A New Jersey state appeals court has upheld an $11.1 million damages verdict against Ethicon Inc., a division of Johnson & Johnson, in the first bellwether trial over allegedly harmful pelvic mesh implants.
On March 29, the three-judge panel said they saw no reason to overturn the award of $3.35 million in compensatory damages and $7.76 million in punitive damages awarded to the plaintiff and her husband, New Jersey Law Journal reports.
Transvaginal mesh—also called pelvic mesh—is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. The Food and Drug Administration (FDA) explains that prolapse occurs when the pelvic walls that support the bladder, uterus and bowel, become weak, stretched, or torn and the organs slip from their normal position and drop (prolapse) into the vagina. Women with POP experience pain and disruption of sexual, bladder, and bowel functions. But many women who have mesh implants experience serious injuries and complications from the devices that are supposed to correct the condition. The mesh may erode through the vaginal lining, or the woman may experience infection, pain, urinary and bowel problems, or even a recurrence of the prolapse.
The woman and her husband filed the lawsuit in 2008 and the trial took place in 2013. During the trial, Ethicon employees were questioned about the design, testing and marketing of the Prolift mesh device, the device the plaintiff had implanted in July 2006 to deal with bowel problems. In the months after surgery, the bowel problem improved but the woman developed persistent pelvic pain. Starting in September 2006, she underwent 22 surgeries to deal with pain, inflammation, and other problems. Despite the surgeries, severe nerve pain ended her nursing career and prevented her from enjoying a normal sex life or participating in many everyday family activities, court documents reveal.
The woman’s doctors eventually concluded that her health problems, including anxiety, depression, and chronic pain, were permanent. At trial, the plaintiff testified that she would not have agreed to have the Prolift implant if she had been adequately warned of the potential dangers that Ethicon allegedly knew about.
“The evidence was sufficient to allow the jury to find an adequate warning would have prevented plaintiff’s injuries,” the panel wrote. Judges Clarkson Fisher Jr., Marianne Espinosa and Garry Rothstadt said, “The record, therefore, contains sufficient evidence from which the jury could have found defendants willfully deceived plaintiff by providing intentionally misleading information in the patient brochure and by suppressing facts they were bound to disclose, that they made the misrepresentations to induce plaintiff to use the Prolift system, that plaintiff relied on the information in the brochure, and that she suffered damages as a result of their deception.”
The jury determined that because the defendants failed to give adequate information to the doctor, the physician could not fulfill the role of “learned intermediary” between the device maker and the patient. Because of the withheld information, the physician “cannot be said to be adequately learned because he or she was not adequately informed,” the judges wrote.
The woman’s attorney called the ruling a “very strong decision that clarifies important points of the law on failure to warn.”