It’s Delaware week here at the DDL Blog. A couple of days ago we brought you a particularly clear-minded order rejecting innovator liability in the First State (so nicknamed because Delaware was the first of the original 13 colonies to ratify the Constitution in 1787), and yesterday we reported on a pair of Delaware orders granting summary judgment in failure-to-warn cases on proximate causation.
Today we highlight another particularly clear-minded application of warning causation in Delaware, and this case has a twist—the product at issue was a generic drug, and the alleged basis for liability was the generic manufacturer’s alleged “failure to update” its label to match the innovator drug. In the end, however, none of that mattered because the prescribing physician did not read the label and had never heard of the generic company, which means that any “failure to update” could not possibly have made any difference.
The case is Boros v. Pfizer, Inc., No. N15C-04-029, 2019 WL 1558576 (Del. Superior Ct. Mar. 25, 2019), and here is how things played out. In February 2013, the FDA approved a stronger warning about QT interval prolongation for the innovator version of a common antibiotic. The agency later requested that the defendant generic manufacturer update its label to match, and it published a Drug Safety Communication about the change. Id. at *1. The generic manufacturer complied, and the FDA approved its updated label three months later. Id. at *2.
In the meantime, the patient at issue was prescribed the antibiotic, and the pharmacy dispensed the Defendant’s generic version. The next day, the patient died. Id. at *1. Because he was prescribed the drug after the innovator changed its label, but before the generic defendant—the manufacturer that actually made and sold the drug the patient allegedly ingested—updated its label to match, the plaintiffs claimed that a “failure to update” caused the decedent’s death. Id. at *2.
We have expressed our opinion on “failure to update” claims. We don’t think much of them. We don’t, however, need to get into all that today because the Delaware court granted summary judgment on warning causation. The following facts are all you really need to know:
The parties do not dispute that [the prescribing physician] does not recall ever reviewing a package insert for [Defendant’s] generic azithromycin or for any other [Defendant] produced drug. [He] has never spoken to or had any written communications with any [Defendant] representative. [He] has never heard of [Defendant].
Id. at *2. That’s right. The prescriber did not read the label, never communicated with the Defendant, and never heard of the Defendant. On those undisputed facts, it was a short way to holding that a “failure to update” the generic label did not cause any harm:
[The prescribing physician’s] failure to review the package insert prevents the Plaintiffs from establishing that the warnings in [the] package insert proximately caused the Decedent’s death.
Id. at *3. Like other plaintiffs in similar situations, the Plaintiffs tried to get around this stark inability to prove their case. First, they emphasized the prescriber’s testimony that if he had seen additional warnings, he would have changed his prescribing practices. This is a version of the “Doctor, wouldn’t you have like to have known” testimony that plaintiffs’ lawyers commonly elicit, usually with an affirmative response. After all, what doctor will deny that he or she would “liked to have known” additional information about drugs they prescribe? Be that as it may, the testimony did not prevent summary judgment in this case because the facts were so clear—the doctor never reviewed or received any information from the Defendant. Under those circumstances there is simply no way that “updated” information would have had any impact on the decision to prescribe the drug. Id. at *4.
Second, the Plaintiffs argued that the learned intermediary doctrine may be “eroded or even nullified by over promotion of the drug.” But even if there is an “over-promotion” exception to the learned intermediary doctrine—and Delaware does not have one—it would not apply here because the prescriber never interacted with the Defendant. Id. at *5.
Third, the plaintiff argued that the learned intermediary doctrine did not apply because the decedent was himself a medical professional and not a “lay person.” That is a new one on us, and we have never seen any authority that a “learned patient” negates a “learned intermediary.” Neither had the plaintiffs, nor the Delaware court. Id.
Finally, the Plaintiffs argued that the Defendant should have sent a Dear Doctor Letter about the strengthened warning to all physicians. For one thing, since the FDA had already sent a Drug Safety Communication on this topic, we are not sure what difference a Dear Doctor Letter would have made. Regardless, the court rejected this argument because the Plaintiffs did not plead it, and they raised the alleged failure to send a Letter for the first time at the summary judgment hearing. Id. at *5. Moreover, on the merits, because federal law prohibits generic drug manufacturers from sending Dear Doctor Letters unilaterally, any claim based on the failure to send a Letter was preempted under Pliva v. Mensing. Id. at *6.
It would be tempting to think that warnings-based orders like this have little impact on “failure to update” claims generally, but that would be a mistake. Failure to read as a basis for negating warning causation is well-established nationwide, as our post here demonstrates. Significantly, Boros is the first Delaware law decision to address this variant of warning causation. Moreover, because generic manufacturers do not typically promote their products or otherwise communicate directly with doctors, and because physicians commonly do not read package inserts, the exceptionally clear facts of this case are likely to recur. The Delaware court’s treatment of the law and evidence was right on the money, and other courts would be wise to follow. Hats off to Delaware.