January Opening Statements in Gynecare NJ Trial
The plaintiff, Linda Gross, of Watertown, South Dakota, accused Gynecare, a division of Johnson & Johnson, of negligence and defective product design.
The Honorable Carol E. Higbee of Superior Court of New Jersey on November 30 signed an order for a pre-trial schedule in the case of Gross v. Ethicon, Inc. et al. Ethicon is the division within J & J that makes Gynecare vaginal mesh.
By December 7, both sides must agree on questions to be submitted to the jury. A December 11, case management conference is scheduled. All papers opposing pre-trial motions needs to be submitted by December 21. Oral arguments on pre-trial motions are set for January 3-4, 2013. Jurors should be selected by January 9, 2013. After opening arguments on the 10th, witness testimony is set to begin on January 14, 2013.
Here is the Case Management Order.
Gross is one of 1,870 women (as of November 30) suing Gynecare (J&J) in the Atlantic City, NJ court. See the case list here.
ABC News reported in September 2011 on the Gross case here. Her Gynecare mesh was implanted in 2006 to relieve bloating, constipation and pelvic organ prolapse. She received the Gynecare Prolift, which last June, Ethicon announced it would discontinue selling along with three other meshes over the next 12 months. See story here.
An Ethicon spokesman insisted it was not a product recall.
“We continue to have confidence in the safety and efficacy of these products. Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics, and is not related to safety or efficacy.”
Gross accuses the company of urinary complications, constant pain and swelling in her body as it tries to reject the mesh. Twelve removal operations have been a failure and she is still in pain, still has mesh and her body is still swollen, reports ABC News. Her doctor reportedly told her the Prolift device was safe and low-risk. He allegedly did not tell her Prolift had been allowed on the market with no clinical trials or checks for safety and efficacy.
“It’s horrible. There are unknown amounts of the mesh still in me. I have extreme pain. It feels like the inside of my vaginal wall is on fire,” Gross told ABCNews.com. “I wouldn’t wish this on anyone.”
Her attorney, Adam Slater, told ABC News that, “the whole concept of the 510 (k) process should be scrapped,” adding that the doctor who created the product even said there needed to be more studies.
The FDA found about 4,000 mesh-related complications that were reported to the agency between 2008 and 2010. Of those complications about 35 percent involved mesh erosion into other organs and tissues. Other complications include pain, infection and bleeding.
You may recall that Johnson & Johnson launched the Prolift without any FDA approval in 2005. When the agency discovered the mesh was on the market and the company had not alerted the agency, it approved the Prolift in 2008.
Gross had her mesh implant two years before the FDA’s first warning issued in October 2008. The second more strongly worded Safety Notification was posted in July 2011.