Johnson & Johnson to pay $9.9 million for failing to disclose risk of surgical mesh devices

SEATTLE — Johnson & Johnson will pay $9.9 million to Washington women who were harmed by the company's failure to disclose the risk of its surgical mesh devices, Attorney General Bob Ferguson announced Monday.

In 2016, Ferguson was the first state attorney general to file a lawsuit against Johnson & Johnson over the mesh devices.

In the lawsuit, Ferguson asserted Johnson & Johnson violated Washington’s Consumer Protection Act by “failing to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.”

“We had testimony admitting that they did know of these various serious risks from the start of the launch of the very first device,” said Assistant Attorney General Breena Roos.

About 14,000 women in Washington had the surgical mesh devices implanted and Ferguson says he believes hundreds of those women have had to go back for another procedure or have had their quality of life impacted dramatically.

Ferguson explained some of the women with the mesh devices experienced chronic pain, pain with sexual intercourse and numerous urinary issues.

The mesh devices, made of polypropylene, are implanted into a woman's body to hold up failing organs. 
"Removing the mesh is extremely difficult, and in some instances, impossible," Ferguson said.

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Among those willing to testify was Diana Iund.

She told KIRO 7 by phone she had four additional surgeries trying to repair the effect of her implants.

“Within just a few months I began to have excruciating pain and had some bleeding instances that turned into hemorrhaging. It curtailed all of my activities. I was a hiker and a fast walker. That has all changed, I now have hobbies where they keep me in my house and I'm right here by the restroom. It was life altering and not for the better. It was life altering,” she said.

Investigators heard many similar stories.

“There were very frustrated and they spent a lot of money and time going from doctor to doctor to doctor to find out what was wrong with them,” said senior investigator Mary Beth Haggerty-Shaw who spent hours speaking with many of the women.

A trial with Johnson & Johnson was scheduled to being Monday.

"Johnson & Johnson's knowing deception caused Washington women to suffer in deeply personal ways," said Ferguson. "I'm proud of my team for holding a powerful interest accountable for its egregious conduct -- and look forward to providing millions of dollars in relief to assist those who were harmed."

The $9.9 million will be used to assist women who received the pelvic mesh implants in addition to any recovery they receive in personal injury lawsuits, Ferguson said.

Ferguson explained that one Washington woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her leg as a result of Johnson & Johnson’s mesh device.

Another woman in Washington underwent three surgeries to partially remove the mesh to treat her incontinence and frequent pain, Ferguson said.

Ferguson said his office will unveil a formal claims process in the future, but due to privacy protections, his office does not know the names of the women in Washington who had a had a surgical mesh implanted and the office cannot reach out to women directly.

He said in addition to paying the $9.9 million, Johnson & Johnson is prohibited from making “unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices.”

“If the company learns about new, significant risks associated with its surgical mesh, it must disclose those risks. Johnson & Johnson's promotional material must be truthful, accurate, and presented in a balanced way. Further, if Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship,” Ferguson wrote in a news release.

Ferguson said that during a deposition, Piet Hinoul, Johnson & Johnson’s head of medical affairs, admitted the company knew of the serious risks “from day 1” but failed to inform patients.

“One woman shared that her consultant likened the mesh removal as to ‘trying to remove chewing gum from hair,” Ferguson said.

Ferguson said Johnson & Johnson continues to sell four of the surgical mesh devices in Washington state.

The Attorney General's Office estimates 14,000 Washington women may have had mesh implants. Anyone who would like a claims administrator to contact them can provide their contact information here.