In the first lawsuit associated with transvaginal mesh implants, a New Jersey jury has ordered Johnson & Johnson to pay $11.1 million to a South Dakota woman who suffered injuries.
Johnson & Johnson and its Ethicon division face 1,800 lawsuits in New Jersey over injuries involving surgical mesh products, which are used to treat pelvic organ prolapse and stress urinary incontinence. Last week, the plaintiff received $7.76 million in punitive damages and $3.35 million in other compensation in Atlantic City Superior Court.
The woman, who filed her lawsuit in 2008, alleged Johnson & Johnson failed to adequately warn her doctor of potential dangers from the vaginal mesh implants. It alleged the company was liable for defective design, manufacture and warnings and instructions.
In Massachusetts and other states, the law allows a consumer to bring a claim against a company which manufactures a defective product that causes them injury. A company has a responsibility to protect consumers from defective design, manufacturer error and to warn the consumer about possible harm. Companies and professionals involved in distribution and sale can also be held liable if they act negligently. There is a statute of limitation restricting how long someone can file a claim.
Surgical mesh is a Class II medical device regulated by the Food and Drug Administration (FDA). It has been used to treat pelvic organ prolapse and stress urinary incontinence (SUI) since the 1990s. In 1996, the FDA approved it as a treatment for SUI. In 2002, it was approved to treat pelvic organ prolapse.
In 2005, Johnson & Johnson introduced its Gynecare Prolift surgical implant, the product which was used by the plaintiff. It was one of several implants on the market, along with others by Johnson & Johnson and other manufacturers such as Boston Scientific and American Medical Systems. Johnson & Johnson discontinued its vaginal mesh implants in 2012 after reports of women suffering injuries and an FDA warning.
The FDA first issued a notification about surgical mesh implants in 2008 and upgraded its warning in 2011, saying research showed approximately 10 percent of women who had received transvaginal mesh surgery experienced mesh erosion within a year. Other complications included pain, infection, bleeding, organ perforation, urinary problems and neurovascular muscular problems. Many women suffered emotional problems.
Treatment of a second surgery or intensive medical care does not always alleviate the symptoms.
Related: Jury awards woman $7.76 million punitive damages for J&J mesh, Reuters.