A year and a half ago we celebrated a rare prescription drug preemption win in the Philadelphia County Court of Common Pleas. Then the decision was appealed, and we held our breath. Preemption is never an easy sell in state courts, and Pennsylvania appellate courts are not exactly defendant friendly in prescription medical product liability cases.
Well, the wait is over and preemption won. See Caltagirone v. Cephalon, Inc., 190 A.3d 596 (Pa. Super. 2018), allocatur denied, No. 248 EAL 2018 (Pa. Oct. 16, 2018). We held off blogging even after the published Pa. Superior Court win, because we didn’t want to jinx anything.
Here’s what went down.
As we described before, the plaintiff had no basis for saying that anything about the drug in question (a strong opioid) was defective. As the court pointed out, the purported wrongful death in Caltagirone was 2½ years after use of the drug at issue had ceased. 190 A.3d at 598 (plaintiff’s physician “stopped prescribing [the drug] for Mr. Caltagirone and moved him to other opioids. About two and a half years later, on May 15, 2014, Mr. Caltagirone died.”). Probably because the drug that killed the plaintiff’s decedent was a generic (that’s a guess on our part, but methadone has been around a long time), plaintiff nonetheless sued the manufacturer of this branded drug despite the 18-month gap. “The overarching theme of the complaint is that even though Mr. Caltagirone died from methadone toxicity. . ., his underlying addiction was proximately caused by [defendant’s] program of promoting [the branded drug] for non-FDA approved pain management.” Id.
In other words, rather than alleging any sort of traditional product liability “defect,” plaintiff attacked the drug because of alleged off-label promotion and off-label use – the decedent had been prescribed the drug for “migraine headaches.” Id. at 597.
However, the defendant’s labeling forcefully warned about the drug’s addictive potential:
[The drug] carries a “Black Box” warning label, (the most serious type of FDA warning, named for the required distinctive black perimeter), advising of the risk of serious adverse health consequences from the use of [the drug], including respiratory depression, addiction, and death. The Black Box label warns against the use of [the drug] for any condition other than cancer pain, including, specifically, migraine headaches.
Id. at 597-98. Thus, the plaintiff’s arguments on appeal focused largely on the alleged off-label promotion of the drug – that it supposedly violated the much–discussed FDA ban on any promotion, truthful or not, of off-label uses of regulated products.
The Superior Court recognized that claim for what it was – an attempt at private enforcement of the FDA’s off-label promotion ban – facially preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001):
[Plaintiff’s] pleadings are legally insufficient. . . . [T]he pervasive claim of [the] complaint is that [defendant’s] various derelictions, (principally, promoting sales for off-label purposes), were not approved or were in direct violation of the FDCA or its implementing regulations.
However, with narrow exceptions not asserted and not applicable here, the general rule is that there is no private right to enforce the law and regulations of the FDCA. [citing 21 U.S.C. §337(a) and Buckman]
Because [Plaintiff’s] claims rely on asserted violations of the FDA’s “off-label” restrictions, which are pre-empted, the trial court properly sustained [defendant’s] preliminary objections.
Id. at 599-600.
Plaintiff appealed again, to the Pennsylvania Supreme Court, but on October 16, that court rejected the appeal. We could stop holding our breath.
So we have another win for Buckman, this time against a plaintiff hell-bent on suing the manufacturer of a drug that didn’t in fact cause the complained-of injuries. Once and for all, “off-label promotion” alone can’t be the basis of a state-law tort claim.