During the first days of testimony, Plaintiff’s attorneys were building the case that the Bard Avaulta is defective and the warnings are inadequate. The following is a review of some of the testimony and evidence presented from live and videotaped witnesses as reported from various outlets. It should be noted that we are focusing on substance and not demeanor or method of presentation so it is impossible to gauge the impact on a jury so far
Cisson v. C.R. Bard Inc. is a bellwether case for more than 23,000 cases involving transvaginal mesh combined in the U.S. District Court for the Southern District of West Virginia. Donna Cisson claims an Avaulta device implanted to treat pelvic organ prolapse caused her pain and permanent injury. The Avaulta line of products is made from a resin called polypropylene, which the resin’s manufacturer warned Bard should not be permanently implanted in humans. The company used a porcine collagen coating on the body of the Avaulta products, but not on the arms, which anchor the mesh in place. The porcine was intended to be a barrier to reduce the body’s inflammatory response and adhesions between the polypropylene resin and tissue.
Bard voluntarily stopped selling the Avaulta line of products in July 2012 rather than meet U.S. Food and Drug Administration (FDA) requirements for further clinical testing. Judge Goodwin has excluded this information from the trial.
Documents Indicating Notice to Bard of Problems
- In the June 14, 2002 Patent application signed by Bard engineer and team leader Douglas Evans, Bard outlined the rationale for the new patent by describing the limitations of synthetic mesh devices made from materials like polypropylene. The application sought a patent to create a sling-type product from a natural biological material.
- A 2002 company e-mail produced in trial reportedly states, “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them. We’re trying to fight some battles around lack of data around kits, and on Avaulta in particular. … We’ve been chided by thought leaders. … Still waiting on data on our kit. Why are we afraid to publish any data?”
- In a September 2008 internal market research memo, Bard executives again highlighted what they call “barriers to adoption,” or reasons many physicians refused to use Avaulta products — mostly pertaining to complications seen in patients. “This additional analysis shows in spades the importance of reducing complications,”
- Another internal company memo titled “The Reality of Complications” addressed complication rates from the Avaulta products, including dyspareunia (painful sexual intercourse), erosion and chronic post-operative pain. The memo compiled market research on doctors who did not want to use the Avaulta line. According to the document, 65 percent of physicians surveyed said they had significant concerns about dyspareunia with pelvic floor products, 58 percent had significant concerns about chronic post-operative pain, and 62 percent had significant concerns with erosion.
- There was a discussion in Court that the arms of Avaulta were “sawing at tissue” in patients. In an e-mail a salesperson said, “The flesh sawing issue came up again last week with a physician” and asked if Bard planned to add the porcine coating to the device’s arms. Adam Silver, marketing manager for BUD’s women’s health division, replied by email. “We’re not going to put (the coating) on our arms any time soon,” he wrote. “We don’t believe it’s needed.”
- A 2007 memo stated in part: “Avaulta Solo is a new product which has not been in humans yet and therefore has no data associated with it. … All major advances like these are based on intuition before there is data to support them.”
Dr. Brian Raybon
The first witness called in the trial was Dr. Brian Raybon, a urogynecologist from Georgia. Dr. Raybon, who also holds an undergraduate degree in Chemistry from University of North Carolina, who spent four plus years working on behalf of Bard teaching physicians about the products. He also is the physician who recommended a Bard Avaulta and implanted it in Ms. Cisson. After conceding he felt it was a good product when he implanted it, he testified he began to learn of problems and patients were showing up with complications requiring additional surgeries to remove the mesh. At that time, Dr. Raybon learned for the first time that the resin the company used to make the mesh was not to be permanently implanted in the human body. According to media reports, he testified his reaction was that he was astounded.
On cross-examination by defense attorney Lori Cohen, he conceded he did not contact Bard to ask about the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS) for the resin, once he found out about it.
Dr. Lennox Hoyte
It was Dr. Hoyte’s testimony in the first trial that triggered the mistrial. Dr. Hoyte is a professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, and the chief of urogynecology and robotic surgery at Tampa General Hospital. He is a graduate of Stanford Medical School.
The net-like device at the heart of the lawsuit includes small mesh “arms” that extend from the device to help hold it in place. Hoyte was critical of the design and indicated it contributed to significant problems both for the women and for doctors attempting to remove the device. Hoyte indicated the mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow through and around it, and the vaginal flesh becomes ingrown so tightly around the mesh that surgical removal can destroy so much tissue that the vagina can be difficult to reconstruct.
Anthony Brennan PhD.
Since 1991, Brennan has been a professor of Materials Science and Engineering and Biomedical Engineering at the University of Florida in Gainesville. Brennan studies how cells interact with materials. He is an inventor and co-inventor on six US Patents. He said his research is funded primarily by the U.S. Department of Defense and stated he did work in this case at the request of Plaintiff’s attorneys and Brennan and his team studied the Avaulta Plus product for more than two years who paid him around $200,000 for his research.
He explained that polypropylene is a polymer made with free radicals, which, once implanted, free radicals produced by the body break down the material. “When you put an implant in, it’s seen as a foreign body,” Brennan said. “The body will try to encapsulate it. … The problem is it continues forming an inflammatory response. If you use free radicals to make it, you use free radicals to break it down.” Brennan testified that polypropylene degrades in the body
The Avaulta Plus device has a design feature called “arms,” or long, narrow strands of mesh that protrude from the “body” of the device. The arms are intended to help anchor the device in place once implanted. Brennan indicated that cutting the arms as testimony has reported some doctors did, weakens the device and exacerbates the problem polymer degradation.
He also was critical of the small pore sizes in the device, indicating the pores should be between 2 mm and 5 mm in. As a result, it is more difficult for tissue to grow and fill in.
The mesh contains many pores by design. Brennan said the pores need to be large enough for the body to create a scab through them, holding the arms and the entire device in place. He said the pore size should be between 2 mm and 3.5 mm.
When Brennan measured the pore size in Avaulta Plus, he found the pores were too small. He also said the practice of rolling the arms during the implantation surgery created an overlap in the material, ultimately deforming the pores.
“If you are deforming the pores, you’re reducing their size and making it more difficult for tissue to grow in, fill it in,” Brennan said.
Previous testimony disclosed it was common practice for surgeons to cut the arms on the Avaulta device during implantation to customize it to a patient’s body. Brennan testified that cutting the arms affects the device’s biomedical properties.
“When you cut something, you weaken it,” Brennan said. “If you cut a notch in a cloth, it weakens. Anytime you take a polymer fiber and cut it, it’s going to further exasperate the problem of polymer degradation. … Those loose ends are places where degradation will start.”
Brennan said that the overall design of the Avaulta Plus was flawed from the beginning.
“The geometry of that mesh and material it’s made of is a poor design,” he said. “Your pore sizes are so small … you’re going to get degradation of polypropylene. We’ve known that from the literature for years. … Once degradation of a medical device begins, it’s like a cascade effect. It just continues and keeps going.”
Dr. Reitman is an expert in polymer science and materials chemistry who testified for the defense on August 8, 2013. She has a Doctorate in materials science and engineering from MIT (1993) and has worked for Exponent for about ten years. According to the Exponent website biography, “Dr. Reitman’s expertise includes polymer and composite technology, mechanics of materials, adhesion science, fiber mechanics, history and technology of plastics, and material failure analysis. She is skilled in the development and use of testing tools and methods and has applied them to plastic, rubber, textile, metal, glass, ceramic, and composite materials and systems. She is experienced in major aspects of product development, including materials selection, formulation, scale-up, end-use testing, failure analysis, certification procedures, and issues related to intellectual property.”
Dr. Reitman testified that Bard paid about $700,000 for 400 to 500 hours of work done on the case conducting tests, researching and investigating, etc. Based on work she did in the case, including examination of explanted Avaulta devices, she said there was biofilm on the device and there was not neither oxidation nor degradation to the material.
Also testifying for the defense was Laura Bigby, Bard’s Director of research and Development since 2007, who was questioned about cadaver studies and the absence of clinical trials in humans prior to marketing to surgeons.
Dr. John Heller
Dr. Heller is a orthopedist from Emory University since 1994 whose website states he is “Specializing in the research and development of instrumentation in cervical spine surgery, including cervical disc replacement and laminoplasty. Dr. Heller is an internationally renowned lecturer and teacher.” Called by the defense, Dr. Heller testified that the pain Donna Cisson was suffering was due to spinal issues, indicating MRIs beginning in 2007 documented degenerative spine issues. One of the usual defenses in drug cases is to show an alternative unrelated reason for a Plaintiff’s symptoms and Dr. Heller provided that to the jury.
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