According to the lawsuit filed by the state's attorney general on
Tuesday, J&J and its Ethicon unit falsely marketed the devices as a
safe and superior option to non-mesh treatments for pelvic floor
disorders, when it was aware that they could cause pain, bleeding,
loss of sexual function and other side effects.
"Johnson & Johnson put millions of women at risk of severe health
problems by failing to provide critical information to doctors and
patients about its surgical mesh products," California Attorney
General Kamala Harris said in a statement. Her office led a
multi-state investigation into J&J's mesh products, which included
46 states and the District of Columbia.
The lawsuit seeks monetary penalties and an order halting any unfair
advertising for mesh.
J&J said in a statement that the lawsuit was "unjustified" and could
discourage women from seeking treatment for incontinence symptoms.
"The evidence will show that Ethicon acted appropriately and
responsibly in the marketing of our pelvic mesh products," said
spokeswoman Samantha Lucas.
J&J is one of several manufacturers that sold the devices to treat
conditions like stress urinary incontinence and pelvic organ
prolapse in women. Those companies are facing tens of thousands of
individual lawsuits from plaintiffs who said they were injured by
the mesh's poor design and substandard materials, which plaintiffs
say led to serious complications that require surgery to repair.
According to California's attorney general, J&J sold more than
787,000 pelvic mesh devices in the United States from 2008 until
2014, including more than 42,000 in California.
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Also on Tuesday, Washington state's attorney general, Bob Ferguson,
filed a similar consumer-protection lawsuit against J&J over its
marketing of pelvic mesh devices.
Over the past several years, the devices have come under increasing
scrutiny by regulators as well as private litigants. The U.S. Food
and Drug Administration says it has received thousands of reports of
complications in connection with mesh used to treat pelvic organ
Earlier this year, the Food and Drug Administration said it was
reclassifying mesh used to treat pelvic organ prolapse
transvaginally from class II, or moderate risk, to class III, for
high-risk devices, which will require manufacturers to submit
extensive data to establish the devices' safety.
(Additional reporting Nate Raymond n New York; Editing by Bernard
Orr and Matthew Lewis)
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