On August 15, 2013 Cisson was awarded $250,000 in compensatory damages and $1,750,000 in punitive damages with costs and interest as allowed by law. Her husband, Dan Cisson, was not awarded compensatory damages.
Document #448 – Memorandum Opinion and Order filed October 18, 2013 outlines the case highlights and what it taught us about the C.R. Bard Corp. and the Avaulta transvaginal mesh it made.
Donna and Dan Cisson filed their action March 10, 2011. This was the first bellwether trial in this federal court alleging a design defect, a failure to warn and loss of consortium related to the Bard Avaulta Plus product.
The Cissons claimed the arms of the Avaulta mesh were defective as was the small pore size of the mesh (3 millimeters) and the use of polypropylene to create the medical device. The warning to Mrs. Cisson was inadequate about the risk and severity of the complications she eventually experienced.
Her Bard Avaulta Plus mesh was implanted in May 2009 by Dr. Brian Raybon of Toccoa, Georgia. She experienced pain during intercourse, while sitting and during an exam. Her mesh extruded, eroded caused excessive scarring and inflammation. By March of 2011 she had the mesh removed by Dr. John Miklos except the arms, which remain behind. He testified the arms were causing her pain.
Dr. Lennox Hoyte testified on behalf of Mrs. Cisson that the arms of the Avaulta Plus had a design defect and that they caused pain.
Dr. Bernd Klosterhalfen a pathologist stated an inadequate pore size can cause mesh to shrink and to cause a rigid scar plate and causes an inflammatory reaction. He also testified it is not biocompatible for long-term implantation because of that. Dr. Jim Ross, Bard’s medical director, also testified that a larger pore of the mesh decreases the scar potential while small pore size can create a ridged scar plate.
The raw material used to create the Avaulta mesh was a polypropylene resin in pellet form which was purchased using a third party supplier, Bard’s Red Oaks. It was spun into monofilament which makes up the mesh of the Avaulta Plus. A Material Data Safety Sheet from Chevron Phillips clearly stated the material should not be used in medical applications “involving permanent implantation in the human body or permanent contact with internal body fluids of tissues.”
Dr. Anthony Brennan, a professor of materials science and biomedical engineering at the University of Florida testified that the polypropylene will degrade and triggers an inflammatory response.
Bard argued that the plaintiffs failed to prove the pore size or polypropylene constituted a design defect. There was one jury instruction for a design defect not three separate. Judge Joseph R. Goodwin denied Bard’s renewed motion for a judgment with respect to the design defect claim.
On the failure to warn claim the plaintiff argued that Dr. Raybon, the implanting physician should have been warned that the smaller size of the pores of the Avaulta plus increased the risk of scarring and that its shrinkage rate was 30 to 50 percent. The porcine layer of the Avaulta Plus only increased the risk of delayed healing, rejection and extrusion. Bard was warned not to use polypropylene in implanted medical devices but Dr. Raybon did not hear any of that information.
Jurors were asked if the defendant had a duty to warn, if they breached that duty and if that breach caused Mrs. Cisson’s injuries. The manufacturer, Bard, knew or should have known about the potential for injury arising from the use of its product. At the same time Bard does not have a duty to directly warn the patient, in this case Mrs. Cisson. Instead the duty to warn refers to the “end user” who is the doctor, also known as a “learned intermediary.” The patient’s injuries need to have been caused by the failure to warn. The warnings should involve those things that are not obvious and not generally known dangers about the medical device.
For its part, Bard argued it did not have a duty to warn about 3 millimeter pore size or the polypropylene (PP) raw material to Dr. Raybon or the rate or severity of possible injuries. However Judge Goodwin argued that is what caused the Avaulta Plus to be riskier than the Instructions for Use (IFU) suggested and therefore it was appropriate for the jury to decide whether Bard provided adequate instructions to Dr. Raybon or whether it breached the duty to warn.
Bard’s Instructions for Use (IFU) do mention erosion inflammation, scarification and extrusion as well as dyspareunia. Because of that Bard argued it did not breach its duty to warn. Again plaintiffs produced evidence that Bard knew about the MSDS which warned against using PP resin for a medical implant and that the porcine sheet created a higher risk of complications and that the inadequate pore size would increase scarring and inflammation. Dr. Raybon was not warned about these risks.
Dr. Raybon says he would not have implanted the Bard Avaulta Plus had he known that the rigid scar plate formed from the pore size “does not integrate well with the host tissue.” Dr. Raybon also expressed concern about a statement from the head of Product Development for Bard, Robert Orr who had recommended an optimal pore size of 2.5 to 3 millimeters. Orr also testified the shrinkage rate for the Bard Avaulta was 30 to 50 percent. Judge Goodwin found sufficient evidence was presented for a jury to believe Dr. Raybon would have opted not to implant the device had he received these warnings.
Additionally Dr. Raybon testified he would not have implanted the mesh had he known the porcine sheet increased the risk of delayed healing, extrusion and rejection; had he known that the polypropylene resin was not to be made into a permanent implant device. In order to establish that the polypropylene caused her injuries Dr. Klosterhalfen explained to the jury that macrophages or inflammatory cells were attaching to the plastic material inside Mrs. Cisson’s body. The buildup of the macrophages around the mesh formed a “fibrotic reaction” or a scar plate, a reaction that is typical with polypropylene meshes.
Dr. Brennan added that free-radicals attach polypropylene mesh and that it’s not biocompatible for long-term use. He testified the degrading polypropylene triggers an inflammatory response. The jury was allowed to infer from the evidence presented the cause of Mrs. Cisson’s injuries.
Bard had argued Judge Goodwin should set aside the punitive damages of $1,750,000. But under Georgia law, punitive damages are awarded when there is “clear and convincing evidence” that Bard showed malice, willful misconduct, fraud wantonness, and conscious indifference to consequence. Bard argues punitive are inappropriate when it complied with industry-wide practices or federal regulations. But based on the entirety of the evidence a jury can still award punitive damages, as they did in the Cisson case.
Ultimately hurting Bard was the clear evidence shown by the company’s possession of the Material Data Safety sheet and the emails exchanged among Bard executives suggesting the polypropylene monofilament be bought through a third party “to avoid a supply issue once the medical application is discovered.” Bard was purchasing monofilament from Shakespeare Co. which became aware of the Phillips MSDS warning, after that, it declined to supply monofilament to Bard even after the company agreed to completely indemnify Shakespeare. Ultimately it was very difficult for the company to get past the fact that it knew at the executive level the polypropylene resin was not to be used for an implant in the human body.
Bard’s Motion to reverse or amend the jury verdict (Judgment Notwithstanding Verdict) was denied by Judge Goodwin who ordered the jury verdict filed with the court. #
Deposition of Dr. Jim Ross:
Dr. Brennan’s U. FL page
Cisson Case 2:11-cv-00195, Document #448
Materials Safety Data Sheet
Bard Avaulta IFU