The Effect of DTC Advertising in Jurisdictions That Have Rejected The Learned Intermediary Doctrine

Transcription

1 The Effect of DTC Advertising in Jurisdictions That Have Rejected The Learned Intermediary Doctrine Paul W. Schmidt * COVINGTON & BURLING LLP 1201 Pennsylvania Avenue N.W. Washington, DC 20004

2 Direct-to-consumer ( DTC ) advertising can affect pharmaceutical litigation in various ways. Plaintiff lawyers may try to show consumer advertisements to a jury during a trial, or they may try to introduce (and misrepresent) regulatory actions taken with respect to that advertising. One of the most serious potential impacts of DTC advertising, though, remains its potential to undermine the Learned Intermediary Doctrine. This article discusses core questions that will arise in pharmaceutical litigation in the two states New Jersey and West Virginia that have wholly or partly eliminated the Learned Intermediary Doctrine. These questions include when the Learned Intermediary Doctrine is eliminated in these states; what patient warnings must be given; how elimination of the Learned Intermediary Doctrine affects physician obligations; and how the elimination of the Learned Intermediary Doctrine implicates preemption concerns. BACKGROUND Almost every state in the country recognizes the Learned Intermediary Doctrine. A list of these states is attached in the appendix. 1 As the Eighth Circuit 1 Among these states are several whose Supreme Court recently recognized the doctrine. See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 770 (Ky. 2004) (acknowledging Perez, but adopting Learned Intermediary Doctrine under Kentucky law); Vitanza v. Upjohn Co., 778 A.2d 829, (Conn. 2001) (confirming, post-perez, that Learned Intermediary Doctrine applies in Connecticut); Freeman v. Hoffman- LaRoche, Inc., 618 N.W.2d 827, (Neb. 2000) (noting widespread acceptance of Learned Intermediary Doctrine and adopting doctrine, post-perez, as Nebraska law). 1

3 observed a few years ago when it predicted that North Dakota would adopt the Learned Intermediary Doctrine, the precedent is truly overwhelming. 2 Two state Supreme Courts, however, have held that DTC advertising obviates the Learned Intermediary Doctrine in part or in whole. In the Perez decision, the New Jersey Supreme Court held that the Learned Intermediary Doctrine does not apply to products that have been subject to DTC advertising. 3 The West Virginia Supreme Court recently went further in the Karl decision, relying on DTC advertising to reject the Learned Intermediary Doctrine altogether, regardless of whether DTC advertising occurred with respect to a given product or not. 4 While other courts have rejected the premise that DTC advertising undermines the Learned Intermediary Doctrine, 5 plaintiff lawyers now predictably 2 Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1017 (8th Cir. 2004). 3 Perez v. Wyeth Labs. Inc., 734 A.2d 1245 (N.J. 1999). 4 Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, (W.Va. 2007); see also id. at (Maynard, J., concurring). 5 See Beale v. Biomet, Inc., 492 F. Supp. 2d 1360, 1376 (S.D. Fla. 2007) ( It is now eight years since Perez was decided, and no other state has followed suit. ); In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791 (N.D. Ohio 2004) (refusing to follow Perez in multidistrict litigation because no state besides New Jersey has recognized direct-to-consumer advertising exception); Hackett v. G.D. Searle & Co., 246 F. Supp. 2d 591, 594 (W.D. Tex 2002) (citations omitted) (rejecting Perez and holding that [t]he Learned Intermediary Doctrine applies even to cases where manufacturers allegedly market directly to consumers, because the prescribing physician is still seen as playing a vital role ); Albertson v. Wyeth Inc., No. 2944, 2003 WL , at *12 (Pa. Comm. Pl. July 8, 2003) (rejecting Perez and holding that, despite advertising of prescription medications, the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate for the patient ); Lennon v. Wyeth-Ayerst Labs., Inc., No EDA 2000, 2001 WL , at *2 (Pa. Super. Ct. June 14, 2001) (same). 2

4 attempt to use the Karl and Perez decisions to evade the Learned Intermediary Doctrine even in states where it has been earlier recognized. The Perez and Karl opinions are subject to obvious policy criticisms, including the fact that their holdings do not flow from the DTC premise on which they rely: while DTC advertising gives manufacturers the opportunity to educate patients about their products, patients can still obtain those products only from medical professionals. 6 These professionals are both licensed and regulated by states: licensed based on their training to prescribe medications and otherwise treat patients; and regulated to ensure that they meet state-set standards of care in prescribing medications. 7 Perez and Karl did not ease the responsibilities placed upon prescribing physicians to understand risks and exercise medical judgment based on their patients individual needs. Instead, these decisions have simply added new responsibilities for pharmaceutical companies that in many instances will conflict with a physician s discharge of her or his responsibilities. 8 6 See 21 U.S.C. 353(b). 7 See, e.g., W. Va. Code (2006); id. 55-7B-3(a)(1). 8 Both physicians and courts have expressed concern over this potential conflict. See William J. Curran, Package Inserts for Patients: Informed Consent in the 1980s, 305 New Eng. J. Med (1981); Larkin, 153 S.W.3d at 764 ( [S]ince the typical manufacturer s warning provides a list with scores of potential side effects, no matter how minute the possibility of occurrence, the lay consumer might overreact to such warnings and forego beneficial, or even vital, medical treatment. ); West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991), aff'd, 879 S.W.2d 412 (Ark. 1994) (expressing concern that direct patient warnings would interfere with the relationship between the doctor and the patient. ); see also Brooks v. Medtronic, Inc., 750 F.2d 1227, 1232 (4th Cir. 1984) ( One in a serious medical condition... as a general matter faces unwanted, unsettling and potentially harmful risks if advice, almost inevitably involved and longwinded, from non- (continued ) 3

5 Setting these policy criticisms aside, though, the Perez and Karl decisions raise important questions about how pharmaceutical cases are litigated under New Jersey and West Virginia law. These questions include: what constitutes DTC advertising for purpose of obviating the Learned Intermediary Doctrine in these states; what is required in a patient warning; what are the physician s responsibilities under a patient warning regime, and how do physician responsibilities affect manufacturer liability; and do patient warning requirements conflict with federal law. DISCUSSION I. When Is the Learned Intermediary Doctrine Eliminated in West Virginia and New Jersey? The West Virginia Supreme Court eliminated the Learned Intermediary Doctrine for all products, regardless of whether they are advertised or not. West Virginia thus apparently requires patient warnings even for the most restricted pharmaceutical products, the use of which is limited to certain specially-trained physicians because of their adverse event profile. The New Jersey Supreme Court attempted to draw a different line in its Perez decision, limiting its evisceration of the Learned Intermediary Doctrine to medicines that are subject to DTC advertising. This, of course, begs the question of what constitutes DTC advertising under the Perez rule. physicians, contrary to what the doctor of his choice has decided should be done, must be supplied to him. ). 4

6 Plaintiff lawyers predictably argue that any form of communication that reaches patients whether in the form of non-branded advertising, patient information materials, or FDA-approved MedGuides constitutes DTC advertising. These arguments could appear with growing frequency as companies make more efforts to provide patient information other than through direct-to-consumer advertising, including if the FDA heavily utilizes the Risk Evaluation and Mitigation Strategies authorized by the Food and Drug Administration Amendments Act of New Jersey law rejects these broad plaintiff definitions of DTC advertising. The Perez decision was clear that it intended its rule to apply only to branded consumer advertising. It discussed branded television advertising in justifying its DTC exception, and it surveyed the regulatory history of consumer advertising (as opposed to other forms of patient education) Plaintiff lawyers also make the related argument that, where companies provide educational materials that may ultimately reach patients, the companies have assumed a duty to warn patients that they can then be held liable for breaching. Courts have uniformly rejected these arguments, both in published decisions, see Presto v. Sandoz Pharm. Corp., 487 S.E.2d 70, (Ga. Ct. App. 1997) (rejecting argument that Sandoz should have warned Greg directly because it did give some direct patient information ) (emphasis in original); Seley v. G.D. Searle & Co., 423 N.E.2d 831, & n.6 (Ohio 1981) (rejecting argument that, by voluntarily giving doctors pamphlets with warnings and instructions in lay language for distribution to patients, the manufacturer extend[ed] its duty to warn under the voluntary duty rule ), and by rejecting plaintiff assumed-duty jury instructions in cases in which the author has been involved. 10 See Perez, 734 A.2d at (discussing Rogaine advertisements and other television advertisements); id. at 1258 (discussing FDA regulation of advertising, as distinct from patient warning materials). 5

7 The New Jersey Appellate Division recently spoke on this point in the Banner case. The plaintiff in that case argued that non-branded advertising, a patient brochure, and related patient warnings materials constituted DTC advertising that allowed her to evade the Learned Intermediary Doctrine under Perez. As the Banner Court stated, these arguments read Perez too broadly. 11 New Jersey thus appears to have sensibly limited the definition of DTC advertising that will obviate the Learned Intermediary Doctrine to branded television or magazine consumer advertising. New Jersey s limitations on what constitutes DTC advertising are consistent with FDA practice regarding DTC advertising. For example, the FDA considers patient brochures to be part of the medication s labeling, rather than advertising. 12 Even where a medication is subject to what is indisputably DTC advertising, plaintiffs must still prove that they saw the advertising and were influenced by it in order to avoid the Learned Intermediary Doctrine. At least one court has expressly reached this conclusion, which flows from basic causation requirements. 13 Absent the consumer actually seeing the purported DTC advertising, there is no basis for 11 Banner v. Hoffmann-La Roche Inc., 891 A.2d 1229, 1236 (N.J. Super. Ct. App. Div. 2006). 12 See 21 C.F.R (L)(2); see also id Appleby v. Glaxo Wellcome, Inc., No. Civ RBK, 2005 WL , at *5 (D.N.J. Dec. 13, 2005). 6

8 proving that the absence of information or presence of misinformation in [the drug] advertising was... a substantial factor in bringing about the harm suffered. 14 II. What Patient Warnings Are Required In West Virginia and New Jersey? A much broader question is what a company must do to meet a duty imposed on it to warn patients directly. The question is complicated, in light of the unique context that led to the adoption of the Learned Intermediary Doctrine in the first place: patients lack medical training, allowing plaintiff lawyers to argue about the volume of information required to warn a patient adequately; and the warnings that might benefit a given patient will vary based on unique patient factors. The case law has not addressed this question in detail. However, existing case law offers some suggestions for reasonable limits on patient warning requirements. These limits must take account of two questions: when a patient must be told about a specific risk; and how that risk information should be communicated. A. Whether To Warn About a Given Risk No developed case law exists regarding when a patient should be warned about a given risk by a pharmaceutical company. While Plaintiff lawyers will no doubt argue for wide-ranging warnings, the patient s limited ability to meaningfully sift through a laundry list of warnings argues in favor of requiring less rather than more warnings. For example, the FDA has determined that, even with physician 14 Perez, 734 A.2d at

9 warnings, it is valuable to identify the most important information in the new Highlights section of the label. Patients will have an even more difficult time tracking through various warnings, and determining which ones are more personally meaningful to them than others, if patient warnings try to capture all known risk information about a medication. This problem would be particularly likely if companies adopted the types of patient warnings that plaintiff lawyers apparently seek warnings about every potential condition for which there is a conceivable safety signal, regardless of how weak that signal is or how rare that condition is. Fortunately, Perez and Karl appear to reject the suggestion that patient warnings should catalogue every possible risk associated with the medication. The Perez court stated that manufacturers who comply with FDA regulations regarding DTC advertising are entitled to the same rebuttable presumption that they are granted by New Jersey statute for their physician package inserts: a rebuttable presumption that the duty to consumers is met by compliance with FDA [advertising] regulations. 15 As the New Jersey Supreme Court more recently reaffirmed, absent deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects, compliance with FDA standards should be virtually 15 Perez, 734 A.2d at The court referred to this latter presumption as compelling evidence that a manufacturer satisfied its duty to warn the physician about potentially harmful side effects of its product. Id. 8

10 dispositive. 16 This presumption that patient warnings are adequate if the relevant DTC advertising complies with FDA regulations helps to ensure that manufacturers are not made guarantors against remotely possible, but not scientifically-verifiable, side-effects of prescription drugs, a result that could have a significant anti-utilitarian effect. 17 FDA regulation of DTC advertising does not require a recitation of the full physician package insert. Instead, print advertisements must meet the brief summary requirement, which can and often is met by reprinting portions of the package insert or by using modified patient labeling that can omit less important risk information. 18 FDA requirements for broadcast advertisements are further limited, mandating a major statement of the most serious and common risks while requiring adequate provision (e.g., a toll-free number or an internet website) of further risk information. 19 Under Perez, each of these types of warnings are presumptively adequate as patient warnings. 16 Rowe v. Hoffman-La Roche, Inc., 917 A.2d 767, 774 (N.J. 2007) (quoting Perez, 734 A.2d at 1245). 17 Perez, 734 A.2d at See, e.g., FDA, Draft Guidance for Industry: Brief Summary Disclosing Risk Information in Consumer-Directed Print Advertisements (Jan. 2004); see also Labson, M., Korenchuk, K., Regulation of Advertising Promotion, and Distribution of Drugs, Medical Devices, and Biologics, FUNDAMENTALS OF LIFE SCIENCES LAW at (2007). 19 See Food and Drug Administration Amendments Act of (d)(3); 21 C.F.R (e)(1); FDA, Guidance for Industry: Consumer-Directed Broadcast Advertisements (Aug. 1999). 9

11 While Karl did not address the interplay between state-mandated patient warnings and FDA rules on DTC advertising, the reasoning of the Karl majority similarly suggested that patient warnings should be limited in scope. One of the concurring Justices to the Karl opinion 20 stated his view that patient warnings should be clear and succinct. This opinion contrasted the desired short and simple patient warnings with lengthier existing physician warnings. 21 The plain upshot of this desired simplicity is that manufacturers must draw lines, focusing their warnings on some set of more serious conditions for which there is a real potential association, more common conditions as opposed to rare conditions, and more serious problems such as drug interactions that can be prevented by patient conduct. In this regard, manufacturer patient warnings could be harmonized with state-law informed consent doctrines. 22 While it makes perfect sense for the law to require physicians to receive warnings that they may not pass on to their patients, it seems perverse to hold manufacturers to a higher warnings standard for patients they never meet and whose medical history they know nothing about. 20 Karl, 647 S.E.2d at 919 (Starcher, J., concurring) (rejecting Learned Intermediary Doctrine because it discourages drug companies from placing clear and succinct warnings and instructions on their products ). Because Karl was a 3-2 decision, each concurrence was necessary to the outcome. 21 Id. 22 Perez, for example, explicitly relied on the growth in the informed consent doctrine to justify its requirement of direct patient warnings in instances where products are subject to DTC advertising. See Perez, 734 A.2d at

12 Informed consent doctrines determine when a physician has met her or his obligations to inform a patient about the risks of treatment. Under informed consent regimens, of course, a patient need not be warned of every single risk or given full information about every single risk associated with a medication treatment. In a state like New Jersey, this requires a focus on what a reasonably prudent plaintiff would have wanted to know, a very different standard than simply forcing defendants to accept claims advanced by individual plaintiffs that they would not have used a medication if only they had been given a slightly different warning. 23 Moreover, because the proximate cause inquiry under an informed consent regime like New Jersey s is essentially the same as applies to manufacturers with regard to defective warnings, 24 manufacturers should be able at a minimum to divide liability with physicians where they warned the physician but where neither the physician nor the manufacturer warned the patient. B. Manner of Warning About Risk A separate question is what must be said about a specific risk in order for the warning to be legally adequate. While substantial case law regarding physician warnings holds them to be adequate as a matter of law when they unambiguously reference the risk at issue, plaintiff lawyers may seek to compel manufacturers to provide even more information about a given symptom or disease in their patient warnings than they do in their physician package inserts. For example, a package 23 Canesi ex rel. Canesi v. Wilson, 730 A.2d 805, 812 & n.3 (1999). 24 See id. at

13 insert may reference hypertension as a potential medication effect. Plaintiff lawyers might argue that patient warnings may not merely warn of hypertension, but instead must explain what hypertension is, how to monitor for it, and what its long-term effects might be. In other words, plaintiff lawyers will argue that pharmaceutical companies must medically train patients on the potential risks associated with their products. Fortunately, even regimes as broad as the Karl regime seem to reject these types of warnings. As noted, one of the Karl Justices concurred in the outcome based on his view that patient warnings should be clear and succinct, as contrasted to lengthier physician warnings. 25 Maintaining clear and succinct patient warnings would require simply warning about the condition or symptom, without providing patient education about these conditions or symptoms that would turn each patient warning into something approaching a textbook. Similarly, the Karl concurrence appeared to cabin its patient warnings regime by relying on continued interaction between patients and their physicians: Patients can read the manufacturer s instructions and ask their doctors about drug interactions, or about adverse drug reactions and side effects. 26 The Karl court thus plainly contemplated that express warnings or even warnings of related conditions, or underlying symptoms could be legally adequate. Such warnings meet the Court s stated desire for short and simple warnings while 25 Karl, 647 S.E.2d at Id. 12

14 also taking account of the fact that patient warnings are best viewed as a prompt for patients to discuss their medication concerns and medical history with their physicians, who can then inform them further about risks associated with a specific treatment. New Jersey law should be no different. Where a manufacturer has complied with FDA regulations, which do not require extensive descriptive information about specific conditions, the patient warnings are presumptively adequate under New Jersey law. III. What are the Physician Responsibilities In West Virginia and New Jersey? Neither Karl nor Perez lessened physician obligations to read package inserts and inform their patients of applicable risks. As the Perez decision stated, neither the physician nor the manufacturer should be entirely relieved of their respective duties to warn. 27 One of the Karl concurrences echoed this view: Nothing in the majority opinion changes a doctor's rights and responsibilities. 28 Correspondingly, both opinions were careful to state that manufacturer liability could be limited by physician wrongdoing. Pharmaceutical manufacturers may seek contribution, indemnity or exoneration because of the physician s deficient role in prescribing that drug Perez, 734 A.2d at Karl, 647 S.E.2d at Perez, 734 A.2d at 1263; see also Karl, 647 S.E.2d at 913 ( [O]ur existing law of comparative contribution among joint tortfeasors is adequate to address issues of (continued ) 13

15 This case law maintains the relevance of physician package inserts even in the two jurisdictions that have partly or wholly rejected the Learned Intermediary Doctrine. Because physicians retain the responsibility to provide their patients with the information necessary to make an informed judgment, and because the package insert remains a primary means of acquiring information about a medication, manufacturers can still rely on warnings contained in package inserts where appropriate to show that they provided a proper warning in the customary manner. Moreover, a manufacturer can rely on a physician s failure to review these warnings or to explain them to the patient as part of its efforts to obtain contribution, indemnity or exoneration. IV. What Preemption Questions Are Presented by the Karl and Perez Decisions? Notwithstanding Karl and Perez, courts remain willing to entertain arguments that patient failure-to-warn claims are preempted where companies can show that the FDA would not approve greater physician warnings in the medicine s package insert. Thus, a West Virginia state trial court recently held that a plaintiff s claim that he should have been directly warned of the suicide risk from Zoloft was preempted by the FDA s repeated decision that the physician package insert should not warn of suicide. 30 The Court briefly referenced Karl, saying that it liability among physicians and drug companies in those cases where patients sue for injuries related to the use of prescription drugs. ). 30 Price v. Cook, No. 99-C-12-R, 2007 WL (W. Va. Cir. Ct. July 9, 2007). 14

16 did not affect the manufacturer s preemption defense because Karl only addressed the question of who should receive the warning. 31 In addition to preemption arguments based on the FDA having rejected the substance of patient warnings through its determinations regarding comparable physician warnings, the state-law imposition of patient-warning requirements raises broader preemption questions. In compelling a broad scheme of patientdirected warnings, the Karl decision in particular conflicts with the FDA s system for prescription drug labeling in at least three respects. 32 First, the FDA s drug labeling requirements are centered on the role of the prescribing physician. While the FDA has recognized the importance of providing safety information to patients, that effort is focused on enhancing patient-physician dialogue, and the agency has never attempted to require that all potential risks associated with all prescription drugs be conveyed directly to patients. Karl s rejection of the Learned Intermediary Doctrine arguably requires a broader range of warnings to be provided directly to patients for all medications. Such a result would significantly undermine the extensive federal system for prescription drug regulation. Second, Karl s rejection of the Learned Intermediary Doctrine and its requirement of patient warnings could dilute the impact of warnings that are 31 Id. n See Imbroscio, M., Schmidt, P., Lietzan, E., Labson, M., Guggenheim, M., Learned Intermediary Doctrine: Required By Fed Law?, Health Law 360 (7/17/2007). 15

17 scientifically justified and could chill the appropriate and beneficial use of drugs. The FDA and courts have repeatedly expressed concerns about overwarning, because of the potential that overwarning will prevent beneficial uses of medication. Recent studies confirm the deleterious health consequences that can arise from overwarning. 33 State tort schemes that leave patients awash in a sea of warnings stand as an obstacle to the FDA s fulfillment of its goal of ensuring appropriate medication use. Finally, requiring extensive patient warnings for every product would cause the FDA to be inundated with patient warnings that it neither wants nor finds appropriate. While manufacturers would not be obligated to seek FDA approval for all patient-directed warning materials, as a practical matter many may think it advisable to do so, just as they currently do for voluntary patient package inserts. On a very real and practical level, this would conflict with FDA regulation, as the FDA is not staffed to handle the deluge of patient warnings that could ensue from a decision like Karl. Similar state tort law regimes that threaten the FDA s efficient function by encouraging companies to inundate the FDA with unwanted filings have been deemed preempted by the United State Supreme Court For example, research has suggested that diminished use of Cox-2 inhibitors as a result of the Vioxx and Bextra withdrawals increased serious gastrointestinal symptoms from traditional NSAIDs (the very symptoms that the Cox-2s were designed to mitigate) by 21 percent. See E.J. Mundell, Vioxx Ban Tied to Rise in Serious GI Trouble, U.S. News & World Report, Nov. 8, 2007, available at 34 See Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 16

18 Conclusion The vast majority of the states continue to reject plaintiff lawyer arguments that DTC advertising requires elimination of the Learned Intermediary Doctrine. Even in the two states that have wholly or partially accepted these arguments, though, Defendants have a range of arguments available to them about the limited scope of patient warnings that are required, the responsibilities that physicians maintain, and the limits on how such patient warnings may conflict with federal law. 17

19 APPENDIX United States Jurisdictions Adopting the Learned Intermediary Doctrine State/Territory State or Key Opinion(s) and Relevant Language Federal Courts 1. Alabama State courts Walls v. Alpharma USPD, Inc., 887 So.2d 881, (Ala. 2004) ( [W]here prescription drugs are concerned, the manufacturer s duty to warn is limited to an obligation to advise the prescribing physician of any potential dangers that may result from the drug s use. ) (quoting Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, (Ala. 1984)). 2. Alaska State courts Shanks v. Upjohn Co., 835 P.2d 1189, & n.6 (Alaska 1992) ( A prescription drug s performance safety depends on many variables, including the nature of the drug itself, the patient s medical history, dosage, and combination with other medications, whose complex interplay is beyond the comprehension of the ordinary consumer.... In a sense, prescribing doctors are the consumers of prescription drugs. It is the doctor s evaluation of the patient s condition and consideration of the available treatment alternatives which leads to the choice of a specific prescription drug product. ). 3. Arizona State courts Gaston v. Hunter, 588 P.2d 326, 340 (Ariz. Ct. App. 1978) ( In the case of prescription drugs... the manufacturer s duty to warn is ordinarily satisfied if a proper warning is given to the prescribing physician. ). 4. Arkansas State courts West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991) (stating that the Learned Intermediary Doctrine applies for three reasons: First, a physician must prescribe the drug, the patient relies upon the physician s judgment in selecting the drug, and the patient relies upon the physician s advice in using the drug. That is to say that there is an independent medical decision by the learned intermediary that the drug is appropriate. Second, it is virtually impossible in many cases for a manufacturer to directly warn each patient. Third, imposition of a duty to warn the user directly would interfere with the relationship between the doctor and the patient. ). 5. California State courts Brown v. Superior Ct., 44 Cal. 3d 1049, (Cal. 1988) ( The manufacturer cannot be held liable if it has provided appropriate warnings and the doctor fails in his duty to transmit these warnings to the patient. ). 6. Colorado State courts Peterson v. Parke Davis & Co., 705 P.2d 1001, 1003 (Colo. Ct. App. 1985) ( Where, as here, an attending physician, in 18

20 prescribing and in supervising the use of a drug, disregards the manufacturer s warnings and instructions, it is that conduct which renders the product unreasonably dangerous, and thus defective, and the adequacy of the warnings and instructions are not relevant. ). Id. at 1004 ( [T]he concern was with the warning given to the attending physician, and whether others were warned is irrelevant. ). 7. Connecticut State courts Vitanza v. Upjohn Co., 778 A.2d 829, (Conn. 2001) ( [P]rescribing physicians act as learned intermediaries between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient s needs and assess [the] risks and benefits of a particular course of treatment. ) (quotations omitted) (alteration in original). Id. at 841 ( The Learned Intermediary Doctrine stands for the proposition that, as a matter of law, the prescribing physician of a prescription drug is the person best able to take or recommend precautions against the harm. ). 8. Delaware State courts Lacy v. G.D. Searle & Co., 567 A.2d 398, 400 (Del. 1989) ( In the final analysis it is the physician who ultimately prescribes the drug or device. Thus, if the manufacturer of prescription products provides the physician with the legally appropriate information, it has satisfied its duty to warn. ). 9. District of Columbia State courts Mampe v. Ayerst Labs., 548 A.2d 798, n.6 (D.C. 1988) (the prescribing physician is the user of a prescription medication; [w]hen the purchase of the product is recommended or prescribed by an intermediary who is a professional, the adequacy of the instructions must be judged in relationship to that professional. ) (quoting Payne v. Soft Sheen Prods., Inc., 486 A.2d 712, 722 n.10 (D.C. 1985)). 10. Florida State courts Felix v. Hoffmann-LaRoche, Inc., 540 So.2d 102, 104 (Fla. 1989) ( [I]t is clear that the manufacturer s duty to warn of [the drug s] dangerous side effects was directed to the physician rather than the patient because the prescribing physician, acting as a learned intermediary between the manufacturer and the consumer, weighs the potential benefits against the dangers in deciding whether to recommend the drug to meet the patient s needs. ). 11. Georgia State courts McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003) ( Under the Learned Intermediary Doctrine, the manufacturer of a prescription drug or medical device does not have a duty to warn the patient of the dangers involved with the product, but instead has a duty to warn the patient s doctor, who acts as a learned intermediary between the patient and the manufacturer. The rationale 19

21 for the doctrine is that the treating physician is in a better position to warn the patient than the manufacturer, in that the decision to employ prescription medication [or medical devices] involves professional assessment of medical risks in light of the physician s knowledge of a patient s particular need and susceptibilities. ) (footnotes and quotations omitted) (alteration in original). 12. Hawaii State courts Craft v. Peebles, 893 P.2d 138, 155 (Haw. 1995) (stating that the Learned Intermediary Doctrine applies to prescription pharmaceutical products because physicians are in a better position [than manufacturers] to assess risks and determine when a particular patient reasonably should be informed about a risk, and applying the Learned Intermediary Doctrine to silicone breast implants) (quotations omitted). 13. Illinois State courts Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 393 (Ill. 1987) ( The doctor, functioning as a learned intermediary between the prescription drug manufacturer and the patient, decides which available drug best fits the patient s needs and chooses which facts from the various warnings should be conveyed to the patient, and the extent of disclosure is a matter of medical judgment. As such, we believe the Learned Intermediary Doctrine is applicable here and that there is no duty on the part of manufacturers of prescription drugs to directly warn patients. ) (citations omitted). 14. Indiana State courts Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 549, 553 (Ind. Ct. App. 1979) ( In the case of ethical drugs, the manufacturer s duty is discharged if adequate warning is given to doctors, who act as learned intermediaries between the manufacturer and the ultimate user. ). 15. Kansas State courts Humes v. Clinton, 792 P.2d 1032, (Kan. 1990) (citations omitted) ( Since prescription drugs are available only to a physician, it is the physician s duty to inform himself or herself of the characteristics of the drugs prescribed and to exercise his or her judgment of which drug to administer in light of the drug s propensities and the patient s susceptibilities.... [W]e have adopted the learned intermediary rule, which relieves the manufacturers of the duty to warn consumers directly, in IUD cases. ). 16. Kentucky State courts Larkin v. Pfizer, 153 S.W.3d 758, 765, 770 (Ky. 2004) ( [P]roviding an adequate warning to the prescribing physician relieves the manufacturer of its duty to warn the patient regardless of how or if the physician warns the patient. ). 17. Louisiana State courts Calhoun v. Hoffman-La Roche, Inc., 768 So.2d 57, 61 (La. Ct. App. 2000) ( The manufacturer has no duty to warn the 20

22 consumer directly of any risks or contraindications associated with the drug. The manufacturer of the drug has fulfilled its obligation when it has informed the prescribing and treating physicians of the risks of harm from the drug so that they may intelligently decide on its use and advise the patient. ) (quoting Cobb v. Syntex Labs., Inc., 444 So.2d 203, 205 (La. Ct. App. 1983)). 18. Maine State courts Tardy v. Eli Lilly & Co., No. CV , 2004 WL , at *2-3 (Me. Super. Ct. Aug. 3, 2004) (holding that the Learned Intermediary Doctrine shields pharmacists from liability for failure to warn and noting that [i]f the doctor is properly warned [by the manufacturer] of the possibility of a side effect in some patients, and is advised [by the manufacturer] of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided ) (quotation omitted). 19. Maryland State courts Nolan v. Dillon, 276 A.2d 36, 40 (Md. 1971) (holding, without specifically addressing whether the Learned Intermediary Doctrine applied, that [manufacturer s] package insert and the label on the 50 milligram concentration fully discharged its duty to warn ). Rite Aid Corp. v. Levy-Gray, 876 A.2d 115, 123 (Md. Ct. Spec. App. 2005) ( The obligation of a manufacturer to warn about risks attendant to the use of drugs and medical devices that may be sold only pursuant to a health-care provider s prescription traditionally has required warnings directed to health-care providers and not to patients. The rationale supporting this learned intermediary rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy. ) (quoting Restatement (Third) of Torts: Products Liability 6 cmt. b). 20. Massachusetts State courts Cottam v. CVS Pharm., 764 N.E.2d 814, 821 (Mass. 2002) ( Because the physician is the appropriate person to perform the duty of warning a patient of the possible side effects of prescription drugs, we now extend [the Learned Intermediary Doctrine] to pharmacies. ). 21. Michigan State courts Smith v. E. R. Squibb & Sons, Inc., 273 N.W.2d 476, 479 (Mich. 1979) ( A manufacturer of a prescription drug has a legal duty to warn the medical profession, not the patient, of any risks inherent in the use of the drug which the manufacturer knows or should know to exist. ). 21

23 22. Minnesota State courts Mulder v. Parke Davis & Co., 181 N.W.2d 882, 885 n.1 (Minn. 1970) (citations omitted) ( The manufacturer has no duty to warn the lay public regarding prescription drugs. ). 23. Mississippi State courts Janssen Pharmaceutica, Inc. v. Bailey, 878 So.2d 31, 58 (Miss. 2004) ( When the product in question is a prescription drug, Mississippi follows the Learned Intermediary Doctrine. Under this doctrine, the manufacturer s failure to warn the patient of the product s risks does not render the product defective or unreasonably dangerous so long as the manufacturer adequately warns the learned intermediary. ). 24. Missouri State courts Krug v. Sterling Drug, Inc., 416 S.W.2d 143, (Mo. 1967) ( [I]n this case we are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser s doctor is a learned intermediary between the purchaser and the manufacturer. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided. ) (quotation omitted). 25. Montana State courts Hill v. Squibb & Sons, E. R., 592 P.2d 1383, (Mont. 1979) ( As a general rule, the duty of a drug manufacturer to warn of the dangers inherent in a prescription drug is satisfied if adequate warning is given to the physician who prescribes it. ). 26. Nebraska State courts Freeman v. Hoffman-LaRoche, Inc., 618 N.W.2d 827, (Neb. 2000) ( Pharmaceutical products have historically been treated differently in regard to a duty to warn.... [I]n cases involving prescription drugs, it is widely held that the duty to warn extends only to members of the medical profession and not to the consumer. This concept, known as the Learned Intermediary Doctrine, is based upon the premise that, as a medical expert, a patient s prescribing or treating physician is in the best position to evaluate the often complex information provided by the manufacturer concerning the risks and benefits of its drug or product and to make an individualized medical judgment, based on the patient s particular needs and susceptibilities, as to whether the patient should use the product.... We adopt 6(d) of the Third Restatement. ) (quotations omitted). 27. New Hampshire Federal courts Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981) (citations omitted) ( In cases involving ethical drugs, the manufacturer must warn the physician, not the patient. ). Nelson v. Dalkon Shield Claimants Trust, No SD, 1994 WL , at *4 (D.N.H. June 8, 1994) ( [I]t is 22

24 generally accepted that in a case involving medical products prescribed or used by a physician or trained medical personnel, the warning runs to the physician not the patient. ) (quoting Knowlton v. Deseret Med., Inc., 930 F.2d 116, 120 n. 2 (1st Cir. 1991)). 28. New Jersey State courts Perez v. Wyeth Labs., Inc., 734 A.2d 1245, (N.J. 1999) ( Obviously, the Learned Intermediary Doctrine [continues to] appl[y] when its predicates are present. ). 29. New Mexico State courts Serna v. Roche Labs., Div. of Hoffman-LaRoche, Inc., 684 P.2d 1187, 1189 (N.M. Ct. App. 1984) ( Where the product is a prescription drug, the manufacturer s duty to warn is fulfilled if it warns the physician, not the patient. ). 30. New York State courts Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) ( Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects. The physician acts as an informed intermediary between the manufacturer and the patient; and, thus, the manufacturer s duty to caution against a drug s side effects is fulfilled by giving adequate warning through the prescribing physician, not directly to the patient. ) (citations omitted). 31. North Carolina Federal courts Holley v. Burroughs Welcome Co., 330 S.E.2d 228, 235 (N.C. Ct. App. 1985) (holding that a pharmaceutical company [is] required to provide adequate warnings regarding its products to [those members of] the medical profession who are responsible for the patient s care, and that manufacturers thus had duty to warn trained anesthetist, without mentioning the Learned Intermediary Doctrine or whether manufacturers had duty to warn patient) (quoting Whitley v. Cubberly, 210 S.E.2d 289, 292 (N.C. Ct. App. 1974)) (emphasis added). Foyle v. Lederle Labs., 674 F. Supp. 530, (E.D.N.C. 1987) (observing that the North Carolina courts have not yet addressed an allegation that the failure to warn a patient was actionable and relying on Holley to hold that, when prescription drugs are used, the manufacturer s duty to warn does not extend to the patient because [t]he doctor is responsible for gathering the information, weighing the dangers and benefits, and making a decision in the best interest of the patient ). 32. North Dakota Federal courts Ehlis v. Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir. 2004) ( [P]rescribing physicians act as learned intermediaries between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient s needs and assess risks and benefits of a particular course of treatment. ) (quotations omitted). 23

25 33. Ohio State courts Vaccariello v. Smith & Nephew Richards, Inc., 763 N.E.2d 160, 164 (Ohio 2002) ( [T]he rationale behind [the Learned Intermediary Doctrine] is that the physician stands between the manufacturer and the patient as a learned intermediary. The physician has the duty to know the patient s condition as well as the qualities and characteristics of the drugs or products to be prescribed for the patient s use. The physician is in the best position, therefore, to balance the needs of patients against the risks and benefits of a particular drug or therapy, and then supervise its use.... The Learned Intermediary Doctrine achieves a proper allocation of responsibility, since not all patients are alike and it is the physician who best knows the patient. ) (quoting Tracy v. Merrell Dow Pharm., Inc., 569 N.E.2d 875, 878 (Ohio 1991)) (omission in original). 34. Oklahoma State courts McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982) ( In the absence of FDA regulations to the contrary, the manufacturer has no obligation to warn a consumer if the prescribing physician has been adequately warned of any adverse side effects. The manufacturer s duty is to warn the physician, who acts as a learned intermediary between the manufacturer and the consumer, because he is in the best position to evaluate the patient s needs, assess the benefits and risks of a particular therapy, and to supervise its use. ). 35. Oregon State courts (but it applies only to causes of action based on negligence, not to causes of action based on Oregon s strict liability statute, Or. Rev. Stat ). McEwen v. Ortho Pharm. Corp., 528 P.2d 522, (Or. 1974) (stating, in a case where the plaintiff s sole theory of recovery was the alleged failure of defendants to adequately warn the medical profession and where the plaintiff thus did not assert that the manufacturer had a duty to warn her directly, that the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient ). Oksenholt v. Lederle Labs., 625 P.2d 1357, 1362 (Or. Ct. App. 1981) (stating, in a case where a physician sued a manufacturer for misrepresenting the risks of a drug that he prescribed, that [a] drug manufacturer s duty, as described in McEwen, is a duty to adequately inform doctors of the harm associated with prescription drugs ). Griffith v. Blatt, 51 P.3d 1256, (Or. 2002) (holding that Or. Rev. Stat does not create a defense to strict liability based on the Learned Intermediary Doctrine, in a case where a pharmacist placed in a generically labeled bottle a lotion that could be used no more than twice and had to be washed off within 12 hours, and the plaintiff suffered severe injury as a result). 36. Pennsylvania State courts Coyle ex rel. Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1385 (Pa. 1991) ( [W]hen a drug is available only 24

26 upon prescription of a duly licensed physician, the warning required is not to the general public or to the patient, but to the prescribing doctor.... We formulated this rule with reference to comment k and the policies expressed therein. ) (quoting Incollingo v. Ewing, 282 A.2d 206, 220 (Pa. 1971)). 37. Puerto Rico Federal courts Guevara v. Dorsey Labs., 845 F.2d 364, 366 (1st Cir. 1988) ( It is generally accepted, and the parties do not contest, that a prescription drug manufacturer has a duty to adequately warn prescribing physicians of the hazards posed by the use of its drugs. The warning is directed not to the ultimate user but to the doctor prescribing the drug, who must then take into account the propensities of the drug and the susceptibilities of the patient and make an informed decision regarding the advisability of its use. ) (citation and quotations omitted). 38. South Carolina 39. South Dakota Federal courts Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) ( Under [the Learned Intermediary Doctrine], the manufacturer s duty to warn extends only to the prescribing physician, who then assumes responsibility for advising the individual patient of risks associated with the drug or device. ). Federal courts McElhaney v. Eli Lilly & Co., 575 F. Supp. 228, 231 (D.S.D. 1983) ( In cases involving prescription drugs the manufacturer must warn the physician, not the patient. The prescribing physician acts as a learned intermediary between the patient and manufacturer. ) (quoting Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981)). 40. Tennessee State courts Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994) ( Under the Learned Intermediary Doctrine, makers of unavoidably unsafe products who have a duty to give warnings may reasonably rely on intermediaries to transmit their warnings and instructions. Physicians are such intermediaries because of the pivotal role they play in the unique system used to distribute prescription drugs.... [T]he manufacturer of an unavoidably unsafe prescription drug can discharge its duty to warn by providing the physician with adequate warnings of the risks associated with the use of its drug. ) (citations omitted). 41. Texas State courts Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex. Ct. App. 2000) ( In prescription drug cases, the courts have found that it is reasonable for the manufacturer to rely on the health care provider to pass on its warnings. This is reasonable because the learned intermediary understands the propensities and dangers involved in the use of a given drug, and as the prescriber, he stands between this drug and the ultimate consumer. ). 25

27 42. Utah State courts Schaerrer v. Stewart s Plaza Pharmacy, Inc., 79 P.3d 922, 928 (Utah 2003) (holding that [u]nder [the Learned Intermediary Doctrine], manufacturers of prescription drugs have a duty to warn only the physician prescribing the drug, not the end user or patient, and thus pharmacist had no duty to warn patient about prescription medication s risks). 43. Virginia State courts Pfizer, Inc. v. Jones, 272 S.E.2d 43, 44 (Va. 1980) ( [I]n the case of prescription drugs, it is the general rule that the duty of the drug manufacturer is to warn the physician who prescribes the drug in question. ) (quotations omitted). 44. Washington State courts Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978) ( Where a product is available only on prescription or through the services of a physician, the physician acts as a learned intermediary between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise an independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should be told to the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprise the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient. ) (footnote omitted). 45. West Virginia Federal courts Ashworth v. Albers Med., Inc., 395 F. Supp. 2d 395, 407 (S.D. W. Va. 2005) ( The Learned Intermediary Doctrine, which the court believes would be adopted by the West Virginia Supreme Court, protects [a pharmacy] from a failure to warn claim with respect to prescription drugs. ). 46. Wisconsin Federal courts Monson v. Acromed Corp., No. 96-C-1336, 1999 WL , at *20 (E.D. Wis. May 12, 1999) (manufacturer had no duty to warn plaintiff because [t]he general rule regarding medical devices is that the manufacturer must warn the physician the so-called learned intermediary and not the patient directly ). Menges v. Depuy Motech, Inc., 61 F. Supp. 2d 817, 830 (N.D. Ind. 1999) (stating, in a case governed by Wisconsin law, that under the Learned Intermediary Doctrine, manufacturers of prescription medical products have a duty only to warn physicians, rather than patients, of the risks associated with the use of the product ). 26