Johnson & Johnson faces fresh legal problems over its vaginal mesh products as two state attorneys general on Tuesday filed lawsuits accusing the health care giant of concealing severe risks and falsely marketing the products to doctors and women.
The lawsuits, which were filed in California and Washington state, allege that Johnson & Johnson failed to disclose a host of problems caused by the devices, which are designed to treat the conditions stress urinary incontinence and pelvic organ prolapse. Among the side effects cited: permanent pain with intercourse; a loss of sexual function; chronic inflammation; and permanent urinary or defecation dysfunction.
“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Washington State Attorney General Bob Ferguson said in a statement.
“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.”
In the lawsuit filed by California Attorney General Kamala Harris, one woman is quoted as saying she “had all kinds of problems with chronic pain, bleeding, dyspareunia (painful sex) … The pelvic pain was keeping me awake at night, and the only relief was to sit on a tennis ball. The thought of living like that, sitting on a ball, wearing a diaper, splinting my perineum to have a bowel movement, having infrequent miserable sex, and marital problems was almost more than I could bear.”
Harris, who led an investigation that involved 46 states and the District of Columbia, noted that Johnson & Johnson’s Ethicon unit sold more 787,200 devices nationally between 2008 and 2014. Worldwide, more than 2 million women have been implanted with the devices. The state lawsuits cite thousands of violations that may expose the company to potentially tens of millions of dollars in penalties.
A Johnson & Johnson spokeswoman wrote us that the lawsuits are “unjustified, and the company plans to vigorously defend itself against the allegations. The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products …” The company is concerned the lawsuits will “keep women from obtaining treatment for the often debilitating symptoms of stress urinary incontinence.”
The health care giant already faces an estimated 35,000 personal-injury lawsuits that have been filed by consumers across the country over the devices. Still more lawsuits have been filed in at least nine other countries, including Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, and Venezuela, according to a filing with the US Securities and Exchange Commission.
And in recent months, the company lost two consecutive jury verdicts in the first two cases to go to trial. One verdict awarded a woman $13.5 million, and the other ordered the company to pay a woman $12.5 million. Both verdicts included punitive damages. Around the same time, Johnson & Johnson reportedly began talks to pay more than $120 million to resolve between 2,000 and 3,000 lawsuits
Earlier this year, the US Food and Drug Administration tightened regulations. The devices were reclassified as high-risk rather than moderate-risk, and all device makers must now submit data to support the safety and effectiveness before they can market their products. The agency noted it had seen a “significant increase” in the number of reported adverse events associated with the devices.