Dive Brief:
- Johnson & Johnson is being sued by the states of California and Washington for failure to disclose risk associated with its vaginal mesh device, reports Stat. The company already faces 35,000 personal-injury suits from consumers in the U.S. over its surgical mesh products.
- The implanted pelvic mesh device is intended to shore up weakened pelvic muscles and control urinary incontinence. However, plaintiffs against J&J claim the device was defectively designed and manufactured, which has led to numerous injuries.
- Women have complained of numerous serious adverse events, including organ perforation, chronic pain and inflammation, urinary dysfunction, and loss of sexual function.
Dive Insight:
Between 2008 and 2014, J&J's Ethicon unit sold roughly 787,232 pelvic mesh devices, according to the California Attorney General's office. Globally, the company has sold two million devices, and also faces lawsuits from women in a number of other countries.
"They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials," said Washington Attorney General Bob Ferguson.
J&J recently lost two jury verdicts, after juries determined its failure to disclose risk led to serious harm for two women. The first woman was awarded $13.5 million in damages, while the other received $12.5 million, according to Stat.
These lawsuits come as J&J is handling legal challenges related to its talcum powder. J&J is facing 1,200 suits which contend the company knew of an alleged link between talcum-based products such as Johnson's Baby Powder and an increased risk of ovarian cancer, yet failed to warn consumers about the risk.
Earlier this month, a judge in South Dakota ordered J&J to pay $55 million to a woman who said the company's talcum powder caused her ovarian cancer.