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19 November 2020
In a significant, albeit unpublished, decision, an intermediate appellate court in Pennsylvania has ruled that there is no recognized Pennsylvania common-law "duty" for prescription medical product manufacturers to send Dear Healthcare Provider ("DHCP", a/k/a "Dear Doctor") letters about label changes. Zitney v. Wyeth LLC, 2020 WL 6129173 (Pa. Super. Oct. 19, 2020).
Zitney arose in the context of litigation involving the plaintiff's ingestion of a generic drug. After PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), virtually all of the usual product liability claims against generics are preempted. One argument plaintiffs sometimes make in opposition to preemption is that communications by "other means" besides labeling are not preempted. This argument has not been very successful on its merits. "[W]e conclude that federal law did not permit the Manufacturers to issue additional warnings through Dear Doctor letters." Mensing, 564 U.S. at 615). Accord, e.g., Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1135 (8th Cir. 2014) (applying Missouri law); Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 611-12 (5th Cir. 2014) (applying Louisiana law); In re Darvocet, Darvon, and Propoxyphene Products Liability Litigation, 756 F.3d 917, 932-33 (6th Cir. 2014) (applying laws of 23 states); Lashley v. Pfizer, Inc., 750 F.3d 470, 474-75 (5th Cir. 2014) (applying Texas and Mississippi law); Strayhorn v. Wyeth Pharmaceuticals, Inc., 737 F.3d 378, 397-98 (6th Cir. 2013) (applying Tennessee law); Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249-50 (11th Cir. 2013) (applying Florida law); PLIVA, Inc. v. Dement, 780 S.E.2d 735, 740-41 & n.24 (Ga. App. 2015); Dietrich v. Actavis, Inc., 138 So.3d 1163, 1163 (Fla. App. 2014). These are only the appellate cases; see our generic preemption scorecard for a full list.
Still, without much else to work with, generic plaintiffs had little choice but to keep firing "Hail Mary" passes, especially in Pennsylvania, where dismissal of this type of claim as preempted had previously been reversed as "premature." In re Reglan/Metoclopramide Litigation, 81 A.3d 80, 95 (Pa. Super. 2013).
But before a plaintiff can argue that a state-law "failure to communicate in other ways" claim was not preempted, such a state-law claim first has to exist. Hence, the Zitney appeal, which was specifically crafted as a test case presenting this question on appeal. That is the reason, as the Superior Court pointed out, that plaintiffs did not challenge the substantive adequacy of the defendants labels (which would have been preempted) but only "the manner in which [defendants] notified [prescribing physicians] of the warnings." Zitney, 2020 WL 6129173, at *2; id. at *4.
Plaintiffs still lost. First, under controlling Pennsylvania law, "the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer's negligence, is the only recognized basis of liability." Id. at *3 (quoting Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996)). Second, "a pharmaceutical product, when accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." Id. (quoting Hahn quoting Restatement (Second) of Torts §402A, comment k (1965)). Third, the learned intermediary rule applies, meaning that the defendants "must direct required drug-safety warnings to physicians, and not to patients." Id. at *4 (citations omitted). Thus, once the defendants had sent a concededly adequate warning to prescribing physicians through the drug's labeling, there was no further common-law duty to do more, and repeat that warning by other means of communication:
[Plaintiffs] conceded the contents of [defendants'] warnings was proper and adequate. Accordingly, since [defendants] distributed their [product] with labels containing warnings that [plaintiffs] concede are sufficient, [defendants] have fulfilled their duty to warn under Pennsylvania law. . . . Pennsylvania law does not impose on drug manufacturers a duty to send DHCP letters to prescribing physicians. . . . Because Pennsylvania law does not impose upon [defendants] the heightened duty advocated by [plaintiffs], and because [plaintiffs] conceded that [defendants] fulfilled their duty to provide content-appropriate warning labels in their . . . packaging, the trial court properly found that [defendants] had not breached their duty to [plaintiffs].
Id. at *4 (citations and quotation marks omitted) (emphasis added).
We think that's the correct result. As Bexis has stated in his treatise, "[o]nce a warning is adequate, the manufacturer has fulfilled its duty, and there is no legal requirement for the manufacturer to tell a physician more." Beck & Vale, "Drug and Medical Device Product Liability Deskbook," 2.04 (ALM, updated 2020) (footnotes and quotation marks omitted). For a complete collection of this precedent, see our previous discussion of Zitney, prior to the appeal, here.
For further information on this topic please contact James Beck at Reed Smith LLP by telephone (+1 215 851 8100) or email (firstname.lastname@example.org). The Reed Smith LLP website can be accessed at www.reedsmith.com.
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