The Case Of A Medical Device Hydrothermablator

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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
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Medtronic, Inc. 552U.S. 312 (2008) and Buckman v. Plaintiff’s Legal Comm., 531 U.S. 341(2001). Due to the district court doctrine of preemption Hughes applied to the Court of Appeals for the Fifth Circuit to determine whether all the claims enforce different or additional state requirements along with the federal requirements.
In this case, the device HTA is a class III device and as per the regulation 21 U.S.C § 360i (a) (1) of Federal Food Drug and Cosmetics Act and 21 CFR § 803.50(a) of Medical Device Regulation, manufacturers of Class III devices are required to provide adequate reports of the serious injuries and device malfunction to the FDA in order to maintain compliance with the post approval conditions and medical device regulation on which the premarket application was approved. Here, the Boston Scientific Corporation developed an algorithm to report injuries in response to a FDA letter inquiring about the Boston Scientific’s criteria for reporting the burns caused by HTA in 2003. In 2008, Boston Scientific’s algorithm was official challenged by the FDA and made mandated to report all the burns related to
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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

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