Johnson & Johnson has been ordered to pay $344 million to settle lawsuits that the pharmaceutical and consumer packaged goods deceptively marketed its transvaginal mesh medical device product.
Pelvic mesh products were intended to help relieve symptoms of stress urinary incontinence and pelvic organ prolapse, two conditions that are not life-threatening or debilitating and can have a range of impact on a patient’s life.
According to the lawsuit, J&J’s marketing scheme around its pelvic mesh product created its own market of women who would not otherwise even look for a solution to their condition. The company disseminated information about the product through brochures and in-office patient counseling materials, a telephone hotline, internet advertising, public relations events and a Find-A-Doctor directory service. In addition, the company partnered with healthcare providers for field marketing, with an aggressive push “to create and grow its doctor market for mesh,” according to the lawsuit.
However, the control of the marketing didn’t advertise the risks clearly in its consistent marketing campaigns. J&J even downplayed FDA warnings and hid what they knew about mesh risks, the lawsuit alleges.
“J&J marketed the benefits of its mesh products without fully and truthful disclosing the accompanying risks and complications,” the lawsuit reads.
The medical devices have been the subject of lawsuits from women for many years, and in this case, which involved thousands of women from California, a judge agreed that J&J owed civil penalties. Originally, California asked for $800 million in damages, but the judgment
The company’s subsidiary Ethicon, which manufactured the products, intends to appeal the settlement, The New York Times reported.
“The Company will appeal the decision reached in the State of California’s transvaginal mesh case,” says a statement from J&J sent to Health Exec. “Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients, and the decision disregards the Company’s full compliance with U.S. Food and Drug Administration (FDA) laws on medical device communications and the appropriateness of its actions.”