The Cisson Transvaginal Mesh Trial Against C.R. Bard – What did we Learn?

Dec 4th, 2013 | By | Category: Legal News
U.S. District Court, Charleston WV

U.S. District Court, Charleston WV

The Donna Cisson product liability trial against C.R. Bard, a New Jersey- based mesh manufacturer is finally over and the Judgment Order was filed in federal court October 18, 2013 confirming the jury verdict which C.R. Bard tried to amend or reverse.

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.

Design DefectBard Avaulta from website 200

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.

Donna and Dan Cisson

Donna and Dan Cisson

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

Dr. Lennox Hoyte

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.

Smoking Gun

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.”

Anthony Brennan Ph.D

Anthony Brennan Ph.D

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.

Failure to Warn

Dr. Brian Raybon on the stand, sketch by Jane Akre

Dr. Brian Raybon on the stand, sketch by Jane Akre

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.

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

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.

Jurors in first Cisson trial, July 2013, art by Akre

Jurors in first Cisson trial, July 2013, art by Akre

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.

Punitive Damages

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.   #

 

Learn More:

Deposition of Dr. Jim Ross:
http://meshmedicaldevicenewsdesk.com/wp-content/uploads/2013/08/Bard-Exhibit-200-61-Jim-Ross-deposition-20113073761.pdf

Dr. Brennan’s U. FL page
http://brennan.mse.ufl.edu/

Cisson Case 2:11-cv-00195, Document #448
Bard Exhibit #448 Cisson Renewed Motion for Judgment as a Matter of Law

Materials Safety Data Sheet
Bard Exhibit #200-1 Marlex Mesh MSDS

Bard Avaulta IFU
Bard Exhibit #148-3 IFU Avaulta

 

 

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12 Comments to “The Cisson Transvaginal Mesh Trial Against C.R. Bard – What did we Learn?”

  1. Outside of all the legal issues….I am totally distraught because I want to find an empathetic physician that can truly help me as I too am a registered nurse (had mesh removal at age 47). I am getting foot drop (I have a confirmed Sacroiliac joint injury diagnosed with EMG, MRI, etc.) even after pelvic physical therapy, etc. and yet I cannot find any physician that will help me as post mesh injuries are taboo. I just would like to get help now before things worsen and I lose my career. Any reply with names of physician’s which deal with mesh related injuries would be greatly appreciated. I have had 4 surgeries, hematomas, reconstructed urethra (mesh eroded through) please forward this to the nurse in your story or anyone who can help me. (I live outside of Louisville, KY) and I would just like to have someone who can see me for the mesh damage…and help me get back to my pre-mesh state (or at least prevent any further nerve damage). (I previously had a cystocele and because of my younger age, my physician wanted me to have a TVT with urethral suspension).

    thank you…and God Bless the person who takes this info. and tries to help me.

    • Jane Akre says:

      Hello~ Since you asked , I’ve sent you to a few people who may help, a doctor and an RN both experienced with mesh. I’m so sorry. It sounds as though you may not have all of the mesh out but I’m not a doctor… they will have a better idea… thank you for writing~ jane a

    • Fred Crane says:

      There is a great Dr. Sean Francis at U of L in Louisville he did my wifes explant and was wounderful, caring, and understands what this mesh has done to women please try to see him he is Great and right in your home town.

    • anny says:

      Look up the autoimmune disease Ankylosing Spondylitis. The disease attacks the SI joints . Go see a Rheumatologist.

  2. a meshed-up nurse says:

    Dear Sheryl, Jane has my contact information which I asked her to please pass on to you. Please call when it’s a good time for you. I agree with Jane- it sounds as if you still have mesh pressing on the nerve(s). Hopefully, I can help you better once I know more details about your situation. Unfortunately, imo, we were guinea pigs for these TVMs being placed, and because no studies were done on removing what were supposed to be “permanent” implants, we are once again guinea pigs when it comes to having the mesh, especially the “arms”, removed. Most doctors who implant TVM for SUI do not have the experienceor skill to remove mesh from “beyond the obturator muscles” because “it’s too dangerous” due to “too many nerves and blood vessels there”. There are, to my knowledge, only a handful of surgeons in the USA, who have the experience necessary to remove mesh from these areas. That is why mesh injured women from Canada petitioned their healthcare system (unsuccessfully) to be able to come to the USA for TVM removal. Please call when you can and we can discuss things further…

  3. guest says:

    It seems so unfair that why some people get advice from some people and some do not? why women have had to go through this mesh mess and suffer and they cannot expose those doctors and nurses , their names , states and more to see some kind of justice for their cruel treatment. to expose these liars, cons , and those that even in politics that did nothing to stop this mesh mess, the fda and the names of those all the way to washington, I am sure the FDA, KNOWS THOSE THAT WORK FOR THEM THAT WOULD NOT LISTEN TO THE WOMEN CALLING ASKING WHAT IS HAPPENING WITH THIS MESH IMPLANT. Some just refused to answer the phones, or if you did get through, they hung the phones up. who took those calls?

    what about the politicians , in every state of america, that also would not get involved how do we find out who got money from these companies for campaigns, you know how they all are seen smiling with those that give to their campaigns, and what about the big news media people, that reporters lie like the devil for their big money
    what do they get more money for cover up. THIS SHOULD HAVE NEVER HAPPENED IN AMERICA, NOR ALLOWED TO HAVE SO MANY THAT MADE BILLIONS OF MONEY OFF OF INS, DOCTORS THAT LIED GOT THOUSANDS FOR EVERY SURGERY AND LIE THEY TOLD TO WOMEN.

    A woman locally at the court house that is a evil as any woman could come, that lied also to me, I bet she has a mesh case, because she said the same doctor that did my surgery did hers and she has not had any problems at all with her mesh, no infections , nothing, BUT IF YOU LOOK UP HER NAME, BET HER NAME IS IN THE COURT DOCKETS, FOR HER TO GET MONEY SINCE SHE LIED FOR THAT DOCTOR AND MORE. i HAD TO CALL HER A LIAR TO HER FACE. THAT STORY GETS DEEPER IN ———-, WITH HER ON HER PART.

    WHEN DO THE WOMEN THAT HAVE SUFFERED AND BEEN GAGGED GET TO TELL THE TRUTH THE WHOLE TRUTH AND NOTHING BUT THE TRUTH ? THAT WOULD TAKE A LIBRARY TO HOLD THE STORIES , AND THE WOMEN NOT LYING HAVE THEIR PROOF , TO BACK THEIR STORIES UP. BUT COURTS WILL NOT ALLOW THEM TO TELL, NOR ATTORNEYS TOO MANY INVOLVED IN LIES AND COVER UP.

  4. guest says:

    Prison and life time is what they need to get, they put animals behind bars and cons behind bars, what about those that did this and covered the truth up, and lied like those cons, playing con game mind games with women, telling them they were crazy to cover for what they did so evil to humans. where are the criminal charges,?

  5. guest says:

    To the doctors, that were truthful , which were very few, that said, I am sorry I cannot help you, I don’t have the knowledge to remove the mesh, , no problem at all with these. but those medical doctors that gave sarcastic remarks and had those women in their offices make sarcastic remarks, shows , that not all that have education, and work in offices , on the outside nice dress, but their evil they have shown and should be exposed they are in the wrong field of profession, to think their authority gives them any right to ridicule and do evil . they need to take their money to hell with them, the buzzards will be all around their beds when it comes for them to die to take everything thing they have and got so evil in lies.

    someone said I was harsh, and I said what do you call what they did to me and other women? laughing at people suffering?

  6. Sandy says:

    I am one of thousands that was hurt by a mesh. I was in pain for a year before a doctor took it out, not the same one who put it in however. Since it has been taken out I still have pain from nerve damage. I have lost relations with my husband, I can do many of the things I use to do and family time has been lost too. I have lost jobs because of having to go to doctors, missing work due to pain. Now I have been told that the usual max on theses settlements is like 150,000.00! I am not greedy but this is not enough! What these bastards did to be can never go away. They have destroyed a lot of my life. I keep struggling to go on and do the best I can. But I deserve to be awarded enough so I can provide a income until I retire, about 10 years. I am just waiting to lose another job. Hey men try sitting all day in pain. Try concentrating on work when all you feel is a throbbing pain all the time. Tell me how much it is worth to go through all of this? My attorney won’t tell me how much he thinks this is all worth either. It’s going on 2 1/2 years of all this garbage and I am worn out and tired. Some one help me know what to do! I try not to bug my attorney I don’t want him pissed at me but I sure would like to know or have an estimate as to how much I might, I say again might be awarded. I don’t know how much longer I can go on with this pain and keep working!

  7. WJH says:

    My wife had an mesh implanted back in January 2009 and has had at least six strokes since May 2010. These strokes were caused by Calcium Deposits according to our stroke doctor. I was wondering if the mesh caused the deposits to form and travel through the bloodstream?

  8. […] the Avaulta Plus.  A Material Data Safety Sheet from Chevron Phillips clearly stated this material should not be used in medical applications “involving permanent implantation in the human body or permanent contact with internal body […]

  9. Sandy says:

    What did we learn from this whole issue women are still Ginny pigs. It doesn’t matter if they hurt us or not. Then when we stand up and say ok pay me for the life i have lost we have to go through years of court trials while we suffer through pain and wondering how to regain our lives. I want to know how much they think this is worth to us. My attorney says a bunch of attorneys are going to get together and decide how much is enough and then negotiate with the medical companies. Do any of us really get to tell them our stories before they decide
    Then there are rules about how to decide each case. I say enough is enough and we all deserve more than we will ever get. I facing having to have an electrical device inplanted just to deal with the pain that will be in for the rest of my life! I have even read that they could end up filing Bankrupcty! Then we are left high and dry. This is BS! I want my life back and the help to make that happen. I have read it could be as little as 20,000.00! For what they did to me it should be 200,000.00 after attorneys fees! Step up take responsibility for what you did and pay up medical companies!

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