Mesh Medical Device News Desk, March 13, 2018~ McGinnis v C.R. Bard will start Monday, March 19th in a New Jersey courtroom, almost seven years to the day after it was filed, with attorney Adam Slater representing the McGinnis family.
She was implanted with a Bard Avaulta pelvic mesh, which is no longer on the market.
**Editor’s Note ** This story contains revisions that have come to light since it was first published.
This is a product liability trial which will attempt to prove the polypropylene pelvic mesh, Bard Avaulta, was defective in design and warnings to doctors were insufficient. Case no. BER-L-17543-14, Superior Court, Bergen Co., N.J.
On March 12, 2009 McGinnis was implanted with a Bard Avaulta Support System at Wake Medical Health and Hospitals in Raleigh, NC to treat pelvic organ prolapse (POP). She was also implanted with the Align transobturator sling at the same time as a treatment for incontinence.
Soon afterward she suffered erosion, scar tissue, dyspareunia, loss of bladder functioning, and severe pudendal neuralgia injury.
She has undergone three separate mesh removal surgeries, the third by Dr. Shlomo Raz in June 2016 involved extensive groin dissections to remove the transobturator arms of both devices.
According to the complaint, the defendant marketed these products as “safe, trusted products” of “unsurpassed stability” implanted by “a minimally invasive surgical procedure,” which would offer a quick recovery time. Defendants should have known that was not true yet they continued to design, manufacture and market and distribute their products.
Even after the 2008 FDA initial Public Health Notification about “Serious Complications Associated with Transvaginal Placement of Surgical Mesh,” Bard continued to market its products, exposing the plaintiff and others to risk of serious and permanent harm. The Defendants have long been award of its dangers and “propensity to fail, erode, migrate throughout the body, and cause significant medical complications and damage to the patient’s anatomy.”
Once placed, the Bard product failed to perform as intended, “due to its defects.”
C.R. Bard is located in Murray Hill, New Jersey, while Bard’s Medical Device Division is located in Covington, Georgia. Bard Urological Division is located in Covington, GA and does business in NJ.
Lori Cohen will represent the defense, the same attorney who represented Bard in the case filed by Donna Cisson and heard in Charleston, WV.
*Late Add** MND will have no electronic access to this trial courtroom feed provided by Courtroom View Network.
This results from what occurred during Kansas City, MO trial MND was covering via a CVN feed in January 2016. In that case, the defense attorney petitioned the judge that MND be excluded from access to the trial after a reader made an insulting comment about defense attorney, Lori Cohen. MND hired a local lawyer to petition the court to retain access, but it was denied during that trial. While print reporters can show up, there are more restrictions placed on electronic news coverage, which CVN provides. See Sheerer case here. Cohen also represents Bard in the upcoming case. *
According to Courtroom View Network, there is an agreement reached during the Hrymoc trial on how CVN will proceed with its camera in the courtroom. It does not include any feed access to MND.
The Avaulta was taken off the market in June 2012 after the FDA required mesh manufacturers to conduct a three-year post-approval monitoring of women already implanted with the mesh product to assess their condition. The company said it was making a business decision not to invest in the clinical trials for the Avaulta.
Bard manufactured various medical devices including:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Pelvitex™ Polypropylene Mesh
Which are still on the market?
Bard Align Urethral Support System, used to treat stress urinary incontinence was taken off the market in the summer of 2016. It and PelviLace were the last two on the market. See here and here. Its brochure (here) currently contains no products to treat POP or SUI.
In April, 2017, it was announced that Bard was to be sold to Becton Dickinson (BD) for $24 billion. The last day Bard could sell all of its SUI products was December 31, 2016, according to the company.
Bard Davol still sells hernia repair and Fixation devices which includes the 3DMax Mesh, (polypropylene), 3DMax Light Mesh, AlloMax (human collagen), AlloMax (human collagen), Bard Soft Mesh (large monofilament pP), Bard Flat Mesh Sheets ( PP), Perfix Plus, and Ventralex Hernia Patch ( PP and ePTFE materials).
In 2015, Bard agreed to settle 3,000 mesh cases for $200 million and 6,254 cases are now listed as closed in this federal consolidated court case. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
C.R. BARD CASES SO FAR
Bard has had a few cases go before juries and either settle or be resolved in the plaintiffs’ favor.
The case of Debra Wise v CR Bard (2:12-cv-01378) received a settlement offer in February 2015 just as it was about to go to trial. The settlement dollars were undisclosed, She too was implanted with the Avaulta Plus Anterior and Posterior BioSynthetic Support System.
Donna Cisson was awarded $2 million by a Charleston, WV jury in August 2013 due to complications from her Bard Avaulta mesh. Since that was the only case against Bard and resulted in a compensatory damages to the plaintiff of only $250,000, (the rest was punitive damages) it set a low bar on compensatory damages to Bard plaintiffs.
Cisson was from Georgia, one of a few states that takes 75% of punitive damages. See MND coverage here.
Avaulta Plus was the same mesh Christine Scott of Bakersfield, California was implanted with in January 2008. She won her trial in a Bakersfield, California trial and was awarded $5.5 million. Bard appealed but eventually ran out of options and the case was finally closed in Scott’s favor.
See MND coverage here.
Mr. Slater has represented plaintiffs implanted with pelvic mesh made by Ethicon.
He has yet to lose a pelvic mesh product liability case, though at least one, Budke, settled before going to the jury. ###