Johnson & Johnson failed to disclose potential debilitating and dangerous complications posed by devices implanted in at least 3,700 women in Oregon, according to a lawsuit filed by state Attorney General Ellen Rosenblum.
The lawsuit alleges that the New Jersey-based medical and consumer goods manufacturer and its subsidiary Ethicon Inc. deceptively marketed transvaginal surgical mesh devices. The net-like devices are made from a synthetic fabric and are surgically implanted to support weakened or damaged tissue in a woman’s bladder or pelvic area.
The devices are used to treat conditions that 30-50% of all women will face in their lifetimes, according to the lawsuit.
According to the lawsuit, filed Dec. 3 in Multnomah County Circuit Court, Johnson & Johnson didn’t disclose to doctors and patients the potential risks of the devices that include chronic pain, urinary dysfunction, pain from sexual intercourse, disfigurement, and the inability to remove the devices. The company, instead, marketed the devices as “minimally invasive with minimal risk” and misrepresented studies regarding their safety, the lawsuit states.
“Johnson & Johnson has blatantly put profits over the health of thousands of Oregon women,” said Rosenblum in a prepared statement. “If these woman and their doctors had been provided accurate information about the risks of these devices — by the company that well knew the risks — they may never have chosen to have them inserted in their bodies, resulting in all manner of painful, horrible outcomes.”
The lawsuit states that some women who have had the implants have become permanently disabled, have seen their marriages suffer from the loss of physical intimacy or undergone multiple surgeries in attempts to remove the devices.
In April, the U.S. Food and Drug Administration ordered manufacturers of the devices to stop selling them for certain procedures. Last month, Johnson & Johnson agreed to pay $117 million to settle a similar lawsuit brought by 41 states and the District of Columbia.
The lawsuit doesn’t specify the total amount of money the state is seeking from the company. But it asks for $25,000 for each violation of the state’s Unlawful Trade Practices Act and an order halting the company from promoting surgical mesh in Oregon.
Ethicon responded with a statement that its pelvic mesh products were responsibly developed and marketed and that the company would defend against the lawsuit.
“Ethicon’s pelvic mesh devices have helped millions of women around the world, including Oregonian women, find relief from pelvic organ prolapse and stress urinary incontinence,” reads the statement. “In fact, Ethicon’s devices for incontinence treatment are recognized as the standard of care by medical professional societies around the world.”