The states of Washington and California are suing the New Jersey-based pharmaceutical giant for misrepresenting the risks of its vaginal mesh implants.
Attorneys General Kamala Harris of California and Bob Ferguson of Washington accused Johnson & Johnson of neglecting to warn patients and doctors about the risks and frequency of serious and sometimes irreversible complications, such as: loss of sexual function, constipation, urinary dysfunction, and severe pain.
California and Washington worked with other states, leading a group of 46 states as well as the District of Columbia in an investigation of the company's practices. California's lawsuit alleges false advertising and deceptive marketing. Harris noted in a news release that Johnson & Johnson sold nearly 800,000 devices nationwide from 2008 to 2014. Over 42,000 of these devices were distributed in California.
Washington's lawsuit seeks penalties that could reach well into the millions of dollars, alleging tens of thousands of violations of the state's consumer protection law. According to Ferguson, Johnson & Johnson sold 12,000 of the devices in Washington, but withheld from the patients information that the mesh harbors infections that can live indefinitely in its small weave, withheld information that the mesh may cause chronic inflammation as their body rejects the foreign material; and withheld information that that the mesh frequently protrudes into an organ or through the vaginal wall, in a condition called erosion.
Johnson & Johnson is just one of several manufacturers that sold vaginal mesh implants to treat conditions like pelvic organ prolapse in women. Massachusetts-based Boston Scientific and Ireland-based Endo International are also under fire. In 2014, Endo said it would pay $830 million to settle over 20,000 personal injury lawsuits. As of now, Johnson & Johnson alone faces more than 35,000 lawsuits.
The U.S. Food and Drug Administration has received thousands of reports of complications related to the devices. In response, the FDA has reclassified the devices from class II (moderate risk) to class III (high-risk). This will require manufacturers in the future to submit extensive data to establish the safety and efficacy of the devices.