BioCentury on BioBusiness,
Politics and Policy
In Matrixx, SCOTUS may require disclosure of non-significant adverse events
Materially insignificant
By Aaron Bouchie
Senior Writer
Published on
Monday, January 17, 2011
The body language from the U.S.
Supreme Court justices in last week's oral arguments in the Matrixx case
suggest drug and device companies will have to disclose more information about
adverse events. How much more will depend on where the justices draw the line.
Matrixx
Initiatives Inc. et al. v. James Siracusano et al. was originally
meant to determine whether investors can claim securities fraud when a
pharmaceutical company does not disclose adverse events that are not
statistically significant. Once it became apparent at the oral arguments that
the answer to that question is a qualified "yes," the justices began
to focus on what level of information about non-significant AEs might be
material to investors.
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