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Fourth Circuit Rejects FCA Claims On Scienter Grounds Based On Ambiguous Regulations - Food, Drugs, Healthcare, Life Sciences


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 , Greer Lab , Greer Labs , Fourth Circuit , ஒன்றுபட்டது மாநிலங்களில் , கிரேர் ஆய்வகம் , கிரேர் ஆய்வகங்கள் , நான்காவது சுற்று ,