The product liability case that could turn the tide for healthcare giant Johnson & Johnson over its controversial transvaginal mesh implants begins Monday, August 25.  Jo Huskey, 54, was implanted with a TVT-O, a vaginal sling made of polypropylene (PP) mesh, on February 23, 2011 to treat stress urinary incontinence (SUI).

She experienced mesh erosion and dyspareunia (painful sex) and as many women do, she had a removal surgery in November, 2011. Only part of the medical device could be removed so her stress urinary incontinence returned as well as constant pelvic and vaginal pain.

In February of last year, J&J lost a similar case in its home turf of New Jersey.

In the Linda Gross case, the jury found for plaintiff Gross and awarded her $11.1 million with $7.76 of that award in punitive damages.  Since then the Linda Batiste case in Dallas last April yielded a $1.1 million jury award.

The only time J&J has had a pelvic mesh case go in its favor was in February of this year when Judge Joseph Goodwin in this same court, granted a directed verdict for the defendant J&J in the Carolyn Lewis case. Mesh News Desk coverage is here.

Judge Goodwin will also oversee the Huskey case and is overseeing more than 66,000 similar defective product cases concerning transvaginal mesh made by seven manufacturers that are consolidated in federal multidistrict litigation in West Virginia. J&J has the most cases at 22,000  before Judge Goodwin and faces approximately 35,000 cases nationwide.

Dr. Christina Pramudji, MD

Dr. Christina Pramudji, MD

Witnesses for the Defense 

The defense will be calling Dr. Christina Pramudji MD from Houston, Harry Johnson from Baltimore and Daniel Sexton on the infectious process.

There will be statements made from medical organizations about the safety of the sling. The American Urogynecologic Society (AUGS) believe the transvaginal tape slings used to treat incontinence are the “Gold Standard” and should remain on the market. See background story here.

The deposition of Dr. Pramudji MD was filed July 14, 2014.

See: Huskey Doc #280-10 Dr. Christina Pramudji MD doc for the defense Expert Report.

The U.S. Food and Drug Administration (FDA) concluded a public comment period last month for a proposal to reclassify Pelvic Organ Prolapse (POP) transvaginal mesh to a more stringent class III that will require clinical trials before it is marketed. No mesh currently on the market whether for POP or stress urinary incontinence (SUI) has had that degree of oversight by the FDA to assure safety and efficacy.

Witnesses for the Plaintiff

Bruce Rosenzweig MD

Bruce Rosenzweig MD

Huskey and her team will be calling Dr. Bruce Rosenzweig, Assistant Professor of Ob/Gyn at Rush University in Chicago. He’s done fellowships in pelvic surgery and urogynecology and urodynamics and has performed over one thousand pelvic floor surgical procedures including native tissue repairs, biological grafts and synthetic mesh repairs, as well as synthetic implants TVT, TVT-O and Prolift.

He concludes that Prolene polypropylene mesh used in TVT “causes a multitude of injuries, including the possibility of multiple erosions that can occur throughout one’s lifetime, chronic and debilitating pelvic pain, recurrence, worsening incontinence, dyspareunia that can be chronic, wound infection, rejection of the mesh, sexual dysfunction, urinary and defecatory dysfunction, vaginal scarring, wound healing problems, injury to ureters, bladder and urethra, pelvic abscess formation, risk of infection and/or the need for additional surgeries, among others.”

He concludes it it not suitable as a permanent implant to treat SUI.

Other Plaintiff Witnesses include:

Jerry Blaivas, MD  a surgeon from NYC who will not use transvaginal mesh. See Mesh News Desk story here:

https://www.meshmedicaldevicenewsdesk.com/removing-mesh-and-getting-healthy/open-letter-to-doctors-a-serious-concern-as-doctor-divide/

Erin Carey, M.D.- U of Kansas, a pelvic pain specialist from Kansas City. See more here.

http://www.kumc.edu/school-of-medicine/ob-gyn/faculty/erin-carey.html

and Scott Guelcher Ph.D.- Assistant Professor of Chemical and Biomolecular Engineering, Chemical & Biomolecular Engineering, with a research focus on polymer science and engineering, biomaterials.

More here: http://engineering.vanderbilt.edu/bio/scott-guelcher

Settlements so Far

While American Medical Systems and C.R. Bard have announced settlements are underway in thousands of their pelvic mesh cases, J&J quietly settled three cases in Missouri but has remained steadfast in its commitment to try these cases in court.  #