TVT SEcur from Russian website
Mesh Medical Device News Desk, June 9, 2017 ~ The trial of Kimberly Adkins enters its 13th day in a Philadelphia Courtroom, focused on the Ethicon pelvic mesh product TVT-Secur, which is no longer on the market.
The trial of Kimberly Adkins v. Ethicon and Johnson & Johnson kicked off Tuesday, May 23rd in the Philadelphia Court of Common Pleas which has become the venue pitting pelvic mesh-injured women against healthcare giant, Johnson & Johnson, and its Ethicon medical device division.
Philadelphia Court of Common Pleas
In this case, on or about July 20, 2010, Kimberly Adkins was implanted with Gynecare TVT-Secur during surgery performed by Dr. George Pettit, at Southern Ohio Medical Center in Portsmouth, Ohio.
Adkins had one mesh removal attempt in September 2012.
The polypropylene mesh implant had eroded into her vagina causing pain and dyspareunia.
The Philadelphia Court of Common Pleas is the same court where jurors delivered a $20 million verdict in Engleman v. Gynecare April 28, 2017. She too was implanted with a TVT- Secur. MND coverage here.
Adkin's law firm, Aylscock Witkin Kreis and Overholtz of Pensacola, Florida, says Ethicon rushed Secur to market despite serious concerns about the potential for a high rate of failure and complications. Internal documents show the company did not conduct randomized clinical trials before it was marketed in September 2006.
Ethicon had tested Secur on 31 women, which showed a 30 percent failure rate, while 60 percent of the women experienced complications, according to trial documents.
Those initials results came one week before Ethicon marketed TVT-Secur.
The defense is represented by Kimberly Bueno, who according to Law 360, stressed this case is not about Ethicon’s conduct but about Adkins’ injuries. She blames Adkins' dyspareunia on vaginal atrophy and a lack of estrogen, common as women age.
Adkins' implant surgeon said they discussed the risks of erosion before surgery.
SECUR OFF THE MARKET
Secur is one of the pelvic meshes the FDA ordered to be run through randomized controlled clinical testing. Instead, in June 2012, J&J pulled Secur and three other meshes from the market, and the FDA lifted its requirement for any further testing.
This is the fifth case to go to trial in Philadelphia over allegations of defects in various pelvic mesh products made by Ethicon.
Design and manufacturing defect, a failure to warn, negligence, common law fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express and implied warranty, violation of consumer protection law, and gross negligence are all alleged. Punitive damages may be awarded.
If previous cases heard in this court are an indication, punitive damages could be substantial.
In the recent Engleman case, jurors delivered $17.5 million in punitive damages. In the Carlino case, heard in this Philadelphia court in February 2016, the jury awarded Sharon Carlino $13.5 million finding her TVT mesh was defective. The award includes $3.25 million in compensatory damages for her pain and suffering, $250,000 for loss of consortium to Mr. Carlino and $10 million in punitive damages.
See Mesh News Desk on the Carlino verdict here.
Patricia Hammons was awarded $12.5 million in December 2015 after jurors listened to her case against the J&J and its Prolift mesh to treat pelvic organ prolapse (POP). The award included $5.5 million in compensatory damages and $7 million in punitive damages. J&J has quietly removed Prolift from the market along with the TVT-Secur.
See Mesh News Desk on the Hammons trial here.
In the Beltz case which just concluded, jurors did not award any punitive damages but a $2.16 million verdict for Ms. Beltz.
Attorneys may argue about the net worth and profit of Secur to Ethicon, estimated to be, from 2006 through 2012, 1,725 units of TVT-Secur sold in the state of Ohio for a total of $5,619,075 in sales the total net profit was $244,157.
The audited net worth of Ethicon based on financial statement as of December 2016 was $2.7 billion. The total net worth of Johnson & Johnson for the year ending January 1, 2017, according to its 10-K annual report was $70.418 billion.
The case is Kimberly Adkins v. Ethicon Inc. et al., case number 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
She is represented by Bryan Aylstock, Daniel Thornburgh and James Barger of Aylscock Witkin Kreise & Overholtz, Ben Anderson, and Lee Balefsky of Kline Specter. ###