C.R. Bard Transvaginal Mesh Trial Goes to the Jury – What Each Side Wants
As the Donna Cisson v. Bard case wraps up it is interesting to see what each side is offering as a final consideration before the case goes to the jury Wednesday, August 14.
On Monday, an expert report prepared by Dr. Maureen Reitman and Dr. Marta Villarraga was presented which includes the history of mesh and its evolution from a hernia product and concludes by saying the Avaulta mesh does not have a defective design or manufacture. It details the case history of Donna Cisson and contains pictures of her mesh.
This report will be used for all four Bard cases to be heard by Judge Joseph R. Goodwin back-to-back.
Also Monday, DrugWatch (here) reports a doctor of osteopathic medicine, Christopher Doerr testified via videotape deposition that Donna Cisson sought his advice concerning extreme pain in her right hip. Dr. Doerr found a disk bulge, mild stenosis a narrowing of two vertebrae and the spinal column as well as degenerative joint disease.
Defense attorney Lori Cohen has suggested Mrs. Cisson suffered from pre-existing conditions that were exacerbated by her weight.
Tuesday afternoon both sides presented their closing arguments.
Bloomberg (here) reports attorneys for Donna Cisson, 55, say mesh maker C.R. Bard put profits first and ignored the red flags about problems with the Avaulta transvaginal mesh. One of the problems revealed early in the trial was evidence the company knew the polypropylene mesh raw material carried a warning it should not be made into implantable medical devices.
Still it pushed ahead with production said Henry Garrard, Donna Cisson’s lawyer in closing arguments. (see back story here)
Attorneys for Bard told jurors the Avaulta Plus, implanted into Donna Cisson in May 2009 as a treatment for pelvic organ prolapse (POP), was properly designed and manufactured despite the fact she has been suffering with pelvic pain ever since the implant and explant surgery.
Lori Cohen who represented Bard said the mesh has been used for 50 years for hernia repair. Donna Cisson’s pain results from back problems, not mesh said Cohen.
The first Cisson v. Bard trial ended in a mistrial July 10. There are currently 4,193 cases filed against C.R. Bard in this federal court (here).
Judge Joseph R. Goodwin will instruct the jurors on the legal issues they must consider in this case to render a verdict. A flurry of last minute filings is not uncommon at a trial’s conclusion.
Filed August 13, Tuesday, in Bard Exhibit #390, Bard has submitted a “proposed limiting instruction” as well as “supplemental jury instructions” which have the goal of limiting the plaintiffs’ evidence of a defective design and punitive damages.
Specifically Bard suggests the jury only consider the September 2, 2008 “Mesh Development Proposal” company document document for one purpose of a defective or failure to warn and not as evidence of design defect.
Both a failure to warn and a design defect, along with defective manufacture, are components of a product liability lawsuit. The Donna Cisson case, as well as the 27,000 others filed in this federal court against five other manufacturers, are all product liability (defective design) civil cases.
Donna Cisson can seek punitive damages if Bard is liable for compensatory damages to Cisson and the jurors find Bard’s conduct justifies the additional award.
In the Linda Gross case in Atlantic City, New Jersey which concluded in February, jurors awarded her $7.76 in punitive damages and $3.35 in compensatory damages.
Lawyers for Bard say that plaintiffs have failed to provide any evidence of egregious conduct on the part of Bard. “This Court should therefore direct a verdict in Bard’s favor on the issue of punitive damages.”
The motion claims that “Bard acted conscientiously and with deliberate concern for the health and safety of patients.” Bard asks for a directed verdict on the issue of punitive damages.
Bard says the Plaintiffs have not established the defective design of the Avaulta Plus, in fact, Bard lawyers claims that polypropylene surgical mesh has been around for over 50 years and is “the most commonly used material for permanently implanted surgical mesh devices.”
Motion for Judgment
Doc. No. 387 – The Plaintiffs’ Motion for Judgment as a Matter of Law on Defendant’s Affirmative Defenses says that the testimony of Donna Cisson and Dr. Brian Raybon are dispositive of Bard’s affirmative defenses of assumption of risk, comparative negligence and mitigation of damages. Cisson says she trusted Dr. Raybon and would not have agreed to the implant if she knew the risks.
Dr. Raybon says he was not informed even though he taught hundreds of doctors how to implant the Avaulta plus. He did not know shrinkage rate was 30-50%, he did not know the mesh was over-engineered with respect to strength, he did not know the mesh scar plant did not integrate well with host tissue, was not told the minimum pore size was 2.5 to 3 mm. He was not told Bard did not collect any data on mesh shrinkage, that the Avaulta plus had a higher risk of delayed healing, but was told the pigskin was intended to reduce mesh erosion. He did not inform Donna Cisson because he was “unaware of all the risks.”
Bard’s Assumption of Risk
Donna Cisson could not have assumed a risk (Assumption of Risk) unless she was fully informed of a product’s defect but choose to proceed nonetheless.
“Georgia law is well-established that one cannot assume the risks of the negligent act of another, in this case, Bard’s negligence in failing to warn and designing the Avaulta products.” Cisson was not aware and instead relied on Dr. Raybon to inform her of any risks and Bard has not presented any evidence she knew of the risks, say her attorneys.
Comparative Negligence of Plaintiff
Again under Georgia law if a defendant is negligent they may have their damages reduced by the jury in the proportion related to their degree of fault. This is commonly used in traffic accidents when the victim of an accident was careless and contributed to his accident.
Her attorneys say Mrs. Cisson did not thing to cause her own injuries. Bard had argued that Cisson failed to lose weight before and after her implant surgery and that contributed to her injuries but Bard failed to provide any evidence of that according to Cisson’s attorneys. She did not use Estrace estrogen cream as she was advised to do by her doctors. Bard did not pursue that question at trial.
Lawyers for Bard had argued that she failed to seek a second opinion or attempt a more conservative treatment route and that contributed to her injuries. Dr. Miklos testified at trial a conservative treatment was not appropriate and that the mesh needed to be explanted. A Bard expert, Dr. Vincent Lucente testified that Dr. Miklos acted appropriately in the treatment of Cisson.
Mitigation of Damages
Cisson’s attorneys say Bard presented no evidence Cisson failed to take diligent steps to mitigate her own damages after sustaining injuries. She complied with her doctor’s instructions and did nothing to cause her own injuries.
Plaintiffs says they are entitled to a Judgment as a Matter of Law on Bard’s defenses of Assumption of Risk, comparative Fault and Mitigation of Damages. August 12, 2013 filed by Henry Garrard.
Document No. 386 – On August 7 Wednesday, Bard moved orally for a directed verdict on certain claims by attorneys for Donna Cisson and on their claim for punitive damages. The court said it will rule at the close of evidence.
It is not unusual to make a motion for a directed verdict at the close of evidence. It says the other side has raised no genuine issues to be tried.
Bard claims it is entitled to a directed verdict on the basis of pore size and polypropylene issues which have not been proven to be a problem. Cisson’s attorneys say they have presented sufficient evidence about the mesh arms, the density of the arms, and about the pig skin layer of collagen that increases the inflammatory response.
Document No. 383– In Bard’s Response and Reply to Plaintiffs’ Punitive Damages filed August 12, Bard asks Judge Goodwin for a directed verdict in its favor claiming Plaintiffs have not sustained their burden of proof because they failed to adduce any evidence of egregious conduct on the part of Bard.
They ask Judge Goodwin to direct a verdict in Bard’s favor on the issue of punitive damages.
The evidence shows Bard acted conscientiously and with “deliberate concern for the health and safety of patients.” Bard argues that none of Mrs. Cisson’s expert witnesses have given their opinion that the design and labeling of the Avaulta Plus failed to comply with industry standards and none of that language appears in their brief. Bard says it has complied with industry and federal regulatory standards in designing, labeling and testing the Avaulta Plus device. Plaintiffs have not established the design of the Avaulta Plus was defective enough to “constitute an entire want of care.” Bard was not the first company to design and manufacture transvaginal polypropylene mesh for pelvic organ prolapse or the first to design and manufacture polypropylene mesh kits that utilize arms.
Additionally Bard says Dr. Raybon testified he had been warned of the potential for erosion, dyspareunia and pain associated with the Avaulta Plus. The IFU (Instructions for Use) is the evidence needed to show that Bard did not act recklessly and without care, a basis for punitive damages.
“Bard indisputably complied with all federal regulations in the designing, testing, manufacturing, labeling and marketing of its Avaulta plus devices.”
The FDA did not require pre-market clinical trials, therefore Bard cannot be blamed for failing to perform them, eliminating punitive awards.#