KV Lawsuit Involving MAKENA and Compounded 17p Concludes . . . . In Sopranos Style

By Kurt R. Karst –      

The years-long, knock-down, drag-out fight between the K-V Pharmaceutical Company (“KV”) – now known as Lumara Health Inc. – and FDA (and the Department of Health and Human Services) involving KV’s pre-term birth orphan drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, has ended.  But that ending is more akin to the final scene from the hit HBO series “The Sopranos” than the final scene from ABC’s “Lost.”  In the former, viewers were treated to a “cut to black” final scene leaving some to feel cheated.  In the latter, there was at least some final resolution of what happened to the “survivors” of Oceanic Airlines Flight 815. 

Last week, just before the Independence Day holiday, KV and FDA filed a Joint Stipulation of Dismissal With Prejudice with the U.S. District Court for the District of Columbia to dismiss the litigation.   The case is now over and we’ll never know what might have been had the court issued a merits decision.  We’re also left hanging as to what (if anything) KV got out of a deal to settle the case. 

As we previously reported (here, here, and here), KV sued FDA on July 5, 2012 alleging that the Agency violated myriad provisions of the FDC Act, the Administrative Procedure Act Section 706(2), and the Due Process Clause of the Fifth Amendment to the U.S. Constitution by failing to take sufficient enforcement action to stop the unlawful competition with MAKENA by pharmacies that were compounding 17P during KV’s period of orphan drug exclusivity.  The DC District Court ruled for FDA in September 2012, and KV appealed to the U.S. Court of Appeals for the District of Columbia Circuit. 

Earlier this year, in an interesting turn of events, the DC Circuit issued an unpublished judgment ordering and adjudging that the DC District Court’s September 6, 2012 order dismissing KV’s claims be vacated and that the case be remanded to the district court for reconsideration in light of the DC Circuit’s July 23, 2013 decision in Cook v. FDA, 733 F.3d 1 (D.C. Cir. 2013), and the November 27, 2013 enactment of the Drug Quality and Security Act (“DQSA”), Pub. L. No. 113-54, 127 Stat. 587 (2013) (see our previous post here).  As we previously noted, in Cook, the DC Circuit largely affirmed a March 2012 decision from the DC District Court permanently enjoining FDA from permitting the entry of (or releasing any future shipments of) foreign manufactured thiopental into interstate commerce.  Title I of the DQSA, the Compounding Quality Act, concerns state and federal oversight of compounding of human drugs. (FDA recently issued several notices concerning the DQSA’s compounding provisions – see here and here).

Perhaps the writing was on the wall that a settlement might be forthcoming.  In several recent court filings, the parties requested (and were granted) extensions to file supplemental briefs “because the parties were engaged in active settlement discussions.”  Most recently, a filing indicated that settlement discussions “have continued, and the parties have reached agreement in principle to resolve this litigation.”  It’s unclear to us what the settlement between KV and FDA might entail. . . . and we might never have a clear picture of that.