Supreme Court of Appeals ofWest Virginia.

STATE EX REL. JOHNSON & JOHNSONCORPORATION, a Foreign Corporation, and Janssen

Pharmaceutica, Inc., a Foreign Corporation and aWholly-Owned Subsidiary of

Johnson & Johnson, Inc., Petitioners,v.

The Honorable Mark A. KARL, Judge of the CircuitCourt of Marshall County,

Daniel W. Wilson, M.D., and Estate of Nancy J.Gellner, by Gregory A. Gellner,

Executor, Respondents.No. 33211.

Submitted Jan. 23, 2007.Decided June 27, 2007.

Concurring Opinion of Justice Starcher June 29, 2007.

Background: Estate of deceased patient broughtproducts liability action against prescription drugmanufacturer for failure to provide adequate warnings.The Circuit, Marshall County, Mark A. Karl, J., deniedmanufacturer's motion to exclude evidence suggestingthat manufacturer had a duty to provide warning topatient personally. Drug manufacturer filed petition forwrit of prohibition.

Holding: The Supreme Court of Appeals, Davis, C.J.,held that as a matter of first impression, the learnedintermediary doctrine would not be adopted to excuseprescription drug manufacturers from the general dutyof manufacturers to warn consumers about the risks oftheir products.Writ denied.

Albright, J., dissented and filed opinion, in whichBenjamin, J., joined.

Maynard, J., concurred and filed opinion.

Starcher, J., concurred and filed opinion.

West Headnotes

[1] Prohibition 9314k9 Most Cited CasesWhen asked to prevent, by writ of prohibition, a lowercourt from enforcing an order it has entered, theSupreme Court of Appeals reviews the order todetermine whether the lower court has committed errorby so ruling; for an award of the extraordinary remedyof prohibition to be proper in a particular case, however,the allegedly improper actions of the lower court mustconstitute more than a simple abuse of discretion.West's Ann.W.Va.Code, 53-1-1.

[2] Prohibition 3(2)314k3(2) Most Cited Cases

[2] Prohibition 11314k11 Most Cited CasesIn determining whether to entertain and issue writ ofprohibition for cases not involving an absence ofjurisdiction but only where it is claimed that the lowertribunal exceeded its legitimate powers, Supreme Courtof Appeals will examine five factors: (1) whether theparty seeking the writ has no other adequate means,such as direct appeal, to obtain the desired relief; (2)whether the petitioner will be damaged or prejudiced ina way that is not correctable on appeal; (3) whether thelower tribunal's order is clearly erroneous as a matter oflaw; (4) whether the lower tribunal's order is an oftrepeated error or manifests persistent disregard foreither procedural or substantive law; and (5) whetherthe lower tribunal's order raises new and importantproblems or issues of law of first impression. West'sAnn.W.Va.Code, 53-1-1.

[3] Prohibition 11314k11 Most Cited CasesExistence of a clear error as a matter of law should begiven substantial weight in a determination of whether adiscretionary writ of prohibition should issue. West'sAnn.W.Va.Code, 53-1-1.

[4] Products Liability 46.2313Ak46.2 Most Cited CasesLearned intermediary doctrine would not be adopted toexcuse prescription drug manufacturers from the

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general duty of manufacturers to warn consumers aboutthe risks of their products.

[5] Courts 97(6)106k97(6) Most Cited CasesWhile federal court opinions applying West Virginialaw are often viewed persuasively, the Supreme Courtof Appeals is not bound by those opinions.

*900 Syllabus by the Court1. " 'A writ of prohibition will not issue to prevent asimple abuse of discretion by a trial court. It will onlyissue where the trial court has no jurisdiction or havingsuch jurisdiction exceeds its legitimate powers. W.Va.Code, 53-1-1.' Syllabus point 2, State ex rel.Peacher v. Sencindiver, 160 W.Va. 314, 233 S.E.2d 425(1977)." Syllabus point 1, State ex rel. Caton v.Sanders, 215 W.Va. 755, 601 S.E.2d 75 (2004).

2. " 'In determining whether to entertain and issue thewrit of prohibition for cases not involving an absence ofjurisdiction but only where it is claimed that the lowertribunal exceeded its legitimate powers, this Court willexamine five factors: (1) whether the party seeking thewrit has no other adequate means, such as direct appeal,to obtain the desired relief; (2) whether the petitionerwill be damaged or prejudiced in a way that is notcorrectable on appeal; (3) whether the lower tribunal'sorder is clearly erroneous as a matter of law; (4)whether the lower tribunal's order is an oft repeatederror or manifests persistent disregard for eitherprocedural or substantive law; and (5) whether thelower tribunal's order raises new and importantproblems or issues of law of first impression. Thesefactors are general guidelines that serve as a usefulstarting point for determining whether a discretionarywrit of prohibition should issue. Although all fivefactors need not be satisfied, it is clear that the thirdfactor, the existence of clear error as a matter of law,should be given substantial weight.' Syllabus point 4,State ex rel. Hoover v. Berger, 199 W.Va. 12, 483S.E.2d 12 (1996)." Syllabus point 2, State ex rel. Catonv. Sanders, 215 W.Va. 755, 601 S.E.2d 75 (2004).

3. Under West Virginia products liability law,manufacturers of prescription drugs are subject to thesame duty to warn consumers about the risks of theirproducts as other manufacturers. We decline to adopt

the learned intermediary exception to this general rule.

Stephen B. Farmer, G. Kenneth Robertson, Farmer,Cline & Campbell, PLLC, Charleston, for thePetitioners.

Robert P. Fitzsimmons, Fitzsimmons Law Offices,Gregory A. Gellner, Gellner Law Offices, Wheeling, forthe Respondent, Estate of Nancy J. Gellner.

D.C. Offutt, Jr., Stephen S. Burchett, Jody M. Offutt,Randall L. Saunders, Offutt, Fisher & Nord,Huntington, Patrick S. Casey, Burns, White & Hickton,Wheeling, for the Respondent, Daniel W. Wilson, M.D.

DAVIS, Chief Justice:

In this action invoking the original jurisdiction of thisCourt in prohibition, a drug manufacturer asks thisCourt to adopt the learned intermediary doctrine as anexception to the general duty of manufacturers to warnconsumers of the dangerous propensities *901 of theirproducts. [FN1] After thorough consideration of thelearned intermediary doctrine in light of the currentstate of the prescription drug industry and physician/patient relationships, we decline to adopt this doctrine.Accordingly, the requested writ of prohibition is denied.

FN1. Under the learned intermediary doctrine,"a drug 'manufacturer is excused from warningeach patient who receives the product when themanufacturer properly warns the prescribingphysician of the product's dangers.' " In reNorplant Contraceptive Prods. Liab. Litig.,215 F.Supp.2d 795, 803 (E.D.Tex.2002) (citingPorterfield v. Ethicon, Inc., 183 F.3d 464,467-68 (5th Cir.1999)) (additional citationomitted).

I.FACTUAL AND PROCEDURAL HISTORY

This case is before this Court on a petition for writ ofprohibition. Accordingly, the facts have not beenconclusively determined below. Nevertheless, it appearsto be undisputed that on May 19, 1999, Mrs. Nancy J.Gellner was prescribed the drug Propulsid® [FN2] byher primary care physician, Daniel J. Wilson, M.D., arespondent to this proceeding (hereinafter referred to as

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"Dr. Wilson"). Petitioner Janssen Pharmaceutica, Inc.,is a wholly-owned subsidiary of petitioner Johnson &Johnson, Corporation (hereinafter collectively referredto as "Janssen"). Propulsid® was manufactured anddistributed by Janssen. In addition to prescribingPropulsid®, Dr. Wilson also provided Mrs. Gellner withsamples of the prescription drug, which samples hadbeen provided to Dr. Wilson by representatives ofJanssen. Mrs. Gellner died suddenly on the third dayafter she began taking Propulsid®. [FN3]

FN2. Propulsid® is the brand name for thedrug cisapride.

FN3. Janssen contends that the evidence willshow that Propulsid® should not have beenprescribed to Mrs. Gellner due to variousmedical conditions from which she sufferedand due to other medications she was taking.Additionally, Janssen avers that it will be ableto establish at trial that it provided adequatewarnings to Dr. Wilson. Dr. Wilson, on theother hand, expects to establish that Janssen'swarnings to physicians, as well as toconsumers, were not adequate.

On May 17, 2001, Mrs. Gellner's estate (hereinafterreferred to as "the Estate"), a respondent herein, filed aproducts liability/medical malpractice action againstJanssen and Dr. Wilson in the Circuit Court of MarshallCounty, West Virginia. [FN4] On August 26, 2004,Janssen filed a motion for summary judgment assertingthat, under the learned intermediary doctrine, it hadfulfilled its duty to warn by providing warningsregarding Propulsid® to Dr. Wilson. Apparently, thecircuit court orally denied the motion for summaryjudgment on March 28, 2005, on the ground thatdisputed questions of fact remained pending in the case.[FN5] Thereafter, Janssen, again relying on the learnedintermediary doctrine, filed a motion in limine toexclude evidence or argument by the Estate suggestingthat Janssen had a duty to provide any warningsregarding Propulsid® to Mrs. Gellner personally.Observing that this Court has not recognized thedoctrine of the learned intermediary, the circuit courtdenied Janssen's motion by order entered on June 13,2006. Janssen filed a petition for writ of prohibition in

this Court seeking to prohibit enforcement of the circuitcourt's June 13, 2006, order. On October 26, 2006, thisCourt granted a rule to show cause. We now deny thewrit.

FN4. The Estate has asserted various claimsagainst Janssen, which include strict liability,breach of express warranty, breach of impliedwarranty, a statutory claim of deceptivepractices, and negligence, as well as anadditional claim of negligence against Dr.Wilson.

FN5. No subsequent written order was filed.

II.STANDARD OF REVIEW

[1] This case is before this Court upon Janssen's petitionfor a writ of prohibition. When asked to prevent a lowercourt from enforcing an order it has entered, this Courtreviews the order to determine whether the lower courthas committed error by so ruling. For an award of theextraordinary remedy of prohibition to be proper in aparticular case, however, the allegedly improper actionsof the lower court must constitute more than a simpleabuse of discretion. " 'A writ of prohibition *902 willnot issue to prevent a simple abuse of discretion by atrial court. It will only issue where the trial court has nojurisdiction or having such jurisdiction exceeds itslegitimate powers. W. Va.Code, 53-1-1.' Syllabus point2, State ex rel. Peacher v. Sencindiver, 160 W.Va. 314,233 S.E.2d 425 (1977)." Syl. pt. 1, State ex rel. Caton v.Sanders, 215 W.Va. 755, 601 S.E.2d 75 (2004).

[2][3] The parties to this proceeding do not claim thatthe lower court lacked jurisdiction when it entered itsorder of June 13, 2006. Rather, Janssen contends thatthe lower court exceeded its legitimate powers byrefusing to apply the learned intermediary doctrine torule in its favor. When it is claimed that the lower courthas acted beyond its legitimate powers, we considermany factors to ascertain whether grantingextraordinary relief through prohibition is warranted.

"In determining whether to entertain and issue thewrit of prohibition for cases not involving an absenceof jurisdiction but only where it is claimed that thelower tribunal exceeded its legitimate powers, this

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Court will examine five factors: (1) whether the partyseeking the writ has no other adequate means, such asdirect appeal, to obtain the desired relief; (2) whetherthe petitioner will be damaged or prejudiced in a waythat is not correctable on appeal; (3) whether thelower tribunal's order is clearly erroneous as a matterof law; (4) whether the lower tribunal's order is an oftrepeated error or manifests persistent disregard foreither procedural or substantive law; and (5) whetherthe lower tribunal's order raises new and importantproblems or issues of law of first impression. Thesefactors are general guidelines that serve as a usefulstarting point for determining whether a discretionarywrit of prohibition should issue. Although all fivefactors need not be satisfied, it is clear that the thirdfactor, the existence of clear error as a matter of law,should be given substantial weight." Syllabus point 4,State ex rel. Hoover v. Berger, 199 W.Va. 12, 483S.E.2d 12 (1996).

Syl. pt. 2, State ex rel. Caton v. Sanders, 215 W.Va.755, 601 S.E.2d 75. See also Syl. pt. 3, id., (" 'Indetermining whether to grant a rule to show cause inprohibition when a court is not acting in excess of itsjurisdiction, this Court will look to the adequacy ofother available remedies such as appeal and to the over-all economy of effort and money among litigants,lawyers and courts; however, this Court will useprohibition in this discretionary way to correct onlysubstantial, clear-cut, legal errors plainly incontravention of a clear statutory, constitutional, orcommon law mandate which may be resolvedindependently of any disputed facts and only in caseswhere there is a high probability that the trial will becompletely reversed if the error is not corrected inadvance.' Syllabus point 1, Hinkle v. Black, 164 W.Va.112, 262 S.E.2d 744 (1979)."). We will now proceed toapply this standard to review the lower court's ruling.

III.DISCUSSION

[4] The issue raised in this original jurisdiction action isone of first impression. In order to decide whetherprohibition should lie in this case to prohibit the circuitcourt from refusing to apply the learned intermediarydoctrine, we must examine that doctrine and determinewhether it should be adopted into the common law ofWest Virginia.

"The learned intermediary doctrine provides anexception to the general rule imposing a duty onmanufacturers to warn consumers about the risks oftheir products." In re Norplant Contraceptive Prods.Liab. Litig., 215 F.Supp.2d 795, 803 (E.D.Tex.2002)(citing Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5thCir.1974); Sterling Drug, Inc. v. Cornish, 370 F.2d 82,85 (8th Cir.1966)).

The learned intermediary doctrine stands for theproposition that

a drug "manufacturer is excused from warning eachpatient who receives the product when themanufacturer properly warns the prescribingphysician of the product's dangers." See Porterfield v.Ethicon, Inc., 183 F.3d 464, 467-68 (5th Cir.1999)(citing *903Alm v. Aluminum Co. of America, 717S.W.2d 588, 591-92 (Tex.1986)). Hence, a drugmanufacturer's duty to warn consumers about thedangers of its prescription drugs extends only to theprescribing physician or healthcare provider, who actsas a "learned intermediary" between the manufacturerand the ultimate consumer and assumes responsibilityfor advising individual patients of the risks associatedwith the drug.

In re Norplant, 215 F.Supp.2d at 803 (additionalcitation omitted).

Some authorities have suggested that the number ofjurisdictions having adopted the doctrine is anoverwhelming majority, but those authorities haveeither included lower court decisions, or have includedjurisdictions where federal circuit courts applying statelaw have concluded that the doctrine would be adopted.See, e.g., In re Norplant, 215 F.Supp.2d at 806-09(including lower state court and federal circuit courtcases to conclude that forty-eight states, District ofColumbia and Puerto Rico have either applied orrecognized learned intermediary doctrine, and providingchart reflecting the same); Vitanza v. Upjohn Co., 257Conn. 365, 379 n. 11, 778 A.2d 829, 838 n. 11 (2001)(finding that forty-four jurisdictions have adoptedlearned intermediary doctrine, and including lower statecourts and federal courts applying state law in thatnumber); Larkin v. Pfizer, Inc., 153 S.W.3d 758, 768 n.4 and accompanying text (Ky.2004) (observing thatthirty-four states have specifically adopted learned

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intermediary doctrine, but relying on decisions of somelower state courts).

Our own research has yielded a markedly differentresult. Considering decisions of only the highest statecourts, we find that a mere twenty-one states haveexpressly adopted the learned intermediary doctrine.[FN6] *904 In one additional state, North Carolina, thedoctrine has been adopted by statute. See N.C. Gen.Stat.§ 99B-5(c) (1995). [FN7] Thus, the total number ofjurisdictions recognizing the learned intermediarydoctrine, either by decision of the highest court or bystatute, is only twenty-two.

FN6. See Stone v. Smith, Kline & French Labs.,447 So.2d 1301, 1303 (Ala.1984) (answeringaffirmatively certified question from UnitedStates Court of Appeals for Eleventh Circuitasking whether "adequate warning [from drugmanufacturer] to the prescribing physician, butnot to the ultimate consumer, [was] sufficientas a matter of law"); Shanks v. Upjohn Co., 835P.2d 1189, 1200 (Alaska 1992) ("Indetermining the adequacy of the warnings anddirections in the context of typical prescriptiondrugs, it is appropriate for the trier of fact toconsider that the warnings and directions weredirected to the prescribing physician rather thanto the patient." (footnote omitted)); West v.Searle & Co., 305 Ark. 33, 44, 806 S.W.2d608, 614 (1991) (concluding that "applicationof the learned intermediary rule is appropriatein the case of oral contraceptives"); Stevens v.Parke, Davis & Co., 9 Cal.3d 51, 65, 507 P.2d653, 661, 107 Cal.Rptr. 45, 53 (1973) ("In thecase of medical prescriptions, 'if adequatewarning of potential dangers of a drug has beengiven to doctors, there is no duty by the drugmanufacturer to insure that the warning reachesthe doctor's patient for whom the drug isprescribed." ' (citations omitted)); Vitanza v.Upjohn Co., 257 Conn. 365, 373, 778 A.2d829, 835 (2001) ("We conclude that:... thelearned intermediary doctrine is part of ourstate law ...."); Lacy v. G.D. Searle & Co. 567A.2d 398, 400 (Del.1989) (applying LID inprescription device context, but plainly stating

that it would apply in prescription drugcontext); Felix v. Hoffmann-LaRoche, Inc. 540So.2d 102, 104 (Fla.1989) (acknowledging that"it is clear that the manufacturer's duty to warnof Accutane's dangerous side effects wasdirected to the physician rather than thepatient.... This is so because the prescribingphysician, acting as a 'learned intermediary'between the manufacturer and the consumer,weighs the potential benefits against thedangers in deciding whether to recommend thedrug to meet the patient's needs." (internalcitations omitted)); McCombs v. Synthes, 277Ga. 252, 253, 587 S.E.2d 594, 595 (2003)(applying the doctrine in a medical devicecontext, but stating that "[u]nder the learnedintermediary doctrine, the manufacturer of aprescription drug or medical device does nothave a duty to warn the patient of the dangersinvolved with the product, but instead has aduty to warn the patient's doctor, who acts as alearned intermediary between the patient andthe manufacturer" (emphasis added)); Kirk v.Michael Reese Hosp. & Med. Ctr., 117 Ill.2d507, 519, 111 Ill.Dec. 944, 950, 513 N.E.2d387, 393 (1987) ("[W]e believe the learnedintermediary doctrine is applicable here andthat there is no duty on the part ofmanufacturers of prescription drugs to directlywarn patients."); Syl. pt. 5, in part, Humes v.Clinton, 246 Kan. 590, 792 P.2d 1032 (1990)("Manufacturers of prescription drugs have aduty to warn of dangerous side effects and risksassociated with the use of such drugs. Thelearned intermediary rule, however, relievesmanufacturers of the duty to warn patientsdirectly...."); Larkin v. Pfizer, Inc., 153 S.W.3d758, 770 (Ky.2004) (recognizing that "we nowadopt Restatement (Third) of Torts: ProductsLiability § 6(d) (duty to warn of possible sideeffects satisfied if adequate warning given topatient's health care provider, subject toexceptions)"); Wyeth Labs., Inc. v.Fortenberry, 530 So.2d 688, 691 (Miss.1988)("We hold that the drug manufacturer has aduty to adequately warn the prescribing

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physician of any known adverse effects whichmight result from use of its prescriptiondrugs.... The general rule is 'that whereprescription drugs are concerned, amanufacturer's duty to warn only extends tophysicians and not to laymen.' " (citationomitted)); Hill v. Squibb & Sons, E. R., 181Mont. 199, 206, 592 P.2d 1383, 1387-88(1979) ("As a general rule, the duty of a drugmanufacturer to warn of the dangers inherent ina prescription drug is satisfied if adequatewarning is given to the physician whoprescribes it."); Freeman v. Hoffman-La Roche,Inc., 260 Neb. 552, 571, 618 N.W.2d 827, 842(2000) ("We adopt § 6(d) of the ThirdRestatement. Accordingly, we apply thelearned intermediary doctrine to Freeman'scase."); Niemiera by Niemiera v. Schneider,114 N.J. 550, 559, 555 A.2d 1112, 1117 (1989)("In New Jersey, as elsewhere, we accept theproposition that a pharmaceutical manufacturergenerally discharges its duty to warn theultimate user of prescription drugs bysupplying physicians with information aboutthe drug's dangerous propensities.... Thisconcept is known as the 'learned intermediary'rule because the physician acts as theintermediary between the manufacturer and theconsumer." (internal citation omitted)); Martinv. Hacker, 83 N.Y.2d 1, 9, 628 N.E.2d 1308,1311, 607 N.Y.S.2d 598, 601 (1993)("Warnings for prescription drugs are intendedfor the physician, whose duty it is to balancethe risks against the benefits of various drugsand treatments and to prescribe them andsupervise their effects. The physician acts as an'informed intermediary'... between themanufacturer and the patient; and, thus, themanufacturer's duty to caution against a drug'sside effects is fulfilled by giving adequatewarning through the prescribing physician, notdirectly to the patient ...." (citations omitted));Syl. pt. 5, Seley v. G.D. Searle & Co., 67 OhioSt.2d 192, 423 N.E.2d 831 (1981) ("Amanufacturer of ethical drugs satisfies its dutyto warn of risks associated with use of@ the

product by providing adequate warnings to themedical profession and not to the ultimateuser."); McKee v. Moore, 648 P.2d 21, 25(Okla.1982) ("The manufacturer's duty to warnthe ultimate consumer of prescription drugs, ordevices, as distinguished from those solddirectly to the consumer, is limited to advisingthe prescribing or treating physician of thedrug's or device's potential dangers in theabsence of contrary FDA regulations. Once thephysician is warned, the choice of treatmentand the duty to explain the risk is incumbent onthe physician." (footnotes omitted)); Incollingov. Ewing, 444 Pa. 263, 288, 282 A.2d 206, 220(1971) ("Since the drug was available onlyupon prescription of a duly licensed physician,the warning required is not to the generalpublic or to the patient, but to the prescribingdoctor."), abrogated on other grounds byKaczkowski v. Bolubasz, 491 Pa. 561, 566, 421A.2d 1027, 1029 (1980), as recognized bySlaseman v. Myers, 309 Pa.Super. 537, 545 n.3, 455 A.2d 1213, 1218 n. 3 (1983); Pittman v.Upjohn Co., 890 S.W.2d 425, 431 (Tenn.1994)("The Upjohn Company's warnings andinstructions to prescribing physicians weresufficient to discharge its duty to those personsto whom it owed a duty to warn.").The Supreme Court of Oregon has adopted thelearned intermediary doctrine with respect tonegligence claims. See McEwen v. OrthoPharm. Corp., 270 Or. 375, 386-87, 528 P.2d522, 529 (1974) ("Although the duty of theethical drug manufacturer is to warn the doctor,rather than the patient, the manufacturer isdirectly liable to the patient for a breach ofsuch duty."). However, the Oregon Legislaturerejected its application in the context of strictliability. See Griffith v. Blatt, 334 Or. 456, 467,51 P.3d 1256, 1262 (2002) ("Neither the textnor the context of those statutes indicates thatthe legislature intended to relieve a seller frompotential strict product liability on the basis ofthe adequacy of a manufacturer's productwarnings to another intermediary (here, thephysician). By contrast, section 402A of the

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Restatement (Second) of Torts, referred to inORS 30.920(3), indicates that the legislatureintended to create no such protection fromstrict liability.").

FN7. Three other jurisdictions have adoptedstatutes reflecting the learned intermediarydoctrine: Mississippi, see Miss.Code Ann. §11-1- 63(c)(ii) (2002); New Jersey, see N.J.Stat. Ann. § 2A:58C-4 (1987); and Ohio, seeOhio Rev.Code Ann. § 2307.76(c) (West1987). As reflected in the preceding footnote,in these three states the doctrine has also beenrecognized judicially.

The highest courts of six other states have eitherreferred to the doctrine favorably in dicta, or haveadopted it in a context other than prescription drugs;but, they have not expressly adopted it with respect toprescription drugs. [FN8]

FN8. See Craft v. Peebles, 78 Hawai'i 287,304-05, 893 P.2d 138, 155-56 (1995) (adoptinglearned intermediary rule for silicone breastimplants); MacDonald v. Ortho Pharm. Corp.,394 Mass. 131, 475 N.E.2d 65 (1985)(rejecting learned intermediary doctrine incontext of oral contraceptives, but indicating indicta that it would adopt in general prescriptiondrug context); Krug v. Sterling Drug, Inc., 416S.W.2d 143 (Mo.1967) (addressing only issueof whether drug manufacturer had properlywarned physician, as that was the issuepresented, but quoting learned intermediarydoctrine favorably in dicta); Alm v. AluminumCo. of Am., 717 S.W.2d 588 (Tex.1986)(commenting favorably about learnedintermediary doctrine in dicta in case that didnot involve prescription drugs); Pfizer, Inc. v.Jones, 221 Va. 681, 684, 272 S.E.2d 43, 44(1980) (addressing issue of whether drugmanufacturer's warnings to physician had beenadequate, but referring favorably to learnedintermediary doctrine in dicta); Terhune v. A.H.Robins Co., 90 Wash.2d 9, 577 P.2d 975(1978) (adopting learned intermediary doctrinewith respect to medical device, but discussion

indicates probable adoption in prescriptiondrug context).

*905 On the other hand, the highest courts of theremaining twenty-two states, Arizona, Colorado, Idaho,Indiana, Iowa, Louisiana, Maine, Maryland, Michigan,Minnesota, Nevada, New Hampshire, New Mexico,North Dakota, Rhode Island, South Carolina, SouthDakota, Vermont, Wisconsin, West Virginia, andWyoming, have not adopted the learned intermediarydoctrine. Likewise, the District of Columbia Court ofAppeals and the Supreme Court of Puerto Rico have notadopted the learned intermediary doctrine. Thus, whilethe doctrine is widely applied among lower courts, thenumber of high courts who have followed suit andexpressly adopted the doctrine, while admittedly in themajority, do not make up the overwhelming majoritythat has often been suggested by courts andcommentators.

Among the primary justifications that have beenadvanced for the learned intermediary doctrine are (1)the difficulty manufacturers would encounter inattempting to provide warnings to the ultimate users ofprescription drugs; (2) patients' reliance on their treatingphysicians' judgment in selecting appropriateprescription drugs; (3) the fact that it is physicians whoexercise their professional judgment in selectingappropriate drugs; (4) the belief that physicians are inthe best position to provide appropriate warnings totheir patients; and (5) the concern that direct warningsto ultimate users would interfere with doctor/patientrelationships. For example, the Supreme Court ofWashington has explained that

[t]he reasons for this rule should be obvious. Where aproduct is available only on prescription or throughthe services of a physician, the physician acts as a"learned intermediary" between the manufacturer orseller and the patient. It is his duty to inform himselfof the qualities and characteristics of those productswhich he prescribes for or administers to or uses onhis patients, and to exercise an independent judgment,taking into account his knowledge of the patient aswell as the product. The patient is expected to and, itcan be presumed, does place primary reliance uponthat judgment. The physician decides what factsshould be told to the patient. Thus, if the product is

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properly labeled and carries the necessary instructionsand warnings to fully apprise the physician of theproper procedures for use and the dangers involved,the manufacturer may reasonably assume that thephysician will exercise the informed judgmentthereby gained in conjunction with his ownindependent learning, in the best interest of thepatient. It has also been suggested that the rule ismade necessary by the fact that it is ordinarilydifficult for the manufacturer to communicate directlywith the consumer.

Terhune v. A.H. Robins Co., 90 Wash.2d 9, 14, 577 P.2d975, 978 (1978) (footnote omitted). [FN9]

FN9. See also West v. Searle & Co., 305 Ark.33, 42, 806 S.W.2d 608, 613 (1991) ("Thereare a number of arguments supporting theapplication of this exception to prescriptiondrug products. They may be summarized as:First, a physician must prescribe the drug, thepatient relies upon the physician's judgment inselecting the drug, and the patient relies uponthe physician's advice in using the drug. That isto say that there is an independent medicaldecision by the learned intermediary that thedrug is appropriate. Second, it is virtuallyimpossible in many cases for a manufacturer todirectly warn each patient. Third, imposition ofa duty to warn the user directly would interferewith the relationship between the doctor andthe patient." (citations omitted)); Carmichael v.Reitz, 17 Cal.App.3d 958, 989, 95 Cal.Rptr.381, 400-01 (1971) ("The rationale of the[learned intermediary doctrine] is: '(1) Thedoctor is intended to be an intervening party inthe full sense of the word. Medical ethics aswell as medical practice dictate independentjudgment, unaffected by the manufacturer'scontrol, on the part of the doctor. (2) Were thepatient to be given the complete and highlytechnical information on the adverse possibilityassociated with the use of the drug, he wouldhave no way to evaluate it, and in his limitedunderstanding he might actually object to theuse of the drug, thereby jeopardizing his life.(3) It would be virtually impossible for amanufacturer to comply with the duty of direct

warning, as there is no sure way to reach thepatient.' (Rheingold, Products Liability--TheEthical Drug Manufacturer's Liability (1964)... 18 Rutgers L.Rev. 947, 987.)." (footnoteomitted)); Lacy v. G.D. Searle & Co., 567 A.2d398, 400 (Del.1989) ("A patient obviously isunable to obtain a prescription drug ... unlesshis physician orders it. When a patient consultswith a physician seeking a prescription drug orrestricted device, the patient also expects thephysician to use his informed independentjudgment to advise the patient and to prescribethe most appropriate use of the drug or device,based on his professional judgment. In the finalanalysis it is the physician who ultimatelyprescribes the drug or device. Thus, if themanufacturer of prescription products providesthe physician with the legally appropriateinformation, it has satisfied its duty to warn.");McCombs v. Synthes, 277 Ga. 252, 253, 587S.E.2d 594, 595 (2003) ("The rationale for the[learned intermediary] doctrine is that thetreating physician is in a better position to warnthe patient than the manufacturer, in that the "'decision to employ prescription medication [ormedical devices] involves professionalassessment of medical risks in light of thephysician's knowledge of a patient's particularneed and susceptibilities." ' "); Larkin v. Pfizer,Inc., 153 S.W.3d 758, 763-64 (Ky.2004)("Three basic rationales have been articulatedto support the rule. The first and best rationaleis that the prescribing physician is in a superiorposition to impart the warning and can providean independent medical decision as to whetheruse of the drug is appropriate for treatment of aparticular patient.... The second rationale forthe rule is that manufacturers lack effectivemeans to communicate directly with eachpatient.... The third rationale for the rule is thatimposing a duty to warn upon the manufacturerwould unduly interfere with the physician-patient relationship." (citations omitted)).

*906 We find these justifications for the learnedintermediary doctrine to be largely outdated andunpersuasive. At the outset, we note that the learned

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intermediary doctrine is not a modern doctrine. Rather,its origins may be traced as far back as 1925.

One of the first intimations that the manufacturer'sduty to the ultimate consumer would be limited in thecase of prescription drugs is found in Hruska v.Parke, Davis & Co., 6 F.2d 536 (8th Cir.1925). Thecourt, while holding that the manufacturer was liableto the consumer despite lack of privity, stated"The defendant deals with the public to be treatedwith its preparations and drugs, not on an equalfooting, but with the understanding the public willtrust to the superior intelligence and generalknowledge of defendant, its agents and employees, inthe manufacture and preparation of its products; also,when its compounds, drugs, and preparations areplaced on the market, that they are safe, harmless andbeneficial in use. In other words, the public relies onthe truth of such statements employed in advertisingby the defendant, and does not seek expert advicefrom others regarding the propriety of the use of thecommodities defendant has manufactured and placedon the market."Id. at 538 (emphasis added)....

Odgers v. Ortho Pharm. Corp., 609 F.Supp. 867, 873 n.12 (E.D.Mich.1985).

The first instance in which a court actually concludedthat a manufacturer's duty to warn was satisfied byproviding warnings to a prescribing physician is the1948 case of Marcus v. Specific Pharms., 191 Misc.285, 77 N.Y.S.2d 508 (N.Y.Sup.Ct.1948). [FN10]Marcus involved an action against a pharmaceuticalcompany to recover for the death of a thirteen-month-old child who had been administered a larger-than-recommended dose of a prescription suppositorymanufactured by the defendant, SpecificPharmaceuticals, Inc. In granting the defendant drugcompany's motion to dismiss the complaint, the Marcuscourt stated:

FN10. See Larkin v. Pfizer, Inc., 153 S.W.3d758, 762. ("The [learned intermediary] ruleoriginated in Marcus v. SpecificPharmaceuticals."); Odgers v. Ortho Pharm.Corp., 609 F.Supp. 867, 873 n. 12(E.D.Mich.1985) ("Apparently the earliestreported case which actually held that the

manufacturer's duty to warn is fulfilled byadequate warnings given to the prescribingphysician is Marcus v. SpecificPharmaceuticals.").

[I]t is difficult to see on what basis this defendant canbe liable to plaintiff. It made no representation toplaintiff, nor did it hold out its product to plaintiff ashaving any properties whatsoever. To physicians itdid make representations. And should any of these befalse it might be claimed with propriety that theywere made for the benefit of the ultimate consumers.But there is no such claim. The sole claim is notmisrepresentation or even concealment, but anegligent failure to give adequate information, and insome instances a failure to use adequate means to callattention *907 to the information given. It may besafely conceded that these allegations would besufficient if the product were sold to the publicgenerally as a drug for which no physician'sprescription was necessary. The situation alleged ismaterially different. There is no reason to believe thata physician would care to disregard his ownknowledge of the effects of drugs and hence of thequantity to be administered, and substitute for hisown judgment that of a drug manufacturer. Nor isthere any reason to expect that if a doctor did chooseto rely on the information given by the manufacturerhe would prescribe without knowing what thatinformation was. In the absence of any such groundsfor belief there would be no negligence.

191 Misc. at 287, 77 N.Y.S.2d at 509-10. [FN11] TheMarcus court clearly found significance in the fact thatno representations had been made directly to theplaintiff by the defendant drug manufacturer. To a largedegree, in a world where prescription medicine iswidely advertised, such a situation is becomingincreasingly rare.

FN11. The actual term "learned intermediary"was first applied to the doctrine in 1967 in thecase of Sterling Drug v. Cornish, 370 F.2d 82(8th Cir.1966). Sterling involved a drug thatproduced a condition that resulted in blindnessin a small percentage of those individuals whoused it. 370 F.2d at 83-84. Maxine Cornish wasa member of that small percentage, and she

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sued Sterling Drug alleging that the companyknew or should have known of this side effectand negligently failed to warn doctors,including her own doctor, to properly monitorusers of the drug. Id. at 84. Ms. Cornishprevailed at trial, and Sterling appealedarguing, inter alia, that the trial court hadimproperly instructed the jury that if Sterling"knew or should have known that a group ofpersons would suffer rare side effects,[Sterling] had a duty to warn the medicalprofession of the susceptibility of such ahypersensitive or idiosyncratic group." TheCourt of Appeals ultimately affirmed theverdict in favor of Ms. Cornish, andcommented with respect to the notice issue that[i]n the instant case there was sufficientevidence for the jury to find that appellant didin fact know, and thus could have foreseen, thatsome persons would be injured by the drug'sside effect. Moreover, in this case we aredealing with a prescription drug rather than anormal consumer item. In such a case thepurchaser's doctor is a learned intermediarybetween the purchaser and the manufacturer. Ifthe doctor is properly warned of the possibilityof a side effect in some patients, and is advisedof the symptoms normally accompanying theside effect, there is an excellent chance thatinjury to the patient can be avoided. This isparticularly true if the injury takes placeslowly, as is the case with the injury inquestion here. Therefore, the reasons given fordenying liability in other cases do not existhere. We believe the court's instruction was anaccurate statement of the law.Id. at 85.

We note the lengthy history of the learned intermediarydoctrine because the very age of the doctrine requires usto pause and engage in a thorough examination, eventhough the doctrine has been widely accepted.Significant changes in the drug industry have post-datedthe adoption of the learned intermediary doctrine in themajority of states in which it is followed. We referspecifically to the initiation and intense proliferation ofdirect-to-consumer advertising, along with its impact on

the physician/patient relationship, and the developmentof the internet as a common method of dispensing andobtaining prescription drug information. [FN12]

FN12. "[O]ne study shows that '43 percent ofthe 40.6 million adults who regularly use theInternet search for health-related topics." 'Patrick Cohoon, Comment, An Answer to theQuestion Why the Time Has Come to Abrogatethe Learned Intermediary Rule in the Case ofDirect-to-Consumer Advertising ofPrescription Drugs, 42 S. Tex. L.Rev. 1333,1352 (Fall 2001) (citation omitted).

When the learned intermediary doctrine was developed,direct-to-consumer advertising of prescription drugswas utterly unknown. "Historically, prescription drugadvertising in the United States was directed primarilyto prescribers, who were once the sole decision-makerswhen choosing prescription medications." Francis B.Palumbo & C. Daniel Mullins, The Development ofDirect-to-Consumer Prescription Drug AdvertisingRegulation, 57 Food & Drug L.J., 422, 424 (2002). Seealso Ozlem A. Bordes, The Learned IntermediaryDoctrine and Direct-to-Consumer Advertising: Shouldthe Pharmaceutical Manufacturer Be Shielded fromLiability?, 81 U. Det. Mercy L.Rev. 267, 274-75(Spring 2004) ("Originally, pharmaceuticalmanufacturers advertised to physicians directly viamedical journals or pharmaceutical*908 representatives.The general public was less aware of what name branddrugs were on the market."). As one court has aptlyobserved,

[o]ur medical-legal jurisprudence is based on imagesof health care that no longer exist. At an earlier time,medical advice was received in the doctor's officefrom a physician who most likely made house calls ifneeded. The patient usually paid a small sum ofmoney to the doctor. Neighborhood pharmacistscompounded prescribed medicines. Without beingpejorative, it is safe to say that the prevailing attitudeof law and medicine was that the "doctor knowsbest." Logan v. Greenwich Hosp. Ass'n, 191 Conn.282, [290,] 465 A.2d 294, 299 (1983).Pharmaceutical manufacturers never advertised theirproducts to patients, but rather directed all salesefforts at physicians. In this comforting setting, the

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law created an exception to the traditional duty ofmanufacturers to warn consumers directly of risksassociated with the product as long as they warnedhealth-care providers of those risks.For good or ill, that has all changed. Medical servicesare in large measure provided by managed careorganizations. Medicines are purchased in thepharmacy department of supermarkets and often paidfor by third-party providers. Drug manufacturers nowdirectly advertise products to consumers on the radio,television, the Internet, billboards on publictransportation, and in magazines.

Perez v. Wyeth Labs. Inc., 161 N.J. 1, 4, 734 A.2d 1245,1246-47 (1999).

Direct-to-consumer prescription drug advertising hasbeen a fairly recent development. "The first U.S.prescription drug print advertisement directed to theconsumer was issued in 1981." Palumbo & Mullins,supra, 57 Food & Drug L.J. at 424. Thereafter,

[i]n 1997, the [Food & Drug Administration] issueddraft guidelines intended to supplement theregulations regarding broadcast advertisements. Theseguidelines led to a rapid proliferation of a newer,more informative broadcast advertisement, allowingthe manufacturers to include both the product nameand indication. The guidelines recommended thatdrug manufacturers provide a means for consumers toobtain more information (e.g. an Internet Web pageaddress).

Patrick Moore & Michael Newton, Prescription Drug

Advertising on the Internet: A Proposal for Regulation,2 W. Va. J.L. & Tech. 1.1, ¶ 3 (Feb. 14, 1998)(emphasis added) (footnote omitted). [FN13] See alsoPalumbo & Mullins, supra, 57 Food & Drug L.J. at 423("[R]ecent changes ... in the Food and DrugAdministration's ... guidance--introduced in 1997 andfinalized in 1999--have opened the door to a plethora ofadvertisements." (emphasis added)). [FN14] Indeed, ithas been observed that "drug manufacturers have spentmore money on direct-to-consumer advertising in thelast few years than on advertising to doctors." Bordes,supra, 81 U. Det. Mercy L.Rev. at 268 (citing Paula C.Ohliger, DTC Advertising and the Potential Liability ofManufacturers, Drug Benefit Trends, 11(8):39-40(1999)).

FN13. This article is available on the internet athttp://www.wvu. edu/~law/wvjolt/ (last visitedJune 14, 2007).

FN14. The massive increase in direct-to-consumer advertising in recent years isstriking. One commentator has provided thefollowing table tracking spending on direct-to-consumer, or DTC, spending from the year1989 to the year 2001:

Year DTC Spending

1989 $ 12 million

1990 $ 48 million

1991 $ 56 million

1992 $156 million

1993 $166 million

1994 $242 million

1995 $313 million

1996 $595 million

1997 $844 million

1998 $1.17 billion

1999 $1.58 billion

2000 $2.24 billion

2001 $2.38 billion

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Palumbo & Mullins, The Development ofDirect-to-Consumer Prescription DrugAdvertising Regulation, 57 Food & Drug L.J. at423 (footnotes omitted).

Since the 1997 proliferation of drug advertising, onlyfour high courts have adopted the *909 learnedintermediary doctrine. See Vitanza v. Upjohn Co., 257Conn. 365, 778 A.2d 829 (2001); McCombs v. Synthes,277 Ga. 252, 587 S.E.2d 594 (2003); Larkin v. Pfizer,Inc., 153 S.W.3d 758 (Ky.2004); Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552, 618 N.W.2d 827 (2000).In deciding to adopt the learned intermediary doctrine,none of those courts gave thorough consideration to thechanges that have occurred in the prescription drugindustry with respect to direct-to-consumer advertising.We, however, find such changes to be a significantfactor in deciding this issue, especially the impactdirect-to-consumer advertising has had on thephysician/patient relationship. See Larkin v. Pfizer, Inc.,153 S.W.3d 758, 770-71 (Wintersheimer, J., dissenting)("This Court should take notice of the abundantlyobvious fact that the development of direct to consumerpharmaceutical advertising has indelibly changed therealities of physician/patient relationships. Anyone whowatches television is regularly bombarded with avariety of pharmaceutical products which suggest thatthe ultimate consumer ask his physician to prescribe aparticular advertised product.").

Opponents of direct-to-consumer advertising have madethe following arguments regarding the impact of suchadvertising on the physician/patient relationship:

[P]hysicians state that they are increasingly asked andpressured by their patients to prescribe drugs that thepatient has seen advertised. For example, the dietdrug combinations known as fen-phen was prescribeddespite little hard scientific evidence of its potentialside-effects. Physicians are under attack forprescribing the pills too often and too readily toinappropriate patients. Physicians argue that it is nottheir fault; rather, they claim pushy patients, proddedby DTC advertisements, pressed, wheedled, beggedand berated them for quick treatments.... Physicianscomplain that it is impossible to compete withpharmaceutical companies' massive advertising

budgets, and resign themselves to the fact that ifconsumers make enough noise, they will eventuallyrelent to patient pressure.Moreover, industry critics of DTC advertisementsargue that the advertisements distort doctor-patientrelationships and may actually increase the use ofprescription drugs. They also believe that drugadvertisements are created to sell products and thusare inadequate sources of information and poorsubstitutes for medical advice. Critics also argue thatthe advertisements do not discuss other medications,alternative treatments and the wisdom of doingnothing. Furthermore, these advertisements are unableto diagnose an ailment. All these factors may create amisinformed patient whom the physician will have toeducate.Studies show that DTC advertising generates anincreased patient load and often causes physicians tospend more time reviewing the benefits and risks of aspecific brand with each patient and explainingformulary restrictions when patients request a brandthat is outside the health plan's drug formulary. Thismay be a potential waste of time for both the patientand the physician, because their discussion will havelittle effect on formulary rules. The doctor-patientrelationship may suffer when physicians must justifydecisions to patients concerning which product theywill prescribe. Physicians also believe that superficialand misleading advertisements create unreasonable orinappropriate patient expectations for producteffectiveness and often lead patients to requestinappropriate products for their medical needs.

Tamar V. Terzian, Note, Direct-to-ConsumerPrescription Drug Advertising, 25 Am. J.L. & Med.149, 158 (1999) (footnotes omitted). See also Bordes,supra, 81 U. Det. Mercy L.Rev. at 280-81 ("Today,doctors still argue that their relationship with patients isundermined by direct-to-consumer advertising. Theyclaim that patients demand a particular drug they sawon television, or in a magazine. Additionally, theadvertisements encourage lay people to make self-diagnoses by listing symptoms and suggesting theviewer may have the condition that the drug can treat....[One doctor] says that direct-to-consumer advertising'has created more conflict between the doctor and the

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patient where the doctor is seen as a barrier to the *910drug the patient wants.' ... [Another] says that if adoctor feels that the requested prescription is not rightfor the patient, doctors find their credibility at issue, notthe manufacturer. She also adds that insurancecompanies may not cover the prescription drug that thepatient wants. The physician must then explain to thepatient it is not covered by the plan. The patient mayask the physician to petition the insurer to get the drugcovered, which can waste valuable time." (footnotesomitted)).

In rejecting the application of the learned intermediarydoctrine to drugs that had been the subject of direct-to-consumer advertising, the Supreme Court of NewJersey opined, and we agree, that such advertisingobviates each of the premises upon which the doctrinerests:

These premises: (1) reluctance to undermine thedoctor patient-relationship; (2) absence in the era of"doctor knows best" of need for the patient's informedconsent; (3) inability of drug manufacturer tocommunicate with patients; and (4) complexity of thesubject; are all (with the possible exception of thelast) absent in the direct-to-consumer advertising ofprescription drugs.First, with rare and wonderful exceptions, the "'Norman Rockwell' image of the family doctor nolonger exists." [Lars Noah, Advertising PrescriptionDrugs to Consumers: Assessing the Regulatory andLiability Issues, 32 Ga. L.Rev. 141, 180 n. 78 (1997) ](citing Paul D. Rheingold, The Expanding Liability ofthe Drug Manufacturer to the Consumer, 40 FoodDrug Cosm. L.J. 135, 136 (1985)). Informed consentrequires a patient-based decision rather than thepaternalistic approach of the 1970s. See Largey v.Rothman, 110 N.J. 204, 206, 540 A.2d 504 (1988)(discussing Canterbury v. Spence, 464 F.2d 772(D.C.Cir.), cert. denied, 409 U.S. 1064, 93 S.Ct. 560,34 L.Ed.2d 518 (1972)). The decision to take a drugis "not exclusively a matter for medical judgment."See Teresa Moran Schwartz, Consumer-DirectedPrescription Drug Advertising and the LearnedIntermediary Rule, 46 Food Drug Cosm. L.J. 829, 831(1991) (citing Margaret Gilhooley, LearnedIntermediaries, Prescription Drugs, and PatientInformation, 30 St. Louis. U. L.J. 633, 652 (1986)).

Second, because managed care has reduced the timeallotted per patient, physicians have considerably lesstime to inform patients of the risks and benefits of adrug. Sheryl Gay Stolberg, Faulty Warning LabelsAdd to Risk in Prescription Drugs, N.Y. Times, June4, 1999, at A27. "In a 1997 survey of 1,000 patients,the F.D.A. found that only one-third had receivedinformation from their doctors about the dangerousside effects of drugs they were taking." Ibid.Third, having spent $1.3 billion on advertising in1998, supra at 12-13, 734 A.2d at 1251-52, drugmanufacturers can hardly be said to "lack effectivemeans to communicate directly with patients," Noah,supra, 32 Ga. L.Rev. at 158, when their advertisingcampaigns can pay off in close to billions individends.Consumer-directed advertising of pharmaceuticalsthus belies each of the premises on which the learnedintermediary doctrine rests.First, the fact that manufacturers are advertising theirdrugs and devices to consumers suggests thatconsumers are active participants in their health caredecisions, invalidating the concept that it is thedoctor, not the patient, who decides whether a drug ordevice should be used. Second, it is illogical thatrequiring manufacturers to provide direct warnings toa consumer will undermine the patient-physicianrelationship, when, by its very nature, consumer-directed advertising encroaches on that relationshipby encouraging consumers to ask for advertisedproducts by name. Finally, consumer-directedadvertising rebuts the notion that prescription drugsand devices and their potential adverse effects are toocomplex to be effectively communicated to layconsumers. Because the FDA requires thatprescription drug and device advertising carrywarnings, the consumer may reasonably presume thatthe advertiser guarantees the adequacy of itswarnings. Thus, the *911 common law duty to warnthe ultimate consumer should apply.[Susan A. Casey, Comment, Laying an Old Doctrineto Rest: Challenging the Wisdom of the LearnedIntermediary Doctrine, 19 Wm. Mitchell L.Rev. 931,956 (1993) (footnotes omitted).]When all of its premises are absent, as when directwarnings to consumers are mandatory, the learned

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intermediary doctrine, "itself an exception to themanufacturer's traditional duty to warn consumersdirectly of the risk associated with any product,simply drops out of the calculus, leaving the duty ofthe manufacturer to be determined in accordance withgeneral principles of tort law." Edwards v. BaselPharms., 116 F.3d 1341, 1343 (10th Cir.1997)(discussing question of adequacy of nicotine patchwarning under Texas law certified in Edwards v.Basel Pharms., 933 P.2d 298 (Okla.1997))....

Perez v. Wyeth Labs. Inc., 161 N.J. 1, 18-19, 734 A.2d1245, 1255-56. See also Patrick Cohoon, Comment, AnAnswer to the Question Why the Time Has Come toAbrogate the Learned Intermediary Rule in the Case ofDirect-to-Consumer Advertising of Prescription Drugs,42 S. Tex. L.Rev. 1333, 1356-60 (Fall 2001)(explaining how each of the bases for the learnedintermediary doctrine no longer exist in light of direct-to-consumer advertising).

Many jurisdictions have addressed the shortcomings ofthe learned intermediary doctrine by developing variousexceptions.

[C]ourts have recognized exceptions [to the learnedintermediary doctrine] regarding: (1) vaccineinoculations; Davis v. Wyeth Laboratories, Inc., [399F.2d 121, 131 (9th Cir.1968) ]; (2) oralcontraceptives; MacDonald v. Ortho PharmaceuticalCorp., 394 Mass. 131, 135-36, 475 N.E.2d 65, cert.denied, 474 U.S. 920, 106 S.Ct. 250, 88 L.Ed.2d 258(1985); (3) contraceptive devices; Hill v. SearleLaboratories, [884 F.2d 1064, 1070- 71 (8thCir.1989) ]; (4) drugs advertised directly toconsumers; Perez v. Wyeth Laboratories, Inc., [161N.J. 1, 21, 734 A.2d 1245, 1257 (1999) ]; (5)overpromoted drugs; Proctor v. Davis, 291 Ill.App.3d265, 279-84, 225 Ill.Dec. 126, [136-40,] 682 N.E.2d1203, [1212-16,] cert. denied, 175 Ill.2d 553, 228Ill.Dec. 725, 689 N.E.2d 1146 (1997); and (6) drugswithdrawn from the market; Nichols v. McNeilab,Inc., 850 F.Supp. 562, 565 ( [E.D.Mich.1993).

Vitanza v. Upjohn Co., 257 Conn. at 393, 778 A.2d at846-47. See also Bordes, supra, 81 U. Det. MercyL.Rev. at 270-74 (discussing exceptions to learnedintermediary doctrine).

Even the version of the learned intermediary doctrine

contained in the Restatement (Third) of Tortsincorporates the foregoing exceptions by including ageneral exception to cover those circumstances wherethe manufacturer knows or should know that aphysician will not be in a position to provide anadequate warning:

(d) A prescription drug or medical device is notreasonably safe due to inadequate instructions orwarnings if reasonable instructions or warningsregarding foreseeable risks of harm are not providedto:(1) prescribing and other health-care providers whoare in a position to reduce the risks of harm inaccordance with the instructions or warnings; or(2) the patient when the manufacturer knows or hasreason to know that health-care providers will not bein a position to reduce the risks of harm in accordancewith the instructions or warnings.

Restatement (Third) of Torts: Products Liability § 6(d),at 145 (1998). [FN15] In Comment e *912 to § 6, theAmerican Law Institute discusses some circumstancesunder which direct warnings to patients may bewarranted under subsection 6(d)(2). [FN16] Ultimately,though, the Institute commented that it "leaves todeveloping case law whether exceptions to the learnedintermediary rule in these or other situations should berecognized." Restatement (Third) of Torts: ProductsLiability § 6 cmt. e, at 149. It has been observed that,"[o]ne commentator described the Restatement'sapproach as a 'tepid endorsement' of the learnedintermediary doctrine." *913Perez v. Wyeth Labs. Inc.,161 N.J. at 14-15, 734 A.2d at 1253 (quoting Charles J.Walsh et al., The Learned Intermediary Doctrine: TheCorrect Prescription for Drug Labeling, 48 RutgersL.Rev. 821, 869 (1994)). [FN17]

FN15. Section 6 of the Restatement (Third) ofTorts: Products Liability states in its entirety,(a) A manufacturer of a prescription drug ormedical device who sells or otherwisedistributes a defective drug or medical deviceis subject to liability for harm to personscaused by the defect. A prescription drug ormedical device is one that may be legally soldor otherwise distributed only pursuant to ahealth-care provider's prescription.(b) For purposes of liability under Subsection

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(a), a prescription drug or medical device isdefective if at the time of sale or otherdistribution the drug or medical device:(1) contains a manufacturing defect as definedin § 2(a); or(2) is not reasonably safe due to defectivedesign as defined in Subsection (c); or(3) is not reasonably safe due to inadequateinstructions or warnings as defined inSubsection (d).(c) A prescription drug or medical device is notreasonably safe due to defective design if theforeseeable risks of harm posed by the drug ormedical device are sufficiently great in relationto its foreseeable therapeutic benefits thatreasonable health-care providers, knowing ofsuch foreseeable risks and therapeutic benefits,would not prescribe the drug or medical devicefor any class of patients. (d) A prescriptiondrug or medical device is not reasonably safedue to inadequate instructions or warnings ifreasonable instructions or warnings regardingforeseeable risks of harm are not provided to:(1) prescribing and other health-care providerswho are in a position to reduce the risks ofharm in accordance with the instructions orwarnings; or(2) the patient when the manufacturer knows orhas reason to know that health-care providerswill not be in a position to reduce the risks ofharm in accordance with the instructions orwarnings.(e) A retail seller or other distributor of aprescription drug or medical device is subjectto liability for harm caused by the drug ordevice if:(1) at the time of sale or other distribution thedrug or medical device contains amanufacturing defect as defined in § 2(a); or(2) at or before the time of sale or otherdistribution of the drug or medical device theretail seller or other distributor fails to exercisereasonable care and such failure causes harm topersons.

FN16. Comment e states in full:e. Direct warnings to patients. Warnings and

instructions with regard to drugs or medicaldevices that can be sold legally only pursuantto a prescription are, under the "learnedintermediary" rule, directed to healthcareproviders. Subsection (d)(2) recognizes thatdirect warnings and instructions to patients arewarranted for drugs that are dispensed oradministered to patients without the personalintervention or evaluation of a health-careprovider. An example is the administration of avaccine in clinics where mass inoculations areperformed. In many such programs, health-careproviders are not in a position to evaluate therisks attendant upon use of the drug or deviceor to relate them to patients. When amanufacturer supplies prescription drugs fordistribution to patients in this type ofunsupervised environment, if a direct warningto patients is feasible and can be effective, thelaw requires measures to that effect.Although the learned intermediary rule isgenerally accepted and a drug manufacturerfulfills its legal obligation to warn by providingadequate warnings to the health-care provider,arguments have been advanced that in twoother areas courts should consider imposingtort liability on drug manufacturers that fail toprovide direct warnings to consumers. In thefirst, governmental regulatory agencies havemandated that patients be informed of risksattendant to the use of a drug. A noted exampleis the FDA requirement that birth control pillsbe sold to patients accompanied by a patientpackage insert. In the second, manufacturershave advertised a prescription drug and itsindicated use in the mass media. Governmentalregulations require that, when drugs are soadvertised, they must be accompanied byappropriate information concerning risk so asto provide balanced advertising. The questionin both instances is whether adequate warningsto the appropriate health-care provider shouldinsulate the manufacturer from tort liability.Those who assert the need for adequatewarnings directly to consumers contend thatmanufacturers that communicate directly with

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consumers should not escape liability simplybecause the decision to prescribe the drug wasmade by the health-care provider. Proponentsof the learned intermediary rule argue that,notwithstanding direct communications to theconsumer, drugs cannot be dispensed unless ahealth-care provider makes an individualizeddecision that a drug is appropriate for aparticular patient, and that it is for the health-care provider to decide which risks are relevantto the particular patient. The Institute leaves todeveloping case law whether exceptions to thelearned intermediary rule in these or othersituations should be recognized.When the content of the warnings is mandatedor approved by a governmental agencyregulation and a court finds that compliancewith such regulation federally preempts tortliability, then no liability under this Section canattach. For the rules governing compliance withgovernmental standards generally, see § 4(b).Restatement (Third) of Torts: ProductsLiability § 6(d) cmt. e, at 148- 49 (1998).

FN17. In this context, the Perez courtcommented:Parallel to the developments in drug marketing,the American Law Institute was in the processof adopting the Restatement (Third) of Torts:Products Liability (1997) .... Despite the earlyeffort to provide an exception to the doctrine inthe case of direct marketing of pharmaceuticalsto consumers, the drafters left the resolution ofthat issue to "developing case law." Id. at § 6dcomment e. One commentator described theRestatement's approach as a "tepidendorsement" of the learned intermediarydoctrine. Charles J. Walsh et al., The LearnedIntermediary Doctrine: The CorrectPrescription for Drug Labeling, 48 RutgersL.Rev. 821, 869 (1994). Thus, under the newRestatement, "warnings may have to beprovided to a health-care provider or even tothe patient," depending on the circumstances.William A. Dreier, The Restatement (Third) ofTorts: Products Liability and the New JerseyLaw-Not Quite Perfect Together, 50 Rutgers

L.J.2059, 2097 (1998).161 N.J. at 14-15, 734 A.2d at 1253.

[5] Given the plethora of exceptions to the learnedintermediary doctrine, we ascertain no benefit inadopting a doctrine that would require the simultaneousadoption of numerous exceptions in order to be justlyutilized. This is particularly so when our existing law ofcomparative contribution among joint tortfeasors isadequate to address issues of liability among physiciansand drug companies in those cases where patients suefor injuries related to the use of prescription drugs.[FN18]

FN18. Petitioner Janssen notes that federalcourts applying West Virginia law have longspeculated that West Virginia would adopt thedoctrine. See Ashworth v. Albers Med., Inc.,395 F.Supp.2d 395, 407 (S.D.W.Va.2005);Pumphrey v. C.R. Bard, Inc., 906 F.Supp. 334,338 (N.D.W.Va.1995); Rohrbough v. WyethLabs., Inc., 719 F.Supp. 470, 478(N.D.W.Va.1989), aff'd, 916 F.2d 970 (4thCir.1990). While federal court opinionsapplying West Virginia law are often viewedpersuasively, we are not bound by thoseopinions. See Life Ins. Co. of North Am. v.Cichowlas, 659 So.2d 1333, 1340(Fla.Dist.Ct.App.1995) ("Opinions of federalcourts which interpret and apply Florida laware persuasive, but the courts of this state arenot bound by such opinions." (citationomitted)); Jacobsen v. Farmers Union Mut.Ins. Co., 320 Mont. 375, 381, 87 P.3d 995, 998(2004) ("[F]ederal court decisions applyingMontana law are not binding on this Court[.]");Garrison Contractors, Inc. v. Liberty Mut. Ins.Co., 927 S.W.2d 296, 300 (Tex.Ct.App.1996)("Decisions of the federal courts of appeals anddistrict courts applying Texas law are notbinding on this court. They are, however,received 'with respectful consideration.' "(citation omitted)).

Furthermore, we believe that if drug manufacturers areable to adequately provide warnings to consumers underthe numerous exceptions to the learned intermediary

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doctrine, then they should experience no substantialimpediment to providing adequate warnings toconsumers in general. "There is no question thatpharmaceutical manufacturers believe they have veryeffective methods to communicate directly withconsumers." Larkin v. Pfizer, Inc., 153 S.W.3d at 771(Wintersheimer, J., dissenting).

Finally, because it is the prescription drugmanufacturers who benefit financially from the sales ofprescription drugs and possess the knowledge regardingpotential harms, and the ultimate consumers who bearthe significant health risks of using those drugs, it is notunreasonable that prescription drug manufacturersshould provide appropriate warnings to the ultimateusers of their products.

Public policy dictates that the manufacturer shouldwarn the ultimate user of the harmful effects of itspharmaceuticals since it involves a person's health.The knowledge of pharmaceutical side effects goeswell beyond the scope of the average individual. Thebenefit in warning the consumer directly is faroutweighed by the costs. It is not as though themanufacturer must incur costs to discover the risks asthey are already known. It is only a matter of addingthe consumer to the list of who to warn....... Since the early 1980's, direct-to-consumeradvertising has boomed into a very profitable venturefor pharmaceutical manufacturers. Yet, consumers'exposure to harm has increased as a result. They aresurrounded by various prescription advertisements inall forms of print and broadcast media.Advertisements directed to consumers, however,often supply partial or incomplete information.Additionally, self-diagnosis by the consumer hasresulted *914 from these advertisements, as well aspatient-demand for the brand-name drugs. It is in thebest interest of the general public that manufacturershave a duty to warn the ultimate user of side effectsand risks. Courts are increasingly motivated to protectthe consumer, and require manufacturers to warnmore than just the physician.....Pharmaceutical manufacturers spend millions to makemillions more. They are pushing their products ontothe general public like never before. Consequently,consumers need more protection. As a response to the

changing times, courts have diminished themanufacturer's shield of the learned intermediarydoctrine. They have imposed a duty to warn theconsumer in addition to the physician. In doing so,the goal of product liability to protect the ultimateuser from harm, is more attainable. In the end, theburden should be on the one producing health care,not the one consuming it.

Bordes, supra, 81 U. Det. Mercy L.Rev. at 286-87(emphasis added). West Virginia physicians naturallyhave duties and responsibilities regarding their role inproviding prescription medicines to consumers. Itwould be unreasonable not to require the manufacturersof those medicines to accept similar responsibilities.

Based upon the foregoing, we now hold that, underWest Virginia products liability law, manufacturers ofprescription drugs are subject to the same duty to warnconsumers about the risks of their products as othermanufacturers. We decline to adopt the learnedintermediary exception to this general rule.

IV.CONCLUSION

In denying Janssen's motion in limine and declining toadopt the learned intermediary doctrine, the circuitcourt concluded that

[e]xisting West Virginia law permits the fulldevelopment of the claims and defenses as to theadequacy and method of communicating warningswithout adopting the Learned Intermediary Doctrine.....West Virginia's law as to comparative contributionamong tortfeasors will adequately address the issuesof warnings as between the manufacturer and Dr.Wilson, without adopting a legal concept not yetembraced by the West Virginia Supreme Court ofAppeals.

We agree with the circuit court's conclusions and findno grounds upon which to grant the requested writ ofprohibition. Accordingly, Janssen's petition for writ ofprohibition is denied.

Writ denied.

ALBRIGHT, Justice, dissenting:

In wholesale fashion, the majority rejected the adoption

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of a doctrine that numerous states [FN1] have seen fit toapply for a number of years. Although I do not believethat a writ of prohibition--due to the limiteddevelopment of facts--presented the optimal case for adiscussion of whether this state should adopt somevariant of the learned intermediary doctrine, I think themajority was exceptionally shortsighted in deciding thatthe doctrine has completely outlived its purpose. Acareful consideration of the doctrine, as modified bycourts and/or the Restatement (Third) of Torts, suggeststhat there still may be a need for its adoption.

FN1. The majority uses the modifier "mere" torefer to the twenty-three states that it identifiesas adopting the learned intermediary doctrine. Ifind it difficult, if not impossible, to discernhow the adoption of the doctrine by twenty-three states, either by court or legislativeaction, does not constitute a significant figure--a figure that clearly approaches a majorityposition. And, while I am not attempting toplay the "numbers game," I note that in Larkinv. Pfizer, Inc., 153 S.W.3d 758 (Ky.2004), theappellate court identified the number of statesthat had specifically adopted the learnedintermediary doctrine as thirty-four. Id. at 767and n. 3.

Rather than trying to enervate the near-majority ofjurisdictions that have already adopted the doctrine, themajority should have earnestly analyzed whether any ofthe rationales which underlie the doctrine remain validtoday. What the majority overlooks by *915emphasizing the direct marketing of drugs to consumersis that the doctrine may still serve a useful purpose forprescription drugs that are not heavily marketed and inthose circumstances where a physician's expertise isrelied upon to make the all-important selection of whichparticular drug(s) to prescribe; to interpretcontraindicative information; and to interpret themyriad of warning-related information distributed by apharmaceutical manufacturer.

As the Kentucky Supreme Court recently recognized inLarkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky.2004),

Three basic rationales have been articulated tosupport the rule. The first and best rationale is that the

prescribing physician is in a superior position toimpart the warning and can provide an independentmedical decision as to whether use of the drug isappropriate for treatment of a particular patient.... Thesecond rationale for the rule is that manufacturerslack effective means to communicate directly witheach patient.... The third rationale for the rule is thatimposing a duty to warn upon the manufacturer wouldunduly interfere with the physician-patientrelationship.

Id. at 763-64. After essentially deciding that advertisingand communication changes have attenuated oreliminated the second rationale stated above, [FN2] themajority rejected any need for the doctrine's adoption

FN2. In fact, the majority concluded inconclusory fashion that all three of therationales for the doctrine were "largelyoutdated and unpersuasive." Johnson &Johnson Corp. v. Honorable Mark A. Karl, ---W.Va. ----, 647 S.E.2d 906, No. 33211 (filedJune 27, 2007) at slip op.13.

Notwithstanding the widespread use of marketingefforts by pharmaceutical companies aimed at theconsumer, the need for a physician's involvement in thedecision to choose a specific drug remains. Just becausea warning can be printed and advertised as part of themarketing plan for a prescription drug does not meanthat a consumer, especially one not educated in medicaljargon, can digest or comprehend the significance ofthat warning in a useful fashion. And, in those cases,where a physician's expertise has been relied upon toselect a specific prescription drug, the learnedintermediary doctrine, with the exceptions identified bythe Restatement (Third) of Torts, is a well-recognizedand reasoned approach to resolving the issue of theadequacy of the warnings issued by a pharmaceuticalcompany for its product.

Both the northern and southern federal district courtsfor this state predicted that this Court, when presentedwith the issue, would choose to adopt the learnedintermediary doctrine. See Ashworth v. Albers Medical,Inc., 395 F.Supp.2d 395 (S.D.W.Va.2005); Pumphrey v.C.R. Bard, Inc., 906 F.Supp. 334 (N.D.W.Va.1995). InAshworth, the court described the doctrine as an "

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'understandable exception' to the general rule thatmanufacturers must warn foreseeable end users aboutthe dangers inherent in their products." 395 F.Supp.2dat 407 (quoting Walls v. Alpharma USPD, Inc., 887So.2d 881, 883- 84 (Ala.2004)). "[T]he superior role ofthe physician in servicing the patient's medical needs"was one of the litany of reasons the court in Ashworthrelied upon in choosing to extend the doctrine's reach toa pharmacy. 395 F.Supp.2d at 407. In addition to citingthe accepted rationale that "the determination ofwhether certain medications and medical devices shouldbe utilized in any given case requires an individualizedmedical judgment which can be made only by thepatient's physician with knowledge of the patient'scharacteristics," the northern district court looked to thefact that "West Virginia generally follows theRestatement of Law in appropriate cases." 906 F.Supp.at 338 (citing draft provision of Restatement of the LawThird: Torts, Product Liability ).

Finding the position taken by the Restatement (Third) ofLaw [FN3] undeserving of adoption, *916 the majorityessentially concludes that the learned intermediarydoctrine is unworkable because it would require theneed for case-by-case consideration of its application"through developing case law" and would also present aneed for recognizing exceptions to the rule. Johnson &Johnson, --- W.Va. at ----, 647 S.E.2d at 912, No. 33211(filed June 27, 2007) (quoting Restatement (Third) ofTorts: Products Liability § 6 cmt. e, at 149). In myopinion, the Restatement position combined with theexceptions recognized in comment e, [FN4] introduce abalanced *917 and fair approach that would allow thisstate both to adopt the doctrine and to develop rules asto its application based on the factual and legalvariations of the cases in which the doctrine wasapplied.

FN3. Section 6 of the Restatement (Third) ofTorts: Products Liability states in its entirety,(a) A manufacturer of a prescription drug ormedical device who sells or otherwisedistributes a defective drug or medical deviceis subject to liability for harm to personscaused by the defect. A prescription drug ormedical device is one that may be legally soldor otherwise distributed only pursuant to a

health-care provider's prescription.(b) For purposes of liability under Subsection(a), a prescription drug or medical device isdefective if at the time of sale or otherdistribution the drug or medical device:(1) contains a manufacturing defect as definedin § 2(a); or(2) is not reasonably safe due to defectivedesign as defined in Subsection (c); or(3) is not reasonably safe due to inadequateinstructions or warnings as defined inSubsection (d).(c) A prescription drug or medical device is notreasonably safe due to defective design if theforeseeable risks of harm posed by the drug ormedical device are sufficiently great in relationto its foreseeable therapeutic benefits thatreasonable health-care providers, knowing ofsuch foreseeable risks and therapeutic benefits,would not prescribe the drug or medical devicefor any class of patients.(d) A prescription drug or medical device is notreasonably safe due to inadequate instructionsor warnings if reasonable instructions orwarnings regarding foreseeable risks of harmare not provided to:(1) prescribing and other health-care providerswho are in a position to reduce the risks ofharm in accordance with the instructions orwarnings; or(2) the patient when the manufacturer knows orhas reason to know that health-care providerswill not be in a position to reduce the risks ofharm in accordance with the instructions orwarnings.(e) A retail seller or other distributor of aprescription drug or medical devise is subjectto liability for harm caused by the drug ordevice if:(1) at the time of sale or other distribution thedrug or medical device contains amanufacturing defect as defined in § 2(a); or(2) at or before the time of sale or otherdistribution of the drug or medical device theretail seller or other distributor fails to exercisereasonable care and such failure causes harm to

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persons.

FN4. Comment e states in full: e. Directwarnings to patients. Warnings andinstructions with regard to drugs or medicaldevices that can be sold legally only pursuantto a prescription are, under the "learnedintermediary" rule, directed to health-careproviders. Subsection (d)(2) recognizes thatdirect warnings and instructions to patients arewarranted for drugs that are dispensed oradministered to patients without the personalintervention or evaluation of a health-careprovider. An example is the administration of avaccine in clinics where mass inoculations areperformed. In many such programs, health-careproviders are not in a position to evaluate therisks attendant upon use of the drug or deviceor to relate them to patients. When amanufacturer supplies prescription drugs fordistribution to patients in this type ofunsupervised environment, if a direct warningto patients is feasible and can be effective, thelaw requires measures to that effect.Although the learned intermediary rule isgenerally accepted and a drug manufacturerfulfills its legal obligation to warn by providingadequate warnings to the health-care provider,arguments have been advanced that in twoother areas courts should consider imposingtort liability on drug manufacturers that fail toprovide direct warnings to consumers. In thefirst, governmental regulatory agencies havemandated that patients be informed of risksattendant to the use of a drug. A noted exampleis the FDA requirement that birth control pillsbe sold to patients accompanied by a patientpackage insert. In the second, manufacturershave advertised a prescription drug and itsindicated use in the mass media. Governmentalregulations require that, when drugs are soadvertised, they must be accompanied byappropriate information concerning risk so asto provide balanced advertising. The questionin both instances is whether adequate warningsto the appropriate health-care provider shouldinsulate the manufacturer from tort liability.

Those who assert the need for adequatewarnings directly to consumers contend thatmanufacturers that communicate directly withconsumers should not escape liability simplybecause the decision to prescribe the drug wasmade by the health-care provider. Proponentsof the learned intermediary rule argue that,notwithstanding direct communications to theconsumer, drugs cannot be dispensed unless ahealth-care provider makes an individualizeddecision that a drug is appropriate for aparticular patient, and that it is for the health-care provider to decide which risks are relevantto the particular patient. The Institute leaves todeveloping case law whether exceptions to thelearned intermediary rule in these or othersituations should be recognized.When the content of the warnings is mandatedor approved by a governmental agencyregulation and a court finds that compliancewith such regulation federally preempts tortliability, then no liability under this Section canattach. For the rules governing compliance withgovernmental standards generally, see § 4(b).Restatement (Third) of Torts: ProductsLiability § 6(d) cmt. e, at 148- 49 (1998).

Consistent with comment e to the Restatement (Third)of Torts, I would follow the American Institute of Law'sproposal that prescription drugs which are marketed viathe mass media should be treated as a distinct category.Because government regulations already require thatthese heavily-marketed drugs must include appropriaterisk-related information as part of the advertisingmaterials, there is an established procedure for requiringthat the manufacturers of such drugs disclose pertinentwarning-related information concurrent with themarketing of these pharmaceuticals. Where the need forthe doctrine's adoption is most clear is where the drugsat issue were not the subject of a massive advertisingcampaign and/or where the physician did in fact assumethe role of a "learned intermediary" in advising andrecommending that the plaintiff/patient use a particulardrug. And, in the case of a defective drug, themanufacturer should always be required to advise boththe pharmacies and all the direct purchasers of the drugat issue as to the nature of the product concerns.

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Because I believe that the issue of adequatepharmaceutical warnings is one that will largely dependon the unique circumstances of the case, I think it wasunwise to completely cast aside the learnedintermediary doctrine. Furthermore, by attaching undueimportance to the effects of direct marketing, themajority downplays the continuing and vital role that aphysician plays in the decision as to which prescriptiondrugs are appropriate for a given patient based upon thatparticular individual's specific medical needs. In thosecircumstances where the physician has receivedextensive warning material regarding the effects of aspecific drug and makes an individualized decision toprescribe that medication based on such information,there is a valid and continuing rationale for permittingthe learned intermediary doctrine to operate. Where onthe other hand, a physician advises against the use of aspecific drug and the consumer insists on a particularmedication based on his or her exposure to a massiveadvertising campaign for a specific drug, the need forthe doctrine's application is arguably reduced. But topresume, as the majority appears to, that the merepresence of pharmaceutical advertising in our societyrelegates the role of the physician to a mere dispensaryof prescriptions is simply not true. In those cases wherethe medications are prescribed in a traditional fashionwith the physician carefully weighing the advantagesand disadvantages of a given drug for a patientpresenting with specific concerns, to deny on an across-the-board basis the application of the learnedintermediary doctrine--a doctrine that has been appliedthroughout this country for years--seems bothprecipitous and unwarranted. Accordingly, I dissent.

I am authorized to state that Justice Benjamin joins inthis dissenting opinion.

MAYNARD, Justice, concurring:

Suppose Patient John Doe visits his small-town WestVirginia doctor. Further suppose he is prescribed a drugby his doctor that causes him serious injury. Supposethat the drug is one that is heavily advertised. PatientDoe then sues his West Virginia doctor and the drugmanufacturer for the injury caused by the drug. If thisCourt were to adopt the learned intermediary doctrine,the West Virginia doctor would remain in the lawsuit,

but the drug manufacturer would not remain in the suitand would not be liable for damages if the drugmanufacturer could show that it warned the doctor ofthe risks of injury associated with the drug. Thus, asmall-town West Virginia doctor would become solelyresponsible for the injury to Patient Doe while an out-of-state multi-million dollar drug manufacturer is offthe hook. This would be the result if the dissentingJustices had their way in this case. This result simplywould be unfair.

One need only look at the massive amounts of direct-to-consumer advertising done by *918 drugmanufacturers in this country to understand this truth.Americans cannot watch an hour of television or skimthrough a magazine without being bombarded bycommercials and advertisements extolling the benefitsof Viagra, Vioxx, Prilosec, Claritin, Paxil, Zocor,Celebrex, Flonase, Allegra, Pravachol, Zyrtec,Singulair, Lipitor, Nasonex, Lamisil, and others. Thefact is that drug manufacturers spend about four billiondollars annually on direct-to-consumer pharmaceuticaladvertising. [FN1] Thanks to these expensiveadvertising campaigns, we consumers are well educatedabout the salutary effects of these drugs. There is noreason why we should not be just as educated abouttheir potential risks. In sum, because of direct-to-consumer advertising, drug manufacturers have aready forum in which to warn health care consumersabout the risks of their products. For this reason, theyshould not be exempt from the general duty to warn thatthis State places on manufacturers. It is a simple matterof fairness.

FN1. Daniel L. Pollock, Blame Canada (AndThe Rest Of The World): The Twenty-Year WarOn Imported Prescription Drugs, 30 Seton HallLegis.J. 331, 345 (2006).

When this Court decides medical malpractice cases, thesingle most important policy issue to consider is thebest interests of patients. In other words, what resultgives patients the best medicine and promotes the besthealth care practices. Quite simply, the goal is to helppatients. If this Court were to adopt the learnedintermediary doctrine, drug manufacturers would havelittle incentive to carefully warn patients, the ultimate

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consumers of drugs, about the risks associated withthose drugs. This is bad policy. On the other hand, bydeclining to recognize the learned intermediarydoctrine, this Court ensures that drug manufacturers,which developed, promoted, and profited from thedrugs, are charged with carefully warning both patientsand doctors about the risks associated with the drugs.As a result, patients are able to make a more informeddecision about their medical treatment.

I also find it significant that the learned intermediarydoctrine is an exception to our general products liabilityrule that manufacturers have a duty to warn consumersabout the risks of their products. Ultimately, drugs are aproduct like any other. If a plaintiff sued John Deereafter being injured by one of its lawnmowers, no onewould accept John Deere's argument that the local JohnDeere lawnmower dealer alone should be liable sincethe dealer is a lawnmower expert who had a duty towarn about the product's risks. Similarly, Toyota couldnot shield itself from a products liability lawsuit byclaiming that the Toyota dealer alone, not the Toyotamanufacturer, had a duty to warn about risks associatedwith the vehicle. Neither would the argument of asprinkler system manufacturer prevail that only thecontractor, and not the manufacturer, had a duty to warnthat the system may fail during a fire. Finally, the sameis true of medical devices such as pacemakers orartificial hips. There is just no good reason to exceptdrug manufacturers from our general products liabilityduty to warn.

Finally, it has been suggested that the learnedintermediary doctrine is so riddled with exceptions, theexceptions would swallow up the rule. If this is so, whyshould this Court adopt a new rule that wouldessentially be of no effect? The way I see it, the learnedintermediary doctrine is either useless, a doctrine thatserves no real purpose, or harmful to West Virginiadoctors and patients. For these reasons, as well as thoseset forth in the majority opinion, I concur.

STARCHER, J., concurring.

(Filed June 29, 2007)I concur with the majority's decision to not adopt the"learned intermediary" doctrine. What the majority

opinion's lengthy discussion suggests, and thedissenting opinion's tenor makes clear, is that thelearned intermediary doctrine is a bad public policy thatis so laced with contradictions, caveats and exceptionsthat it is impossible to apply the doctrine fairly andconsistently. The doctrine is a giant toothless tiger thatcauses great mischief, but accomplishes little good.

The doctrine therefore has no place in our common law.Simply because many other jurisdictions have adoptedthe doctrine isn't *919 enough to say the doctrine isrational, fair, and good public policy. My motheralways said to me that "just because other people aredoing it doesn't mean it's the smart thing to do." Thereshould first be a good reason before the Court adopts amajor alteration to our jurisprudence; following otherstates off the cliff like lemmings isn't enough.

Drug companies spend years developing drugs, andmore years testing the use and effect of drugs onvarious medical conditions, and more years being theexclusive manufacturer, marketer and distributor ofdrugs. In all that time, it is the drug manufacturer thathas the best opportunity to discern the proper andimproper uses of a drug. And in all that time, the drugmanufacturer has the best opportunity to carefully craftinstructions regarding the safest uses of the product.

In a typical "failure to warn" product liability lawsuit,we say that a product is defective when the labeling,instructions or warnings didn't sufficiently warn theproduct's end-consumer of some hazard.

At its heart, the learned intermediary doctrine isdesigned to artificially shift liability away from thecareless manufacturer of a product, and onto aninnocent intermediary who is responsible fordistributing the defective product to the consumer. Thedoctrine says that if the manufacturer warns anintelligent, trained middleman that the product isdangerous if used a certain way, then the manufacturerhas no liability to the end-consumer if the middlemanfails to pass on the warnings.

In the context of prescription drugs, the learnedintermediary doctrine makes doctors the insurers ofmajor pharmaceutical companies. Under the doctrine,the drug companies can profit by marketing their drugs

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directly to consumers, but they only have to givewarnings of known hazards to doctors. The presumptionis that patients are too simpleminded to understand theinstructions and warnings, so they don't even need toknow they exist. And because the doctor is "learned,"then the warnings don't have to be short and simple;instead, the instructions can drone on for pages so thatonly the highest trained doctor with tons of free time onhis or her hands will be able to decipher the safe, anddangerous, uses for the drug. The doctor becomes solelyresponsible for making the product safe, not themanufacturer.

I refuse to subscribe to such an archaic and parochialview of the law.

Our product liability law is motivated by many validpublic policies, one of which is to improve the safety ofproducts by improving the warnings and instructionsthat end-consumers receive. Adopting the learnedintermediary doctrine in the context of prescriptiondrugs impinges upon this public policy. The doctrinediscourages drug companies from placing clear andsuccinct warnings and instructions on their products. Itdiscourages giving any warnings to end-consumers, anddiscourages clear warnings to physicians. And itpresumes that physicians have the training and the timeto discern every potential problem that a drug maycause a consumer.

The majority opinion's rejection of the doctrinerecognizes that patients should have a say in theircourse of treatment. Patients can read the labels,instructions and warnings, and if the manufacturermakes them clear enough, then patients can be proactivein working with their doctors to receive the best care.Patients can read the manufacturer's instructions and asktheir doctors about drug interactions, or about adversedrug reactions and side effects.

And refusing to adopt the learned intermediary doctrinedoes nothing to alter a doctor's duty of care toward thepatient. A doctor always has a duty to obtain theinformed consent of a patient for a course of treatment.To me, this means that doctors have always had, andwill always have, a duty to talk to their patients aboutthe proper uses, improper uses, and risks of drugs and

medical devices. Nothing in the majority opinionchanges a doctor's rights and responsibilities. Byrejecting the doctrine, the gist of the majority opinion isto say that the party making all the money in thistransaction--that is, the drug manufacturer--cannotescape responsibility for their actions or inactions. Justlike a doctor has always done, *920 the drugmanufacturer must attempt to fully and understandablyinstruct the end-consumer of the proper and improperuses for the product.

There are, of course, some occasions where there is noconceivable way for a drug manufacturer to giveinstructions and warnings to the end-consumer. Forinstance, patients in the emergency room or in surgeryhave little ability to read warnings, and all decision-making must rest in the learned intermediary--thedoctor, or the nurse, or the paramedic. And besides, theend-consumer isn't the one "using" the product in thatcircumstance. It is the medical care provider who ismaking all the decisions.

There may also be instances where the doctor choosesto prescribe a drug in an "off label" and experimentalway. However, existing product liability law alreadyholds that a manufacturer is not expected to warn ofhazards caused when the product is used inunanticipated ways. [FN1]

FN1. If a doctor uses or prescribes a drug in anunanticipated, experimental way, then anysubsequent lawsuit is likely going to begoverned by standard malpractice liability law:did the doctor breach the standard of care owedto the patient? However, if a doctor uses a drugin an experimental way, but was encouraged todo so by the drug manufacturer, then undersuch circumstances the drug manufacturer hasa duty to reasonably instruct and warn ofknown hazards.

But in most instances, drug manufacturers can providewarnings and instructions to the end-consumer. Labelscan be placed on bottles, pamphlets tucked into boxes,and brochures packed in with the boxes of drugs ordevices shipped to hospitals and doctors' offices.Samples distributed in doctor's offices can have

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warnings affixed to the sample boxes. Pharmacists canand already do tape warnings onto pill bottles, and ofteninclude printed instructions and warnings with anymedication that is dispensed. Before or after surgery,the end-consumer could--if necessary--receive apamphlet describing the drug or implanted medicaldevice, instructing how it should be used and warningof known problems. And so on.

In sum, I am entirely against adopting the learnedintermediary doctrine into our product liability law. Ourexisting law of contribution and indemnity, ofcontributory negligence, and of joint and severalliability, serves us well in allocating fault when amanufacturer inadequately instructs and warns about thesafe and dangerous uses of a product.

I therefore concur with the majority opinion.

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