Ethicon Prolift Pelvic Mesh Case Results in $15M Verdict

Late last week, a New Jersey jury ordered Johnson & Johnson and it’s Ethicon unit to pay $15 million in damages to a woman who suffered painful complications following pelvic mesh surgery where Ethicon Prolift and TVT-O products were implanted for treatment of pelvic organ prolapse and stress urinary incontinence. 

The verdict came in a lawsuit filed by Elizabeth Hrymoc and her husband, Tadeusz. Hrymoc received the transvaginal mesh products in 2008. However, instead of treating her conditions, the pelvic mesh allegedly caused her to suffer debilitating pain that resulted in the need for revision surgery.

Surgeons have been unable to remove all of the mesh, even after multiple surgical procedures.

Allegations raised at trial are similar to those presented in tens of thousands of Ethicon mesh lawsuits filed against Johnson & Johnson in recent years. Women throughout the United States claim that the company sold dangerous and defective products for treatment of pelvic organ prolapse or female stress urinary incontinence, which are prone to migrated through the vagina, cause infections and other painful injuries.

The Bergen County jury ordered the manufacturers to pay $4 million in compensatory damages for Hrymoc, $1 million to her husband for loss of consortium, and an additional $10 million in punitive damages, which were designed to punish the defendants for recklessly disregarding the health and safety of consumers.

This is the second trial and second plaintiff’s victory in a bellwether Ethicon pelvic mesh case being tried in New Jersey state court. The first, in 2014, ended in an $11 million verdict for the plaintiff. Efforts by Johnson & Johnson to overturn that verdict failed.

New Jersey is not the only state dealing with the cases, and this verdict is the latest of a number of massive jury awards in recent years. In September, a Pennsylvania jury hit the manufacturers with a $57.1 million verdict over complications from the TVT vaginal mesh. There was also a $2.1 million verdict in May, a $20 million verdict in April, a $13.5 million verdict in February 2016, and a $12.5 million verdict in December 2015.

Although some vaginal mesh settlements have been reached by Ethicon, the manufacturer continues to defend many of the cases in courts nationwide.

Pelvic Mesh Lawsuits

Ethicon was one of several manufacturers hit with product liability lawsuits over pelvic mesh products in recent years, with over 100,000 women bringing claims nationwide, in what has become one of the largest mass torts.

The number of cases began to increase rapidly after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.

After a review of all available data, the FDA concluded that there was no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, and establish whether they pose an unreasonable risk of injury for women. Since then, a number of manufacturers have decided to stop making the devices to avoid the need to spend money studying the safety of products they have sold for years.

Following several years of litigation, other manufacturers have resolved the vast majority of claims filed, including Endo’s American Medical Systems, C.R. Bard, Boston Scientific, Coloplast and others.