March 12, 2013

$3.35 Million Dollar Award Considered a Victory for all Upcoming Mesh Cases



Linda Gross, a 47-year old hospice nurse from South Dakota was awarded $3.35 million dollars as a result of her lawsuit against Ethicon and Johnson & Johnson—the manufacturers of the Prolift vaginal mesh implant. This is the first trial of over 4,000—nearly half of which will take place in the same New Jersey court. In addition to the compensatory award, a second phase of the trial will allow jurors to consider punitive damages. Under New Jersey law, punitive damages of up to five times the compensatory damages are permitted. This first trial, Gross v. Ethicon, took over six weeks with five days of jury deliberation following closing arguments by both sides. Claims of defective design were rejected by the jury however the jury did find sufficient evidence of failure to warn physicians and patients of the potential harm as well as fraudulent representation.

Serious Harm Suffered as a Result of Ethicon’s Prolift Mesh Device
Of the $3.5 million award, $185,000 was awarded to Gross’s husband for loss of consortium with $680,000 as compensation for past and future wages due to Gross’s inability to work following the mesh implantation. The remainder of the jury award addressed household-help expenses, medical expenses, disability, impairment and pain and mental anguish. Following her implantation of the Prolift in 2005 as a treatment for pelvic organ prolapse, Gross claimed she suffered debilitating injuries.

Gross underwent 18 surgical procedures to correct complications from the Prolift, had over 400 doctor visits and currently takes over 20 daily medications to address the chronic pain she suffers. The mesh device hardened in Gross’s body leading her to characterize her life as a “living hell” when she testified. Gross stated she had suffered scar tissue formation, mesh erosion, chronic inflammation and neurologic compromise which had rendered her unable to engage in sex with her husband, unable to sit for even twenty minutes without experiencing excruciating pain, and unable to return to work.

How Ethicon Circumvented the FDA
The Prolift surgical mesh somehow evaded FDA approval prior to its being marketed in March, 2005. That evasion exposed thousands of women to serious complications after being implanted with Prolift. Ethicon withdrew the Prolift from the market in 2012, claiming the mesh implants lacked commercial practicality—with no mention of safety concerns. As opposed to the prior generation mesh, the Gynemesh PS, the Prolift comes pre-cut in a kit, however was comprised of a larger volume of mesh which had the potential to lead to greater inflammatory reactions. Further, the “arms” of the Prolift were put in locations which would be both difficult and dangerous to access should complications arise.

Because there was technically no “substantially similar” product on the market at the time the Prolift became available, the FDA’s 510(k) process was not deemed the appropriate process. Medical devices which are significantly different than their predecessors require classification by the FDA as well as time-consuming and expensive pre-market application. These rules are meant to assure the safety and performance of a medical device, evaluating all potential risks to patients. A representative of Ethicon claimed the changes made to the Prolift were not significant enough to warrant 510(k) approval.
FDA Approval—Three Years after Prolift Marketing Began
When the FDA realized the approval omission—nearly three years after the device had been marketed and implanted in thousands of women—they granted approval to Ethicon. The instructions for use, patient brochure and website for the Prolift all failed to warn of potential complications of the mesh product. Further, nothing warned that surgeons implanting the device could need special training.

A Victory for Other Plaintiffs
Lawyers and their clients who have currently filed suit against Ethicon and Johnson & Johnson believe this verdict to be a victory for their own upcoming cases. Thousands of women suffered serious complications and harm from the Prolift because of Ethicon’s rush to get Prolift to market and increase company revenues.