The trade group Advanced Medical Technology Association (AdvaMed) has filed an amicus brief in a Supreme Court case regarding the disclosure of adverse medical events. AdvaMed says medical device-makers should not be liable for failing to publicly disclose all adverse event reports regardless of whether the event and the product are connected.
The Food and Drug Administration "has long recognized that individual adverse event reports do not constitute reliable information upon which patients or health care providers should base actual medical decisions, because there is no certainty that the reported event was linked to the product cited," AdvaMed said in a statement. "The adverse event could have been caused by an underlying disease, another treatment or simply chance."
The Supreme Court will review a decision by the Ninth Circuit that held that life science companies could be sued under the Securities Exchange Act. The case is Matrixx Initiatives Inc. vs. James Siracusano.