“The best lack all conviction, while the worst are full of passionate intensity.”

– Yeats, The Second Coming

We remember the early days of ESPN’s Sportscenter when Stuart Scott constantly complained about how he always had to do the summaries of the week’s crappiest football games (the bad teams back then were Tampa Bay, Green Bay, and Pitt Bay). Lately, we’ve been feeling the same way, as Bexis seems to open the kennel doors when it comes time for us to do a post. This week continues the trend, as we visit with a wretched-failure-to-warn analysis in Maynard v. Abbott Laboratories, 2013 U.S. Dist. LEXIS 26068 (E.D. Wisc. Feb. 20, 2013).  If Maynard was a football game, the final score would be 5-2, the field would be muddy, both quarterbacks would leave the game with concussions, and the cheerleaders would all look like Clint Howard.

In Maynard, the pro se plaintiff brought a failure-to-warn action, alleging that he suffered neurological damage from using Humira. The plaintiff took Humira “on a consistent basis” between 2003 and 2009. 2013 U.S. Dist. LEXIS 26068 at *2.  On September 16, 2009, the plaintiff began experiencing vision loss in his left eye. Doctors determined that the plaintiff was suffering from demyelination disease from his Humira use.  (We in the defense business would call that a bad specific causation fact.) The plaintiff also exhibited symptoms of optic neuritis and multiple sclerosis.

The central issue in the case was the adequacy of the Humira label. Under “WARNINGS,” the October 2003 Humira label stated:

Neurologic Events

Use of TNF blocking agents, including HUMIRA, has been associated with rare cases of exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. Prescribers should exercise caution in considering the use of HUMIRA with preexisting or recent-onset central nervous system demyelinating disorders.

In 2005, the Humira warning was updated to state that in addition to being associated with rare cases of exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease, use of Humira has also been associated with rare cases of new onset of such symptoms.

As is typical, risks are referenced in other places in the label .  Thus, the Humira label also stated that the most serious adverse reactions include “neurologic events” and referred to the neurologic events explained in the warnings section. Further, the Humira patient insert warned that patients should tell their doctor before starting to take Humira if they have experienced “any numbness or tingling or have or have ever had a disease that affects [the] nervous system like multiple sclerosis.” Nevertheless, the plaintiff argued that the Humira warnings “were misleading because they omitted material information regarding the severity of the potential side effects and were not clear in explaining that patients without preexisting neurological conditions could also be at risk.”  Id. at *11.

The defendant  filed a motion to dismiss on the grounds that the label warned of the neurologic risks at issue. Normally a court sticks to the pleadings in resolving a motion to dismiss, but since the Complaint referred to the Humira label, that label was fair game in deciding the issue. So far so good.  But the Maynard court then engaged in a myopic analysis.  It purported to apply Twombly and Iqbal and held that the plaintiff’s reading of the label was “plausible” insofar as the warning regarding adverse neurological side effects “reasonably appears to be applicable only to patients with preexisting demyelinating disorders or other existing symptoms of central nervous system disorders.”  Id. at *12. The court goes on to say that “[a]t the very least, before 2005, the WARNINGS section of the label was arguably unclear.” Id. Hmmm. But the plaintiff kept taking Humira even after the label was revised in 2005, so how can the pre-existing-only point be material?  Don’t we have clear evidence that a label that warned of potential onset of neurological conditions would not have dissuaded the plaintiff from taking Humira?  Further, is there any way to say that it was the plaintiff’s pre-2005 ingestion that played a role in the disease?

The Maynard opinion indulges in a nit-picking approach that renders any label vulnerable to post hoc attack. We’d criticize the reasoning, but we’re not sure “reasoning” is quite the right characterization when the court relies on Wisconsin authority holding that “[i]mplicit in the duty to warn is the duty to warn with a degree of intensity that would cause a reasonable man to exercise for his own safety the caution commensurate with the potential danger.” Id. at *13 (quoting Schuh v. Fox River Tractor Co., 63 Wis. 2d 728, 739 (1974)).   How to assess intensity?

This outcome is both good news and bad news for us. It is bad news because intensity is such a slippery notion and it is all too easy for plaintiff lawyers to complain that even warnings that address the very risks at issue lack the requisite intensity. Under this “standard,” every label is susceptible to attack. Maybe a label warns of a rash, but it does not say it is a really, really bad rash. However many “reallys” do reside in the label, the plaintiff lawyer can argue that there should have been at least one more. But here is the good news: we’ve been worrying about how the Drug and Device Law Daughter is taking classes in college on creative writing and poetry. Until this moment, we could not foresee how that curriculum would end in employment. Now we are relieved to learn that she might get a job with a drug or device company, applying her poetic skills to label-writing and ensuring that warnings emit intensity. Adverse events, meet Dylan Thomas. Or William Butler Yeats.

Creative writing, indeed. What’s annoying about the Maynard court’s reasoning is that it indulges in the vast fiction that the intensity, or, indeed, the literal words of the warning, had any effect on the plaintiff at all. We know of cases where a warning listed death as a possible consequence, but the plaintiff got through the pleading stage and even summary judgment merely by arguing that the label did not lay out other risks with sufficient detail or color. If a label does not describe a particular pain with enough purple prose, or if it does not go into ghoulish detail about a neurological consequence or rash, then any plaintiff can assert that they were misled and that they would have steered clear of the product if only the label contained that one thing it did not have. Maynard is an exercise in hindsight, but it is through a glass, dumbly.

The reality is that patients tend to listen to their doctors, not the label and all its lack of intensity. And now we arrive at the fundamental problem with Maynard. It says that “Wisconsin does not apply the learned intermediary doctrine. “ Id. at *15. Really?  In fact, several other federal courts have predicted that the Wisconsin Supreme Court would follow the learned intermediary rule.  See Menges v. Depuy Motech, Inc., 61 F. Supp.2d 817, 830 (N.D. Ind. 1999); Monson v. AcroMed Corp., 1999 WL 1133273, at *20 (E.D. Wis. May 12, 1999); Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963 (D. Wis. 1981), modified on other grounds, 523 F. Supp. 206 (D. Wis. 1981).  See our prior post offering a head count on which jurisdictions have adopted the learned intermediary rule.

Moreover, Maynard is an example of why we need the learned intermediary rule.  A plaintiff has every litigation interest in asserting that he or she would have made medical decisions based on the intensity of a warning.  It is utter nonsense, but if a court is desperate to cobble together a disputed issue of fact, there it is.  But in reality, a learned intermediary is unlikely to hinge a prescribing decision on intensity.

We dislike the Maynard decision.  We dislike it intensely.