The First Circuit affirmed the dismissal of nearly all securities class action claims against Ariad Pharmaceuticals, Inc. (Ariad) and four corporate officers, in In re Ariad Pharmaceuticals, Inc., Securities Litig., 842 F.3d 744 (1st Cir. 2016). The litigation focused on Ariad’s public statements about the potential for FDA approval of an experimental drug designed to treat a particular type of leukemia. Ariad made robust public statements about the efficacy of the drug, until the FDA pulled the drug from clinical trials amid negative side effects. The First Circuit found that other than one statement, the allegations of misrepresentations were insufficient to support a strong inference of scienter. The court also held that the allegations of insider trading were not actionable.

Ariad is a pharmaceutical company employing R&D to develop new products. One such product showed promise in treating a chronic form of leukemia. After a series of clinical trials, Ariad sought FDA approval. The FDA initially rejected Ariad’s application, but eventually approved limited use, with the caveat that the packaging must indicate a significant risk of adverse cardiovascular events (a so-called “black-box” label). Black-box labels are the strictest warnings issued by the FDA and indicate that evidence of a serious hazard exists with the drug. Despite the concerns and the required label, Ariad projected public confidence about the drug’s effectiveness, which included a statement that management believed the drug would be approved “with a favorable label.” Within a year, however, clinical studies showed increased medical complications, ultimately resulting in the decision to suspend commercial distribution of the drug. Ariad’s stock price went from $23/share to $2.20/share.

Plaintiffs brought claims under both the Exchange Act and the Securities Act. Plaintiffs identified two categories of alleged misstatements: (1) those statements made before the FDA approved the drug for limited use; and (2) those statements made post-approval. On either side of the FDA approval timeline, the crux of the alleged misstatements related to what Ariad knew and said (or failed to say) about the rate of cardiovascular events attributed to the drug’s use. To bolster their scienter allegations, plaintiffs alleged that certain executives sold shares during the class period.

On appeal, the First Circuit affirmed, in part, the district court’s dismissal. The court overwhelmingly rejected plaintiffs’ theory because, while the complaint was replete with conclusory allegations that the Ariad defendants knew about the rate of cardiovascular events, “plaintiffs’ theory of fraud suffer[ed] from a glaring omission”—plaintiffs failed to make concrete allegations of contemporaneous knowledge. The allegations, taken as a whole, did not establish when the adverse events occurred or, more importantly, when the defendants knew about those adverse events. Instead, the complaint sought to impermissibly establish fraud by hindsight. As such, plaintiffs failed to create the required strong inference of scienter.

The court did find, however, that one statement did support a strong inference of scienter. After the FDA had informed Ariad that its limited approval would include a black-box label requirement, Ariad published a report indicating the drug would likely receive a favorable label. The court found this allegation sufficient.

The First Circuit also dispensed with the stock-sale allegations. Relying on its decision in Greebel v. FTP Software, Inc., 194 F.3d 185 (1st Cir. 1999), the court analyzed the insider trading allegations under its holding that insider trades may be probative of scienter, but do not, on their own, establish scienter. The court found that the bulk of insider trades occurred well before the high point of Ariad’s stock price, an indication that the trades did not appear to be suspicious. Ariad’s CFO made trades closest to the stock’s high point, but, significantly, the court concluded a pharmaceutical company’s CFO is not likely to have access to nonpublic information obtained through clinical trials. As such, it was unlikely, in the court’s estimation, that the CFO’s trades indicated knowledge of negative information not yet available to the public. The upshot: none of the insider trading allegations bolstered the plaintiffs’ scienter allegations.

Finally, the First Circuit held that plaintiffs did not adequately plead that the purchase of their shares was traceable to the relevant offering. Based on the plaintiffs’ allegations, the court found it more plausible than not that they purchased shares that were issued prior to the date(s) of the alleged misstatements.