In a significant, albeit unpublished, decision, an intermediate appellate court in Pennsylvania has ruled that there is no recognized Pennsylvania common-law “duty” for prescription medical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

Although Czimmer v. Janssen Pharmaceuticals, Inc., 2014 WL 1335511 (Pa. C.P. Philadelphia Co. Jan. 2, 2014), was decided several months ago, we only became aware of it (because of our ongoing automatic searches) the other day.  While there are a number of grounds for feeling uneasy about what went on in Czimmer, we’re

Under the learned intermediary rule, for a warning claim to succeed, at a bare minimum the prescribing (or sometimes another) doctor at least has to read the allegedly defective warning.  After all, there’s a causation element to every warning claim – the defect (whatever’s allegedly wrong with the warning) has to cause the injury.  If the prescribing physician never even read the purportedly inadequate warning, none of those inadequacies could have affected his/her treatment of the patient.  This common-sense notion, that a warning that’s not read cannot be causal, has been bedrock law in prescription medical product liability litigation for decades:


In re Trasylol Products Liability Litigation, 2011 WL 2117257, at *5 (S.D.Fla. May 23, 2011) (applying Alabama law) (“no record evidence indicating that [the prescriber] read the warning that Plaintiff claims was inadequate”); Emody v. Medtronic, Inc., 238 F. Supp.2d 1291, 1293, 1296 (N.D. Ala. 2003) (prescriber “did not even read the package insert”; thus he “he did not rely on [defendant’s] warnings”).


Gebhardt v. Mentor Corp., 15 Fed. Appx. 540, 542 (9th Cir. 2001) (“evidence at trial showed that [the prescriber] did not read or rely upon the allegedly inadequate warnings of the [defendant’s] device”) (applying Arizona law).


Ramirez v. Plough, Inc., 863 P.2d 167, 177 (Cal. 1993) (where plaintiff “neither read nor obtained translation of the product labeling . . . there is no conceivable causal connection between the representations or omissions that accompanied the product”) (over-the-counter drug case; plaintiff did not read warning); Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299, 308, 318-319 (Cal. App. 2008) (“[t]here can be no proximate cause where, as in this case, the prescribing physician did not read or rely upon the allegedly inadequate warnings promulgated by a defendant about a product”); Lord v. Sigueiros, 2006 WL 1510408, at *3-4 (Cal. Super. April 26, 2006) (prescriber “admits that he had not read the [drug’s] label before prescribing it to the decedent”), aff’d, 2007 WL 4418019, at *4 (Cal. App. Dec. 19, 2007) (“evidence does not raise an issue of material fact regarding causation because [the prescriber] testified that he did not read the warning label prior to or after prescribing [the drug] to [plaintiff]”); Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“the doctor who prescribed [the drug] . . . failed to read [the defendant’s] published warnings before prescribing the drug.  Because the doctor testified that he did not read the warning label that accompanied [the drug] or rely on information provided by [the manufacturer’s] detail men before prescribing the drug to [plaintiff], the adequacy of [the] warnings is irrelevant”) (applying California law); Latiolais v. Merck & Co., 2007 WL 5861354, at *3 (C.D. Cal. Feb. 6, 2007) (the “inserts played no role in his decision to prescribe” because “[the prescriber] could not recall if he ever read the package insert”), aff’d, 302 Fed. Appx. 756 (9th Cir. 2008).

Continue Reading Dear Doctor Letters As The Next Warning Frontier – Kapps Vs. Winter