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We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard all of the incredulous “how could you??” exclamations. Yes, there was lots of violence. There was the ursine animatronic latter-day cousin of “Bruce,” who, like his predecessor, failed to engage or convince us. Bottom line for us was that there was plenty of dramatic stuff going on, but none of it added up to a compelling story.

Without meaning to be flip about the truly tragic facts of today’s case, that was essentially what the court held. In Batoh v. McNeil-PPC, Inc., et al., — F. Supp. 3d –, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the plaintiff’s decedent, her adult son, developed SJS/TEN (Stevens Johnson Syndrome/Toxic Epidermal Necrolysis) after taking over-the-counter Motrin. SJS and TEN are “severe cutaneous adverse reactions” (“SCAR events”) in which skin becomes inflamed, blistered, and necrotic, and sloughs off. The results can be catastrophic. In the plaintiff’s decedent’s case, the SJS/TEN left him with “significant wounds and scarring throughout his body, and damage to his nervous system, eyes, genitals, and feet.” Batoh, 2016 WL 922779 at *4 (citation omitted). A year later, he committed suicide, telling relatives that he could not tolerate living with these residual injuries.

The plaintiff sued the drug’s manufacturer, alleging violations of the Connecticut Products Liability Act based on theories of failure to warn, design defect, breach of warranty, and fraud/misrepresentation. The defendant moved for summary judgment on all of the plaintiff’s claims, and the plaintiff cross-moved on the defendant’s preemption defenses.

Failure to Warn

The plaintiff argued that the medication’s label did not adequately warn of the risk and severity of potential SCAR events, and that her decedent would not have ingested the medication if the label had included adequate warnings. The defendant argued that, even if the warning was defective, the plaintiff could not, as a matter of law, prove warnings causation, because “no admissible evidence show[ed] that [the decedent] would not have taken Motrin if the warnings on the label had been different.” Id. at *7. The decedent, of course, was dead — that’s different from the protagonist in The Revenant.

As evidence of causation, the plaintiff submitted, 1) testimony from the decedent’s family “that he was a cautious person who was careful with medications and had a habit of checking their warnings;” 2) his “statements to his mother and brother that he would not have taken Motrin if it had borne a different warning,” and 3) the defendant’s “failure to warn the decedent’s physicians” of the medication’s risks. Id.

The court held that the testimony about the decedent’s “cautious nature” and “habit” of reading labels was “character evidence,” inadmissible under Fed. R. Civ. P. 404 to “prove that on a particular occasion the person acted in accordance with the character or trait.” Id. at *8 (citation omitted). It was not “habit evidence,” which would have been admissible under Fed. R. Evid. 406, because the plaintiff “offer[ed] no examples of which she [had] personal knowledge of [the decedent’s] reading he label or warnings for a medication to establish a pattern of conduct.”

The decedent’s statements were blatant hearsay and were also inadmissible, because they lacked the “circumstantial guarantees of trustworthiness” which would have allowed them to be admitted under the Fed. R. Civ. P. 807’s “residual exception” to the hearsay rule. Id. at *9.

Finally, the court held that the defendant had no duty to warn the decedent’s physicians about the non-prescription Motrin the decedent ingested. It was an OTC product, so the learned intermediary rule does not apply.

For all of those reasons, there was no admissible evidence that the decedent would not have taken the medication if the SJS/TEN warnings had been different. Thus, the plaintiff could not prove warnings causation and the court granted summary judgment for the defendant on the plaintiff’s failure-to-warn claims. The same lack of evidence doomed the plaintiff’s fraud-based claims, as there was no admissible evidence that the decedent read and relied on the medication’s label warnings. Since those statements conveniently popped up after death, had no contemporaneous corroboration, and were repeated by someone with a financial interest, this ruling is manifestly correct.

Design Defect

Arguing that defendant should have changed the active ingredient in Motrin after the drug was marketed, the plaintiff alleged that the defendant was liable for designing Motrin in a manner that was “unreasonably dangerous for normal use.” Id. at *16. The defendant argued that this claim was preempted by SCOTUS’s Bartlett decision which held that ““state-law design-defect claims … that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling.” Id., citing Mut. Pharm. Co. v. Bartlett, ––– U.S. ––––, 133 S.Ct. 2466, 2479 (2013). The plaintiff protested that Bartlett “turned on a law only applicable to generic drug manufacturers, not to branded OTC manufacturers.” Id.

The court disagreed. The court emphasized that, under Bartlett, “[o]nce a drug – whether generic or brand-name – is approved, the manufacturer is prohibited from making any major changes to the qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application without prior approval by the FDA.” Id. at *17 (internal punctuation, citation to Bartlett, and additional citations omitted). Thus, the court held, if the defendant “had unilaterally changed the active ingredient of Motrin . . . to satisfy their state law duty, they would have violated federal law,” id., and the plaintiff’s design defect claim was therefore preempted.

This is the most important ruling in the decision – adopting an argument that we’ve been pushing from almost the moment Bartlett was decided (two of our top three 2015 decisions involved the same argument). However, Batoh is the first time Bartlett impossibility has been recognized with respect to a design claim against an OTC drug. This is the most important ruling in the decision – adopting an argument that we’ve been pushing from almost the moment Bartlett was decided (two of our top three 2015 decisions involved the same argument). However, Batoh is the first time Bartlett impossibility has been recognized with respect to a design claim against an OTC drug.

Finally, the court granted summary judgment for the defendant on the plaintiff’s remaining claims, holding that the plaintiff had failed to raise a genuine issue of material fact as to any of them. And so, as it should have, the defendant won summary judgment on all of the plaintiff’s claims. Catastrophic injury and tragic facts, but nothing that added up to a liability claim. End of discussion, right? Wrong. Though it was entirely mooted by the grant of summary judgment on the plaintiff’s failure-to-warn claims, the court felt compelled to decide the plaintiff’s motion for summary judgment on the defendant’s preemption defense as it applied to the already-dismissed warnings claims. In this dictum, the court perpetuated very bad law to which we have devoted two previous blog posts.

Preemption, SJS/TEN Warnings, and Reckis.

The defendant argued that, under Levine, “clear evidence” established that plaintiff’s warnings claims were preempted by federal law. Over the course of many years, the FDA had repeatedly and explicitly determined the SJS/TEN warnings the defendant was required to include in the Motrin label. Nevertheless, the plaintiff argued that the defendant should have unilaterally strengthened the SJS/TEN warning pursuant to the FDA’s “changes being effected” (“CBE”) regulation.

What was the “clear evidence?” The agency had already rejected precisely the same warning when proposed in a Citizens’ Petition. Inexplicably, the court disagreed. Citing Reckis v. Johnson & Johnson, 28 N.E.3d 445 (Mass. 2015) for the proposition that the FDA’s rejection of the Citizens’ Petition did “not answer whether the FDA would have rejected the warning had it been sought by the defendants themselves,” id. at *15 (citation to Reckis omitted), the court held that the defendant had “failed to provide clear evidence that the FDA would not have approved a change to the Motrin label;” thus, the plaintiff’s failure-to-warn claim was not preempted by federal law. Id. at *16.

We hate Reckis. We said so here, here, and here (naming it worst decision of 2015). As we said about Reckis, under these interpretations, the Levine “clear evidence” standard is “clear as mud.” We complained, “This exercise in wavy line-drawing is but one more illustration of the folly that Levine permits in the name of “clear evidence.” The [so-called] “fact-specific” application of the [Levine] standard continues to mean that conflict preemption bows to the whims of courts, especially where the injuries are sufficiently compelling. The FDCA applies exactly the same standard of scientific evidence to Citizens’ Petitions as it does to submissions from manufacturers, so the Reckis argument assumes that the FDA will act illegally.

End of current rant.

And so a good and correct decision is marred by an entirely unnecessary – and entirely illogical – preemption discussion. We remain confounded by this, and continue to hope that some court, somewhere, will take on Reckis and reach the correct conclusion about its reasoning. (We had hoped that SCOTUS might be that court, but it denied certiorari, Johnson & Johnson v. Reckis, 136 S.Ct. 896 (2016)). We will keep hoping, and we will keep you posted.