We reported previously on yet another implied certification case raising significant questions about materiality and falsity in the post-Escobar world, United States ex. rel. Campie v. Gilead Sciences, Inc., in which the Ninth Circuit reversed the district court’s dismissal of the case.

Gilead subsequently petitioned the Ninth Circuit to rehear the case or rehear the case en banc. That petition was denied on September 27. Gilead then filed a motion seeking a stay of the mandate to allow it to file a cert petition with the Supreme Court. That motion was granted and the mandate has been stayed pending Gilead’s petition to the Court.

Gilead’s motion previewed that its cert petition will present substantial questions regarding:

  • whether, under Escobar, a complaint fails the materiality requirement of the FCA when there is evidence the Government continued to pay claims despite knowledge of the alleged misconduct; and
  • if continued FDA approval of a drug after allegations of FDA regulatory violations is fatal to a complaint premised on such violations.

In granting the stay, the Ninth Circuit agreed that Gilead’s certiorari petition would present “substantial questions,” noting that it had split with other circuits on both issues raised by Gilead. The Ninth Circuit also found that there was good cause for a stay because continued proceedings in the district court would “saddle” both parties with “costly and potentially unnecessary discovery” and “wast[e] judicial resources on claims the Supreme Court may well reject as a matter of law.”

Gilead’s petition for certiorari is due December 26, 2017. We will continue to monitor this case.