It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness.  Okay, fine.  We are not Charles Dickens, but we have often commented on courts applying TwIqbal’s more exacting and imminently fair pleading standard to dismiss claims (the best of times), only to grant the plaintiffs leave to amend when it seems the pleadings are already at a dead end (the worst of times).  We understand the need to give plaintiffs a fair opportunity to plead, and we understand that leave to amend is properly granted in many cases.  We still find it frustrating at times, particularly in drug and device cases where everyone in the room understands what needs to be pled.  Under many circumstances, courts should give the plaintiffs a little less rope, and it might even ease their often-overcrowded dockets along the way. 

            An example that hit our inboxes this week is Zacharias v. Bayer Healthcare Pharmaceuticals, No. 5:14-cv-00101, 2015 U.S. Dist. LEXIS 19189 (W.D. Ky. Feb. 18, 2015), a product liability case involving a hormone-eluting intrauterine contraceptive device.  The plaintiff alleged a condition known as pseudotumor cerebri or idiopathic intracranial hypertension (“PTC/IIH”), which can have severe consequences, and she attempted to plead a variety of the usual claims.  Id. at *1-*2. 

            The complaint, however, was short on specifics, so the defendant moved to dismiss under TwIqbal.  That motion was well received, resulting in familiar language explaining that even though the court will draw all reasonable inferences in favor of the plaintiff, it need not accept unwarranted factual inferences. Moreover,

[e]ven though a “complaint attacked by a Rule 12(b)(6) motion to dismiss does not need detailed factual allegations, a plaintiff’s obligation to provide the grounds of his entitlement to relief requires more than labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” . . .  If, from the well-pleaded facts, the court cannot “infer more than the mere possibility of misconduct, the complaint has alleged—but not ‘shown’—‘that the pleader is entitled to relief.’ . . . Only a complaint that states a plausible claim for relief survives a motion to dismiss.” 

Id. at *4 (quoting Twombly and Iqbal).  The standard for the plaintiff’s fraud claim was even more exacting under Rule 9(b), which requires “at a minimum” that the allegations contain “the time, place, and content of the alleged misrepresentation on which [the plaintiff] relied; the fraudulent scheme; the fraudulent intent of the defendants; and the injury resulting from the fraud.” Id. at *5 (citations omitted). 

            This is the “best of times” part, and the district court held that the complaint fell short in a passage that is more pointed that what we are accustomed to seeing:

The complaint fails to provide certain bedrock facts-including, for example, the name and locations of the practitioner who placed [Plaintiff’s] Mirena, the practitioner who removed the IUD, and the practitioner who diagnosed her with PTC/IIH. Significantly, she does not indicate when these procedures and diagnoses occurred, which could prove essential to a statute of limitations analysis. Moreover, [her] complaint does not satisfy the legal prerequisites of several of her nine claims. These deficiencies raise particular concern in the context of her fraud-based claims, which fall far short of the detail required by Sixth Circuit precedent.  Consequently, [Plaintiff] has failed to state a claim upon which relief may be granted.

Id. at *6 (citation omitted).  This passage caught our interest because it is exceptionally specific on what the district court expected to see, including the specific treatment-related details such as the names of her doctors and information relevant to the statute of limitations.  This, of course, is information that every plaintiff has (or should have) before he or she ever files a complaint, so we view it again as imminently fair that the district court called out this plaintiff in this fashion. 

Now for the “not so best of times” part.  The Court granted leave to amend, which as we said at the outset is properly granted in many cases.  Here, we have our doubts.  To begin with, there have been other cases involving this contraception product, and it seems deficient pleadings in those cases has been a recurring problem.  The court itself commented that it “has confronted similar factual and legal deficiencies in other cases involving” this product, yet it gave this plaintiff another chance.  Id. at *6-*7.  Another district judge under similar circumstances might bring the history to bear and show less patience, with substantial justification. 

In addition, the defendant brought non-TwIwbalchallenges and argued that some claims should be dismissed as a matter of law.  Id. at *7 n.1.  The district court recognized that and even commented that the complaint failed to meet the “legal prerequisites” of several of the plaintiff’s claims.  Id. at *6.  The court nonetheless defers ruling on these arguments because an amended complaint was forthcoming.  Id. at *7 n.1.  We can see the court’s logic, but it would have been better if the court had reached and ruled on those arguments.  At the very least, that would have given the parties guidance for the next round of pleadings, and it might even have eliminated some of the claims, depending on whether the legal deficiencies could be fixed by amendment.  Often, they cannot.  It is also possible, though not likely, that the plaintiff will decline leave to amend and will stand on his or her pleadings, in which case the defendants would have to bring the same challenges again. 

All in all, the order in Zacharias is a good exposition of the TwIqbal standard and what one court would require in a prescription medical device case.  Leave to amend is a thornier issue, and the case provides a good platform for discussing that, too.  To return to our Dickensian theme, we have Great Expectations for the future of TwIqbal and suspect that this plaintiff will fall on Hard Times in attempting to cure the deficiencies in her pleadings.  Indeed, a forum without consistent and disciplined rules for pleading would appear to us to be a Bleak House.