Updated at 6:27 p.m. May 24, 2016:
California Attorney General Kamala Harris filed a lawsuit in San Diego Superior Court Tuesday against Johnson & Johnson, alleging false advertising and deceptive marketing of its surgical mesh products for women.
The complaint alleges that Johnson & Johnson neglected to inform both patients and doctors of possible severe complications and misrepresented the frequency and severity of risks.
California co-led a multi-state investigation, involving 46 states and the District of Columbia, into Johnson & Johnson’s surgical mesh products for women, and is seeking injunctive relief and monetary penalties.
Johnson & Johnson, based in New Jersey, called the lawsuit “unjustified” and denied any inappropriate activity in the marketing of the products.
“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,” according to the company.
The company noted that the American Urogynecologic Society has endorsed the products by stating that “the polypropylene midurethral sling has helped millions of women with (stress urinary incontinence) regain control of their lives by undergoing a simple outpatient procedure that allows them to return to daily life very quickly.”
Harris, who is running for a U.S. Senate seat, alleged that “Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products.”
“Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being,” Harris alleged. “My office will continue to hold companies accountable for misleading consumer and patients for financial gain.”
The surgical mesh device is designed to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. The lawsuit alleges that Johnson & Johnson misrepresented the safety of the devices by concealing the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse and/or loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and a potentially devastating impact on overall quality of life.
The suit further alleges that Johnson & Johnson knew about potential risks and side effects prior to the launch of its mesh products, yet omitted that information from educational and marketing materials provided to doctors and patients.
According to the lawsuit, Johnson & Johnson sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California in that time period. Worldwide, more than 2 million women have been implanted with the mesh products, the suit says.
In addition to the lawsuit filed today, Johnson & Johnson faces more than 35,000 personal injury lawsuits in state and federal court related to the surgical mesh products, Harris said.
In denying the allegations of the lawsuit, Johnson & Johnson officials also said they were concerned that the legal action by Harris “will keep women from obtaining treatment from often-debilitating symptoms of urinary incontinence.”
— City News Service
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