Mesh Medical Device News Desk, August 7, 2017 ~ Johnson & Johnson won a pelvic mesh trial in Philadelphia on June 9th, the first after four other pelvic mesh trials awarded damages to the mesh-injured plaintiff. The case isn't over yet.
Kimberly Adkins was the first plaintiff in the Philadelphia Court of Common Pleas to lose her pelvic mesh trial against Johnson & Johnson and its subsidiary Ethicon.
Now she getting another bite of the apple.
Philadelphia Court of Common Pleas
On July 19, Judge Michael Erdos granted her motion for a new hearing limited to damages, specifically on design defect, contending the jury findings were against the weight of evidence and inconsistent on whether the TVT-SECUR (TVT-S) pelvic mesh caused her injuries.
What this unprecedented ruling means and how it will play out is uncertain to both sides, according to a rash of documents being filed in the case (No. 130700919).
Will a new jury be convened for a new trial or will the issue be heard by a judge? If so, how would a jury understand enough of the nuances of the case to award damages? Will punitive damages be on the table? These questions are, at the present time, unanswered.
Dr. Bruce Rosenzweig, expert for Adkins
WHAT WE DO KNOW
On June 9, after a three-week trial, a Philadelphia jury concluded Ms. Adkins’ injures were not caused by her mesh implant, the TVT-S.
She was implanted with the polypropylene small pore, laser cut, mid-urethral sling July 20, 2010 in Portsmouth, Ohio to treat stress urinary incontinence (SUI). Dr. George Pettit was the implanting physician.
At the same time in an apparent contradiction, the jury decided the TVT-S (Secur) was defectively designed and that Ethicon had failed to warn doctors about its potential risks.
Plaintiffs’ counsel, Bryan Aylstock noted Adkins should be awarded damages since her June trial delivered an inconsistent message.
At the trial’s conclusion he told MND, “They found the product defective in design and in warning under OH law. (Adkins is from Ohio). They found however it wasn’t the cause of her injuries. We will be moving for new trial as the defense had stipulated to at least it cause some of her injuries.”
This was a first.
In the five previous trials in this Philadelphia court, the juries had found for the mesh-injured plaintiff awarding compensatory and punitive damages to the injured in the amounts of $2.16 million, $12.5 million, $13.5 million and most recently, $20 million.
If she had not been injured by the implantation of the TVT-Secur, which was defectively design, how then did you explain its erosion into her vagina and chronic pain?
THE QUESTION OF CAUSATION
One of Ms Adkins' treating doctors told jurors the mesh erosion caused her pain.
Defense expert, Dr. John Wagner told the jury Adkin’s pain with intercourse was caused by mesh erosion and she would not have the mesh erosion but for the mesh having been implanted in her. Wagner testified it is impossible to “say definitely why anybody get an erosion specifically,” rather he said it is a known complication that happens in about one to two percent of patient who have any type of mesh implant in the vagina.
He did not rule out her smoking history as a contributing factor to her mesh erosion.
An Ethicon expert testified that mesh can cause dyspareunia and erosions into the vagina and these are known complications, not defects. They are risks the implanting surgeon must weigh against the benefit of the device said Dr. Jaime Sepulveda.
There is no “risk-free mesh,” said the doctor.
Dr. Sepulveda said when TVT Secur was marketing in 2006, there was a learning curve for doctors to adopt to implanting this new device, resulting in higher rates of erosions and dyspareunia (painful sex) during this learning curve. The rate of erosion is reduced nearly to zero after the doctor passed the learning curve, he said.
THE ISSUE OF JUROR #1
In post-trial motions, Adkins' lawyers argued they should have been allowed to strike juror #1. That juror was a biopharmaceutical engineer with GlaxoSmithKline (GSK) who had worked with polypropylene mesh. Adkins' attorneys say the juror made comments suggesting Adkins' injuries were pre-existing.
The outcome could potentially adversely effect GSK, the juror’s employer, said Adkin's team.
Judge Erdos denied that motion.
Supreme Court Justice Sonia Sotomayor, one dissenting vote
DEFENSE ARGUES PERSONAL JURISDICTION
Despite its win, J&J filed a Motion for Reconsideration July 26 that asked the court to deny the damages hearing saying it’s improper because the jury decided the defectively designed TVT-Secur was not liable for her injuries.
Then there is the issue of personal jurisdiction.
The U.S. Supreme Court recently ruled ( See MND story here) that defendants and plaintiffs must stick to courts that are close to their corporate or personal interests, not file in courts that produce more favorable results for either side. Three pelvic mesh cases were recently moved out of the Philadelphia court for that very reason.
See Mesh News Desk story here.
Defense said the issue of personal jurisdiction had been raised earlier in the litigation but Judge New denied a defense motion to dismiss for lack of personal jurisdiction. Mesh makers Boston Scientific and Johnson & Johnson are trying to have nearly 100 pelvic mesh cases dismissed from this court based on a lack of jurisdiction.
See the Legal Intelligencer on challenges to 91 mesh cases in the Philadelphia venue. August 7 story here.
See the Mesh News Desk story on the issue here.
The issue of personal jurisdiction does not stand as an impediment to the Court ordering a new trial, Lee Balefsky (Kline Specter) wrote for the plaintiff.
This is the first Ethicon trial where the doctor who implanted the device did not appear. Because of unspecified medical reasons, Dr. Pettit never testified about the impact a more adequate warning would have made on his implanting of the TVT-Secur.
Because of that, defense argued that case law dictates the failure to warn should be dismissed summarily.
It will be up to Judge Erdos to decide just how big a bit of the apple Ms. Adkins wins. ###