D R U G A N D M E D I C A L D E V I C EHow Do I Warn <strong>The</strong>e?Let Me Count the WaysBy Eric A. PaineConsumer-DirectedPharmaceuticalWarningsEffectively presentingthe myriad warningsthat were provideddirectly to a plaintiffmay make the differencein a pharmaceuticalproduct liability case.Under the learned intermediary doctrine in effect in manyjurisdictions, a manufacturer of a prescription drug has aduty to provide an adequate warning of the risks associatedwith that manufacturer’s drug to a prescribingphysician. <strong>The</strong> learned intermediary doctrineis an exception to the general productliability rule that requires a manufacturerto warn the ultimate user directly.Regardless of the learned intermediarydoctrine’s focus on the warning provided toa physician, as a practical matter, the mantra,“I would never have taken this drugif I had known there was a risk,” can turna case into an issue about whether a consumerwas effectively warned. Whether aplaintiff received a warning may be legallyirrelevant under the learned intermediarydoctrine; however, ask yourself, howmany jurors will likely ignore that plaintiff’stestimony?As a practical matter, consumers ofprescription medications receive myriadwarnings from different sources regardingthe risks associated with their medications.<strong>The</strong>se sources could reasonably be expectedto result in well- informed consumers whomake considered decisions about the risksand benefits of the drugs that they take. Asmentioned in a recent FDA report, “Whena person decides to use a medication, heor she is agreeing to take certain risks.”See Safe Use Initiative, U.S. Food & DrugAdmin., FDA’s Safe Use Initiative: Collaboratingto Reduce Preventable Harm fromMedications 4 (Nov. 4, 2009). In litigation,appropriately emphasizing the risk informationprovided to a patient may make jurorsless willing to reward a plaintiff whoclaims that he or she had no idea that riskswere associated with his or her medication.But even if a patient directly receiveswarning of the risks associated with a prescriptionmedication, the legal effect of thewarning remains unsettled in today’s productliability jurisprudence.This article will address juridical attitudestoward consumer- directed pharmaceuticalwarnings in relation to the learnedintermediary doctrine. It will then exploresome of the current ways that patientsreceive information about the health risksassociated with prescription medications.■ Eric A. Paine, a Nelson Mullins Riley & Scarborough LLP partner, practicesproduct liability and business litigation. Mr. Paine’s work focuses onthe defense of pharmaceutical and medical device cases with emphasis onscientific and medical causation issues. He is a member of <strong>DRI</strong>’s Drug andMedical Device Steering Committee and the Trial Tactics Committee.Consumer-DirectedWarnings in the CourtsSurprisingly few published opinions haveaddressed consumer- directed warnings inrelation to the learned intermediary doctrine.<strong>The</strong>re is no clear consensus among38 n <strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong>
courts that have taken up whether the doctrineinsulates drug manufacturers fromliability.One school of thought considers thelearned intermediary doctrine and warningsdirected to consumers as inherentlyinimical and that the advent of consumerwarnings on prescription medications aswarranting abolishing the learned intermediarydoctrine. <strong>The</strong> allegedly pervasiveinfluence of direct- to- consumer advertisinghas undermined the doctrine in somestates. See, e.g., Perez v. Wyeth, 734 A.2d1245 (N.J. 1999); Centocor, Inc. v. Hamilton,<strong>2010</strong> Tex. App. LEXIS 1623 (Tex.App. Mar. 4, <strong>2010</strong>). West Virginia has outrightrejected it. State of West Virginiaex rel Johnson & Johnson Corp. v. Karl,647 S.E.2d 899 (W.Va. 2007). Those infavor of abrogating the learned intermediarydoctrine typically claim that the doctrineis an anachronism that reflects thepaternalistic “doctor knows best” relationshipthat prevailed when the doctrine wasfirst articulated. Similarly, they emphasizethat patients have unprecedented access tomedical information today and are nowgreatly empowered to make informed decisionsabout their own health care, whichfrees them from strict and unquestioningreliance on their physicians’ advice. Inaddition, they claim that cases holding thelearned intermediary doctrine inapplicableto prescription oral contraceptives andmass vaccinations provide analogous precedentfor the inapplicability of the doctrinein other instances if warnings have beenprovided directly to patients.Relying on the underpinnings oforal contraceptive cases, the OklahomaSupreme Court in Edwards v. Basel Pharmaceuticals,933 P.2d 298 (Okla. 1997), heldthat the learned intermediary doctrine didnot automatically protect a manufacturerfrom liability when the FDA required amanufacturer to provide a warning directlyto patients. Note that in Edwards, the decedentsmoked cigarettes while wearing twonicotine patches, the professional labelingstated that an overdose of the product couldbe lethal, but the patient insert stated thatan “overdose might cause you to faint.” Id.at 299.While there is some validity to observationsregarding the evolving nature of thepatient- physician relationship, it hardlycompels the conclusion that we should discardthe learned intermediary doctrine.Prescription pharmaceuticals are, afterall, still available to patients only withprescriptions from licensed health careproviders. Even Internet savvy medicalmavens still lack the training, experience,and judgment to diagnose their own maladiesand to identify appropriate treatment,risks, and benefits.Even if an independent duty arises fromFDA- mandated, direct- to- consumer warnings,the more reasoned conclusion is thatthe learned intermediary doctrine andconsumer- directed warnings can peacefullycoexist and provide independentdefenses for pharmaceutical manufacturersdefending failure- to- warn claims.When warnings are provided directly toconsumers, why shouldn’t manufacturershave independent opportunities to avoidliability based on either of two or morewarnings advising patients about drugrisks?Rush v. Wyeth, 514 F.3d 825 (8th Cir.2008), represents a step in the right direction.In Rush, the plaintiff admittedreceiving patient package inserts with hermedication, but she testified that she didnot read them. <strong>The</strong> Eighth Circuit agreedthat, under Arkansas law, the defendant,the manufacturer, was entitled to assumethat the plaintiff would exercise ordinarycare and, therefore, that she would read theinsert’s warnings. <strong>The</strong> Eighth Circuit thenheld that although an adequate warning toa patient’s physician can suffice to defeat afailure- to- warn claim, the doctrine doesnot preclude informing a patient directly.In other words, if a patient is independentlyaware of a drug’s risk, then the drugmanufacturer’s failure to warn adequatelyof the danger is irrelevant. <strong>The</strong> Eighth Circuitin Rush concluded that the trial courtproperly instructed the jury to find for thedefendant if the plaintiff was aware of thedrug’s risks before the diagnosis of herinjury. Rush recognized that warning consumersdirectly, in addition physicians, isconsistent with underlying principles oftort law and not antithetical to the learnedintermediary doctrine.Sources of Direct-to-Consumer WarningsBegin planning your trial cross-examination of a plaintiff and identifyingthe evidence that you will need to demonstratethat he or she received an effectivewarning of the risks associated with a drugearly in your case. Generally speaking,aside from the risk information providedby a prescribing health care professional,warnings about the risks associated witha prescription drug potentially may reacha patient through four broad categories ofpatient- directed information.Patient Package InsertsPatient package inserts, sometimes abbreviatedas “PPIs,” are FDA- approved, consumerfriendly adjuncts to the approvedprofessional labeling for certain prescriptiondrugs. <strong>The</strong> FDA requires patientpackage inserts only for a few drugs. <strong>For</strong>instance, 21 C.F.R. §310.501 sets forth therequirements for patient package insertsaccompanying oral contraceptives, as does21 C.F.R. §310.515 for estrogen- containingmedications. Among other things, a patientpackage insert for an oral contraceptivemust contain a boxed warning, a discussionof the drug’s contraindications, astatement of the risks and benefits associatedwith the drug, and a list of potentialadverse reactions. <strong>For</strong> other drugs, thecontent of a patient package insert variesaccording to the drug and its risks. Butpatient package inserts commonly discusswhat the drug is, how it works, who shouldnot take the drug, and possibly or reasonablyanticipated side effects.Although patient package inserts arerarely required, a manufacturer may voluntarilysubmit one for FDA approval. Severaldrugs currently reach consumers accompaniedby FDA- approved patient packageinserts, including, for example, certainantibiotics, retinoids, and chemotherapeuticagents.As the name implies, a patient packageinsert is usually included in the actualpackaging intended for the consumer. Thisliterally puts risk information and warningsin a patient’s hands every time a patientfills a prescription. If a patient opens a drugpackage to take the drug, the patient can inno way avoid the insert. <strong>The</strong> more a patientrefills a prescription, the more times he orshe will receive a warning!Although they cover some of the sametopics, a patient package insert tends to<strong>For</strong> <strong>The</strong> <strong>Defense</strong> n <strong>October</strong> <strong>2010</strong> n 39
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