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Day Two: Batiste v. Ethicon

Aaron Horton, the Mesh Warrior

Aaron Horton, the Mesh Warrior

Aaron Horton has spend her second day in the Dallas Courtroom where Linda Batiste is attempting to hold Ethicon, a division of Johnson & Johnson, accountable for her mesh-related injuries. In 2011 she was implanted with the incontinence mesh TVT-O and today she continues to suffer the complications. 

Horton, whose mother is mesh-injured (see background story here),  reports she found much of the testimony painful, but she stayed there and even had her picture taken with Ms. Batiste (see end of story).  Here are her observations from the Dallas courtroom.

Linda Batiste v. Ethicon

Dr. Peggy Pence, A toxicologist and pharmacologist expert

Dr. Peggy Pence, A toxicologist and pharmacologist expert

We start Day 2 around 9:30 with Peggy Pence on the stand again – testifying that senior executives and global medical directors within Ethicon knew of the TVT-O’s increased danger as compared to the product line’s former iterations (like the company’s TVT).

The plaintiffs’ attorneys have done a good job providing a “preponderance of evidence” that Ethicon did not act in a “reasonable and prudent” manner with regards to its safety warnings and Instructions for Use (IFU) how-to manual for doctors, which is the primary way doctors inform patients of risks of using the product.

Remember on Sesame Street in the 70s when they would have the letter of the day?

Well, today’s letter of the day would be “O.”

Ethicon attorney David R. Noteware

Ethicon attorney David R. Noteware

The first “O” of the day is: OBJECTION, OBJECTION, OBJECTION

Defense counsel Mr. Notewhere Objects so many times, citing “no foundation” or “outside the scope of the expert witnesses” expertise or “leading the witness” that he finally asks the judge and court reporter to take note of his ongoing Objection so that he can just sit down instead of continuing to stand up to object.  He also repeatedly states his team’s Objection on the “grounds of repetition,” citing to the judge that the information presented by plaintiff’s attorneys had already been covered well enough.

The second “O” word of the morning would be: OVERRULED, OVERULED, OVERULED. 

Judge Ken Molberg

Judge Ken Molberg

Judge Ken Molberg overrules these objections consistently, but the lead defense attorney persists by continuing to describe and speak in detail about why he objects.  Yesterday, Judge Molberg had interjected, OVERULED! I don’t like speaking Objections.”  Today was no different.  Still the defense attorney persists in Objecting.  Today, Judge Molberg is visibly more stern, saying “I’ve already overruled your Objections; OVERRULED,” adding upon a subsequent Objection, “I will afford you the same courtesy as I did last time: OVERRULED.”  Then speaking to plaintiff’s counsel,  “Please continue.”

Judge Molberg calls a resting recess for 15 minutes around 10:30.

Obturator Approach (TVT-O)tvt0

After the morning recess, we hear more in depth through scientific and peer reviewed studies as well as internal Ethicon documents that Ms. Batiste was implanted with the TVT-O, mechanically cut version of transvaginal tape, when a better option (a lighter weight, larger pore) option was available, but was not used on Ms. Batiste.  The heavier weight mesh used in Ms. Batiste is by admission of Ethicon, the same mesh that was invented in 1974, with a new procedure, which has proven to display statistically significant differences in negative outcomes/symptoms, particularly with regard to leg/groin pain, dyspareunia, particle loss and migration of particulate matter, the plaintiff’s attorney would later claim.

BiO – mechanics

The plaintiff’s team showed through several high-resolution slides that the method of cutting the mesh, is paramount to a successful patient outcome.  Ms. Batiste’s mesh was cut mechanically, which the plaintiff claimed (using many of Ethicon’s own documents) causes more fraying, roping and sets a precedent for adhesion, fistula formation and erosion than the latter mesh products cut more precisely and “cleanly” by laser in the attempt to seal the outside edges, the theory being that fraying, and roping would be kept to a minimum.  Even with that, plaintiffs and their experts claims that both TVT and TVT-O can contract or shrink up to 50% causing chronic and nerve pain syndromes long associated with the mesh implants.

TVT-O from TVT Meshed Up Mesh, UK

TVT-O from TVT Meshed Up Mesh, UK

Ethicon’s Internal “Issue Reports” Revealed

The Internal J&J document used to record complaints coming into the company concerning a medical device the company has manufactured, is recorded by the company via “Issue Reports.”  Per yesterday’s testimony, J&J/Ethicon employs a passive approach to complaints whereby doctors and/or companies must seek out the correct department within the mammoth company to report adverse events.  At the time Ms. Batiste was implanted, the company had already received several complaints via this passive system, but yet, did not react by revising or recalling the product or updating the product’s IFU.

The Plaintiff’s Expert Witness Testimony Concludes

B. Todd Heniford, MD

B. Todd Heniford, MD

After the lunch recess, the plaintiffs’ counsel shows Ethicon’s own promotional video from the 1990s as a hernia specialist is recorded in what is a television-commercial type production and hosted by Dr. B. Todd Heniford.  The Ethicon consultant explains that heavyweight polypropylene mesh hardens in almost every instance in which it is used.  Plaintiffs’ attorneys and the expert witness confer saying the polypropylene mesh acts same in a woman’s body and in the pelvic region of a woman’s body as it had for years in both sexes for hernia repair – it shrinks and deforms into a painful, hardened, irremovable object (for lack of a better word).

About one- third of the way through the video, the explanted heavyweight mesh from a human patient is shown.  The jury and many members of the courtroom watch with looks of shock and what seems like confusion, as several jurors look to one another for seeking something – maybe reassurance about what they are seeing.  The video continues.  The explanted mesh is knocked against a stainless steel surface by a pair of latex-gloved hands, each time making a hard thump and tingeing noise that becomes more poignant with each repetition of the motion.  The explanted mesh looks like petrified wood, coated in blood.  There is no give in the mesh – not one inch.  It simply doesn’t resemble the original product in shape, form or texture at all.  It has hardened to the point where it is not at all recognizable as the device received by doctors in a box with Instructions for Use from Ethicon as its manufacturer.  The video’s narrator goes on to say, “You can see how a patient would feel this mesh with every abdominal movement.”

It is quite clear by this Ethicon-produced video that the company understood its mesh product Prolene could harden into a plastic mass. Yet the company continued to use Prolene for the TVT- and TVT-O transvaginal mesh.

If you’ve ever broken a rib or have done a few too many sit-ups, you understand, that the abdomen is used in nearly every movement we make – sneezing, laughing, coughing, moving, stretching, reaching, sitting down, standing up, virtually any movement we make during our daily lives.  The point is well made by the plaintiff, and after bringing home a few of the most important defects in the product, the plaintiff’s counsel rests, and it’s time for cross-examination of the Dr. Pence, the expert witness.

The “O” in Notewhere

David Noteware

David Noteware

Mr. Notewhere – Defense’s Lead Counsel Takes to the Podium

We’ve not heard him in any capacity except to object repeatedly.  He starts his cross-examination by introducing his wife, who is sitting in the courtroom and dressed nicely in a red jacket.  She smiles and waves timidly.  Counsel moves on to address the witness about her background, noting that the witness and his wife are fellow LSU graduates.  He cites the witness’s credentials again, asking her to agree or correct him if he’s inaccurate in any way.

He then challenges the witness’s use of her credentials, stating that many people choose not go by “Dr.” even if they are in fact the recipient of a legitimate Ph.D., citing a possible reason: that the “Dr.” may no longer practice daily in the specialty in which the Ph.D. was earned.  It seems combative, and the witness handles herself well as she states, as doctors, when we receive our degrees, we are called doctors, as it is appropriate to do so.  I cannot comment on whether others choose not to be called by “Dr.” for whatever reason, but in my profession, we are called doctors.”

Dr. Peggy Pence

Dr. Peggy Pence

Counsel continues, “So would you prefer to be called Dr. Pence or Ms. Pence, inferring that there is some material area within her lengthy pedigree that she no longer practices daily in a patient or research setting.  The witness agreeably states, “I do go by doctor Pence, but you many even call me Peggy if you like.  I don’t take offense to either.”  With that answer the counsel chortles a bit under his breath making known his disapproval.

Mr. Notewhere begins to review the same studies as the plaintiff’s counsel, alleging that Dr. Pence and plaintiff did not consider the whole conclusion of the study when pointing out to the jury significant statistical findings, like a high percentage of groin pain.

Notewhere brings to the attention of Dr. Pence two other studies during the course of the afternoon asking if these studies were among the 4,000 plus reports she’s reviewed in preparation for this case.  They were not.  Mr. Notewhere is forceful, his voice loud and filled with aggression.  Many of his asides note that he has been waiting to rebut many of the expert witness statements.

The jury doesn’t fail to notice.  Many of them are displaying body language typical of one a person who might be offput or defensive.  Several jurors have crossed arms and are poised far back in their seats.  Some of them look at one another will a roll of the eyes occasionally.

This reporter observes it is apparent that convincing the jury that his facts are true may not be the most difficult challenge for Mr. Notewhere.  He simply is not likeable as a presenter and comes across as a bully.  It is a noticeable and palpable shift in the courtroom with the first words he utters, much closer to the witness, much more intense, much more aggressive.  The time is around 2:15 in the afternoon.  The plaintiff, Ms. Batiste is getting very uncomfortable.  I see her shifting in her seat and see the all-too-familiar motion of rocking from one side to the other as an attempt to relieve pain, and my compassion compels me to move to the front and hold her hand.   She is strong, and after a while, I feel embarrassed that I seem to need her more for comfort than she needs me.  Maybe I sat next to her for me.

Anyway, it’s clear that the two of us don’t fit with either side.  We are both alone in the scenario to an extent.  We are the injured, she physically, emotionally, mentally and every other kind.  Me: I don’t know what I’m feeling, but I am hurting for the many women I know who still have a petrified piece of wood inside them, and I want to flee and call my mother to tell her I love her.

After another 15-short recess, the defending counsel dives back into medical literature.  Ms. Batiste is no longer comfortable to sit through the trial, so a paralegal escorts her out of the courtroom to go home.  It’s around 3:15 now, and it’s clear the remainder of the day will be likely be spent with the defense team rebutting the expert witness’s testimony regarding certain aspects of the many scientific studies done on the mesh since 1974.

Aaron Horton and Linda Batiste

Aaron Horton and Linda Batiste

After a little while, Ms. Batiste is no longer comfortable to sit through the remainder of today’s proceedings, so a paralegal escorts her out of the courtroom to go home.  During another short recess I briefly exchange words with several of the plaintiff’s team members – nothing too significant.   I do the same with Ms. Batiste, as I find her waiting for her escort as I’m leaving the courtroom.  I hug her for the privilege of having my picture taken with her.  She is a steadfast and constitutionally solid woman.  I ask an associate attorney if he can take the picture.  He does, and that, coupled with holding her hand was the highlight of my day.

I am able to give her my card, because, unbelievably, she does not know any other mesh-injured women.  I briefly tell her there is a community of women waiting for her when she’s able to reach out.  She is touched and grateful, and I know this not by her words, but by her smile, nod and her respectful look directly into my gaze with a simple, “Thank You.”  Ms. Batiste is set to take the stand Friday.

That’s all it takes for me to keep going for one more day.  Here is the lovely picture of the lovely woman that I hope many of you can talk with and support one day. #

19 Comments

  1. karen says:

    Thank you very much for this story. I was starting too give up, but this might be my safety net. This story is like mine story same company , same procedure. I wish Ms.Batiste the best. Again thank you Aaron and jane.

  2. Jaramillo says:

    Aaron , is there any way to post a clip from the video that was used by the plaintiff? Is there a place that the research on the dog study can be retrieved? Will you let us know if there is mention of the destruction of records by J@J?. Please let Ms. Batiste know that she is surrounded in spirit by those of us that read the trial daily. If she does not know how many of us are out here, it is not likely that she knows how her courage, and willingness to face the giant, is a support to all of us! I hope that the two of you are shielded today. For me, the plaintiffs testimony is always so painful. It is difficult to know that the defense will once again, attempt to shred her physically and emotionally. Thank you for being with her. Having a caring person to hold your hand and remind you that you are not alone is such a gift for any of us. Ms. Batiste you are a warrior for thousands! Safe journey Lets remember that without Jane and Aaron we would not have the access to this information , it’s a good day to get our donations in as the cause is important and, as we all know expensive..

  3. stopmeshimplants says:

    I am already appreciating the tone of this courtroom and the respect this judge is giving to the facts of this case. I can only imagine what Ms. Batiste must be going through. I will pray for her. I am extremely hopeful this case will bring to light all of the facts that could not be brought up in West Virginia for whatever reason. Thank you, Aaron for your sensitivity to Ms. Batiste. I hope you will continue to remind her that she is not alone. There are thousands of us supporting her!

  4. Laurie MacKenzie says:

    She is a very brave lady….she is definitely not alone either but I can understand exactly how she feels…so many of us women have felt alone for a lot of years not knowing what was going on inside our bodies…certainly not an ounce of support or compassion from our doctors and family members and still not to this day…we are conditioned that our doctors are the experts and we put our trust in them that they are doing the right thing by their patient…as my doctor said when he first implanted my sling back in 2000, “I will be creating a nice little sling to take care of your problem” Who knew? The company’s that made them, they knew and profits outweighed the risks to women…I am still baffled that this is not headline news…Women’s bodies across this country and other countries were implanted with an experimental device that even a rat rejected, yet they went ahead and implanted in thousands of women and are still to this very day…It is an outrage and a disgrace of PROFITS over human life….and if you think for a minute that they (Big Companies) are going to admit wrong doing, think again, the mighty dollar is at stake!!!~

  5. Betty says:

    Tell her she is not alone as there is 100,000 of us out here from all over the world that thinks we are the only one’s. I found you all last yr. when my doctor didnt know what to do to help me as all the big wig doctor’s she spoke to told her they had NO problems with the TVT-O and it was probley me going thourgh meapous?’ and alot of women complain alot going thourgh it!! We ( Doc & self) have learned alot about this mesh in the last couple of yrs.

    We all have to stand together to fight this, like we would stand to fight for our right to breath. I cry almost everyday because of pain and lack of affection because our other halves have no idea how or what to do to help us and it makes me so DAMN mad that big companies say it is our faults this happened to us!!!! Bull sh.. it was thier greed that did this to all of us women & men that are having these problems.

  6. HE says:

    Bravo Aaron! Your compassion is showing through and I’m sure you helped Ms. Batiste more than you know. I was reading this out loud to my family member and she wondered how Ms. Batiste could not know that there were thousands and thousands of others who were injured. It isn’t being covered by any major news network. If you’re not on the computer searching for help, you won’t find it. What a difference there is from state courts to the Federal Court. The judge seems interested in getting the truth out and not too worried that the jury wouldn’t be able to understand the testimony (Judge Goodwin ruled that 510K testimony is off limits because it would be too hard for the jury to understand). I am flabbergasted at the contrast of the way trials are run from state to federal court level. I have learned many new facts that I was not previously aware of through this case and to the plaintiffs lawyer’s I give a big thumbs up. I wonder if the other lawyer’s knew of these pieces of evidence or if they were barred from showing them. It is scary to hear some of this – the idea of permanent nerve damage – YIKES! I have been hoping that Dr. Raz would be able to solve all of my problems on this next surgery. It also explains why I have “pieces” floating around. I pray that Ms. Batiste get’s real justice and that Ethicon suffers the consequences of making decisions based on profits. Hopefully this will be the start of the STOPPING THE MADNESS, which claims many victims daily. To everyone: Hang in There. The story isn’t over yet. I wonder if there is a way to get the trials out of Judge Goodwin’s courtroom and back into the original state where they occured?

  7. top_bard says:

    Thousands upon thousands of individuals suffering mesh complications support your bravery Linda. All the judge and jury have to do is listen but really listen and the truth will prevail. TVT-O mesh tape devices seem to be the most problematic. In Scotland, United Kingdom it geographically appears to be the device of choice.

    Please if you read this comment take the time to click on this link and pass it on at every opportunity http://www.scottish.parliament.uk/gettinginvolved/petitions/scottishmeshsurvivors and please sign this petition to suspend the use of mesh medical devices in Scotland and global suspension should follow. We need to show the Scottish Government that internationally thousands of individuals are suffering debilitating complications from polypropylene mesh and mesh tapes and that includes hernia mesh and by signing this petition they will see the true picture of mesh

  8. Tammy says:

    Thank you Aaron, great reporting. Im thankful for your willingness and compassion . Linda, please know your not alone or crazy. I felt both for awhile. God bless you and your in my prayers. The truth shall stand when all else fails.

  9. Paula says:

    Thanks for the updates Aaron

    Truly appreciate all your hard work , very informative.

    As Tammy indicated, I too felt alone and was made to

    believe it was all in my head until I found this site

    Is there any updates after day 2 of testimony?

  10. jade says:

    Aaron – Can you update us on the current status of this trial? Thank you.

  11. Jane Dowdall says:

    Aaron – I too am curious as to how the trial is progressing.

  12. Marie says:

    Gag order, media blackout

  13. Jaramillo says:

    IF YOU GO TO MATHEWS AND ASSOCIATES LAW FIRM IN DALLAS, THEY HAVE SOME ADDITIONAL INFORMATION ABOUT EVIDENCED USED IN DAY 2. I HAVE NOT BEEN ABLE TO LOCATE MUCH ADDITIONAL INFO. I WONDER WHY A GAG ORDER? THEY HAVE NOT DONE THAT IN PREVIOUS TRIALS. KEEP PRAYING LADIES

  14. jade says:

    What happened to Aaron Horton? Her coverage was very detailed above of Day Two. She must have some information on current status that she can report even IF it’s to say “we are in settlement talks” – status information is NOT privy to a “gag order” – it is good journalism. Journalist report the facts without bias. Period.

    “In a democratic society access to free information plays a central role in creating a system of checks and balance, and in distributing power equally between governments, businesses, individuals, and other social entities. Access to verifiable information gathered by independent media sources, which adhere to journalistic standards, can also be of service to ordinary citizens, by empowering them with the tools they need in order to participate in the political process.”

  15. Aaron Leigh says:

    Hi all- yesterday’s story to be published soon. I’m here in the courtroom again today.

  16. Aaron Leigh says:

    No gag order. Matthews communications rep has not covered trial since mid-day Wed. It would help if any of you following the trial could light up the phones at the Dallas Morning News to get media reps here other than MND, the only outlet here reporting. Also, donations are graciously asked for as we a recovering this trial without pay and have expenses. Thank you for your consideration all & God Bless.

  17. Jen Narciso says:

    Thank you for the excellent reporting, I’m totally capitvated. Defense council sounds like total a**hole, hate that, I’m sure Jury does too. Aaron I’ve been wondering something maybe you could answer, what is the difference between this trial and the others being tried in the State Courts? I thought all were consolidated into the MDL? So glad you are showing the real truth to the public…keep up the good reporting Brave Warrior!

  18. jade says:

    Hmmmmmm!

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