A Pennsylvania jury has ordered Ethicon, Inc. to pay $41 million in damages to a woman who suffered debilitating complications after receiving three of the company’s transvaginal mesh implants to treat pelvic organ prolapse.
The transvaginal mesh verdict as announced on January 31st, and followed a five-week trial in the Philadelphia Court of Common Pleas. The total award included $15 million in compensatory damages, $25 million in punitive damages, and $1 million for loss of consortium for the plaintiffs’ husband. (Emmett v. Ethicon, Case ID 130701495)
Suzanne Emmett, now 57, received Ethicon’s Gynemesh, TVT-O, and Prolift mesh implants in 2007.
According to her transvaginal mesh lawsuit, the devices eroded into her vagina, resulting in urinary incontinence, painful bladder contractions, and pain during sex.
Despite nine corrective surgeries and 40 nerve treatments, Emmett continues to suffer.
Among other things, she claims Ethicon and its parent company, Johnson & Johnson, concealed the implants’ high-failure rates and failed to warn doctors and patients about their risks.
Transvaginal mesh implants were approved under the U.S. Food & Drug Administration’s (FDA) 510(k) program, which does not require that a new product undergo human clinical trials if a manufacturer can show it is “substantially equivalent” to a device that was previously approved through the agency’s far stricter pre-market approval process.
At one time, the devices were considered the gold standard for treating women suffering from pelvic organ prolapse or stress urinary incontinence. That all changed in 2008, however, when the FDA warned that transvaginal mesh had been cited in more than 1,000 adverse event reports involving mesh erosion, organ damage, chronic pain, and other painful complications.
The agency published another warning just three years later, after the number of such reports had tripled. Among other things, the FDA cautioned that transvaginal mesh complications following prolapse repair were not rare, a reversal of the position it had taken in 2008.
In 2016, the agency reclassified transvaginal mesh used in pelvic organ prolapse surgery as high-risk medical devices. As a result of the reclassification, transvaginal mesh was no longer eligible for the FDA’s 510(K) program.
Over the past decade, more than 100,000 transvaginal mesh lawsuits have been filed in courts throughout the United States. In addition to Ethicon, defendants include American Medical Systems, Inc., Boston Scientific Corp., C.R. Bard, Inc., and other medical device manufactures.
Suzanne Emmett’s lawsuit transvaginal mesh verdict was the sixth win for plaintiffs in Pennsylvania. So far, Philadelphia juries have ordered Ethicon to pay more than $147 million to women injured by its products.
In recent months, Ethicon and other device manufacturers have settled large groups of transvaginal mesh lawsuits pending in the various federal and state litigations around the country.