Check Out Our New Forum!
The Your Turn Forum provides a space where people can post questions about mesh and medical device related issues and get advice and support from the Mesh News Desk community.
Join the Discussion!
Prosima for sale on ebay, Sept 21, 2015
MND, September 21, 2015 ~ CAVNESS V. JOHNSON & JOHNSON
Jury selection got underway Monday in the pelvic mesh case of case of Carol Cavness v. Ethicon DC-14-04220. This is the third pelvic mesh trial before Judge Ken Molberg in the 95th Judicial District of Texas. Last April the trial of Linda Batiste resulted in a $1.2 million jury award for Ms. Batiste who had been injured by Ethicon’s TVT-O, which jurors also found defectively designed.
Ethicon is as division of Johnson & Johnson (J&J).
Last October, also before Judge Molberg, Plaintiff Martha Salazar was awarded an unprecedented $73.4 million against Boston Scientific due to the injuries from her Obtryx mesh implant. Both jury awards are being appealed. See story here.
A total of a dozen jurors would be chosen this day and two alternates out of a pool of sixty potential jurors.
Richard Freese, Freese & Goss
Dave Matthews and Richard Capshaw represent Ms. Cavness. William Gage, previously seen as an attorney for Defendant Johnson & Johnson in the Linda Gross trial, again represents J&J.
William Gage, Butler Snow for J&J
Adam Evans of Hollis Law Firm, Prarie Village, Kansas is also in attendance. He has clients who were also implanted with the Prosima mesh.
Ms. Cavness was implanted with the Prosima Pelvic Floor Repair System by Dr. Teresa Kowalczyk, MD. The Plaintiff is suing her doctor, Hunt Regional Medical Center, Baylor Healthcare System.
Mesh News Desk will cover the trial courtesy of a feed from Courtroom View Network and will abide by the restrictions imposed on MND coverage. Court watcher, Joleen Chambers of FIDA (Failed Implant Device Alliance) sat in the proceedings today for jury selection.
Dave Matthews
PROSIMA PELVIC FLOOR SYSTEM
This is the first trial of the Prosima pelvic floor system, implanted in women to treat prolapse to determine if it was defectively designed and manufactured.
Dr. Kowalczyk, implanting physician
In her complaint, Ms. Cavness said her doctor knew or should have known the Prosima had a high rate of failure, injury and complications and failed to perform as intended. Despite that, Dr. Kowalczyk implanted Ms. Cavness on April 24, 2012, nearly a year after the U.S Food and Drug Administration (FDA) said that complications from a mesh implant are “not rare.” The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.
The Cause of Action includes negligence; a failure to warn the Plaintiff prior to implantation; defective design of a product that was unreasonably dangerous; defective manufacture, breach of an implied and express warranty the products were safe for the purpose for which they were intended.
Cavness claims she is in physical and mental pain that will likely continue into her future. She says she has lost the ability earn a living, lost wages and will have medical care and expenses now, and in her future.
The upcoming case of Rabiola v Ethicon to be held in Austin, Texas, October 26 will also examine the Prosima and the TVT-S, both taken off the market.
ETHICON
Surgical mesh was retrofitted from hernia mesh in the late 1990's to be used to support the pelvic organs. Pelvic mesh was approved through the FDA's 510(k) approval process that does not require clinical trials or assurances of safety before being marketed.
In a June 4, 2012 letter from Butler Snow taking four meshes off the market, the law firm representing J&J, Ethicon agreed to “stop commercializing" the Gynecare Prosima Pelvic Floor Repair System, along with three other meshes - the TVT Secur System, Gynecare Prolift and Gynecare Prolift +M.
Prosima on ebay, Sept. 21, 2015
Ethicon attorney's requested the FDA allow it 120 days to "cease commercialization" however, Mesh News Desk found a Prosima for sale in "New Condition" on eBay September 21, 2015.
Within that letter, Ethicon’s attorneys requested the FDA’s place on hold the agency's orders to conduct three-year additional safety studies on mesh already on the market.
Johnson & Johnson/ Ethicon has the largest number of pelvic mesh product liability cases filed in Charleston, West Virginia. At this writing there are 28,868 cases filed against J&J in that federal court where multidistrict litigation is consolidated and a total of 83,301 cases have been filed against seven manufacturers.
J&J continues to fight women in trial rather than offer settlement dollars as some of the other six mesh manufacturers have done.
JURY INSTRUCTIONS
Three pages of jury questions helped both sides select those who will listen to this case. Among the questions typically are – have you ever been arrested or involved in a lawsuit, what is your job, what were your parent’s occupations, what bumper stickers do you have on your car, do you listen to the radio, what are your sources of news, what are your political leanings, among other questions.
The Defendant wanted the judge to instruct jurors not to use the internet during the proceedings.
Late Update- Most of Tuesday was taken up with jury selection. MND will begin coverage of opening arguments Wednesday morning. #
LEARN MORE
Cavness Complaint - Cavness Dallas Original petition
MND, October 19, 2014 ~ Salazar $73 Million Transvaginal Mesh Award Slashed in Half Due to Tort Reform
https://www.meshmedicaldevicenewsdesk.com/salazar-73-million-transvaginal-mesh-award-slashed-in-half
MND, September 8, 2014 ~ Boston Scientific Must Pay Salazar $73.5 Million
Clinical Trial of Prosima, by Ethicon, 2007
https://clinicaltrials.gov/ct2/show/NCT00521066
FDA MAUDE Adverse Event Report: Prosima, 7/24/2012
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2819037
