Case: 23-2086 Document: 00118234131 Page: 1 Date Filed: 01/10/2025 Entry ID: 6692285
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`January 10, 2025
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`Via CM/ECF
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`Anastasia Dubrovsky
`Clerk of Court
`U.S. Court of Appeals for the First Circuit
`John Joseph Moakley U.S. Courthouse
`1 Courthouse Way
`Boston, MA 02210
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`Re: United States v. Regeneron Pharmaceuticals, Inc., No. 23-2086
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`Dear Ms. Dubrovsky:
`Defendant-Appellee Regeneron Pharmaceuticals, Inc., writes to bring to the Court’s
`attention a recent opinion issued by Judge Saris in Omni Healthcare, Inc. v. MD Spine
`Solutions LLC, No. 18-cv-12558-PBS, 2025 WL 32676 (D. Mass. Jan. 6, 2025). That case,
`like this one, featured a False Claims Act (“FCA”) theory premised on an alleged violation
`of the Anti-Kickback Statute (“AKS”). Id. at *7. “The parties dispute[d]” what kind of
`causal connection—but-for causation or something less demanding—is required to show
`that a claim “‘result[ed] from a violation of [the AKS].’” Id. at *8 (final alteration in
`original) (quoting 42 U.S.C. §1320a-7b(g)). Consistent with Judge Saylor’s conclusion
`below and Regeneron’s arguments on appeal here, Judge Saris held “that the ‘resulting
`from’ language in § 1320a-7b(g) requires a plaintiff to show that the AKS violation was a
`but-for cause of the inclusion of the item or service in a claim for payment.” Id. As Judge
`Saris explained, “construing ‘resulting from’ to mandate a showing of but-for causation is
`consistent with basic principles of statutory interpretation,” whereas “the Third Circuit’s
`approach,” under which exposure to an allegedly tainted claim suffices, is not. Id. at *7-9;
`see United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d 89, 96 (3d Cir.
`2018). What is more, as Judge Saris aptly put it, “[t]here is ‘no textual or contextual
`indication’ that Congress intended to give a different meaning to the phrase ‘resulting from’
`in § 1320a-7b(g).” Omni Healthcare, 2025 WL 32676, at *9.
`Judge Saris also explicitly rejected the argument that the government has advanced
`here that Guilfoile v. Shields, 913 F.3d 178 (1st Cir. 2019), “reached a binding holding
`adopting the Third Circuit’s approach.” Omni Healthcare, 2025 WL 32676, at *8. Rather,
`she observed that Guilfoile went out of its way not to “define what type of causal
`connection is ‘sufficient’” under §1320a-7b(g). Id. (quoting Guilfoile, 913 F.3d at 190).
`Given Judge Saris’ extensive experience with FCA litigation, her opinion adds persuasive
`force to the parallel judgments reached by the Sixth and Eighth Circuits and Judge Saylor
`below.
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`706 Duke Street • Alexandria, VA 22314
`202.742.8900 • www.clementmurphy.com
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`Case: 23-2086 Document: 00118234131 Page: 2 Date Filed: 01/10/2025 Entry ID: 6692285
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`Ms. Anastasia Dubrovsky, Clerk of Court
`January 10, 2025
`Page 2 of 2
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`Cc: All counsel of record (via CM/ECF)
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`Respectfully submitted,
`
`s/Paul D. Clement
`Paul D. Clement
`CLEMENT & MURPHY PLLC
`706 Duke Street
`Alexandria, VA 22314
`(202) 742-8900
`paul.clement@clementmurphy.com
`
`
`706 Duke Street • Alexandria, VA 22314
`202.742.8900 • www.clementmurphy.com
`
`