Life Sciences Legal Update : Life Sciences Lawyers & Attorneys : Reed Smith Law Firm : Healthcare, Food and Drug Law, Biotechnology, Privacy, Product Liability

"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 possiblysuffice 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.

In Adkins v. Cytyc Corp, No. 4:07CV00053, 2008 WL 2680474 (W.D. Va. July 3, 2008), plaintiff brought suit against the manufacturer of a device called the NovaSure, used during a surgical procedure called endometrial ablation that was performed on plaintiff. In addition to the usual product liability claims, plaintiff pleaded a cause of action implicating direct actions of defendant’s representative (presumably a sales representative; the opinion describes the person simply as a “corporate representative”) during the surgery in mistakenly instructing the operating physician. Id. at 1. Because of an error in measuring the size her uterine wall, plaintiff suffered injuries during the ensuing ablation procedure.

Defendant moved to dismiss under Rule 12(b)(6) of the Federal Rules of Civil Procedure, based upon the Supreme Court’s decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008). Because the NovaSure device is a Class III medical device that received pre-market approval by FDA, the court dismissed with little fanfare all of plaintiff’s causes of action “that sound in negligence or breach of duty related to the design, manufacturing, and labeling of the NovaSure device.” Id. at 2. To allow plaintiff to proceed with her action “would impose requirements that differ from by the FDA on [the manufacturer].” Id.

But the preemption issue was not the end of the court’s analysis. Plaintiff also pleaded that “defendant’s corporate representative” had “a duty to ensure that the NovaSure device was operating correctly and that [the surgeon] followed the proper procedures when using the NovaSure device.” Id. (internal citation omitted). 

The court found that FDA did not regulate plaintiff’s agency theory of liability, and that preemption did not reach this claim. Describing such “localized situations,” id. at 3, as traditional matters for the common law, not FDA’s regulatory approval process, the court held that the agency claim “does not challenge the design, manufacture, and labeling of the NovaSure device so as to implicate Riegel preemption, but rather challenges negligence by a corporate agent acting as a de facto physician’s assistant during a surgical procedure.” Id.

However, plaintiff’s complaint failed to adequately plead, under Bell Atlantic Corp. V. Twombley, 127 S.Ct. 1955 (2007), facts to explain what defendant’s representative did or failed to do as part of his alleged duty. Further, the complaint did not specify whether plaintiff’s alleged injuries were caused by a failure of the NovaSure device or by a treatment error induced by instructions from the corporate representative. Therefore, under Twombley, the complaint fell short and, as a result, the court dismissed the complaint without prejudice and granted plaintiff leave to re-plead only on her agency theory of recovery. Id. (Query whether plaintiff will in fact state an actionable claim if she re-pleads, as some courts have rejected attempts to impose liability on non-physicians for failing to control a physician’s delivery of medical services for policy reasons. See, e.g., Kernke v. The Menninger Clinic, 173 F. Supp. 2d 1117 (D. Kan. 2001) (physician running clinical trial, not clinical trial sponsor, owed study participants duty to provide adequate medical care and duty to obtain informed consent); McKee v. American Home Prods. Corp., 113 Wash. 2d 701, 716 (1989) (non-physician without patient’s medical history not qualified to determine propriety of treatment, as that would require non-physician to improperly interfere with physician-patient relationship, where physician might have sound medical reasons for what appears to be a non-standard treatment); Cottam v. CVS Pharmacy, 436 Mass. 316, 321 (2002)(same)).  

That the majority of this decision is devoted to the issue of whether plaintiff stated a claim against defendant’s corporate representative demonstrates the strength of the Riegeldecision in cases involving PMA-approved devices – as does the court’s willingness to grant a preemption dismissal on a Rule 12(b)(6) motion. Also of significance is the court’s application of Twombley to product liability claims, which all product liability defendants should consider when analyzing whether a plaintiff’s complaint uses mere labels, conclusions, or simply a formulaic recitation of the elements of a cause of action.

Use the following links to read the court's Memorandum Opinion, the original Order, and its Amended Order.