Preview Newsletter
Ethicon Media Monitoring 09/22/2015
-
Ethicon’s Prosima Latest Pelvic Mesh Trial Gets Underway
Sep 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
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. -
Plaintiff with murder conviction drops pelvic mesh lawsuit against Boston Scientific
Sep 21, 2015 | MassDevice
By Brad Perriello
The plaintiff in a pelvic mesh lawsuit, who wanted evidence of her murder conviction kept out of her case against Boston Scientific (NYSE:BSX), dropped the suit last week. -
Addressing Mesh Recall Questions
Sep 21, 2015 | Surgical Products
By Rebecca Rudolph
Surgical meshes have garnered recall attention from the media, and currently most of those are in regards to pelvic mesh used in gynecology practices.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
-
Ethicon’s Prosima Latest Pelvic Mesh Trial Gets Underway
Sep 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
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.
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 sat in the proceedings today for jury selection.
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.
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 by Butler Snow, 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.
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.
The jury will reconvene for opening arguments Tuesday.
-
Plaintiff with murder conviction drops pelvic mesh lawsuit against Boston Scientific
Sep 21, 2015 | MassDevice
By Brad Perriello
The plaintiff in a pelvic mesh lawsuit, who wanted evidence of her murder conviction kept out of her case against Boston Scientific (NYSE:BSX), dropped the suit last week.
Ramona Winebarger, who in 1995 pleaded guilty to murder in the death of her 1st husband and the shooting of another man, withdrew her suit Sept. 17, according to court documents. Winebarger served 8 years of a 35-year sentence. Earlier this month she lost a bid to quash a Boston Scientific subpoena seeking her employment records, according to court filings.
After suing Boston Scientific in November 2013, Winebarger and 2nd husband Rex Winebarger asked Judge Richard Voorhees of the U.S. District Court for Western North Carolina to exclude evidence of her murder conviction, and another charge of giving a false statement. The Winebargers contended that the statute of limitations and the fact that both events stemmed from “a domestic violence situation” makes the evidence inadmissible.
Marlborough, Mass.-based Boston Scientific argued that Voorhees should allow the evidence, saying it goes toward her claim to have suffered mental anguish from the implantation of its Uphold vaginal support device in 2010.
“Mrs. Winebarger’s medical records, however, establish a long history of anxiety, depression, and flashbacks unrelated to her 2010 surgery. Mrs. Winebarger’s emotional history – which is necessarily intertwined with her criminal record – is directly relevant to her claimed damages,” the company argued. “Moreover, this evidence is also relevant to Mr. Winebarger’s claim for loss of consortium. Boston Scientific does not seek to impeach Mrs. Winebarger’s character for truthfulness – but rather to rebut her claim for damages.”
Boston Scientific also argued that the domestic violence claim calls her credibility into play, as it contradicts her 1995 confession in which she admitted to lying in wait at her 1st husband’s friend’s house before shooting him and wounding the friend.
“Mrs. Winebarger’s current claim that her convictions stemmed from a ‘domestic violence situation’ contradicts her earlier admission that she lied in wait for her husband and ‘had been planning [his murder] all day,'” the company contended in an August 25 court filing.
-
Addressing Mesh Recall Questions
Sep 21, 2015 | Surgical Products
By Rebecca Rudolph
Surgical meshes have garnered recall attention from the media, and currently most of those are in regards to pelvic mesh used in gynecology practices. With the public attention this has attracted, Dr. L. Michael Brunt, immediate past president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), said it’s important to answer any questions patients have about meshes confidently, and also to be educated about the different hernia meshes available. “There’s just a lot of mesh material and types out there,” he explained.
Dr. Niels-Derrek Schmitz, medical affairs lead of Ethicon Wound Closure and Repair, agreed and pointed out that hernia mesh has been used for hernia repair since the 1950s, meaning both patients and surgeons should still be confident in the procedure if the mesh is chosen correctly. “Since that time, it has been adopted as the standard of care for hernia treatment in adults, and has reduced hernia recurrence rates significantly,” Schmitz said. “One of the most important things physicians must do is to inform their patients about their treatment options – both surgical and non-surgical, such as watchful waiting - and their specific benefits and risks.”
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Full Text of Stories Below
Add recipients
Suggested