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Last year, pharmaceutical companies reportedly spent $4.5 billion on direct advertising to consumers, or about 400 times more than they spent 20 years ago. Drug company spending on advertising to consumers is increasing twice as fast as spending on promotions to physicians or on the research and development of new drugs. Given this exponential growth in direct-to-consumer advertising, it is hardly surprising that prescription drug makers’ traditional immunity from consumer “failure-to-warn” claims has increasingly come under assault. Although many courts have resisted calls from the plaintiffs’ bar to allow such claims, recent decisions have created uncertainty about the future. Under the “learned intermediary doctrine,” drug manufacturers are not liable for failing to warn consumers of risks associated with prescription drugs as long as they disclose those risks to doctors. The New Jersey Supreme Court held in a landmark decision eight years ago that this rule did not protect drug manufacturers when they advertise directly to consumers. Perez v. Wyeth Labs. Inc., 734 A.2d 1245 (N.J. 1999). More dramatically, in June, the West Virginia Supreme Court of Appeals rejected the learned intermediary doctrine in its entirety, on the ground that direct-to-consumer advertising made the rule “outdated.” Johnson & Johnson v. Karl, No. 33211, 2007 WL 1888777, at *8 (W.Va. June 27, 2007). Time will tell whether Perez and Johnson & Johnson are harbingers of things to come. As a general rule, prescription drug manufacturers are legally obligated to disclose dangers inherent in their products. Restatement (Third) of Torts � 6 (1998). The reasons are obvious. Warnings help consumers use these drugs properly and enable them to make informed decisions about whether to use them at all. In many jurisdictions, however, a prescription drug maker need only warn the prescribing physician, not the end consumer, of the risks its product poses. Once the manufacturer warns the doctor, or “learned intermediary,” who is expected to pass the information along to the patient as necessary, the company’s legal duty is satisfied and it is immune from liability for any failure to warn the end consumer. Courts have given four reasons for adopting the learned intermediary rule. First, patients justifiably rely on their physicians’ advice, and the doctor-patient relationship should not be undermined by transferring liability from doctors to pharmaceutical companies. See, e.g., Seley v. G.D. Searle & Co., 324 N.E. 831, 840 (Ohio 1981). Second, physicians’ direct contact with patients puts them in a better position than drug manufacturers to weigh and communicate to individual patients the risks associated with a particular course of treatment. Id. Third, most patients lack the scientific training needed to understand the risks of a prescription drug without the help of their physician. See, e.g., West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991). Finally, drug manufacturers generally lack an effective means to communicate with patients because drugs are prescribed through doctors and distributed by pharmacies. See, e.g., Reaves v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1290 (E.D. Mich. 1991). For these reasons, many courts have concluded that it would be unreasonable to expect drug manufacturers to disclose risks directly to each and every patient. Moreover, plaintiffs have repeatedly criticized the learned intermediary doctrine for artificially assuming that doctors can disclose every risk to each patient, disregarding the fact that prescription drug package inserts often contain disclosures on which patients rely, and ignoring the pressure patients often exert on doctors to prescribe particular medications. Such criticisms have persuaded some courts to create exceptions to the learned intermediary doctrine when they have concluded that doctors could not realistically be expected to act as the conduit for information about product risks, or that the choice of product was patient-driven. See, e.g., Davis v. Wyeth Labs. Inc., 399 F.2d 121, 130 (9th Cir. 1968) (mass immunization); MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 68-70 (Mass. 1985) (oral contraceptives); Hill v. Searle Labs., 884 F.2d 1064, 1071 (8th Cir. 1989) (contraceptive devices); Proctor v. Davis, 682 N.E.2d 1203 (Ill. Ct. App. 1997) (risks drug manufacturer did not disclose to doctor); Nichols v. McNeilab Inc., 850 F. Supp. 562 (D. Mich. 1993) (drug recalled from market after it was prescribed). The holding in ‘Perez’ In Perez, the New Jersey Supreme Court eroded the learned intermediary doctrine still further by recognizing the “direct-to-consumer advertising” exception. In that case, five women sued the manufacturer of Norplant, a contraceptive implant. They alleged that the defendant had failed to provide adequate warnings of various side effects. The defendant moved for summary judgment on the ground that under the learned intermediary doctrine, it had no duty to provide warnings to the plaintiffs. The plaintiffs argued that the learned intermediary doctrine should not immunize the manufacturer from liability because the latter had engaged in a “massive advertising campaign” directed at women, rather than their physicians, to convince them to choose the contraceptive, and none of the ads warned of Norplant’s potential side effects. 734 A.2d at 1248. The trial court granted summary judgment in favor of the defendant, and the Appellate Division affirmed. The New Jersey Supreme Court reversed, holding that if a drug manufacturer engages in direct-to-consumer advertising to influence a patient’s choice of a drug, the manufacturer has a duty to warn consumers directly of the risks associated with its product. The Perez court allowed only a rebuttable presumption that the company has satisfied its duty if it proves that it complied with Food and Drug Administration (FDA) regulations requiring print and broadcast prescription drug advertisements to state the drug’s “side effects, contraindications, and effectiveness.” Id. at 1257-60 (citing 21 U.S.C. 352(n)). The recent West Virginia ruling These incremental erosions of the learned intermediary doctrine culminated most recently in the West Virginia Supreme Court of Appeals’ pronouncement in Johnson & Johnson that direct-to-consumer advertising has made the learned intermediary doctrine simply “outdated.” 2007 WL 1888777 at *8. In so holding, the court explained that “[w]hen the learned intermediary doctrine was developed, direct-to-consumer advertising of prescription drugs was utterly unknown” and “the prevailing attitude of law and medicine was that the ‘doctor knows best.’ ” Id. at *10 (citation omitted). Given the “ proliferation of drug advertising” and “the impact direct-to-consumer advertising has had on the physician/patient relationship” has had over the past decade, the court reasoned, it is no longer “unreasonable that prescription drug manufacturers should provide adequate warnings to the ultimate users of their products.” Id. at *12, *17. Citing Perez, the Johnson & Johnson court concluded that direct-to-consumer advertising “obviates each of the premises on which the [learned intermediary] doctrine rests”: “if drug manufacturers are able to adequately provide warnings to consumers under the numerous [existing] exceptions to the learned intermediary doctrine, then they should experience no substantial impediment to providing adequate warnings to consumers in general.” Id. at *17. Until Johnson & Johnson, the reported opinions discussing Perez came mainly from federal courts sitting in diversity that simply punted on the question of whether to recognize a direct-to-consumer advertising exception because the plaintiffs failed to prove reliance on such advertising (e.g., Madsen v. American Home Prod. Corp., 477 F. Supp. 2d 1025, 1034 n.13 (E.D. Mo. 2007)), or came from states that recognized the learned intermediary doctrine but had not yet addressed Perez (e.g., In re Norplant Contraceptive Prod. Liab. Litig., 165 F.3d 374, 377 (5th Cir. 1999); Cowley v. Abbott Labs. Inc., 476 F. Supp. 2d 1053, 1060 (W.D. Wis. 2007); Colacicco v. Apotex Inc., 432 F. Supp. 2d 514, 547 n.30 (E.D. Pa. 2006); In re Vioxx Prod. Liab. Litig., 239 F.R.D. 450, 456 n.8 (E.D. La. 2006)) or had not shown that the advertising at issue failed to comply with FDA regulations (e.g., In Re Meridia Prod. Liab. Litig., 328 F. Supp. 2d 791, 812 n.12 (N.D. Ohio 2004), aff’d. 447 F.3d 861 (6th Cir. 2006) (describing Perez as “certainly well reasoned”)). Potential impact of ‘J&J’ It remains to be seen whether courts will be less inclined to punt on the latter two grounds in the wake of Johnson & Johnson. Courts adopting the learned intermediary doctrine have described it as overwhelmingly the majority view, but they disagree on the size of the majority. Compare In re Norplant, 215 F. Supp. 2d 795, 806-09 (E.D. Texas 2002) (asserting that courts in 48 states, the District of Columbia and Puerto Rico have recognized the learned intermediary doctrine) with Vitanza v. Upjohn Co., 778 A.2d 829, 838 n.11 (Conn. 2001) (listing 44 jurisdictions) and Larkin v. Pfizer Inc., 153 S.W.3d 758, 768 (Ky. 2004) (listing 34 jurisdictions). As the West Virginia Supreme Court pointed out in rejecting the doctrine in Johnson & Johnson, if one disregards decisions of lower state courts and federal courts sitting in diversity, only a minority of state supreme courts and legislatures have actually mandated the application of the learned intermediary doctrine in prescription drug cases. 2007 WL 1888777 at *4-6. Moreover, Johnson & Johnson appears to go further than Perez by not recognizing any “safe harbor” for drug manufacturers that comply with the FDA’s regulations governing drug advertisements. Apparently the drug manufacturer’s only options in West Virginia and other states that might follow Johnson & Johnson are to persuade the trier of fact that its warnings were adequate without the benefit of any presumption that the FDA knew what it was doing if it pre-approved the advertisements (an unappealing prospect for drug companies sued in hostile fora) or to sue the doctor for contributory negligence (an equally unattractive result for doctors). See id. at *18 (“our existing law of comparative contribution among joint tortfeasors is adequate to address issues of liability among physicians and drug companies”). Courts considering whether to follow Perez or Johnson & Johnson will face important policy concerns. Those concerns will likely frame the debate in future cases in which courts must decide whether to adopt a direct-advertising exception to the learned intermediary doctrine or even abandon the doctrine altogether. Case for an exception Proponents of a direct-to-consumer advertising exception argue that it ensures that advertisements created by prescription drug manufacturers give consumers a sufficient understanding of the risks posed by a medication. They argue that this is necessary for several reasons. First, the expansion of managed health care systems has placed pressure on doctors “to perform more services in less time,” leaving them little time to discuss drug warnings with their patients. Tim Hall, “Reimagining the Learned Intermediary Rule for the New Pharmaceutical Marketplace,” 35 Seton Hall L. Rev. 193, 227 (2004). Second, they argue that direct-to-consumer advertising downplays risks “by bombarding patients with slick, misleading television and radio commercials.” Caroline Nadal, Note, “The Societal Value of Prescription Drug Advertisements in the New Millennium: Targeted Consumers Become the Learned,” 9 J.L. & Pol’y 451, 363, 492 (2001). Third, they argue that the average consumer cannot accurately weigh the benefits of a medication against the risk of side-effects when they are presented in a condensed television or radio advertisement. Id. Defenders of the learned intermediary doctrine argue that despite changes in the health care industry, the fact remains that “consumers cannot legally obtain prescription products without a physician’s consent.” Richard Ausness, “Will More Aggressive Marketing Practices Lead to Greater Tort Liability for Prescription Drug Manufacturers?,” 37 Wake Forest L. Rev. 97, 121 (2002). Physicians, not drug manufacturers, are still in the best position to advise individual patients about the risks and benefits of a prescription medication. Id. at 122. Role of consumer ads Consumer advertisements educate the public on warning signs for ailments, and inform them of new treatment options, and thereby enable patients to become more active participants in the delivery of health care. See Jeffrey J. Wiseman, “Annual Survey of South Carolina Law: Another Factor in the Decisional Calculus: The Learned Intermediary Doctrine, the Physician-Patient Relationship and Direct to Consumer Marketing,” 52 S.C. L. Rev. 993, 1016 (2001). Indeed, it has been shown repeatedly that direct-to-consumer advertising encourages patients to talk to their doctors about previously undiagnosed conditions and enables them to receive appropriate treatment. See U.S. Government Accountability Office, Report GAO-07-54 (Nov. 2006). Finally, opponents of direct-to-consumer advertising exceptions claim that courts should abstain from imposing liability on prescription drug makers because the FDA already regulates drug advertising. See Wiseman, 52 S.C. L. Rev. at 1014. Are Perez and Johnson & Johnson the beginning of a trend? If so, we can look forward to even longer and more graphic prescription drug warnings of the kind that are already the fodder for jokes on late-night talk shows. We can also look forward to the ugly prospect of doctors and drug companies suing each other to apportion blame when patients take to the courts. One thing is certain. Direct-to-consumer advertising is not only profitable but also an effective way to involve patients in their own health care, and therefore is here to stay.

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