not made a specific determination as to the sufficiency of the scientific evidence to support a particular warning). Even if the Court were to assume that Teva could not unilaterally make changes to its label through the moderate changes procedure, Teva still had the option and the obligation to apply for a labeling change through the major changes procedure, through which the FDA provides a prompt determination regarding the sufficiency of the link between a drug and the reported problem. See 21 C.F.R. §314.70(c). Moreover, the preamble, amicus brief, and case law are in agreement that when the FDA makes a determination and “has considered and found [a label change] scientifically unsubstantiated,” preemption applies. 71 Fed. Reg. 3935 (2006); see also Perry, 456 F.Sup.2d at 685-86 (<HOLDING>); Ackermann v. Wyeth Pharms., 2006 U.S. Dist.
holding that the trial courts classification of property will not be disturbed as long as there is competent evidence to support that determination holding that district court is not required to word jury instructions in any particular way so long as it correctly states the law holding that where the state law has only an indirect effect on the plan and where it is one of general application which pertains to an area of important state concern the court should find there has been no preemption holding it is more in keeping with the narrow scope of preemption to allow state law to require the addition of warnings so long as there has been no specific fda determination as to the sufficiency of the scientific evidence to support a particular warning holding that a prosecutor may comment on the absence of evidence so long as there is sufficient evidence to support the prosecutors version of events