The case of Donna Cisson v. C.R. Bard began for a second time in a federal court in Charleston, West Virginia today.
Cisson, 55, was implanted with a Bard Avaulta Plus Posterior mesh on May 8, 2009 in Toccoa, Georgia. The initial product liability trial began July 8, but two days later, a statement by a doctor that the mesh was off the market resulted in the judge declaring a mistrial.
This is the first federal trial of transvaginal mesh. Six manufacturers have thousands of lawsuits filed in this one court to be overseen by the Honorable Judge Joseph R. Goodwin. The first four cases naming the Avaulta mesh maker C.R. Bard will be heard back-to-back.
This morning four men and four women were chosen as jurors. Opening statements began around 1:30. A court witness tells MDND the opening was a replay of the initial case, though the attorneys were “more polished.”
Attorney Henry Garrard of Blasingame Burch Garrard & Ashley of Athens, Georgia represents Ms. Cisson and her husband, Dan.
Garrard must show that Bard was aware of the risks associated with the Avaulta transvaginal mesh but failed to inform doctors; that Bard failed to test its Avaulta transvaginal mesh; that Bard did not study how to remove the polypropylene material if there were complications; that Marlex was the raw material used to make the Avaulta mesh even though the company knew there was a warning not to use Marlex for medical devices to be permanently implanted in the human body.
Bard argues it warned physicians of the risks associated with the Avaulta transvaginal mesh, that it “complied with FDA regulatory and industry standards and was ‘never subject to any enforcement action in relation to its Avaulta Systems; and even if Plaintiffs’ design defect claim survives summary judgment, plaintiffs can by no means show that any design defect was so obvious that punitive damages would be warranted.”
Judge Goodwin has allowed for punitive damages in these cases.
The lawyer for Bard, Lori Cohen of Greenberg Traurig of Atlanta tried to keep a Marlex memo out of court in the form of a motion in limine, but Judge Goodwin denied that motion before the first trial.
The memo shows Bard executives discussing a Material Safety Data Sheet (MSDS) issued by Chevron Phillips Chemical Co. warning the resin-based plastic should not be used in medical devices implanted in the human body. Company e-mails warned colleagues not to tell Chevron Phillips about the intended use. See back story here.
During the first trial, Garrard said one executive, Roger Darois, knew about the MSDS but never contacted Chevron to see what the red flag was about, instead Bard set up a company called Red Oaks to make the purchases of the raw material as a cover for Bard. He also said Bard did not conduct any studies to see how much the Avaulta mesh would shrink. Tests on sheep, rabbits and rate did not result in any safety assurances on how the plastic mesh would react in women. “Animals didn’t have prolapse,” he told the court.
Lori Cohen insists the product is safe and effective and based on hernia mesh which has been used for five decades. In her opening on trial one, she insisted the raw material is different from the final medical device and that polypropylene is a time-tested safe material.
“This is not some fly-by-night company or fly-by-night design that was tossed on the market, not in the slightest,” she said during her first opening arguments.
Documents filed in the Cisson case since the mistrial show Cohen requested a mistrial on July 9 based on the opening statement by Henry Garrard. She objected to his statement about animal studies that revealed Avaulta was never tested on humans.
“The door has been opened we believe allow us to explain it in response to those missteps in those violations exactly why we did not do human clinical studies premarket, prelaunch. And that would relate back to, of course, the FDA 510(k) issue,” she said in the court transcript.
Judge Goodwin had ruled that the failure to test prior to market in human trials could only be presented to the jury if the “plaintiff can lay a foundation for the admissibility.”
In her July 9 motion for a mistrial she also cited the MSDS and Garrard’s statement that it was produced by court order from the files, “as if to suggest we were hiding that and hadn’t produced it and had to be ordered to product it.” She called that “very prejudicial” and that the jury had “been tainted irreparable and we should not proceed with this trial.”
On June 23, 2013, Judge Goodwin ruled neither side would be able to discuss the Food and Drug Administration’s 510(k) process and lack of enforcement action. The 510(k) is an FDA safety loophole that allows many medical devices to be marketed merely by naming a similar “predicate” device. No clinical trials are required to assure safety or efficacy. Here is that ruling.
“Given the parties’ filings throughout this case, it is abundantly clear that there would be a substantial mini-trial on the 510(k) process and enforcement should it be allowed.” Both sides were precluded from introducing any evidence related to the FDA 510(k) process and enforcement.
On June 10, during the first trial, Cohen claimed when Dr. Lennox Hoyte told jurors the Avaulta mesh was taken off the market it opened the door to a full explanation about why Bard made that decision. It was for financial reasons, she claimed. Rather than spend money to conduct a three-year FDA-mandated study, Bard decided instead to remove Avaulta from the market. There was no way to explain the company’s move to jurors without going into the FDA. Judge Goodwin agreed.
Dr. Hoyte is expected to be called again as a witness for Ms. Cisson.
Last year a lawsuit filed against Bard over the Avaulta Solo resulted in a $5.5 award to Christine Scott of Bakersfield, California. Bard has appealed the award.
The Cisson case is the first of 4,086 cases against C.R. Bard filed in the same federal court in the Southern District of West Virginia as part of MDL (multidistrict litigation) No. 2187. Judge Joseph R. Goodwin will coordinate the cases and issue consistent rulings so they move through the courts smoothly and quickly.
Here is the list of upcoming cases against Bard:
Cisson, et al. v. C. R. Bard, Inc. 2:11-cv-00195
Queen, et al. v. C. R. Bard, Inc. 2:11-cv-00012
Rizzo, et al. v. C. R. Bard, Inc. 2:10-cv-01224
Jones v. C. R. Bard, Inc. 2:11-cv-00114
So. District of West Virginia (here)
Donna Cisson Complaint (here)
Motions in Limine (510k discussion), June 27, 2013, 17 pages
Judges MEMORANDUM OPINION AND ORDER , July 23, 2013, 14 pages
(Plaintiffs’ Motion for Clarification on the Court’s Ruling on Bard’s Failure to Test, and for a Ruling on Bard’s Objections to Evidence that Bard Claims “Implies Bard had a Duty to Conduct Clinical Trials or Additional Testing)