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 …show more content…
50, is not expressly preempted because the defendant Boston Scientific Corporation has violated the federal regulation by not reporting serious injuries and device malfunction. The Court asserted that § 360k does not prevent a State from providing the damaging remedy for the claims premised on violation of the FDA regulation as the state duties parallels the federal requirements rather than adding to it. Here, the violation of FDA regulation breaches the state duty to warn about the risk associated with the usage of the device. Thus, the Court of Appeals for the Fifth Circuit asserted that Hughes failure to warn claim is not preempted. In addition to that the court did not express an opinion for an appeal of negligence per se claim because it is up to Hughes if she wants to incorporate negligence per se claim or not in order to support her
Hughes filed complaint in the district court against Boston Scientific Corporation and argued on the basis …show more content…
50, is not expressly preempted because the defendant Boston Scientific Corporation has violated the federal regulation by not reporting serious injuries and device malfunction. The Court asserted that § 360k does not prevent a State from providing the damaging remedy for the claims premised on violation of the FDA regulation as the state duties parallels the federal requirements rather than adding to it. Here, the violation of FDA regulation breaches the state duty to warn about the risk associated with the usage of the device. Thus, the Court of Appeals for the Fifth Circuit asserted that Hughes failure to warn claim is not preempted. In addition to that the court did not express an opinion for an appeal of negligence per se claim because it is up to Hughes if she wants to incorporate negligence per se claim or not in order to support her