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.
