Inside the $13 Million Pelvic Mesh Award: A Defendant Without Empathy

Philadelphia, PAFollowing the refusal of a Pennsylvania state judge to strike down a $13.7 million transvaginal mesh lawsuit verdict, defendant Johnson & Johnson and its Ethicon unit immediately signaled they would appeal the award to the state Supreme Court, in spite of the judge’s admonitions that the plaintiff’s suffering was real and chronic.

According to court documents, plaintiff Sharon Carlino filed her mesh lawsuit in June, 2013. She had received transvaginal tape manufactured by Ethicon Inc. to treat urinary stress incontinence in 2005. Two years later, in 2007 Carlino began to experience a sharp pain in her vagina. Her doctor subsequently discovered the mesh had become exposed, and surgery was performed to correct the problem.

Three years later, surgery was performed a second time for the exact same reason. Then, in 2012 – a year before Carlino filed her transvaginal mesh side effects lawsuit – the plaintiff began to experience pulling sensations and additional pain due to scarring from the previous surgical procedures, and the implant itself.

Carlino won a jury verdict of $13.7 million in February of last year, with the jury finding that the TVT sling used for the plaintiff’s surgery was not reasonably safe. The verdict, as it happened, came within a month of the US Food and Drug Administration (FDA) re-classifying transvaginal mesh from a Class II (moderate risk) to Class III (high risk), and has since opined that in the regulator’s view the use of TVM mesh is no longer considered the preferred method of treat SUI or Pelvic Organ Prolapse (POP), two conditions common to women later in life who have borne children.

Carlino alleged in her lawsuit that transvaginal mesh complications left her with constant pain and discomfort, together with reduced capacity to engage in sexual activity with her husband.

Ethicon, however tried to have the award disqualified, claiming in its view that Carlino’s pelvic pain was intermittent at best, and that the plaintiff’s claims for emotional harm were “unqualified.”

Judge Kenneth Powell, of the Court of Common Pleas of Philadelphia County, Pennsylvania, took exception to that argument.

“To characterize [plaintiff’s] testimony in this way is to minimize her real damages to an unreasonable degree,” he said in an opinion. “This is not merely ‘intermittent’ pain – it is chronic pain, pain that will be with her for the rest of her life, with no real prospect of resolution.”

Ethicon, through a spokesperson, reiterated their intent to appeal.

“The denial of post-trial motions is not unexpected and we have already begun the appeal process,” said Kristen Wallace, in a statement to Law360. “We filed an appeal in this case because we believe the evidence showed Ethicon’s TVT midurethral sling was properly designed and labeled, that Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT was not the cause of the plaintiff’s continuing medical problems. We have always made patient safety a top priority and will continue to do so.”

The case is Sharon Carlino et al. v. Ethicon Inc. et al., Case No. 130603470, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

Meanwhile, Boston Scientific noted in its Form 10-Q report filed with the US Securities & Exchange Commission (SEC) in November of last year that it was in excess of 40,000 lawsuits related to transvaginal mesh filed by plaintiffs asserting various transvaginal mesh complications.