The Bard Mesh Litigation

All filed federal product liability lawsuits claiming injuries with transvaginal mesh or bladder slings used for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) are centralized. In February 2012, multidistrict litigation (MDL) cases against the mesh manufacturers began. This legal process streamlines hundreds of individual claims against the companies.

The U.S. District Court for the Southern District of West Virginia is the site of the coordinated litigation for transvaginal pelvic mesh lawsuits. There are approximately 70,000 plus cases against different manufacturers in the MDL, including C.R. Bard. The Bard consolidated cases are In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation.

Defendant’s pelvic mesh products listed in the C.R. Bard master complaint are:

• The Align Urethral Support System
• The Align TO Urethral Support System
• The Avaulta Anterior BioSynthetic Support System
• The Avaulta Posterior BioSynthetic Support System
• The Avaulta Plus Anterior BioSynthetic Support System
• The Avaulta Plus Posterior BioSynthetic Support System
• The Avaulta Solo Anterior Synthetic Support System
• The Avaulta Solo Posterior Synthetic Support System
• The InnerLace BioUrethral Support System
• The Pelvicol Acellular Collagen Matrix
• The PelviLace BioUrethral Support System
• The PelviLace TO Trans-obturator BioUrethral Support System
• The PelviSoft Acellular Collagen BioMesh
• The Pelvitex Polypropylene Mesh
• The Uretex SUP Pubourethral Sling
• The Uretex TO Trans-obturator Urethral Support System
• The Uretex TO2 Trans-obturator Urethral Support System
• The Uretex TO3 Trans-obturator Urethral Support System

The women in these lawsuits allege the mesh implants can erode, cause infection, pain, bleeding and require mesh-removal surgeries. Often the mesh cannot be entirely excised because the parts of the devices called “arms”, used to secure the mesh to the patient’s tissue are so deeply embedded they can not safely be removed. Women contend that some of the devices erode after being implanted, which can cause organ damage, pain and make sexual intercourse painful (dyspareunia).

Bellwether trials have been used in our legal system where there are large numbers of similar claims or lawsuits against the same defendant. A bellwether trial is a procedure where a representative case or cases are selected to be tried before a jury to assist the court and the parties in evaluating information and evidence and possibly predicting future trends about a larger group of cases.

The first C.R. Bard bellwether trial was brought by Donna Cisson where she asserted the following counts against C.R. Bard in her complaint.

• COUNT I: NEGLIGENCE
• COUNT II: STRICT LIABILITY – DESIGN DEFECT
• COUNT III: STRICT LIABILITY – MANUFACTURING DEFECT
• COUNT IV: STRICT LIABILITY – FAILURE TO WARN
• COUNT V: BREACH OF EXPRESS WARRANTY
• COUNT VI: BREACH OF IMPLIED WARRANTY
• COUNT VII: LOSS OF CONSORTIUM
• COUNT VIII: PUNITIVE DAMAGES

Donna Cisson, a resident of Georgia, was implanted with a Bard Avaulta Plus mesh in May 2009. She complained of chronic pain and permanent injuries. Bard had argued that Ms. Cisson’s damages should be mitigated by her failure to lose weight has she had been told to do by her doctors and by a failure to use estrogen cream.

On August 15, 2013 the jury after 12 hours, returned a verdict in favor of Mrs. Cisson for $2 million. Of that, $250,000 was for pain and suffering, while $1,750,000 was a punitive award. The evidence convinced the jury that C.R. Bard did not adequately test its Avaulta implant in humans or use “reasonable care” in designing the implant. The jury also found the company caused the plaintiff’s injuries by failing to warn her doctor about Avaulta’s risks. The award included compensatory damages, and punitive damages because of Bard’s “conscious indifference to [the] consequences” of its conduct.

The six jurors found Mrs. Cisson had proven her claims the Bard Avaulta Plus mesh implanted in her in 2009 was defective in both its design and in a failure to warn her implanting physician, Dr. Brian Raybon of Toccoa, Georgia.

The jury also found Bard did not prove its assumption of the risk defense and that Mr. Cisson did not prove his claim for loss of consortium. This is the first federal case pending in this federal court that allege the polypropylene medical device was not suitable for human implantation.

C.R. Bard requested a new trial, but Judge Goodwin denied C.R. Bard’s motion for a new trial. He also refused to find unconstitutional a Georgia rule that requires the Cissons to pay 75 percent of the $1.7 million punitive award to the state.

A second federal bellwether case against C.R. Bard was scheduled to begin a few days after the $2 million verdict, but the parties settled the case hours before the trial started.

The next bellwether trial was scheduled for February 2015. There, Debra Wise, she suffered problems after having a Bard Avaulta Plus Anterior and Posterior BioSynthetic Support System implanted at a West Virginia hospital on July 16, 2007. Mrs. Wise and her husband’s lawsuit is one of over 10,000 cases pending in the federal court system involving women who suffered severe and catastrophic complications from Bard vaginal mesh. This bellwether trial settled prior to the trial for an amount that is confidential.

Judge Goodwin has ordered that two large waves of Bard cases be prepared to be “trial ready.” A third wave of cases was proposed this year, including 298 cases involving problems with the Bard Avaulta Plus Anterior Support System, Avaulta Plus Posterior Support System, Avaulta Solo Anterior Synthetic Support System or Avaulta Solo Posterior Synthetic Support System.