Of the 1,800 lawsuits in South Dakota to go to trial for transvaginal mesh implants, there had been reports made stating that Johnson & Johnson knew of the severe risks it posed. According to patient Linda Gross, who had the Gynecare Prolift implanted July 2006, she has undergone over 18 different surgeries to repair the damages caused by the implant. During the trials, her attorney told the jury in New Jersey, that these damages were caused by Johnson & Johnson’s failure to warn of the risks when first selling Prolift in 2005.
“They knew every single catastrophe before it happened, They knew Linda Gross was going to happen.” Attorney Adam Slater had stated in his opening statement to the court.
While Johnson & Johnson is the largest manufacturer of health care products, they have been accused of knowing about the products defective design and risks, yet chose to neglect warning anybody.
However, Christy Jones, a lawyer for the New Jersey based Johnson & Johnson, had denied Gross’ allegations in her opening statement.
“You heard a lot of allegations and accusations and some of them were no doubt disturbing, frankly, I imagine you’ve got some questions about Ethicon and Johnson & Johnson, and that’s understandable. Certainly, if those accusations were true, your concerns would be warranted. But they are not.” Johnson & Johnson’s attorney, Christy Jones stated.
She then went on to claim that Ethicon had warned both Gross and her surgeon properly of the risks that may be associated when implanting their Prolift device, a design made to help women after organ failure through the pelvic floor. She stated that Gross had needed relief after her rectum had fallen, and that her pelic floor was weakened from earlier surgeries.
“The Prolift did exactly what it was supposed to do, it put her organs back in the correct anatomical position.” Stated Jones.
In August, Johnson & Johnson had stopped selling 4 of their mesh devices in the United States, which included the Prolift. Last January, the FDA told Johnson & Johnson, including 31 other manufactures of vaginal mesh implants, hey needed to study the rates of organ damages and other complications. In 2010, doctors had implanted more than 70,000 of these medical devices in women.
Due to her pain, Gross is not able to work at her nursing job any longer. She has since suffered other physical complications due to the mesh failure in her body.
According to Jones, she said that Prolift had “never caused anything that wasn’t expressly warned about at the time of the surgery in 2006. All of her injuries were warned about.”
Slater mentioned of Johnson & Johnsons failure to do any clinical testing to learn of any risks Prolift may cause to a woman’s pelvic area. He had said that the mesh hardens, and contracts as tissue grows around it, which causes chronic inflammation and scarring.
“They never ever studied how can you get this stuff out, what’s the best way to do it,” Slater stated.
Johnson & Johnson had first began selling Prolift without even filing a new application with the FDA. The company had determined themselves that their product was similar to Gynecare Gynemesh, which was another one of its devices that the FDA had already approved.
The FDA claimed in 2007 that Johnson & Johnson Prolift sales had begun without the appropriate clearance. After 9 months of negotiation with Johnson & Johnson, the FDA cleared the device in May 2008.
Slater told the jurors Gross’s doctor would have never have implanted Prolift in her if he had he known the product didn’t have clearance by the FDA.
“If he had been warned and given that information, he wouldn’t have used it with Linda, it wouldn’t have gotten in her body,” said Slater.