A New Jersey appellate court has upheld a $11 million jury award against Johnson & Johnson’s Ethicon subsidiary in a case concerning injuries caused by the company’s Prolift pelvic mesh.

Plaintiff Linda G. claimed the vaginal mesh device (also known as a bladder sling) caused debilitating nerve pain and said that better labeling and warnings regarding the pelvic mesh device could have prevented injuries.

She added that the vaginal mesh product resulted in multiple complications which required intensive medical treatment and over 20 corrective surgeries to try to repair the damage, according to court documents.

Linda’s vaginal mesh lawsuit centered on the allegation that Johnson & Johnson and its subsidiary Ethicon were aware from their own studies that their Prolift pelvic mesh posed many risks for women.

However, the defendants failed to properly warn patients about the complications of the device and continued to market the pelvic mesh aggressively to both doctors and patients.

During the trial, Linda testified that the years after she had the Prolift pelvic mesh device implanted were a “living hell.” She further accused the manufacturer of the vaginal mesh device, Johnson & Johnson, of using thousands of women as “guinea pigs” for the unsafe pelvic mesh device.

The jury agreed with the plaintiff that Johnson & Johnson and Ethicon failed to provide warnings of complications they knew existed with the bladder sling, thereby committing fraud against Linda and putting her at deliberate risk.

Linda was initially awarded $3.35 million in compensatory damages in the vaginal mesh lawsuit.

In February, a jury in New Jersey awarded the couple an additional $7.8 million in punitive damages.

Johnson & Johnson argued that the trial judge “erroneously failed to apply the learned intermediary doctrine to the fraudulent misrepresentation or deceit claim,” and failed to recognize causation evidence as sufficient to prove a failure to warn. They also said that punitive damages should not have been considered by the jury.

The appeals court held up the original finding and the award initially issued.

“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff’s injuries,” the panel wrote.

The panel further stated that “the judge also relied on plaintiff’s testimony that she would not have selected the Prolift option if she had known of the risks and recognized there was overwhelming evidence to show the company had information about Prolift that it chose not to provide to the physician,” according to the court ruling.

Pelvic Mesh Problems

The Ethicon Gynecare Prolift pelvic mesh system has been linked to a growing number of adverse events reported to the U.S. Food and Drug Administration. The device often is proscribed for pelvic organ prolapse, or POP, as well as urinary incontinence.

Although minimally invasive, the bladder sling product can lead to a litany of problems including bleeding, infection and organ perforation caused by the erosion of the mesh over time.

Linda’s vaginal mesh lawsuit was one of the first of thousands of pending vaginal mesh personal injury lawsuits to go to court. Over 40,000 pelvic mesh lawsuits have been naming a wide range of plaintiffs and medical devices—including Ethicon, C.R. Bard, Boston Scientific, and American Medical Systems.

Some plaintiffs are claiming that the vaginal mesh was not designed properly, and others allege that the companies were aware of the risks but continued to market their products without warnings. All of the plaintiffs filing claims have endured injury or chronic pain as a result of the surgery—suffering mesh erosion, surgical revision, organ damage and other vaginal mesh complications.

The Ethicon Pelvic Mesh Lawsuit is Case No. Atl-L-6966-10, in the Superior Court of the State of New Jersey, County of Atlantic.