Plaintiff who suffered from severe hypophosphatemia (Severe HPP) brought a products liability action against the manufacturer of Injectafer, a medication prescribed to treat iron deficiency anemia.
Denying a Rule 12 Motion to Dismiss premised on preemption, the Court held as follows: “Defendants refer to the two non-approvable letters from the FDA which cited concerns about ‘clinically important hypophosphatemia’ and recite generally that state law may not countermand the FDA’s approval. Specifically, they rely on a single paragraph in the Complaint — stating that the FDA initially sent Defendants non-approvable letters for Injectafer citing a concern about ‘clinically important hypophosphatemia’ — and the FDA’s subsequent approval of the drug with its current label, as evidence of the fact that the FDA considered the Severe HPP risk and chose not to warn of it. Defendants do not argue or point to any ‘evidence’ that they proposed a stronger warning to the FDA or that the FDA would have rejected a different warning label. Accordingly, Defendants have not shown that they fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning.”
Crockett v. Luitpold Pharmaceuticals, No.19-276, 2020 WL 433367 (E.D.Pa. Jan. 28, 2020).