This post was written by Adam M. Masin.

The American Dialect Society named “truthiness” as the word of the year for 2005 and Merriam-Webster followed suit in 2006. Popularized by political satirist Stephen Colbert’s character “Stephen Colbert,” truthiness is generally defined as “knowledge” based on emotion and gut instinct rather than on information, facts, evidence, or logic. A true proponent of truthiness, for example, would “feel” the definition and would never look it up in a book. Whether on Colbert’s show, in academic and political circles, or in the pages of the New York Times, the concept of truthiness has been on a lot of important minds lately. Add the United States Supreme Court to that list. Although the Court did not explicitly invoke that word in discussing why the Complaint had to be dismissed in Iqbal v. Ashcroft, 2009 WL 1361536 (May 18, 2009), truthiness, it said in essence, is not the pleading standard under Rule 8. Welcome to the world of reality-based pleading.

Finally, our clients might add. As the Drug and Device Law Blog recently noted, defenders of the Iqbal decision have been more reticent that those horrified by it. The authors of that blog have ably raised a number of defenses for Iqbal and its older brother Twombly and took issue with plaintiffs’ claims that Iqbal and Twombly stand as obstacles to filing meritorious cases, arguing that “the hallmark of a meritorious case is that it’s factually supported from the get go.” That is undoubtedly true, and it should be added that all Iqbal and Twombly require is that plaintiffs give the trial judge some reason to belief that their case is meritorious “from the get go.”

“Plausibility” is the touchtone of pleading under Rule 8 for all civil cases and Iqbal confirmed that the Complaint must be scrutinized to determine the “plausibility” of all allegations, including state of mind allegations. No claim will be considered plausible on its face unless “the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Conclusions won’t do anymore, no matter how convincingly they are stated, repeated, or deeply believed. Moreover, the plausibility determination is “a context-specific task that requires the reviewing court to draw on its judicial experience and common sense.” As context is not frequently a favorite concept of the plaintiffs’ bar, judicial experience and common sense are fabulous tools to review factual allegations in context — the who, what, where, when, why, and how — to determine whether they plausibly support the existence of a cause of action. See, e.g., Sugawara v. Pepsico, Inc., No. 2:08-cv-01335-MCE-JFM, 2009 U.S. Dist. LEXIS 43127 (N.D. Cal. May 20, 2009) (dismissing putative class action complaint based on claims that consumers were misled to believe that “Crunchberries” cereal contained real berries). But judicial experience and common sense are not particularly relevant tools to review truthiness.

A quick review of the case helps put this discussion into context. Iqbal was about whether the plaintiff, a post-9/11 detainee, had adequately pleaded the intent element of his discrimination claim as there was no real dispute that the government’s alleged post-9/11 detainee policy would produce a “disparate” impact on Arabs and Muslims. The Court made it clear that factual allegations of conduct that are merely “consistent” with intentional wrongdoing are not enough if there are “more likely explanations” for that conduct than intentional wrongdoing. As a result, the Court would not infer purposeful, invidious discrimination from the government’s alleged post-9/11 detention policies where there was an “obvious alternative explanation” for them. The Court was unable to find factual allegations in the Complaint that established the plausibility of wrongdoing as the more likely explanation for the policies than an innocent explanation, no matter what anyone’s gut might say about to them about the Bush Administration and its detention policies or, indeed, what any facts that are outside of the Complaint might actually reflect.

It is here where the Court’s rejection of truthiness was complete. The Court did not simply reject the sufficiency of “consistent” facts, it was also unwilling to presume the truth of the conclusory allegations of wrongdoing, which in the Court’s view “alleged” but did now “show” any entitlement to relief. The Court did not even assume the truth of conclusory allegations relating to members of the Bush Administration’s participation and knowledge of the allegedly invidious policy, which it deemed “nothing more than a “formulaic recitation of the elements” of a constitutional discrimination claim. As the Court put it, “[t]hreadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice.”

In essence, the Court was unable to find sufficient reality-based allegations — or, as the Court said more formally, “respondent’s complaint does not contain any factual allegation sufficient to plausibly suggest petitioners’ discriminatory state of mind.” It is difficult to see how Iqbal’s Complaint could have survived without alleging at least some real-life examples of the defendants’ knowledge or conduct that, taken as true, evidenced the defendants’ discriminatory state of mind. Maybe it’s not “fanciful” to believe that these real-life examples exist. But if they are not pleaded, the Court said, the Complaint does not state a claim.

The question that Iqbal should therefore require trial court judges to ask when reading a plaintiff’s conclusory allegations is this: “How do you know?” The Complaint should be dismissed if it does not allege facts that plausibly answer that question if taken as true. Iqbal should therefore put an end to complaints that provide no factual basis for believing that any of the plaintiffs’ conclusory allegations about the product are true, that any of the conduct alleged generally actually happened, or that anyone was actually injured as a result. Iqbal should also put a stop to plaintiffs who attempt to plead claims for fraud and punitive damages simply by adding words like “intended” or “knew” to other conclusory allegations.

In the drug and device context, “How do you know?” should be an easy question for to answer at the pleading stage if plaintiffs’ claims have any plausibility and if their lawyers have done any homework. If plaintiffs claim that the warnings were inadequate, then plaintiffs should be able to allege why the warnings are inadequate and allege some scientific basis for making that claim. If they claim that the manufacturer “overpromoted” its product or engaged in “off-label promotion,” then they should be able to identify some real-life examples of this conduct actually happening somewhere, particularly as they have exclusive access to the users of the products, their physicians, and any other publicly available information like advertisements and webpages where such conduct might have occurred. If they claim that the manufacturer violated the FDCA or FDA regulations, then they should at least be able to identify which provision was violated and some facts indicting how and when it was violated. And if they make claims that require proof of a certain state of mind, such as claims for fraud or punitive damages, then Iqbal made clear that the Complaint should be carefully assessed to determine if it contains any factual allegations plausibly indicating the kind of state of mind that is typically required to prove such claims.

Before the plaintiffs’ bar gets all riled up, neither Iqbal nor Twombly require that plaintiffs allege every fact required to state a claim under Rule 9(b) (unless that Rule applies naturally), every fact that could possibly suffice to state a cause of action, which is what amended pleadings are for, or every fact that proves the “How do you know?” question, which is what discovery is for. But if “How do you know?” has no answer at the pleading stage at all, then the Complaint is based on nothing more than its truthiness – plaintiffs’ gut feeling that they must have some kind of claim to litigate about the product, even if they cannot recite any facts to support one.

As Colbert has explained it, it is completely unimportant whether “truthy” facts are actually true or false. The only thing that matters is that you believe them to be true without regard to the facts. By requiring factual content, context, and the judicial use of logic and common sense, the Supreme Court has made it clear that it wants Complaints derived from facts rather than from the guts of plaintiffs’ lawyers. Truthiness, it seems, will have to remain the pleading standard in the political arena.