California and Washington state have filed lawsuits accusing Johnson & Johnson of failing to adequately warn patients and doctors about the side effects associated with its pelvic mesh implants.
Attorneys General Kamala Harris of California and Bob Ferguson of Washington are accusing the health care company of misrepresenting the risks of their implants intended to treat pelvic organ prolapse in women. They are claiming that potentially irreversible complications like constipation, loss of sexual function, urinary dysfunction, and severe pain are affecting victims as a result of the deception.
According to Harris, tens of thousands of lawsuits have been filed against manufacturers of the product, including Johnson & Johnson, Edo International, and Boston Scientific. In 2014, Endo International said it would pay more than $830 million in order to settle over 20,000 lawsuits. There are reportedly 35,000 lawsuits against Johnson & Johnson.
Ethicon, a subsidiary of Johnson & Johnson responsible for marketing the pelvic mesh implants, called the lawsuits unjustified in an emailed statement:
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” the company said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”
California and Washington led an investigation, along with 44 other states and the District of Columbia, into the company’s practices. Harris, in a news release, stated that Johnson & Johnson almost 790,000 of the pelvic mesh implants across the U.S. between 2008 and 2014.
Earlier this year, the Food and Drug Administration (FDA) said it was reclassifying pelvic mesh implants from moderate risk (class II) to high-risk (class III), which will require manufacturers to submit comprehensive data in order to establish the device’s safety.
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