Sandbox/v29

Hy’s Law cases have the following three components:

1.	The drug causes hepatocellular injury, generally shown by a higher incidence of ≥3xULN of ALT or AST than the (nonhepatotoxic) control drug or placebo.
2.	Among trial subjects showing such AT elevations, often with ATs much greater than 3xULN, one or more also show elevation of serum TBL to >2xULN, without initial findings of cholestasis (elevated serum ALP).
3.	No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C; preexisting or acute liver disease; or another drug capable of causing the observed injury.