Linda Gross in NJ trial, Feb 2013

Mesh Medical Device News Desk, December 6, 2016 ~ J&J appeal to the New Jersey Supreme Court has been rejected for consideration. It was the last appeal for Johnson & Johnson. 

It was February 2013 when South Dakota nurse, Linda Gross was awarded $11.1 by an Atlantic City New Jersey jury after a seven-week trial.

Ms. Gross alleged the Prolift Pelvic Floor Repair System, she received to treat pelvic organ prolapse, caused her permanent damage and the jury agreed.

J&J, maker of the Prolift and its subsidiary, Ethicon immediately appealed.

In March of this year a state appeals court upheld the jury award. J&J took the issue to the highest court in New Jersey. It’s been three years, but on Monday, the New Jersey Supreme Court declined to second-guess the case of Gross v. Gynecare.

Adam Slater, Mazie Slater Katz Freeman

“I’m happiest for Linda and Jeff who have sacrificed so much and are heroes as far as I am concerned. This decision will help the thousands of women who are still fighting this fight with us in the Courts,” said Ms. Gross attorney Adam Slater to MND this evening.

Theoretically, J&J can file another motion for the high court to rehear and reconsider the denial.

The state Supreme Court will generally only consider a Petition for Certification if there are conflicted rulings in the lower court.

In an appeal filed after trial, J&J argued that the lower court failed to apply the learned intermediary doctrine to the fraud or deceit claim. The learned intermediary is the doctor who is supposed to inform a patient about all risks and benefits of a medical device.  He doctor then has the burden to warn the patient about risks, not manufacturer J&J.

The company also argued the trial court mistakenly allowed the jury to consider punitive damages.

The jury found Prolift was not defectively designed and that the defendants did not provide adequate warning to the implanting surgeon, Dr. Kevin Benson.

New Jersey Law Journal reports on Dec 7, Ethicon spokeswoman Kristen Wallace issued a statement on behalf of the defendants.

“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,” Wallace said. “We believe Ethicon acted appropriately and responsibly in the research, development and marketing of the Prolift pelvic organ prolapse repair kit,” the company statement said. “We empathize with all women suffering from pelvic organ prolapse, which can be a serious and debilitating condition, and we are always concerned when a patient experiences adverse medical events. We have always made patient safety a top priority and will continue to do so.”

MONETARY AMOUNTS

What the court awarded Ms. Gross was:  

Past pain and future pain of suffering, disability loss of enjoyment of life  $1.1 million.

For her past wages  $180,000.

For her future wages $500,000.

For the reasonable value of past medical services  $385,000.

For the reasonable cost of future medical treatment and household services $1 million.

Compensation to Jeff Gross $185,000 for loss of the companionship of his wife.

After additional proceedings, the jury awarded $7.76 million in punitive damages.

 

Prolift kit

BACKGROUND

The Prolift Pelvic Floor system was an innovative new transvaginal mesh that for the first time would be sold pre-cut in a kit with hook like trocars of metal implanting devices.

Made by Ethicon, the medical device division of Johnson & Johnson, Prolift would use the Gynemesh soft prolene (PS) used for hernia repair.

Gynecare, Prolift (J&J)

During the trial jurors saw that the marketing team always worked closely with Research & Development and Regulatory Affairs with a targeted March 2005 launch date.  The date was important. Ethicon wanted to take advantage of the market and beat out the upcoming competition and charge a “premium price” for the Prolift, according to internal company records.

But as late as January 2005 the launch team was hearing from its French scientists who developed the TVM procedure (how to use new tools to place the mesh).  Evidence at trial showed the team suggested a different type of mesh be used to replace the Gynemesh because early indications on cadaver and animal testing showed a 21 percent and higher complication rate with Gynemesh placed in the pelvis.

Gynemesh was called the “worst of a bad lot” of meshes and some inside the company thought it caused too many complications.

Ms. Gross who had worked as a hospice nurse, is now unable to sit any more than 20 minutes. She has to self-catheterize in order to urinate and has chronic pain in her legs and pelvis. She has undergone more than 20 mesh removal operations and hundreds of doctors consults since the Prolift was implanted in July 2006.

In mid 2012, Ethicon decided to remove Prolift and three other transvaginal meshes from the market in a phased stages over 18 months.

Only one other jury trial award has been paid, that in the case of  Ms. C. Scott v C.R. Bard. Her $5.5 million judgment was paid after Bard exhausted the appeals process.    ###

Prolift on eBay July 2013

Prolift explant