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Ebaugh Trial Continues as J&J Defends TVT-SECUR

TVT-SECUR from RU website

Mesh Medical Device News Desk, August 29, 2017 ~ As the Ebaugh trial continues in Philadelphia,  the sixth pelvic mesh case to be tried in the Philadelphia Court of Common Pleas, it may be close to wrapping up, as early as this Friday. 

All eyes are watching this latest in a series of transvaginal mesh trials in this venue and the third focusing on the Ethicon/ Johnson & Johnson pelvic mesh product – TVT-SECUR.  It has been found defectively designed twice before in this Philadelphia court.

This is the first time in this venue, that a plaintiff has two meshes, made by defendant, Johnson & Johnson and its division, Ethicon.

Ebaugh, photo contest entry, York, PA

At age 39,  Pennsylvania resident, Ella Ebaugh, had a TVT- SECUR, (TVT-S) implanted on May 31, 2007, at Apple Hill Surgical Center in York, PA by Paul Douglass, MD.  She went in to treat occasional incontinence. Her doctor reasoned since she was so young and had a very active lifestyle, it was the most minimally-invasive procedure that would allow her to get back to doing sports.

Today Ms. Ebaugh is 51-years-old, but her legal team says her urethra is mangled from the implants surgeries and the implants she has endured.

Kila Baldwin, Kline Specter

Ebaugh is represented by Kline and Specter law firm of Philadelphia. Kila Baldwin is her attorney. The Ebaugh trial began July 31 in the Philadelphia Court of Common Pleas where there have been four jury awards in the plaintiffs’ favor totaling $48 million.

The question- will this be the fifth?

Last June 9, plaintiff Kimberly Adkins was the first in this Philadelphia court to lose her pelvic mesh trial against Johnson & Johnson/ Ethicon on the issue of causation – whether or not the defective mesh, a TVT-SECUR, caused her injuries.

This was an unprecedented and split jury decision since the jury found the TVT-SECUR was defectively designed.  The judge will allow another hearing in the case limited to damages and whether they were caused by the TVT-SECUR mesh.

See Mesh News Desk story here.

 

Defense Opening

Defense attny w. Curt Webb

The trial transcript from the opening day of Ebaugh v. Ethicon  August 4, Case no 130700866, show that attorney, W. Curt Webb, delivered the opening statement to the 12 jurors in the afternoon after the plaintiffs’ open by Kila Baldwin of Kline Specter.

Mr. Webb representing Ethicon/ J&J said that one in three women will get incontinence, the other side of the story from what Ms. Baldwin told you.

It’s not just a few drops of urine. Ms. Ebaugh had stress and urge incontinence (SUI). Stress is when you put pressure on the bladder from coughing or sneezing or athletic movements and a little urine leaks.  Urge incontinence is when you suddenly have to go and don’t make it.

“None of the TVT products have anything to do with urge incontinence,” said Mr. Webb. For urge incontinence you use medications, he said, to treat overactive bladder and bladder spasms.  Stress urinary incontinence (SUI)  is the only thing that the TVT will cure and treat, not urge incontinence.

“A lot of what Mrs. Ebaugh complains about now is that she has to stay close to the bathroom, that she doesn’t have any warning.  It’s two separate things….She’s got stress urinary incontinence and she’s got urge incontinence. They’re two different things…..And the reason that’s important is because you’re going to have every doctor who testifies in here is going to tell you that the stress urinary incontinence is what the TVT products are supposed to cure, and the urge incontinence is completely different and none of them, none of the TVT products have anything to do with urge incontinence.” ~ W. Curt Webb, Defense attny. 

Dr Douglass, professor at the University of Pennsylvania and the implanting physician, trained under preceptor/consultant, Dr. Vincent Lucente,  in TVT and TVT-Secur implantation.

Dr. Paul Douglass, implanted Ebaugh

Dr. Douglass no longer trained on the Burch and MMK after the TVTs came out.

And by the way, Dr. Douglass was not paid a penny by Ethicon or Johnson & Johnson. He’s not one of these doctors that either trained other doctors – all he did is buy the products or his hospital bought the products. He just used the products with his patients.”~ W. C. Webb

He said he told her the TVT-Secur had a higher rate of failure but it was less invasive and better for someone who was younger and active. Dr. Douglass implanted  Ms. Ebaugh in 2007. The TVT-Secur didn’t work.  So he came back and has a third discussion about risks and benefits-erosion into the bladder, erosion of the urethra, bleeding, infection, perforation of major blood vessels, perforation of the bladder, possibility of having to wear a catheter for a week or so.

TVT-Secur had problems in Australia, according to three doctors, Mr. Webb says  in his opening statement.  That’s why the defense brought in Dr. Jamie Sepulveda as an expert witness, who has a lot of experience with TVT-S and he’s not happy it’s no longer on the market. He liked the product, said Webb.  He had huge success with it.  It was minimally invasive.

Dr. Howard Mirsky

These are Mr. Webbs’ words:

When she had problems in 2011, Dr. Douglass was no longer around so she sees Dr. Mirsky. Ms. Ebaugh underwent surgery to remove what eroded into the urethra and he takes out 98%. She had a mid-urethral erosion. Dr. Mirsky still uses the mid-urethral sling today.

One year later she still had erosion and tape particles around her bladder.  She goes to Dr. Chai at University of MD, he’s now up at Yale.  He sees some of the mesh up in the bladder. He found strands in the urethra not the bladder.  After more problems, she sees a Dr. Wright.

No doctors say the TVT products are defective.  Erosion in the urethra is very rare, “it happens in one tenth to one percent of the women that are treated with these mid-urethral slings.”

TVT SEcur from Russian website

“Just because Mrs. Ebaugh’s TVT-Secur didn’t work doesn’t necessarily mean that it’s defective.”

Her occurrence was one in a thousand. Then Mr. Webb suggested an outcome the company might live with, (verbatim trial transcript):

”But it comes out at the end of it you’re sitting there saying it’s a 50/50, they haven’t met their burden of proof. They’ve got to prove by a preponderance of the credible evidence that, in fact, there was a defect in the TVT-Secur, defect in the TVT, or that we were negligent, Ethicon and J&J, the way that we tested and marked this product.”

He then apologized that Mrs. Ebaugh did not have a good result.

“But we can’t guarantee a result, a good result, every time…The fact that you may had, that you may have a very rare occurrence that happens, one in a thousand, we wish that it didn’t happen at all…And we’re sorry for that, but it doesn’t mean we had a defective product and it doesn’t mean we’re a bad company.”  ###

 

 

LEARN MORE:

Philadelphia Court of Common Pleas

Philadelphia Court of Common Pleas

$2.16 million – Sharon Beltz, Prolift mesh, no punitive damages
https://www.meshmedicaldevicenewsdesk.com/beltz-case-jj-jury/

$12.5 million – Patricia Hammons including $7 million in punitive damages over Prolift mesh. Defective design, https://www.meshmedicaldevicenewsdesk.com/philadelphia-prolift-mesh-case-yields-12-5-million-verdict-for-plaintiff/

$13.5 million – Sharon Carlino including $10 million in punitive damages, TVT mesh
https://www.meshmedicaldevicenewsdesk.com/just-in-carlino-pelvic-mesh-found-defective-awards-13-5-million-against-jj/

$20 million – Peggy Engleman, includes $17.5 million in punitive damages. TVT-SECUR
https://www.meshmedicaldevicenewsdesk.com/14521-2/

$0 – Kimberly Adkins, TVT-SECUR, defective design but did not cause her complications
https://www.meshmedicaldevicenewsdesk.com/jj-wins-first-pelvic-mesh-trial-philadelphia/

 

13 Comments

  1. Disgusted says:

    “But we can’t guarantee a result, a good result, every time…The fact that you may had, that you may have a very rare occurrence that happens, one in a thousand, we wish that it didn’t happen at all…And we’re sorry for that, but it doesn’t mean we had a defective product and it doesn’t mean we’re a bad company.”

    GIVE ME A BREAK!!!

    It should say, we can guarantee 1/1000 will have a bad to very bad outcome from maiming to even death. You may lose everything, including your sex life. Your independence. The ability to be pain free. But hey, think of all the happy people with good outcomes. We are a good company and we help people every day. Why are you picking on us?

    I cannot fathom this!!! Why do we hold anyone accountable anymore. GM had to pay for faulty breaks. It didn’t hurt every car. Some breaks did just fine. They are a good american company. Why did they get labeled defective, it wasn’t 100% of the time, there are always exceptions.

    The only thing he didn’t say was “get over it”. No accountability whatsoever. IT MAKES ME SICK!

  2. Anon says:

    AMEN!………..Disgusted

  3. Terri says:

    I never had urge incontinence until I had the sling. And after the removal which was medically necessary, it became worse. It’s a horrible thing to have to deal with.

  4. Janet says:

    There numbers are definatly off on the complication rate compared to the FDA data on SUI complications. The FDA states the rate to be 2% within the first 12 months. From 2008 to 2011 the FDA received 1,876 reports concerning complications. If you are one of those 1,876 women you know the complications are not rare. Data has not been complied and released since 2011. We also know that most of the complications reported to the FDA were done so by the patient not the doctors or the manufacturers. How many go unreported…….

    • Bejah Blue says:

      Thanks Janet. FYI I never reported to the FDA. What is the point? It seems pretty clear where they stand on this issue. Remember the expression “Actions (or lack thereof) speak louder than words”. My guess is that there is gross under reporting for many reasons. I will never report to the FDA just as I will never provide data to UCLA, the entity responsible for my implantation by Ha-Jong Kim.

      Bejah

  5. Diva64 says:

    R they trying to set an example to by duress get plaintiffs to sign for the low ball settlements being offered now. . With all the damages we suffer from Mesh how can they come up with that ? How are we to trust the American System if this is what were shown ? Sad Sad .

  6. Still Standing says:

    The FDA also reports that all of the complications also occur from non-mesh SUI surgery except for mesh erosion. No surgery is without risk. If we removed all potential risk, there would be no more medicine, no surgery. I’m certainly not siding with J&J arguments, but we need to realize that there are elements of risk with any pelvic surgery. Mesh became popular because traditional SUI surgery had a high recurrence and reoperation rate. Unfortunately, there is no perfect solution that can work in every single person.

    • Bejah Blue says:

      I would like to know how many of us went to doctors asking to have this material implanted in them. I did not and I think many did not. Yes, there is always risk with any surgery so the important question becomes what degree of risk is acceptable. In this situation the 5% we are told of is way too high because of the nature and degree of damage. Let us remember that the FDA was slow to act and perhaps most important, there is the deeply disturbing matter of a failure to warn, and the problem of informed consent. We will not allow this to be whitewashed. We may lose because life is grossly unfair, because we are individuals without substantial resources and power, because we are women… but we will meet the beast in battle nonetheless knowing that statements like “We are sorry”, “We are a good company” and “Many others are happy with their result” is a blatant and irresponsible attempt to belittle the plaintiff and her counsel. We will, each in our own way, never stand for this.

      Bejah

  7. Dani S says:

    Waoo, seriously?
    How are these mesh complications going to be reported, if there are not medical codes assign . IT WILL BE A MUCH BETTER WAY OF MEASURING THIS DISASTER, THAN WASTING TIME REPORTING IT TO THE DAD.

    • Jane Akre says:

      Do you mean FDA? Honestly, even though the FDA is not fully onboard with monitoring adverse events, it is the only way that the agency knows about any complications, so I suggest they be flooded with complaints….

      • Bejah Blue says:

        And then what Jane…with all due respect, do you think they will then ban the material? The economic truths make that highly improbable. And do you really think the FDA is neutral, innocent in all of this? Anything we give to the opposition we must assume will potentially be used against us in some way. If they are not with us, they are against us.

        Bejah

        • Jane Akre says:

          Do you have another system where you can report adverse events? I don’t know of one…. unfortunately that’s what we have….agreed it’s not really functioning.

  8. Dani S says:

    Sorry for the type-o, I meant to FDA

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