Posts Tagged Donna Cisson vs. C.R. Bard
According to a report in Fierce Medical Devices, the trial court has upheld the 2 million verdict in the Donna Cisson v. C.R. Bard, Inc. transvaginal trial. Judge Joseph Goodwin reaffirmed that the initial award was appropriate and that attorneys representing Donna Cisson successfully proved the company’s vaginal mesh was the cause of her injuries.
Donna Cisson brought her case for severe injuries resulting from her use of Bard’s transvaginal mesh. Cisson alleged that the Bard Avaulta Plus vaginal mesh implant gave her bladder spasms and caused bleeding as well as pelvic pain.
Click here to read the full Fierce Medical Devices article: Bard Vaginal Mesh Verdict Sticks as Judge Reaffirms $2M Award
On August 15, 2013, the jury found for Donna Cisson compensatory damages in the amount of $250,000 for her injuries and $1.75 million in punitive damages after considering all the evidence from the numerous experts from each side. The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.
Bard has lost two jury trials, settled a third case after a jury selected, and settled a fourth before trial commenced. Bard’s implants have been targeted in more than 12,000 cases, while Boston Scientific said in an August regulatory filing that it faces more than 12,000 suits over its vaginal devices. Additionally Endo’s American Medical Systems Inc. unit faces about 13,500 vaginal-mesh claims between state and federal suits, and Coloplast and Cook face about 1,000 claims combined. J&J faced 12,250 pelvic mesh claims through June 30, according to a regulatory filing.
In August 2013, Judge Joseph Goodwin announced the bellwether case schedule for the Boston Scientific vaginal mesh cases occurring in West Virginia. The first set of Boston Scientific trials is set to begin 2/11/2014 and the second set commencing on 6/17/2014.
We believe that ultimately the cause of injuries suffered by vaginal mesh users will be shown to be the defects in the mesh products and the absence of appropriate warnings. If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.
On August 29, 2013, Judge Joseph Goodwin announced the bellwether case schedule for the Boston Scientific vaginal mesh cases occurring in West Virginia. The following cases were selected for the first and second bellwether trials in this MDL:
- Carol Lynn Fawcett, et al. v. Boston Scientific Corp. 2:12-cv-07497 Pinnacle
- Roseanne Sanchez, et al. v. Boston Scientific Corp. 2:12-cv-05762 Pinnacle
- Carolyn F. Smothers v. Boston Scientific Corp. 2:12-cv-08016 Obtryx
- Katherine L. Hall v. Boston Scientific Corp. 2:12-cv-08186 Obtryx
The first set of Boston Scientific trials is set to begin 2/11/2014 and the second set commencing on 6/17/2014.
Vaginal Mesh Trial History
In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product. In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries. The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations. On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages. The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective. In Queen vs. Bard, starting trial immediately after Cisson, a settlement was reached.
On August 21, 2013, after a jury of five men and four women had been selected and opening statements in the trial were ready to commence, the parties in the Wanda Queen vs. C.R. Bard Inc. Avaulta vaginal mesh case settled. The amount was not disclosed. Ms. Queen had the mesh inserted because of pelvic prolapse by Dr. Elizabeth Barbee at Wake Medical Center in Raleigh, North Carolina.
Bard has now lost two jury trials and settled the third before a jury could hear the evidence. Bard now faces thousands more suits over its Avaulta product. The next case against C.R. Bard Inc. for its Avaulta vaginal mesh is scheduled to begin October 8, 2013. The stock closed up almost three dollars per share after last week’s $2 million Cisson vs. Bard verdict on news of the settlement, finishing over $114 per share.
Over 23,000 women have filed suits detailing their injuries from the mesh inserted in them. We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings. If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.
In 2012, Bard lost its first vaginal mesh case and was ordered to pay $3.6 million following the California state court jury’s decision. On August 15, 2013, a West Virginia jury ordered Bard to pay $2 million to Donna Cisson for her injuries due to her use of what the jury found to be the defective Avaulta product. Thousands more vaginal mesh claims are building up against Bard in the MDL proceedings in Judge Goodwin’s court in West Virginia.
Timothy M. Ring is the Chairman and Chief Executive Officer for C. R. Bard, Inc., serving in that capacity since August 8, 2003. He joined Bard in June 1992 as Corporate Vice President and has steadily risen through the ranks to assume corporate leadership. Prior to Bard, he worked ten years at Abbott labs in personnel positions and before that was with General Motors. He has a degree in Industrial relations from Cornell.
C.R. Bard Inc. stock closed at approximately $111 per share on August 16, 2013. Shares are up about 16% for 2013 year to date. Currently there are 5 analysts that rate C.R. Bard a buy, 1 analyst rates it a sell, and 12 rate it a hold. It is a global company with 12,000 employees and business operations in 90 countries. In the first quarter of 2013, the stock made a profit of $90.7 million dollars. In the second quarter of 2013, the company reported a loss of $161.6 million because it took a $275.1 million litigation charge for product liability charges that virtually wiped out its profits. In the remainder of 2013, Bard anticipates receiving payments from W.R. Gore & Associates, which has been ordered to pay hundreds of millions of dollars to C.R. Bard as a result of a patent infringement case related to prosthetic vascular grafts used in bypass procedures. In June 2013, Bard reached a deal to sell its electrophysiology business for$275 million dollars to Boston Scientific. On August 19, 2013 Bard announced that it has entered into a definitive agreement to acquire privately held Medafor, Inc., a leading developer and supplier of plant-based hemostatic agents for the purchase price of $200 million.
No doubt, Bard, like many similar companies faced with massive suits, did focus groups trying out its best arguments on mock juries, and then tailored those arguments as they applied them to the actual cases. However Bard has now seen what two real juries have thought of its efforts to say there was nothing wrong with the Avaulta mesh product, they acted reasonably, and the pain the women are suffering is really from something else. Bard gets another chance immediately as the next Avaulta Plus vaginal mesh lawsuit is slated to begin in West Virginia on August 19, 2013.
Soon Bard will learn the lessons of history. Perhaps Mr. Ring will see the inevitable tide advancing and do the right thing for the injured women, their families, and the Bard shareholders.
On August 15, 2013, after about 12 hours of deliberation, the jury found for Donna Cisson in her vaginal mesh trial against manufacturer C.R.Bard Inc, and found damages in the amount of $250,000 and $1.75 million in punitive damages. The jury found that Bard failed to provide adequate warnings as to the defects in its vaginal mesh product and that the device was defective.
This is the third victory for women in the three trials as Donna Cisson joins Christine Scott and Linda Gross in holding manufacturers responsible for their injuries. In July 2012, a California jury awarded Christine Scott and her husband $5.5 million after she underwent nine revision surgeries. Scott sued C.R. Bard in 2009 over its Avaulta Plus mesh product. In February 2013, Linda Gross won $11.11 million in her lawsuit against Johnson & Johnson’s Ethicon brand over its Prolift vaginal mesh product. Gross had 18 surgeries. The New Jersey jury found that J&J failed to warn patients and doctors about the risks of its mesh products and made fraudulent misrepresentations.
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.
The trial is continuing and deliberations by the jury are expected to start shortly. If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.
U.S. District Judge Joseph Goodwin declared the mistrial last week after determining that jurors would not be able to disregard improper testimony by a plaintiff’s witness Dr. Lennox Hoyte had testified that no one implants or sells the mesh anymore. The answer was given in response to a Plaintiff’s attorney question: ‘What body of evidence exists in your opinion that supports your ideas sitting here today that Avaulta Plus armed mesh is a bad idea”. Dr. Hoyte is reported to have replied; “Here’s what I know. I take a lot of these meshes out. I know that nobody implants them anymore, and I know that no one sells them anymore.”
According to a report in the Charleston Gazette, Judge Goodwin stated: “I don’t think it’s a bell that can be unrung — and I want to say this in the context of, to my knowledge, never declaring a mistrial in a civil case in nearly 20 years on the bench — I think it would have been very difficult for the jury to disregard it.” The case is Donna Cisson vs. C.R. Bard, Inc, a 54-year-old public health nurse from Toccoa, Georgia, who was inserted in 2009. She contends she has suffered injuries and required two surgeries to repair the damage.
In his opening statement, one of Plaintiff’s attorneys told the jury
- Bard knew of the risks associated with Bard Avaulta transvaginal mesh and failed to inform doctors.
- Bard did not do clinical testing or studies to learn the risks of Bard Avaulta transvaginal mesh.
- Bard did not study how to remove Bard Avaulta transvaginal mesh.
- Bard marketed and sold Bard Avaulta transvaginal mesh despite knowing the material used to make it, Marlex, was not designed to implant in the human body.
- Bard did not tell doctors that Bard Avaulta transvaginal mesh was not fit for human use.
“The company knew in 2002 and 2003 that synthetic vaginal mesh could cause significant erosion of the patient’s tissues, and infection.”
However, Lori Cohen gave the jury a different view on behalf of Bard. In her opening statement, Ms. Cohen created a picture of the evolution of surgical transvaginal mesh that runs contrary to the image of mesh manufacturers dispatching a legion of sales rep to push doctors to start using polypropylene (PP) mesh in the late 1990’s and early 2000.
Click here to read the full article: Bard Opening Arguments in Federal Transvaginal Mesh Case
Over 12,000 women who have filed suits detailing their injuries from the mesh inserted in them. We believe that ultimately the cause of their injuries will be shown to be the defects in the mesh products and the absence of appropriate warnings. If you would like more information, check the video below, go to our website, or contact us at 1-800-481-1615 or email us.