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Andrew J. Sylora

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On June 1, 2023 the U.S. Supreme Court vacated and remanded two Seventh Circuit decisions involving the False Claims Act (FCA), holding in a unanimous opinion that the FCA’s scienter element turns on a defendant’s subjective belief and intent, not by an after-the-fact analysis of whether the defendant’s actions were “objectively reasonable.”

The two cases at issue, United States et al. ex rel. Schutte et al. v. SuperValu Inc. et al. and United States et al. ex rel. Proctor v. Safeway Inc., alleged that respondents SuperValu and Safeway separately defrauded Medicaid and Medicare by offering discount programs to their customers while knowingly submitting claims for the higher retail prices exceeding the “usual and customary prices” customers paid. Ruling in favor of SuperValu and Safeway, the Seventh Circuit applied an “objectively reasonable” scienter standard, determining that SuperValu and Safeway would be liable for submitting false claims only if their respective interpretation of the FCA’s “usual and customary” language was not “objectively reasonable.”Continue Reading U.S. Supreme Court Clarifies Usage of Subjective Standard for FCA Scienter Element

The FDA has recently stepped up its enforcement activity with respect to animal and pet food manufacturing. On February 8, 2023, the FDA announced an expansion of a voluntary recall for a Nestlé Purina dog food product. On March 10, 2023, the FDA announced a voluntary recall of cat and dog supplements distributed by Stratford Care USA due to elevated levels of vitamin A found in the supplements. And on March 14, 2023, the FDA published a warning letter issued to Primal Pet Foods, Inc. in relation to the company’s recall of its dog food product, stating the company had not taken sufficient steps to address operational and manufacturing deficiencies found during an FDA inspection of the manufacturing facility.Continue Reading Navigating FDA Manufacturing Guidelines for Animal and Pet Food Products