David A. Kotler
New York +1 212 698 3669
This pending case considers whether a publicly traded life-science company may be held liable for securities fraud for not publicly disclosing a statistically insignificant number of “adverse event reports” regarding one of its products. Prior to the Ninth Circuit’s decision below, the lower courts had recognized that a plaintiff must show that the purported undisclosed adverse event reports rise to the level of statistical significance before disclosure to investors is required. On behalf of the Advanced Medical Technology Association (“AdvaMed”), Dechert submitted an amicus brief addressing the nature of the FDA regulatory scheme underlying adverse event reports and explaining why, absent statistical significance, the non-disclosure of such reports cannot give rise to any inference of scienter. Steven A. Engel (counsel record), Steven G. Bradbury, William K. Dodds, David A. Kotler, James M. Beck, David T. Jones and Brielle Rey were on the brief.