Pharmaceutical

States prosecute Johnson & Johnson alleging ‘deceptive practices’ related to transvaginal mesh

2012 TVM serious complications States prosecute Johnson & Johnson alleging deceptive practices related to transvaginal meshBesides the 35,000 personal injury lawsuits that Johnson and Johnson faces related to its transvaginal mesh (TVM), the company is also facing suits by both the states of Washington and California. According to Law360, the states’ attorneys general filed complaints against the company and its subsidiary Ethicon Inc. alleging false advertising and deceptive marketing related to the devices. The complaints claim J&J knowingly concealed the risks associated with its TVM product and misrepresented the severity and frequency of common complications. The complaints also claim violations of the states’ unfair competition and consumer protection laws.

Law360 reported that “Both states are seeking injunctive relief and monetary penalties potentially in the millions of dollars ‘to ensure that J&J stops its deceptive practices,’” as Attorney General Kamala D. Harris of California wrote.

“Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products,” Harris said in a statement. “Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”

“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,” Attorney general Bob Ferguson of Washington said. “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.”

These surgical mesh products were designed to treat pelvic floor disorders that are relatively common, such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). More than 42,000 mesh devices were sold in California between 2008 and 2014. However, very serious complications have been reported, some that don’t come up until years after surgery.

In a January press announcement, the U.S. Food and Drugs Administration (FDA) reclassified all transvaginal mesh devices as high risk, stating “over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.”

The states’ suits against Johnson and Johnson declares that one of these serious complications is a “devastating impact on overall quality of life,” Law360 reports.

Sources:
Law360
U.S. Food and Drug Administration