SAN DIEGO – Closing arguments in a trial to decide if Johnson & Johnson sold pelvic mesh kits to treat female incontinence allegedly knowing the devices were causing women injuries were heard on Thursday, the first trial launched by a state attorney general seeking damages alleging unfair competition and false advertising.
Attorneys for the state set a penalty on the company at $798 million.
The trial which began on July 15 pitted attorneys for the California Attorney General's Office who alleged J&J deliberately withheld information on the dangers of the mesh devices to make them easier to sell, versus attorneys for Johnson & Johnson who contend the instructions accompanying the mesh kits were never intended as a complete list of every possible complication. They maintain doctors didn't use the instructions called "IFUs" anyway because they already knew the surgical procedures,
The trial was streamed live courtesy of Courtroom View Network.
The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over a pelvic mesh device called Prolift, made by 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.
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 (tension-free vaginal tape) slings.
Jinsook Ohta, attorney with the California Attorney General’s Office, said the case amounted to a deceptive advertising campaign by Johnson & Johnson.
“This took many forms,” she said. “Everything boils down to what J&J said to the public as opposed to what they knew. By lying to doctors and patients they ignored their responsibility.”
Ohta said the mesh kit IFU’s listed only a few possible complications from an implant such as erosion or extrusion, while ignoring long-term chronic pain, life changing complications, chronic painful intercourse (dyspareunia), and difficulty of removal of the mesh resulting in permanent vaginal injury and infections.
“They (J&J) knew the complications could be severe and long-term,” Ohta said. “They knew the complications were specific to the mesh.”
Ohta played a video in which a woman in tears described the pain she endured and the loss of her sex life with her husband after an implant.
“A false advertising case only requires a likelihood of deception,” Ohta said. “We don’t need to show literal falsity. It is not required, if a company only tells the good (of mesh) and leaves out the bad.”
Ohta said company IFUs never mentioned the possibility of complications such as chronic pain, dyspareunia, fibrotic bridging of mesh, chronic foreign body reaction, deformation of mesh and bacterial infection.
“They (J&J) knew it (mesh) could stiffen and contract, but they misled that it would stay soft and supple,” Ohta said.
Ohta said the company hired and paid preceptors (teachers) to promote the mesh to doctors and directed sales reps to downplay the potential risks.
“The deception was that the mesh was a quick, safe and minimal procedure without risks,” Ohta said.
Ohta said the $798 million damages request given the net worth of Johnson & Johnson at $70.4 billion, amounted to no more than a “speeding ticket” against the company.
William Gage, attorney for Johnson & Johnson, said the state had failed to present a single doctor who said he was misled by the company.
He called the state’s case “categorically false.”
Gage said doctors who used the mesh kits neither relied on the IFUs that came with them nor used them.
“The IFUs most of the time were put in the trash,” he said. “The IFUs came out of the package and were thrown away. Even the state’s own witness (Dr. Bruce Rosenzweig) doesn’t use them.”
Gage said the state’s position giving the impression doctors could not operate without an IFU was “ridiculous.”
Instead he exhibited a chart that said doctors relied on training, medical literature, clinical experience, discussion with colleagues and professional conferences—not IFUs.
“We did not omit risks in the IFU,” Gage said. “Look at the 2008 (mesh) IFU and combine it with the patient brochure. It warns of pain, dyspareunia, bleeding, neuro-muscular problems and complications that might require hospitalization.”
Gage said the state’s case disagreed with professional medical societies that had found polypropylene mesh to be durable, safe and effective for long-term treatment of pelvic conditions.
“There is no dispute there have been women with poor (implant) outcomes,” he said. “But there also are with native tissue procedures. Doctors have said it’s not perfect but it’s the best we’ve got. The burch procedure had an infection rate nine times higher than slings.”
Gage said 90,000 women tested had revealed a 3.3 percent removal (complications) rate. He indicated it would be hard to do better than that rate.
Gage added that Food and Drug Administration (FDA) findings ran counter to accusations made by the state. He cited a 2011 survey he said that found slings to be safe and effective. As a result Gage said the FDA had requested no labeling changes in the mesh devices.
“How many changes were required by the FDA?” Gage asked.
He displayed for the jury the number zero.
“Maybe the state ought to sue the FDA,” Gage said.