Northern California Record

Sunday, November 17, 2019

Johnson & Johnson attorneys ask court to toss state’s suit during pelvic mesh trial

State Court

By John Sammon | Aug 30, 2019


SAN DIEGO – Attorneys for Johnson & Johnson on Thursday asked a judge for summary judgment in an attempt to shut down a case in which the state of California sued the company over allegations it fraudulently sold harm-causing pelvic mesh devices.

“Ethicon is entitled to judgment,” the attorney for J&J told Superior Court Judge Eddie Sturgeon.

J&J attorneys said the state had not carried out its burden of proof.

Attorneys for the California Attorney General’s Office countered that J&J had used half-truths and withheld important long-term risk information on packaged pelvic mesh kits to sell the devices 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 eight thin connecting arms.  

Attorneys for J&J said the trial was not a products liability case but one of allegations of fraudulent business practices. They said the court had not heard sufficient testimony from doctors who used the Ethicon products or the sales reps who sold the products.

“The state has to show that a portion of the targeted consumers were misled,” the J&J attorney argued. “If it’s only a few, it’s not actionable.”

J&J attorneys contended the risks of the pelvic devices were well known to doctors and that testimony and studies had revealed the risks were very rare.

They added that nine different Ethicon products were at issue for stress urinary incontinence (SUI) and prolapse (sagging bladder), and had warnings about the risks in different terms.

State attorneys contended the warnings on product packaging for the mesh devices were not complete in describing possible complications, for example not including the terms "life-long" and "life-changing." One printed list of possible adverse reactions on company materials cited the possibility of punctures, transitory local irritation, potential for existing infection, temporary or permanent lower urinary tract obstructions, extrusion, erosion, fistula formation and inflammation.

J&J attorneys sought to establish that surgeons did not read the instructions for use (IFU), a brief description of procedural steps and possible complications, because they already knew the risks of pelvic mesh procedures due to their training. When the kit package for the mesh was opened by the doctor with a patient waiting on an operating table, the IFU went into the trash, they maintained.

“The state has to show that doctors would forget their medical knowledge without the IFU,” the J&J attorney contended. “There is no evidence a California doctor read an IFU.”

As an example, the J&J attorney said the word “pain” that already appeared on the warnings did not have to specifically say “chronic pain” to be accurate.

In rebuttal, Daniel Osborn, an attorney with the California Attorney General’s Office, said the defendants knew the full range of complications and that they could be severe and long-term, but withheld such information from doctors on IFUs and company promotional materials.

“The mesh could lead to foreign body reaction and retraction,” Osborn said. “The company knew the dangers of the mesh, but did not include it in the marketing materials. A surgeon would not know the mesh itself could lead to chronic pain. It (complication) is coming from the mesh, not the (implant) procedure.”

The company was accused of failing to make known options other than mesh implants and thus providing patients with an “exit strategy” alternative.

Osborn said warning statements that only mentioned erosion and exposure, even though true, fell short because such a warning left out other risks amounting to a misleading statement.

“J&J knew the risks but left out key risks,” Osborn said.

He said in aggressively marketing the devices while downplaying the risks, J&J had misled consumers and doctors. He asked that the defendant's motion for judgment be denied.

Sturgeon said he would review the lawyers' statements and return with a decision next week.

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.

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California Attorney GeneralSan Diego Superior CourtJohnson & Johnson

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