and applying that standard to plaintiffs claim). Though a formal finding of a violation by the FDA is not required, id. at 509 (citing Hughes v. Boston Scientific Corp., 631 F.3d 762, 772 (5th Cir.2011)), the plaintiff must at least “speciffy] with particularity what went wrong in the manufacturing process and citef ] the relevant FDA manufacturing standards [the defendant] allegedly violated.” Id. at 510 (quoting Funk v. Stryker Corp., 631 F.3d 777, 782 (5th Cir.2011)). Here, plaintiff has alleged only that St. Jude “deviated from FDA requirements” and “failed to comply with the FDA approved specifications for the device.” She does not identify which FDA regulations were violated or explain how the design, manufacture, or sale of the device deviated from FDA requirements. Cf. id. (<HOLDING>). The plaintiff has alleged that the leads were
holding that a cause of action on the theory of strict liability may be properly pled by alleging 1 the manufacturers relationship to the product in question 2 the unreasonably dangerous condition of the product and 3 the existence of a proximate causal connection between the condition of the product and the plaintiffs injury holding that the district court had jurisdiction over the assets of a corporation into which the defendant in the underlying enforcement action had tunneled proceeds of his securities law violations holding that the plaintiff had adequately pleaded his parallel claims by identifying the regulations that were allegedly violated providing a letter in which the fda had warned the defendant of violations of particular regulations showing that the defendant had issued a voluntary recall of the allegedly defective product and pleading a causal connection between the violations and the harm suffered holding that causal connection between alleged injuries and advertising activity cannot be satisfied by a mere showing that the allegedly infringing product was advertised holding that consistent with our rejection of the group pleading doctrine we do not construe allegations contained in the complaint against the defendants as a group as properly imputable to any particular individual defendant unless the connection between the individual defendant and the allegedly fraudulent statement is specifically pleaded