The California Department of Justice said it sued Johnson & Johnson in May 2016 following a multiple state investigation that uncovered the company did not inform patients and doctors about potential severe complications of using the products and misrepresented the frequency and severity of risks the products posed.
This judgment marks the first time a court of law has issued findings of fact and ruled Johnson & Johnson engaged in illegal business practices.
“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies,” Attorney General Becerra said in a statement. “Johnson & Johnson knew the danger of its mesh products but put profits ahead of the health of millions of women. Today we achieved justice for the women and families forever scarred by Johnson & Johnson’s dishonesty.”
Pelvic mesh, also known as transvaginal mesh, is a synthetic implanted through the vagina of a woman whose pelvic organs have sagged or who suffer from stress urinary incontinence when they cough, sneeze, or lift heavy objects. According to the National Association for Incontinence, stress urinary incontinence affects an estimated 15 million adult women in the U.S.
From 2008 to 2014, Johnson & Johnson sold over 470,000 pelvic mesh products nationally. More than two million women have had the mesh products implanted worldwide.
Johnson & Johnson spokeswoman Mindy Tinsley said the company will appeal, and noted the process can take up to three years.
“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 laws on medical device communications and the appropriateness of its actions,” Tinsley told The Hill.
Johnson & Johnson has faced more than 35,000 personal injury lawsuits related to its pelvic mesh. The company has settled similar claims with Washington state for $9.9 million and with a coalition of 42 other states for $117 million.