Mesh News Desk, January 18, 2016 ~ The pelvic mesh trial against manufacturer C.R. Bard three years ago, was the first bellwether case to be held in the newly formed multidistrict litigation in Charleston, West Virginia.
Right out of the gate, Donna Cisson’s attorney, Henry Garrard, presented to the jury the Material Safety Data Sheet that accompanied the raw polypropylene resin used to make her Avaulta Plus transvaginal mesh.
Garrard showed jurors company emails exchanged between high ranking executives, that they would form a dummy company so the supplies of the resin would not be disrupted. That’s because the supplier, Chevron Phillips, included a warning on the MSDS, not to use the resin to make implantable medical devices and would not sell to Bard had it known that was exactly what C.R. Bard would do.
That was how the trial of Donna Cisson v. C.R. Bard began in July 2013.
On August 15, 2013, jurors awarded Ms. Cisson $250,000 in compensatory damages and $1,750.000 in punitive damages to send Bard a message. The jury included damages for design defect and failure to warn claims. The jury returned a verdict for Bard on the consortium claim.
The company immediately appealed.
One year ago, Judge Joseph Goodwin, who is overseeing the mesh trials, denied Bard’s request for a new trial. See background story on MND here.
A federal appeals court on Thursday, January 14, upheld the $2 million verdict. The 41-page decision is written by Judge Roger L. Gregory.
It puts her one step closer to finally resolving her lawsuit against the mesh maker.
Ms. Cisson filed a lawsuit in March 2011 in the Northern District of Georgia. She had received a Bard Avaulta Plus pelvic mesh on May 6, 2009 to address prolapse and incontinence. Dr. Brian Raybon performed the surgery. He had been a preceptor or teacher/consultant to Bard. Eventually Dr John Miklos explanted most of the Avaulta.
Testimony was presented that the pores of Avaulta are too small and the mesh shrank after it was implanted. What resulted was a rigid scar plate. The mesh was attacked by the patient’s body causing inflammation of the tissue and degradation of the mesh, and causing Ms. Cisson’s permanent injuries.
The 4th U.S. Circuit Court of Appeals rejected arguments presented in the appeal by attorneys for Greenberg Traurig (Lori Cohen) that represented Bard.
The company sought to have a reduction of the $1.75 million punitive damage or a new trial.
The company argued that it complied with the Food and Drug Administration’s 510(k) process for approval (implying safety) and that information should have been allowed to be presented to the jury. The U.S. Chamber of Commerce supported that argument a friend of the court.
Readers of Mesh News Desk understand that the FDA’s 510(k) approval is a “clearance to sell” and does not require the company meet the higher standards of premarket approval (PMA) required of drugs.
The appellate court agreed with Cisson:”…. [w]hile some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value.” Thus, the Court concluded, “it is clear that the court did not abuse its discretion by excluding Bard’s evidence of 510(k) clearance.”
Bard also challenged the decision to include the Material Safety Data Sheet (MSDS) as hearsay. The three-judge appellate panel decided the Material Safety Data Sheet was not prejudicial to the defendant company.
Judge Goodwin one year ago had called creating the dummy company evidence of “This secretive conduct in an effort to sidestep the MSDS warnings suggests reprehensible conduct, weighing against remittitur.”
Also part of the appeal, Bard said that under Georgia law, causation needs to be demonstrated by expert testimony stated to a “reasonable degree of medical probability” and that jurors were presented with insufficient evidence of causation. Punitive damages were excessive and in violation of the Due Process Clause, said the mesh maker. The appeals court did not agree.
Cisson’s attorneys asked the appeals panel to rule that the Georgia state law (Georgia Tort Reform Act of 1987) that splits the punitive damages is unconstitutional. However, the appellate court said she had provided no basis to find the state’s actions unconstitutional.
The state of Georgia will receive 75% of the punitive award of $1,750,000. Ms. Cisson receives the remainder. #
Here is a link to Thursday’s opinion by the the U.S. Court of Appeals for the Fourth Circuit
Cisson v. C.R. Bard, Inc., No. 15-1102 (4th Cir. Jan. 14, 2016).
Cisson is represented by Anthony J. Majestro of Powell & Majestro PLLC, Allison Van Laningham of Turning Point Litigation and Henry G. Garrard III and Josh B. Wages of Blasinggame Burch Garrard & Ashley PC.
Bard is represented by Lori G. Cohen, Brigid F. Cech Samole, Elliot H. Scherker Jay, Andrew Yagoda and Sean Jessee of Greenberg Traurig LLP.
MND, January 2016, Cisson $2 Million Verdict Will Stand
Law 360 on the appeal
Legal Examiner on Cisson decision
Friend of Bard, Cook Medical
Friend of Bard, U.S. Chamber of Commerce