To properly allege parallel violation claims, [a] complaint must set forth facts showing action or inaction in [defendants’] efforts to take part in the PMA process or implement its results. A plaintiff cannot plead non-specific violations as a basis for a parallel claim because this is inconsistent with Riegel and the pleading requirements under Twombly, Iqbal, and Fowler.
Any proposed amended claims in which Plaintiff seeks to allege a parallel violation would fail to state a claim because Defendants have not violated a federal regulation. . . . Plaintiff, here, would be unable to state a claim and show inaction regarding Defendants’ efforts to take part in the PMA process because the facts clearly show that Defendants went through the PMA process and received PMA for the device. This Court confesses it’s unable to discern how a plaintiff pleads around the 360k preemption.