Summary judgment is a manufacturer's goal in almost every
case. Often, it's an uphill battle. For example, a recent
Supreme Court decision has made summary judgment more difficult to
obtain in prescription drug cases that allege a failure to
adequately warn, by limiting the scope of the federal preemption
defense.1 Thus, a Food and Drug Administration
("FDA") decision that a particular risk need not be
identified in the labeling is rarely a basis to preclude Plaintiffs
from proceeding with litigation criticizing the FDA-approved
labeling. Additionally, courts are reluctant to adjudicate, at the
summary judgment stage, that labeling adequately warns of the risks
at issue because this is perceived by many courts as a question for
the jury.2 Moreover, Plaintiffs' lawyers can easily
find "experts" to criticize labeling and to offer
opinions that the labeling, albeit FDA-approved, should have
disclosed additional or different risks, or disclosed them in a
different manner.
