Prolift Transvaginal Mesh – “A Stupid Idea”
Mesh Medical Device News Desk, November 28, 2017 ~ The opening day of the Elizabeth Hrymoc v. Ethicon trial put the focus on the Prolift transvaginal mesh.
While the defense, Johnson & Johnson, and its Ethicon division, stands by its product, saying it’s helped countless women with prolapse and incontinence, the plaintiffs’ attorney compared it to a plastic octopus and called it “a stupid idea.”
The case promises to be similar to the last Ethicon Prolift transvaginal mesh case, heard more than four years ago in New Jersey, the case of South Dakota nurse, Linda Gross.
Hrymoc’s attorney, Adam Slater (Mazie Slater), also represented Gross and will call many of the same experts.
During the opening Monday, he held the moving piece of polypropylene, with its six arms flailing around, describing it to the jurors as a “defective design that is unreasonably dangerous.”
The case is Elizabeth Hrymoc v Ethicon, Case No. L-13696-14, heard in New Jersey Superior Court, Bergen Co. NJ, moved from the original New Jersey venue of Atlantic City.
Representing Ethicon is Judy Wahrenberger, Ruprecht Hart Weeks and Ricciardulli LLP, Riker Danzig Scherer Hyland & Perretti LLP and Butler Snow.
Courtroom View Network is covering the proceedings (Subscriber based).
Hrymoc, 71, a research technician from South River in Middlesex County, sat with her husband, Tad, listening to Slater’s opening. They are seeking damages in what NorthJersey.com calls the “largest tort claims litigation in history.”
The website has a video segment of Slater’s opening from Monday, November 27, here.
Hrymoc was 62-years-old when she had the two implants – the TVT-O for incontinence the the Prolift, a larger piece of mesh used to shore up sagging pelvic organs.
Slater told jurors that Prolift was sold beginning in March 2005 and withdrawn from the market by J&J, quietly without an official recall, on August 31, 2012.
Four years later, the FDA would reclassify the Prolift and other larger pelvic organ prolapse (POP) meshes as “High risk” or class III, raising the bar on clearance and requiring clinical trials to assure safety and efficacy.
Manufacturers were given 30 months to prove their POP meshes were safe or phase them off the market.
Hyrmoc claims she suffers from pelvic pain and dyspareunia, painful sex.
Slater told jurors that polypropylene (PP) mesh could potentially injure the body when implanted and Ethicon knew PP, mixing with bodily fluids, could cause the mesh to stiffen and become brittle. Doctors, even experts agree, it’s almost impossible to completely remove.
PP poses more risk in vaginal tissue and Ethicon knew that but withheld the information from doctors and their patients said Slater.
“This is too much mesh and you will see it in document after document, they knew it was too much mesh… they were looking for lighter weight, larger pore. They had to figure out a way to solve this.”
Defense will say that polypropylene mesh was used safely for 60 years but consider the fact that historically that mesh was made into a suture. Transvaginal mesh implants involve a larger quantity of mesh. “The risk/benefit ratio is completely different for a suture than for mesh,” he said.
Jurors must decide based on “the preponderance of evidence.”
Evidence for the plaintiff will show an Ethicon power point plan to bring doctors in and teach them how to use Prolift. Sales reps were told to bring in doctors for training who can do a lot of surgery and influence other doctors, “because this is about money,” he said.
Explaining that some women experience a foreign body reaction to the PP mesh implant, he added that too much material creates a foreign body reaction and “the body rejects the invader.”
“They knew it was too much mesh.”
J&J is a company worth $70 billion and it should pay for its mistakes. “We know the only language they speak is money….. the only way to deter them and to punish them is to make them pay.”
Attorney for Ethicon, Judy Wahrenberger, said Hrymock had a long history of pelvic problems and that all surgeries carry risks. She claimed that Hrymoc’s complications resulted from surgery, not the meshes.
Scott Ciarrocca was called as the first witness. He was an Ethicon engineer who helped bring Prolift to market. Ciarrocca has a background in electrical engineering and still works for Ethicon.
During testimony in the Hammons trial (here), Ciarrocca told jurors that safety concerns over Prolift had been answered and the conclusion was it was safe and effective, despite the 20.1 % failure rate.
Slater told jurors “The defective design is unreasonably dangerous, It’s a stupid idea.”
Prolift has been found defectively designed in two cases heard in the Philadelphia Court of Common Pleas – Hammons ($12.5 million) and Beltz ($2.16 million).
TVT-O was found defectively designed in the September 2014 case of Jo Huskey ($3.27 million). TVT-O (obturator) remains on the market.
J&J is facing more than 55,000 similar cases worldwide including a class action case of 700 women currently underway in Sydney Australia.
Expect the Hrymock trial to last at least four weeks before New Jersey Superior Court Judge Rachelle Harz. ###
MND, The Launch of Prolift Pelvic Mesh- What the Company Knew, MND January 9, 2015
MND, Ethicon Stops Selling Four Pelvic Meshes, June 2012
MND, Pelvic Mesh Trial Outcomes So Far, October 2017
MND, Day 18 Linda Gross Trial, February 6, 2013, Surgeon says Prolift Warnings were Adequate
MND, Day 16, Linda Gross v. Ethicon, February 4, 2013, Scientist Knew Prolift Transvaginal Mesh was Defective
MND, Dec. 10. 2015, Witnesses in Philadelphia Mesh Trial Tell Tale of Prolift Mesh Marketing