Adam Slater, Courtroom View Network

Mesh Medical Device News Desk, December 14, 2017 ~ The case of Elizabeth Hrymoc returned with a jury verdict of $15 million for the mesh injured woman including $10 million in punitive damages.

This was the second New Jersey product liability trial naming as defendant Johnson & Johnson and its Ethicon division.

The Prolift transvaginal mesh used to treat prolapse, and the TVT-O were both implanted in Ms. Hrymoc. 

The jury was charged with finding a wanton disregard for patient health.  In its findings, the jury of ten decided the company displayed malicious intent.

The  breakdown is as follows:

$5 Million Compensation ($4 million for her,  $1 million for husband)

$10 Million Punitive Damages

Prolift- Defectively Designed AND  Failure to Warn

TVT-O Failure to Warn

The Hrymoc (RYE-mock) v. Ethicon case went to the jury about 9:30 this morning, Thursday, December 14. See Superior Court of New Jersey Law Division – Bergen Co Docket No BER-L-13696-14 MCL.

The ten jurors (6 men, 4 women) from Bergen Co., New Jersey decided the Prolift transvaginal mesh was defectively designed and that warnings given to surgeons were inadequate.  They also decided warnings from Ethicon to end user, surgeons, was inadequate with the medical device mesh TVT-O.

Slater did not pursue a defective design claim against TVT-O.

Both meshes have been found defectively designed in previous product liability trials.

Slater  tells MND: 

Adam Slater, Mazie Slater Katz Freeman

“I want to talk about the women who have shown courage and resolve – this verdict is for them!  Elizabeth Hrymoc always made it clear she was going to trial for the other women still in the court system, waiting for their trials and settlements and for the opportunity to go to trial.  This outcomes gives hope -their time will come.”

Elizabeth Hrymoc and her husband, Tad have been in the courtroom listening to both sides in this product liability trial ever since it began Monday, November 27. See MND story here.

The 71-year old research technician from South River in Middlesex County, claims the two meshes caused her injuries.

Slater adds that the jury loved Ms. Hrymoc. She came to the U.S. from Poland in her 20s.  She went to college full time studying to be a chemical research technician while raising three kids. Eventually she worked for Mobil.

In the Hrymoc trial opening, Mr. Slater called Prolift, “a stupid idea” with too much mesh that incites a foreign body reaction.

See MND story on Mesh Explant findings (here).

This is only the second pelvic mesh case to be heard in New Jersey.

Linda and Jeff Gross, from PBS Need to Know

The Linda Gross trial concluded in February 2013 with an $11.1 million jury award, which Ethicon (J&J) immediately appealed. The appeals were exhausted and the case finally concluded one year ago.

See verdict story here  and  here.

*Late Add here*  Ethicon in a statement, reported by Northjersey.com says:

“Ethicon intends to appeal this verdict, as we believe that the evidence showed that the company appropriately informed surgeons of pertinent complications and that the products were properly designed and studied,” said Mindy Tinsley, a company spokeswoman. 

Slater and Prolift, NorthJersey.com

THE TESTIMONY

Hrymoc had two mesh implants made by the Ethicon division of J&J – Prolift, a large multi-armed mesh implant used to hold up sagging internal organs, and a TVT-O, used to support a urethra to treat stress urinary incontinence. Both are made by Ethicon.

The TVT-O is still on the market but the Prolift was quietly taken off the market in 2012.

Prolift, MedTech Marketing

Ms. Hrymoc underwent three revision/removal surgeries but the last one had to be stopped midway through because she lost too much blood and needed transfusions.

Now she lives with chronic pain, mesh erosion and dyspareunia.

The arms of the Prolift were banded, evidence showed.

It seems obvious she is suffering, emailed one observer in the courtroom.

Her implanting surgeon was gynecologist, Dr. Mark Mokrzycki.  Hrymoc says she never received adequate warning about the potential risks.   Dr. Mokrzycki testified at trial that he would not recommend the product today with what he now knows.

The Ethicon consultant taught Prolift procedures to others. At trial, J&J attacked him blaming him for overtensioning the Prolift mesh.

The two-week trial included testimony from Ethicon’s Scott Ciarrocca, an electrical engineer by training who helped bring Prolift to market.

During testimony in a previous trial (Hammons), 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 and concerned expressed by scientists within Ethicon.

Both Prolift and TVT-O were cleared for marketing by the FDA without any clinical trials required under the agency’s 510(k) regulation. Prolift was marketed by J&J even before the company had alerted the FDA, evidence showed in the Gross trial from 2013.

Elizabeth Kaveler, a urogynecologist consultant, also appeared for Ethicon. She testified that mesh “does not have a life of its own,” and does not move around within the pelvis.

The issue of spoliation, or intentional destruction of documents that were under a litigation hold in this case, were to be addressed.  See MND story on that issue here.

 

TVT-O from beckenbodenzentrummuenster.de

JURORS MUST DECIDE

The jury was asked to meet the “wanton and willful disregard for patient health and safety” standard.  This can be a big hurdle to clear as it goes to malicious intent.

The ten jurors (six men, four women) will decide if the Prolift has a design defect and whether J&J failed to warn doctors about its risks.

For the TVT-O jurors will decide if Ethicon adequately warned doctors about its risks.

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).

Nearby Philadelphia pelvic mesh trials have yielded jury awards ranging from $2.16 million to $57 million.

Jurors have the option to award punitive damages, which typically exceed compensation for injuries in these pelvic mesh trials.

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,” Slater told jurors.

Ethicon/ Johnson & Johnson is facing in excess of 55,000 product liability cases filed around the world, according to its SEC filing.  ###