The Applicability of Twombly and Iqbal to Pharmaceutical Product Liability Litigation

This article originally appeared in the November 2009 Drug, Device and Biotechnology Committee Newsletter. Since the adoption of the Federal Rules of Civil Procedure, and similar state procedural rules, the threshold that must meet to survive motion to dismiss for failure to state claim has been very low. Two recent Supreme Court decisions dramatically change that requirement for and, while not returning to the pre-rules technical and formal requirements, make clear that mere allegations will longer satisfy burden in pleading claim for relief. Bell Atlantic Corporation v. Twombly? involved the sufficiency of class complaint brought by the against telephone and/or high speed internet services providers alleging Sherman Act violations. In response to motion challenging the sufficiency of the complaint, the cited Conley v. Gibson,2 and argued that they had satisfied the long established standard that a complaint should not be dismissed for failure to state the claim unless it appears beyond doubt that the plaintiff can prove set of in support of his claim which would entitle him to relief....3 The Supreme Court, however, explained that while complaint need not contain detailed factual allegations, plaintiffs obligation to provide the 'grounds' of his 'entitlement to relief, requires than labels and conclusions, and formulaic recitation of the elements of cause of will not do.4 The Court recognized that the Conley standard would allow wholly of claim to survive motion to dismiss if there were some set of that could support recovery. As such, the Court concluded that the no set of facts standard is best forgotten as an incomplete, negative gloss on an accepted pleading standard...5 The Court then set forth the following analysis to be used in Sherman Act case: A complaint with enough factual matter (taken as true) to suggest that an agreement was made. Asking for plausible grounds to infer an agreement does not impose probability requirement at the pleading stage; it simply calls for enough to raise reasonable expectation that discovery will reveal evidence of illegal agreement. The need at the pleading stage for allegations plausibly suggesting (not merely consistent with) agreement reflects threshold requirement Rule 8(a)(2) that the plain statement possesses enough heft to sho[w] the pleader is entitled to relief.6 Later, in 2009, in Ashcroft v. Iqbal,7 the Supreme Court extended the reach of Twombly to all civil actions and proceedings in United States District Court. The Court explained that the complaint must assert more than an unadorned, the - defendant - unlawfully - harmed - me accusation, and that bare assertions . . . amounting] to nothing than formulistic recitation of the elements of cause of action are rejected as conclusory and not entitled to be assumed to be true.8 Following these two cases, pharmaceutical defendants in personal injury cases have argued for dismissal on failure to state claim grounds, achieving mixed results. Whether the court grants or denies Twombly motion is based upon the factual allegations contained in the complaint at issue and it is, therefore, decided on case by case basis and not subject to generalizations. However, as discussed below, when such motions are granted, courts typically find the allegations too conclusory. Likewise, review of the cases in which motions to dismiss are denied reveals that the court has concluded that the complaint goes beyond mere allegations and specifically alleges facts, even if only very few, to support the causes of at issue. CASES GRANTING MOTIONS TO DISMISS A number of courts have granted motions to dismiss finding the complaint fails to comply with Twombly. In Frey v. Novartis Corporation,9 the plaintiff brought claims against Novartis Pharmaceuticals Corporation involving the drug Trileptal. …