SAN DIEGO – A Massachusetts gynecologist called as an expert witness by attorneys for Johnson & Johnson said on Wednesday he didn't depend on instructions for use (IFU’s) that came with the mesh kits, in a trial alleging that the company ignored the injuries their devices were causing.
“I didn’t use it (IFU),” Dr. Peter Rosenblatt told a jury. “It (IFU) comes in a sterile pack, it gets thrown out. The patient is under anesthesia.”
William Gage, attorney for Johnson & Johnson, asked why the IFU instructions are discarded.
“I’m aware of the (Implant) procedural steps,” Rosenblatt said. “There is no need to use it.”
The questioning was intended to undercut a central allegation of attorneys for the California Attorney General’s Office, that J&J deliberately withheld important information on the product IFU’s to minimize the risks from pelvic mesh devices making it easier to sell them to doctors.
The trial in the San Diego Superior Court is being streamed live courtesy of Courtroom View Network.
The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over the Prolift pelvic mesh device, made by its subsidiary Ethicon, for allegedly causing vaginal injuries in women and allegedly for selling the product through the use of deceptive marketing practices. Prolift is a clear polypropylene mesh with several thin connecting arms.
The case in San Diego is the first at trial by a state attorney general and seeks damages over allegations of unfair competition and violation of false advertising laws.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014. The mesh is designed to help a sagging bladder condition called pelvic organ prolapse, or POP. Two of the products at issue are called Prolift and TVT slings.
Rosenblatt appeared for a second day of testimony.
He said the risks for the TVT mesh device is about the same as the later TVT-O mesh made by Gynecare a division of Ethicon.
“We were educated on the risks,” Rosenblatt said. “There was no need to review the IFU. I’ve been doing mesh slings since the 1990s and there was no difference in the procedural steps. The risks are the same.”
Gage displayed a document stating that IFUs were not meant to be a comprehensive reference to the surgical techniques for correcting stress urinary incontinence (SUI).
During testimony Rosenblatt touted the effectiveness of mesh devices and noted their ability to maintain shape and their elasticity.
A list of possible “adverse reactions” to a mesh implant listed on IFUs included punctures, erosion, extrusion, infection and urinary obstruction. Rosenblatt said each of the possible complications listed on the IFU were true statements.
“Are there any that are misleading?” Gage asked.
“No there are not,” Rosenblatt responded.
Added information on IFUs was submitted by Ethicon in 2015 to the possible complications list including punctures and lacerations of vessels, nerves and structures “that may require surgical repairs.”
‘Would a reasonably prudent surgeon understand what that means (IFU information)?” Gage asked.
“Everyone who operates in the vagina knows about it,” Rosenblatt said.
He added that any prudent surgeon would also understand the possibility of chronic or temporary pain after a procedure.
“Pain can occur any time you make an incision,” he said.
Rosenblatt said it was also true for the possibility of painful intercourse or dyspareunia.
“Pain with intercourse can happen immediately or chronically,” he said.
Rosenblatt said recurrence of incontinence the procedure is designed to fix can also happen.
“There is no surgery that is 100 percent effective,” he said. “There is a failure and it (incontinence) can reoccur. You can also get bleeding or hematomas. This is no surprise.”
Gage asked Rosenblatt is a surgeon would know if mesh devices made of polypropylenes would know the implants were permanent.
“After four years of residency you would have to know,” Rosenblatt said. “You have to know which devices are permanent or absorbable.”
Attorneys for the California Attorney General's Office took over cross examination of Rosenblatt in the afternoon. He was asked if he had been paid $1.2 million since 2016 by Ethicon as an expert witness.
"It's possible," Rosenblatt said.
Rosenblatt agreed he was also a paid consultant and trainer for the company training doctors to do the mesh implant procedures.
"The more surgeons you trained the more you got paid?" the state's attorney asked.
"To an extent," Rosenblatt said. "I couldn't bring a group in. The most I had in an operating room were three people."
"You were paid (by Ethicon) to give speaking engagements and seminars?"
"Yes."
"Johnson & Johnson had to approve what you said?"
"No," Rosenblatt disagreed.
An exhibited Ethicon contract stated, "You shall not make any representation unless approved in advance by the company."
Rosenblatt disagreed with an exhibited document that read, "Complications (pelvic mesh) are not always reversible."
"In my practice I've never seen a complication that can't be reversed," he said.
In 2012, the Food and Drug Administration ordered further study by mesh manufacturers after receiving 3,874 reports of injuries to women who had mesh devices implanted. Ethicon officials decided to discontinue selling the Prolift, Prosima and TVT SECUR mesh devices.