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Batiste v. Ethicon: Contentious Q & A with Medical Director Hinoul

Thomas Cartmell, Wagstaff, attorney for Batiste

Thomas Cartmell, Wagstaff, attorney for Batiste

Thursday’s transcript in the Linda Batiste v. Ethicon shows a contentious back and forth between Thomas Cartmell, the attorney for Ms. Batiste and Dr. Piet Hinoul, Medical Director for Ethicon, as the product liability enters its second week in a Dallas courtroom.

Piet Hinoul, Ethicon from Linda Gross trial

Piet Hinoul, Ethicon from Linda Gross trial

In the beginning of the afternoon, defense attorney William Gage moved for a mistrial based on alleged violations of a court order not to mention multidistrict litigation (MDL) taking place in a West Virginia courtroom where 65,000 cases are amassed against seven manufacturers.

When Thomas Cartmell put up the CV of Ethicon Medical Affairs Director, Dr. Piet Hinoul he referenced the MDL.

“The reference was inflammatory and unfairly prejudicial,” said Mr. Gage.

“Motion for mistrial is denied,” said Judge Ken Molberg.

Plaintiff, Linda Batiste, 64, was implanted with an Ethicon TVT-O to treat stress urinary incontinence in January 2011. She has suffered pelvic and nerve pain ever since. Her action claims that the pelvic mesh is a defective product that contained insufficient instructions and warnings to the doctor.

Hers is just the second case to be heard in a state court naming Ethicon, a division of Johnson & Johnson. Last year, a jury in New Jersey awarded Linda Gross $11.1 million including $7.76 million in punitive damages. That case is on appeal.

Conflicts of Interest

Mr. Cartmell addresses Dr. Hinoul in the afternoon showing him a study in the International Urogynecologic Journal that Professor Ulf Ulmsten edited.  Ulmsten was the inventor of TVT and sold his patent to Ethicon for $25 million along with a number of studies Ethicon relies on to assure its safety.

TVT-O from TVT Meshed Up, UK

TVT-O from TVT Meshed Up, UK

One 2009 article written by paid consultant Ingegerd Olsson says there was no conflict of interest at the time she was working as a consultant for Ethicon. Earlier, Dr. Olsson had been working with a group of surgeons in Sweden along with Dr. Ulmsten on an earlier study despite a 1998 payment of $400,000 to Dr. Ulmsten for favorable results the company would rely on to market the device.

Cartmell then showed Hinoul an article in JAMA (Journal of the American Medical Association). In a metanalysis looking at studies and addressing conflict of interest issues, the authors conclude there is a 500% increase in a favorable conclusion in the paper if there is a conflict of interest.

Q. You will invite doctors to come some place?

A. Right.

Q. A hotel or a hospital, and say we’re going to do cadaver studies and we’ll give you this product for free and we’ll pay you to do it. We talked about that, correct? Is that correct?

A. Now, you’re confusing professional education with a seeding trial.

Q. Can you answer whether that’s correct?

A. Well, it’s incorrect what you say.

Q. Creating influential word-of-mouth advocates for the product. And one of the things your company does, you want to go out and get the influential doctors so that they can become word-of-mouth advocates for the product, correct? Is that correct?

A. Not through a seeding trial. You’re reading this —

Q. I didn’t ask you if it was a seeding trial. Does your company go out and get the influential doctors so that they can, by word-of-mouth, be advocates for your doctor, yes or no?

A. If that is based on scientific credibility, we like them to confirm that our products are safe and efficacious.

Q. Is that yes?

A. Yes.

Q. By involving the opinion leaders as testers, does the your company actually tell the opinion leaders you can be our testers of the products? We talked about research and development. You do that, correct?

A. That’s not a seeding trial, right?

Q. I’m not asking you — I’m asking you specifically if you do that with the doctors?

A. Yes, we have them help us with the development of improving our products.

Foreign Body Reaction 

Dr. Hinoul agreed with the research that shows mesh frays and stretches and particles can drop off causing a foreign body reaction and inflammation which can cause pain. Again he and Mr. Cartmell went back and forth.

Q. And too much scar, excessive scarring, can cause pain, correct?

A. The amount of scar will not be influenced by minute particle when you have a big piece of mesh sitting on top of it.

Q. Has your company ever studied that?

A. Yes.

Q. You did a study to determine — because I want to be very precise. Did your company, Ethicon, ever do a study to determine whether or not the particles that fall off in a woman’s vagina could cause pain to a woman?

A. It would have been an integral part of the animal studies we did with mechanically cut mesh, which we would have studied, that mechanically cut mesh could have the same particles that we have seen.

Q. I think we’re miscommunicating.

A. Okay.

Q. Did your company ever do a study, design a protocol, get investigators to determine whether or not the particles that fall into a woman’s vagina, whether they could cause pain in a woman? Did you ever do that study in a woman?

A. No, there was no reason to.

Q. And doctors, your paid consultant doctors who you relied on in certain respects related to the safety of the product actually were telling the company that those particles that fall off mesh, polypropylene mesh,  they can migrate into women’s vaginas into the tissues and cause pain correct?

A: I would disagree.

Efficacy

Mr. Cartmell pointed to a study done by a Dr. Ward Hilton on the TVT, a randomized trial, the only one the company had done, here,  that showed a cure rate with TVT Prolene mesh of 63 percent and for  the Burch procedure, using sutures only, 57 percent. He too was a paid consultant for Ethicon and a key opinion leader. Hinoul calls him an investigator. Hinoul, who joined Ethicon in October 2008, said he was a surgeon himself and did see the particles and it did nothing to alter the wound healing.

The two then talked about the Instructions for Use (IFU), the product label insert, and whether they contained all of the potential complications of TVT mesh so a doctor could provide a full informed consent to his patient.  Again, answers were difficult to obtain.

Q. Would you agree that the IFU does not mention chronic pelvic pain anywhere?

A. In those words, no, but everything that leads to chronic pelvic pain —

Q. Can you answer that question, yes or no?

A. I did. And I feel like I cannot answer it with a yes or no.

Q. You can’t answer whether or not those words appear in the IFU?

THE COURT: Excuse me, counsel.

Doctor –Repeat your question. Answer the question.

THE WITNESS: Okay.

Q. Would you agree with me that the IFU does not mention chronic pelvic pain anywhere?

A. Not in those words, correct.

Q. Would you have agree that in fact the word pain does not — is not anywhere in the IFU?

A. Not that exact word, but everything that would lead to it is.

LEFT5: Object, move to strike, ask that it be stricken from the record.

THE COURT: Sustained. So ordered.

Judge Molberg Admonishes

William Gage, Butler Snow, attorney for Ethicon

William Gage, Butler Snow, attorney for Ethicon

After the jury left the room Judge Molberg asked Mr. Gage:

Judge Ken Molberg

Judge Ken Molberg

“What am I going to do with this? I cannot make this man object every time the witness is nonresponsive.

I have—I’m about up to here with it. And this has gone on for hours and hours and essentially the reason we are now way behind is because you’ve got your main witness who can’t answer a question.

If you   don’t get him under control he is either coming off the witness stand or he is going to go with Robert (bailiff) and be down in Dallas, Texas for awhile.”

Mr. Gage said he would talk to the witness to try and have him be more responsive.  The Batiste v. Ethicon trial could wrap up next week.

Thursday’s transcript (here, March 27, 2014) Linda Batiste v. Ethicon shows the following attorneys are present:

Present Tim Goss, (Freese & Goss), Thomas Cartmell (Wagstaff Cartmell), David Matthews (Matthews Law) , David Noteware (Thompson & Knight of Dallas), Helen Kathryn Downs (Butler Snow), William Gage, Michael Brown (Butler Snow. LLP),  Richard Bernardo (Skadden, Arps, Slate, Meagher and Flom, LLP, NY, NY), N. Kay Deming (Troutman Sanders, LLP, Atlanta), Philip J. Combs (Thomas, Combs & Spann, Charleston WV).

 

 

 

19 Comments

  1. stopmeshimplants says:

    Oh Jane,

    I love this judge and his actions Finally someone who wants to get at the truth! So wish I could be in Dallas to watch this trial. So glad Aaron is there to be our eyes and ears and to provide support LB. She is a brave woman.

    • love says:

      tears! We have waited so long for a honorable judge to allow the truth of what we have been through and lies told. keep that judge on the bench, I don;t care for a lot of judges but this one , the people rejoice at having on the bench, when we do not have just and honorable judges the people suffer and mourn. especially the common people. not many found these days. The attorney also , was a stern tough attorney, he threw some truth stones .I like those that stand on their own merit of being the best in america not riding on the backs of some not good.

      lies bind>> truth sets free those that suffer.

      ty jane

    • Shari says:

      Very encouraging that the judge is listening. I just had my 4th surgery for this nightmare on 3/26. Wish we had a time frame on this wrapping up. But hopefully at least this will be my last surgery. Good luck everyone. Take care

      • Jane Akre says:

        Shari- I hope your surgery was successful…. if so, you might want to share your surgeons with others.. they are all ears!

  2. Evelyn says:

    Jane I Love this judge so wished I could be there but glad you are.. This has to be a plus for all of us and ABC news I hope that all the rest of the news stations get on this world wide..

    • Aaron Leigh says:

      Evelyn- I wasn’t there Thursday or Friday – just too exhausted and dealing with some personal family issues as my mom prepares for surgery. Jane and I were able to work together, but Jane went back to the original transcripts for a lot of her info on Thurs-Fri, a great deal of work, indeed! Thanks Jane!

  3. jade says:

    Good reporting, Jane. Factual and unbiased journalism.

  4. Tammy says:

    Jane,

    As always, great reporting. What a Wonderful judge.

  5. Jaramillo says:

    The secrets just keep coming out! There was so much evidence presented that I was not even aware of. I have never heard about the particles dropping when they are inserting the device. I am just so sad after reading this. I can’t believe how much they knew and they allowed us to be implanted anyway. It is absolutely criminal. I am of the opinion their punishment needs to be their own, personal tvt implant. That will be a great long term punishment! They believe the long term pain is only rare in women. Then that will give them solice that their implant may not degrade and cause permanent long term pain. LOL We all know that he will have long term pain. I am confident if he were implanted he would suffer like we do. He will beg to have it removed.

  6. Injured says:

    You go Judge Molberg! Finally someone in a power position is LISTENING! Great story Jane and Aaron! We all had such high hopes for the Fed. court but it seems that they don’t want to admit anything that really shows how this mesh has destroyed so many lives. I had heard such good things about that Judge but with reading all the important things he’s saying is ‘inadmissable’ or ‘will not allow’ then he’s cut all of us off at the knees and wants us to waddle to the stand! Again I say “You go Judge Molberg!”…thanks again for such a great story guys! Loving you for all you are doing for us!

  7. jade says:

    Reading the entire deposition brings it into light on how little Ethicon, as all the other manufactures, thought of the women who would ultimately become the victims of these unconscionable marketing strategies. They displayed not one word , comment or concern for the women who would ultimately become their unsuspecting victims. Their ONLY concern was keeping their market share by selling “defective medical devices”. What a travesty and blatant assault on women. You’d have to conclude that these individuals must have been spawned instead of “born”. But, I’m sure the perpetrators of this conspiracy will race back to their own mother on Mother’s Day, Sunday, May 11th. As a group, we need to make sure that the World hears our MESHage for hope and justice especially on Mother’s Day!

    • Jane Akre says:

      Jade I think you are right. It is pervasive that the women at the other end of the pelvis were not even thought of at all… When doctors work to have the organs placed “anatomically correct” and leave out quality of life issues (QOL)? You have to wonder if they think women are Barbies!! Non feeling and detached from the lower half of their body. Almost as if women have exhausted their usefulness when they are past their reproductive years (not all are) and now can become and bread and butter for the medical profession desperately trying to keep their revenues as healthcare and insurance erodes their once profitable profession.

  8. jade says:

    Agreed, Jane. I have expressed from the beginning – we were considered “dispensable” – looked upon as an object that had outlived their usefulness as a physical partner and a vessel of life. Therefore, we were an “available” and “easy” target in the minds of these researchers, doctors and marketers! Today, women are not “old” and “useless” in later years. They are vibrant, involved persons in both their personal and professional lives. Women work hard to make it through all the physical and emotional obstacles we have encountered along the way – especially those of us growing up in the 60’s and 70’s. The World view of who we are today has changed drastically from those past years – mostly due to those of us who spoke out and continue to speak out against the sexual harrassment in the workplace, equal pay issues and abuse…etc. These companies wanted to “learn from our suffering”, however, I think with what is coming out in these depositions and trials, they are beginning to “learn about what it means to commit crimes against women” and it is they that will be suffering the consequences – both personally and professionally!

  9. All Meshed Up says:

    I think all the manufacturers thought of us as guinea pigs to use ‘new’ products on. TVT has the spot light on it now. I just hope that all of the victims with Hernia mesh are not left in the dark as we have been for so long. It is good to read about a Judge that is not taking any BS from the witnesses. It is about damn time. Now, let us hope that the ‘main street media’ clues into what Jane has been doing and report this as it should be. This is the largest Medical Fraud ever. Thanks Jane, for another great article!

  10. Rhonda says:

    This judge is a breath of fresh air! I must admit, after the ilast trial my hopes for jus tce hit an all time low. I’m hoping the legal community are watching this trial closely. Thank you Jane and Aaron for all your hard work and dedication.

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