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J&J Medical Expert – No Problems with TVT-SECUR

Dr.Janet Tomezsko, medical expert for J&J

Mesh Medical Device News Desk, September 5, 2017 ~ Today the 5-week trial of mesh-injured plaintiff Ella Ebaugh, wrapped up with closing arguments (Case No. 130700866) this morning in the Philadelphia Court of Common Pleas.

The following continues a series of insider reports into this, the sixth pelvic mesh trial in this court, which accuses Johnson & Johnson and its Ethicon division of manufacturing and selling defective pelvic mesh products , the TVT-SECUR (TVT-S) and the TVT (Tension-Free tape), implanted to treat stress urinary incontinence (SUI). 

Two previous trials here have found the TVT-SECUR (TVT-S) defectively designed. Of the five previous, all but one has resulted in compensatory awards for the mesh-injured plaintiff totaling $48 million.

Last week, J&J, the maker of the TVT-SECUR and TVT (tension-free tape) implanted in Ms. Ella Ebaugh, brought its medical expert to the stand.

The dozen jurors, all African-American, were introduced to urogynecologist, Dr. Janet Tomezsko, from NorthShore University Health System in the Chicago area. She graduated medical school in 1991 attending both Penn State and Drexel.

Dr. Vincent Lucente, MD

Dr. Lucente, preceptor for Ethicon

Dr. Tomezsko trained at Christ Hospital during her residency with Ethicon flying her to study with Dr. Vincent Lucente, a consultant and preceptor for J&J from Allentown, Pennsylvania who has been cited in many of these cases as a the doctor whose job it was to bring new doctors into the J&J fold and train them on using the J&J pelvic meshes.

For his part, he was compensated millions of dollars.

The medical expert was questioned by Kat Gallagher, representing Johnson & Johnson.

Dr. Tomezsko examined Ella Ebaugh for the defense and was there to testify about the medical issues, not to give her opinion about the TVT or the TVT-SECUR. Ms. Ebaugh was implanted with both pelvic meshes to treat incontinence.

The medical expert received medical records, depositions in the case, medical expert reports, the literature and some company documents to write her report. Most of those are submitted by the defense team for the doctor’s review.

Dr. Tomezsko had been trained on the Burch procedure and fascial slings before the invention of the midurethral sling.

She called the Burch procedure very invasive because it involves a bikini cut incision of several inches and a three-day stay in the hospital. Later the Burch procedure was done through small holes, which was less invasive.

Compare that to a midurethral sling which is a 20-minute procedure where the patient can go right home. It was considered an enormous improvement for both patient and doctor.

Dr. Tomezsko is a published scientist in her field in peer reviewed journals. She takes occasional mission work trips to Bolivia where she uses the J&J TVT Retropubic sling on patients and teaches doctors there how to do the procedures.

TVT, Courtesy Teri Rogers

“I really like the TVT product and I feel this is very easy to teach. It is so well proven. I feel very comfortable when I leave and go 4,000 miles away that I am leaving the patients in good hands with a good product.” ~ Dr. Janet Tomezsko, urogynecologist, consultant to J&J

Her current hospital has a contract with a different manufacturer of mid-urethral slings.

It is established by Ms. Gallagher that Dr. Tomezsko makes $400 an hour to review documents and $5,000 a day to appear at trial and testify. She has earned about $220,000 from Ethicon for work as a consultant on 16 cases and appearing at trial.

Kat Gallagher submitted to the court the qualifications of Dr. Tomezsko so that she should be considered an expert in the field.

Then it is the turn for the plaintiffs to question Dr. Tomezsko.

PLAINTIFFS CORRECT THE RECORD 

Kila Baldwin, Kline Specter

Kline Specter’s Kila Baldwin for the Plaintiff continued with her line of questions.

First, a correction for the record.

The doctor received her certification in urogynecology in 2013, not 2008 as she had previously testified, Baldwin states. The doctor apologized for her earlier misstatement.

Baldwin establishes, through a series of questions, that Dr. T is not there to offer any opinions about the safety or efficacy of the TVT-S.

“Correct.”

Baldwin also establishes that Dr. T is not there to testify about the safety and efficacy of the TVT.  “I am not here to give that opinion.”

Baldwin asks “Who decided which Ethicon documents to put on this list,” referring to the documents the doctor uses to form her expert opinion.

Gallagher: “Objection.”

The Court: “Overruled.”

Dr. T:  “Those are the Ethicon documents that were provided to me from the attorneys.”

The list and reports were prepared by the attorneys for Johnson & Johnson, Baldwin establishes. The stack of documents grows tall on the witness stand. “I don’t think the Judge will mind if the stack gets too heavy for you,” says Baldwin.

TVT Secur, Megamed Service, RU

Dr. Tomezsko does not use the TVT-SECUR (TVT-S) but does use the TVT in her practice today. She has implanted a TVT-S once or twice.  She is listed as qualified in non-surgical treatment of TVT complications. Baldwin asks her if she is an expert in the removal of slings.

“Yes I am.”

“I have a wealth of knowledge regarding complications from multiple different procedures. I think in my experience I’ve only needed – I’ve only had one patient come to me who needed a complete midurethral sling removed. So it’s just not – it’s so uncommon.” ~ Dr. Janet Tomezsko

Baldwin establishes that Dr. T has only tried to remove one TVT device.

“That’s correct because it’s so infrequently necessary.”

Baldwin launches into a litany of other doctors who have had other experiences – Dr. Bruce Rosenzweig at Rush University in Chicago and Dr. M. Tom Margolis, a San Francisco area urogynecologist. Both have testified in numerous cases for the plaintiff that they have removed hundreds of midurethral slings.

Even the testimony of defense witness, Dr. Denise Elser, has included her experience with attempting to remove hundreds of midurethral slings.

Dr. T did not choose to examine Ms. Ebaugh bladder with a cystoscope, therefore she could not testify about the current state of scarring inside her urethra.

Dr. T says she is offering opinions based on her medical records of her treating physicians.

During her training with Dr. Lucente at Allentown, PA, she received a certification in Prolift pelvic floor repair system profession education in 2005 signed by Dr. Martin Weisberg, MD for Ethicon. Baldwin reveals an Ethicon e-mail about an upcoming two-day event dinner and proctorship which Dr. Tomezsko would attend in July, 2009.

Dr. Lucente steered her career toward urogynecology, “And he’s been my mentor ever since.”

Baldwin: “Do you know how much money he’s been paid by Ethicon?”

Gallagher:  “Objection”

The Court: “Sustained”

Another Ethicon document read by Baldwin states, “Anyone who has ever trained with Dr. Lucente  and, more importantly, has been unconditionally loyal to the first and best sling material on the market since its introduction, is invited to any event that we host in said trainee’s respective geography, “provided that loyalty still exists, exclamation point, exclamation point. Ha, exclamation point.”

With the jury out of the room the judge interrupts the proceedings.

His wife has informed him that his children have Johnson & Johnson stock, under about $9,000, probably given by their grandparents. Neither side raises any motions to object.

Kat Gallagher, attorney for J&J

BLAME THE VICTIM

As part of any courtroom strategy it is necessary to deflect blame from the allegedly defective product. That task was address in the defense questions by Kat Gallagher.

Eubaugh had pain complaints before her mesh surgeries, she asked Dr. T.

Yes, the doctor answered, for example she has chronic back pain that radiates down her left leg, and a charlie horse in her lower abdominal muscles. She experiences abdominal cramps that double her over with pain, fatigue and malaise.

Dr. T said that suggests an electrolyte imbalance or myopathy, where something is wrong with the muscle.  Ms. Ebaugh complained about headaches.

Recall earlier it was revealed before this jury that Ms. Eubaugh had to undergo a hip implant. She had been a national championship softball player but there was no history of trauma to the body. There was a history of osteoarthritis from wear and tear.  She tested positive for leukocytes and blood in her urine, consistent with patients who are potentially having urinary tract infections. She had a strong sense of urgency to urinate and SUI (stress urinary incontinence).

Dr. Janet Tomezsko, MD

Dr. T says this is consistent with the condition of overactive bladder.

Midurethral slings are not designed to treat urge incontinence or overactive bladder, she confirms.

As a treatment, Dr Douglass did urethral dilation or stretching, using instruments to stretch the urethra open. Ms. Ebaugh underwent pelvic floor physical therapy and she was placed on Enablix medication to treat overactive bladder, which did not help much.  He increases her dosage from 7.5 to 15 milligrams.

Eventually she had a TVT-Secur, though Dr. Tomazsko does not implant those. The doctor had no criticism of Dr. Douglass or his surgery.  TVT-S did not stop Ms. Ebaugh’s SUI. He then offered her the TVT.

The jury received their instructions after lunch today, Tuesday. They then went into deliberations.  Mesh Medical Device News Desk will keep you updated on the outcome!  ###

13 Comments

  1. Kitty says:

    I am confused. Who has 9k stock?

  2. Kitty says:

    There is a conflict of interest.

  3. stopmeshimplants says:

    I find it shocking that this Dr. Tomezsko states that surgical removal of these slings happens so infrequently. Who is she kidding? Everyone can see from the lawyer ads on tv these mesh kits must be causing problems for thousands of women or there would not be any need for lawsuits or lawyers. Praying for Ms. Ebaugh and her legal team to win big and get the justice she deserves. These women who’s cases have been tried are my heroes. I so appreciate them putting themselves through this grueling testimony and the most intimate details of their lives put out there for everyone to see and hear. J & J and the other manufacturer’s should be criminally punished for what they have done to our bodies and our lives. I will never let go of hope that somehow someday these corporate leaders will be made to reveal the entire truth about their greed and how bad these products are for everyone! Thank you, Jane for these updates.

  4. bejahblue says:

    Look at this line up for the defense….looks like a nest of WASPS to me. I am a white anglo saxon Protestant but I am no WASP. I find myself wondering how many in our community are African American, how many are Hispanic, how many are not caucasian. If the number were high that would be interesting. Is anyone tracking such stats in this population? I would like to know the name of the salesman in my operating theater when I was implanted. Where is that information noted or is it. I would like to know why UCLA could get away with throwing away the tag that identified the exact product that was implanted in me when there was a standing legal requirement that it be saved and noted whenever any device is implanted in a human being. Clearly that is not being done and no one is monitoring it…why does the FDA have this requirement written in the literature even…is it so there is the appearance of propriety? And what can I do about it? NOTHING. They all get away with murder. We are no threat to them. They can destroy documents, refuse to allow expert witnesses in court, do whatever they want and they get away with it all. I do not trust any of them, not the FDA, not the judges, not the “system”, and not my own government. I have been asked why I do not go back to UCLA and demand that the one good doctor who has removed the hellish mesh to remove mine. I do not because I believe they would kill me. I am sure of it.

    Bejah

    • Anon says:

      I have the same concerns about some hospitals, some doctors.
      Some people will do anything for a dollar, even murder.
      That fact has been proven over and over in this process.

  5. Diva64 says:

    I suppose it is to much to ask that the manufactures of TVM, go ahead and admit guilt and accept responsibility. Why are the hiding behind lies and not showing concern for our lives the years of normal life, without pelvic pain, loss of pleasure , the bodies response of autoimmune illness from a defective material that was never meant to be placed in the human body. IF you calculate court cost, expert witness testimony, other expenses, these manufactures are throwing away $ fighting for innocent when they’re guilty and a patient/client lacks funds to seek medical help, of the very few able bodies well skilled of gynecologist use that $ to start settlements against plaintiffs. Not by the tier system, toss it. Treat us as humans. Admit your mistakes, pay damages.
    They can not beat God who is clearly in charge of this world. They might want to consider where they will spend eternity if they don’t help those they injured.

  6. Lea P. says:

    From I can see Dr. T. is a business driven physician, she graduated from Penn State which is one of the most well known school of business. simultaneously got her MD and finally got her cert in Urogynecology just recently in 2013. where she got this “vast” experience from?

    • Bejah Blue says:

      Good question Lea! I guess it depends in part on how one defines “Vast body of experience” and surely considering the source is also important…”public relations” or some such office in concert with risk mgt., etc….the usual players.

      Bejah

  7. Bejah Blue says:

    I just wanted to mention that this morning I came upon a film on STARZ called “Misconduct”. Catchy title, eh? It stars Anthony Hopkins and Al Pacino. Anthony is playing the bad guy (He seems to enjoy these roles). It is about a corrupt pharma company exec and the manipulation of drug trials, just in case you thought you had heard it all by now. Made in 2016. I missed the last half as someone called. It will probably be on again. Just FYI people.

    Bejah

  8. Jody P says:

    Blame the victim I hope I get my day in court this witch doctor will be shown all the damage I sustained, no it was not incontinence problem it low hanging bladder and we tried many things, I had to go thru a humiliating test to get that stupid destructive implant that has made my marriage hell in many ways so bring it on j&j.

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