on the basis that the plaintiff had exceeded a two-year statute of limitations; that the design defect claims are preempted by federal law; and that the plaintiff cannot show the product was unsafe for every woman for every purpose.

This was the seventh transvaginal mesh trial in the Philadelphia Court of Common Pleas.  All but one have awarded plaintiffs compensation for their injuries as well as punitive damages totaling more than $105 million.

 

Interestingly, Johnson & Johnson also had a mistrial declared in a Pasadena, California courtroom on the same day over its baby powder the plaintiff alleged was laced with asbestos causing her mesothelioma.  The last similar case in a St. Louis courtroom awarded $4.69 billion in July to 22 women who b lame the talcum powder for their cancers.

 

BACKGROUND ON TVT-O

This is the first transvaginal mesh case in this jurisdiction concerning the TVT-O polypropylene mesh. TVT-O is run through the obturator space (see the graphic at head of this story for a full explanation).

In September 2017, Palmer along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon over another mesh in the TVT family (TVT-Secur).

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.

 

MCFARLAND BACKGROUND

Dr. Liang Bartkowiak MD

Susan McFarland, 67,  underwent the implantation of a Tension Free Vaginal Tape-Obturator system (TVT-O) by Liang R. Bartkowiak, M.D. on April 3, 2008.

Since then she has experienced vaginal pain, urinary tract infections which are frequent, dyspareunia, recurrent SUI, new onset urge incontinence and urinary frequency.  Within the year she complained to Dr. Bartkowiak she could “feel something in her vagina” and she had vaginal bleeding and dyspareunia.   She was identified with a “right periurethral TVT erosion through the vaginal vault.”

On September 29, 2009, Dr. Bartkowiak performed a revision surgery on Ms. McFarland. She removed “very tight adhesions of the tension-free vaginal tape on the right periurethral area” and “trimmed” the TVT-O.

Ms. McFarland continued to experience vaginal bleeding, dyspareunia, frequent urination and leakage as well as frequent and severe urinary tract infections.  An appointment with another doctor, urologist, Henry C. Wong, M.D. and he performed a cystoscopy on Ms. McFarland and noted incomplete emptying with a recent increase in urinary tract infections and dyspareunia since implantation of the TVT-O device.

In August 2013, she was diagnosed with vaginal atrophy and dyspareunia and received a Premarin prescription.

A third doctor, urologist Stephen Yanoshak, D.O diagnosed her with “urinary frequency, nocturia, incomplete emptying of bladder, recurrent urinary tract infections and both SUI and urge incontinence.”

She continues to suffer from SUI and urge incontinence, urinary tract infections that are frequent and severe, dyspareunia so painful she rarely engages in intercourse and emotional and psychological injuries.

 

RUSHED TO MARKET 

The plaintiffs claim TVT-O was rushed to market in 2001 without properly evaluating its safety or efficacy, and that it is defective in its design and unsafe for use in women, and that Ethicon continues to market and Sell the TVT-O without proper warnings, despite its knowledge of the defects.  From Motion in Limine (here).

Both the TVT and TVT-O were cleared to market through the FDA’s 510(k) process which requires only to name a predicate device. In this case it was the ProteGen made by Boston Scientific. ProteGen was voluntarily recalled from the market because it did not perform as intended.  The TVT-O was intended to be an improvement on the TVT and sales profits were estimated to exceed $34 million by 2010.

Feeling the pressure from competitors, Project Mulberry’s goal was to bring the TVT-O to market. Ethicon’s product development plan called for 24 months of review, which was shortened to eighteen month, then 12 months.  Finally, considering the eroding TVT business, a revised timetable of just 9 months was settled upon.

“Project Mulberry is critical to GYNECARE’s success in the incontinence marketplace,”   and “We MUST make this project happen in a short period of time,” said an email from Ronnie Toddywala to multiple recipients on June 24, 2003.~ Toddywala, Ethicon VP of Research & Development.

To meet the company goals of nine month before launch, defendants decided to forgo any clinical studies of the TVT-O, even though Dan Smith had suggested six months of clinical testing.

 

DEFECTIVE MESH/ v  Negligent Design?

Plaintiffs in previous cases have determined the TVT-O is defective because

*Polypropylene is unsuitable for use in a woman’s vagina

*The transobturator insertion technique carries the risk of additional complications including injury to obturator nerve

*the mesh is machine cut making it excessively rigid, frays, degrades, rope and lose particles (laser cut mesh became available in the 4Q of 2006 for TVT products)

*the mesh degrades

*the mesh causes chronic foreign body reaction

*the mesh causes infections and the formation of bio-film

*the mesh incites fibrotic bridging leading to scar plate formation and mesh encapsulation

*the mesh shrinks and contracts

*toxicity testing reveals it is cytotoxic, meaning toxic to the body’s cells causing cell death or injury

Ethicon never studies what effect there might be on patients implanted with machine cut mesh, while Ethicon continued to market and sell TVT products with machine cut mesh, including the TVT-O.

 

SIX PRIOR CASES

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.

By | 2018-10-04T17:57:27+00:00 September 24th, 2018|Legal News|18 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.

18 Comments

  1. Advocate September 24, 2018 at 6:08 pm - Reply

    And there you have it… this is why trial(s) are not done deals and why we work to minimize this kind of result. Now they will come back and take another run at it, doubling down on the cost and time to get back into line. It’ll be interesting to hear in the back rooms what the jury had issues with and how many jurors were in the play.

  2. M September 25, 2018 at 8:20 am - Reply

    So I am curious Advocate! What would you suggest the permanently injured victim do when…the manufacturer refuses to offer an adequate settlement to cover just the future surgery needed to somewhat/try to correct the (documented) injuries that their defective mesh has caused?

    • Advocate September 26, 2018 at 1:41 pm - Reply

      Hello M. This is the dilemma that we have to work with. I wish there were a clear cut, right and wrong answer, but there isn’t one. Remember the adage of a bird in the hand is better than two in the bush? It’s kinda like that. The first reality that must be recognized, there was never going to be an offer made to take care of the long term needs of some. Settlements tend to reflect the middle of the road and not the longest point on the road. Those with long term documented medical challenges, should get more than the middle of the road, but again, it’s never enough to resolve the needs. In a way, it’s like an under insured motorist who is at fault for an accident, but you’ll never be able to get enough money out of the insurance to cover all of your medical needs. Not your fault but you are left to make up the difference. Or for another analogy, they wrecked your car and the value replacement isn’t sufficient to get you into another like conditioned car. You end up with a check and then have to come up with the money to get a new vehicle.
      The reality of foregoing the bird in the hand is certainly an option, but that brings us to the second reality. Trial is not like watching a television drama. We all know this, but somehow believe it applies to others and never us. We live with our injuries and just given a chance to expose the underhanded work of the manufacturer, we’re sure the jury will see it our way. You know Ms. McFarland thought that way. Now she’s trying to figure out, as is her trial team, why they didn’t see her reality. So if it’s a trial that one insists on, in hopes of getting the money (that’s compensation, not justice) then one must also be prepared to gain nothing as a result. For some injured, the for sure money, even if not what they believe the compensation value should reflect, is better than the risk of no compensation. The ongoing medical bills were not going away either way. So for some, it’s better to have the hand than the bush. Each client has to answer for their own best interests and firms can’t guarantee any success at all. Feeling good about a case as you enter a courtroom, won’t make it a slam dunk. I wish it weren’t like this but those are the realities of this world, fair or not. Betting on a dozen strangers to see it as you see it, is 50/50 on a trial’s best day.

      • Jane Akre September 26, 2018 at 2:54 pm - Reply

        Advocate- if you look at the trial tally, you actually have a better than 50/50 chance that a jury will hear all the misdeeds of the manufacturers and vote your way, just saying.

        • Advocate September 26, 2018 at 4:24 pm - Reply

          I love you! You have heard and read the disclaimers of attorneys and investment bankers that says, past results are not a guarantee of future outcome! Again, before Ms. McFarland’s trial, it was by your view of the records, better than 50/50 in her favor. The reason 50/50 stands, is because each venue, judge, jury is different.

          • Jane Akre September 26, 2018 at 4:47 pm

            True, true, you never know what a jury brings into the courtroom that might not have been sorted out in voire dire…..

      • M September 26, 2018 at 5:03 pm - Reply

        Than You Advocate for responding but…I am going to take my chances in a court room.

        • Advocate September 27, 2018 at 1:18 pm - Reply

          I wish you and your trial team much success M.

  3. Danyelle September 25, 2018 at 3:29 pm - Reply

    I am constantly reminding doctors that everything we think is a normal part of aging, may instead be a normal part of aging with an implanted medical device. It’s time to look at this from a research perspective.

    • Jane Akre September 25, 2018 at 3:48 pm - Reply

      After all science is the key says AUGS.

  4. Anon September 25, 2018 at 6:34 pm - Reply

    Ok so a normal part of aging is wetting yourself at age of 53 to point of adult diapers. Got this crap at 40 barely peeing a little when coughing sneezing laughing hard. Normal is not being able to have sex without pain peeing during sex and pain afterwards along with uti constant. Mine degraded into vagina and bleed till surgery they removed a small part and came out of that in total incontenence and total pain worse than before. Had birch method done fixed incontenance but couldn’t handle pain so got .85 removed now wear diaper again no sex without paying big price. I’m 53 and they ruined my life.

  5. Crystal September 26, 2018 at 9:31 am - Reply

    I’m scheduled for a revision where the dr is removing mine. I need to lawyer up? Any advice? I’ve been affected 8 yrs. Its not age related I was in my early 30’s experiencing these negative health effects, pain etc It’s not in our heads it’s physical pain, torture! Help

    • Jane Akre September 26, 2018 at 1:12 pm - Reply

      Hi Crystal- I hope your doctor has performed many revisions/removals and not a few in his office. It’s very important to see a specialist who is dealing with complications. Need a lawyer? There are only a few left in the tvm arena….. email me privately and I will provide you with a few names…. I’m not a referral service but know who they are that remain. I’m sorry you have gotten the runaround and hope it does not effect your statute of limitations.

  6. Onewhodoesknow September 26, 2018 at 8:19 pm - Reply

    I was not menopause when I had the mesh implanted. I was 47. My wetting was just from having babies. This was to make my life so much better. Well it ruined my life. No more Sex, pain, bladder infections, pelvic pain. .
    This case blamed the the women’s age for the issues.,They may have got lucky on that one but all of us were not 67 when we had the mesh implanted.Many of us were very young..

    Crystal.depending on your case have you ever though about contacting the law firm in Philly that just lost the case. They are taking all their cases to court. They have won some big cases.

  7. S September 27, 2018 at 2:15 pm - Reply

    The McFarland case was not lost. McFarland has another chance at Ethicon. She is represented by one of the most trustworthy firms in this process.

  8. Advocate September 28, 2018 at 1:30 pm - Reply

    You are correct S, the case was not lost. Kline Specter is an outstanding firm and will have learned from these proceedings what information defense used to influence the jury members, that they can better counter. Each jury makeup is obviously different. The facts of the case, such as age, obviously do not change. How that information is delivered and rebutted will be key. I won’t be surprised if Ethicon does an out of court settlement with Ms. McFarland. It won’t be for the money that verdict might have brought, but it won’t be at the average settlement level either. Of course that number will be sealed and not made public.

  9. Janine October 24, 2018 at 7:02 pm - Reply

    My name is janine I’ve had 5 surgery due to mesh ,Ian totally disabled. I’m so tired of trying to be brave,this is awful what they can do to us woman. Went in for a leaking bladder came out with lower back pain leg pain in both legs and one month later back into surgery mesh was already eroding. My life is always challenging every day.iam so sorry for all of you .

  10. Shirley November 21, 2018 at 7:51 pm - Reply

    Jane Can I get your email address? I have a question about which X-ray/sonogram/ultrasound
    is best to see mesh.Thank you.

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