“Heightened” Pleading Standards in Pharmaceutical Product Liability

The U.S. Supreme Court’s decisions in Twombly and Iqbal have altered the pleading landscape for pharmaceutical product liability actions.  The new decisions unravel nearly sixty years of precedent established by the Supreme Court in Conley v. Gibson, which held that, “a complaint should not be dismissed for failure to state a claim unless it appears beyond doubt that the plaintiffs can prove no set of facts in support of his claim which would entitle him to relief.”

The “no set of facts” standard of Conley was retired in favor of the more stringent approach advanced in Twombly, which required a complaint to have enough “factual enhancement” to cross the line “between possibility and plausibility of entitlement to relief.”  Iqbal subsequently confirmed that the “decision in Twombly expounded the pleading standard for all civil actions.”  The Court explicated that Rule 8 demanded “more than an unadorned, the-defendant-unlawfully-harmed-me accusation.”

As a result of the shifting pleading burden, pharmaceutical product liability complaints are increasingly met with motions to dismiss.  Beyond alleging the individual elements of each cause of action, a complaint must now provide the court with a sufficient basis to test the factual allegations against each element and assess whether the possibility to plausibility barrier has been traversed.  Plaintiff’s counsel must now seek, for example, to specifically identify how a product’s labeling is insufficient or how a product is defectively designed without the typical benefit of discovery.

Trief & Olk has experience navigating this new terrain, and has dealt with numerous pharmaceutical product liability actions in the wake of Twombly and Iqbal.