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.
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.
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?
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?
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?
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.
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.
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.
Object, move to strike, ask that it be stricken from the record.
THE COURT: Sustained. So ordered.
Judge Molberg Admonishes
After the jury left the room Judge Molberg asked Mr. Gage:
“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).