The judge in AstraZeneca’s 340B contract pharmacy lawsuit yesterday ordered both sides to file a joint status report by no later than Friday—a sign, lawyers say, that his decision in the case is still in progress.
U.S. District Judge Leonard Stark’s Jan. 5 oral order says the drug company and federal government’s report “may include any updates that the parties would like to share with the court, including any further developments in related cases in other district courts, in the [340B administration dispute resolution] ADR proceedings, or in any interactions with the Office of the Inspector General regarding potential civil monetary penalties.”
Stark, whose chambers are in Wilmington, Del., is the only judge assigned to one of the original six 340B contract pharmacy cases who has not yet handed down a decision on the legality of the government’s determination that manufacturers may not impose unilateral conditions on 340B sales.
Two federal judges—Sarah Evans Barker of the District of Southern Indiana and Freda Wolfson of the District of New Jersey—have held that manufacturers may not impose such conditions. Judge Dabney Friedrich of the District of Columbia has held that manufacturers may impose some but not all conditions.
“It sounds to me as if [Stark] is gearing up to write his decision and wants to know if there are any new developments before he does,” a lawyer whose work frequently involves the 340B program said yesterday.
Stark has twice before ordered the parties to AstraZeneca’s suit to file joint status reports. The most recent one was due Nov. 12. That report “presumably included factual information that is now outdated,” another attorney who frequently works on 340B matters said yesterday. “It may simply be that the court wants to work with a current report.”
Elevation to Appeals Court Could Come Soon
Despite overseeing Astra’s case from its inception, Stark might not be the district court judge who decides it, however.
President Biden has nominated him for a seat on the U.S. Court of Appeals for the Federal Circuit in Washington, D.C., a special court that mainly decides patent disputes. The Senate Judiciary Committee is scheduled to vote on Stark’s nomination today and is expected to report the nomination favorably to the full Senate. The full chamber is expected to approve his nomination, probably soon. If it does so before Stark delivers his opinion in Astra’s case, it will be up to a different District of Delaware judge to write the opinion.
A third lawyer who specializes in 340B issues said yesterday that the fact that Stark gave both sides in the Astra case just two days to write and deliver the joint status report might be a sign that Stark knows his time as the judge in the case is almost up. He could be making a final push to finish the opinion, the lawyer said. Or he knows he will be off the case soon and wants to give his successor the most up-to-date information possible with which to write the ruling.