Mesh Medical Device News Desk, April 28, 2017 ~ In the last 15 months J&J and its Ethicon medical device division has accrued $34.5 million in punitive damages over its transvaginal meshes.
Another 200 cases await trial in this Philadelphia courtroom and hundreds are poised in a Bergen, New Jersey court ready for trial.
The three-week transvaginal mesh trial of Engleman v. Ethicon (140305384) concluded in a Philadelphia court Friday afternoon with a $20 verdict for Ms. Peggy Engleman, 56 of Cinnaminson, PA.
The jury awarded $2.5 million in compensatory damages for the complications she suffered from the TVT-Secur transvaginal tape used to treat incontinence after being implanted in 2007.
Jurors also hit Ethicon with $17.5 million in punitive damages, the highest amount of punitive damages awarded so far among the transvaginal mesh cases heard in this court.
Jurors decided TVT-Secur was defectively designed and the instructions were inadequate and the device maker failed to warn the doctors and patients about its potential dangers.
The TVT-Secur (TVT-S) is a polypropylene mesh “hammock” that cradles the urethra to treat incontinence. It is tethered in place with two arms that extend up through the buttocks.
TVT-S was cleared for market in 2006 without any clinical trials through the U.S. Food and Drug Administration’s 510(k) clearance process.
It was removed from the market voluntarily by J&J in mid-2012 along with three other problematic pelvic meshes. The company said it was for financial reasons. See MND story here.
Engleman v. Ethicon began April 10 before Judge Ann Butchart of the Philadelphia Court of Common Pleas. It was the first transvaginal mesh trial in this court in 14 months.
Ms. Engleman was represented by Christopher Gomez of Kline Specter, Ben Anderson of Anderson Law and Bryan Aylstock of Aylstock Witkin Kreiz and Overholtz.
Representing Johnson & Johnson/ Ethicon was Jim Campbell, Rita Maimbourg and Burt Snell of Butler Snow.
This is the third in a series of Johnson & Johnson losses in the Philadelphia Court of Common Pleas.
In the previous cases, Hammons and Carlino, heard in the same court in December 2015 and February 2016, delivered a $12.5 million verdict and $13.5 million to the plaintiffs, respectively, which included $17 million in punitive damages.
With today’s verdict, J&J is facing $34.5 million in punitive damages from three transvaginal mesh trials recently heard in this court.
Testimony for the plaintiff included Dr. Bruce Rosenzweig, who told jurors that polypropylene mesh will degrade, fray and lose particles. It can cause chronic foreign body reactions, fibotic ridging, mesh contracture/shrinkage and loss of pore size with tension.
Dr. Rosenzweig, a urogynecologist from Rush University in Chicago, has been an expert in a number of previous transvaginal mesh trials.
No information was included in this case about the role the Food and Drug Administration plays in clearing transvaginal mesh for market through the fast-track 510(k) approval process.
The Philadelphia Court has nearly 200 transvaginal mesh cases waiting to heard primarily naming defendants Johnson & Johnson and Boston Scientific.
There are 102,000 product liability lawsuits consolidated in federal court in Charleston, West Virginia naming six defendant mesh makers, J&J and Boston Scientific among them.
DETAILS ABOUT THE TRIAL
Ben Anderson tells Mesh News Desk that the jury was made up of four men and eight women of varying ages. There were two Caucasians, an Asian and the rest were African-American.
After experiencing incontinence, Ms. Engleman received the TVT-S in 2007 but within one month she reportedly had a return of her condition. She also began experiencing pain and discomfort when her mesh device eroded into her vagina.
Doctors were unable to remove the TVT-S during the three surgeries she endured.
Today, she still has urinary dysfunction, pelvic floor spasms and vaginal pain.
CBS News (here) quoted Engleman as saying, “I’m happy I could be a voice for other women, It’s been a nightmare, and I feel justice was truly served today.”
Testimony at trial revealed TVT-Secur was tested on live sheep and dead sheep, cadavers and 31 women for five weeks before it was rushed to market.
Trying to improve on TVT (tension-free tape) the TVT-S is considered a mini-tape since it is shorter than a typical incontinence device. Anderson says it was completely different because it came with fleece tips like velcro that had never been used before and arrowhead introducers. The polypropylene mesh material is heavy weight and small pore.
Ethicon’s own documents were the most powerful. It said “Our cardinal sin was to rush to market without sufficient clinical data.”
Ms. Engleman’s ob-gyn and urogynecologist both blamed her injuries on the TVT-S. TVT-S and three other
70% FAILURE RATE
Some of the most damaging testimony came from the Ethicon consultant Dr. Haab who wrote in an article “Promises Made-Promises Broken” (here) that the failure rate of TVT-S was 70%.
Dr. Haab was a consultant for Gynecare, the women’s health division of Johnson & Johnson.
In that study almost 40% of the women participating suffered serious adverse events with the device. Ethicon/ J&J never published the study.
When J&J preceptor Brian Flynn was asked if J&J ever shared the data, he said No.
Anderson asked, “Was it important?” “Yes.”
The report said the TVT-Secur cannot be recommended for a first-line treatment.”
Anderson asked Flynn, “Did they share this with you?” “No.” Was it important? “Yes.”
Anderson tells MND that Flynn appeared shocked. Sitting on the stand before the jury was a watershed movement when he first learned about the existence of this document.
Anderson pointed to an empty chair during his closing arguments pointing out that the company, though only 100 miles away, failed to put a single representative on the stand to defend their product. He pointed to the empty chair during the closing.
“When the jury saw the amount of information on serious health risks to women that existed before it was ever launched, they decided there was clear and convincing evidence that Ethicon and Johnson & Johnson maliciously and with wanton disregard for women put this device on the market, that they put profits before people and they deserved to be punished,” said Anderson.