Dr. Christina Pramudji, MD was the witness called by Ethicon as the defense wraps up its case in the second week of this product liability case, Huskey v Ethicon.
The Houston- based urogynecologist was chosen by Ethicon (Johnson & Johnson) to do a physical exam on plaintiff Jo Husky to determine her mesh-related injuries.
This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from the market until their safety can be demonstrated.
Mrs. Huskey’s claim is she’s continued to experience chronic pelvic pain since 2011. It began five months following the implant of a TVT-O (transvaginal tape obturator) to treat stress urinary incontinence (SUI).
With a girlish voice and her hair back in a ponytail, Dr. Pramudji’s appearance belied her credentials – a board certified urologist with a subspecialty in Pelvic Floor Medicine and Reconstructive Surgery who’s performed more than 900 obturator sling procedures.
Her sling of choice – Ethicon’s TVT-O (transvaginal obturator).
For her enthusiasm, the doctor has been paid $75-thousand in recent years to consult with Ethicon and teach other doctors how to implant the polypropylene medical device.
A: “I feel like I have an obligation to teach other doctor how to do it properly and safely,” said Dr. Pramudji.
As is customary by both sides, after certifying her as an expert it was established that Dr. Pramudji charged $600 an hour for her work here and $700 an hour for a deposition or court testimony. She’s put roughly 100 hours into this case.
Much of the afternoon was spent with J&J attorney Christy Jones leading a choreographed Q and A with the doctor.
The doctor said pelvic pain and dyspareunia (painful sex) is very common in post-menopausal women, even without a medical device implant. A failure of the sphincter around the urethra to squeeze shut can affect up to 50 percent of older women.
The burch (sutures) and pubovaginal sling (using the patient’s tissue) have fallen out of favor because they represent major surgery, said Dr. Pramudji.
But there is a known downside to mesh slings such as the TVT and TVT-O, she admitted – the 3 R’s – mesh exposure, erosion and extrusion.
PAIN PRE-EXISTED TVT-O
The defense attempted to establish that Mrs. Huskey had complained of pelvic pain to her primary care doctor prior to her TVT-O surgery in February 2011. The discomfort was so bad she had gone to the emergency room in November 2010 where the doctor found a solid mass in one ovary.
Following two partial removal surgeries, Mr. Huskey complained of pelvic pain particularly on her left lateral side where one doctor had yanked on the sling to try to remove it. The same doctor performed an exam using a speculum, which escalated her pain creating a spasm on the pelvic floor.
“Yes, she reported a muscle spasm syndrome. That’s where it hurts. That is where she is tender on examination. This is what’s causing her discomfort,” said Dr. Pramaduji adding the area is far away from where she had her implant surgery.
“We don’t know what caused it, it happened well after she was done with the sling so I can’t link those two together in any way.”
“Do you have any opinion whether or not the TVT-O she received caused the muscle spasms she is currently experiencing?”
“No, it did not.”
Regardless of her undiagnosed pelvic pain, the doctor added Huskey was a perfect candidate for the TVT-O and the IFU (instructions for use) were sufficient.
CROSS EXAM- ETHICON’S MILLION PLUS FRIENDS
In the afternoon on cross examination, the attorney for Huskey, Fidelma Fitzpatrick (Motley Rice) shot out of the gate.
Dr. Pramudji agreed the pelvic pain noted in the emergency room visit turned out not to be gynecologic but was gastrointestinal in origin.
Why put a TVT in a patient with pelvic pain of unknown origin? Do you think it would be better to know the origin especially when it’s an elective procedure?
“No, I think it was an appropriate decision.”
“Would you agree, you don’t want it to be put it in the body unless you can say it’s not possible it could be the TVT or TVT-O?
“It’s clear there is no correlation.”
Even though Dr. Pramudji said she had spent about 100 hour reading documents to get ready to testify for the trial, as of last April, when Fitzpatrick conducted her deposition, she had put about 50 hours in.
“You spent more time getting ready with lawyers from Ethicon for this jury than to read her medical research!” she accused.
“Your examination of Mrs. Huskey wasn’t independently done was it? It was done for Ethicon they paid you?
“They paid for your opinion
“They paid me to give my opinion, not to give a certain opinion.
“They paid you in excess of $60,000 for your opinion in this case?
“About $600 of that was earned in time dong the exam of Mrs. Huskey?
WARN OF RISKS?
Fitzpatrick asked if a medical device manufacturer has an obligation to disclose all of the information it has about the risks of its products?
“No I disagree. Its responsibility is to tell me about the majority of the risks possible for patient. You cannot possibly warn everyone about every risk, about everything, that’s unreasonable.”
Who should makes that decision? The medical community, said Dr. Pramudji. “If it’s not enough warning, as a medical community we will let them know you need to give us more waning. This is not adequate.”
Fitzpatrick pointed out that every document Dr. Pramudji reviewed in preparation for forming her expert opinion was supplied by Ethicon. Yes, she agreed. But what about the documents she wasn’t shown?
Had Ethicon shown her a document where Dr. Kirkemo, the former urology medical director for Ethicon, called the TVT-O a “kludgy” device.
Kludgy is an actual word. It means a clumsy or inelegant solution to a problem; a badly assembled collection of parts, hastily assembled.”
“Were you shown this document?”
“No, I haven’t seen this one.”
“And here Dr. Kirkemo says in May 14, 2010, nine months before Mrs. Huskey’s surgery he hated the obturator and wouldn’t use it. Is that relevant?
“No that’s one surgeon’s opinion.”
“You don’t think it’s relevant that the medical director doesn’t like the TVT-O”?
“No, not at all.”
Dr. Pramudji also wasn’t shown a document stating the opinions of Dr. Carl Gustav Nilsson, one of the creators of the TVT. He strongly disliked laser cut mesh. He was concerned about the efficacy of it and whether it will work as well as mechanically cut mesh. The TVT-O is made of laser cut mesh. Portions remain behind in Mrs. Huskey’s body.
“Dr. Nilsson who authored data on the safety and efficacy of the TVT doesn’t believe it translates to the safety and efficacy of the TVT-O laser cut mesh does he?
Does it affect your opinion at all that he will not use the TVT-O?”
MILLIONS OF ETHICON FRIENDS
As the day’s testimony wrapped up, Fitzpatrick carried three bulky accordion brown envelopes filled with papers, one for the plaintiff, one for the witness and one for the defense table.
The information also was not provided to the expert witness in connection with her work on this case. It contained the compensation for “key opinion leaders” were paid to build goodwill around Ethicon products. The paper was entitled “TVT Tactics.”
In 2002 the TVT was not the Gold Standard; the burch and retropubic suspension were.
Under the chart that says “Tactics,” Ethicon planned to tip the scales in favor of the TVT, Ethicon would hold professional education events with medical societies – American Urogynecologic Society, AUA, SUFA. The expense noted was $75 million in 2002 with $50 million allocated for panel debates.
“Do you see in 2002, Ethicon had budgeted $200 million to build that goodwill with medical societies?” “Correct.”
Dr. Pramudji was not familiar with the names of AUGS board members who have been identified as deeply financially indebted to industry in the form of honorariums, consulting and teaching agreements. #
The trial will continue Thursday with defense expected to wrap up its case. Judge Goodwin warned if a schedule is not kept, he may have to curtail closing arguments. The jury could receive the case as soon as Thursday.#