Johnson & Johnson and its subsidiary Ethicon have agreed to pay nearly $117 million to end litigation brought by 41 states and the District of Columbia over claims that the companies deceptively marketed their transvaginal mesh and did not adequately warn that the devices could cause adverse effects including incontinence and vaginal scarring.
“Patients can’t make the best decision for their health unless they and their health care providers know all the pros and cons of a product. These companies didn’t paint a clear picture of the device’s medical risks, preventing patients from making well-informed decisions,” said Ohio Attorney General David Yorst in a statement.
Under the settlement agreement, Johnson & Johnson and Ethicon agreed to change how they market their transvaginal device. The companies will also disclose the risks associated with the devices and warn that complications may require surgeries, that the surgeries may not be successful, and that they may lead to other adverse effects.
The states launched an investigation into Johnson & Johnson and Ethicon’s transvaginal mesh in October 2012 following a slew of complaints that the product, used to treat stress urinary incontinence and pelvic organ prolapse, could erode into the vaginal wall and puncture tissue and organs, resulting in chronic pain, incontinence, and disability.
The states’ investigation found that the companies violated consumer protection laws by misrepresenting the safety and efficacy of their transvaginal mesh products.
Johnson & Johnson and Ethicon’s transvaginal device was approved through the Food and Drug Administration’s (FDA) accelerated approval process, and was marketed without first conducting human trials. In 2016, amid reports of adverse events with transvaginal mesh products, the FDA reclassified the devices as high-risk, and required that they be reviewed before they could be approved for marketing.