Day Two: Batiste v. Ethicon

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

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

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 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)

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

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

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

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

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

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. #