SAN DIEGO – In a trial to decide if Johnson & Johnson allegedly harmed women by selling incontinence devices it knew were dangerous, a former medical device consultant for the Food and Drug Administration (FDA) said instructions for use (IFUs) on pelvic mesh devices were not misleading.
“Were the IFUs misbranded?” asked William Gage, an attorney for Johnson & Johnson.
“They were not misbranded,” answered Timothy Ulatowski, a former medical device consultant for the FDA.
On cross-examination, attorneys for the California Attorney General’s Office said the FDA medical device approval process had not been without criticism.
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 eight 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.
A central issue in the trial is whether IFUs that come with pelvic mesh kits adequately warned of potential adverse complications with the devices. Attorneys for the state allege such adverse complications like long-term or life-changing chronic pain were left out to minimize risk and sell mesh kits. Johnson & Johnson attorneys maintain the IFUs were never intended to warn of every possible consequence of an implant.
Ulatowski was involved in the approval process for pelvic mesh devices at the time the company’s Prolift product was marketed.
He explained that there were two types of FDA approvals of medical devices: free market approval, an independent approval of a new device, or the 510K process, which is an approval of a device that is similar to a device already on the market. Ethicon devices at issue in the trial were approved under the 510K process.
“How do you know what information to include in a 510K?" Gage asked.
“You look for product guidance and previous submissions,” Ulatowski said.
Ulatowski indicated a medical device needed to demonstrate “biocompatibility,” or compatibility of an implant in the body.
“What if an IFU was not sufficient?” Gage asked.
Ulatowski said more information or revision of the IFU would be requested by the FDA.
“To what extent would all the known risks be (FDA) required (in an IFU)?” Gage asked.
“That would not be the case,” Ulatowski said.
“Why was this a policy of the FDA?”
“You want to be judicious and not overburden the physician,” Ulatowski said. “Call it over-warning.”
Ulatowski said false or misleading claims made on an IFU would be handled by notification to the manufacturer, including warning letters and enforcement actions for noncompliance.
During cross-examination, Jon Worm with the Attorney General’s Office asked Ulatowski if he testified mainly for medical device manufacturers.
“That’s been predominant,” Ulatowski said.
“You’re paid $500 per hour?” Worm asked.
“I have two consultant companies that bill and they give me a portion,” Ulatowski said.
Ulatowski agreed Ethicon had paid him approximately $500,000 for his work and a similar amount from another Johnson & Johnson company DePuy.
“You got paid a million from J&J companies?” Worm asked.
“I’d say that’s fair,” Ulatowski said.
Worm said a 510K clearance was not a finding that a medical device was safe and effective. Ulatowski agreed.
“The FDA has been subject to criticism for its 510K process?” Worm asked.
“Yes,” Ulatowski said.
Worm exhibited a document that stated the Center for Devices and Radiological Health faced challenges because of fiscal and staffing limitations.
“You agree?” Worm asked.
“On mesh, no,” Ulatowski said.