CHAPTER

8

PHARMACIST MALPRACTICE LIABILITY AND RISK MANAGEMENT STRATEGIES

CHAPTER OBJECTIVES

Upon completing this chapter, the reader will be able to:

▶  Identify the elements of a professional malpractice action against a pharmacist.

▶  Describe the legal standard of care for a pharmacist in processing prescriptions and medication orders.

▶  Recognize the types of prescription processing errors that can lead to pharmacist liability.

▶  Discuss the available defenses to a claim of professional negligence.

▶  Describe the purposes of professional malpractice insurance.

▶  Discuss appropriate strategies for risk management.

▶  Describe the expanding liability of pharmacists for the failure to practice pharmaceutical care.

▶  Differentiate professional negligence from drug product liability.

Like other professional people, pharmacists can be held legally accountable for the consequences of their conduct. A pharmacist who unintentionally causes harm to a patient through inattentiveness or carelessness, for example, can be considered legally negligent. Negligence is classified in the law as a “tort,” a civil wrong rather than a criminal wrong. It is different from an intentional tort, however, which occurs when one person consciously causes harm to another. Allegations of intentional torts occur infrequently in pharmacy.

Malpractice law serves two purposes: compensation and deterrence. It operates to compensate the victims of a person’s negligent conduct by placing them back in the position in which they would have been (as near as possible) had the negligence not occurred. It also operates as a constant reminder that actions have consequences, so the specter of legal liability will deter people from acting carelessly and irresponsibly toward one another.

In the case of Troppi v. Scarf, 187 N.W.2d 511 (Mich. Ct. App. 1971), the court explained the underlying rationale for malpractice law. The court was asked to rule that a pharmacist could be held liable for dispensing Nardil, a monoamine oxidase (MAO) inhibitor, to a woman whose prescription had been for Norinyl, an oral contraceptive. The woman gave birth to a healthy child, and the pharmacist argued that no real harm had occurred. The court responded:

In theory at least, the imposition of civil liability encourages potential tortfeasors to exercise more care in the performance of their duties, and hence, to avoid liability-producing negligent acts. Applying this theory to the case before us, public policy favors a tort scheme which encourages pharmacists to exercise great care in filling prescriptions. To absolve defendant of all liability here would be to remove one deterrent against the negligent dispensing of drugs. Given the great numbers of women who currently use oral contraceptives, such absolution cannot be defended on public policy grounds. (187 N.W.2d at 517)

The pharmacist was held liable for the medical expenses of the pregnancy and for the costs of rearing the child.

LEGAL PROCEDURE

Most pharmacist malpractice cases do not reach a jury verdict. This is not unusual for any type of litigation because out-of-court settlements commonly make it unnecessary to carry the case through to completion. Although law established by a jury verdict that is affirmed on appeal is binding within the same jurisdiction and persuasive outside the jurisdiction, settlements carry no such authority and establish no precedent. Thus, a settlement before the trial of a pharmacist malpractice case, with a payment being made by the defendant pharmacist, does not in any way obligate the same court or another court to decide a similar case in the same way at a later time.

Even though a case may not proceed to trial and appeal, the court may rule on preliminary motions early in the course of proceedings. The most important of these is the motion for summary judgment, in which the defendant says in effect, “Even if everything the plaintiff says is true, I cannot be held legally accountable for what the plaintiff says I did.” A ruling granting a defendant-pharmacist’s motion for summary judgment legally absolves the pharmacist from liability, no matter what the facts may later show. If the court denies the defendant’s motion for summary judgment, the pharmacist may be held liable as a matter of law if the facts support liability, but a jury must consider whether the facts show that the legal requisites for liability have been met.

These early rulings may be appealed, and the decision of the appellate court on a point of law raised on appeal may be binding (on lower courts in the same jurisdiction) or persuasive (on courts outside the jurisdiction). Thus, even though an out-of-court settlement may leave an underlying allegation unresolved, court rulings on preliminary motions in the case make substantive law and reveal the legal expectations of pharmacists.

  TAKE-AWAY POINTS

THE MALPRACTICE ACTION

A legal cause of action for negligence has four elements:

1.  Duty owed

2.  Breach of duty

3.  Causation

4.  Damages

The plaintiff must prove each of these elements. If any one element cannot be proved, there will be no legal liability. Once the plaintiff has established all four elements, the defendant tries to show one or more affirmative defenses that should absolve the defendant of liability. The most frequently used affirmative defenses are (1) contributory negligence and (2) statute of limitations. These defenses are called “affirmative defenses” because the defense has responsibility to assert them or the court will not consider them. The plaintiff’s challenge is to prove the four elements of negligence and disprove the affirmative defenses. The defendant’s response is to disprove the four elements of negligence, prove the affirmative defenses, or both.

ELEMENTS OF NEGLIGENCE

Duty of Care

The well-established rule is that a pharmacist must use the degree of care that a reasonable and prudent pharmacist would use under similar circumstances. Recognizing the dangerousness of the products that pharmacists dispense, courts have described the pharmacist’s duty of care as “a high degree of care” and “great care.” The potential for serious harm that drugs present, combined with the fact that patients usually cannot fully appreciate that harm, creates a special situation in which pharmacists must be particularly cautious. Yet, the duty of care expected of pharmacists is not excessive. A pharmacist is bound simply to exercise the skill generally possessed by well-educated pharmacists who are considered competent in the profession of pharmacy.

As a practical matter, however, pharmacists may be the only healthcare professionals who are legally required to practice in a completely error-free manner. Pharmacists have traditionally adopted a “no mistakes” approach to practice, and legal standards have reflected this impossible-to-achieve and self-imposed standard.

The case of DeCordova v. State of Colorado, 878 P.2d 73 (Colo. App. 1994), affirms this error-free standard. In this case, the hospital pharmacist inadvertently dispensed an overdose of an intravenous antibiotic to an infant patient, resulting in the infant suffering permanent severe hearing loss. The trial court found that the pharmacist’s mistake constituted negligence as a matter of law (essentially meaning that the mistake itself amounts to negligence, and whether the pharmacist may have acted reasonably is largely irrelevant). On appeal, the pharmacist argued that human error is unavoidable and therefore should not be considered negligence as a matter of law. The court, however, noted that a pharmacist is responsible for accurately filling a prescription and that the error here was avoidable and fell below minimal standards of pharmacy practice. Concluded the judge: “To err is human, to forgive is divine. To be responsible for injuries caused by undisputed negligence is the law of this state.”

In contrast to nonjudgmental types of errors, a professional judgment that seems wrong with the benefit of hindsight but was reasonable given the circumstances at the time, is not generally actionable as negligence. Thus, a physician who prescribes two digoxin tablets daily when one tablet is the dosage that most physicians would have chosen, or a physician who prescribes ephedrine when most physicians would have prescribed theophylline is not regarded as a malpractitioner if the prescription was reasonable (albeit somewhat unusual) at the time it was initiated. If harm results to the patient and it becomes obvious in retrospect that the physician made a mistake in prescribing, that mistake will be forgiven as the unavoidable consequence of fallible human judgment.

Pharmacists, on the other hand, would virtually always be held liable if they were to instruct the same patient to take two digoxin tablets daily when one was prescribed or if they were to dispense ephedrine to a patient for whom theophylline had been prescribed. The possibility that two digoxin tablets or ephedrine might have been reasonable for the patient at that time would be considered irrelevant. Unlike prescribing errors, dispensing errors of a nonjudgmental nature are not forgiven. Human fallibility and the inevitability of occasional human error is no defense for a pharmacist in these situations.

Pharmacists have a duty to provide patients with the best care possible. That duty arises out of the relationship between pharmacists and patients, and the extent of the duty is determined by the nature of that relationship. In U.S. law, there is no traditional duty to come to the aid of a stranger. Thus, a passerby who sees a person in a burning building has no duty to help that person, although a firefighter would have such a duty. There is a relationship between people in danger and those whom society trusts to help the endangered. The relationship between pharmacists and the people to whom they dispense medications makes pharmacists something more than casual bystanders when there is a problem with drug therapy.

The key test for the existence of a duty is foreseeability. This point was clearly made in Docken v. Ciba-Geigy, 739 P.2d 591 (Or. Ct. App. 1987). In that tragic case, Tofranil had been prescribed for a young boy whose even younger brother took the drug hoping the drug would remedy a problem similar to that for which the drug had been prescribed for the older boy. The younger boy died as a result. The plaintiffs alleged that the dispensing pharmacy should have provided a warning regarding the potentially fatal accumulation of the drug over a short period of time. The pharmacy asserted a “no duty” defense and filed a motion for summary judgment, contending that it only owes a duty to the patient to whom the drug is dispensed. The court noted that a “no duty” defense is only another way of stating that the harm the child suffered by using a drug prescribed for his brother was not a foreseeable risk of the conduct alleged as negligence by the pharmacy. The court felt that it could not say as a matter of law that the harm was not foreseeable and refused to dismiss the case. Rather it remanded the issue to the trial court to determine whether a reasonable pharmacist could foresee this type of harm. On remand, the jury found that the harm was not foreseeable and that the pharmacy was not liable. The plaintiff appealed, but the court affirmed the trial court’s ruling (790 P.2d 45 (Or. Ct. App. 1990)).

The issue of whether the pharmacist owes a duty to someone other than the patient has also arisen in caregiver situations. In Huggins v. Longs Drug Stores, Inc., 862 P.2d 148 (Cal. 1993), the pharmacy negligently labeled that the drug Ceclor be administered to a 2-month-old child in doses of 2.5 teaspoonfuls every 8 hours rather than 2.5 ccs. After administering a few doses, the patient’s mother noticed that the child was lethargic and unresponsive. The error was ultimately discovered, and the parents sued on the basis of the emotional distress they suffered while observing the harm occur to their child. The California Supreme Court, reversing the court of appeals, found that pharmacists in California owe no duty to the caregiver of the patient. This decision is consistent with the majority of decisions in other states; however, the Utah Supreme Court recently found differently (B.R. ex rel. Jeffs v. West, 275 P.3d 228 (Utah 2012)). In this case, the father of the plaintiff children, allegedly under the influence of several prescribed drugs, killed the children’s mother, and the plaintiff children sued the prescriber for negligent prescribing. The court reversed the lower court decision and held that healthcare providers owe a duty to third parties not to prescribe medications that affirmatively cause patients to harm third parties.

In a Nevada case that drew national attention, the patient of several pharmacies, who was an abuser of controlled substances, while driving struck and killed one person and seriously injured another. She was arrested for driving under the influence of controlled substances. One year prior to the accident, a Nevada substance abuse task force had sent a letter to the pharmacies informing them that the patient had obtained approximately 4,500 hydrocodone tablets at 13 different pharmacies over the past year. The plaintiffs (those injured in the accident) sued many of the pharmacies that had continued to dispense the hydrocodone to the patient, alleging that after receiving the task force letter the pharmacies had a duty not to dispense to the patient (Sanchez ex rel, Sanchez v. Wal-Mart, 221 P.3d 1276 (Nev. 2009)). The Nevada Supreme Court held that the pharmacies owed no duty to the plaintiffs on the basis that they had no direct relationship with the plaintiffs; and, because the plaintiffs were unknown to the pharmacies, there was no special relationship that would warrant a duty. The court further reasoned that there was nothing in the Nevada Pharmacy Act at the time of the accident that would require the pharmacies to protect third parties from their patients.

Breach of Duty

Dispensing Errors

As noted previously, it is generally accepted that a pharmacist who fills a prescription in a manner other than the way it was ordered by a prescriber has breached a duty of ordinary care owed to the patient. This principle is so well established that, even though the plaintiff technically bears the burden of proof in pharmacist malpractice litigation, evidence of a misfilling error is virtually sufficient for a presumption of negligence.

In most professional malpractice cases, however, proof of breach of duty requires evidence that a standard of professional practice exists and that the defendant did not adhere to the standard. This evidence is frequently offered through the testimony of expert witnesses because a jury of lay people usually must rely on a member of the profession to explain the intricacies of professional practice. When a pharmacist fills a prescription incorrectly, however, the obviousness of the error usually makes expert testimony unnecessary. For example, in Parker v. Yen, 823 S.W.2d 359 (Tex. App. 1991), the defendant pharmacist had improperly filled a prescription for Sinequan with Dalmane. There was no need to establish through expert testimony that standards of practice for pharmacists require accuracy in prescription processing. Law requires this sort of accuracy. The pharmacist must introduce evidence to rebut the presumption created by the fact of error. Unless there is some highly unusual extenuating circumstance (e.g., a natural disaster, an epidemic that has taxed available resources), the pharmacist’s rebuttal is likely to be ineffectual.

Courts have clearly established pharmacists’ responsibility to dispense the correct medication to patients, and pharmacists accept this responsibility. One of the most common reasons for a wrong drug error by pharmacists is a misunderstanding between the prescriber and the pharmacist, either because of sloppy handwriting or because of slurred speech. In either case, the pharmacist who misfills the prescription has breached a duty because the pharmacist always has the last opportunity to clarify an unclear communication. Attempting to focus blame on physicians who issue unclear orders or manufacturers who use similar drug names does not effectively relieve the pharmacist of responsibility. As the last link in the drug distribution chain, the responsibility for the failure to clarify ambiguity stays with the pharmacist.

Dispensing errors may involve the wrong strength or dosage of the correct drug. In Lou v. Smith, 685 S.W.2d 809 (Ark. 1985), the defendant pharmacist changed a prescription for Reglan from the prescribed dosage of 1 mg daily to 10 mg daily because the product was distributed as 10-mg tablets. The higher dosage would have been correct for an adult, but the patient was a 4-month-old child, who had a severe reaction. The pharmacist was held liable.

Dosage errors become particularly important when the drug dispensed is one with a narrow therapeutic index; that is, the toxic dosage is only slightly higher than the therapeutic dosage. Pharmacists have adopted various practice conventions to avoid incorrect dosages. One such convention is an understanding that decimal points are used only when they are absolutely necessary. For example, a dose of one tenth is written 0.1 rather than .1 because the presence of the zero suggests that a decimal should go before the number one, even if the decimal has become smudged or is otherwise difficult to visualize. Likewise, the convention requires that a dose of one unit be written 1 rather than 1.0 because an illegible decimal point would lead to an overdose. Of course, writing out the dosage by hand, such as 0.1 (one-tenth) mg is the best method of avoiding an overdose because of a disappearing decimal point. The use of such conventions reduces the risk of error even when a pharmacist is rushed or is otherwise momentarily inattentive.

Doctrine of Negligence Per Se

In addition to liability for breach of a professionally recognized standard of care, a pharmacist who violates a statute or regulation concerning the distribution of pharmaceutical products may be liable under the doctrine of negligence per se. Under this doctrine, the court bases its decision on whether the plaintiff is of the class of plaintiffs that the statute or regulation was intended to protect and whether the harm done to the plaintiff was of the type against which the statute or regulation was intended to provide protection. Although not required to do so, a court may choose to adopt the standard expressed within the statute or regulation as the standard for civil liability in a malpractice case. If the defendant has clearly violated the statute or regulation, causation and damages are the only elements left for the plaintiff to prove. Under negligence per se, for example, a court may determine that a pharmacist who substituted a generic drug product for a brand-name product in a way that was not permitted by state law had breached the duty of care if the patient was harmed because the two drugs lacked bioequivalence. Patients are the people whom the law seeks to protect, and harm from bioinequivalence is the type of harm that the drug product selection statute seeks to prevent.

An interesting application of the negligence per se doctrine was presented in Izzo v. Manhattan Medical Group, 560 N.Y.S.2d 644 (N.Y. App. Div. 1990). In this case, the widow of an alleged drug addict sued a pharmacy for negligence in filling a forged prescription for the addict. The pharmacy had violated New York law by filling a controlled substance prescription that did not have the prescriber’s name imprinted on it.

Although the violation of this law could certainly expose the pharmacist to administrative action, there was some question as to whether it could also expose the pharmacist to civil liability for malpractice. The pharmacist contended that a drug addict who forges a prescription and dies from the effects of the fraudulently obtained drug is not the type of person whom the statute was intended to benefit. The court ruled that this was indeed one type of person whom the statute was intended to protect, however, and allowed the case against the pharmacist to proceed.

Causation

Even if a pharmacist owes a duty of care and that duty is breached, malpractice under the law requires proof that the pharmacist’s misconduct caused the alleged damage. Proof of causation is a two-step process. First, the plaintiff must prove that the defendant’s conduct was a substantial factor in the harm that occurred (i.e., actual causation). Second, the plaintiff must fix liability with the party or parties whose misconduct most directly caused the damages (i.e., proximate causation). It would be unfair to hold people responsible for every consequence of their conduct, no matter how remote the consequences might be, so proximate causation operates to limit the liability of a person whose conduct was a substantial factor in the harm of another.

Actual Cause

One major problem with proving causation in drug-related cases is that the dispensed drug has often been ingested and eliminated from the body by the time a thorough investigation can be conducted. There may be nothing to do but speculate as to what really happened. When a pharmacist has allegedly dispensed the wrong drug, the identity of the wrong drug may be unknown, and it will be difficult to determine whether the adverse effects are of a kind that the unknown substance can cause. Even when the substance is known, it may not be clear whether the adverse effects are due to the drug or to some other causal factor. This determination is a question of fact that the jury must resolve on the basis of expert testimony. The standard of proof requires an expert’s reasonable degree of scientific certainty that the drug dispensed probably caused the adverse effect. The plaintiff does not have to disprove all other possible causal factors, but simply must establish the reasonableness of a causal inference by a preponderance of the evidence.

A pharmacist may have negligently caused some, but not all, of a patient’s injuries. In Cazes v. Raisinger, 430 So. 2d 104 (La. Ct. App. 1983), the pharmacist mislabeled a prescription, and the patient ingested an overdose of digoxin. The patient died five months later. The trial court ruled that the pharmacist’s error had caused the patient’s death. The appellate court limited liability to those damages suffered during the two or three days after the overdose, however. Even though the pharmacist had made a mistake, and the patient ultimately died, the pharmacist’s action was held not to have been the cause of the patient’s death.

Proximate Cause

The rules of proximate cause relate primarily to limiting the liability of a defendant whose conduct has been shown to be the actual cause of harm to the plaintiff. Most proximate cause cases address the liability of a defendant who breached a duty of care when the defendant’s negligent conduct had an unforeseeable result. For example, assume a pharmacist dispenses the wrong medication to a patient that has a side effect of drowsiness. The patient takes the medication and while driving on a city street, falls asleep, hitting an oncoming car that in turn swerves into a house injuring the occupant. Clearly the pharmacist’s negligent act was the cause of the accident. The issue under proximate cause would be the extent to which the pharmacist would be liable. Should the pharmacist be liable for the injuries to the occupants of the other car? To the occupant of the house? The extent of liability often depends upon a determination of foreseeability (although in some jurisdictions the pharmacist could be found liable for all the injury). Because foreseeability is such an important factor in most proximate cause determinations, sometimes the issue is indistinguishable from that of duty. Thus, instead of asking if the pharmacist was the proximate cause of the injury to the occupant of the house, one could also ask whether the pharmacist owed a duty to the occupant of the house.

The rules of proximate cause define the circumstances that break the chain of causation between the defendant’s act and the plaintiff’s harm. If causation is viewed as a chain of events, with the defendant’s conduct at one end of the chain and the plaintiff’s harm on the other end, the links in the chain connect the defendant’s conduct with the plaintiff’s harm. If the defendant is to be liable for the harm, each of the links must be foreseeable to the defendant. Any unforeseeable link in the chain operates as an intervening act between the negligence of the defendant and the harm to the plaintiff; it breaks the chain of causation, so the defendant is no longer responsible for the harm. Called a superseding cause, the intervening act becomes the true causal factor rather than the defendant’s conduct. Most cases in which a pharmacist is relieved of liability on the issue of proximate cause involve unforeseeable misuse of the drug by the patient.

In Speer v. United States, 512 F. Supp. 670 (N.D. Tex. 1981), the court discussed the superseding cause doctrine. Pursuant to both new prescriptions and refills, Etrafon 4-25 had been dispensed to a patient at frequencies far exceeding what the patient should have needed. The patient was stockpiling an excess quantity of the medication, with which he subsequently committed suicide. The deceased patient’s spouse sued the pharmacy, contending that the pharmacists were negligent for refilling the drug in excess of that authorized by the psychiatrist and that the negligence caused the patient’s death. In the ensuing lawsuit, the court ruled that although the pharmacists were negligent, the evidence did not establish that they should have foreseen the patient would use the drug to commit suicide. In other words, the ingestion of an overdose by the patient broke the chain between the negligent filling of the Etrafon prescriptions and the patient’s death. According to the court, the mere sale of a toxic substance does not give the pharmacists sufficient information to foresee suicide; however, the court left open the possibility that more extensive knowledge would lead to a finding of foreseeability and, thus, to liability.

Causation also was the issue in Hayes v. Travelers Insurance Co., 609 So. 2d 1084 (La. Ct. App. 1992). In this case, the pharmacy had erroneously filled a prescription for L-tryptophan with Tofranil; as a result, the patient ingested an overdose of Tofranil. The physician ordered the Tofranil discontinued until the patient’s blood level of the drug returned to normal and then restarted the Tofranil therapy. Thereafter, the plaintiff prescribed two other drugs for the patient, which apparently caused an adverse reaction. The plaintiff contended that the two other drugs had been used to treat the Tofranil overdose, which would not have occurred had it not been for the pharmacist’s error. Therefore, the plaintiff argued that the pharmacy should be held causally responsible for the adverse reaction. It is well established in the law that if a pharmacist’s mistake necessitates medical treatment for an adverse effect, and if the treatment causes harm to the patient, the pharmacist is liable for the harm caused by the medical treatment. In this case, however, the court reasoned that it would have made no sense for the physician to restart Tofranil therapy if the two drugs had really been used to treat the Tofranil overdose. The court concluded that the pharmacy was not the legal cause of the patient’s adverse reaction.

Damages

There is no recovery for malpractice if no harm was done. The law does not deal in hypothetical cases. A patient may actually be distressed over a mistake that a pharmacist made, and the distress may actually cause emotional problems. If the mistake was detected and rectified before any physical harm could occur, however, there are unlikely to be any compensable damages.

In malpractice cases, compensable damages are of many types. They can generally be divided into actual damages and punitive damages.

Actual Damages

The purpose of actual damages is compensation. When a patient loses a week of wages, suffers impaired vision, or has severe pain for a month because of a pharmacist’s negligence, the legal system seeks to compensate the patient for the harm. The goal is to return the patient to the position in which the patient would have been if the pharmacist had not been negligent.

Reimbursement for lost wages or for medical expenses incurred to treat the problem is relatively easy to determine. A dollar-for-dollar repayment can be arranged to shift the financial burden of the problem from the party who suffered the harm to the party who caused the harm. Compensation for physical injuries, emotional injuries, or pain and suffering are much more difficult to calculate. Usually, it is impossible to correct the injury, remove the pain, and simulate a return to the preinjury status quo. Instead, a second-best approach must be adopted—providing a financial payment to the harmed person. The goal is not to remove the harm (because that cannot be done) but to make the harm more bearable.

Determining the dollar value of harm that has no real value presents a challenge to any court. The jury must decide what dollar figure it believes is reasonable as compensation for essentially noncompensable harm, and the appellate court will uphold any sensible award. Several rules apply to judicial review of this issue. First, the court uses the “eggshell plaintiff” rule, which requires defendants to accept whatever underlying condition the plaintiff had before the defendant’s negligent act. A patient who is peculiarly susceptible to harm will not be penalized for that susceptibility. If the patient had a condition that predisposed the patient to harm from the pharmacist’s conduct, the plaintiff is still compensated for the harm (even if most other people would not have been harmed in similar circumstances). Second, the plaintiff may be required to mitigate the damages by seeking timely medical assistance or using some other mechanism. If a patient suffered harm and could have done something to lessen the impact of the harm, but did nothing, the avoidable harm is not considered the result of the pharmacist’s actions. Finally, reform statutes in a number of states place “caps” or ceilings on liability awards, specifying a maximum dollar amount that can be recovered in a malpractice case. These dollar limits prevent excessive recoveries for the difficult-to-quantify types of harm, and they make it easier for insurance companies to predict what their losses are likely to be during a given time period.

Punitive Damages

Under certain circumstances, the law allows recovery for damages in an amount greater than that necessary to compensate the plaintiff for harm actually suffered. Such damages are known as punitive or exemplary damages because their purpose is to punish or to make an example of the defendant. The plaintiff receives punitive damages only if there is evidence of the defendant’s wanton and reckless disregard of the plaintiff’s rights or morally culpable conduct. The most likely reasons for punitive damages in a pharmacist malpractice case are a cover-up of a dispensing error; carelessness so significant that an error is almost inevitable; failure to follow a standard procedure in dispensing medications, such as not appropriately supervising technical support personnel; or ignoring the rule that pharmacists observe a compounding machine while a solution is being prepared.

A classic example of willful and wanton conduct that justifies punitive damages appears in Burke v. Bean, 363 S.W.2d 366 (Tex. Civ. App. 1962). In this case, the pharmacist discovered that he had mistakenly dispensed Oxsoralen instead of Oxacholin. On the next refill, the pharmacist changed to the correct medication but did not tell the patient about the earlier mix-up. In fact, the pharmacist sold the correct medication at the same price he had charged for the wrong medication so as not to give a clue that a mistake had occurred. The jury found that the pharmacist had affirmatively attempted to conceal his mistake. According to the court, the jury was justified in concluding that the pharmacist had shown a conscious indifference to the rights and welfare of the patient and that he had been grossly negligent. An award of punitive damages was upheld.

DEFENSES TO NEGLIGENCE

Even if the plaintiff can prove the four elements of an action for negligence, the defendant may be able to prove affirmative defenses that will absolve the defendant of liability. Alternatively, of course, the defendant may be able to disprove one of the four initial elements and avoid liability without needing to prove an affirmative defense. The plaintiff bears the burden of proof, and the defendant often chooses to contest every point vehemently.

Contributory and Comparative Negligence

Tort law requires that a plaintiff must act as a reasonable, prudent person in the same or similar circumstance. If the plaintiff could have avoided the consequences of the defendant’s negligence by ordinary care, then there is no recovery under the defense of contributory negligence. Until the 1970s, contributory negligence was a complete bar to recovery, even if the plaintiff’s fault was slight and the defendant’s fault was great. This harsh rule resulted in some unusual verdicts, in which obviously negligent plaintiffs were found not to be at fault because the unfair effect would have been to deny a recovery altogether. If a pharmacist refilled a prescription with the wrong drug, for example, and the physical dissimilarity between the correct drug and the dispensed drug was so obvious that any thoughtful patient should have recognized it as a problem, a court trying to avoid a complete bar to recovery might have pointed out that the patient who did not notice the difference was obviously ill or would not have been taking medication. There could be no contributory negligence, therefore, because people who are ill cannot be expected to think clearly. The unfairness of a complete bar to recovery was a strong bias against finding any contributory negligence whatsoever.

The harshness of the complete bar to recovery for the slightest negligence by the plaintiff, combined with the absurdity of some judicial efforts to contrive explanations of the innocence of plaintiffs who were obviously somewhat at fault, led to a new rule. Comparative negligence has now replaced contributory negligence in most jurisdictions. Although comparative negligence is essentially the same as contributory negligence (i.e., plaintiffs suing a defendant who harmed them are held accountable for the harm that they themselves caused), the complete bar to recovery has been replaced. It is now possible to reduce a plaintiff’s recovery by the percentage that corresponds with the percentage of fault attributed to the plaintiff. Thus, assume that a plaintiff was harmed and the dollar value of the harm was determined to be $100,000. If the plaintiff was assigned 20% of the fault, and the defendant was assigned 80% of the fault, the plaintiff’s recovery would be reduced by $20,000.

Most jurisdictions permit recovery under “modified” comparative negligence, in which the plaintiff is permitted to recover whatever percentage of the damages corresponds with the defendant’s percentage of fault, provided that the plaintiff is less than 50% at fault. In a few jurisdictions, “pure” comparative negligence permits a recovery against a defendant no matter how much at fault the plaintiff was.

Statute of Limitations

A pharmacist who has negligently caused harm to a patient may be able to use the statute of limitations as a defense. Under the statute of limitations, a plaintiff must bring a claim within a specified period of time after the cause of action accrues. The purpose of the statute of limitations is to prevent the litigation of stale claims years after the events that allegedly led to the harm, after memories have faded and witnesses have disappeared.

The public policy favoring the unencumbered practice of the healing arts, without fear of groundless and unjustified malpractice lawsuits, has led to the enactment in many jurisdictions of reform laws that reduce the number of years of a statute of limitations for medical malpractice. For example, if the general negligence statute of limitations is two years, the medical malpractice statute of limitations may be one year. In many states, pharmacists have specifically been granted this added protection. This approach does nothing to impair the rights of honest and legitimate plaintiffs, but it provides some protection to medical practitioners from the claims-conscious plaintiff whose motives are improper.

Sometimes in drug-related litigation it is difficult to determine when a cause of action accrues. Adverse effects of drugs may not be evident until months or even years after the drug was used, and the time period within which to sue cannot begin until the adverse effects are apparent. A modification of the statute of limitations known as the “discovery rule” specifies that a cause of action does not accrue until the date on which the plaintiff discovers the injury, which could be years after the date the medication was dispensed. In many states, a “statute of repose” limits the length of time after the defendant’s alleged negligent action during which the discovery rule can postpone the accrual (and expiration) of the statute of limitations. If this were not the case, drugs that cause latent problems (e.g., diethylstilbestrol [DES]) could give rise to litigation decades after their use despite the statute of limitations.

VICARIOUS LIABILITY

It is well established under tort law that an employer is liable for the negligent acts of its employees. This is vicarious liability under a doctrine called respondeat superior, which places liability upon the employer without regard to any negligence on the part of the employer. Thus, the employer of a pharmacist who commits a negligent act that harms a patient is liable for the act, as is the pharmacist. The justification for respondeat superior arises from the notion that the employer has an obligation to hire and train competent employees.

The plaintiff has the choice of suing either the employer or the pharmacist individually or jointly. Often the plaintiff will sue only the employer on the basis that the employer has greater resources. The employer does have a right to sue the employee for contribution; however, this seldom occurs.

Sometimes the plaintiff will sue both the employer and pharmacist jointly for jurisdictional reasons. For example, in Crain v. Eckerd Corp., 1997 WL 537705 (E.D. La. 1997) and Aucoin v. Vicknair, 1997 WL 539889 (E.D. La. 1997), the plaintiffs joined the pharmacists as codefendants with the employer, Eckerd, to prevent Eckerd from removing the cases to federal court. Because Eckerd is a Florida corporation and the plaintiffs are Louisiana citizens, the federal courts would have had jurisdiction over the cases on the basis of diversity citizenship. By joining the Louisiana pharmacists who committed the errors, the plaintiffs defeated diversity jurisdiction and were allowed to proceed in state court. Plaintiffs often prefer state court, believing it to be a more sympathetic venue.

  TAKE-AWAY POINTS

    STUDY SCENARIOS AND QUESTIONS

LIABILITY FOR FAILURE TO PERFORM EXPANDED RESPONSIBILITIES

Pharmacists have always been charged with the legal responsibility to process prescriptions and drug orders accurately, and this responsibility will continue for the foreseeable future. Times are changing, however, and pharmacists are increasingly being given the legal responsibility to improve the outcomes of drug therapy. Ironically, the law has traditionally placed limits on pharmacists that would prevent the type of expanded practice that it is now demanding.

The pharmacist’s exercise of professional discretion has been limited primarily because of the omnipotent position that physicians occupy in health care. Until recently, generic substitution was the only discretionary function that pharmacists have been permitted to perform (in many states it is now actually required), and they received legislative authority to perform that function only after repeatedly expressed consumer demand overcame opposition from physicians and the pharmaceutical industry. The opposition was because of fear of interference with physician autonomy and the reduction of revenue from the sale of brand-name drug products. Because of the limiting effect of the law on pharmacy practice, pharmacists have come to think of the law as a set of mandates and prohibitions rather than as an opportunity to serve the public. To survive the transformations in health care that will occur in the future, that view of pharmacy law will have to change. The law should be viewed as enabling rather than restricting, because expanded legal expectations provide pharmacists with the authority to grow professionally.

One of the first judicial opinions to recognize an expanded role for pharmacists was in the case of Riff v. Morgan Pharmacy, 508 A.2d 1247 (Pa. Super. Ct. 1986). The plaintiff was a woman who had been given Cafergot suppositories for the treatment of migraine headaches without being told to limit her use to two suppositories per headache or five suppositories per week. The directions were to use one suppository every four hours. The pharmacist filled the prescription exactly as written. Unfortunately, the patient used too many suppositories (always one every four hours as she had been directed, but for three or four days), and she had a toxic reaction to ergotamine. In her subsequent lawsuit against the pharmacy and the physician, the pharmacy argued that the limits of a pharmacist’s responsibility to a patient are to process medication orders accurately, which was done in this case. The court disagreed with the pharmacy, specifically noting that each member of the healthcare team “has a duty to be, to a limited extent, his brother’s keeper” (508 A.2d at 1253). The court in Riff eloquently justified this position.

Fallibility is a condition of the human existence. Doctors, like other mortals, will from time to time err through ignorance or inadvertence. An error in the practice of medicine can be fatal; and so it is reasonable that the medical community, including physicians, pharmacists, anesthesiologists, nurses, and support staff, have established professional standards which require vigilance not only with respect to primary functions, but also regarding the acts and omissions of the other professionals and support personnel in the health care team. (508 A.2d at 1253)

The duty that Morgan Pharmacy was found to have breached was a duty to warn the patient or to notify the prescribing physician of the obvious inadequacies on the face of the prescription that created a substantial risk of serious harm to the patient. The duty is one of notification only. The pharmacist has no duty to assume complete control of the patient’s drug therapy. The Riff opinion opened the door to expanded legal responsibility for pharmacists, but it did not open the door widely. Subsequent legal developments have, however, built on the foundation established by Riff.

EXPANDED RESPONSIBILITIES IN PERSPECTIVE

The history of pharmacy practice reflects the limitations put in place by pharmacy laws, with their clear distinction between the practice of medicine and the practice of pharmacy. For example, before the 1950s, pharmacists were often taught not to tell patients about prescribed medications. In 1951, the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act (FDCA) listed for the first time the information that federal law required a pharmacist to place on the label of a dispensed medication, and the name of the drug was not on the list. Although patient counseling and other patient-oriented facets of practice have played a significant role in pharmacy since the middle of the twentieth century, the promise that patient-oriented practice brings with it has not yet fully materialized. Many pharmacists today still practice within the technical model. They believe that it is their responsibility to tell the patient several important facts about a drug but not to elaborate further by providing clinical information.

The clinical pharmacist does more than provide warnings. Clinical practitioners interview patients and explain the importance of drug therapy. They collaborate with physicians on decisions about therapeutic alternatives. Historically, a significant component of clinical pharmacy has been assuring patients that the physician knows what is best and admonishing patients about problems that can arise if the physician’s orders are not followed. This historic approach to clinical pharmacy, however, is yielding to one of pharmaceutical care.

The pharmaceutical care model empowers a pharmacist to encourage patients to assume responsibility for drug therapy within the framework of their own lifestyle, values, and environmental factors. Pharmaceutical care is the responsible provision of drug therapy for the purpose of achieving definite outcomes that improve the patient’s quality of life. A pharmacist who practices pharmaceutical care is not as concerned with the objective correctness of therapy from a medical viewpoint as it is with the subjective appropriateness of therapy from a patient viewpoint. Pharmaceutical care is patient oriented rather than physician oriented. In recent years, courts of law have come to understand the significant role that pharmacists can play in the care of patients, but this recent understanding did not develop without a struggle, and in fact has not been completely realized yet today.

Historically, the courts have taken a narrow view of the role of pharmacists, a role that certainly does not include pharmaceutical care. The case of Ingram v. Hook’s Drug, 476 N.E.2d 881 (Ind. Ct. App. 1985) typifies this view. In Ingram, the pharmacist dispensed Valium to the plaintiff, providing no warnings of possible adverse effects or side effects. A few days later the plaintiff fell off a ladder and fractured his leg, allegedly due to the dizziness and drowsiness caused by the Valium. He sued the pharmacy contending that the pharmacist had a duty to warn him of the drug’s dangers. The trial court granted the pharmacy’s motion for summary judgment and the plaintiff appealed. On appeal, the court held that the duty to warn of a drug’s dangers rests with the physician and that the pharmacist has no duty to warn.

Court decisions such as Ingram that have rejected the pharmacist’s duty-to-warn argument have articulated similar rationale in support for their decisions. That rationale is that the pharmacist has no duty to advise a patient about a drug’s risks, or to monitor a patient’s drug use because the physician is the primary healthcare provider and the one upon whom the patients place their reliance (this rationale often is called the learned intermediary doctrine, as discussed later in the “Drug Product Liability” section); that pharmacists do not have access to sufficient medical information about the patient in order to advise the patient properly; that pharmacists would interfere with the physician–patient relationship; and that to require pharmacists to warn would place an undue burden on them because they would have to question every prescription and warn of every danger. (For a detailed analysis of these rationales, see McKee v. American Home Products, Inc., 782 P.2d 1045 (Wash. 1989).) These rationales seem specious when applied to today’s practice of pharmacy yet are still persuasive today to courts in many jurisdictions, even in the face of state regulations requiring the maintenance of patient medication records, the screening of prescriptions for potential problems, and counseling of common and severe adverse risks.

AN EXPANDED VIEW OF PHARMACIST DUTY

One of the first cases to describe pharmacist duty consistently with the precepts of pharmaceutical care was Hooks SuperX, Inc. v. McLaughlin, 642 N.E.2d 514 (Ind. 1994), in which the Indiana Supreme Court reversed an earlier ruling of the Indiana Court of Appeals. Filed in late 1994, the opinion in this case thoroughly analyzed the concept of duty, based on three factors:

1.  Relationship

2.  Foreseeability

3.  Public policy

The Hooks SuperX decision warrants discussion because the rationale the court used to find duty was the basis for recent court decisions finding that pharmacists owe a patient a duty beyond simply dispensing prescriptions correctly and accurately.

Factual Background of the Hooks SuperX Case

The plaintiff in this case injured his back while working as a lumberjack. In the course of treatment for that injury, he became addicted to propoxyphene. He was treated for the addiction in 1982, 1983, and 1987, but he did not stop using the drug. In 1988, because he was still having pain from the injury, he began treatment under a new physician. Over a period of months in 1988, the plaintiff obtained from the physician numerous prescriptions for drugs containing propoxyphene. Most of these prescriptions were filled at the defendant pharmacy. The propoxyphene was dispensed on the basis of valid written prescriptions, telephoned prescriptions, or authorized refills.

The plaintiff ingested propoxyphene at a much greater rate than prescribed. The records of the defendant pharmacy showed that dozens of prescriptions for propoxyphene were filled for the plaintiff between May 1987 and December 1988. For example, during one 60-day period in 1988, the plaintiff received 24 separate refills of propoxyphene compounds totaling 1,072 tablets. If consumed according to the prescription, the dosage units dispensed would have lasted 138 days, yet the plaintiff consumed the tablets in 62 days. In one month alone, propoxyphene prescriptions were filled 12 times, which meant that the plaintiff or his wife appeared in the defendant pharmacy every two or three days.

In late 1988, the physician, apparently aware that the plaintiff was consuming propoxyphene tablets at the increased rate, refused to furnish any more prescriptions. Shortly thereafter, the plaintiff’s wife found her husband holding a shotgun to his head during an acute episode of depression. He did not pull the trigger. After treatment for drug addiction in early 1989, the plaintiff stopped taking all prescription medication.

The plaintiff sued the pharmacy under the theory that the pharmacy had breached its duty of care by failing to stop filling the prescriptions because the pharmacist knew that the plaintiff was consuming the drugs so quickly that they posed a threat to his health. The defendant moved for dismissal of the case on the grounds that it owed no such duty. The trial court denied the motion and the defendant appealed. The Indiana Court of Appeals concluded that no duty existed and that imposition of a duty for pharmacists to monitor drug therapy and intervene to prevent potential problems would be contrary to public policy because it would undermine the physician–patient relationship.

On appeal to the Indiana Supreme Court, the most important issue was whether pharmacists have any duty to refuse to fill validly issued prescriptions that pose a threat to the welfare of the patient. As indicated earlier, the opinion in this case analyzes the concept of duty on the basis of three factors. In essence, the court reasoned that it would make good legal precedent to expand pharmacist duties to include the duty to monitor and intervene if:

1.  The relationship between pharmacist and patient is of the kind that should give rise to an expanded duty.

2.  Harm to the patient is reasonably foreseeable to a pharmacist.

3.  Public policy concerns (such as increased healthcare costs and diminished patient confidence in physicians) favor recognizing such an expanded duty.

The Relationship Factor

The court in Hooks SuperX reaffirmed that the law recognizes the relationship between pharmacist and patient as one that creates a duty under traditional order-processing circumstances. Pharmacists are clearly liable for dispensing the wrong medicine or for failing to inform the patient of warnings included in the prescription. The court noted that the relationship between the pharmacist and the patient is a direct one, independent of the physician–patient relationship. The court recognized that pharmacists possess expertise in the dispensing of prescription drugs and that patients rely on them for that expertise. All these factors combined led the court to conclude that “the relationship between the pharmacist and customer is sufficiently close to justify imposing a duty” (642 N.E.2d at 517) to monitor drug use and intervene when a problem becomes evident.

The court apparently recognized that in evaluating the relationship of one party to another, it is necessary to first identify the characteristics of the two parties. A relationship is forged from the identities of the individuals in the relationship; thus people relate to each other only in ways that reflect their own personal, or professional, characteristics. The Hooks SuperX opinion noted that a pharmacist is a person who knows about drugs and that a patient is a person who needs information about drugs. Given these individual characteristics, it is logical to conclude that the pharmacist–patient relationship is one in which the pharmacist has a duty to provide information. Under this analysis, the duty of a pharmacist expands and contracts on the basis of the pharmacist’s knowledge. A knowledge-based duty would serve as the foundation for requiring some action by pharmacists but not for requiring unlimited action. Pharmacists would have a duty to warn patients of known risks, but there would be no duty to warn of risks that are not known. Thus, the answer to a question of pharmacist duty would begin with a determination of pharmacist knowledge. The availability of knowledge would define the minimum that could be expected of a pharmacist, and the unavailability of knowledge would set limits on what could be expected of a pharmacist.

Knowledge, by itself, however, is not a sufficient foundation for a duty from pharmacists to patients. For there to be a duty to intervene to protect patients from known adverse effects, it is also necessary that pharmacists foresee harm to patients.

The Foreseeability Factor

Turning to the factor of foreseeability, the court found it undisputed that an individual who consumes sufficient quantities of addictive substances may become addicted to them, and that such an addiction carries with it certain foreseeable consequences. The court was satisfied that, for the purpose of determining whether a duty exists, the risk of the plaintiff’s addiction was foreseeable from the events that took place. Under the court’s analysis, it would be good legal precedent to require that one who can anticipate harm to another intervene to prevent that harm. Simply knowing of a potential adverse effect would not be sufficient to require that a pharmacist provide a warning to a patient; it would also be necessary for the pharmacist to foresee harm to the patient.

The foreseeability requirement takes the pharmacist’s duty from the realm of the hypothetical into the realm of the practical. A known but relatively unlikely adverse effect would not require a warning because it would not be foreseeable. Under this approach, a pharmacist’s duty to warn requires first that the adverse effect be known and second that there be foreseeable negative consequences for the patient if a warning about the adverse effect is not given. Many adverse effects are known because they have occurred at some time in the past, and at that time they were associated with the use of a medication. However, the incidence of the adverse effect may be so low that it is not realistically foreseeable. Although McLaughlin’s addiction to propoxyphene was foreseeable under the circumstances, many adverse effects would not be foreseeable.

Public Policy Considerations

The final factor considered in determining the existence of the duty for pharmacists was that of public policy. The court deemed three public policy considerations to be at stake:

1.  Preventing intentional and unintentional drug abuse

2.  Not jeopardizing the physician–patient relationship

3.  Avoiding unnecessary health costs

The court’s purpose in identifying these considerations was to determine whether public policy should or should not favor recognition of the duty.

On the first issue, the court recognized that there are a variety of reasons why a patient might try to have a prescription for a potentially harmful drug refilled at a rate higher than that prescribed, of which an addiction to the drug and diversion of the drug for an illicit purpose were two. Both of these explanations for too-frequent refills give rise to a strong public policy interest in preventing intentional and unintentional drug abuse. This public policy interest is reflected in the enactments of the state legislature. For example, the Indiana Code empowers a pharmacist to exercise professional judgment and refuse to honor a prescription when the pharmacist believes in good faith that honoring the prescription might aid or abet an addiction or habit. This statute demonstrates that public policy concerns about proper dispensing of prescription drugs and preventing drug addiction are paramount to policy concerns about interfering with the physician–patient relationship. A physician–patient relationship that is causing drug addiction or diversion needs to be interfered with. As a matter of policy, pharmacists should be required to act to prevent intentional and unintentional drug abuse.

Next, the court reasoned that, as a matter of public policy, the imposition of a duty to cease filling prescriptions in certain circumstances would not lead to the development of an adverse relationship between pharmacists and physicians. The court offered three separate reasons for this conclusion:

1.  Pharmacists already have authority to intervene through statute.

2.  Physicians remain ultimately responsible for the proper prescription of medications, and recognition of a duty on the part of pharmacists would not replace the physician’s obligation to evaluate a patient’s needs.

3.  The recognition of a legal duty would encourage pharmacists and physicians to work together in considering the best interests of their patients. Public policy should encourage collaboration to protect the public.

The last public policy concern reviewed by the court related to the possibility of an increase in healthcare costs if the duty in question were to be imposed on pharmacists. The court implied that if healthcare costs were to rise as the result of recognizing the expanded duty, public policy might not favor the recognition. The defendant had argued that recognition of the expanded duty would require pharmacies to buy expensive new technologies, thus driving up the cost of health care. However, the defendant pharmacy already had a computer-based information system that showed the plaintiff’s entire prescription history on the screen at the time of each fill or refill. The cost of computerizing the pharmacy had already been incurred and would not increase with recognition of the expanded pharmacist duty. Thus the public policy of holding down healthcare costs was not at odds with recognition of the duty.

The court concluded that all three relevant factors (relationship, foreseeability, and public policy) supported imposition of the expanded duty on pharmacists. Although any of the three factors could individually have justified the decision, the collective force of the three was compelling.

RATIONALE FOR EXPANDED PHARMACIST DUTIES

Consistent with the rationale of the Hooks SuperX opinion, some courts across the country have begun to recognize expanded responsibilities for pharmacists. To escape liability for negligence, it is still necessary for pharmacists to process orders accurately, but it is no longer sufficient to be technically accurate. Pharmacists must competently monitor drug therapy and thoroughly discuss drug therapy with patients if they wish to avoid exposure to legal liability.

The emerging judicial view of the pharmacist–patient relationship was summarized by Judge Pittman in his opinion in Griffin v. Phar-Mor, Inc., 790 F. Supp. 1115 (S.D. Ala. 1992). Judge Pittman stated:

The relationship between a pharmacist and a client is one in which the client puts extreme trust in the pharmacist. Pharmacists possess important specialized knowledge that is possessed by few, if any, non-pharmacists, and it is this specialized knowledge that puts patients in the position of having to put complete trust and confidence in a pharmacist’s skill. (790 F. Supp. at 1118)

Judge Pittman then described the specific responsibility of pharmacists to educate patients about their medications.

The importance of the particular facts does not need to be explained in any great detail. In general, it is important that a person know the type of medicine the person is taking. For example, a person may be allergic to a particular medicine, or a person may need to inform another doctor of what medications the person is taking. Also, and this is another thing that patients depend on pharmacists to provide, a person needs to know the type of medicine he or she is taking so the person can know what activities (i.e., drinking alcohol or dairy products) to avoid while taking the medications. (790 F. Supp. at 1118)

The responsibility of pharmacists to convey such information is important; in fact it is potentially lifesaving, and the cost of providing this information is not great.

The Tennessee Supreme Court has described the drug information responsibility of pharmacists using similar language. In the opinion from Pittman v. The Upjohn Co., 890 S.W.2d 425 (Tenn. 1994), the court quoted with approval rules of the Tennessee Board of Pharmacy, which state:

A pharmacist should, on dispensing a new prescription, explain to the patient or the patient’s agent the directions for the use and a warning of all effects of the medication or device that are significant and/or potentially harmful. (890 S.W.2d at 435)

The disclosure standard recognized by this language relates to both the content of the information to be given by a pharmacist to a patient and the process through which the information is to be provided. Accurate and complete information must be provided in a way that will promote appropriate medication use.

A Florida appellate court took a similar position to Pittman in a 2005 decision, diverting from prior Florida court decisions. In Powers v. Thobhani, 903 So. 2d 275 (Fla. Dist. Ct. App. 2005), the defendant pharmacy filled numerous lawful controlled substance prescriptions issued by the prescriber too closely in time to previously issued prescriptions. The patient ultimately overdosed and died, and her husband brought a wrongful death action against the pharmacy for failure to exercise due and proper care by not notifying the prescriber or the patient of the risks associated with frequently prescribed multiple controlled substance prescriptions. The trial court followed prior Florida court decisions and held that pharmacists have no duty other than to properly dispense a lawful prescription. The appellate court, however, reversed the trial court, noting that “There is a strong policy basis to support a pharmacy’s duty to warn customers of the risks inherent in filling certain repeated prescriptions” (903 So. 2d at 279). The court found the social policy was reflected in Florida laws and regulations requiring that pharmacists interpret and assess prescriptions and counsel patients. (For more discussion of this issue see Case 8-1: Happel v. Wal-Mart Stores, Inc. and the notes following the case.)

The Baker Case: Assumption of a Duty

An interesting case regarding the pharmacist’s expanded duty is Baker v. Arbor Drugs, Inc., 544 N.W.2d 727 (Mich. Ct. App. 1996). Decided by the Michigan Court of Appeals, Baker departed from a clear line of precedent in the Michigan appellate courts. Before Baker, courts in Michigan had been reluctant to recognize expanded responsibilities for pharmacists. Although the pharmacist’s duty to process prescriptions correctly was clear, Michigan courts had held that pharmacists had no duty to warn the patient of possible side effects of a medication or to monitor drug use. The Baker opinion adopted a different perspective on the issue in part on the basis of the compelling facts of the case.

The plaintiff in Baker was a patient who suffered from depression and was prescribed the drug tranylcypromine after an attempted suicide in October 1989. The patient was well aware of the dangers of adverse reactions with tranylcypromine, and he had strictly followed instructions given by his physician and the drug’s manufacturer. On February 26, 1992, the patient developed a cold and went to see a different physician. This physician’s records indicated that the patient was taking tranylcypromine. In addition, the patient later told his wife that he had twice told the physician that he was taking this drug. The physician prescribed two products for the patient. One product contained the drug phenylpropanolamine.

The patient took his prescriptions to the pharmacy where he normally had his prescriptions for tranylcypromine filled. A prescription for that drug had been filled for him at this pharmacy 11 days earlier. A computer at the pharmacy detected a potential interaction between the previously prescribed tranylcypromine and the newly prescribed phenylpropanolamine. However, a pharmacy technician overrode the computer prompt, and a pharmacist filled the prescription without becoming aware that the patient was also using a drug with which the prescribed drug could interact.

The patient ingested his prescribed cold remedy. Later that evening he complained to his wife that he was not feeling well. The two of them referred to literature that had been provided to them with tranylcypromine and concluded that the patient was suffering from a hypertensive attack. The patient was taken to the hospital, where he was diagnosed as having suffered a stroke. The stroke was a result of having ingested both the MAO inhibitor and phenylpropanolamine. The patient eventually died.

The defendant pharmacy had advertised that its computer system was designed in part to detect harmful drug interactions such as the one that led to Baker’s death. For example, one advertisement said:

Do you know what happens when you bring your prescription to Arbor Drugs? First, it’s checked for insurance coverage and screened for possible drug interactions and therapeutic duplication. That’s done very quickly by the Arbortech Plus computer. Then your prescription is filled and labeled. That’s done very carefully, by your Arbor pharmacist. The bottom line? Your prescription is not just filled quickly, it’s filled safely. Only at the Arbor Pharmacies. You can’t get any better. (544 N.W.2d at 731)

Despite providing this assurance in its advertising, the defendant did not prevent the plaintiff’s drug interaction. The available technology was not used correctly because the pharmacy technician overrode the interaction indicated on the computer.

In reversing summary judgment granted in favor of the defendant pharmacy by the trial court, the Michigan Court of Appeals held that the pharmacy “voluntarily assumed a duty to utilize the Arbortech Plus computer technology with due care” (544 N.W.2d at 731). Citing prior case law for the precedent that a defendant can be held liable when it voluntarily assumes a function that it was under no legal obligation to assume, the court expanded pharmacist responsibilities in Michigan beyond technical accuracy to include drug therapy monitoring with the assistance of computer systems.

Representations, Reliance, and Duty

The ubiquitous nature of computers in contemporary pharmacy practice turns what could have been a narrow exception to a general rule of “no duty” into a new and opposite general rule. Computers are hardly voluntary in pharmacy practice of the twenty-first century. They are as necessary as prescription vials (which replaced paper envelopes) and machine-printed instructions for patients (a vast improvement over pen and ink scribbling by a pharmacist or physician). Escaping liability such as that imposed by Baker is hardly possible by opting not to use computers. Technology has enabled pharmacists to provide greater value to patients, and the pharmacist who fails to use available technology has failed in a duty owed to patients.

Pharmacists have the ability to define the relationship they have with patients. The opinion in Baker recognized that the “defendant’s advertisements were made to induce customers to utilize its pharmacy” (544 N.W.2d at 733). If patients are told to expect nothing more than technical accuracy from pharmacists, then they are likely to expect only that they will receive the right drug, in the right strength, with the right directions for use. “Rightness” would be determined only by the physician’s prescription, not the patient’s needs. However, a pharmacy that advertises, “We accept responsibility for accurately filling your prescription with the drug ordered by your physician” is not likely to see an increase in business. Patients expect pharmacists to be accurate, and such an advertisement does not distinguish the advertising pharmacy from any other pharmacy.

If patients are told to expect more than technical accuracy from pharmacists, they likely will elevate their expectations. The Baker opinion noted that the “decedent reasonably relied on the allegedly false representation” (544 N.W.2d at 732). This finding served as the basis for the court’s ruling that the pharmacy could be liable for fraud or deception. Pharmacist duties expand with patient expectations. Representations by a pharmacist that are relied on by a patient create a covenantal relationship between pharmacist and patient. A pharmacist’s promise to perform, in exchange for a patient placing himself or herself in the care of the pharmacist, obligates the pharmacist to keep the promise and meet a duty to the patient.

EXPANDED RESPONSIBILITIES: A JUDICIAL COMPROMISE

Many recent court decisions have been reluctant to find that pharmacists have a general duty to warn, but instead have held that pharmacists have a duty to warn only in certain circumstances. In essence, these courts have fashioned a middle ground. The case of Happel v. Wal-Mart Stores, Inc. (see Case 8-1) is one example. Another example is Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455 (Tex. App. 2000), which was cited favorably in Happel. In Morgan, the plaintiffs sued the pharmacy, alleging that the death of their son was caused by an adverse reaction to Desipramine. The plaintiffs contended that the pharmacy was negligent for failing to warn of the possibility of the adverse reaction. The court held that pharmacists do not have a generalized duty to warn absent “special circumstances.” The court interpreted special circumstances as: (1) when the manufacturer gives special instructions to warn patients, (2) contraindications, and (3) when the pharmacist has special knowledge of the patient’s medical condition. In Morgan, the court found against the plaintiff because these special circumstances did not exist. In contrast, Happel found that special circumstances did exist.

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