Northern California Record

Thursday, November 21, 2019

Johnson & Johnson pelvic mesh trial on hold as judge takes vacation

State Court

By John Sammon | Sep 4, 2019

Sturgeoneddie
Judge Sturgeon

SAN DIEGO – A trial to determine if Johnson & Johnson and its pelvic mesh subsidiary Ethicon allegedly sold harm-causing pelvic prolapse mesh kits to women through fraudulent misrepresentations has been put on hold for two weeks.

“The (J&J) trial has been postponed in California because the judge is on vacation,” Mindy Tinsley, a spokeswoman for Ethicon, said.

San Diego Superior Court Judge Eddie Sturgeon will return on Monday, Sept. 16.

The trial is being streamed live courtesy of Courtroom View Network.

The state of California, through its Attorney General Xavier Becerra, sued Johnson & Johnson over its pelvic mesh devices, including one called Prolift, designed to support a sagging bladder or alleviate incontinence. Prolift is a clear polypropylene mesh with several thin connecting arms.

Made by its subsidiary Ethicon, attorneys for the state allege the devices caused vaginal injuries in women. They also allege that J&J sold the products through the use of deceptive marketing practices.

The trial began on July 15.

On Aug. 19, the state rested its case and lawyers for Johnson & Johnson began calling their own expert witnesses to testify. On Aug. 29, attorneys for J&J asked Sturgeon for summary judgment, arguing the state had not carried its burden of proof.

A central issue in the trial has been the use of instructions for use, called IFUs, that come with the mesh kits. IFUs include a brief description of possible complications that could result from an implant, such as erosion and extrusion, and the procedures involved in the implant.

Attorneys for the state are contending that important possible negative events like “chronic pain” and “life-changing” complications had been left out of the IFUs to minimize the risks.

J&J attorneys maintain the IFUs were never meant to offer a complete list of all complications and that doctors who already knew the risks from their formal education didn't read the IFUs anyway.

Jason Yarrow, a J&J attorney, in asking Sturgeon for summary judgment said the risks of the pelvic devices were well-known to doctors and that testimony and studies had revealed the risks were very rare.

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

Yarrow said as an example, 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.”

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.

Sturgeon said he would review the motion for judgment from the J&J attorneys and return with a decision.  

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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