Pfizer, Inc. v. HHS, No. 21-2764 (2d Cir. 2022)Annotate this Case
Plaintiff Pfizer, Inc. brought an action in the United States District Court for the Southern District of New York under the Administrative Procedure Act, 5 U.S.C. Section 706(2), challenging an advisory opinion issued by the United States Department of Health and Human Services Office of Inspector General ("HHS OIG"). Pfizer produces and sells a drug called tafamidis that treats a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. To make the expensive treatment more affordable, Pfizer proposed a Direct Copay Assistance Program, through which Pfizer would directly cover the cost of a patient's co-pay for tafamidis.
HHS OIG issued an advisory opinion stating that the Direct Copay Assistance Program would violate the federal Anti-Kickback Statute, 42 U.S.C. Section 1320a-7b(b)(2)(B). The district court granted summary judgment to defendants, rejecting Pfizer's argument that liability under the Anti-Kickback Statute requires an element of "corrupt" intent.
The Second Circuit affirmed the decision holding that the agency’s interpretation of the Anti-Kickback Statute is not contrary to law. Specifically, the court explained that it has no doubt that hat at least some kind of quid pro quo, direct or indirect, exists here. However, the court does not think it is the case that every quid pro quo is inherently corrupt. Thus, while Pfizer relies heavily on two cases to argue that the word "induce" implies corruption. Neither supports its position.