Could medical product firms have to file a disclosure with the Securities and Exchange Commission or issue a press release for every adverse event report?
Device Makers To Supreme Court: Investors Don't Need Adverse Event Reports Without Statistical Backing
Article preview from "The Gray Sheet" - August 31, 2010
"Yes," says AdvaMed, if the Supreme Court does not reverse a 2009 appeals court decision in its upcoming term. And the implications would be negative for companies and investors, the trade group argues in an amicus curiae 1 brief recently sent to the high court.
The case: Matrixx Initiatives Inc. v. Siracusano, which the Supreme Court has agreed to hear during its session beginning in October.
It involves a manufacturer of cold medicines targeted with a class-action lawsuit in 2004 by investors alleging failure to disclose material information. Specifically, Matrixx did not disclose reports of patients developing anosmia (the loss of the sense of smell) after taking Zicam , an intranasal drug.
To read this article in its entirety, purchase this article online or get it FREE when you subscribe to "The Gray Sheet".
Plus:
To find out about more about more about Elsevier Business Intelligence's medical device publications and databases, multi-user access and/or advertising with Medical Devices Today, please contact Kristy Kennedy at (480) 985-9512
Comments