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.