Mesh Medical Device News Desk, November 19, 2018 ~ Suzanne M. Emmett, from Lancaster Pennsylvania is getting ready for the trial that will determine her future.
Suzanne is in her 60s and is married to Michael. Their defective product case is filed in the Philadelphia Court of Common Pleas before Judge Kenneth J. Powell [No.1307-014975] and involves some names familiar to readers of Mesh News Desk.
The defendant is Ethicon Women’s Health and Urology along with Secant Medical, Prodesco, Johnson & Johnson, Gynecare. Ethicon is the medical device division of Johnson & Johnson.
Emmett has a Prolift implant as well as a TVT-O, 10 mesh erosions, 9 revision surgeries, and several Botox injections, and multiple silver nitrate applications. She continues to work in the insurance industry. Prolift is one of the largest meshes ever put in a kit complete with trocars used to implant it in a blind procedure. In mid-2012 it was removed from the market.
Image: Dr. Patricia Reddy, implanting physician
Prolift, MedTech Marketing
On May 14, 2007, Ms. Emmett was implanted with Prolift by surgeon Patricia Reddy, MD, board certified in obstetrics and gynecology, at Pinnacle Health in Harrisburg, Pennsylvania. On the same day she also received a TVT-O. She had delivered two large babies vaginally and was suffering from prolapse.
By the next year she had corrective surgery to remove one of more the products with Dr. Vincent Lucente at St. Luke’s Hospital in Allentown, PA.
On or about January 2012, she underwent another corrective surgery to remove pelvic meshes during a third surgical procedure conducted by Dr. Nils Stenman at May Grant Associates in Lancaster, PA. She had another revision in 21012, again by Dr. Lucente in Allentown. By the spring of 2012, Emmett underwent another corrective surgery to revise or remove the mesh during a fifth surgical procedure conducted by Dr. Vincent Lucente. There was a sixth procedure, again done by Dr. Lucente, and then a seventh one year later.
Today she suffers permanent injury, mental and physical pain, economic loss says her complaint.
Prolift was introduced into the market in early 2005 without any FDA clearance. The defendants felt it was unnecessary because the mesh made of Prolene, already had clearance, even though The Prolift system was an entirely new product, pre-cut, prepackaged with tools in one-size fits all, for the repair of pelvic floor prolapse.
Contrary to its claims, there was a high vaginal mesh erosion rate of 15.6 % in one multi-center randomized controlled trial in August 2010. It concludes there was “no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.”
Prolift, and three other problematic meshes were quietly removed from the market by Ethicon after the Food and Drug Administration announced it would order the company to conduct randomized, controlled clinical testing of pelvic mesh products. It remains off the market in the U.S.
Kila Baldwin, Kline Specter
Ms Emmett is represented by Kila Baldwin and Elia Robertson of Kline Specter. Likely jury selection will begin on Monday, the 26th and could continue for up to three days. Judge New will select the judge to oversee the trial. The plaintiff expects its side to take about 8 days. The trial could conclude mid-December.
The complaint states that Ethicon, the medical device division of J&J, defectively designed the manufactured Prolift, the complaint alleges and failed to warn doctors of all of the potential dangers. The company was negligent in its manufacture, design labeling, warnings, instructions, sale and marketing and it had a duty to exercise reasonable and ordinary care in the recruitment and training of physicians and surgeons to implant mesh products. A failure to do so has resulted in catastrophic injury.
The complaint also alleges common law fraud; there were other products and procedures; mesh was not adequately tested; the defendant deliberately failed to follow-up on adverse results coming into it and from clinical studies; the company failed to monitor implanted patients and was negligent in its misrepresentations to the medical community and assurances the mesh was safe and effective; breached an express warranty; breach of implied warranty; and the defendant violated state consumer protection laws; and expressed a grossly negligent disregard for the rights of others , the public and plaintiff Emmett.
Also the Emmetts’ have entered a claim for loss of consortium impacting the marital relationship.
Melissa A. Merck of Drinker Biddle & Reath, Joseph O’Neil of Lavin, O’Neil Cedrone & Disipio, Julie Callsen of Tucker Ellis and Nils Burt Snell of Butler Snow and Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum represents J&J/Ethicon.
MOTION FOR PROTECTIVE ORDER
Dr. Lucente at work
In October, Ethicon filed a protective order to prevent lawyers from deposing for a second time Dr. Patricia Reddy. Ethicon argued that since Dr. Reddy hadn’t treated Ms. Emmett since 2007, and since Kline and Specter fully participated in taking her deposition, that she shouldn't be required to undergo another deposition.
The original deposition was conducted June 21, 2018.
In it, Dr. Reddy said she was she was trained on how to do a Prolift implant by Dr. Lucente at his facility in the Lehigh Valley. She was also trained on the transobturator tape or TVT-O. Altogether she was trained on four Gynecare devices by Dr. Lucente.
Documents from the Linda Gross trial show Dr. Lucente was compensated millions of dollars to be a “preceptor” or trainer of doctors encouraging their use of J&J pelvic mesh products. He also trained the implanting physician in the Joan Budke's wrongful death case in Missouri in 2014.
During the deposition Dr. Reddy affirmed that today she would stand by her decision to use mesh to treat Ms. Emmett.
The Motion to Quash the second deposition was granted by the court Judge Arnold New, but on October 29, attorney Baldwin re-issued a subpoena for Dr. Reddy to testify live at trial instead of via videotape. To avoid that fate, Dr. Reddy agreed to another videotaped deposition November 8..
Dr. Reddy, continues to practice medicine in York County, Pennsylvania.
This will be the first pelvic mesh case tried in this Philadelphia court since, McFarland v Ethicon which resulted in a deadlocked jury September 24. That case has been reset for a March 11,2019 re-trial.
So far, of seven trials conducted in this venue, all but two have been decided for the plaintiffs amounting to more than $105 million. There are 89 other cases against Ethicon and Secant waiting for trial in this venue. ###