Pelvic mesh, or trans-vaginal mesh, the controversial medical device made famous by those late-night infomercials that personal injury attorneys use to seek victims, is slowly facing its day in court, or thousands of days to be exact.
Tens of thousands of lawsuits have been filed against device makers like Johnson & Johnson’s subsidiary Ethicon over mesh products. The suits describe horrific side effects patients say they experienced from the implant.
Cases stalled in two courts
So many cases concerning mesh have been filed that the courts have consolidated thousands of the complaints in two courts, one in West Virginia and another in New Jersey under a system called Multi-District Litigation. But rather than more efficiently manage the case load, plaintiffs and personal injury attorneys complain that the consolidation has only caused the cases to drag slowly along.
“This is probably the most complicated MDL in history,” plaintiffs’ attorney Robert Salim told a legal publication last year. Though Johnson & Johnson is the largest purveyor of mesh, several other companies also sell the product and are similarly facing lawsuits. Even cases in which different mesh-producing defendants are named have been consolidated under the same system. “Over 80,000 cases have been filed, which means over 25 percent of every civil case in America is in mesh MDLs,” Salim added.
Mesh, a permanent surgical implant made of plastic, is in theory supposed to offer a net-like support system for women suffering from either pelvic organ prolapse or incontinence. Instead, however, women and some doctors critical of the product say it causes horrendous physical pain, destroys patients' sex lives, and can even worsen incontinence.
Because the product was designed to be a permanent implant, there is no simple way to remove it. Small nonprofits and patient advocates like Aaron Thornton have raised money to fund expensive mesh removal surgery for women.
Fight over the first mesh case finally ends
But some plaintiffs, the few lucky enough to have actually seen their cases go to trial, are winning major victories in the court system. Linda Gross, a nurse from South Dakota, is the first woman to have her suit against Johnson & Johnson heard in a New Jersey court room. She filed her lawsuit against Johnson & Johnson in 2008, but her trial did not go before a jury until 2013.
In her testimony Gross reportedly told jurors: “Who you see standing here now is not who I was,... I was eager and energetic, loved to go to work, loved to participate in church activities, school activities.” Her implanting surgeon later performed three surgeries on her to remove the mesh and cure her pain, jurors learned. They ultimately sided against Johnson & Johnson and awarded Gross $11.1 million dollars.
Johnson & Johnson has been appealing that landmark ruling ever since. Finally, over eight years after she filed the lawsuit, New Jersey’s Superior Court this month made a definitive ruling in Gross’ favor. On December 7, New Jersey’s superior court declined to hear an appeal of Gross’ $11.1 million award, effectively ending Johnson & Johnson’s fight to overturn the jury’s verdict.
"We are disappointed that the Supreme Court of New Jersey has denied the petition for certification and will not be considering the important issues we raised," Kristen Wallace, representative for Johnson & Johnson’s subsidiary Ethicon, told reporters in a statement.
Jury's verdict stands
The decision follows a ruling that New Jersey’s superior court made in March 2016, finding no merit in Ethicon’s arguments to overturn the jury’s verdict.
Ethicon’s mesh product for pelvic organ prolapse, the Prolift Pelvic Floor Repair System, was approved by the Food and Drug Administration under a process called 510(K) clearance, which the judges note, “does not require clinical trials but requires the company to compare its product to one already on the market...” The 510(K) clearance system is problematic to independent researchers, including those on a 2011 Institute of Medicine Panel which called the process "fatally flawed."
Emails and documents presented at Gross’ trial, reviewed again in March by the New Jersey superior court judges, showed that company executives documented serious side effects caused by Prolift, as well as concerns that Prolift was actually not so similar to anything already on the market.
"Clearly, for most physicians, the Prolift procedure will be a deviation from what they are currently doing,” Ethicon wrote in 2005.