Holding that on a motion for judgment on the pleadings, a court may, in addition to the complaint itself, consider "any written instrument attached to it as an exhibit, materials incorporated in it by reference, and documents that, although not incorporated by reference, are ‘integral to the complaint"
Holding that "where . . . the allegations of the complaint do not necessarily require the doctrine's applicability, then the primary jurisdiction doctrine may not be applied on a motion to dismiss"
905 F. Supp. 2d 1013 (N.D. Cal. 2012) Cited 31 times 3 Legal Analyses
Holding that "[i]n absence of any FDA rules or regulations (or even informal policy statements) . . . the court declines to make any independent determination of whether [the label] was false or misleading" and the claims were barred under the primary jurisdiction doctrine
Case No. 13-cv-04828-TEH (N.D. Cal. May. 5, 2014) Cited 8 times 2 Legal Analyses
Noting that the FDA is likely to make a final pronouncement on the issue of ECJ labeling, and that such likelihood of resolution supports deferring judgment