While Mesh News Desk (MND) is not in the courtroom in Philadelphia for the Hammons v. Ethicon pelvic mesh trial (Case No. 130503913, Court of Common Pleas), reports are that two of the witnesses who have appeared on the stand in Philadelphia have appeared for plaintiffs during previous Prolift pelvic mesh trials.
Their stories tell a tale of how the Ethicon Prolift mesh kit mesh made it to market, blowing through any stop signs of safety and efficacy.
Ms Hammons received a Prolift pelvic mesh implant in 2009 to treat prolapse. She contends mesh particles had become implanted in her bladder, she has pain, infection, urinary and sexual dysfunction.
Ethicon is a division of Johnson & Johnson, the company facing in excess of 30,000 pelvic mesh product liability lawsuits, more than any of the other six manufacturers.
Ethicon engineer, Scott Ciarocca was on the stand and questioned by Adam Slater (Mazie Slater) in the Hammons case as was Dr. Anne Weber.
Both also appeared in the Budke Prolift case in Missouri in January, 2015. See MND on the Budke trial here.
Scott Ciarocca still works as an engineer for Ethicon Inc of Sommerville, NJ, the medical device division of Johnson & Johnson. Ciarocca started in research and development with the company in 1997. By June 2002, with just a bachelor’s degree in electrical engineering, he would became the head of the unit that would bring the Prolift to market.
Prolift is no longer marketed in the U.S. as a medical device to shore up sagging pelvic organs. It is one of the largest meshes ever produced and came in a box sent to doctors who had been trained on its use by other doctors/ consultants known as ‘preceptors.’ The company launched Prolift in March 2005, despite warnings from doctors inside the company.
Ciarocca would rely on the medical expertise of the Worldwide Medical Director Dr. Charlotte Owens, plucked from obscurity from a Florida women’s clinic and just four years out of her residency. The gynecologist would be in charge of signing off on documents presented to her to launch the Prolift.
A french team of doctors worked for Ethicon as consultants help bring Prolift to market. Among them was Professor Bernard Jacquetin, who led the group and held the patent on Prolift. Eventually he would sell his invention to the company.
In the Budke trial, Slater asked Ciarocca if a six-month study would provide enough assurance the product was safe.
“We did have extensive experience with suture mesh and Gynemesh PS” answered Ciarocca in the Budke case, comparing suture thread and flat hernia mesh with the Prolift.
The group performed more than 200 transvaginal mesh (TVM) implants with no slippage. But mesh erosion wand retraction was a problem and the European clinical study failed the grade. The failure rate at six months was 12.6 percent but when the confidence interval was applied it went to 20.1 percent. At the same time, the clinical strategy recurrence rate needed to be under 20 percent.
Ciarocca said he was not familiar with what was going on with the TVM group in Paris, he didn’t know if the design evaluation was flawed. However, in the Budke case, Slater affirmed Ciarocca was the principal developer of Prolift and in a position to know.
Two months before the March 2015 launch of Prolift, a member of the French team, Dr. Axel Arnaud, wanted to add a warning to the Instructions for Use (IFU) about a vaginal placement of mesh and the potential for complications but Ciarocca’s said the IFU stock was already printed. They would have to wait until the next revision.
On March 4, 2005 Prolift received the product release authorization to sell the Prolift. No studies had been done on the marketed kit, just on the tools (trocars) but not on the pre-cut mesh that would be the Prolift.
Law 360 reports here Ciarrocca testified in the Hammons case, the company had concluded Prolift pelvic mesh was safe and effective before it was sold. Adding to his testimony in the Budke case he explained the 20.1 percent failure rate was only revealed after the device was on the market. Prior studies had shown lower rates, he told jurors.
During testimony in the Hammons trial, Ciarocca he told jurors that safety concerns over Prolift had been answered and the conclusion was it was safe and effective.
ANNE WEBER, MD
Anne Weber has appeared as an expert witness for the plaintiffs in at least three pelvic mesh trials concerning Ethicon. (See the Linda Gross trial here. See the Budke trial here.) During the Budke trial, defense told jurors she is no longer a licensed urogynecologist and has never implanted a Prolift. She has made hundreds of thousands of dollars as an expert.
Weber helped develop the sub-specialty of urogynecology and has authored numerous articles on the field. She testified during the Budke trial that the ACOG (American College of Obstetrics and Gynecology) bulletin she authored had described the the mesh placement practice as “experimental.” That was later edited to remove the word “experimental” after numerous preceptors (industry consultant/ doctors) complained to ACOG. Weber testified doctors were concerned that insurance would not pay for an ‘experimental’ procedure.
She told jurors in the Budke case that Ethicon doctors/ developers were unhappy about the long-term complications for the Prolift mesh and wanted to replace it. It failed to fulfill expectations, Dr. Weber said.
Lawyers for defense include Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP. Adam Slater of Mazie Slater and Shain Specter of Kline & Specter. The trial is expected to take two weeks. #
Philly.com coverage of Day One