Fourth Circuit Joins Other Circuits Recognizing Safeco ‘Objectively Reasonable Interpretation’ Standard as FCA Defense
In a defendant-friendly opinion, a split panel held that conduct based on an “objectively reasonable” reading of an ambiguous statute, absent contrary circuit court precedent or agency guidance, cannot constitute “knowing” misconduct under the False Claims Act.
In United States ex rel. Sheldon v. Allergan Sales, LLC, a split Fourth Circuit panel affirmed the dismissal of a non-intervened qui tam, or whistleblower, action alleging fraudulent price reporting by a drug manufacturer to Medicaid in violation of the False Claims Act (FCA). Relying on the Supreme Court’s analysis of the Fair Credit Reporting Act’s (FCRA) “analogous” scienter provision in Safeco Insurance Company of America v. Burr , the majority held that the defendant “did not act ‘knowingly’ under the [FCA]” because its reading of the relevant statute was “at the very least objectively reasonable” and because the defendant “was not warned away from that reading by authoritative guidance.” In applying Safeco’s scienter requirement in the FCA context, the court aligned with “every other circuit to consider the issue.”
Background and District Court Dismissal
The Medicaid Drug Rebate Statute is part of the complex landscape of federal Medicaid payments to states to help defray state spending on prescription drug reimbursements to low-income individuals. Under the statute, manufacturers must report pricing data for each prescription drug to the Centers for Medicare and Medicaid Services (CMS). That reporting includes the “Best Price” at which the manufacturer sells the product “to any purchaser in the United States,” including “prices to wholesalers, retailers, [nonprofits], or governmental entities” and net of rebates and other discounts.
The defendant interpreted “Best Price” to mean the lowest price for the drug given to any individual customer net of discounts to that customer. The relator, in contrast, argued that the statute requires manufacturers computing “Best Price” to aggregate all discounts given to different customers, such as drug wholesalers, insurers, and pharmacies. Under that view, not aggregating all discounts to multiple entities anywhere on the distribution chain in determining Best Price made defendant’s invoices to Medicaid false claims under the FCA.
To survive a Rule 12(b)(6) motion to dismiss, under the relevant FCA provisions, a plaintiff must plausibly plead four elements: (1) false statements or a fraudulent course of conduct, (2) made with the requisite knowledge, (3) that were material, and (4) that caused the government to issue payment. At issue in Allergan were the first two, falsity and scienter; the district court considered them together, focusing chiefly on scienter. This meant determining whether the relator adequately pled one of the three statutory definitions of “knowing” conduct: (1) actual knowledge, (b) deliberate ignorance, or (3) reckless disregard.
Proving scienter in FCA actions alleging legal falsity can be particularly difficult where the statute or regulation in question is ambiguous. The district court, finding the Rebate Statute ambiguous, applied the two-step analysis laid out by the Third Circuit in Streck, asking (1) whether the defendant’s interpretation of the ambiguity “was objectively reasonable” and (2) even if it was reasonable, whether the defendant “was warned away from that interpretation by available administrative [or] judicial guidance.” In light of the imprecisions and inconsistencies in the relevant statutory and regulatory texts, the court found that the defendant’s interpretation was objectively reasonable, and that CMS did not “warn [the defendant] away” from that interpretation. Therefore, the district court found both falsity and scienter defeated, and granted the motion to dismiss.
Fourth Circuit Decision and Safeco
A divided panel of the Fourth Circuit affirmed, relying heavily on the Supreme Court’s “objectively reasonable interpretation” test from Safeco concerning the FCRA’s scienter provision, which the majority characterized as “analogous” to that under the FCA. In particular, the majority drew on Safeco’s treatment of the FCRA’s “willfulness” requirement, which the Supreme Court interpreted to include not just “knowing” misconduct but also “reckless disregard”—paralleling the inclusion of “reckless disregard” among the ways the FCA’s knowledge element can be met.
In Safeco, plaintiffs brought an FCRA action against an auto insurer. That statute requires a company taking an “adverse action” against a consumer (such as cancelling or raising the cost of insurance coverage) based on information in a consumer credit report to notify the consumer; where a violation is “willful,” punitive damages may be awarded. The defendant argued it had reasonably (though incorrectly) interpreted an ambiguous statute; the issue became whether only “knowing” violations of the statute were “willful,” or whether “reckless disregard” of the statute’s requirements could also qualify. The Supreme Court held that, because the statute did not define the term “willful,” the common law meaning prevailed, which embraced both knowledge and recklessness. To determine whether the defendant acted in “reckless disregard” of a statutory obligation, the Court then looked both to whether the defendant’s reading of the statute was reasonable, and whether it had the benefit of “guidance from the courts of appeals” or from the relevant government agency. The Court found the defendant’s reading was reasonable, particularly given the absence of any authoritative guidance that might have pointed the defendant in another direction.
In Allergan, the majority carried out a two-step reckless disregard analysis within a framework grounded in Safeco. The inquiry asked first “whether defendant’s interpretation was objectively reasonable,” and then whether “authoritative guidance” existed that “might have warned defendant away” from its interpretation. In the first step, the majority examined the defendant’s reading of the Best Price reporting requirement and concluded it was objectively reasonable. Indeed, the majority found the defendant’s interpretation “best” comported with the statute’s “plain and natural” meaning.
Next, the majority considered whether the defendant was “warned away” from its reasonable, though incorrect, interpretation. As the opinion stressed, even an “objectively reasonable” interpretation can be defeated by the existence of contrary circuit court precedent or agency guidance to which a “bad faith defendant” may not “turn a blind eye.” Agency guidance, moreover, must be more than merely “related” to the at-issue question, but must address it with “a high level of specificity.” And, although the Allergan majority did not emphasize this point, Safeco makes clear that “authoritative” guidance means guidance promulgated through “substantive rulemaking authority” and not in informal, non-binding opinion letters. Ultimately, the majority found CMS provided no such guidance regarding price aggregation, despite manufacturer requests for clarification. Instead, CMS instructed manufacturers, “in the absence of specific guidance,” to calculate Best Price using “reasonable assumptions.”
The majority concluded that the defendant “made eminently reasonable assumptions based on the statutory text, and CMS invited assumptions of precisely this sort.” Therefore, it met both Safeco prongs, and did not “knowingly” submit a false claim. For the majority, the punitive nature of the FCA makes notice all the more vital: “If the government wants to hold people liable for violating labyrinthine reporting requirements,” it must “indicate a way through the maze.”
The strongly worded Allergan dissent charged the majority with “effectively neuter[ing] the False Claims Act” by “eliminating” the knowledge and deliberate ignorance scienter standards and so distorting the remaining standard that “fraudsters [can] escape any liability so long as they can come up with a post hoc legal rationale that passes the smell test.”  However, it is not apparent that Safeco actually gives FCA defendants an all-purpose liability escape hatch. Safeco, as the majority cautioned, is not a “blank check” but instead requires a defendant’s reading of a statute to be both “objectively reasonable” and not contravened by on-point circuit court precedent or agency guidance.
The dissent also questioned the strength of the consensus among the circuits, noting that two of the five opinions invoked by the majority were unpublished. Additionally, the dissent cited the Eleventh Circuit in Phalp as “declin[ing] to import” into the FCA “the recklessness standard recognized in Safeco,” and thus contradicting the majority’s assertion that “every other circuit to consider the issue” has endorsed Safeco as an FCA defense. But Phalp does not mention Safeco; what it declines to adopt is a rule permitting reasonable interpretation of an ambiguous statute, without more, to defeat scienter. The dissent therefore cited no circuit court opinion expressly rejecting Safeco‘s applicability to FCA scienter.
Overview and Outlook
The majority’s holding in Allergan adds to the emerging consensus among the circuit courts that Safeco’s “objectively reasonable interpretation” test can be applied as a defense to FCA scienter. Four published circuit court opinions now adopt this holding, and two other circuits have done so in unpublished form. Defendants operating in an ambiguous statutory or regulatory framework can stand on firm ground asserting that they interpreted the relevant provisions in an objectively reasonable way, provided they can demonstrate the statute’s ambiguity, and show that no circuit court authority or relevant agency guidance available at the relevant time pointed away from that reading.
Allergan stands strongly for the principle that proper notice is required before liability can be imposed on a defendant, particularly under a statute like the FCA with its punitive treble damages scheme. Rejecting “liability through ambush,”  the majority underscored the government’s duty to “provide a reasonably clear standard of culpability” both to put parties on notice of their obligations and to “circumscribe the discretion of the enforcing authority.”
 No. 20-2330, 2022 U.S. App. LEXIS 2310 (4th Cir. Jan. 25, 2022). The district court case, differently styled, was United States ex rel. Sheldon v. Forest Labs., LLC, Civ. A. No. ELH-14-2535, 2020 U.S. Dist. LEXIS 249501 (D. Md. Feb. 5, 2021).
 Allergan, 2022 U.S. App. LEXIS 2310, at *11.
 551 U.S. 47 (2007).
 See Allergan, 2022 U.S. App. LEXIS 2310, at *2–3, 21.
 Id. at *11 (citing, inter alia, United States ex rel. Schutte v. SuperValu Inc., 9 F.4th 455, 459 (7th Cir. 2021)).
 Id. In addition to the Seventh Circuit’s holding in Schutte, the court also cited the Third, Ninth, Eighth, and D.C. Circuits. See id. at *4 (citing United States ex rel. Streck v. Allergan, Inc., 746 F. App’x 101, 106 (3d Cir. 2018); United States ex rel. McGrath v. Microsemi Corp., 690 F. App’x 551, 552 (9th Cir. 2017); United States ex rel. Donegan v. Anesthesia Assocs. of Kansas City, PC, 833 F.3d 874, 879–80 (8th Cir. 2016); United States ex rel. Purcell v. MWI Corp., 807 F.3d 281, 290–91 (D.C. Cir. 2015)).
 Forest Labs., 2020 U.S. Dist. LEXIS 249501, at *5–9, 11.
 Id. at *8–9.
 Id. at *8–10.
 See id. at *19–21, 50; Allergan, 2022 U.S. App. LEXIS 2310, at *22–28.
 See Forest Labs., 2020 U.S. Dist. LEXIS 249501, at *3.
 Id. at *3.
 Id. at *46 (citing United States ex rel. Rostholder v. Omnicare, Inc., 745 F.3d 694, 700 (4th Cir. 2014)).
 Id. at *48–49 (citing United States ex rel. Lamers v. City of Green Bay, 168 F.3d 1013, 1018 (7th Cir. 1999)).
 Id. at *47 (citing 31 U.S.C. § 3729(b)).
 Id. at *48 (citing United States ex re. Purcell v. MWI Corp., 807 F.3d 281, 288 (D.C. Cir. 2015)).
 Id. at *48 (citing Streck, 746 F. App’x at 106) (alteration added).
 Id. at *59–60.
 Id. at *60–62 (alteration added); see also id. at *61–62 (observing that CMS, recognizing “the complexity of the Rebate Statute and price reporting requirements, . . . encourages manufacturers to make reasonable assumptions in calculating Best Price”) (international quotation marks omitted).
 Id. at *62
 See Allergan, 2022 U.S. App. LEXIS 2310, at *11 (citing Safeco, 551 U.S. 47 (2007)). The Allergan majority’s reliance on Safeco was not novel in the FCA context; indeed, although the district court did not cite Safeco, it cited opinions from other circuit courts that relied on Safeco in their own scienter analysis. See, e.g., Forest Labs., 2020 U.S. Dist. LEXIS 249501, at *47–48 (citing United States ex rel. Purcell v. MWI Corp., 807 F.3d 281, 287–88 (D.C. Cir. 2015)).
 Id. at *11–12 (citing Safeco, 551 U.S. at 57).
 Id. at *13 (citing Safeco, 551 U.S. at 57, 68; 31 U.S.C. § 3729(b)(1)(A).
 15 U.S.C. § 1681 et seq.
 In reality, the case involved two separate insurance companies; for simplicity, this article refers to “company” in the singular. The relevant defendant to the “reckless disregard” determination was Safeco. See 551 U.S. at 69–70.
 Safeco, 551 U.S. at 53 (citing 15 U.S.C. § 1681a(k)(1)(B)(i)).
 Id. at 52 (citing 15 U.S.C. § 1681m(a)).
 Id. (citing 15 U.S.C. § 1681o(a) (2000 ed., Supp. IV), and § 1681n(a) (2000 ed.)).
 Id. at 56.
 Id. at 56–57, 69.
 Id. at 69–70.
 See Allergan, 2022 U.S. App. LEXIS 2310, at *19 (citing United States ex rel. Schutte v. SuperValu Inc., 9 F.4th 455, 468 (7th Cir. 2021)); see also, e.g., Schutte, 9 F.4th at 465 (“Under Safeco, an objectively reasonable interpretation of a statute or regulation does not shield a defendant from liability if authoritative guidance warned the defendant away from that interpretation.”).
 Id. at *21–26.
 Id. at *26.
 Id. at *19 (citing Schutte, 9 F.4th at 468) (alteration added).
 Id. at *27 (quoting Schutte, 9 F.4th at 471); see also id. (citing Safeco, 551 U.S. at 70 n.20) (agency guidance that “allow[s]” defendant’s interpretation does not warn away).
 Safeco, 551 U.S. at 70 & 70 n.19 (explaining that an informal, non-binding opinion letter did not meet this standard); see also United States ex rel. Purcell v. MWI Corp., 807 F.3d 281, 288-89 (D.C. Cir. 2015) (holding that guidance in a person-to-person communication from the relevant agency failed to meet the “authoritative guidance” standard in Safeco and noting that Safeco held that that “informal guidance . . . is not enough to warn a regulated defendant away from an otherwise reasonable interpretation”).
 Allergan, 2022 U.S. App. LEXIS 2310, at *27.
 Id. at *31.
 Id. at *34.
 Id. at *19 (citing Gates & Fox Co. v. OSHRC, 790 F.2d 154, 156 (D.C. Cir. 1986)).
 Id. at *38 (Wynn, J., dissenting); see also id. (“[T]he majority opinion’s legal hand-waving cannot cover the stench here.”).
 Id. at *18.
 Id. at *12 (citing Safeco, 551 U.S. at 69-70). In the fact pattern at issue, the dissent itself acknowledged the majority’s recognition that the “reasonable assumptions” CMS invited drug manufacturers to make in their price reporting had to be “consistent with the general requirements and the intent” of the Rebate Statute and federal regulations. Id. at *85–86 n.8 (Wynn, J., dissenting).
 Id. at *53; see United States ex rel. Streck v. Allergan, Inc., 746 F. App’x 101 (3d Cir. 2018); United States ex rel. McGrath v. Microsemi Corp., 690 F. App’x 551 (9th Cir. 2017).
 Id. (citing United States ex rel. Phalp v. Lincare Holdings, Inc., 857 F.3d 1148 (11th Cir. 2017)).
 See Phalp, 857 F.3d at 1155 (citing United States ex rel. Minn. Ass’n of Nurse Anesthetists v. Allina Health Sys. Corp., 276 F.3d 1032, 1053–54 (8th Cir. 2002)) (scienter established where defendant knowingly disregards proper interpretation of an ambiguous regulation). The dissent also placed significant stock in Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. 93 (2016), where the Supreme Court declined to apply Safeco in the Patent Act context. See Allergan, 2022 U.S. App. LEXIS 2310, at *53–56 (Wynn, J., dissenting). The majority, however, considered Halo inapposite because the Patent Act provision at issue there, unlike the FCA and the FCRA, contains no explicit scienter standard. See id. at *14–16.
 Allergan, 2022 U.S. App. LEXIS 2310, at *34, 71–72.
 Id. at *20 (quoting United States v. Hoechst Celanese Corp., 128 F.3d 216, 224 (4th Cir. 1997)).
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