A Medical Device Hydrothermablator ( Hta ) Essay

1083 Words Feb 7th, 2016 null Page
A medical device HydroThermAblator (HTA) indicated for use to treat menorrhagia or excess uterine bleeding is designed, manufactured and marketed by Boston Scientific Corporation. The device is classified as Class III device and was approved in 2001 through premarket approval process by the Food and Drug Administration. Jan Hughes was diagnosed with menorrhagia and advised by Dr. Weber for ablation procedure to treat menorrhagia on October 25, 2006. When Dr. Weber performed surgery on her using Boston Scientific Corporation’s HTA, the device leaked hot liquid that caused second degree burn for which she took treatment for about 2 months following the surgery1.
Hughes filed complaint in the district court against Boston Scientific Corporation and argued on the basis that Boston Scientific violated Medical Device Regulations by not reporting serious injuries and malfunctions that could be caused by device malfunction as mandated by medical device reporting requirements. The district court expropriated Hughes claims and granted summary judgement to Boston Scientific Corporation as construed in Reigel v. Medtronic, Inc., 552 U.S. 312 (2008) and Buckman v. Plaintiff’s Legal Comm., 531 U.S. 341(2001) by the Supreme Court. Thus, Hughes’s appealed to the Court of Appeals for the Fifth Circuit to determine the extent to which Hughes’s claims are preempted1.
Procedural History
Hughes claimed Boston Scientific Corporation, under the circuit court of Mississippi county on March 26,…

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