Analysis Of Jan Hughes, Plaintiff Appellant V, Boston Scientific Corporation, Defendant Apellee

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Name of the Case and Citation: Jan Hughes, Plaintiff-Appellant v, Boston Scientific corporation, Defendant-Apellee., 631F .3d 762 (2011), United States Court of Appeals, Fifth Circuit (January 21, 2011) Facts: Boston Scientific was the producer and seller of HydroThermAblator (“HTA”), a medical device marketed for treating menorrhagia, or excess uterine bleeding. The working of this device was by closed cycle circulation of hot saline solution at 194° F into and then flushing it from the uterus so that the lining of the uterus can collapse and release. In 2001, the Food and Drug Administration (“FDA”) approved HTA for entry into the market under its rigid premarketing approval (“PMA”) process. As HDA was classified under Class III medical device as per MDA, it received the highest level of FDA oversight. Dr. Weber was Hughes treating physician and on October 25, 2006 performed an ablation procedure on her with the use of HTA device. While conducting this procedure, hot liquid leaked from HTA device and caused a three-inch burn on Hughes’s outer perineal body and an area of similar size inside the vaginal introitus. These burns were characterized as second degree burns. Hughes visited Dr. Weber every other day for two weeks, and later once a week for six to eight weeks for treatment. A complaint was filed against Boston Scientific on March 26, 2008 by Hughes to solicit recovery for injuries allegedly caused by HTA device. The complaint was under the Circuit Court of Jones

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