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Mistrial Declared in First Federal Transvaginal Mesh Trial

Judge Joseph R. Goodwin

Judge Joseph R. Goodwin

July 10, 2013~  Saying it was the first time in his 20 years on the bench he had declared a mistrial, federal Judge Joseph R. Goodwin ended the first federal trial involving one of six transvaginal mesh manufacturers, C.R. Bard, after just two days of testimony.

More than 25,000 cases have been consolidated in the Charleston, West Virginia federal courtroom. This was the first case to go to trial.

The problem was contained in a statement made by Dr. Lennox Hoyte, who took the stand this morning.

Dr. Lennox Hoyte

Dr. Lennox Hoyte

Days ago, Judge Goodwin ruled that any mention of the Food and Drug Administration (FDA) and 510(k), the fast-track approval process that allows mesh on the market, should be excluded from trial.

Dr. Hoyte opened that door by a statement he made just before the lunch break.

A Harvard educated professor of female pelvic medicine at the University of South Florida in Tampa, Dr. Hoyte had nothing good to say about the Bard Avaulta Plus posterior mesh that had been implanted in plaintiff Donna Cisson, 55, in 2009.

Dr. Hoyte said he now removes mesh at least twice a week and has explanted about 400 meshes made by various manufacturers which is implanted in women to shore up pelvic organs.  How many were Bard Avaulta, he was asked. About one-quarter, or 100 mesh removals, he answered.

Mesh Problems Continue

Women continue to have complaints with the Avaulta long after the mesh is removed because the arms are firmly implanted in the levator ani muscles, which provide support for the pelvic floor and aids in urination and defecation, Dr. Hoyte said.  The mesh will shrink and cause the muscles to spasm and the bare mesh arms serve as a saw cutting the pelvic floor muscles, he said, causing a woman’s ongoing pain, long after the center portion of the mesh is removed.  Dr. Hoyte testified he felt it was too dangerous to retrieve the mesh arms used to anchor the mesh in place because how deeply they are placed.

Bard Avaulta from website 200“The Avaulta Plus posterior is the Avaulta Solo with porcine collagen. The thought is it would decrease the risk of erosion. That’s not how it turned out,” he told the 8 jurors of 5 women and three men.

Clean Contaminated Field

Another complication with transvaginal mesh (TVM)  is its passage through the highly acidic vaginal area where incisions are cut and steel tools are used to pull the plastic mesh into the pelvic region.

“Passage of the TVM through the vagina creates the set-up for erosion and failure,” he told the jury. “The vagina is a clean contaminated field that can never be sterilized. If infection is introduced during the passage, there will be erosion of the mesh.”

Dr. Hoyte demonstrates to jurors

Dr. Hoyte demonstrates to jurors

Almost professorial, Dr. Hoyte stood before the jurors and illustrated a 3-D version of mesh like the one that had been implanted in Donna Cisson. Although he had never examined Ms. Cisson, he had reviewed the medical records of her two doctors, Dr. Bryan Raybon, who took the stand yesterday (see back story here), and Dr. John Miklos, her implant and explant surgeons. Both were competent, Dr. Hoyte testified; it was the mesh itself that caused her ongoing pain.

“The blind passage of trocars through the area with important blood vessels and muscles, the side-to-side attachment, puncture of the levator ani area and mesh shrinkage affects normal sexual functioning and pain,” he said.

During an examination by attorney Paul Ferrell, a plaintiff attorney from Huntington, West Virginia, Hoyte was asked if the instructions for use (IFU) or warning label that accompanied the product were accurate. Bard has contended that Ms. Cisson and her doctor both understood complications. (Editor note*- back and forth added below from my notes for further clarity).

Ferrell: “The instruction read, “Potential adverse reports, are those associated with any permanently implanted materials.”

Hoyte: “No because  the vagina is not a sterile environment, it’s a clean contaminated, you can’t keep it clean like hernia mesh.”

Ferrell: “When did you think it was a bad idea?”

Hoyte: “When I was informed by the Bard company representative.”

Ferrell: “What made you think it was a bad idea?”

Hoyte: “Blind trocar- based passage through a clean contaminated environment prone to infection with side-to-side anchoring that can shrink. I take a lot out, nobody is implanting it anymore. No one sells it anymore.”

Ferrell: “To your knowledge, is anyone in the U.S. still implanting mesh with arms?”

Hoyte: “No [objection- overruled] It’s not for sale in the U.S. It was withdrawn.”

Ferrell continued to ask why polypropylene mesh does not have the same complications as polypropylene sutures. Dr. Hoyte explained the sheer volume in the Avaulta mesh overwhelms the amount of mesh you might find in a suture.     [Editors add* –  It has been said by doctors “the more mesh, the more mess.”]

Ferrell asked the doctor if he believes the Avaulta Plus Posterior is reasonably safe for its intended use?

The answer is no!” the doctor said quite emphatically.

Defense attorney Lori Cohen objected. The jury was ushered out of the room.

Lori Cohen

Lori Cohen

Cohen told the courtroom that she had, upon the judge’s instructions, removed from her opening statement anything about the FDA and the 510(k) approval process that allowed mesh on the market with no safety and efficacy studies. That also meant there would be no mention of the post approval 522 studies ordered by the FDA to follow women for three years to gauge mesh complications.

Two years ago, after the FDA discovered that mesh complications had increased five-fold with no explanation, it ordered 33 mesh manufacturers to go back and conduct three years of monitoring the health of women who had been implanted.   The FDA has the authority to issue post-approval monitoring of a medical device under a 522 order. 

By June 2012, C.R. Bard, as well as Ethicon, a division of Johnson & Johnson, had voluntarily removed their mesh kits from the market, allegedly for financial reasons. The move, however, also relieved them of having to conduct the post-approval monitoring studies ordered by the FDA.  See the back story here and here.

Cohen told the judge she would have trouble telling the jury why Bard had removed its Avaulta line of meshes from the market without going into the FDA’s order.

“It is intertwined. It raised the whole 510(k) issue. Because it’s been opened, that’s grounds for a mistrial,” she told the judge.

“I’ll think about it,” Judge Goodwin said dismissing everyone for lunch.

By 2 pm the jury was not back and neither was the judge.  Shortly afterword, Judge Goodwin returned and said about the utterance, “I don’ think its a bell that can be unrung,” and that the spontaneous statement would not withstand an appeal in the 4th Circuit Court.

Judge Joseph R. Goodwin

“Ive never declared a mistrial in my 20 years on the bench, but it would be very difficult for a jury to ignore it and a discussion of the FDA would confuse the jury. I’m declaring a mistrial.”

The Donna Cisson v. C.R. Bard case was rescheduled to start July 29.

Henry Garrard III

Henry Garrard III

Plaintiff attorney Henry Garrard gave a bear hug to Donna and her husband, Dan.  “Its gonna be okay, it’s gonna be okay,”  he assured them.

Lori Cohen told MDND, “I’m disappointed what  the plaintiff’s witness blurted out and forced us to move for a mistrial. I look forward to the next trial.” #

 

 

33 Comments

  1. MarieAnn says:

    Unbelievable! It seems the jury should know the FDA was concerned in some way to warrant post market studies of these torture devices! How can this information not be presented to the jury??? Also, the fact the Avaulta was pulled from the market? WTH!! I do believe we women are not going to see justice with this gag order from the judge.

  2. dawn says:

    It was withdrawn for financial reasons right ???????? How does this bring the FDA into the picture ? That was the Manufacturer’s story , why aren’t they sticking to it ? Now it’s good enough to declare a mistrial for just telling the truth. All of us that have been implanted with MESH KNOW the truth….we just want to be heard 🙁

  3. Betty says:

    Does sound like they’re covering their butts. Looking for an out. Delaying the inevitable. I hope the judge does let the truth out. I can see how knowledge of the 510(k) could affect the jury for the plaintiffs and why Bard does not want that ground covered. However, what happened to the Hippocratic oath? First – do no harm. Bard took a risk in withdrawing their product from the market, it makes them look guilty. The risk must have been a good “business decision” which wasn’t taken lightly. I’d hedge my bets on taking it off the market too. I personally don’t see how it would get through a 3 year trial phase. If the defense lawyer stated it was withdrawn for financial reasons she’d get skeptical looks for sure, although I’m sure the finances would be affected by any study. None of us mesh patients ever believed it was taken off the market for financial stability. So now we won’t see the “whole truth”. I believe the jury was able to understand the 510 (k) process, it could have been explained to them. I wonder what other ground is off limits? How can the truth come out if there are gag orders on anything that can sound prejudicial? The trial is already limited to 3 weeks. I’ve spent at least 4 times that amount in just reading over the studies that are out there. If the jury only knew . . .

  4. Melynda says:

    I’m having a hard time understanding why the FDA warnings and 510(k) discussion are being excluded from the trials. Can someone help me understand why this is happening?

    • Jean says:

      melynda, It is wrong for any court to stop truth of all involved in what has happened and caused women to suffer so horrible, I do not understand it either. That is the way people get by with murder in the usa. Those in power seats that can stop truth coming out to where only distorted truth told. I have seen it many times. Those rich that made money off of the mesh do not care, as they said the fda , wants to use the women for the rest of their life for guinea pigs to find out what went wrong with mesh they approved. I want to know what the doctors and nurses and others got as gifts for allowing the mesh to be implanted in women? What doctor or anyone in medical , would ever implant this into a humans body knowing that humans would be the guinea pigs testing it? Surely the doctors and nurses , asked questions before they would, destroy so many humans lives.? What kind of human being would it?

      what kind of people would sell this mesh without testing it first, TOO MANY RICH PEOPLE WOULD PAY FOR WHAT  THEY DID TO HUMANS, WOMEN, i DO NOT LIKE THIS AT ALL WHERE THE TRUTH AND ANYTHING IS KEPT FROM BEING TOLD IN COURTS TO STOP TRUTH FROM COMING OUT.

      guinea pigs , animals for the rest of our life for fda, so they can make more studies of our bodies ? why the mesh protruded out, cutting and more infections, stopping our lives completely to where every day life is so hard to deal with , in suffering from the mesh, , the cruelty of medical and fda, phones being hung up on us, before , in my case that I KNEW WHAT HAD HAPPENED TO ME, GOING FROM 1 DOC, TO ANOTHER, THAT NOT 1 WOULD TELL ME THE REASON INFECTIONS COULD NOT CLEAR UP WAS BECAUSE MESH WAS CUTTING ME INSIDE. IT TOOK 2 YEARS, TO FIND 1 THAT FINALLY TOLD THE TRUTH TO ME, BUT SAID SHE QWAS SO SORRY BUT SHE DID NOT HAVE KNOWLEDGE TO REMOVE IT. that was about 2 years ago, after a doctor tried to remove it , it still is protruding out, and worse, because he was 1 that should have never attempted to remove the mesh. ONLY VERY SKILLED DOCS SHOULD EVEN ATTEMPT TO REMOVE IT,

      i DO NOT WANT TO BE A GUINEA PIG FOR MEDICAL RESEARCH OR FDA , or any doctor for the rest of my life I am not an animal to test products on,.

      MY LYNDA, WHY WOULD ANY HONORABLE JUDGE EXCLUDE ANY TRUTH FROM BEING TOLD IN HIS COURT ROOM?

    • Nonie Wideman says:

      why the gag? too big a can of worms that would slow down the trials..the judge felt there was enough evidence of harm already to go to trial on failure to warn of all the serious complications and possibly defective product allegations…..tis a pity the whole package would be too cumbersome…….just my opinion….wish the jury could hear the whole truth as when they question us in a court of law we swear to tell the whole truth and nothing but the truth,,, to bad it isn’t fair play

  5. Bill Thompson says:

    Lori Cohen is only concerned about Lori Cohen. She has never lost a case in all of the 55 cases she has tried and she will do and say anything to win this one. She entered the courtroom on day one and commanded the floor before the trial even began. She was all things to all people from drawing attention to herself by being everyone’s friend and her strategy has obviously worked until now. I love the whole concept of MDL and the sharing of ALL information from ALL previous cases. It’s like having all the plaintiff attorney groups working together for the common good. The facts are so detailed out that even the other brands of mesh help this case. I for one cannot wait to see Lori Cohen go down in flames and get frustrated with the undeniable truth that is about to smack her into reality starting on July 29th. Don’t worry about the delay, the plaintiff attorney group has had a heaping helping of Lori Cohen and her “Thank goodness for the arms,” rhetoric and will even be more prepared. Donna Cisson, I pray right now for the peace that surpasses all understanding and asking God to bring swift justice for you and your family.

    • Jane Akre says:

      Just an observation, she worked the court like it was her own personal party…. very upbeat and effervescent. Then again why not have a positive mindset, you can’t blame anyone for that. Thank you for your comments.

      Unclear to me is WHY the FDA allowed both Ethicon and Bard to skip the post approval monitoring of the health of the women ALREADY IMPLANTED with their meshes. It seems like that was a giant concession to industry that the FDA has long been known to grant. Just because they withdraw the mesh, isn’t it still a viable question how their “safe and effective” product was doing in the intended recipients? Hadn’t they already made profit by the sales of the product? Why let them off the hook just because they chose to remove the product from future sales? Just a thought and I believe a good question that has never fully been answered by the FDA!

      • Mary Pat says:

        Who governs the FDA? How do we (we mesh victims and anyone else who cares about justice) unite and send letters, a petition, a complaint…… The FDA has to answer to someone. There has to be a higher authority who can investigate the FDA and reprimand them. We deserve to know why the FDA allowed the mesh makers to skip out on the post market study. We deserve an answer to that question and, more importantly, we want to know what the post market study was supposed to reveal. Are the pharma companies doing post-market studies on the mesh products that are still on the market? Does that mean the pharma companies are policing themselves? We can’t let the FDA get away with this! Is the FDA subject to public disclosure requests? I hope someone reading this can guide us and direct us.

  6. Jane Akre says:

    Just FYI- I jumped into the elevator with a few of the dismissed jurors. It would okay to talk to them now (never during the trial).

    The one who spoke said she thought both lawyers were very good. Asked which way she was leaning, she said she’d think one thing, then the other side would counter it and she’d think something else.

    I did commend them for taking notes. It seemed like they took the whole thing seriously.

    I asked if she knew why a mistrial was declared. I said it was because the product was withdrawn. She said, yes, she knew it when she heard it. She shook her head, she knew that was something……

    • Melynda says:

      Jane – I cannot thank you enough for being our advocate and our eyes and ears in the court. You are truly a hero.

  7. Michele says:

    Jane… A very personal thanks for being the eyes and ears for us. I know I would not be able to contain myself and would have to sit on my hands and have my mouth duct taped. Do you know why the FDA and 510 (k) be eliminated from the testimony? Im not the sharpest tool in the shed but know wrong when I see it. I know for any of this to matter, responsibility has to be taken for the errors. and misleading information (or lack of) given to the victims. I was told I needed this surgery not an option, sign my surgical consent forms like a good doggy and that was my part. Im not a doctor, and had no option to research true facts about what was being implanted in my body. Trusting the doctors when you are ill is such a risk. I wish I was told the truth prior to my surgery. Sorry for the rant, this topic has been my unleashed giant for many years and many years to come for sure. Once again thanks for doing what you are doing.

  8. Kathy says:

    It is now “our job” to warn each and every human being that may in the future be hurt as we have been. Why is the honest truth so difficult for us to hear? We know that we must face what has been done to us and not allow it to be done to our children and grandchildren in the future.

  9. Mary Pat says:

    The post market study would have clearly brought the ugly truth to light. The fact that the FDA allowed the mesh makers to avoid the study is proof to all that the FDA helped the pharma companies sweep the ugly truth under the rug. Why, or WHY is Judge Goodwin sweeping the truth under the rug? Without Jane and the mesh lawyers, our truth would never be revealed.

  10. Sandra says:

    I understand that in today’s world some women strive to be a top runner, many pull out all the stops to land a respectful role in what used to be a mostly male world. It’s indeed shameful when one feels the need to abolish her decent qualities in exchange for temporary gratification; the hoopla from one’s peers will earn transitory respect that will be accompanied by a dishonorable personal reputation. It’s obvious that Lori Cohen has an arrogance that can put the most egotistical man to shame. She seeks high publicity, this alone sends up warning flags. Ms Cohen strives to keep her profile blemish free, she does appear flawless as she takes center stage in a courtroom. But is she so foolish to assume that her intellect can conceal the shady and unethical practices that she publicly displays? I wonder how she handles her conscience, she can’t possibly be at peace when she lays her head down at night – can she? Perhaps her narcissistic qualities have made her completely callous. I hope and pray this woman receives some sort of moral awakening before July 29. We must trust the Lord, praising Him along the way. He is the ultimate judge. I trust that He will provide healing and strength in His perfect timing. God can change circumstances in an instant, even when things seem impossible.

  11. Janet says:

    I also want to thank Jane and everyone who was in that courtroom for keeping us posted. Many of us have lawsuits pending and have no idea what we’re in for. I also want to thank Donna and all the other women who are leading the way for us in the bellweather trials. Because they are willing to sit uncomfortably (probably in much pain) in a courtroom, and tell their stories in front of a bunch of strangers, it may make things easier for the rest of us down the road. I’m sad that there have to be limits on what info can be shared in the courtroom – if it’s true, it should be included – then let the jurors decide how relevant it is.

  12. Terri says:

    In my humble opinion, nobody does anything in the corporate world without some financial gain. The FDA somehow got compensated.

  13. John says:

    This makes me wonder whose hand is feeding the judge, apparently he’s trying hard to make sure that he doesn’t bite this generous hand! Try this formula… (2+2=) (federal court / the government) says [“don’t mention the FDA”] (FDA / the government) = disaster in the courtroom!!! They obviously will not allow the truth to be told! This is where the victims need to band together and start screaming “WERE NOT GOING TO PUT UP WITH THIS”. Now is the time to throw a monkey wrench into this machine.

    • Melynda says:

      John – I was thinking the same thing. This is a case in federal court. The judge is a federal judge. The FDA is a federal entity, too. What’s going on here? I simply do not buy into the reasoning, “The jury won’t understand the 510(k) process” or that it will make a trial to “lengthy.” That information is a key factor to the case. Why aren’t OUR attorneys pushing harder to have it included? Why is the defense being allowed to have it excluded???? Maybe we all need to be calling our attorneys and asking why they aren’t advocating more aggressively on our behalf.

  14. david mccomas says:

    i agree with John and hope and pray that we as americans will stand up although obviously in this trial as one stands they are pushed back to the ground . but we need to let it be known that “we the people” will not stand to be guinea pigs. And thank you Janet for all you do ! i noticed DR MIKLOS Took the stand and am in the stages of trying to find my fiance a competent doctor who is familiar and a front runner on mesh removal as she has had one surgery to remove what had protruded through the vaginal wall . can anyone here give mention of a doctor that will take this seriously as here in north carolina we have been pushed out of ER Doors with medication for a UTI ONLY TO INCURR THOUSANDS OF DOLLARS of debt as my fiance has no insurance due to loss of job due to the complications . ANY HELP ADVISE AS TO WHERE TO GO AND HOW TO GET HELP will be so greatly appreciated ! and i as a man that watches somone i love suffer daily will be there to stand up and let my voice be heard and will watch this site for more information , thank you all !

    • Jane Akre says:

      David- thanks for writing. It is unclear to me why some doctors seem to have more success in removing the arms of mesh, described here as “sawing” into Ms. Cisson, and some seem to have more success. I invite any comments by doctors who may have a handle on that. From talking to many women, the doctor with the most success in total removals continues to be Dr. Shlomo Raz at UCLA’s Urology Dept. Post your question on the Facebook page that goes with this site and you will get comments from women who have been there. Thank you and I’m sorry you and your fiance are going through this.

  15. Terri says:

    There is a huge difference from “it being pulled from the market and they took it off on their own accord” . I think one opinion is jumping to conclusions. They most likely pulled it themselves when they realized what a liability it would be for them to leave it on the market.

  16. Betty says:

    I agree with all of you. It is disgusting. My husbands first and only comment was – “the judge has been bought off”. He is angry too. I would like to know a way “that we can band together” to make a big stink in this case. I’ve tried contacting the governors who are in control of the FDA, they won’t even consider talking or hearing from me because I do not live in their jurisdiction (state). I wrote to my own governor and the head of the FDA numerous times. I’ve filled out the federal form 3500. I’ve written to news stations and anyone I can think of. NO ONE seems to be interested in the truth. AND WE ARE NOT THE ONLY ONES HURT. There are several other medical products out there that are hurting people and many cannot get a trial because the FDA APPROVED. This is the tip of the iceberg. Thank you Jane again. FRUSTRATED!!! IN PAIN!!!

  17. a meshed-up nurse says:

    I forwarded this on to Dr Shuren, head of the CDRH at the FDA and to the OB-GYN Panel that makes recommendations to the FDA regarding TVM. The OB-GYN Panel decided on Sept 2011 that TVM for SUI did NOT need the same increased warnings as TVM for POP because they felt that the “complications are manageable”. So do all of you with SUI TVM feel like your complications have been “managed” well? Just wondering.

    I believe the judge is underestimating the intelligence of the jury if he truly believes that the jury would be “confused” by information about the FDA’s 510(k) “clearance”, NOT “approval” process, and it’s impact on these products coming on the market (with inadequate testing). As a nurse, I believe that the jury NEEDS this very important information (that we all should have had) to make an informed decision in this case (and the other 25,000+ cases).

    Thank you so much, Jane, for reporting on and writing about these very important cases (consistently the ONLY one doing this), whose outcomes will affect so many mesh-injured women.

  18. Dawn says:

    TVM for SUI’s is just as harmful.. Mine moved and wrapped itself around both sides of my pelvic bones. Has caused chronic inflammation along with so many other complications. Now I am waiting to have a liver biopsy to see why my enzymes are 4 times what they should be. So I say mesh is mesh is mesh 🙁

  19. Terri says:

    The FDA ad it’s clearance process are irrelevant when it comes to the damage the MESH and all it’s uses, Manufacturers etc., the Plaintiffs’ doctor was very emphatic when asked “whether or not it was a safe product to use in the body or vagina for that fact.” The truth will be heard, the warnings were not there, they cannot create them after the fact. All of the counts brought up against the manufacturers if they are answered and proved in truth, the Plaintiff will win. That’s my thought.

  20. Terri says:

    To be quite honest I am in bed, healing from yet another surgery post Mesh removal. Had a Fistula in my urethra 1/2 ” opening , cause: a three year infection. MESH, removal surgery March 28th, freakin Painful. All of this is horrible. I want these manufacturers, doctors, All involved to be RESPONSIBLE for their money making schemes at the cost of people’s health, lives, careers, husbands etc. I can only hope the truth will be told and heard by intelligent human beings!

    Thanks to those reporting on this.

  21. Douglas ‘Doug’ Kohrs served as Chief Executive Officer of American Medical Systems (AMS) Holdings, Inc. (producer of failed vaginal surgical mesh) from April 1999 until January 2005. He served on the board of directors of American Medical Systems Holdings from 1999 to May 2006, and served as chairman of the board from March 2004 to May 2006. Follow the money!

  22. Mark Factor says:

    I just found this site and am finding it very informative. U gys gt me coming back for more info, my wife is part of this whole ordeal going on. I’d like to c tht Lori Cohen gt something implanted in her tht was “FDA” approved n c how fast her mind gets changes my wife has had 4 surgeries and it seemed like we were in the clear, but she just started developing some pains inside of her again she’s knw afraid to go back to the doctor in Cincinnati for wht thy may find tht was left after the mesh was extracted!!!

  23. rick viccaro says:

    Just got back to reading this site after work required relocation. Dr. Hoyte performed 2 mesh removal surgeries on my wife in Tampa, FL from a 2010 mesh installation. The mesh is barbaric at the least, my spouse has suffered tremendously. At the least Dr. Hoyte is 2 or 3 levels above any doctor i have ever talked to, He can be difficult to understand until he goes down to your level of understanding. Than it is very clear what this mesh does, what causes the pain, how it is caused. Truth is a very sharp 2 edge sword ,Judge Goodwin is very disappointing to me at this time. Dr. Hoyte is a pioneer with robotic surgery, he also holds a mechanical engineering degree and is on the cutting edge of robotic surgery, the second surgery he spent 20+ minutes ( an eternity in surgical time)searching for any remaining mesh except the anchor points that cannot be removed. If the court wants the truth listen to Dr. Hoyte.

    • Michele Barnett says:

      Can anyone tell me if there is a doctor that will do the surgery and take payments. I have no insurance because my husband was laid-off. He has been having troubles finding one. I do not know how much more pain I can take. The thing is I will pay it.

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