Attorney General Ellen Rosenblum today announced a $5.5 million settlement with Johnson & Johnson and its subsidiary Ethicon, Inc. for deceptive marketing of transvaginal surgical mesh devices. The settlement is the result of an investigation finding that the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.
“Companies must fully disclose the risks associated with their products,” said Attorney General Rosenblum. “We alleged that Johnson & Johnson and its subsidiary knew about possible serious medical complications associated with transvaginal surgical mesh, but failed to warn the patients and physicians who used their products. I’m pleased we were able to negotiate a settlement that makes these companies address some of the harm they’ve caused to women and requires significant corporate change to ensure that, going forward, patients and medical professionals have all the information they need to make sound decisions.”
The state will receive $2 million under the settlement. Johnson & Johnson will distribute the remaining funds to five non-profit medical clinics that provide health care to women in Oregon, including Outside In ($951,086), Virginia Garcia Memorial Health Center ($608,640), North by Northeast Community Health Center ($190,274), Planned Parenthood Southwestern Oregon ($825,000) and Planned Parenthood Columbia Willamette ($925,000).
Last October, Johnson & Johnson agreed to pay $117 million to settle a lawsuit brought by 41 states and the District of Columbia. Oregon declined to join that settlement and instead filed suit in Multnomah County Circuit Court. The state ultimately negotiated a better settlement that will help pay for health services for women.
“This settlement supports clinics that provide critical health care to women,” Attorney General Rosenblum said. “It couldn’t come at a more important time for women’s health needs in Oregon.”
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse. Oregon’s complaint alleged that the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. The state’s complaint also alleged that Johnson and Johnson and its subsidiaries were aware of the possibility for serious medical complications but did not provide sufficient warnings to patients or the surgeons who implanted the devices.
Other companies have faced similar lawsuits. In September, Oregon received almost $900,000 as a party to a $60 million multistate settlement with mesh maker C.R. Bard.
In addition to the financial settlement, Oregon’s agreement 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.
The settlement has been filed and requires court approval to become final.
The Oregon Department of Justice (DOJ) is led by Attorney General Ellen Rosenblum and serves as the state’s law firm.