Case details

Surgical mesh was defective, lacked proper warnings: plaintiff

SUMMARY

$5500000

Amount

Decision-Plaintiff

Result type

Not present

Ruling
KEYWORDS
chronic pain syndrome, incontinence, loss of consortium, sexual dysfunction, urological
FACTS
In January 2008, plaintiff Christine Scott, 53, was implanted with a suburethral sling to treat her urinary incontinence, and with an Avaulta Plus Biosynthetic Support System to treat her anterior and posterior pelvic organ prolapse. The transvaginal surgical mesh products were implanted by Dr. Tillaikarasi Kannappan, and follow up care was provided by Kannappan and Dr. Gregory Klis. Immediately after the surgery, Scott suffered urinary retention, which required the use of a catheter for approximately six months and additional surgeries to loosen the mesh. The products were ultimately determined to have eroded into her vagina and colon, allegedly causing fecal incontinence and chronic pain. In October 2008, the Food and Drug Administration issued a Public Health Notification to doctors about “rare,” but “serious,” complications in some patients who had been implanted with all types of transvaginal mesh products manufactured by multiple manufacturers. However, in 2011, the federal agency revised the notification and said that complications were “not rare.” In January 2009, Scott filed suit against the manufacturer and designer of the Avaulta Plus Biosynthetic Support System, C.R. Bard Inc. She alleged that C.R. Bard defectively manufactured and designed its vaginal implant product, and failed to warn of the possible risks of using this product. She also alleged that its negligence constituted breaches of express and implied warranties and fraud. Scott also filed suit against Kannappan and Klis, alleging medical malpractice, but the claims against Klis were voluntarily dismissed prior to trial. Also, the case against Kannappan was severed and will be tried separately before a different jury. During the trial against C.R. Bard, plaintiffs’ counsel argued that the Avaulta Plus Biosynthetic Support System was defectively designed, in that the arms of the posterior mesh posed an unreasonable risk of injury and that the design was not tested sufficiently. Counsel also argued that C.R. Bard did not adequately warn physicians of all the possible risks and complications of Avaulta Plus, and misrepresented the safety and efficacy of its product. In addition, plaintiffs’ counsel argued that C.R. Bard failed to properly train physicians in how to properly implant the product. C.R. Bard maintained that its products are safe and effective when implanted by skilled surgeons for the proper patient. Thus, its counsel argued that Kannappan implanted the products too tightly, causing immediate urinary retention, and that the additional surgeries that were performed to loosen the products before the plaintiff was able to urinate caused the erosion of the mesh. Counsel further argued that the infected mesh was not promptly removed by Scott’s treating physicians, leading to further infection, pain and erosion of the mesh into her colon., Immediately after the implantation surgery in January 2008, Scott suffered from urinary retention due to the mesh being too tight against her urethra. She subsequently required the use of a catheter for approximately six months, and three additional procedures by Kannappan and Klis to loosen the suburethral sling and the Avaulta Plus. However, Scott developed an infection and chronic pain in late 2008 and was referred to UCLA, where she received three additional surgeries to remove portions of the surgical mesh. However, the mesh products were determined to have eroded into her vagina and colon, causing fecal incontinence. Scott claimed that despite the surgeries, the Avaulta Plus vaginal implant remains in her body because many surgeons felt that the permanent implants cannot be safely removed. She alleged that as a result, the implanted device leaves her incontinent, in chronic pain and unable to have intercourse. Scott’s husband, Roy, presented a derivative claim, seeking recovery for his loss of consortium. Defense counsel disputed the cause of the Mrs. Scott’s , contending that the initial improper implantation caused the urinary retention, and that the three additional surgeries that were performed to loosen the products before Mrs. Scott was able to urinate led to the infection, inflammation and erosion of the mesh. Counsel also contended that Mrs. Scott’s fecal incontinence was caused by further infection, pain and erosion of the mesh into the plaintiff’s colon due to the treating doctors’ failure to promptly remove the infected mesh.
COURT
Superior Court of Kern County, Bakersfield, CA

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