On this fifth day of the Huskey v Ethicon case, it would be important for Johnson & Johnson to raise questions about the credibility and conclusions of Thursday’s expert witness for the plaintiff, world renowned urogynecologist Dr. Jerry Blavais.
Plaintiff, Jo Huskey had a TVT-O implanted in February of 2011 to treat urinary incontinence and had experienced chronic and devastating pelvic pain since shortly afterward.
In a rather contentious back and forth, J&J attorney, Christy Jones, continued with Dr. Blavais in an effort to impeach his testimony.
First, she used a series of documents to try and show fascia lata slings, which he uses, (human muscle) have fallen out of favor among the mainstream doctors, while polypropylene or synthetic slings are considered the “Gold Standard.”
“Ninty-five percent of members of the American Urogynecologic Society (AUGS) use mid-urethral slings don’t they?” she asked when showing the doctor documents.
“Yes,” he said.
She showed him a paper he wrote (here) where he said pubovaginal slings never achieved widespread popularity. Yes, he said. “That’s because surgeons don’t have the skills.”
A medical group, Urinary Incontinence Treatment Network, conducted a 24-month study comparing complications between the retropublic and transobturator mid-urethral sling. It showed mesh exposure of 1.3 percent with the original TVT and one mesh exposure with the transobturator, correct? Yes said Dr. Blaivas.
“Yes. But that’s not the transobturator in discussion today,” said Blaivas. “And it goes directly toward my concern that long-term complications need to be addressed.”
“You know many patients that have been treated with mid-urethral slings without complications?”
“And in fact the mid urethral sling surgical procedure is taught at the hospitals you have privileges is that correct? “That’s correct.”
“And you have not done anything to block the use of the mid urethral polypropylene slings at those hospital have you?”
“That’s not true. I have.”
“As a practical matter doctor (she regroups), they’re still being used aren’t they?”
Often Jones would prompt, “Are you with me doctor?” Yes.
The terms were fast and furious. One had to wonder if the nine jurors truly appreciated the difference between a mid urethral sling, transobturator procedure (TVT-O) and a retropublic procedure (TVT), autologous fascia pubovaginal sling (using your own tissue) or whether they just would have to rely on the body language displayed during this confusing line of questioning.
None of the jurors seemed to be taking notes. They were all paying attention but after an hour looked weary of the back and forth.
Fidelma Fitzpatrick (Motley Rice) addressed Dr. Blaivas again on her redirect.
Did any of the articles Mrs. Jones talk about deal with laser cut mesh? Did any of them specifically deal with the TVT-O device? Did any articles relate to type of complications Mrs. Huskey has?
“No, they were omitted from every one,” Dr. Blaivas answered and the majority did not deal with the transobturator approach, the type implanted in Mrs. Huskey.
“Do you have an opinion to a reasonable degree of medical certainty whether choices should be based on popularity?” she asked, referring to Jones’ characterization of synthetic slings as the popular choice among most physicians.
“Yes. Popularity has nothing to do with science and it should be based on benefits and risks of the operation,” said Dr. Blaivas.
“Did any of the the recent articles she showed you show more danger than you had previously thought? “No.”
Talking about popularity, do you have an opinion over time there have been a lot of medical devices that were once popular that are no longer used? asked Fitzpatrick.
“I do think there are medical devices that are no longer used today that we find out cause major complications after time” said Blaivas.
Later Judge Goodwin would throw out as an example the use of leaches as a once popular medical procedure.
Jo Huskey’s husband, Allen wrapped up Friday morning for his wife, the plaintiff.
He has a claim for loss of companionship or consortium.
Attorney Ed Wallace (Wexler Wallace) stood at the podium and quietly questioned Mr. Huskey, a nice looking man in his 50s with silver hair and a goatee. He has worked at the same Illinois compounding pharmacy for 20 years. Mr. Huskey looks nervous.
Jo’s stress urinary incontinence (SUI) was not even something Allen knew about until she had the TVT-O procedure in February 2011, he testified.
“We bike we walk, I had never flown in my life, she has me flying she got me doing things I’d never done before. She improved my life and we’ve lost a lot of that now.”
Intimacy has also been impacted. When they do attempt, Jo pays for it for days, he said.
What are the other things you can’t do today?
Huskey puts his hand over his mouth, he looks down and weeps despite his best effort to hold it back. Wallace is empathetic, the courtroom is silent. The jury appears stoic.
“We can move on,” said Wallace sympathetically.
What were Mr. Huskey’s expectations from the incontinence surgery? A 30 minute procedure, outpatient, no big deal, he answered, but the pain began months after the surgery and one revision led to another, and a series of steroid injections to try and quiet her pain.
“They were some big needles,” he added. Jo has stopped the injections and is managing with pain medications now.
What are you doing to cope today?
“Just hanging on each other.”
With the conclusion of the Allen Huskey testimony, the plaintiffs’ case rested. ##