Pharmacy in History Excerpt


Pharmacy in History Excerpt (PH)

The following excerpts are from the quarterly journal of the AIHP, Pharmacy in History. Each issue of Pharmacy in History includes scholarly articles, popular pieces on museums and artifacts, pharmaco-historical news, and book reviews.

The following copyrighted article appeared in Pharmacy in History , volume 38, #1, 1996, pp. 3-14:

How Old Legal Precedents Produce New Rules of Law:

A Case Study of Jones v. Walgreen

by David B. Brushwood*

Pharmacists of late twentieth-century America have watched with interest as judges wrestled with legal standards that defined the role of pharmacists in drug distribution and pharmaceutical care. Over the course of the ten years between 1985 and 1995, a firm trend has emerged, and that trend is for judges to recognize expanded responsibilities for pharmacists.1 This article will suggest that the trend toward recognizing expanded responsibilities for pharmacists is not a significant departure from precedent. The argument that pharmacists should be legally required to do more than correctly process prescription orders is amply supported by decades of decisions under the common law. Pharmacists have always been expected to perform at the highest professional level under the common law. A judicial decision that imposes upon pharmacists a standard that requires detecting and rectifying potential problems with drug therapy, in addition to accurate dispensing, has solid support in common law precedents from as far back as the early nineteenth century.

The common law is a body of judge-made rules with roots in centuries of resolved disputes. The term “common law” refers to law developed from judicial decisions, rather than from legislative enactments or administrative rulemaking. Much of the common law of the United States of America is based on law developed in England during the 200 to 300 years following the Norman conquest in 1066. Because the English kings in this period wanted to establish a uniform set of national laws, judges recorded their decisions and they followed the reasoning of previous court decisions. The result is a body of law that courts are still following today. The English colonists retained the common law system when they came to North America.

The essence of the common law system is the recording of judicial opinions and the reliance of courts on those previous opinions. This procedure is called stare decisis, meaning “let the decision stand.” In practice, a court’s establishment of a certain rule of law based on a particular set of facts becomes a precedent that all lower courts in that jurisdiction must follow. While the legal rationale of a previous factually similar case is binding authority only in the jurisdiction where the case was decided, the rule of precedent is so highly regarded that courts from jurisdictions in which the issue has not yet been considered may look to the established case law of another jurisdiction as persuasive non-binding authority. Stare decisis serves two important purposes: (1) it establishes continuity of decisions, thus permitting people to know what is expected of them, and (2) it expedites judicial decision making, thus preventing the inefficient reconsideration of policy arguments every time an issue is litigated.

Stare decisis is not an inflexible principle. A court may vary from precedent for two reasons. First, there may be factual distinctions between the case before the court and previous decisions on which the court has been asked to rely. Second, courts may vary from a precedent because of changing times or circumstances since the precedent was established. However, there must be compelling reasons to depart from established precedent. Factual distinctions must be certain and significant.  A change in circumstances must be firmly based on a shift in social mores, if there is to be a justifiable departure from precedent.

Jones v. Walgreen Co.

In 1932, the Appellate Court of Illinois wrote a lengthy opinion in deciding a case that now serves as a significant bridge between early pharmacy precedents and contemporary pharmacist malpractice judicial opinions. The case of Anna Jones v. Walgreen Company,2 is perhaps the first to apply nineteenth-century logic to a twentieth-century set of facts. The rule of law put forth in this case has been relied upon by judges deciding cases as recently as the final two months of 1994. An analysis of the cases cited as precedent by the Jones court, as well as the cases that cite Jones as precedent, shows a consistently high level of expectation of pharmacists, an expectation that pharmacists will practice at a level of care that is commensurate with the danger to which the public they serve is exposed. This high level of expectation is not a recent development; it has spanned almost two centuries of litigation.

Anna Jones sued the Walgreen Company, alleging that she received pure strontium salicylate, which is ten to twelve times stronger than the effervescent strontium salicylate that she alleged was prescribed for her. The facts showed that on 13 July 1929, the plaintiff was suffering from a dull pain in her arm and the family physician diagnosed her ailment as “muscular rheumatism.” The physician gave her a prescription that read, “Strontium Salicylate four ounces (Wyatt), teaspoonful in water four times a day.” Maurice Zaritsky, who had graduated in pharmacy the previous month, and was then about twenty-two years of age, filled the prescription with pure strontium salicylate prepared by Parke-Davis & Company. The plaintiff suffered severe harm as the result of using the dispensed medication.

The following appears from the court’s summary of Zaritsky’s testimony:

That prior to July 13, 1929, he had passed the State Board examination for the position of assistant registered pharmacist; that he was familiar with the principal pharmaceutical manufacturers, including Parke-Davis & Company and John Wyeth & Brother; that doctors sometimes indicated on their prescriptions P-D for Parke-Davis & Company, and Wyeth for John Wyeth & Brother; that he knew that Wyeth did not make strontium salicylate; that the defendant had in stock strontium salicylate made by Parke-Davis & Company, and also effervescent strontium salicylate made by John Wyeth & Brother; that when he received the prescription to fill he “dispensed four ounces of strontium salicylate” from the “stock bottle probably Parke-Davis & Company’s”; that before he filled the prescription he saw on it the word “Wyatt” but “it didn’t mean very much to me, it seemed to indicate the doctor had in mind a brand of strontium salicylate”; that he looked in the “red book” to see if there was a manufacturer by the name of Wyatt but did not find one; that there is no manufacturer with a name that sounds like Wyatt; that Wyatt sounds like Wyeth “if you slur it”; that “when you get a prescription and you don’t know what it means” you call up the doctor; that he did not examine the catalogue of Wyeth & Brother; that he knew that Wyeth made an effervescent strontium salicylate compound and that “Wyeth doesn’t make strontium salicylate.”3 (Emphasis in original.)

The argument used by the pharmacy in defending the claim made against it was that “the legal duty of a druggist to a purchaser can go no further than to dispense the identical substance which his prescription calls for.”4 In effect, the pharmacy was contending that any mistake in a prescription is the physician’s responsibility exclusively, and that pharmacists have no responsibility to detect and rectify prescribing errors. This is an argument that contemporary pharmacists use as well. Yet the court in the Jones v. Walgreen case was unconvinced. The court stated, “The instant contention is primarily based upon the assumption that a pharmacist is obliged to fill any and all prescriptions. Such is not the law. As a chemist he may know that the physician has erred in his prescription and that to fill it might cause death or serious injury to the patient.”5 The court relied in part on the statements of a physician who testified as an expert witness. The physician stated “that when a doctor has prescribed an overdose it is the duty of the pharmacist to refuse to fill the prescription.”6

The court upheld a verdict for the plaintiff, but reduced the amount of the award from $20,000 to $10,000. This case firmly established the pharmacist’s responsibility to screen prescriptions for potential problems and to contact the prescriber when a potential problem was evident. It recognized the pharmacist’s important gatekeeper role; to prevent harm to the patient from prescribed medications. Yet, it did not recognize a role for pharmacists in promoting benefit for patients; that legal recognition would come decades later.

Precedents to Jones v. Walgreen

In determining that the duty of a pharmacist goes beyond technical accuracy in prescription processing, to include monitoring for potential harm to the patient, the court in the Jones v. Walgreen case cited nine cases as precedent on the issue of pharmacist duty. Foremost among these cited cases was the 1910 Supreme Court of Maine opinion in the case of Tremblay v. Kimball.7 This case was extensively cited by the Jones opinion, and in it were four citations to earlier cases that were referenced in the Jones opinion. A separate set of four cases was also briefly listed as a source of authority by the court in the Jones case. The four cases that were cited in addition to those from the Tremblay opinion were: Tombari v. Connors,8 (substitution of calomel for calumbra); McGahey v. Albritton,9 (incorrect inclusion of calomel in a compounded medication); Martin v. Manning,10 (harmful ophthalmic preparation substituted for harmless one); and Faulkner v. Birch,11 (atropine substituted for codeine). Each case recognized the principle that pharmacists must accept responsibility for their actions or for their failure to act. A pharmacist cannot point to another party as being solely responsible for causing drug-related harm, if the pharmacist had the opportunity to prevent the harm.

The Tremblay v. Kimball opinion, upon which the Jones court relied heavily, resolved a dispute between a patient and a pharmacist in which the patient alleged that the pharmacist had dispensed corrosive sublimate tablets (each containing 7.3 grains of bichloride of mercury and 7.3 grains of muriate of ammonia) instead of the chlorodyne tablets that had been prescribed by the patient’s physician. The jury returned a verdict in favor of the patient in the amount of $1,400. The pharmacist appealed.  In affirming the plaintiff’s verdict, the court provided a primer on early twentieth-century pharmacy law:

The rules of law governing this class of cases are closely analogous to those applicable to physicians and surgeons. A registered apothecary or any person who undertakes to act in the capacity of a qualified druggist in preparing medicines and filling physicians’ prescriptions is required by law, in the first place, to possess a reasonable and ordinary degree of knowledge and skill with respect to the pharmaceutical duties which he professes to be competent to perform. He is not required to possess the highest degree of knowledge and skill to which the art and science may have attained. He is not required to have skill and experience equal to the most eminent in his profession. He is only required to have that reasonable degree of learning and skill which is ordinarily possessed by other druggists in good standing as to qualifications in similar communities.

In the second place, the law imposes upon the druggist the obligation to exercise all reasonable and ordinary care and prudence in applying his knowledge and skill in compounding medicines, filling prescriptions, and performing all of the other duties of an apothecary. He is not bound to use extraordinary care and prudence, or a greater degree of care than is ordinarily exercised by other qualified druggists. Ordinary skill is the test of qualifications, and ordinary care is the test of the application of it.

Finally, in applying his knowledge and exercising care and diligence, the druggist is bound to give his patrons the benefit of his best judgment; for even in pharmacy there is a class of cases in which judgment and discretion must or may be exercised. The druggist is not necessarily responsible for the results of an error of judgment which is reconcilable and consistent with the exercise of ordinary skill and care. He does not absolutely guarantee that no error shall ever be committed in the discharge of his duties. It is conceivable that there might be an error or mistake on the part of a qualified druggist which would not be held actionable negligence.12

This quoted language is noteworthy for several reasons. First, it recognizes pharmacy as a profession, analogous to medicine. It speaks of varying levels of skill among pharmacists, and denies that a pharmacist must practice at the highest level to avoid malpractice. Second, it distinguishes skill and care; suggesting that one may be skillful but careless, or unskilled but careful, and violate a duty to the patient either way. The pharmacist’s professional responsibility is to be both skillful and careful. Lastly, it recognizes that judgment is a component of what pharmacists do. The simple fact that a bad outcome occurred from drug therapy does not, in and of itself, mean that a pharmacist is responsible for an error in judgment. Pharmacists can guarantee only that they will be skillful and careful; not that the results of their skill and care will be good. For there to be negligence by a pharmacist, it must be shown that there was a lack of skill and/or care, not just that a mistake occurred.

This sort of analysis of responsibilities in pharmacy practice has only recently begun to reappear in pharmacist litigation, after several decades of legal analysis that denied the role of judgment in pharmacy and that resulted in a virtual presumption of negligence when an error occurred. To recognize, at the end of the twentieth century, that pharmacists have a judgmental role to play in pharmacotherapy is not to make new law, it is a return to an earlier approach at the beginning of the century, when pharmacists were recognized as having valuable knowledge and skill, separate and distinct from their technical prowess.

The Tremblay opinion describes expansively the level of care required of pharmacists:

But while, as has been seen, the legal measure of the duty of druggists towards their patrons, as in all other relations of life, is properly expressed by the phrase “ordinary care,” yet it must not be forgotten that it is “ordinary care” with reference to that special and peculiar business. In determining what degree of prudence, vigilance, and thoughtfulness will fill the requirements of “ordinary care” in compounding medicines and filling prescriptions, it is necessary to consider the poisonous character of so many of the drugs with which the apothecary deals, and the grave and fatal consequence which may follow the want of due care. In such a case “ordinary care” calls for a degree of vigilance and prudence commensurate with the dangers involved. “Ordinary care” with reference to the business of a druggist must therefore be held to signify the highest practicable degree of prudence, thoughtfulness, and vigilance and the most exact and reliable safeguards consistent with the reasonable conduct of the business in order that human life may not constantly be exposed to the danger flowing from the substitution of deadly poisons for harmless medicine.13

This fundamental analysis is applicable to any pharmacist malpractice case. Pharmacists are required to be knowledgeable (the prudence requirement), alert to potential problems (the thoughtfulness requirement), and attentive to the patient’s interests (the vigilance requirement). These requirements are not absolute, but instead are balanced against the need to be efficient in the conduct of business. Pharmacists must exercise a high level of care when the dangers to the patient are great, and only ordinary care when the dangers to the patient are not so great. It would be fully consistent with this analysis to expand pharmacists’ responsibilities as pharmacotherapy becomes more complex, because the dangers to the patient increase. While the fundamental rule of responsibility would stay the same, the actions expected of pharmacists would increase due to the circumstances.

The reasoning of Tremblay v. Kimball serves as ample precedent for the result and analysis of Jones v. Walgreen. In Jones the court concluded that pharmacists have a responsibility to question prescriptions that appear out of the ordinary, and cited testimony that pharmacists should refuse to fill a prescription if it calls for an overdose of medication. The Tremblay opinion supports this conclusion, refuting any notion that pharmacists merely follow doctors’ orders. The role for pharmacists as guardians of patient welfare that the Jones opinion envisioned is based on the professional duty enunciated in Tremblay v. Kimball. That duty requires pharmacists to act for the benefit of patients when danger to patients is apparent.

Foundational Precedents of Jones v. Walgreen

The case of Tremblay v. Kimball cited as authority four other cases that were also referenced in the Jones opinion.  The 1882 case of Brown v. Marshall,14 a Supreme Court of Michigan case, was relied on by the Tremblay court due to the observation in Brown that “people trust not merely their health but their lives to the knowledge, care and prudence of druggists, and in many cases a slight want of care is liable to prove fatal to some one.”15 The Brown court concluded that the care required of a pharmacist “shall be proportioned to the danger involved.”16 A verdict in favor of the plaintiff, who had received sulfate of zinc instead of the requested Epsom salts, was reversed. The trial court had provided to the jury an incorrect instruction that did not incorporate negligence as an element of liability, thus justifying reversal on appeal. However, the duty of pharmacists to be knowledgeable and to protect patients was affirmed. The results of two other cases cited in Tremblay, Norton v. Sewall,17 (tincture of opium dispensed instead of tincture of rhubarb), and McDonald v. Snelling,18 (recognizing pharmacist liability for mislabeling drugs) are consistent with the views expressed in Brown.

The oldest of the precedents cited by Tremblay is the case of Thomas v. Winchester,19 a New York Court of Appeals case from 1852.  In this case, the allegation was that the defendant had negligently put up, labeled, and sold extract of belladonna as extract of dandelion. The patient suffered “very alarming effects,” but recovered, although for a short time her life was thought to be in grave danger. The legal question in this case was the concept of duty; particularly the source of the duty that a pharmacist has to a patient. The court declared:

The defendant’s duty arose out of the nature of his business and the danger to others incident to its mismanagement. Nothing but mischief like that which actually happened could have been expected from sending the poison falsely labeled into the market; and the defendant is justly responsible for the probable consequences of the act. The duty of exercising caution in this respect did not arise out of the defendant’s contract of sale to Aspinwall.20

This important point recognizes that the duty of a pharmacist arises out of the nature of the relationship between a pharmacist and a patient; and out of society’s expectations of a pharmacist as a public figure who is trusted to meet societally imposed responsibilities. The pharmacist’s duty does not derive from an agreement (contract) between a specific patient and a specific pharmacist. Thus, the pharmacist’s duty does not vary from one patient to the next depending on the specifics of an agreement; it remains constant for all patients due to a socially recognized standard.

Of minor importance, but major interest, is a concurring opinion filed separately by one of the justices in the Thomas case. This justice agreed that the pharmacist should be held liable, but gave as his rationale the simple fact that the pharmacist had committed the misdemeanor of selling belladonna without the statutorily required “poison” label.  The view that pharmacist’s responsibilities are defined by rule of statute, rather than by societal expectations (and that a pharmacist has failed to meet a responsibility only when a specific rule has clearly been broken), is a minority view that persists to this day.

Another case from 1852, Fleet and Semple v. Hollenkemp,21 was referenced as authority by Brown v. Marshall, thus it is a twice-removed precedent of Jones v. Walgreen. In this case from the Kentucky Supreme Court, the justices authoring the opinion noted a special character of pharmacy as distinct from that of others who provide products to consumers:

The purchasers of wines and provisions, by sight, smell, and taste, may be able, without incurring any material injury, to detect their bad and unwholesome qualities; but many are wholly unable, by the taste or appearance of many drugs, to distinguish those which are poisonous from others which are innoxious, so close is their resemblance to each other; purchasers have, therefore, to trust the druggist. It is upon his skill and prudence they must rely. It is, therefore, incumbent upon him that he understands his business.  It is his duty to know the properties of his drugs, and to be able to distinguish them from each other. It is his duty so to qualify himself, or to employ those that are so qualified, to attend to the business of compounding and vending medicines and drugs, as that one drug may not be sold for another; and so that, when a prescription is presented to be made up, the proper medicines and none other, be used in mixing and compounding it. As applicable to the owners of drug stores, or persons engaged in vending drugs and medicines by retail, the legal maxim should be reversed.  Instead of caveat emptor, it should be caveat vendor.22

The clear message of this case is to impose upon pharmacists a responsibility to protect patients, who are unable to protect themselves. This is a public trust, and is derivative of the knowledge pharmacists possess.

The earliest precedent in the Jones v. Walgreen line of cases is the 1828 English case known as Tessymond’s Case.23  Cited as authority by Thomas v. Winchester, this is a criminal prosecution of a pharmacist for dispensing laudanum labeled as paregoric, and instructing that the dose for paregoric be administered to an infant. The infant died from an overdose of laudanum, and the jury held that the pharmacist had been negligent.  The pharmacist was found guilty of manslaughter and was fined five pounds. The responsibility for harm to the patient rested squarely on the shoulders of the pharmacist.

The early precedents underscore fault as the basis of pharmacist liability in the nineteenth century, rather than causation, which characterized liability from the Anglo-Saxon period up until the early nineteenth century. Under a causation-based approach, one would say “I caused it, therefore I am responsible,” after harm has occurred. The approach is entirely retrospective, imposing no duty other than that of reparation after the fact.  Under a fault-based approach, however, one would say, “I am responsible, therefore I caused it,” after harm has occurred. The approach is prospective, requiring a duty of vigilance and protection for the benefit of another who is in one’s care. The pharmacy cases reviewed here were among the first American negligence cases to serve as examples of the evolving fault-based approach of American law.

There are two important rules of law that can be derived from the precedents of Jones v. Walgreen. First, the legal duty of a pharmacist arises out of the socially recognized relationship between patients and pharmacists. It is dependent upon public expectations. Because medications differ from other products in that they cannot be inspected and evaluated by patients prior to their use, pharmacists, who have specialized knowledge of medications, must protect from harm those who use medications. This standard for a pharmacist-patient relationship is not created by a specific pharmacist with a specific patient who seeks pharmaceutical products and services. It precedes the establishment of a specific pharmacist-patient relationship, and then defines that specific relationship each time services or products are sought by a patient from a pharmacist.

Second, the extent of the duty of a pharmacist within a pharmacist-patient relationship expands and contracts with the level of danger to which a patient is exposed. This means that, although the nature of a relationship is conceptual, the extent of a duty is factual. Once a relationship is held to exist, the extent of the duty within the relationship varies depending on the potential harm to the patient. This very fundamental approach to pharmacist duty has continued through the late twentieth century. It has served as the foundation for a series of cases that have followed Jones v. Walgreen, relying on the rationale of Jones and on the precedents that led up to it.

Jones v. Walgreen Cited as Precedent

The Jones v. Walgreen opinion was not cited as authority in a subsequent judicial opinion for a little over half a century following its issuance in 1932. During that time, American pharmacists were being sued for routine misfilling errors of commission, but not for errors of omission in failing to monitor drug therapy or counsel patients.24 In fact, during the five decades following the Jones v. Walgreen opinion, pharmacists became insulated from liability if they had processed a prescription correctly. That the prescription may have posed a threat of harm to the patient, and that the harm could have been prevented by the pharmacist, was irrelevant during that period. Technical accuracy in prescription processing was a pharmacist’s best insurance policy against liability.

The pharmacist’s shield against expanded liability began to crack in the early 1980s.25 It is not surprising that one of the first in a wave of cases from a new era of pharmacist liability turned to the precedent of Jones v. Walgreen in search of authority for an evaluation of allegations that a pharmacist has a duty to warn the patient or notify the prescriber that a drug is being prescribed in dangerous amounts. In the February, 1985 case of Jones v. Irvin,26 the United States District Court for the Southern District of Illinois refused to hold that a pharmacist has an expanded duty beyond accuracy in prescription processing. In keeping with the holdings of the majority of the first wave of cases that considered, but rejected, expanded responsibility for pharmacists, this court reasoned that “Placing those duties to warn on the pharmacist would only serve to compel the pharmacist to second guess every prescription a doctor orders in an attempt to escape liability.”27

The patient, who allegedly had been prescribed “massive doses of Placidyl, along with other drugs,” pointed to the precedent of Jones v. Walgreen in arguing that “the pharmacist’s legal duty goes further than merely dispensing the identical substance which a prescription calls for.” Yet the court in 1985 held that the facts of Jones v. Walgreen differed significantly from the facts of the case it was considering (the pharmacist in the early case “could not make out the name of the brand on the prescription,” while the pharmacist in the 1985 case had no cause to wonder what had been prescribed). Although the court refused to recognize an expanded responsibility for pharmacists, it nevertheless referred to its position as “a narrow one,” and concluded with a citation to Jones v. Walgreen for the proposition that a pharmacist owes a patient the “highest degree of prudence, thoughtfulness and diligence.”

Nine months later, in November of 1985, the Appellate Court of Illinois for the Fourth District cited Jones v. Walgreen to support a similar result.  In the case of Eldridge v. Eli Lilly & Co.,28 that court ruled against a plaintiff who alleged that his wife’s death was caused by Darvon dispensed accurately according to the prescription, but in excess of what his wife should have received. The court recognized that “a pharmacist owes a duty of ordinary care in practicing his profession but such care requires the highest degree of prudence, thoughtfulness and diligence, and it is proportional to the danger involved.”29 This familiar language was supported by a reference to Jones v. Walgreen. Nevertheless, the court held that there was no duty for a pharmacist beyond that of technical accuracy, because to impose such a duty would require interference with the physician-patient relationship. The possibility that this particular physician-patient relationship was harmful to the patient, and that it warranted interference, was not considered.

In the opinion from the 1993 case of Fakhouri v. Taylor,30 the First District Appellate Court of Illinois also cited, but rejected, the reasoning of Jones v. Walgreen. The court held that the defendant pharmacy had no duty to do anything more than fill prescriptions as ordered by a physician. The Fakhouri opinion closely followed the rationale of previous Illinois cases that were typical of the first wave of expanded duty cases brought against pharmacists. These cases recognized a hypothetically expansive duty for pharmacists, but they refused to impose such a duty as a practical matter.

The mid-1980s, when most of these cases denying expanded duties for pharmacists were decided, was not a time in which the judiciary found itself receptive to what appeared to be an expansion of liability. The “malpractice crisis” (whether perceived or real), focused criticism on the judicial system as being unrestrained and unrealistic in its expectations of health care practitioners. Stung by severe criticism, judges were reluctant to expand liability during this period, because they were afraid that expansion might create another crisis and generate more criticism. The fact that pharmacotherapy had become more complex, and that pharmacists had become more responsible, mattered little. The principle of high expectations for pharmacists was often-cited in legal opinions, but the result of most first-wave lawsuits against pharmacists was to impose low expectations.

A second wave of expanded duty cases against pharmacists took a significant step in the direction of implementing legal principles from years earlier into a contemporary context. The second-wave cases developed a pattern of referring to a general rule of no expanded duty, while at the same time carving out fact-based exceptions to the general rule, and imposing an expanded duty on pharmacists due to compelling facts rather than recognized principles.

Among these cases is Dooley v. Everett,31 a 1991 Tennessee case. The Dooley opinion cites Eldridge as authority, thus it is a second generation offspring of Jones v. Walgreen. In Dooley, the court ruled that a pharmacist may have a duty to provide warnings to a patient, even if a prescription is filled correctly. The prescription, for erythromycin, was filled for a patient who was already using theophylline. The patient suffered adverse effects from elevated serum theophylline caused by the use of the two drugs together. Failure to detect or warn about the drug-drug interaction led to a holding that the pharmacist could be liable for harm caused by the interaction. It was the pharmacist’s ability to know of the interaction that led to the ruling of an expanded duty. Had the facts shown that such knowledge was not available, the court would not have recognized a fact-based exception to the “no-duty” rule.

Another second-wave judicial opinion that cited Eldridge was the January, 1994 Court of Appeals of Indiana opinion in the case of Hooks-Superx, Inc. v. McLaughlin.32 The allegations in this case were that the defendant pharmacy should have intervened to prevent harm to the plaintiff, who was being prescribed propoxyphene in excessive doses. The court ruled that there was no such duty of intervention. Yet, while adhering to the “no duty” rule, the court noted several exceptions based on specific facts that would give rise to an expanded pharmacist duty. These exceptions consisted of: obvious lethal doses, inadequacies in the instructions, known contra-indications, or incompatible prescriptions.33

Even though Dooley v. Everett, and Hooks-Superx, Inc. v. McLaughlin, and other second-wave cases, recognized the potential for expanded pharmacist liability, that expansion had not so much to do with a general understanding of pharmacists and their professional relationship with patients; it had more to do with an analysis of isolated incidents and the capacity of one individual to prevent harm to another. The general rule of “no-duty” persisted throughout the second wave of judicial decisions. The list of exceptions to the rule became lengthy, but the exceptions did not become the rule.

Restoration of Traditional Legal Duties

Beginning in 1994, a third wave of expanded-duty cases against pharmacists began to reject the no-duty rule developed by the first-wave cases and continued (with exceptions) by the second-wave cases. This rejection of prior case law was based on the recognition of a new principle of pharmacist duty. It was not based on factual exceptions to a general rule of no duty. In developing this new approach to pharmacist duty, the third-wave cases have clearly distinguished themselves from the second-wave cases. They adopted a rationale virtually identical to the original approach to pharmacist duty from the earliest days of American jurisprudence. Under the rationale of the third-wave cases, a pharmacist is recognized as having a relationship of trust with patients to whom medications are dispensed. Within this relationship, a pharmacist is expected to use the level of care warranted by the circumstances.

Perhaps the most compelling evidence of a shift toward third-wave thinking is the Supreme Court of Indiana opinion from the Hooks-Superx v. McLaughlin case.34 In November, 1994, the higher court rejected the second-wave thinking of the Court of Appeals, which had described fact-based exceptions to a no-duty rule, as listed above. The higher court determined that relationships, not facts, determine legal duties.

The court stated that, “It is a matter of common expectation as well as statute that pharmacists possess expertise regarding the dispensing of prescription drugs. It is a matter of common understanding that customers rely upon pharmacists for that expertise. Upon this basis, we conclude that the relationship between pharmacist and customer is sufficiently close to justify imposing a duty.”35

The court then noted that, having recognized a duty, the next step was to determine what standard of care should be imposed. The court reasoned that the traditional negligence standard should apply. The court concluded:  “[W]e hold that pharmacists must exercise that degree of care that an ordinarily prudent pharmacist would under the same or similar circumstances. What constitutes due care in a particular case will depend upon the circumstances of that case, and will usually be a question of fact.”36 Thus, the existence of a duty was held to be a relationship issue, while the question of whether a recognized duty has been met was held to be a fact issue. The Court of Appeals was overruled and the Supreme Court held that pharmacists do have an expanded duty to patients.

Earlier that year, the Court of Appeals of Arizona had issued a similar third-wave ruling in the case of Lasley v. Shrake’s Country Club Pharmacy.37 The allegations in that case were that the defendant pharmacy breached a duty to warn either the patient or his physician that prolonged use of a prescribed drug may lead to addiction, or that use of the drug in combination with another prescribed drug may lead to adverse effects. The court reviewed the no-duty rationale from the first-wave cases, then stated flatly, “We reject the analysis relied upon in these cases.”38 The court criticized the approach taken by other courts in determining whether a pharmacist’s duty existed based on the specific facts of a situation. The court said:

It is better to reserve ‘duty’ for the problem of the relation between individuals which imposes upon one a legal obligation for the benefit of the other, and to deal with particular conduct in terms of a legal standard of what is required to meet the obligation. In other words, ‘duty’ is a question of whether the defendant is under any obligation for the benefit of the particular plaintiff; and in negligence cases, the duty [if it exists] is always the same–to conform to the legal standard of reasonable conduct in the light of the apparent risk. What the defendant must do, or must not do, is a question of the standard of conduct required to satisfy the duty.39

As to standard of care, the court noted that in an ordinary negligence action, the standard of care imposed is that of the conduct of a reasonably prudent person under the circumstances. However, health care providers and other professionals are held to a higher standard of care than that of the ordinary prudent person when the alleged negligence involves the defendant’s area of expertise. The court concluded, “We impose this higher standard of care upon pharmacists because they are professionals in the health care area.”40 Dismissal of the case against the pharmacy was reversed.

Yet another third-wave judicial opinion supported this expanded view of pharmacist duty when the Supreme Court of Tennessee decided the case of Pittman v. The Upjohn Co.41 In this unusual case, the grandson of the patient sued the manufacturer, as well as the prescriber and dispenser, of an oral hypoglycemic medication that was intended for his grandmother. The grandson, suffering from the flu while visiting his grandmother, was told by the grandmother to get some aspirin from on top of the refrigerator. Unfortunately, the grandson retrieved the oral hypoglycemic, which he mistook for aspirin, and he suffered ill effects that he contended could have been prevented had the pharmacist counseled the grandmother on the symptoms to expect from an overdose of the drug.

The court noted that the law imposes upon all persons the duty to use reasonable care under the circumstances. Then the court observed that:

The increased complexity of pharmacotherapeutics and the accompanying adverse reactions to drugs and interactions between drugs have resulted in an expanded role for pharmacists as drug therapy counselors. A pharmacist’s formal education stresses patient counseling as an integral role in health care. Leadership within the profession advocates continued expansion into new areas of patient education. A trend toward patient-oriented clinical pharmacy practice, which was opposed initially by many pharmacists, now appears to have firmly taken hold.42

As regards the duty to the patient, the court concluded:

The record shows that the duty owed Richards was greater than merely filling the physician’s prescription correctly. As indicated by the evidence in the record, Micronase posed a danger to Richards even if taken according to the physician’s order. The pharmacy’s customer was not aware of that danger because she had not been advised by either the physician, who prescribed the unavoidably unsafe drug, or the pharmacy which dispensed the drug. A significant factor affecting the pharmacy’s duty was the knowledge that no warning had been given by the physician. Under these circumstances, it was reasonably foreseeable that Richards was at risk of injury. Consequently, the pharmacy, as well as the physician, owed her the duty to warn.43

However, because the plaintiff bringing the case was not the patient, the court ruled that the pharmacist was not liable to the plaintiff. Applying a rule of reasonable foreseeability, the court determined that the plaintiff (the non-patient grandson) was too remote from the pharmacist for there to be a relationship giving rise to a duty. The court found that an adult house guest reaching high upon a refrigerator, taking down the wrong medication, and ingesting it without the owner’s knowledge, was not reasonably foreseeable to the pharmacist. Since one owes a duty only to those whom one may reasonably foresee as being affected by one’s action, there was no duty in this case.

A New Tradition of Pharmacist Duty

As the end of the twentieth century approaches, pharmacists’ legal duties are expanding. Pharmacists are expected not only to accurately process medication orders, they are expected also to properly respond to potential problems with prescribed medications if the specific facts of a case indicate that a potential problem was known or was knowable by the pharmacist. The most recently decided cases have added a new responsibility. Pharmacists must actively promote good therapeutic outcomes by counseling patients and empowering patients to protect themselves from harm. The secondary responsibility of preventing bad outcomes is necessary, but not sufficient, as the basis of a pharmacist’s duty. A primary responsibility to promote good outcomes exists as well.

The new tradition of expanded pharmacist duty is based on the rationale that pharmacists and patients have a relationship of trust, and that this relationship serves as the justification for a duty of care. The scope of the pharmacist’s duty of care depends on the potential danger to the patient. If the patient is at slight risk of harm, then the standard of care for a pharmacist is ordinary. If the patient is at great risk of harm, then the standard of care for a pharmacist is extraordinary. This is not a new standard, of course. It is virtually identical to the nineteenth-century standard. However, because drug therapy has become more complex now than it was then, the actions that must be taken to meet the standard of care are more complex now.

The third wave of pharmacist expanded liability cases has created a duty for pharmacists to use their skill and knowledge for the benefit of patients. Pharmacists have a duty to promote good outcomes for all who seek the pharmacist’s services in the provision of pharmaceutical products and care. This duty arises out of public expectations that a patient can trust a pharmacist to care for the patient. In meeting the expanded duty, pharmacists use their knowledge to detect potential problems with drug therapy, and they use their skill to resolve the problems and prevent harm to the patient. This does not mean that pharmacists guarantee good outcomes from drug therapy. But it does mean that pharmacists guarantee that they will use the best of their ability to promote a good outcome.

Conclusion

The case of Jones v. Walgreen established the legal principle that a pharmacist’s responsibility to a patient goes beyond technical accuracy in order processing, to include screening prescriptions for physician errors.  This 1932 case was based on solid precedent from a century of prior cases that can be directly tied to it through case citations. The consistent message from that line of cases was that pharmacists are not mere retailers of an ordinary consumer product, subject to the prevailing “let the buyer beware” maxim. Rather, pharmacists are professionals whose duty it is to protect patients from harm. This duty owed to patients is derivative of social expectations, and is correlated with the legally recognized authority granted to pharmacists by society through licensure. Pharmacists who assume authority also accept the attendant responsibility, and they can be held legally accountable if the responsibility is not met.

The panel of judges deciding the Jones v. Walgreen case in 1932 could not have anticipated that six years later the federal government would, through regulations that permitted certain labeled medications to be dispensed only under the authority of a physician, begin the process of relegating pharmacists to a less participatory role in drug therapy; and they could not have anticipated that technological advances would remove from pharmacy practice much of the traditional compounding role. For five decades pharmacy struggled to establish a patient care role beyond the dispensing role it had been formally assigned in the legal community. And during that time, the responsibility recognized by Jones v. Walgreen went unnoticed in legal opinions. Yet, when the efforts of pharmacy to expand its role began to succeed, and when legal actions to define that role emerged, the principles of Jones v. Walgreen were available and useful. The precedents of the early nineteenth- century opinions, as modified by a century of litigation, served a useful purpose when the judiciary began to recognize expanded responsibilities for pharmacists. While the expansion of pharmacist liability over the past decade is truly new, because the technological circumstances are unprecedented, the basic principles of law are the same as those that were applied in the early years of American pharmacy.


Notes and References

*Professor of Pharmacy Health Care Administration, The University of Florida College of Pharmacy. This article reports research undertaken pursuant to a Fischelis Grant awarded by the American Institute of the History of Pharmacy. Throughout this paper, the terms “pharmacist” and “patient” are used for consistency, even though the terms “druggist,” “apothecary,” “client,” and “customer” might be more appropriate given the historical context of the period being discussed.

  1. D. Brushwood, “The Pharmacist’s Duty to Warn: Toward
    a Knowledge-Based Model of Professional Responsibility,” Drake Law Review 40(1991):1-60.
  2. Jones v. Walgreen, 265 Ill.App. 308 (1932).
  3. Jones v. Walgreen, 265 Ill.App. at 316-317.
  4. Jones v. Walgreen, 265 Ill.App. at 320.
  5. Jones v. Walgreen, 265 Ill.App. at 320.
  6. Jones v. Walgreen, 265 Ill.App. at 319-320.
  7. Tremblay v. Kimball, 77 A. 405 (Maine 1910).
  8. Tombari v. Connors, 85 Conn. 231 (1912).
  9. McGahey v. Albritton, 107 So. 751 (Ala. 1926).
  10. Martin v. Manning, 92 So. 659 (Ala. 1922).
  11. Faulkner v. Birch, 120 Ill.App. 281 (1905).
  12. Tremblay v. Kimball, 77 A. at 407.
  13. Tremblay v. Kimball, 77 A. at 408.
  14. Brown v. Marshall, 47 Mich. 576 (1882).
  15. Brown v. Marshall, 47 Mich. at 583.
  16. Brown v. Marshall, 47 Mich. at 583.
  17. Norton v. Sewall, 106 Mass. 143 (1870).
  18. McDonald v. Snelling, 14 Allen 290 (Mass. 1867).
  19. Thomas v. Winchester, 6 N.Y. 397 (1852).
  20. Thomas v. Winchester, 6 N.Y. at 410.
  21. Fleet and Semple v. Hollenkemp, 13 B.Monr. 219
    (Ky. 1852).
  22. Fleet and Semple v. Hollenkemp, 13 B.Monr. at 228.
  23. Tessymond’s Case, 1 Lewins’s Crown Cases 169 (1828).
  24. Annotation, “Druggists Civil Liability for Injuries
    Sustained as Result of Negligence in Incorrectly Filling Drug Prescriptions,” 3 A.L.R.4th 270 (1981).
  25. See, Brushwood, Note 1.
  26. Jones v. Irvin, 602 F.Supp. 399 (S.D.Ill. 1985).
  27. Jones v. Irvin, 602 F.Supp. at 402.
  28. Eldridge v. Eli Lilly & Co., 485 N.E.2d 551 (Ill.App. 1985).
  29. Eldridge v. Eli Lilly & Co., 485 N.E.2d at 552.
  30. Fakhouri v. Taylor, 618 N.E.2d 518 (Ill.App. 1993).
  31. Dooley v. Everett, 805 S.W.2d 380 (Tenn. 1991).
  32. Hooks-Superx, Inc. v. McLaughlin, 632 N.E.2d 365 (Ind.App. 1994).
  33. Hooks-Superx, Inc. v. McLaughlin, 632 N.E.2d at 369.
  34. Hooks-Superx, Inc. v. McLaughlin, 642 N.E.2d 514 (Ind. 1994).
  35. Hooks-Superx, Inc. v. McLaughlin, 642 N.E.2d at 517.
  36. Hooks-Superx, Inc. v. McLaughlin, 642 N.E.2d at 519.
  37. Lasley v. Shrake’s Country Club Pharmacy, 880 P.2d 1129 (Ariz.App. 1994).
  38. Lasley v. Shrake’s Country Club Pharmacy, 880 P.2d at 1134.
  39. Lasley v. Shrake’s Country Club Pharmacy, 880 P.2d at 1132.
  40. Lasley v. Shrake’s Country Club Pharmacy, 880 P.2d at 1132-1133.
  41. Pittman v. The Upjohn Co., 890 S.W.2d 425 (Tenn. 1994).
  42. Pittman v. The Upjohn Co., 890 S.W.2d at 434.
  43. Pittman v. The Upjohn Co., 890 S.W.2d at 435.