On Thursday, September 15, 2022, an en banc panel of the Fourth Circuit Court of Appeals heard oral argument in the rehearing of an important case concerning the “knowledge” element of the False Claims Act—United States ex rel. Sheldon v. Allergan, No. 20-2330.  The panel was active, posing numerous questions for both parties during the oral argument, which spanned approximately 94 minutes. The audio recording of this hearing is available here.

As Covington has reported in the past, this appeal concerns questions related to the scope of the False Claims Act’s “knowledge” requirement. In its January 25, 2022 decision, the Fourth Circuit upheld the district court’s dismissal, finding that under the FCA “a defendant cannot act ‘knowingly’ as a matter of law if it bases its actions on an objectively reasonable interpretation of the relevant statute when it has not be warned away from the interpretation by authoritative guidance” and that “this objective standard precludes inquiry into a defendant’s subjective intent.”  United States ex rel. Sheldon v. Allergan Sales, LLC, 24 F.4th 340, 348 (4th Cir. 2022). That opinion was also subject to a strong dissent by Judge Wynn, which argued that the majority opinion disregarded two of the three FCA’s enumerated forms of knowledge (actual knowledge and deliberate ignorance), focusing only on the Safeco test for objective recklessness.

At the September 15 rehearing, counsel for the government went first, having moved to participate in oral argument despite declining to intervene in the case.  The government began by arguing that the “fundamental point” at issue was that the court’s application of the Safeco standard would allow defendants to escape liability under the FCA even if they actually intended to defraud the government, or acted with deliberate indifference to the falsity of claims submitted, so long as their lawyers develop an after-the-fact basis to claim that the conduct at issue was objectively reasonable.  The government also disputed one panelist’s view that the “judicial drift” clearly favors application of Safeco to FCA cases by noting that only one of the other circuit court decision was decided at the motion to dismiss stage (United States ex rel. Schutte v. SuperValu Inc., 9 F.4th 455 (7th Cir. 2021) (available here)).  In addition, the government argued that a contrary outcome was required by the 2016 decision Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016), which declined to apply Safeco when interpreting the scienter standard of the Patent Act.

The relator’s counsel also emphasized that this case was determined at the motion to dismiss stage, arguing that it was entirely possible that discovery would show that the allegations in the complaint concerning deliberate ignorance of the law were fully supported.  At least one member of the panel appeared to agree, stating that a defendant should not be able to stick its head in the sand and then claim after the fact that its actions had been objectively reasonable.

One panelist queried whether the relator was asking the court to rule that Safeco does not apply to the FCA at all.  Counsel responded that it was not necessary to make such a ruling, as the key question was whether a defendant can be liable on the alternative basis of actual knowledge or deliberate ignorance even if the recklessness standard was not met.

The panel also closely questioned the relator’s counsel about whether the statute was ambiguous as to whether it prohibited the alleged method of calculating average manufacturer price (AMP).  Several members of the panel stated that if the underlying statute unambiguously permitted the defendant’s actions, then it would be irrelevant whether agency rules or guidance materials suggested a contrary position. However, the relator’s counsel argued that the statute was at minimum ambiguous as to whether it permitted the activity in question, and that deference was owed to CMS in light of that ambiguity.

Counsel for the defendant argued first that there was no falsity because the statute and regulations did not prohibit the actions alleged.  Pushing this argument a step farther, panelists including Judge Niemeyer asked questions that suggested agreement with the district court that it was not possible for actions to be “objectively false” if they were supported by a reasonable interpretation of the law. 

Then, as to knowledge, the defendant’s counsel argued at length that the previous Court of Appeal decision had gotten the issue right by finding – with numerous other circuit courts that have addressed the issue – that Safeco’s objective reasonableness requirement applies under the FCA.  Addressing a question from the panel, the defendant’s counsel emphasized that the governing regulations allow the government to recover its money if it makes a payment based on an accidental or good faith violation of a legal requirement.  However, the FCA is only intended to apply to cases of fraud, which requires a more serious level of culpable behavior.

On the panel, Judge Wynn in particular emphasized arguments made by Senator Grassley in an amicus brief in support of a pending petition for certiorari of the Seventh Circuit’s SuperValu decision, which argued that courts applying Safeco have engaged in improper judicial activism by negating two of the three forms of knowledge.  And, Judge Harris asked about the common law history of fraud statutes depending on the subjective knowledge of the defendant, and whether a single footnote in Safeco concerning a different statute should be read to wipe out that history.  In response, defendant’s counsel argued that in statutes with multiple forms of culpable knowledge, it is inevitable that not every level of knowledge will apply in every case, and that the Safeco objective reasonableness standard was consistent with the FCA’s language and the common law understanding of recklessness.

However it is resolved, the en banc decision in Sheldon is unlikely to be the last word on the application of Safeco in FCA cases.  Petitions for certiorari are pending for two Seventh Circuit cases that applied Safeco under the FCA: Supervalu, and the earlier decision United States ex rel. Proctor v. Safeway, Inc., 30 F.4th 649 (7th Cir. 2022), which Covington addressed here. The parties have completed briefing on the SuperValu petition, and the Solicitor General has been invited to file a brief stating the views of the United States.  The brief opposing certiorari in Safeway is due October 6, 2022. If you have any questions concerning the material discussed in this client alert, please contact the members of our False Claims Act practice.

Photo of Krysten Rosen Moller Krysten Rosen Moller

Krysten Rosen Moller focuses her practice on representing clients in internal investigations, government investigations, and follow-on civil litigation, with an emphasis on serving clients in the life sciences and healthcare industries.

Krysten assists companies with complex internal and government investigations covering a broad…

Krysten Rosen Moller focuses her practice on representing clients in internal investigations, government investigations, and follow-on civil litigation, with an emphasis on serving clients in the life sciences and healthcare industries.

Krysten assists companies with complex internal and government investigations covering a broad range of issues, including fraud and abuse, advertising and promotion, and bribery and corruption. Krysten has particular experience conducting targeted and efficient internal investigations and representing pharmaceutical and medical device companies against investigations from the Department of Justice or other government regulators. Krysten’s complementary litigation practice focuses on defending life sciences and healthcare companies in related litigation, including cases arising under the False Claims Act and other follow-on litigation arising from government investigations.

Krysten also counsels clients on compliance matters. She regularly represents companies negotiating HHS OIG Corporate Integrity Agreements (CIAs) and advises companies on implementing and operating under CIAs. She has also conducted False Claims Act risk assessments and advised on other fraud and abuse issues.