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Wanda and Greg Queen v. C.R. Bard- Transvaginal Mesh Trial Day One

Scales of Justice, WikiCommons

Scales of Justice, WikiCommons

It just seems like yesterday that the first federal transvaginal mesh trial concluded with a $2 million verdict for Donna Cisson.

Just as Judge Joseph R. Goodwin promises, the second of four bellwether cases to test legal theories will begin Monday, August 19. This case has Wanda L. and Greg T. Queen v. C.R. Bard.

Here is the complaint:  Queen Document 1 Complaint

Bard has filed an answer to the Queen complaint here: Queen Answer to Complaint by Bard 20111858517

Background

Wanda was implanted with the Bard Avaulta Solo Anterior Synthetic Support System during surgery performed by Dr. Elizabeth Barbee at Wake Medical Center in Raleigh NC. It was used to treat pelvic organ prolapse.

As a result of having the product implanted in her, Plaintiff Wanda Queen has experienced significant mental and physical pain and suffering, has sustained permanent injury, and permanent and substantial physical deformity, has undergone or will undergo corrective surgery or surgeries, and has endured impaired physical relations with her husband, Plaintiff Greg Queen.”

Count I is Negligence – Manufacturer had a responsibility to use reasonable care in designing manufacturing marketing labeling, packaging and selling the product.  Defendant was negligent in failing to use reasonable care in designing manufacturing marketing labeling packaging and selling the product.  Due to negligence, Queen was caused and in the future will be caused to suffer severe personal injuries, pain and suffering severe emotional distress, financial or economic loss including but not limited to obligations for medical services and expenses, present and future lost wages and other damages.

Count II  – Design Defect Strict Liability – the product was not reasonably safe for its intended use and was defective which caused her injuries.

Count III – Manufacturing Defect Strict Liability – It  was defective with respect to its manufacture which was the direct and proximate cause of Wanda Queens injuries and future injuries and emotion distress, pain and suffering, financial loss and economic loss due to medical expenses.

Count IV –  Failure to Warn – The product was defective  in its lack of appropriate and necessary warnings.

Count V –  Breach of Express Warranty – Defendant assured the public hospitals and health care professionals that the product was safe and reasonably fit for its intended purpose. That’s why she and her health care provider chose the product.  Defendant breached these express warranties because the product was unreasonably dangerous and defective and not as defendant had represented.

Count VI –  Breach of Implied Warranty  – Defendant impliedly warranted that the product was merchantable and were fit for the ordinary purpose for which it was intended.”  Which was to be implanted in Wanda Queen.

Count VII  – Loss of Consortium –  Greg Queen suffered loss of “his wife’s consortium companionship society affection services and support.”

Count VIII  – Punitive Damages – Defendant knew the risks or should have known the product was defective and presented an unreasonable risk of harm to Wanda Queen.  The defendants conduct “manifested a conscious indifference to, and /or flagrant disregard of, the safety of those persons who might foreseeable have been harmed by the Product, including plaintiff Wanda Queen, justifying the imposition of punitive damages.” They ask for costs attorney fees, interest or any other relief that is reasonable.

Expect jury selection to take place beginning 9 am August 19. In the Cisson case, it took one morning to select six jurors and 2 alternates.  Presumably the case can then begin Monday afternoon.

This is the second of four cases naming defendant, C.R. Bard of New Jersey accusing it of making a defective Avaulta transvaginal mesh used to treat pelvic organ prolapse and failing to warn implanting physicians.  The four cases may determine the course of the other 28,000 consolidated in this court naming six manufacturers.

Witnesses

Dr. Anthony Visco, Pres AUGS

Dr. Anthony Visco, Pres AUGS

Expect Dr. Anthony Visco to be called as a witness (see background story here). Dr. Anthony Visco is Chief of Urogynecology at Duke Univ. Medical Center and President of AUGS.  The American Urogynecologic Society (AUGS) was founded in 1979 and is a professional organization of 1,400 physicians and allied health professionals who care for women with pelvic floor disorders, specifically pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Dr. Denniz Zelnoun

Dr. Denniz Zelnoun

Also expect to see implanting physician, Dr. Elizabeth Barbee, Dr. Denniz Zelnoun who is an assistant professor at the University of North Carolina, Chapel Hill in the Department of Obstetrics & Gynecology, division of Advanced Larascopy & Pelvic Pain.

Also called as a witness is former FDA Commissioner, David Kessler.  #

Learn More:

For those of you with Pacer accounts which allow you to look at court documents from the Southern District of West Virginia, the Wanda Queen Case number is 2:11-cv-00012.

7 Comments

  1. Betty says:

    Jane, it sounds like the witnesses you mentioned are for the defense. Do we know who is testifying for the plainfiffs? Dr. Visco is a slick politician who sides on keeping “choices open” for all women. It sounds like a “PC” comment, when in reality women in Dr. offices are not being given options at all. I took my friend to different appointments for her grade 2-3 cystocele and the only options she was given was within the slings. Either polypropylene or porcine. Both have issues and are permanent solutions. She had an “old fashioned” procedure 20 years ago and it was not permanent. After reading about these slings in detail I cannot recommend any of them to any one. The Dr. we saw had about 11 sheets on the wall showing he had been trained in several of the slings on the market. In the last case it was brought out that the Dr.’s would use (their attendance) the training sheets to show how well trained they were. In reality there was no testing or even oversight as Bard claimed that was not their job. How I wished I knew this when this Dr. pointed out his wall. Finding someone in our area who even knows about the “old fashioned” procedures is next to impossible. Haven’t found one yet. My life has been ruined by a SUI sling. The callous way the medical community is handling this is just OUTRAGEOUS!! Surely there are enough of us injured that it’s becoming better known now?? Still no media coverage. I hope this next jury will also see the truth – it seems the only avenue where the truth can come out.

  2. Mary Pat says:

    I have seen 2 urologists (one is very young and the other is middle aged) who don’t even know how to do the Burch Urothropy which was the gold standard for repairing prolapse prior to the mesh slings. These doctors and most young urologists are not trained to do anything more than mesh slings in med school! It’s no wonder Dr. Visco is so determined to keep slings on the market. First of all, if the slings were removed from the marketplace, that would be an admission of liability for the mesh makers which would make all these trials unnecessary. The victims would not have to prove they have been permanently injured. The mesh makers would be paying victims for the permanent damage they have caused rather than lining the pockets of the likes of Dr. Visco. If the mesh slings were no longer available, it also would require doctors to get additional training so they could correct prolapse without mesh slings! Imagine the hardship all those doctors would incur. They would have to return to med school for more training and they wouldn’t be getting rich from implanting slings and from being bought off by pharmaceutical companies. What a tragedy that would be! Wouldn’t that be far worse than destroying women’s bodies and lives?????? Wake up world! This is one of those stories that someday the world will look back at and say “how on earth did this torture go on? Why wasn’t it stopped sooner? Why didn’t we hear about it sooner?”

    I imagine there is a special place in hell for people like Dr. Visco. He can join the Nazi doctors who also tortured and abused people.

    I wish someone could research medical schools to see what they are teaching med students about mesh??????? Although with Dr. Visco at the helm, it’s obvious. Sadly. Tragically. Shame on Dr. Visco. He really should put mesh in his wife, his mother and his daughters. The mesh tragedy continues because of people like him.

  3. Betty says:

    This whole process is making me sick. My pain level has been at an average of 8. I just read the defense answers to the plaintiffs complaints. What a waste of paper. One thing is very clear – they deny the allegations. By reading this one would think that they were in the judge seat, calling for a dismissal of charges. Thank God the last jury listened to the last case, I hope this one does too. After reading the deposition of Donna Cisson and the way the defense tried to get across that she signed off on the complications of the procedure thus being informed of everything that could happen. No one would sign off on these complications if they believed they could be permanent. We sign off on so many things every time we have surgery, but we expect them to use due diligence. If someone were to die from anesthesia for instance we know that the hospital and staff would be investigated and it would be a BIG DEAL. Even though we sign-off saying there is a risk. The word permanent is not contained in any of the clauses. These are very serious complications and very serious complaints. They are not rare and there is a protective covering allowing for these travesties to occur in precious lives. Only when money is no longer the bottom line and true values of health and the best for the patient are believed in, will we begin to see integrity and true care return to the medical industry. Until then, read everything very carefully, ask questions, do research and run away from anyone who gets upset by being questioned. I’m tired of living in pain, of having surgery after surgery, of being given this that and the other thing to try. Of being experimented on to overcome the experiment they performed on me in the name of helping women (mesh). SICKENING!!!

  4. GINGER says:

    Hi to comment on the above I did do research on the mesh but there was not much out there to look at. You had to be in the medical field to understand alot of the reports out there. I was not so they only thing I could do was rely on the opinion of my Dr and have faith he knew what the was doing. Now the big question is if Dr are not informed of the sever results of the mesh THEN the Manufacturer of this Mesh is the only one that is accountable for its demise or success. It is a clear cut case right… but no they played GOD with our lives for pure PROFIT and we are not supposed to ask for restitution on this…. maybe we should become a society like the Germans and Russians, who took there a Anger out on the less fortunate and lined the up and shot them or put them in camps to work with no food or water this GENOCIDE on woman has to stop and the only way is for these companies to hurt then so be it….. I have been in a prison in my own body for three plus years with no answers how it will end MY LIFE WAS COMPROMISED THE MOMENT MY DR PUT THE MESH IN ME AND WILL NOT REST TILL JUSTICE IS SERVED I WILL BE AT THE COURT ON THE DAYS MY COMPANY IS ON TRIAL…. I SUGGEST ALL WOMEN DO THE SAME SHOW UP LET THESES MANUFACTURERS KNOW WE ARE NOT A NUMBER BUT HUMAN FLESH AND DESERVE TO BE HEARD

    • Betty says:

      To note: I also did research online and like you in 2007 there was nothing out there except positive outcomes. It was the “gold standard”. Today this is not the case. We can now look up individual products and find information from various sources. There are still areas that are not covered. Hopefully you are correct and this avenue will stop the abuse of women (and men). To be used as unsuspecting guniea pigs is totally unacceptable. The FDA needs to be held accountable – this I have no idea of how to do. The FDA is the one who is allowing even more meshes without arms on the market, without being tested either. Some Dr.’s have testified they are safer in court. I don’t believe it. This is a very complicated issue. These are the only options being made available at this time. That is sickening as well!!!

      • Jane Akre says:

        Betty- To answer your question, and it’s a good one, Zelnoun is testifying for the plaintiff, but as you know both sides get to ask questions of the witness. I will do a better job specifically citing who has called each witness. I think the addition of David Kessler is an interesting choice.

  5. Amber says:

    Thanks for Keeping us up to date.

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