Prolift Trial Moves into Closing Arguments

Mesh Medical Device News Desk, January 30, 2019 - Emmet Closing Arguments

The trial of Suzanne Emmet moves into closing arguments today in a Philadelphia courtroom after a lengthy trial that began before the holidays. *Please note, Emmet is spelled both ways in filed documents, with one "t" or two.

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Image: Kila Baldwin, Kline Specter Law

Emmet was implanted with a Prolift pelvic mesh used to treat pelvic organ prolapse (POP).

The Prolift is made by Ethicon (Johnson & Johnson) as was the TVT-O she also received as a treatment for incontinence.

The trial began in November before Judge Kenneth Powell (Case No. 01495) in the Philadelphia Court of Common Pleas.

The allegations are negligence, defective design and failure to warn.

Dr. Patricia Reddy, implanting physician

Emmet received the polypropylene mesh devices May 14, 2007, implanted by Dr. Patricia Reddy at Pinnacle Health in Harrisburg, PA. She had given birth to two large babies, which allegedly weakened and damaged her pelvic floor.

According to lawyer and blogger Deborah Silver (here) Dr. Reddy had five training sessions with Ethicon and “believes the risks of the mesh were temporary and could be treated.”

Since that time she has been treated for ten mesh erosions, had nine revision surgeries, several Botox injections and multiple applications of silver nitrate.

Dr. V. Lucente

Her 2008 removal surgery was conducted by Dr. Vincent Lucente, of Allentown, PA, well known as a consultant to Ethicon. He removed a 3 by 1 cm piece of eroded mesh, also known a partial removal. Dr Lucente treated her for eight years.

Ms. Emmet claims her injuries are permanent, and she suffered mental and physical pain, an inability to have sexual relations, as well as economic loss. The mesh allegedly eroded into her vagina and left a scar plate and vaginal deformation. She experienced frequent and chronic urinary tract infection and inflammation.

She is represented by Kila Baldwin and Elia Robertson of Kline Specter.

Attorneys for Ethicon are Tarek Ismail, Anita Modak Truran and Joe O’Neil.

Dr. M. Tom Margolis

THE TRIAL

Dr. M. Tom Margolis was called as the first witness.

Margolis has appeared at many defective product trials. He is a pelvic floor surgeon and still does about 10 surgeries a week with many more requests for revision surgeries. He says he’s removed about 600 transvaginal meshes over the past 20 years.

He currently uses about 5 inches of suture material to treat a prolapsing vagina versus a mesh implant which contains 500 feet of mesh.

He testified that Prolift is defective and the risks outweigh the benefits. The same for Gynemesh and TVT-O.

from Women of Influence, 2018

Dr. Margolis did examine Ms. Emmet in his California office, a basis for his expert opinion and testimony.

He testified that a polypropylene medical device is not inert, the immune system recognizes it is there; scar tissue shrinks taking with it the mesh, nerves, muscles and surrounding tissue causing pain. The vagina cannot move when that happens.

He testified that Ms. Emmet had a “garden variety” prolapse, and no symptoms from her prolapse.

In Medieval times women suffering prolapse were hung upside down and Dr. Margolis opined that using Prolift is also barbaric. Prolift was voluntarily removed from the market in June 2012.

As is often the case, defense wants to show the jury that he is paid – Dr. Margolis charges $3,000 for a day of trial testimony and $400 an hour to review records. This is the standard exchange for experts on both sides of an issue. In the last ten years he reported earnings of $604,126.84 on pelvic mesh cases he has worked on but that represents 5% of his overall income.

He also spends time on self-funded trips to Uganda to provide medical services.

DANIEL ELIOTT UROLOGIST, PLAINTIFF EXPERT

Dr. Daniel Elliott, Mayo Clinic Urology, Rochester MN

Another expert for Emmet was Dr. Daniel Elliott, a urologist at Mayo Clinic in Rochester, MN and long-time opponent of the use of pelvic mesh. Dr. Elliott is board certified in urology, gynecology and reconstructive surgery.

He sees between 3-5 women a week suffering from complications. He used absorbable mesh sutures as part of his treatment.

Dr. Elliott signed onto the 2011 Public Citizen campaign to recall synthetic surgical mesh.

Dr. Elliott told jurors Prolift mesh was not needed, suture repairs can be used to repair prolapsed organs. He recounted the rate of erosion in mesh six to 12 % when using mesh to repair prolapse and there is a 21% erosion rate for the Prolift leading to the need to re-operate.

He called the concept of “tension-free” impossible in the human body which needs to be able to move.

Dr. Elliott disagrees with reports of native tissue repair failing 30-40% of the time.

The defense pointed out that Dr. Elliott never did a Prolift implant in any patient by choice and has not received any training in the procedure.

Looking for more trial testimony go to the blog of lawyer Deborah Silver on Dr. Lucente and Dr. Katrin Elbert, an engineer at Ethicon here.

PHILADELPHIA COURT OF COMMON PLEAS

Philadelphia Court of Common Pleas

The Philadelphia venue has been very favorable to mesh-injured plaintiffs in the past considering the jury verdicts so far including:

Hammons $12.5 million (Prolift), Dec. 2015

Carlino $13.5 million; (TVT), Feb 2016

Engleman $20 million, (TVT-S), April 2017

Beltz $2.16 million (Prolift), May 2017

Ebaugh $57 million (TVT and TVT-S), September 2017

McFarland, mistrial but set for a new trial, September 2018

LEARN MORE:

MND, After a Lull, Philadelphia Readies for JNJ Prolift Mesh Case, November 19, 2018
https://www.meshmedicaldevicenewsdesk.com/after-a-lull-philadelphia-readies-for-prolift-mesh-case-against-jnj/

MND, Emmet Prolift TOT Mesh Trial in Philadelphia Adjourns Until January, December 11, 2018
https://www.meshmedicaldevicenewsdesk.com/emmett-prolift-tot-mesh-trial-underway-in-philadelphia/

MND, Philadelphia Gets Green Light as Venue for J&J Pelvic Mesh Cases, May 23, 2018
https://www.meshmedicaldevicenewsdesk.com/philadelphia-gets-green-light-for-ethicon-pelvic-mesh-cases/

MND, Public Citizen: Recall Synthetic Surgical Mesh, August 2011
https://www.meshmedicaldevicenewsdesk.com/public-citizen-recall-synthetic-surgical-mesh/

MND, Mesh Trials so Far Plaintiff v Defendant
https://www.meshmedicaldevicenewsdesk.com/mesh-trials-far-tally-plaintiff-v-defendant/