Batiste v. Ethicon trial: An unexpected emotional rollercoaster in Texas

by Aaron Leigh Horton

Aaron and Linda

Aaron Leigh Horton arrived in the Dallas courtroom this morning, Monda,y March 24, to continue witnessing the trial of Linda Batiste v. Ethicon, now in its second week. Aaron, The Mesh Warrior, reports she had to leave the courtroom during some of the morning testimony because of the emotional toll it took on her with a family member suffering from a polypropylene (PP) plastic mesh implant.

The following observations are in her words:

The jurors in the Batiste v. Ethicon case are taking notes and the women are very attentive this morning. Men of the jury are intensely focused on the lawyers for Ethicon, primarily presenting attorney William Gage, of Butler Snow here presenting for the first time today on behalf of the healthcare giant.” Gage was the attorney who represented J&J in the federal case, Carolyn Lewis v. Ethicon (part of the MDL) last month in Charleston, WV.

Judge Ken Molberg

Ms. Batiste’s case is being held in Texas State courts, presided over by Judge Ken Molberg, as the case was originally a medical malpractice suit, which is brought to trial in a state’s jurisdiction.

Linda Batiste (L.B.) has spent the majority of her 64 years in Dallas. On January 12, 2011 she was implanted with an Ethicon TVT-O PP mesh by Dr. John Robert McNabb at the Baylor Medical Center as a treatment for stress urinary incontinence.

Interestingly, the implanting surgeon in the Lewis trial, Dr. Muriel Boreham, is also with Baylor Medical Center of Dallas.

The TVT-O was launched by Ethicon, in 2004 as an update to the TVT (transvaginal tape). The “O” stands for obturator approach, a new way to attach the mesh inside the pelvis as opposed to the retropubic approach. The obturator approach has been proven through several peer-reviewed studies to have a much greater change of injuring the obturator nerve, which among other functions, controls the adduction movements of the leg.

At some point some jurors looked shocked and angry, shaking their heads and wincing at graphic slides and the Ethicon-produced training video (for doctors) they were shown by the plaintiff’s counsel. Other times, mostly the male jurors (and there are seven, seven women also) appeared to be laughing as the defense team seemed disorganized, looking for files, exhibits and being corrected often by the expert witness, Dr. M. Tom Margolis, a urogynecologist and female pelvic surgeon from the San Francisco Bay area here.

The women were fastidiously taking notes.

Dr. M. Tom Margolis, urogynecologist

On the stand Monday, Dr. Margolis has long been vocalizing his aversion for any use of the surgical polypropylene or in his words, “any kind of synthetic mesh.”

He has never implanted synthetic mesh in any woman for SUI or POP, and he prefers to use organic materials, including the woman’s own tissue (medically referred to as a “fascia,” harvested from the patient’s thigh). His preference is to use human fascia, sterile bovine (cow) or porcine (pig) tissues to reinforce sagging or weakening pelvic tissues.

He appeared at the Food and Drug Administration’s expert gathering on transvaginal mesh in September 2011 to testify that delivery of the permanent polypropylene (PP) implant through the vagina (transvaginal) introduced the material through a clean/contaminated field, which violates “all acceptable surgical practices.”

William Gage, Butler Snow, attorney for Ethicon

Gage was solicitous towards Dr. Margolis, almost appearing to go overboard with familiarity, saying, “I feel like I already know you, as I’ve read so much of your research and other work.”

Dr. Margolis said in response, “Well if you knew me that well, you wouldn’t get that close.”

The jury and courtroom could be heard audibly laughing in response.

Dr. Margolis was brought on the stand to talk about the fact that he currently performs at least three and sometimes up to five surgeries per week to explant synthetic (PP) mesh products, including the TVT-O, which have caused patients what, at this time, seem to be irreversible adverse events. He commented that there appears to be an uptick in the need for explants, which he experiences in his everyday urogynecologic practice. Testifying to the 14 jurors, Margolis said there are more than 200 other procedures/alternatives to synthetic mesh products, like Ethicon’s TVT and TVT-O products.

TVT-O from TVT Meshed Up Mesh, UK

Dr. Margolis stood up on the stand to explain one procedure he often uses and what the fascia sling is: a tendon harvested from a patient, a tendon which is one of the strongest in the body, and thus, used for repair of pelvic injury. In the morning he also made a good point of how misleading Ethicon has been in calling the TVT and TVT-O procedures “minimally-invasive” particularly with regard to the size of the incisions used for organic transvaginal procedures or abdominal procedures.

He used Ethicon’s own marketing materials to illustrate his point. Instead of a long incision from the knee to hip bone (shown on the Ethicon-produced slides), Dr. Margolis said a fascia harvest could be done with an incision from 0.5 to 1 cm long.

Mr. Gage at one point on cross-examination spent an inordinate amount of time trying to scrutinize how much money Dr. Margolis is paid as an expert witness. While $500 an hour is customary for any expert, Dr. Margolis said he makes $350 an hour to review documents in preparation for trial, $500 an hour for depositions and $2,000 a day to testify in trial.

Mr. Gage attempted to show a study from 1987, by Galloway et. al regarding the Burch procedure and using sutures alone to correct SUI which indicated a return of the condition of SUI in many of the patients in the study here.

Trying to show Dr. Margolis that the Burch and Colposuspension procedures are also invasive, Mr. Gage goes back to the 1987 study again and again, and Dr. Margolis corrected Mr. Gage many times, especially over whether the procedures have to be redone and how they are redone.

Aaron Horton

The doctor informed the jury that a 1987 study and the terminology used in it are old and outdated, as new terminology, methodology and vernacular has developed over the more than 25 years since the 1987 study (produced by Ethicon as its first supporting documentation/study presented on cross-examination of Margolis).

Mr. Gage, highlighted in yellow the conclusion of the 1987 Burch Procedure study, saying "Not a very good outcome is it?" Dr. Margolis agreed saying the study only used 50 individuals, “so it's not a very good or valid study at all, since the series (meaning patient population measured in the study) is not large enough in my opinion to produce clinically significant results."

A few male jurors continue to laugh, appearing to me, as if to enjoy the defense's bumbling to find correct slides and documents as, during this part of the trial, the defense appears disorganized.

The afternoon ended with an excellent observation by Dr. Margolis. Mr. Gage showed exhibits of the IFU (instructions for use) and the patient brochure, both given to doctors. One is for the doctor as the end user (the IFU) and is much more technically and medically-focused to instruct doctors for implanting the TVT-O. The patient brochure is to be used primarily to inform a patient as the end user, including less technical language. It is up to the doctor to inform the patient based on information provided in the IFU. The manufacturer has no direct responsibility to inform a patient.

Gage displayed both, seemingly to attempt to confuse the uses of each pamphlet, both the IFU and patient brochure. Since the patient doesn’t know what erosion is typically, she must rely on what the doctor tells her are the primary risks for her individual case.

Dr. Margolis reacted quickly to the situation saying to Mr. Gage, “You are comparing two documents which have two completely different purposes and audiences. You are asking about the IFU while the slide currently showing is of the patient brochure. I am not sure which you’d like me to refer to during this line of questioning,” said Dr. Margolis.

Toward the conclusion of the afternoon proceedings, the two were discussing the IFU and patient brochure and debating about whether the Burch Procedure can cause the same adverse events, for the same duration, events which are now widely known as “not rare” as defined by the FDA’s July 2011 warning and most recently this February (2014) by the American Urogynecological Society (AUGS) also as “not rare.”

Both policy and medical organizations have changed their stances from “rare” to “not rare” over the last three years as more and more women come forward with the long and often permanent list of painful, life-altering adverse events. Dr. Margolis would continually refer to these events as, “serious, profound, life-altering, irreversible, traumatic, chronically painful” adverse events, “attributable specifically to the synthetic PP suite of mesh products including Ethicon’s TVT and TVT-O products.”

Dr. Margolis said more than once, and I think this hit home with the jury, that the reason he uses organic material and why the Burch Procedure has to been used for decades but often is necessary to perform more than once over a woman’s lifetime redone is that, “We expect that organic material, over time, will be absorbed and dissolved by the patient’s immune system. We have to repeat the Burch Procedure sometimes, using organic material, by adding more tissue, and that is to be expected.” But, he said, “Our bodies did not evolve to have an immune system that can attack and eliminate plastic.” And he was the first expert witnesses to use the word “plastic” repeatedly, not polypropylene (as plastic is often referred to during trial). This reporter believes “plastic” is a more accessible word for jurors to understand the reality of what the mesh actually is.

Prolift explant

And Margolis added, “There is no way to remove 100 percent of the mesh,. . . ever.” He said it is a permanent implant that no doctor can currently remove 100% of, including the free floating particulate matter, as the mesh breaks down or when partial surgeries are performed in an attempt to explant as much mesh as possible. “Your immune system will attack [the plastic] and attack it, and attack it for the rest of the your life, but our bodies did not evolve to be able to reject mesh through the mechanism of our autoimmune systems.” In other words, the body’s attempt to attack the foreign invader will continue as long as the mesh is present in any amount, and it will do so to no avail, try as it might. Several women sitting with me, some mesh-injured, and I, began to cry when Dr. Margolis testified to this fact. It is the first time I have ever heard that the mesh can never be 100% removed. This news was devastating to all of us.

But I am an optimist, and I believe this area of medicine, this unknown and unchartered water, will continue to be a very important area of study for compassionate doctors like Dr. Margolis, now, and long into the future.

Concluding the day, Dr. Margolis said he studies fascia slings in Africa, particularly with regard to fistula formation, which means “one organ has inappropriate contact with another organ, most often the bladder and the vagina. In the United States and other developed countries, the vaginal-to-bladder fistula formation is the result of a surgical procedure, almost invariably, while in Africa, he notes his area of study on a very young population - little girls who have been. . . ", he pauses, who have been impregnated too early, creating fistulas as a result of vaginal delivery in a young body.

His work in Africa seemed to make an impression on the jury, making him even more likeable and respected by them. He came across as extremely compassionate, as a doctor and as like the rest of us, simply a human being, trying to figure out this preventable, man-made catastrophe. He was very polite to both sides as a witness, but it was clear to this reporter, via Mr. Margolis’ body language that he clearly has an awareness of the devastation and irreversible harm these devices have done and still are doing to women, as the TVT-O is still on the market and placed in women every day. #