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It seems so obvious as not to require a citation – but this is the Drug and Device Law Blog, so we’ll provide some anyway.

Furnishing an adequate warning satisfies a product manufacturer’s duty to warn.

Thus, in a prescription medical product case, “if the manufacturer provides complete, accurate, and appropriate warnings about the product to the learned intermediary, it fulfills its duty to warn the consumer.”  Watts v. Medicis Pharmaceutical Corp., 365 P.3d 944, 949 (Ariz. 2016).  “[P]roviding an adequate warning to the prescribing physician relieves the manufacturer of its duty to warn the patient regardless of how or if the physician warns the patient.”  Larkin v. Pfizer, Inc., 153 S.W.3d 758, 765 (Ky. 2004).  Or, as Bexis puts it in his book, “Once a warning is adequate, the manufacturer has . . . no legal requirement [to] tell a physician more.”  Drug & Medical Device Product Liability Deskbook, §2.04[2], at 2.04-67 (LJP updated 2018).

Bexis’ book, of course, collects citations from all over the country.  Here are just some of those greatest hits.  Virginia − Pfizer, Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980) (“[w]e do not think that the duty of the defendant extended to explaining exactly how the danger against which he had been warned might operate”) (citation and quotation marks omitted).  Ohio − Kennedy v. Merck & Co., 2003 WL 21658613, at *5 (Ohio App. July 3, 2003) (“there exists no requirement that [defendant] give any warnings for [its drug] to the consumer if the warnings provided to the physician are adequate”).  Louisiana − Brown v. Glaxo, Inc., 790 So.2d 35, 39-40 (La. App. 2000) (“We are not concerned with what [defendant] could have included in the warning.  The test is adequacy.”).  Illinois − Pluto v. Searle Laboratories, 690 N.E.2d 619, 622 (Ill. App. 1997) (“[defendant] had no duty to warn women in the suspect category that use of the [device] may result in an increased risk of infection because it is not [defendant’s] product which causes infection, rather, it is the lifestyle choice of persons in the suspect category”).  Michigan − Nichols v. Clare Community Hospital, 476 N.W.2d 493, 495 (Mich. App. 1991) (“A manufacturer fulfills its duty to the medical community when it warns of the risk inherent in use of the drug.  There is no requirement that the warning apprise the doctor of how to properly diagnose the condition that renders use dangerous.”).  Kansas − Wright v. Abbott Laboratories, Inc., 259 F.3d 1226, 1233 (10th Cir. 2001) (having adequately warned of all “dangers caused by drug use,” manufacturer “was required to do no more”; no further duty to warn about product “storage-related problems”).  Florida −  Christopher v. Cutter Laboratories, 53 F.3d 1184, 1193 (11th Cir. 1995) (error to “forc[e] [defendant] to prove that [the prescriber] had a level of knowledge greater than that disclosed by the warning” the adequacy of which was unchallenged).  California −  Chao v. Smith & Nephew, Inc., 2013 WL 6157587, at *4 (S.D. Cal. Oct. 22, 2013) (“Plaintiffs have cited no legal authority . . . for the proposition that a [product] manufacturer owes a duty, beyond providing a warning, to dissuade a physician from using [the product] on a particular patient”).  Minnesota −  Kapps v. Biosense Webster, Inc., 813 F. Supp.2d 1128, 1153 (D. Minn. 2011) (“[a] manufacturer does not have a duty to communicate any and all information that might affect a customer’s decision to use one of its products”; unnecessary to warn that device reprocessing may not have been FDA approved).

This obvious proposition that an adequate warning is enough in a warning case is also the law in Pennsylvania.  “[I]n an action against a drug manufacturer based upon inadequate warnings, the issue to be determined is whether the warning, if any, that was given to the prescribing physicians was proper and adequate.”  Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909, 924 (Pa. Super. 2011) (quoting Taurino v. Ellen, 579 A.2d 925, 927 (Pa. Super. 1990)).

In Demmler v. SmithKline Beecham Corp., 671 A.2d 1151, 1155 (Pa. Super. 1996), the defendant “specifically warned of the hazard of hypertensive crises associated with [the drug] and suffered by [plaintiff].”  Id. at 1155.  That was enough.  The law imposed no duty to do more and include other “helpful information” about how to treat the warned-of adverse reaction.

[Plaintiff’s] expert opinion, even if wholly credited, however, does not evidence that [defendant’s] instructions or warnings to the medical community concerning [the drug] and its side effects were inadequate.  [Plaintiff’s expert] merely points out that [defendant] had the opportunity, but not the obligation, to include helpful information about [a drug that treated hypertensive crisis] when warning physicians about [the drug].  Accordingly, the record supports no basis upon which a reasonable jury could impose liability on [defendant] based on the alleged defect in the [drug’s] warning supplied to prescribing doctors.


Likewise, in Salvio v. Amgen, Inc., 2012 WL 517446, at *5-6 (W.D. Pa. Feb. 15, 2012), the defendant warned in bold print about “serious infections . . . including fatalities.”  There was thus no need to go further and specifically address “fungal” infections.

[T]he manufacturers of [the drug] issued a broad warning of the risk of infection and highlighted some specific risks. . . .  [Examples omitted]  Therefore, the Court finds that the [drug’s] Package Insert in effect when Decedent was prescribed the drug adequately warned doctors of the risk of serious infections, such as the one which allegedly led to Decedent’s death.

Id. at *6.  See Kline v. Zimmer Holdings, Inc., 2015 WL 4077495, at *25 (W.D. Pa. July 6, 2015) (“Plaintiffs point to no support for the contention that a defective warnings case can be based on information provided to a plaintiff’s treating physician other than via the official warning on the package.”); aff’d, 662 F. Appx. 121 (3d Cir. 2016); Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489, at *7 (M.D. Pa. Dec.2, 2013) (“The law does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians, who are in the best position to monitor and treat their patients and make medical judgments with respect to their care.”); Aaron v. Wyeth, 2010 WL 653984, at *8-9 (W.D. Pa. Feb. 19, 2010)  (“two (2) pages of suicide related warnings including an FDA mandated pediatric ‘black box’ warning” adequate as a matter of law; no need to warn separately about “potential suicidal ideation” in adults).

However, it looks like some Pennsylvania plaintiffs are giving this discredited liability theory a go.  In Zitney v. Wyeth, LLC, 2020 WL 499137, at *1 (Pa. C.P. Philadelphia Co. Jan. 9, 2020), the plaintiffs have “conceded the content of Defendants warnings was proper and adequate.”  Id. at *5.  Yet they still appeal from the court’s grant of summary judgment on their warning-related claims.  Why?

Plaintiffs argue Defendants . . . should have sent “Dear Healthcare Professional” letters to physicians, including [their prescriber], alerting those physicians of the [drug’s] labeling change.

Id. at *5.  They didn’t cite any case law – only a nine-year-old amicus brief (2011 WL 741927) filed in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), that merely argued that “this practice would not be prohibited by federal law.”  Zitney, 2020 WL 499137, at *4.

However, given that the warnings at issue were themselves concededly adequate, the availability of some other means of communication was beside the point:

Plaintiffs’ argument fails. . . .  Nothing in Pennsylvania law suggests that a drug manufacturer must convey those warnings in a manner other than by including them on the drug’s label.  Over the past 50 years, the Pennsylvania Supreme Court continuously suggested a drug manufacturer meets its obligation to include an appropriate warning with the drug at issue by providing the warnings in the drug’s label.  [String citation omitted]  Plaintiffs do not argue [defendants] distributed their [drug] without the FDA approved label. . . .  Accordingly, since [defendants] distributed their [drug] with labels containing warnings that Plaintiffs concede are sufficient, Defendants have fulfilled their duty to warn under Pennsylvania law.

Id. at *5.  What precedent do plaintiffs cite in support of their argument that drug manufacturers must do more than provide adequate warnings?  Zilch.  “Plaintiffs do not cite any precedent, binding or persuasive, to support their claim Pennsylvania law imposes such a duty.”  Id.

Should be a fun appeal.

Note:  the elephant in the room here is preemption.  Zitney is a generic drug case.  As our generic preemption scorecard demonstrates, just about every court ever to consider the plaintiffs’ “Dear Healthcare Provider Letter” argument has held it to be preempted.  Pennsylvania, however, is an extreme generic preemption outlier.  See In re Reglan/Metoclopramide Litigation, 81 A.3d 80, 94 (Pa. Super. 2013), which we discussed here.  But even if a theory of liability hypothetically escapes preemption, it must, of course, still state a cause of action under state law.  DHCP letter claims simply don’t, and that’s what is at issue in Zitney.