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Preemption Issue in Medical Device Tort Case
In In re: Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., No. 09-2290, consolidated actions by patients with implanted Sprint Fidelis Leads, an implanted defibrillator component, asserting tort and breach of warranty claims for injuries allegedly caused by the defective leads, the court affirmed the dismissal of the action where the claims were preempted by 21 U.S.C. section 360k(a), which preempts certain state law claims concerning medical devices that had received FDA approval.
As the court wrote: "Defendant Medtronic, Inc., designed, manufactured, and sold the Sprint Fidelis Lead, a wire that delivers signals that allow an implantable cardiac defibrillator to detect an abnormal heart rhythm and deliver a shock to help the heart return to an appropriate rhythm. After Medtronic recalled the product in October 2007, Anna Bryant and other patients with implanted Sprint Fidelis Leads filed suits across the country against Medtronic and its affiliates (collectively, Medtronic) asserting tort and breach of warranty claims for injuries allegedly caused by the defective leads. The cases were transferred to the District of Minnesota for pretrial proceedings by the Judicial Panel on Multidistrict Litigation."