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

Attorney General Bob Ferguson announced April 22, 2019 that Johnson & Johnson will pay $9.9 million to avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. Ferguson is the first state attorney general to file a lawsuit against Johnson & Johnson regarding surgical mesh devices.

Approximately 14,000 Washington women had these devices implanted. While precise information is not available, the Attorney General’s Office believes hundreds of those have been adversely impacted so far, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.

The trial was scheduled to begin today.

In May 2016, Ferguson filed a lawsuit against Johnson & Johnson asserting that the multi-billion dollar corporation 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. Washington women experienced pain, suffering, and life-altering complications that Johnson & Johnson knew were associated with its devices, including chronic pain, pain with sexual intercourse, and numerous urinary issues. Furthermore, the mesh is very difficult and sometimes impossible to remove.

“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.”

To avoid trial, Johnson & Johnson will pay $9.9 million. Today, Ferguson announced the payment will be used to assist women who received pelvic mesh implants. This is in addition to any recovery they receive in a personal injury lawsuit. Many lawsuits have been filed across the country regarding these devices.

The Attorney General’s Office will announce a formal claims process in the future. Due to privacy protections in law, the Attorney General’s Office does not know the names of the women implanted with surgical mesh in Washington state. Consequently, the Attorney General’s cannot reach out to affected women directly. If you would like a claims administrator to contact you, provide your contact information here.

In addition to paying $9.9 million, the resolution prohibits Johnson & Johnson 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.

Johnson & Johnson knew of the risks of its surgical mesh devices

The surgical mesh devices manufactured and sold by Johnson & Johnson and its subsidiaries are implanted through the vagina and used to treat two conditions in women — pelvic organ prolapse, when organs shift from their normal position, and various urinary issues, including incontinence. These conditions are non-life-threatening and can be treated via multiple, surgical and non-surgical methods.

The devices, made of polypropylene, are permanently implanted into a woman’s body to hold up falling organs. Removing the mesh is extremely difficult, and in some instances, impossible.

Johnson & Johnson knew that some of the most serious risks it failed to include — chronic pain, pain with sexual intercourse and more — were associated with the use of its mesh devices. It also knew that the impact of these reactions would exponentially increase due to the difficulty of removing the mesh once implanted.

During a deposition, Johnson & Johnson Global Head of Medical Affairs Piet Hinoul admitted that the company knew about the serious risks “from day 1”, but did not inform patients of the risks.

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

Johnson & Johnson is one of the largest manufacturers and sellers of surgical mesh devices in the U.S. It continues to sell four of the devices in Washington state.

Some Washington women have suffered lifelong pain as a result of Johnson & Johnson’s devices. One Washington woman has suffered chronic urinary tract infections, constant lower back pain and cramps in the back of her leg. After years of these conditions, she is now largely homebound and suffers from depression and loneliness. She has described her complications as a “nightmare.”

Another Washington woman endured three separate surgeries to only partially remove the mesh and treat her incontinence and frequent pain.

One doctor wrote to Johnson & Johnson in 2009 that their patient would have “a permanently destroyed vagina” due to complications from her surgical mesh devices.

Case background

In May 2016, Attorney General Ferguson filed a lawsuit against Johnson & Johnson asserting that the company failed to include several serious, life-altering risks associated with its surgical mesh devices in materials for patients and doctors.

Ferguson asserted that Johnson & Johnson omitted known risks from the devices’ marketing materials for patients and “Instructions for Use” packets for doctors. Instructions for Use inserts provide doctors with important information about a medical device. The instructions should include any risks or adverse reactions associated with the device or its use.

The lawsuit asserted that Johnson & Johnson knowingly omitted debilitating complications associated with the mesh devices from the instructions included with every device sold from 1999 to late 2015. The lawsuit also asserted Johnson & Johnson made omissions and misrepresentations in patient marketing materials distributed in Washington.

In addition to omitting serious risks, Ferguson asserts that Johnson & Johnson downplayed some of the serious complications caused by some products.

Assistant Attorneys General Daniel Allen and Breena Roos are lead attorneys on the case, assisted by Assistant Attorneys General Katharine Barach, Heidi Anderson, Beth Howe, Patricia Bower and Jeffrey Grant.

 

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