Johnson & Johnson withheld the risks and horrendous side effects of its Ethicon vaginal mesh but touted the dangerous product anyway to tens of thousands of women. For those lies, a California judge has blasted the company with a $343.99 million civil penalty.
“While J&J’s marketing vividly portrayed the benefits of the company’s products, J&J misstated, downplayed and omitted the risks of its pelvic mesh products,” wrote San Diego Superior Court Judge Eddie Sturgeon.
“J&J knew the grievous risks and also knew full well why they should have disclosed them.” The omissions were in the product’s instructions for use and in educational and marketing materials provided to doctors and patients.
Judge Sturgeon’s 128-page ruling on January 29, 2020, came in a suit filed by former California Attorney General Kamala Harris in 2016. The verdict was characterized as a penalty instead of damages. Sturgeon may grant additional injunctive relief as well.
Even the medical director for Ethicon, who designed and manufactured the mesh, testified that the company knew “that its mesh slings caused severe, long-term complications such as excessive contraction or shrinkage of tissue surrounding the mesh” and “debilitating and life-changing chronic pain, pain to their sexual partner,” among other issues, according to Sturgeon’s ruling.
Profits before patients
“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,” said current California Attorney General Xavier Becerra.
“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.”
The company, which has been held liable for making addictive opioids and cancer-causing baby powder, is facing 20,000 plaintiffs alleging injuries caused by its pelvic mesh.
In separate federal litigation, there are 2,554 lawsuits pending before Sr. District Judge Richard W. Story regarding Ethicon Composite Hernia Mesh in MDL 2782 in Atlanta.
J&J has previously settled litigation charging that the pelvic mesh was deceptively marketed, including an October 2019 agreement to pay $116.9 million to 41 states and the District of Columbia, plus an April 2019 settlement of $9.9 million in a case by the Washington Attorney General.
The total payouts by a handful of mesh manufacturers to injured women now stand at nearly $8 billion. Earlier this month, the 7th US Circuit Court upheld a $20 million verdict to a woman who was permanently injured by the company’s Prolift pelvic mesh device.
Ethicon pelvic mesh products, also called transvaginal mesh, are permanent surgical implants designed to treat stress urinary incontinence and pelvic organ prolapse. The mesh causes bleeding, searing pain, permanent incontinence and loss of the ability to have sex. Many women have undergone surgeries unsuccessfully to remove the implants.
After years of complaints, the Food and Drug Administration stopped the sale of pelvic mesh in 2019 to treat organ prolapse, but J&J and other manufacturers still sell similar products to treat urinary incontinence.
Judge Sturgeon said Johnson & Johnson had abused its trust by “depriving physicians of the ability to properly counsel” patients about the risks of having a synthetic device implanted in their bodies. “This abuse of trust is particularly egregious when it comes to selling a permanent implant with no exit strategy while hiding its risks,” he said.