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Fourth Circuit Rejects FCA Claims on Scienter Grounds Based on Ambiguous Regulations | Jones Day


In Short
The Situation: Manufacturers of allergenic extracts that are injected into a patient must obtain a Food and Drug Administration ( FDA ) approved license in order to ensure their products are safe for consumption. Until the FDA issued regulatory guidance in 2015, most manufacturers interpreted the FDA regulation at issue as allowing a general license for the custom mixes of extracts. But the FDA s 2015 guidance clarified that a separate license was required for custom mixes. Seizing on the guidance, relators have sought False Claims Act ( FCA ) liability for earlier claims that do not comport with the regulations as they stand today. ....

United States , Omnicare Inc , Greer Lab , Greer Laboratories Inc , Greer Labs , Fourth Circuit , ஒன்றுபட்டது மாநிலங்களில் , ஓம்நிகரே இன்க் , கிரேர் ஆய்வகம் , கிரேர் ஆய்வகங்கள் இன்க் , கிரேர் ஆய்வகங்கள் , நான்காவது சுற்று ,