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____________________________________________________________________________________________Portfolio Media, Inc. | 648 Broadway, Suite 200 | New York, NY 10012 | www.law360.comPhone: +1 212 537 6331 | Fax: +1 212 537 6371 | customerservice@portfoliomedia.com______________________________________________________________________Pharmacogenomics And The "Learned Intermediary"Friday, Sep 28, 2007 --- Pharmacogenomics—the notion that drug therapiescan be tailored to an individual’s genetic makeup—is one of the greatbreakthroughs for the pharmaceutical and medical device industries.It is a research area that promises advances in more effective drugadministration by identifying populations for whom certain drugs are likely tobe most effective, thereby avoiding unnecessary use of such drugs inpopulations for whom the drug may not be effective.Moreover, pharmacogenomics may help address certain safety concerns ifhealthcare providers can look at genetic data to identify patients who wouldbe genetically predisposed to adverse reactions to certain drugs.In addition to medical and scientific unknowns about these advancements in“personalized medicine,” uncertainty exists in a number of related legalissues, such as the “learned intermediary doctrine.”It is unclear how the learned intermediary doctrine may play in personalinjury cases involving pharmcogenomic-based drugs and how it will exist, ifat all, in this brave new world of personalized medicine.The learned intermediary rule acts to insulate drug manufacturers fromliability if they provide adequate product warnings and instructions tophysicians.[1]The doctrine is rooted in the 1948 decision, Marcus v. SpecificPharmaceuticals Inc. In this failure-to-warn case, the court drew a distinctionbetween drugs sold to the public directly and those necessitating aphysician’s prescription.[2]The intervention of a prescribing doctor shielded the drug manufacturer fromliability.The actual phrase, “learned intermediary,” was first used in 1966 in SterlingDrug, Inc. v. Cornish.[3] There, the court reasoned that if physicians werewarned by manufacturers of a drug’s potential side effects, the doctor, as the“learned intermediary,” would be in the best position, as liaison between themanufacturer and the consumer, to protect patients from adverse drugreactions.[4]One of the strongest rationales to cloak the physician with potentialliability–while shielding the manufacturer -was the perceived inability ofmanufacturers to adequately inform and personally warn consumers of_____________________________________________________________________________________________All Content Copyright 2007, Portfolio Media, Inc. 1

____________________________________________________________________________________________potential side effects.[5]Under the learned intermediary rule, the manufacturer bears the duty to warnonly the physician of product risk, not the patient directly.[6]Physicians, as informed decision makers, have the duty to then relay productwarnings to patients on a case-by-case basis.[7] Thus, the physician, not themanufacturer, incurs liability for adverse drug reactions in thesefailure-to-warn cases.Opponents of this rule argue that because of the proliferation ofdirect-to-consumer drug promotion through mass media outlets, patients nowplay a more active role in deciding which drugs to use.As a result, they argue, drug companies can no longer deny theirresponsibility or ability to inform consumers about product risks andconsequently escape liability by hiding behind the shield of the learnedintermediary defense.[8]In situations where the patient has greater control in choosing drug productsor where there is limited communication between physicians and patientsregarding drug selection, several courts have recognized three generalexceptions to the learned intermediary rule.The first exempts mass immunizations. The rationale behind this exception isthat mass inoculations are generally administered to the entire populationwithout the physician’s balancing of associated risks.[9]These courts reason that because there is no learned intermediary to relaythe risks involved, the manufacturer has the duty to warn consumers directlyof all relevant information pertaining to the vaccine’s safety.[10]The second exception, which has been rejected by most jurisdictions, is fororal contraceptives.[11] Here, the basis lies in the patient’s unique position tochoose whether to use the pill and the reduced role of the physician as theprimary decision maker.[12]The third exception is for directly advertised drugs.In a recent decision, State of West Virginia Ex. Rel. Johnson & JohnsonCorp. v. Karl, the court considered whether adequate warnings to health-careproviders should insulate the manufacturer from tort liability. [13]Following the lead of the landmark decision, Perez v. Wyeth Labs Inc., theWest Virginia court concluded that manufacturers who communicate directlywith consumers should not escape liability, and furthermore that there is aduty to warn both the physician and the patient-consumer of productrisks.[14]The Perez court previously held that the learned intermediary doctrine did not_____________________________________________________________________________________________All Content Copyright 2007, Portfolio Media, Inc. 2

____________________________________________________________________________________________apply to prescription drugs advertised directly to consumers, reasoning thatthe shield had dissipated because patients were playing an increased role intheir medical decision making.[15]Furthermore, money spent on direct-to-consumer advertising evidenced thatthe manufacturer was able to warn consumers directly of risks associatedwith drugs, thereby alleviating a concern which originally placed the doctor inthe line of liability.[16]Not all jurisdictions see direct-to-consumer advertising as the end of thelearned intermediary defense. In fact, since the issuance of the 1997 Foodand Drug Administration (“FDA”) guidance on broadcast advertisements,which triggered the upsurge in direct-to-consumer advertisements, four of thehighest state courts have adopted the doctrine.[17]Furthermore, several federal courts have faced the issue of whether to applythe direct-to-consumer exception. These courts have refused to implementthe exception because no other states had adopted the Perez rationale.[18]Where does personalized medicine fit in with these latest developments inthe arena of the learned intermediary? As this doctrine, which hastraditionally served as a shield for pharmaceutical manufacturers, is eroded,the question remains as to who will shoulder the liabilities in the new age ofpharmacogenomics? The answer is: It depends.Drug effectiveness is often determined by genetic variations that affect themetabolism, transport, distribution, absorption and excretion of the drug. [19]Products of pharmacogenomics already include: Herceptin, a drug used inbreast cancer patients;[20] Erbitux, which is used for colorectal cancer;[21]and Gleevec, used for chronic myeloid leukemia and gastrointestinal stromaltumors.[22] These drugs already take advantage of individualized geneticinformation. Still, the real wave of pharmacogenomics is still a long way off.Thus, while pharmacogenomics will no doubt decrease the consequences ofthe “trial and error” drug administration associated with clinical practice,which some believe results in as many as 3 million ineffective drugprescriptions each year,[23] it is still far from clear how consumers will obtainthese drugs.Will there be direct-to-consumer advertising for drugs which may have fewertakers than today’s blockbuster medications? Will genetic information need tobe communicated by specialists or will present day practitioners be theprimary source of information and advice for most consumers? What role, ifany, will manufacturers have in informing healthcare practitioners about theimplications of genetic information in drug effectiveness?The method by which drugs are promoted and drug presecriptions written —and how pharmacogenomically-based medicines arrive on the medicine shelfof consumers — may play a significant role in how powerful an ongoing_____________________________________________________________________________________________All Content Copyright 2007, Portfolio Media, Inc. 3

____________________________________________________________________________________________The author wishes to acknowledge the able assistance of Amy Chung, anassociate at Sedgwick, and Margot Wilensky, a 2007 Sedgwick summerassociate, in the preparation of this article.Eric M. Kraus, a partner with Sedgwick, concentrates his practice on complexcivil litigation matters with an emphasis on pharmaceutical products andmedical device liability.[1] Thom v. Bristol-Myers Squibb Co., 353 F.3d 848, 851 (10th Cir. 2003);Brook v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984); Davis v. WyethLabs., Inc., 399 F.2d 121, 130 (9th Cir. 1968); Vitanza v. Upjohn Co., 778A.2d 829, 836-37, 257 Conn. 365, 376 (Conn. 2001); Restatement (Third) ofTorts: Prods. Liab. § 6(d)(1); Castagnera, James Ottavio and Richard RyanGerner, The Gradual Enfeeblement of the Learned Intermediary Rule and theArgument in Favor of Abandoning it Entirely, 36 Tort & Ins. L.J. 119, 122(2000).[2] 77 N.Y.S.2d 508, 509 (1948).[3] 370 F.2d 82, 85 (8th Cir. 1966)[4] Id.[5] Perez v. Wyeth Labs., Inc., 734 A.2d 1245, 1254-55 (N.J. 1999).[6] Larkin, 153 S.W.3d 758, 762 (Ky. 2004); Restatement (Third) of Torts:Prods. Liab. § 2 cmt. i; Cohoon, Patrick, An Answer to the Question Why theTime Has Come to Abrogate the Learned Intermediary Rule in the Case ofDirect-to-Consumer Advertising of Prescription Drugs, 42 S. Tex. L. Rev.1333, 1334 (2001)..[7] Larkin v. Pfizer, 153 S.W.3d at 763; Restatement (Third) of Torts: Prods.Liab. § 6 cmt. b.[8] State of West Virginia Ex. Rel. Johnson & Johnson Corp. v. Karl,, 647S.E.2d 899, 909 (W.Va. 2007).Castagnera, supra note 5, at 119-120.[9] Reyes v. Wyeth Labs., Inc., 498 F.2d 1264, 1277 (5th Cir. 1974); Davis v.Wyeth Labs., Inc., 399 F.2d 121, 131 (9th Cir. 1968); Cunningham v. CharlesPfizer & Co., 532 P.2d 1377, 1381 (Okla. 1974).[10] Cf., Plummer v. Lederle Labs., 819 F2d 349 (2d Cir.), cert denied, 484U.S. 898 (1987) (holding that the learned intermediary doctrine applies in thecase at hand since, unlike in a clinic setting, the injured child was vaccinatedby the physician in the physician’s office).[11] See In re Norplant Contraceptive Liab. Litig., 955 F.Supp 700, 704,05(E.D.Tex 1997)._____________________________________________________________________________________________All Content Copyright 2007, Portfolio Media, Inc. 5

____________________________________________________________________________________________[12] MacDonald v. Ortho Pharm. Corp., 394 N.E.2d 65, 70 (Mass 1985).[13] 647 S.E.2d 899 (W.Va. 2007).[14] Id. at 913.[15] Perez, 734 A.2d at 1255.[16] State of West Virginia, 647 S.E.2d at 908.[17] Vitanza v. Upjohn Co., 257 Conn. 365, 778 A.2d 829 (2001); McCombsv. Synthes, 277 Ga. 252, 587 S.E.2d 594 (2003); Larkin v. Pfizer, Inc., 153S.W.3d 758 (Ky.2004); Freeman v. Hoffman-La Roche, Inc., 260 Neb. 552,618 N.W.2d 827 (2000).[18] See In re Meridia Prods. Liab. Litig., 328 F.Supp.2d 791, 812 n. 19 (N.D.Ohio 2004) (holding that while the Perez opinion is well-reasoned, no otherstate has adopted it and therefore, the Court would not apply it); Colacicco v.Apotex, Inc., 432 F.Supp.2d 514, 547 n.30 (E.D.Pa. 2006) (noting that nostate had followed New Jersey’s lead in Perez in adopting the DTC exceptionand that “absent an intervening change in the applicable law, in this Court’sview, Pennsylvania law does not provide any exception to the LID based ondirect-to-consumer advertising); Beale v. Biomet, Inc., 492 F.Supp.2d 1360,1376-77 (S.D.Fla. 2007) (declining to adopt the exception because of“Florida’s longstanding recognition of the learned intermediary doctrine” andbecause no other states in the eight years since the Perez decision hadrecognized the exception).[19] Liebert, Mary Ann, Realizing the Promise of Pharmacogenomics:Opportunities and Challenges, 26 Biotechnology L. Rep. 261, 266 (2007).[20] Kelton, Teresa, Pharmacogenomics: The Re-Discovery of the Conceptof Tailored Drug Therapy and Personalized Medicine, 19 NO.3 Health Law.1, 5 (2007).[21] Erbitux,[22] Gleevac,[23] Liebert, supra note 19, at 266.[24] Kumorowski, Victoria M., Assessing Legal Liability in PharmacogeneticCases, 42 Washburn L.J. 623, 626 (2002-2003)._____________________________________________________________________________________________All Content Copyright 2007, Portfolio Media, Inc. 6

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