So learned plaintiff in United States ex rel. Plaintiff v. Novo Nordisk, Inc., 2024 U.S. Dist. LEXIS 174825 (W.D. Wash. Sept. 26, 2024), when the court granted defendant’s two motions to compel obviously relevant documents and information.
Plaintiff relator and intervening plaintiff, the State of Washington, assert False Claims Act (“FCA”) claims against the manufacturer of a hemophilia drug alleging defendant promoted the drug off-label for prophylaxis and in high doses leading to the submission of non-reimbursable claims. Id. at *3. Before we get to the discovery requests at issue, the merits of this action are even more questionable than the other off-label FCA claims. The FCA penalizes anyone who presents, or causes to be presented, to the federal government “a false or fraudulent claim for payment or approval.” 31 U.S.C. § 3729(a)(1). So, there must be a “false claim.” But where is the falsity in the case of truthful off-label promotion? It doesn’t exist. In this case, the off-label use at issue was in fact later approved by the FDA for marketing. So, we ask again, where is the false claim if—medically—the use was safe, effective, and necessary.
Since, however, the case is moving forward in discovery, at a minimum that discovery needs to be reciprocal. It is not uncommon for state plaintiffs to dish it out, but try not to have to take it—discovery that is.
Besides defendant’s drug, there was one available alternative therapy that for years was likewise prescribed off-label for prophylaxis and in high doses. Defendant requested claims data from the state showing how it reimbursed prophylaxis or high dose claims of the alternative drug. Information about how and why the state reimbursed these claims was directly relevant, particularly to materiality. The state’s “assertion that similar reimbursements for similar off-label [drug] use . . . are irrelevant is difficult to follow, and it is not persuasive.” Id. at*8. This information goes directly to the state’s “decision-making” and bears on causation, materiality, and damages.
Having lost its relevance argument, plaintiff attempts to claim undue burden beyond what is proportional to the needs of the case. First, plaintiff waived that argument by not making a burden objection in its discovery responses. Second, plaintiff alleges tens of millions of dollars in damages, so discovery of the state’s historical reimbursement practices was neither disproportionate nor overly burdensome. Id. at *9.
Defendant’s second discovery request was for documents created by since-retired state employees that include “developing coverage policies and determining whether the drugs were medically necessary.” Id. at *9-10. Those documents specifically included data concerning claims made for defendant’s drug and records of consultations with clinicians about use of the drug. Plaintiff did not dispute that these records are relevant and discoverable, but had “not even bothered to try to find” them. Id. at *10. The court rejected plaintiff’s procedural objection to defendant’s motion to compel and ordered the documents produced.
State plaintiffs often fail to meet their discovery obligations in similar situations, so this is valuable precedent that governmental plaintiffs have to comply with discovery like all other parties.