Philadelphia Jury Awards $13.5 Million Against Ethicon Over TVT Sling That Eroded and Needed Removal

A Philadelphia jury returned a $13.5 million verdict on February 10, 2016, against Ethicon, Inc. and its parent Johnson & Johnson. The case was brought by Sharon Carlino, a New Jersey woman, and her husband Charles over the company's TVT transvaginal sling, a mesh tape sold to treat stress urinary incontinence.

On August 18, 2005, Carlino's surgeon implanted the TVT during a laparoscopic hysterectomy. The hysterectomy relieved the back pain caused by uterine fibroids, and for a time the sling seemed to work. In 2007 she felt something sharp in her vagina. Part of the mesh had become exposed, and she had corrective surgery that November. In 2010 the sharp pain came back, along with pain during sex, and a urogynecologist found a second exposure and removed part of the sling that December. Her pain returned in late 2012. An expert who examined her before trial found the mesh left on one side had contracted into a band that could be felt through the vaginal wall, and said a further surgery could not remove all of it.

The trial turned on what Ethicon knew and told patients. The plaintiffs argued the sling was defectively designed and that its instructions and patient brochures left out known risks. Testimony from Ethicon's own medical directors, including Piet Hinoul, Martin Weisberg and David Robinson, acknowledged complications such as erosion, chronic pain, painful intercourse and the possible need for repeat surgery. Robinson, a former medical director, testified that the risk of erosion lasts as long as the mesh stays in the body. The plaintiffs said none of that appeared in the warnings Ethicon gave patients. Ethicon answered that the TVT was properly designed and labeled and that it was not the cause of her continuing medical problems.

Shanin Specter of Kline & Specter tried the case for the Carlinos, and Charles L. Becker later argued for them on appeal. The jury found the TVT defective in design and in its warnings, and found Ethicon's conduct willful and wanton. It awarded $3.25 million to Sharon Carlino for her injuries and $250,000 to Charles Carlino for loss of consortium, a combined $3.5 million in compensatory damages, plus $10 million in punitive damages. It was the second pelvic mesh case to reach a verdict in Philadelphia, two months after a jury there returned an award against Ethicon in the first.

After trial the court denied Ethicon's post-trial motions and added $238,119 in delay damages. On appeal Ethicon argued that Pennsylvania courts lacked jurisdiction over it, that the 2013 lawsuit came too late, that the trial court wrongly excluded evidence about the FDA's clearance of the device, and that the compensatory and punitive awards could not stand. The Pennsylvania Superior Court rejected each argument in an opinion filed April 11, 2019. On the deadline, it noted conflicting evidence over whether her doctors had blamed her 2007 and 2010 problems on the mesh or on the surgery itself, so the question belonged to the jury, which found she could not reasonably have known the cause before June 2011. She had connected her symptoms to mesh products after seeing a television advertisement in April 2013.