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Take two of these and sue me in the morning: efficacy of the learned intermediary doctrine in prescription drug failure to warn cases.

 I. Introduction
 II. The Learned Intermediary Doctrine: The Doctrine Explored
 III. The Learned Intermediary Doctrine: Policy Explored
 IV. The Learned Intermediary Doctrine: Exceptions to the Rule
 V. The Role of Warnings in Tort Law Generally
 VI. Shortcomings of the Learned Intermediary Approach
 VII. Solutions--How to Improve Upon the Current Learned Intermediary
VIII. Conclusion


Consider Rex, (2) who wakes up one morning to find he suffers from an ailment and therefore pays a visit to his doctor's office. His physician, Dr. Pharm, discusses Rex's symptoms, examines Rex, and then prescribes Drug X. Rex picks up his prescription via the drive-thru window at his local drug-store chain. Rex takes the medication as instructed on the bottle whereupon he suffers an undesired side-effect--known to affect a small percentage of users--rendering him even more severely ill....

Under the Learned Intermediary Doctrine--elaborated below and representing the majority approach to manufacturer liability in prescription drug cases (3)--Rex holds no recourse against the pharmaceutical manufacturer of Drug X. While logic would seem to impose a manufacturer duty to the ultimate user, for purposes of tort liability in prescription drug cases it is the physician, not the patient, deemed to be the consumer. (4) Thus, so long as the manufacturer conveys sufficient warning of possible side effects to the prescribing physician Dr. Pharm alone, a learned intermediary, the pharmaceutical manufacturer is absolved from any liability to Rex--the ultimate user of the drug. (5)

Representing an exception to ordinary tort doctrines of manufacturer-to-consumer duty, (6) the reasoning and policy behind the Learned Intermediary Doctrine will be explored below. (7) Common exceptions to the doctrine, as well as the role of warnings generally in tort law, will be discussed. (8) Shortcomings of the doctrine--causing the public to be put at unnecessary risk--will be related, and novel solutions will be presented for shoring up the flaws, ultimately leading to a doctrine better serving of its intended policy aims, and more protective of the general public. (9)

Back to our legally powerless ailing patient Rex, who has suffered an unintended side effect from the medication he was prescribed--should any of the following altered scenarios have an effect on his ability to hold the pharmaceutical manufacturer liable? Whether Rex merely telephoned his doctor to receive the prescription instead of visiting in person? Whether he telephoned his doctor's office but only spoke to a doctor's assistant instead of the doctor? Whether he went inside the pharmacy to pick up his prescription instead of utilizing the drive-thru? Whether, once inside the store, the pharmacist informs Rex of the medication's common possible side effects? Whether the pharmacist does not convey this information? Whether the bottle containing the medication conveys the medication's common possible side effects, or whether along with the medication Rex is provided a thick packet of literature which somewhere inside conveys the medication's common possible side effects? Whether a television or radio commercial advertising the medication commonly aired and such advertisement was seen or heard by Rex? These quandaries will similarly be explored below. (10)


As related above, the Learned Intermediary Doctrine absolves a pharmaceutical manufacturer from any duty to warn the ultimate user of its prescription drug--the patient. (11) Rather, the doctor--the learned intermediary--and not the patient, is viewed by law as the consumer. (12) The manufacturer's duty to warn, therefore, extends only as far as the doctor. (13) One of the earliest cases formally adopting the concept of the Learned Intermediary Doctrine is the Eighth Circuit decision Sterling Drug, Inc. v. Cornish. (14) Sterling Drug involved a suit against a pharmaceutical manufacturer for failure to warn when a patient suffered permanent eye injury as a side-effect to a prescribed drug. (15) The patient contended the pharmaceutical manufacturer was negligent for failing to warn prescribing doctors of the side effect--chloroquine retinopathy--resulting in retina blindness in a small percentage of users. (16) The appellant, the pharmaceutical manufacturer, argued the doctor instead deserved liability for "negligently fail[ing] to keep up with medical literature, including appellant's literature." (17) In upholding the verdict for the plaintiff, the court found the pharmaceutical manufacturer held a duty to properly warn the doctor of the risk of the side effect--a duty not met. (18) Limiting its decision to the arena of prescription drugs alone, rather than an over the counter product, the court explained the uniquely limited duty imposed on the pharmaceutical manufacturer:
 [In the realm of prescription drugs] 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. (19)

In a later case, Johnson v. American Cyanamid Co., (20) the Kansas Supreme Court similarly applied the Learned Intermediary Doctrine in determining liability for an infant's contraction of polio resulting from a vaccination. (21) The court overturned a lower ruling for the patient, finding "under such circumstances the 'learned intermediary' concept comes into play." (22) The court found that, in effect, the concept dictates the pharmaceutical "manufacturer's duty is to adequately warn the physician of a known risk," (23) and that such duty was met. (24)

Application of the Learned Intermediary Doctrine became more widespread to the degree that a Federal District Court noted, in 1995, that the doctrine "clearly reflects the law in an overwhelming number of jurisdictions." (25) It is therefore safe to say the doctrine represents the majority position in the realm of pharmaceutical manufacturer duty to warn. (26) And while the doctrine was not part of the Second Restatement of Torts, (27) it is incorporated directly into the Third Restatement of Torts, adopted in 1998. (28)

The rationale behind the Learned Intermediary Doctrine, as noted above, states that "for purposes of determining consumer expectations and risk-utility" (29) in the context of prescription drugs, the doctor is deemed the consumer. (30) Ironically, therefore, the patient is not considered, by law, to be the consumer despite the reality that the patient is the ultimate user of the drug. (31) Thus, a warning to the doctor alone will suffice under most circumstances. (32) The Supreme Court of Alaska explained away the doctrine's perceived irony in this way:
 [P]rescribing 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. Also, the
 doctor has ready access to the FDA-approved warning information
 contained in the package insert and the Physicians' Desk Reference.
 Thus it is the doctor's expectation, and not that of the patient,
 regarding the performance and safety of prescription drugs which is
 the relevant inquiry.... (33)

Therefore, the pharmaceutical manufacturer's duty to warn the doctor alone stems from the doctor's professional knowledge of medicine and the doctor's unique position as a liaison between the pharmaceutical manufacturer and the patient. (34) From a legal perspective, the doctor's unique position makes her the party responsible for determining the patient's use of the drug. Therefore, under ordinary circumstances it seems the patient's ability to make an informed choice to take a given prescription drug is deemed non-existent or too negligible to factor into the calculus of tort duties to warn. (35)

As has been seen, the Learned Intermediary Doctrine limits a pharmaceutical manufacturer's duty to warn to a doctor alone--not a patient. (36) Even this limited duty, however, has at times been interpreted narrowly--to the benefit of the manufacturer. (37) In Swayze v. McNeil Laboratories, Inc., (38) the Fifth Circuit went as far as finding that a manufacturer had no duty to limit the improper use of its product. (39) Such a ruling came in the face of a common practice by which certified registered nurse anesthetists (CRNA)--not doctors--were given sole discretion to determine dosage and ultimately administer anesthetic to patients. (40) An improperly high dosage of anesthetic, by a CRNA, amounted to an overdose causing the plaintiff cardiorespiratory arrest and ultimately permanent brain damage. (41) The Swayze Court found that the manufacturer held no duty to combat this practice and thereby "intervene" in the doctor-patient relationship, which the court found did exist in this case. (42)

Moreover, a manufacturer's duty to warn a doctor may be limited further to the extent that experts generally need not even receive warning in the first place regarding "dangers commonly associated with the use of products about which he has expert knowledge." (43) For example in York v. Union Carbide Corp., (44) a state court of appeals found the defendant, who was a supplier of argon--a potentially deadly gas used in the production of steel--held no duty to warn the individual employees of the purchaser steel company. (45) Rather, the purchaser was deemed a "sophisticated user of argon," and could therefore be counted on to properly convey warnings in order to properly train employees as to the dangers of argon--thereby discharging the defendant's duty to warn. (46) Additionally, in Smith v. Walter C. Best, Inc. (47) the Third Circuit found that the seller of sand held no duty to warn the individual employees of the purchaser as to the dangers of silica dust inhalation from the sand. (48) The court based its ruling on the fact that the seller reasonably considered the purchaser to be a "knowledgeable purchaser," and that reliance on the purchaser to provide warning to its employees--the ultimate users of the sand--was therefore justified. (49) Under this line of reasoning, a doctor's expertise in medicine--gained through countless years of training--would surely deem such a professional a knowledgeable purchaser or sophisticated user under the standards utilized above. The implications of such status would be an even further diminished duty upon a pharmaceutical manufacturer. (50)


The rationale behind the Learned Intermediary Doctrine is that the doctor, not the patient, represents the ultimate consumer of prescriptions drugs from a legal perspective. (51) However, what policy aim is served through this arrangement? The answer stems from the nature of the doctor-patient relationship and specifically the "individualized balancing" (52) provided to the patient by the doctor. The individualized balancing or assessment, provided by the doctor to the patient, primarily entails an explanation to the patient of the risks involved from taking a given drug in light of the ailment suffered by the patient. (53) Since an ordinary patient lacks the level of medical and scientific expertise to adequately understand the risks involved in order to make an informed choice, it seems that the Learned Intermediary Doctrine empowers the doctor to become the patient's proxy, in a way, to determine the cost-benefit analysis of taking the drug. The proxy, in a way, determines the cost-benefit analysis of taking the drug by considering the cost, the inherent risks posed by the drug, (54) in light of the benefit, the possible improvement of the patient's ailment. (55) By warning the proxy, therefore, the pharmaceutical manufacturer dispenses its duty.


In light of the previous policy and rationale discussion, specifically the notion by which doctors provide individualized balancing to patients under the traditional doctor-patient relationship, three categories of exceptions to the Learned Intermediary Doctrine flow logically. Under the following scenarios, a manufacturer would retain some direct duty to the patient.

First, public health clinics, mass immunizations or other such scenarios designed to provide community-wide health care conceivably lack the element of individualized balancing ordinarily present in the doctor-patient relationship. (56) In such cases, it does not follow that a pharmaceutical manufacturer would dispense its duty through warning the doctor alone. Rather, a manufacturer would be held to a higher duty to warn in a way more likely to reach the patient, the ultimate user of the drug. (57) In such settings, it is unlikely for a doctor to be available to act as proxy for the patient. (58) Under certain circumstances, however, courts may consider non-doctor, medical personnel to sufficiently constitute learned intermediaries for purposes of providing individualized balancing. (59)

Second, courts are apt to nix the Learned Intermediary approach in instances where there is active patient involvement in the decision to use a given drug. (60) In such instances, the doctor's role as learned intermediary, and the potency of the doctor's individualized balancing on the patient's decision is diminished. (61) For example, in the realm of birth control medication, one state supreme court noted:
 Whereas a patient's involvement in decision-making concerning use
 of a prescription drug necessary to treat a malady is typically
 minimal or nonexistent, the healthy, young consumer of oral
 contraceptives is usually actively involved in the decision to use
 "the pill," as opposed to other available birth control products,
 and the prescribing physician is relegated to a relatively passive
 role. (62)

Under such circumstances, therefore, it follows that the pharmaceutical manufacturer would owe a duty-to-warn to the direct user; a warning to the doctor alone is insufficient. (63) It seems, as a general rule, that the greater the participation of the patient in the decision to use a given drug or a given category of drugs, the more likely that a court will shift the recipient of a pharmaceutical manufacturer's duty to warn from the doctor to the patient. (64)

Third, courts are likely to forego the Learned Intermediary approach in the event of direct-to-consumer advertising of a drug. (65) Such advertising serves to inform the patient about the drug prior to the patient communication with his or her doctor. It follows that such advertising reduces the traditional role of the doctor as the sole educator in the doctor-patient relationship. Direct-to-consumer advertising reduces the likelihood of individualized balancing by the doctor, and, at the least, serves to diminish the magnitude individualized balancing will come to bear on a patient's decision to use a given drug. (66) The growing prominence of direct-to-consumer advertisements recently led one state supreme court to abrogate the Learned Intermediary Doctrine entirely from the realm of prescription drugs. (67)


This section will explore what requirements a warning must meet to constitute an adequate warning under products liability law. In the most broad terms, an adequate warning conveys to the user a message of BEWARE! It informs the user of a possible danger, the nature of such danger, as well as the likelihood of the user being confronted with such danger. (68)

Additionally, an adequate warning must account for the environment in which the product will be utilized, as well as the people likely to use the product. (69) Symbols or pictorial depictions of danger may be required in addition to textual warnings. Textual warnings are required when it is likely that users of the product will be illiterate or non-fluent in the language utilized to convey the warning. (70) For example, Hubbard-Hall Chemical Co. v. Silverman, (71) involved the death of two farm workers from using a certain insecticide without protective masks or coats. (72) The court found the manufacturer of the pesticide liable, despite the pesticide label's warning paragraph. The court found the warning inadequate "because of its lack of a skull and bones or other comparable symbols or hieroglyphics. ..." (73)

Other requirements that courts impose are that warnings must anticipate "the foreseeable misuse of its products," (74) enable use of the product in light of a concealed danger, (75) and be communicated in a "reasonably effective" way. (76) Additionally, countervailing representations are a prominent aspect of a product's physical appearance that downplays or runs contrary to the danger the products presents; this deems inadequate a warning otherwise found adequate, or causes a product to require a warning when under ordinary circumstances its danger would be readily apparent and therefore not requiring of one. (77) For example, in Jonescue v. Jewel Home Shopping Service, (78) despite the manufacturer's contention that the danger of ingesting its cleaning fluid was apparent, and therefore no warning was required, the court pointed to a number of physical characteristics of the product seeming to neutralize its obvious danger. (79) Additionally, in Ziglar v. E.I. Du Pont de Nemours & Co., (80) the court found the plaintiff substantiated a claim against the manufacturer for negligent manufacture and packaging of an insecticide, despite a skull and crossbones warning on the label, because the insecticide resembled drinking water. (81)

A duty to warn is less likely to attach to a product entailing an obvious danger. (82) However, in such instances, a duty may nevertheless be imposed by statute, and a violation of such a statute would constitute negligence per se. (83)


The Learned Intermediary Doctrine unnecessarily places the public at risk in several key ways related below. As noted above, under the Learned Intermediary Doctrine, the doctor, not the patient, is viewed as the consumer under the law for purposes of a manufacturer's duty to warn. (85)

Ironically, the manufacturer gets to take the consumer's money, in the form of sales and profits, yet garners no liability risk to this paying consumer. This arrangement smacks more of fantasy than reality. It is rather like the 16-year old being presented by a parent with a credit card and no spending limit or consequence, or like the gambler going to the craps table knowing he will get to keep any profits he earns but any debt accrued will automatically be erased by the casino once he leaves.

No-risk arrangements, such as these, encourage high-stakes gambling! So does the Learned Intermediary Doctrine. An arrangement whereby pharmaceutical manufacturers take all of the profits, while assuming no duty to the consumer and assuming no risk, encourages high-stakes gambling. (86) The metaphorical free lunch does not exist. In each of the two no-risk financial arrangements mentioned above, someone or some entity ultimately bears the burden of the financial risk. In the credit card scenario, the parent bears the risk of irresponsibility on the part of the 16-year old. In the gambling scenario, the casino similarly bears the risk.

In the no-risk, high reward financial arrangement of the prescription pharmaceutical world, under the Learned Intermediary Doctrine, the public bears the risk and the patient loses. The nature of this risk borne by the public, and why, therefore, the Doctrine represents bad policy, can be understood in the two ways provided below.

From a macro perspective, the Learned Intermediary Doctrine is bad policy because it takes the burden to warn off of the manufacturer. (87) Without such burden, manufacturers avoid the concurrent risk of punishment for noncompliance. Without accountability to the patient, the ultimate consumer, the deterrent effect is also lost on manufacturers, and this is the effect that would serve as a powerful tool to improve the researching and testing of drugs. Thus, the Learned Intermediary Doctrine increases the risk of defective or overly risky drugs being put into the market at large. From a macro perspective, this is extremely problematic due to the difficulty of taking drugs off of the market once present there. (88) By removing accountability, (89) the Learned Intermediary Doctrine also encourages hastiness in getting drugs from the lab to the market. This is particularly bad policy as such hastiness spells a recipe for minimizing clinical testing and leaving the consumer greater exposed to side-effects from drugs. (90)

From a micro perspective, taking the burden to warn patients off of the manufacturer, the day-to-day consumer, i.e. the patient, is placed at greater risk. With fewer parties holding a legal duty to warn the patient, the patient will be less informed. Rather than being legally entitled to information from both the manufacturer of a drug, as well as the practitioner directly prescribing the drug, the patient only gets to hear from one, the practitioner. And as noted above, even the doctor's duty to warn is variably dependant on the patient's knowledge and involvement in decision to use the given drug. (91) Such a policy result is flawed. Rather than favoring the manufacturer of a potentially harmful product, whose aim is to profit financially, public policy should instead support the public consumer and should strive foremost to protect the public consumer's interests. A policy that favors profit-garnering pharmaceutical manufacturers, at the expense of the public consumer, is particularly troubling in light of industry trends by which doctors receive incentives from pharmaceutical manufacturers, monetary or otherwise, to prescribe their drugs over other options. (92) The scenario as described, therefore, amounts to two strikes against the consumer's medical interest, and the monetary incentives pit both the manufacturer's and the doctor's interests against those of the patient.


How can this two strikes against the consumer arrangement be replaced with a policy more favoring the consumer? How can we rectify the current policy, under the Learned Intermediary Doctrine, by which the financial interests of the manufacturer and the doctor are favored over the health interests of the public consumer? How can a policy be implemented which simultaneously favors the medical interests of the consumer, while at the same time, avoids a rash of lawsuits against pharmaceutical manufacturers that would cripple their abilities to provide beneficial products to the public at large? (93)

One option would be to require manufacturers to provide doctors with literature explaining the full extent of possible side-effects and other risks from taking a given medication. In turn, the doctor would then be required to pass along this mass of literature to each patient to whom the given medication is prescribed. This throw the book at 'em approach is clearly flawed due to the risk of over-warning. In all likelihood, the average patient would not read the literature. The end result would therefore leave the patient no better off than if no literature was given in the first place. (94)

A more sensible approach is to empower medical personnel, other than doctors, to work in tandem with doctors to ensure that patients are adequately informed. While imposing a direct manufacturer to patient duty is not practical or feasible in ordinary situations, other trained personnel with whom the patient regularly comes into contact can fill the void left by the eliminated manufacturer duty. The Restatement Third of Torts alludes to such an approach by extending the manufacturer duty to warn to both prescribing doctors as well as "other health-care providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." (95)

While the Restatement fails to elaborate or specify who makes up the group of "other health-care providers," (96) of all the various medical personnel whom patients are likely to come into contact with over the course of a typical doctor visit, this author proposes that the pharmacist is uniquely situated to best be able to work in tandem with the doctor to ensure a patient is adequately warned. It is upon the pharmacist that a more definite duty to warn should be imposed.

Why the pharmacist? The pharmacist always has face-to-face contact with the patient, specifically when the patient picks up the medication at the pharmacy. This face-to-face contact of the pharmacist may at times even be greater than that of the physician in instances where physicians may opt to prescribe a drug to a patient over the telephone. Pharmacists have specialized training in pharmaceutical drugs and how they interact with the body. (97) This knowledge and training, coupled with the likelihood that the pharmacist will interact face-to-face with the patient, places the pharmacist in a unique position among health-care personnel. Pharmacists should be saddled with a duty to warn. This duty would supplement the manufacturer's duty to warn the doctor and would accompany any subsidiary duties held by the doctor to the patient. This arrangement would create duties in tandem upon both the manufacturer and the pharmacist to convey warnings to the patient. In this way, the interests of the consumer can be bolstered from its current state and thereby provide a greater degree of safety to the prescription drug consuming public.


Other medical personnel, and specifically pharmacists, need to be empowered and brought into the prescription medication duty to warn equation. Under this theory, it should matter whether our friend from earlier, Rex, communicated with a doctor's assistant. It should matter to what degree Rex interacts with his pharmacist. Both of these categories of personnel, and specifically the pharmacist, with whom Rex necessarily has to interact when obtaining the actual medication, should hold a duty to Rex under the law.


(1.) Law clerk for the Honorable J. Robin Hunt of the Washington Court of Appeals, Division Two. J.D., Washington University School of Law (2009); B.A., Brandeis University (2006). The analyses, views, and opinions expressed in this article are the author's alone and in no way reflect a position of the Washington Court of Appeals. Many thanks to Professor Kimberly Jade Norwood for her assistance with the writing of this article and to Professor Peter A. Joy for his guidance regarding the publication process. I am grateful for the love and encouragement of my father C. Marshall Friedman, the first lawyer I ever knew, my mother the late Carol S. Friedman, and my beautiful wife Kate and daughter Adira.

(2.) All names in the following episode are entirely fictitious and are designed for illustrative purposes.

(3.) See discussion infra Part II.

(4.) Shanks v. Upjohn Co., 835 P.2d 1189, 1195 (Alaska 1992).

(5.) See Johnson v. Am. Cyanamid Co., 718 P.2d 1318, 1323 (Kan. 1986).

(6.) See, e.g., Terlinde v. Neely, 271 S.E.2d 768, 770 (S.C. 1980) ("By placing this product into the stream of commerce, the builder owes a duty of care to those who will use his product, so as to render him accountable for negligent workmanship.").

(7.) See discussion infra Part III.

(8.) See discussion infra Parts IV and V.

(9.) See discussion infra Part VII.

(10.) See discussion infra Part IV and VIII.

(11.) See Johnson v. Am. Cyanamid Co., 718 P.2d 1318, 1323 (Kan. 1986).

(12.) Shanks v. Upjohn, 835 P.2d 1189, 1195 (Alaska 1992).

(13.) See Johnson, 718 P.2d at 1323, 1324; see also JERRY J. PHILLIPS, PRODUCTS LIABILITY IN A NUTSHELL 225-29 (West Publ'g Co.) (4th Ed. 1993) (providing hornbook discussion of the Learned Intermediary Doctrine).

(14.) Sterling v. Cornish Drug, Co., 370 F.2d 82 (8th Cir. 1966).

(15.) Id. at 83.

(16.) Id. at 83-84.

(17.) Id. at 85.

(18.) See id. (finding that under the facts of this case the appellant had a duty to warn).

(19.) Id.

(20.) Johnson v. Am. Cynamid Co., 718 P.2d 1318 (Kan. 1986), aff'd, 758 P.2d 206 (Kan. 1988).

(21.) Id. at 1320.

(22.) Id. at 1324.

(23.) Id.

(24.) See id. at 132556 (explaining how, in this case, the defendant met his duty to warn the physician of a known risk).

(25.) Pumphrey v. C.R. Bard, Inc., 906 F. Supp. 334, 338 (N.D.W. Va. 1995).

(26.) See id. (discussing the doctrine and how it is widely accepted in a large number of jurisdictions).

(27.) See id.

(28.) See RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. [section] 6(d)(1) (1997).
 A prescription drug or medical device is not reasonably safe due to
 inadequate instructions or warnings if reasonable instructions or
 warnings regarding foreseeable risks of harm are not provided to
 ... prescribing and other health-care providers who are in a
 position to reduce the risks of harm in accordance with the
 instructions or warnings.

Id.; see also id. at [section] 6 cmt. e ("Warnings and instructions with regard to drugs or medical devices that can be sold legally only pursuant to a prescription are, under the 'learned intermediary' rule, directed to health-care providers."). For additional discussion of the Learned Intermediary Doctrine and its relationship to the Third Restatement of Torts, see generally Timothy A. Pratt & John F. Kuckelman, The Learned Intermediary. Doctrine & Direct-To-Consumer Advertising of Prescription Drugs, 51 FED'N INS. & CORP. COUNSEL Q. 17 (2000), available at

(29.) PHILLIPS, supra note 13, at 228.

(30.) See Shanks v. Upjohn, 835 P.2d 1189, 1195 (Alaska 1992).

(31.) Id.

(32.) Johnson v. Am. Cyanamid Co., 718 P.2d 1318, 1324 (Kan. 1986).

(33.) Shanks, 835 P.2dat 1195.

(34.) See RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. [section] 6(b) (1997).

(35.) See Shanks, 835 P.2d at 1195 (finding it is the expectation of the doctor, and not the expectation of the patient, which is the relevant inquiry).

(36.) Johnson, 718 P.2d at 1324.

(37.) See Swayze v. McNeil Lab. Inc., 807 F.2d 464 (5th Cir. 1987), reh'g denied, 812 F.2d 1405 (5th Cir. 1987).

(38.) Id.

(39.) See id. at 472.

(40.) Id. at 471 (finding facts in the case which could reveal a practice where physicians in Mississippi allow CRNAs to have too much discretion in a role they are not trained to be a part of).

(41.) Id. at 466.

(42.) Id. at 471 (finding when there is a physician-patient relationship, the court hesitates to encourage, much less require, intervention from a drug manufacturer); see also United States v. Livdahl, 459 F. Supp. 2d 1255, 1265 (S.D. Fla. 2005) (acknowledging the principle set in Swayze where drug manufacturers have no duty to intervene in the physician-patient relationship to prevent the improper use of its product, but stating the case had no relevance to the one at hand).

(43.) PHILLIPS, supra note 13, at 225; see, e.g., York v. Union Carbide Corp., 586 N.E.2d 861, 871-72 (Ind. Ct. App. 1992).

(44.) York, 586 N.E.2d at 871-72.

(45.) Id. at 869.

(46.) Id. at 864.

(47.) Smith v. Walter C. Best, Inc., 927 F.2d 736 (3d Cir. 1990).

(48.) Id. at 741.

(49.) Id. (justifying seller's "reliance on [purchaser], as a knowledgeable purchaser, to warn the ultimate sand users," and "[t]he sand suppliers, therefore, owed the [employee of purchaser] no duty to warn").

(50.) See White v. Weiner, 562 A.2d 378, 385-86 (Pa. Super. Ct. 1989), aff'd, 583 A.2d 789 (Pa. 1991); see also Sheryl Calabro, Breaking the Shield of the Learned Intermediary Doctrine: Placing the Blame Where it Belongs, 25 CARDOZO L. REV. 2241, 2250-53 (2004). An alternative argument may also be proposed, however, that a doctor would not constitute a knowledgeable purchaser or sophisticated user from the perspective of the pharmaceutical manufacturer. See, e.g., House v. Armour of Am., inc., 929 P.2d 340, 345 (Utah 1996) (stating that the professional status relieves the duty to warn if the user actually knew of the danger, or the supplier reasonably believed the user knew). Doctors are not necessarily expert chemists or scientists or lab technicians or researchers as ordinarily would be employed by the manufacturer, and as ordinarily would be responsible for designing, testing and producing the drugs in question, and, therefore, they may not be held to the expert standard by the manufacturer. See, e.g., Calabro, supra, at 2283 (pointing out that the Daubert Trilogy Standard prevented doctors testifying as expert witness for plaintiffs against pharmaceutical companies because the doctors were not privy to the facts or data, thus they could not demonstrate causation).

(51.) See Shanks v. Upjohn Co., 835 P.2d 1189, 1195 n.6 (Alaska 1992).

(52.) See Davis v. Wyeth Lab., Inc., 399 F.2d 121, 131 (9th Cir. 1968). The Davis Court used the term, individualized balancing, to explain how a physician informs a patient of the risks involved with a particular prescription drug in light of the benefits the drug is likely to bring about, Id. at 130-31. Through determining an exception to the usual application of the Learned Intermediary Doctrine--by which a pharmaceutical manufacturer dispenses its obligation by warning the doctor alone--namely in a mass health clinic type situation, the court explained that "individualized balancing by a physician of the risks involved" is the key ingredient empowering the Learned Intermediary Doctrine. See id. at 131. Absent this ingredient, the Learned Intermediary Doctrine may not be applied. See Lloyd C. Chatfield II, Medical Implant Litigation and Failure to Warn. A New Extension for the Learned Intermediary Rule?, 82 KY. L.J. 575, 593 (1994).

(53.) See Davis, 399 F.2d at 131 (pointing out the "individualized balancing by a physician of the risks involved") (emphasis added).

(54.) See Calabro, supra note 50, at 2250.

(55.) See Schaerrer v. Stewart's Plaza Pharmacy, Inc., 79 P.3d 922, 928 (Utah 2003). "It is the physician who has the superior knowledge in the circumstances because he or she is able to balance the risks associated with the prescription drug against its utility 'in light of his [or her] personal knowledge of the patient's medical history.'" White, 562 A.2d at 386 (quoting Leibowitz v. Ortho Pharm. Corp., 307 A.2d 449, 458 (Pa. Super. Ct. 1973)).

(56.) See Davis, 399 F.2d. at 131. Logistically, such individualized attention by doctors is not feasible in these situations. See Mitchell S. Berger, A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-to-Consumer Drug Promotion, 55 FOOD & DRUG L.J. 525, 551 (2000). Mass immunizations offered at a grocery store, civic center, educational institution or other non-hospital setting would not be expected to allow for the same level of individualized attention as would ordinarily be found at a hospital or doctor's office. See id. at 552.

(57.) See Berger, supra note 56, at 552.

(58.) See Davis, 399 F.2d at 131 (refusing to apply the Learned Intermediary Doctrine since "although... a prescription drug it was not dispensed as such. It was dispensed to all comers at mass clinics without an individualized balancing by a physician of the risks involved.").

(59.) See, e.g., Mazur v. Merck & Co., 964 F.2d 1348, 1356 (3d Cir.1992). "[A]ssuming there are circumstances in which a nurse may act as a learned intermediary under Pennsylvania law, we do not think it can be said, as a matter of law, that Nurse Frederick acted as a learned intermediary under the facts here." Id. at 1358. But see Walker v. Merck & Co., 648 F. Supp. 931, 934-35 (M.D. Ga. 1986), aff'd, 831 F.2d 1069 (11th Cir. 1987) (finding Georgia law considered nurse practitioners to be learned intermediaries); see also PHILLIPS, supra note 13, at 225-29 ("Persons To Be Reached").

(60.) See MacDonald v. Ortho Pharm. Corp., 475 N.E.2d. 65, 69 (Mass. 1985); see also PHILLIPS, supra note 13, at 228-29.

(61.) Id. at 69; see also Calabro, supra note 50, at 2254-55.

(62.) MacDonald, 475 N.E.2d at 69.

(63.) See id. at 70. To establish that a warning to the doctor alone was insufficient, the MacDonald Court looked at a number of ways by which oral contraceptive drugs differ from traditional prescription drugs, including "heightened participation of patients" in decisions regarding its use, "substantial risks" associated with its use, the "feasibility of direct warnings" by the manufacturer to the user, as well as the "limited participation of the physician" and the inherent inadequacy of "communications between physicians and consumers" concerning the drugs' risks. See id. Based on these findings, the court therefore concluded "that the manufacturer of oral contraceptives is not justified in relying on warnings to the medical profession to satisfy its common law duty to warn, and that the manufacturer's obligation encompasses a duty to warn the ultimate user." Id. Thus, a manufacturer has a duty to notify the consumer of "known or knowable side effects...." Id.

(64.) Id. On its face, this general rule seems to represent a directly proportional relationship between the manufacturer's duty and the patient's consumer-intelligence; in other words, the more intelligent of a consumer the patient is, the more likely the patient will be actively involved in the decision to use a given drug or category of drug. Therefore, a greater burden is on the manufacturer to hold a duty to effectively warn a lay-person consumer. Cf Stephens v. G.D. Searle & Co., 602 F. Supp. 379, 380-81 (E.D. Mich. 1985) (finding the language in a dissenting opinion to a similar certified question should be adopted concerning the duty of a manufacturer to warn a lay-person of the dangers involved with contraceptives). This is a higher burden than merely warning an expert doctor. See, e.g., Bryan J. Maedgen & Sheree Lynn McCall, A Survey of Law Regarding the Liability of Manufactures and Sellers of Drug Products and Medical Devices, 18 ST. MARY'S L.J. 395, 403 (1986) (surmising that the duty to warn is limited when the drug manufacturer is required to only warn the prescribing doctor). Perhaps it can be viewed as an inverse relationship of patient intelligence and doctor duty--i.e. the more intelligent the patient, the less burden upon the doctor to warn the patient, since such duty is now carried by the manufacturer. Thus, depending on the circumstance, the doctor's role as middle-man or intermediary between the manufacturer and the patient may diminish from a legal perspective. Perhaps there is no proportional relationship at all, just merely a shifting burden in relation to who has the duty of warning the patient--i.e. ordinarily the doctor holds the burden of warning the patient, under the Learned Intermediary Doctrine, but this burden shifts back to the manufacturer the more intelligent the patient, amounting to lesser involvement of said learned intermediary.

(65.) See, e.g., Roney v. Gencorp, 654 F. Supp. 2d 501, 503-05 (S.D.W. Va. 2009) (citing State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 901 (W. Va. 2007) (relating the reasons for why some states do not find application of the learned intermediary doctor in direct-to-consumer advertising). This is the type of television commercial for prescription allergy drug X featuring a sunny outdoor scene with a robust, ruddy narrator describing the pleasures of life now available to him/her after taking the drug ... followed by the second half of the commercial which consists of the same narrator listing, in an undertone, the risks of side effect associated with the drug and warning the viewer about which symptoms to be alert for and how to know when to seek immediate medical attention. See, e.g., YouTUBE.COM, Nasonex Clock, (last visited Oct. 12, 2009). The latter portion of the commercial seems to go on interminably but most usually is followed by a brief return to the sunny meadows earlier in the commercial, before the advertisement ends. Id.

(66.) See Roney, 654 F. Supp. 2d at 505.

(67.) See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 901 (W. Va. 2007) ("After thorough consideration of the learned intermediary doctrine in light of the current state of the prescription drug industry and physician/patient relationships, we decline to adopt this doctrine."). In telling fashion, the court explained its reasoning:
 We note the lengthy history of the learned intermediary doctrine
 because the very age of the doctrine requires us to pause and
 engage in a thorough examination, even though the doctrine has been
 widely accepted. Significant changes in the drug industry have
 post-dated the adoption of the learned intermediary doctrine in the
 majority of states in which it is followed. We refer specifically
 to the initiation and intense proliferation of direct-to-consumer
 advertising, along with its impact on the physician/patient
 relationship, and the development of the internet as a common
 method of dispensing and obtaining prescription drug information.

Id. at 907; see also Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 GA. L. REV. 141, 160-61 (1997); Patrick Cohoon, Comment, An Answer to the Question Why the Time has Come to Abrogate the Learned Intermediary Rule in the Case of Direct-to-Consumer Advertising of Prescription Drugs, 42 S. TEX. L. REV. 1333, 1337 (2001).

(68.) See, e.g., Perfetti v. McGhan Med., 662 P.2d 646, 649 (N.M. Ct. App. 1983) (stating that if a seller "has reason to anticipate danger may result from a particular use" of a product, he may be required to give adequate warning); see also PHILLIPS, supra note 13, at 211 ("To be adequate, a warning must describe the nature and the extent of the danger involved.").

(69.) See, e.g., Campos v. Firestone Tire & Rubber Co., 485 A.2d 305, 309 (N.J. 1984) (stating the duty to warn extends to foreseeable users of all hidden and patent dangers that the product may inflict); see also PHILLIPS, supra note 13, at 213-14. The manufacturer should take into consideration all foreseeable dangers which are presented by the product. See Freund v. Cellofilm Properties, Inc., 432 A.2d 925, 932 (N.J. 1981).

(70.) See Hubbard-Hall Chem. Co. v. Silverman, 340 F.2d 402, 405 (lst Cir. 1965) (declaring that a jury could reasonably find that a defendant should have foreseen that an illiterate worker would not recognize the danger of the products based on the warnings used); see also PHILLIPS, supra note 13, at 214.

(71.) Hubbard-Hall Chem. Co., 340 F.2d at 405.

(72.) Id. at 404.

(73.) Id. at 405. The warning label stated the following:

CAUTION: May Be Fatal If Swallowed, Inhaled or Absorbed Through Skin. Rapidly Absorbed Through Skin. Do not get in eyes or on skin. Wear natural rubber gloves, protective clothing and goggles. In case of contact wash immediately with soap and water. Wear a mask or respirator of a type passed by the U.S. Department of Agriculture for parathion protection. Keep all unprotected persons out of operating areas or vicinity where there may be danger of drift. Vacated areas should not be reentered until drifting insecticide and volatile residues have dissipated. Do not contaminate feed and foodstuffs. Wash hands, arms and face thoroughly with soap and water before eating or smoking. Wash all contaminated clothing with soap and hot water before re-use.

Id. at 403.

(74.) Haugen v. Heitkamp Constr., Inc., No. 3:04-cv-0146, 2006 WL 3544347, at *6 (S.D.N.D. Nov. 3, 2006); see also PHILLIPS, supra note 13, at 214 (citing Evridge v. Am. Honda Motor Co., 685 S.W.2d 632 (Tenn. 1985) (regarding warning on motorbike, and finding that a genuine issue of fact existed as to "the adequacy of the warnings given by the defendants to bring home to a reasonably prudent user of the Honda Express, particularly a young child, the nature and extent of the danger involved in 'doubling' passengers on it")).

(75.) See PHILLIPS, supra note 13, at 215 (citing DCR, Inc. v. Peak Alarm Co., 663 P.2d 433 (Utah 1983) (stating that manufacturer of alarm system had duty to warn user of system's vulnerability to deactivation by burglars)).

(76.) See Jaclyn Shoshana Levine, The National Vaccine Injury Compensation Program: Can it Still Protect an Essential Technology?, 4 B.U.J. SCI. & TECH. L. 9, 34 (1998) (stating that a lack of a requirement to provide "reasonably effective warnings" is dangerous in view of the fact that warnings are very effective); PHILLIPS, supra note 13, at 217 ("[I]f the plaintiff asserts that the defendant failed to use a reasonable effective way of communicating the warning, then failure to read the warning as given may not bar recovery."); see also Seibel v. Symons Corp., 221 N.W.2d 50, 55 (N.D. 1974) (stating "the duty to warn also involves the concept of the adequacy of any warning given, both as to clarity and completeness and as to the means used to communicate the warning to users and others within the zone of danger of injury or damage").

(77.) See, e.g., McCully v. Fuller Brush Co., 415 P.2d 7, 8-10 (Wash. 1966) (pointing out the liability that attaches when the packaging of the harmful product conveys the message it is safe). A woman used a cleansing product, the label of which said, "It's Kind to Your Hands," and the message prevented her from thinking to wear gloves when she used the product that was actually toxic and severely injured her. Id.; see also PHILLIPS, supra note 13, at 229 ("Countervailing Representations").

(78.) 306 N.E.2d 312, 318 (Ill. App. Ct. 1973).

(79.) Id. at 317 ("The cleaner was contained in a white, plastic bottle with a red, white, blue and aqua label, lending to it a colorful and harmless appearance ... [t]he labels include a guarantee which states 'money back with a smile if not satisfied with this item.'"); see also 10 Children Drink Windshield Fluid, TIMES (Trenton, N J), Mar. 14, 2009, at A5 (reporting a modern example of cleaning fluid being mistaken for a soft-drink and thereby consumed). The author is reminded of a personal experience at an exercise gym whereby a wall-dispensing translucent plastic container or jug--with an open/close nozzle of sorts at the bottom--contained a non-labeled pink liquid. Its location in the gym, its container, and its absence of label pointed toward this liquid being drinkable. In fact the color closely resembled many popular sports drinks consumed in gyms today. The author is sure the cleaning solution would not have tasted very good.

(80.) 280 S.E.2d 510 (N.C. Ct. App. 1981).

(81.) Id. at 519 ("[W]e hold that plaintiff substantiated a products liability claim against the defendant manufacturer on three grounds ... its negligent manufacture and packaging of Vydate L."). Plaintiff made a showing that defendant "manufactured the highly toxic chemical as a colorless liquid and packaged it in clear plastic jugs ... [leading it to] be easily mistaken for water in its appearance." Id. at 515.

(82.) See McDaniel v. Williams, 23 A.D.2d 729, 729 (N.Y. App. Div. 1965) (stating where a consumer knows about the dangerous propensities of a product, "no warning of danger is required"). "[A] retail seller [had] no duty to warn of an obvious hazardous condition which a 'mere casual looking over [would] disclose.'" Ziglar, 280 S.E.2d at 515 (quoting the RESTATEMENT (SECOND) OF TORTS [section] 388 cmt. k (1965)). Under Texas law, there was no duty upon manufacturers or sellers of handguns to warn since danger of a firearm is obvious. See Keene v. Sturm, Ruger & Co., 121 F. Supp. 2d 1063, 1069 (E.D. Tex. 2000) (citing Perkins v. F.I.E. Corp., 762 F.2d 1250, 1275 (5th Cir. 1985) ("[D]angers of handguns are obvious and well-known....")). "Although some commentators [argue] that consumers must be warned about the dangers of handgun use and the possibility of handgun theft ... there is no duty to warn of 'dangers' that are obvious and commonly known." Patterson v. Gesellschaft, 608 F. Supp. 1206, 1209 n.7 (N.D. Tex. 1985). "Obviously, it is not 'necessary to tell a zookeeper to keep his head out of the hippopotamus' mouth." Id.; see also PHILLIPS, supra note 13, at 218 ("A warning is not required for a danger that is obvious."). Is a hot cup of coffee purchased from a drive-thru window an obvious danger from which a manufacturer or merchant would be immune from liability? At least one jury in New Mexico answered this question with a resounding NO! Here is one court's account of the famed McDonald's Coffee Spill Case:
 On August 17, 1994, a state court jury in Albuquerque, New Mexico,
 awarded 81-year old Stella Liebeck $160,000 in compensatory damages
 and $2.7 million in punitive damages, after she was burned by
 coffee purchased from a drive-through window at a McDonalds
 restaurant. The trial judge later reduced the punitive damages to
 $480,000, and the parties settled the case before an appeal.
 According to news reports, Mrs. Liebeck contended that for taste
 reasons McDonalds served coffee about 20 degrees hotter than other
 fast food restaurants, and in spite of numerous complaints, had
 made a conscious decision not to warn customers of the possibility
 of serious burns. The jury's verdict received world-wide attention.

Greene v. Boddie-Noell Enterprises, Inc., 966 F. Supp. 416, 418 n.1 (W.D. Va. 1997) (citing Andrea Gerlin, A Matter of Degree. How a Jury Decided That One Coffee Spill Is Worth $2.9 Million, WALL ST. J. EUR., Sept. 2, 1994, at 1); see also Kevin G. Cain, And Now the Rest of the Story... The McDonald's Coffee Lawsuit, 11 J. CONSUMER & COM. L. 14, 15, 17 (2007).

The litigious nature of our society has a way of captivating our attention even years after the fact through references in popular media like music. See, e.g., TOBY KEITH, AMERICAN RIDE (Show Dog Nashville) (2009) (including the following lyric: "Plasma getting' bigger--Jesus gettin' smaller Spill a cup of coffee--make a million dollars").

(83.) See, e.g., 15 U.S.C. [section] 1334 (2009) (pertaining to cigarette labeling); 27 U.S.C. [section] 215 (2009) (pertaining to alcoholic beverage labeling).

(84.) The remainder of this article consists of the author's original analysis, unless otherwise noted.

(85.) See Shanks v. Upjohn Co., 835 P.2d 1189, 1195 n.6 (Alaska 1992).

(86.) See Calabro, supra note 50, at 2241 (stating that if any other product caused as many annual deaths as do prescription drugs, the manufacturer may be liable, yet the manufacturer of prescription drugs easily avoids such liability).

(87.) See Nicole Endejann, Is the FDA's Nose Growing?: The FDA Does Not "Exaggerate its Overall Place in the Universe" When Regulating Speech Incident to "Off-Label" Prescription Drug Labeling and Advertising, 35 AKRON L. REV. 491, 532-34 (2002) (pointing out that manufacturers of prescription drugs are exempted from the requirement of providing adequate warnings to the ultimate consumer to avoid product liability).

(88.) See Michelle Meadows, Why Drugs Get Pulled Off the Market, FDA CONSUMER, Jan.-Feb. 2002, at 11, available at mi_m1370/is_1_36/ai_83144660/?tag=content;coll (describing that before a drug is removed from the market, the FDA employs several risk management tools, such as writing letters to health-care professionals, and adding new warnings to labels); see also William B. Schultz, Deputy Comm'r, Policy, Food & Drug Admin., Guest Lecture to Wash. Univ. Law School Products Liability Class: Drugs, Medical Devices, the FDA, the Learned Intermediary Doctrine, Preemption (Feb. 6, 2009) (reporting that only fifty or so out of approximately eight thousand drugs have ever been taken off of the market once in circulation).

(89.) See Catherine A. Paytash, The Learned Intermediary Doctrine and Patient Package inserts: A Balanced Approach to Preventing Drug-Related Injury, 51 STAN. L. REV. 1343, 1344 (1999); RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. [section] 6 cmt. d, reporters' note (1998).

(90.) See Margaret Gilhooley, Addressing Potential Drug Risks. The Limits of Testing, Risk Signals, Preemption, and the Drug Reform Legislation, 59 S.C.L. REV. 347, 360-61 (2008) (offering a comprehensive discussion of the shortcomings of clinical trials, including the fact that the tests yield little information regarding the effects of long-term exposure). There are contrary opinions also, such as the director of the FDA's office of medical policy, Robert Temple, M.D.:
 If we want reasonably rapid access to needed drugs, it's not
 practical to require that they be tested in 15,000 to 30,000
 people, which is what you'd need to be reasonably sure you saw even
 one case that occurs at a rate of I in 5,000 to 10,000.... [a]nd
 the case would need to be recognized as drug induced.... So drugs
 are typically tested in several thousand subjects, allowing
 detection of relatively common serious adverse events, such as
 those affecting 1 in 1,000 people. This practical size of clinical
 trials means we can't know everything about a drug when it gets on
 the market. Rare events will only surface when the drug is used in
 larger numbers of people.

Meadows, supra note 88, at 11.

(91.) See discussion supra Part IV.

(92.) See, e.g., Cash To Doctors Can Ruin Patients' Trust, Our Opinion: Make Rebates For Using A Particular Medicine Illegal, MIAMI HERALD, May 15, 2007, at A14; see also Sandeep Jauhar, M.D., Essay, The Pitfalls of Linking Doctors' Pay to Performance, N.Y. TIMES, Sept. 9, 2008, at F5.

(93.) See Jack B. Harrison & Mina J. Jefferson, Some Accurate Information is Better than No Information at All: Arguments Against an Exception to the Learned Intermediary Doctrine Based on Direct-to-Consumer Advertising, 78 OR. L. REV. 605, 623-24 (1999). A policy which eliminates any consumer barrier to litigate against a pharmaceutical manufacturer would surely lead to some version of a parade of horribles result by which the conducting of medical research and the providing of medication to the public at large via the commercial market would simply become too expensive an undertaking for the manufacturer, and the critical distribution of prescription drugs would be discontinued to the detriment of all. Id. at 606.

(94.) See Lars Noah, The Imperative to Warn. Disentangling the "Right to Know"from the "Need to Know" About Consumer Product Hazards, 11 YALE J. ON REG. 293, 295 (1994). The reader can surely relate to this phenomenon of overwarning--from televisions, to over-the-counter medications, to gasoline pumping, to sporting equipment, even to the disposable coffee cup sold to you by your favorite barista, etc.... do you read the warnings?

(95.) RESTATEMENT (THIRD) OF TORTS: PROD. LIAB. [section] 6(d)(1) (1998).

(96.) See id.; see also id. at [section] 6 cmt. d;
 [Section 6(d)] basically states the current learned intermediary
 doctrine as applied by the courts except that it extends the duty
 to warn to "other health-care providers" in addition to prescribing
 physicians. It has been suggested that this provision, if adopted
 by courts, could substantially increase the burden on drug
 manufacturers to provide warnings necessary to meet the
 requirements of the learned intermediary rule. It is unclear who is
 included in "other health care providers," what type of warning
 must be given to "other health care providers," under what
 circumstances such warnings must be given, or the appropriate type
 and method of warning.

Pratt & Kuckelman, supra note 28, at 17.

(97.) See HEALTH GUIDE USA, Pharmacist Training, (last visited Oct. 14, 2009).
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Author:Friedman, Robert J.
Publication:St. Thomas Law Review
Date:Jan 1, 2010
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