Mesh News Desk, Feb 23, 2016 ~ A federal trial in Georgia delivered another blow to Johnson & Johnson over its pelvic mesh.
On Thursday, February 18, a jury deliberated three hours to award plaintiff Teresa Taylor $4.4 million, which includes $400,000 in compensatory damages and $4 million in punitive damages.
Taylor had the Mentor ObTape transobturator vaginal sling implanted in March 2014 to treat incontinence.
Taylor alleged the device eroded and caused “chronic, infections, pain, exacerbation of her urinary incontinence and the need for multiple additional surgical procedures and medical treatment as well as the need for extensive future medical care.”
She has had a partial removal of the Mentor ObTape and another mesh implanted made by Coloplast, the Aris. See the link here .
Johnson & Johnson, which acquired Mentor Corp in 2009, agreed last month to settle about 100 ObTape pelvic mesh cases.
Ed Blizzard, of Blizzard & Nabers, a Houston, Texas firm (here) tells Mesh News Desk the Mentor ObTape (transobturator mesh placement) was made of a different mesh and should never have been put on the market.
“It was made of nonwoven heat welded polypropylene (PP) mesh, laid out on a conveyor belt. A device like a heated waffle iron then fuses the fibers together. The diamond-shaped melted areas of tape that hold the fibers together, those are impermeable.”
In other words, unlike current woven PP mesh with small pores (about 1 mm), the Mentor ObTape was a solid piece of plastic that blocked oxygen from the pelvic region causing chronic pain and infections.
Blizzard adds that the heat welding process began the degradation process even before the mesh was implanted.
The case was Teresa Taylor v. Mentor Worldwide, LLC, Case No. 4:12-CV-176 (CDL), In The United States District Court For The Middle District Of Georgia, Columbus Division.
The case included expert witness Dr. Catherine Ortuno, who used to work for Johnson & Johnson in charge of device vigilance, testify ObTape needed to be off the market. Ethicon consultant Dr. Michel Cosson had reported serious infection to the company in May 2004 telling J&J his patient had a serious leg wound that needed a hyperbaric chamber for treatment.
FIRST PELVIC MESH MDL
The Mentor cases were consolidated under the first multidistrict litigation (MDL) ever formed concerning pelvic mesh.
In December 2008, the Judicial Panel on Multidistrict Litigation created MDL No. 2004 in the Middle District of Georgia to consolidate the 17 initial defective product cases naming the ObTape. See In re Mentor Corp. ObTape Transobturator Sling Products Liability Litigation, 588 F.Supp.2d 1374 (J.P.M.L. 2008),
The day before the MDL was formed, J&J settled 111 Mentor ObTape claims.
Of an estimated 35,000 women who were implanted with the Mentor ObTape between the years of 2003 and 2006, when it was taken off the market, about 300 cases remain unresolved.
Coloplast bought the Mentor product line in summer 2006 to obtain the Aris pelvic mesh.
J&J acquired Mentor for its breast implant division.
MENTOR OBTAPE BACKGROUND
a June 8, 2010 settlement resolved the majority of cases in the MDL against J&J unit Mentor Corp over its ObTape transobturator sling. It happened in the fifth day of trial in US District Court for the Middle District of Georgia. The settlement covered three cases consolidated against Mentor with attorney Henry Garrard representing the plaintiffs before Judge Clay D. Land.
Plaintiffs argued Mentor had a defective design manufacture and marketed the ObTape used to treat incontinence it was brought to the market in 2003 and taken off the market in 2006. J&J acquired Mentor Corp in January 2009.
In November 2015, Mentor settled with a plaintiff just weeks before her trial was scheduled to begin. She was one of six bellwether trials. The plaintiff had the ObTape implanted in 2004. By 2011 she suffered abscesses, scarring and infections and underwent multiple surgeries. ##
By August 2006 an article in the Journal Urology cited the high rate of vaginal erosions associated with the Mentor ObTape.
Despite using a new material, there were no clinical trials to assure the safety of the material. There were no warnings about the potential problems of infection, scarring mesh extrusion abscess, as well as ongoing incontinence. When the Journal of Urology in 2007 said the Mentor tape has been recalled, Mentor reportedly demanded a retraction from the authors, which was printed in the subsequent issue. According to the company, the marketing of the OBTape was discontinued “because of an introduction of a second generation product” by Mentor Corp in March 2006. Read more here.
Urology, by Andrew Siegel, November 2005
Siegel writes the Mentor ObTape was the first transobturators sling developed as an alternative to the retropubic suburethral sling to support the urethra. Micropore monofilament minimally elastic, nonwoven pp mesh. Use results in unacceptably high rate of defective vaginal wound healing and mesh extrusion, says an article in November 2005 Urology.
Government Publishing Office, Mentor Corp. ObTape Transobturator Sling Products Liability Litigation