10 . The district court repeatedly referred to the implied preemption of Hughes's "negligence per se claim.” 11 . § 337(a) states that "[e]xcept as provided in subsection (b), all such proceedings for the enforcement, or to restrain violations, of this Act shall be by and in the name of the United States.” 12 . Hughes has asserted other causation theories which are untenable. She asserts that had Boston Scientific properly reported all bums (1) the FDA would have taken some regulatory action against the HTA, including but not limited to removing the HTA from the market; and (2) the HTA labels or user manual would have warned of the risk of burns associated with use of the HTA. The first theory is entirely speculative, Rod v. Home Depot USA, Inc., 931 So.2d 692, 695 (Miss.Ct.App.2006) (<HOLDING>), and could impermissibly allow the juiy to
holding that prejudice cannot merely be alleged it must be affirmatively proved holding that causation cannot be proved based on speculation holding that court may not accept claims of fraud based on speculation holding that securities fraud claims cannot rest on speculation and conclusory allegations holding that speculation and conjecture cannot support an adverse credibility finding