A Weighty Issue: Will Pharmacists Survive the Fen-Phen Feeding Frenzy? Kohl V. American Home Products Corporation and a Pharmacist's Duty to Warn of the Dangers of Prescription Drugs
Fox, Karina, Brigham Young University Law Review
In 1996, pharmacists dispensed over 18 million prescriptions for fenfluramine in the United States.' As the more dangerous half of the diet drug combination popularly known as "Fen-Phen," fenfluramine promised overweight Americans something that seemed too good to be true: the body of their dreams as excess flab melted away without hunger.2
The honeymoon, however, was short-lived. Americans' love affair with Fen-Phen came to a bitter end when, in July of 1997, the U.S. Food and Drug Administration ("FDA") published a report linking valvular heart disease to the use of Fen-Phen.3 On September 15,
1997, the FDA announced the withdrawal of fenfluramine from the market.4 Sales ground to a halts stock plummeted,6 and thousands of Fen-Phen consumers lined up at their doctor's offices for echocardiograms.
No one was surprised8 when these same consumers found their way en masse into lawyers' offices around the country as a wave of litigation ensued. As of May 2000, "approximately 18,000 individuals" had filed lawsuits against American Home Products, the maker of fenfluramine.9 Although a federal judge recently approved a $3.75 billion class action settlement against American Home Products,' 44,423 plaintiffs exercised their right to opt out," thousands more are challenging the settlement as unfair,12 and many more cases remain pending in state court.13
As the unwitting middlemen caught in a litigation feeding frenzy, pharmacists and the future of their profession are on shaky ground. 14 While courts traditionally have held pharmacists to a duty
of clerical accuracy only, some courts recently have shown a willingness to extend this duty to include the duty to warn of the dangers of prescription drugs.ls
Kohl v. American Home Products Corporation, the principal case in this Note, purported to apply the traditional rule but nevertheless suggested that a pharmacist could be held liable for failing to second-guess labeling information supplied by the manufacturer of fenfluramine.16 While the holding itself is unimportant (the court eventually dismissed the plaintiffs claims on procedural grounds), the court's rationale is significant because it further muddied the waters of pharmacists' liability. More importantly, as the Kohl court was the only judicial body in the country to address squarely the issue of a pharmacist's duty to warn of the dangers of Fen-Phen, other courts will likely look to the Kohl rationale as the Fen-Phen litigation filters down into the state courts.
Part IT of this Note gives a brief synopsis of the Fen-Phen controversy and traces the recent judicial history of pharmacists' liability. Part III gives the facts of Kohl and explains the court's reasoning in suggesting that a pharmacist could be held liable for failure to warn of the dangers of fenfluramine. Part IV analyzes the court's opinion, compares that opinion with other recent decisions involving a pharmacist's duty to warn, and argues that the court improperly expanded and confused the scope of pharmacists' liability. Furthermore, this Note concludes that the modern trend toward expanding pharmacists' liability could displace the physician's role and thereby compromise patient care.
Fenfluramine leapt from relative obscurity in 1992 to become one of the hottest selling diet drugs of the century." Sales were brisk
until reports surfaced in 1997 linking fenfluramine to heart disease.18 Although the Mayo Clinic suspected an association between the use of fenfluramine and valvular heart disease in March 1997, the FDA did not make those findings public until July 8, 1997.19 When the FDA did issue a public warning about the use of fenfluramine, it pointed out that the evidence linking fenfluramine to heart disease was not yet conclusive.20 The FDA did not officially withdraw fenfluramine from the market until September 15, 1997, over two months after the initial reports were made public.21
Most of the 18,000 plaintiffs that filed lawsuits against American Home Products claimed the manufacturer either knew or should have known of the adverse effects of fenfluramine well before the FDA's official withdrawal of the drug.22 Likewise, the Kohl plaintiff alleged that the defendant pharmacy either knew or should have known of the dangerous defects of fenfluramine even before the FDA's announcement.23 While courts have been receptive to such claims against drug manufacturers,24 courts have traditionally declined to impose such a duty to warn on individual pharmacists.2
The sections below outline the doctrines and rationales supporting the traditional rule that pharmacists have no duty to warn and contrasts those rules with the modern view that a pharmacist's duty extends beyond clerical accuracy.26
A. Unavoidably Unsafe Drugs and Strict Liability
This is not the first time that the dangerous effects of a prescription drug were discovered only after the drug was ingested by millions of consumers, and it will not be the last.27 The competing interests of promoting useful medical innovations and protecting the public against dangerous products have led the American Law Institute to propose that prescription drugs should be excepted from the strict liability provision of the Restatement of Torts. Many states have adopted the 402A comment k exception to strict liability for prescription drugs under the view that all prescription medications are unavoidably unsafe.29 In a further effort to protect prescription drugs, the Utah legislature declared that FDA-approved drugs are presumed to be free from defects as a matter of law.so
However, the Utah Supreme Court pointed out that the protections of comment k apply only when the plaintiff alleges a design defect.31 Thus, only prescription drugs that are "properly prepared and accompanied by warnings of [their] dangerous propensities" will be sheltered under comment k.32 Because of the above protections, most plaintiffs recognize that they face an uphill battle in proving a drug was sold in an unreasonably dangerous condition due to a defective design. Some plaintiffs, therefore, allege the product was rendered unreasonably dangerous by the
pharmacist's failure to warn.33
Although Utah courts have yet to address the issue, such strict liability claims have been largely unsuccessful in other jurisdictions?34 In support of these holdings, courts have recognized that subjecting pharmacists to strict liability would hardly serve the purposes of such a standard; namely, to provide an incentive for issuing safer products, "for the pharmacist presented with a prescription ordered by a duly licensed physician is not at liberty to substitute his judgment of the product's safety for the patient for that of the physician."as
In addition, courts have found that subjecting pharmacists to strict liability would produce untenable practical ramifications; namely, that such liability would impose on pharmacists the obligation to independently test new prescription drugs, thereby making them the "absolute insurer" of the products.36 Courts also have speculated that, to avoid liability, pharmacists might even "refuse to fill prescriptions, notwithstanding decisions by licensed physicians that a particular drug was necessary and appropriate for their patients' medical treatment."37 Such a cost to society, courts have concluded, would be "unduly high."38
More importantly, courts have pointed out that even a manufacturer's duty to warn does not extend to individual consumers, but only to prescribing physicians.39 Thus, if drug manufacturers complied with their duty to warn physicians of dangerous side effects, the drug product as shipped to the pharmacy could not be considered unreasonably dangerous due to a defective
warning.44 In order for the plaintiff to prevail in such a case, a court "would have to conclude that the product somehow became unreasonably dangerous in [the hands."41 Such a conclusion, one court noted, would be "unreasonable."42 Therefore, the majority of courts have declined to impose a more stringent duty to warn on pharmacists than that imposed on manufacturers.43
The common thread in the above arguments is that the duty to warn individual patients of the potential hazards of prescription drugs properly lies with the physician-not the pharmacist, or even the manufacturer. This traditional view finds its rationale in the "learned intermediary doctrine," discussed next.
B. The Learned Intermediary Doctrine
The learned intermediary rule, as described in Coyle ro. Richardson-Merrell, Inc., posits that the physician is the person who can best evaluate and explain the dangers of prescription drugs "to the patient in the context of his or her individual medical circumstances.",44 The Coyle court noted that "[p]hysicians exercising sound medical judgment act as intermediaries in the chain of distribution, preempting, as it were, the exercise of discretion by the supplier-pharmacist, and, within limits, by the patient-consumer."45
In keeping with the justification for strict liability, courts point out that it is not the pharmacist on whom the public is "forced to rely" for prescription drugs, but rather the physician.46 Thus, courts are reluctant to impose any rule that would shift this reliance from the physician to the pharmacist because of the destructive effect it would have on the physician-patient relationship.47 In the prescription drugs context, courts realize that pharmacists'
interaction with patients comes only after the patient has obtained a signed prescription from the physician, during which time the dangers of the drug would presumably have already been discussed. Therefore, requiring the pharmacist to supplement the physician's warnings with his own would "have the effect of undermining the physician-patient relationship by engendering fear, doubt, and second-guessing."48 In such a scenario,
the patient-consumer would be receiving information about the risks of medication, information he or she would likely be unable to properly assess and weigh, from someone unfamiliar with the patient's medical condition, after those risks had already been weighed by a physician having specific knowledge of the patient's medical needs.49
In short, these courts beleive such a rule would significantly jeopardize the standard of health care in this country.50
Under the rationale of the learned intermediary doctrine, most, if not all, courts have declined to impose a strict liability duty to warn on pharmacists.51 And while most courts apply the learned intermediary rule with equal force to negligence,52 the modern view-that pharmacists should be required to do more than merely follow physicians' orders-appears to be gaining acceptance. Thus, the real controversy lies in how courts apply (or decline to apply) the learned intermediary rule to negligence cases.53
1. The traditional view
Under the traditional view, courts rely heavily on the learned intermediary rule. This view encourages the manufacturer, physician, and pharmacist to remain in their respective traditional roles. Accordingly, the manufacturer will provide adequate warnings to the physician, the physician will relay the warnings to the patient in the context of individual medical circumstances, and the pharmacist will fill the prescription according to the physician's instructions.54 Under the traditional view, any deviation from these roles will jeopardize the standard of patient care."
Thus, the traditionalists would limit a pharmacist's duty to "clerical accuracy."56 While the modern view takes issue with denigrating the pharmacist's role to that of a mere "pill-counter," the traditionalists are quick to point out that the "clerical accuracy" rule is subject to some limitations. For example, pharmacists are responsible for spotting clear or patent errors, such as "obvious lethal dosages, inadequacies in the instructions, known contraindications, or incompatible prescriptions.""
Advocates of the traditional view also point to the practical implications of imposing a duty to warn on pharmacists. Because some drugs are shipped in bulk from the manufacturer to the pharmacist, each shipment contains only one package insert or warning. Thus, requiring pharmacists to reproduce the warning and give it to patients with every prescription filled would be unduly burdensome and unreasonable." Moreover, federal statutory law specifically exempts prescription drugs from the package labeling requirements reserved for over-the-counter drugs.59 Turning again to the learned intermediary rule, courts assert that it makes much more sense for the physician to provide such warnings in the context of the patient's individual medical circumstanes. 60
2. The modern view
In contrast to the traditional view, the modern view asserts that "pharmacists are trained professionals" and argues that, in some cases, pharmacists should be required to do more than "unquestionably obey the written orders [of] ... physicians."61 Specifically, the modern view takes offense at the learned intermediary rule's hesitation to vest pharmacists with any independent judgment and posits that, at least in some circumstances, pharmacists have a duty to warn consumers of the potential hazards of prescription drugs.62
a. State statutory provisions. Some courts have found justification for requiring pharmacists to exercise independent judgment in state statutory provisions.63 The Utah Pharmacy Practice Act includes the following provisions under "Practice of Pharmacy": "(a) interpreting prescription orders; . .. [and] (f) providing information on drugs or devices, which may include advice relating to therapeutic values, potential hazards, and uses; . .. (i) providing patient counseling, including adverse and therapeutic effects of drugs.""
In perhaps the most liberal interpretation of a pharmacy statute, one court relied on the state pharmacy act to find not only that the pharmacist should have exercised his independent judgment over the physician's, but that, as between a physician and a pharmacist, "[e]ach has an affirmative duty to be, to a limited extent, his brother's keeper."65
Although another court refused to use the state pharmacy act to define a pharmacist's duty, it did so in part because the act was not in effect at the time the pharmacist filled the prescription in question. Therefore, the court in Raynor v. Richardson -Merrell, Inc.66 left open the possibility of applying the statute to define a pharmacist's duty at a later date.67
The traditionalists respond to these arguments by asserting that state statutory pharmaceutical provisions are definitional only, and do "not purport to set forth duties."68 In specifically addressing whether, as the plaintiff alleged, the pharmacist must advise of the "therapeutic values, hazards, and the uses of drugs and devices,"69 the McKee court concluded that the statutory language did not impose "a mandatory duty on all pharmacists to warn customers of all dangers associated with a drug."7 Rather, the court construed the language to apply only where pharmacists possessed "prescriptive authority.",71
b. Standard of care vs. duty. At least one court rejected the traditional rule by laboring to distinguish "duty" from "standard of care."7 Although its line of reasoning was somewhat unclear, the Arizona Court of Appeals concluded without discussion that the
pharmacist could have breached its duty to the patient.73 The court noted that determining whether the pharmacist breached that duty required the trier of fact' to examine the standard of care for pharmacists. To determine the standard of care, the court relied on an expert affidavit that imposed a duty on pharmacists to "advise a customer of the addictive nature of a drug, to warn of the hazards of ingesting two or more drugs that adversely interact with one another, and to discuss with the physician the addictive nature of a prescribed drug and the dangers of long-term prescription of the drug."75 Thus, the court reversed the trial court's grant of summary judgment in favor of the pharmacist.'
At most, the Lasley case suggests that pharmacists will always have a duty to warn their patients. Furthermore, the case stands for the proposition that whether or not a pharmacist breached the standard of care can be determined by any number of criteria, including expert witnesses" and standards enunciated by the American Pharmaceutical Association.?
Unlike the Lasley court, the Kohl court declined to distinguish "duty" from "standard of care." Nevertheless, the Kohl court reached a similar result by suggesting that the defendant pharmacists could be held liable in negligence.79 Although the two courts took different paths to reach the same result, both can be seen as expanding the scope of pharmacists' liability.
Ill. KOHL V. AMERICAN HOME PRODUCTS, INC.
Patricia Ann Kohl began taking fenfluramine as prescribed by her physician in May of 1996. Although the record is unclear as to how long she took the drug, Kohl filed suit against the manufacturers of fenfluramine" as well as Sims Drug and Clinic Pharmacy on October
8, 1999. Kohl "allege[d] she contracted valvular heart disease ... as a result of taking [the] diet drugs."81
The manufacturers sought to have the case transferred to the consolidated pretrial proceedings for the multi-district class action against American Home Products.82 In response, the plaintiff moved to remand to state court on the grounds that the pharmacies, both Arkansas citizens, destroyed diversity of citizenship.83 The defendants maintained that the pharmacies were fraudulently joined and asked the district court to stay the proceedings pending transfer to the class action.84
In order to rule on whether the defendant pharmacies were fraudulently joined, the court had to examine the merits of Kohl's claims, specifically whether strict liability and negligence were valid causes of action against the pharmacies?85 After examining the reasoning behind both the traditional and modern views of pharmacist liability, the court ruled that the strict liability claim against the defendant pharmacists was not cognizable, but that the negligence claim was valid.86 The court's reasoning for these conclusions is set out below.
B. The Court's Reasoning
1. Strict liability
In finding that the defendant pharmacists could not be held strictly liable for failure to warn the plaintiff of the potential hazards of fenfluramine, the court addressed two theories: (1) both public policy and the learned intermediary rule prohibit application of strict liability to pharmacists, and (2) plaintiffs strict product liability claims fail because pharmacists provide a service, not a product.87 The court dealt with each of these arguments in turn.
a. The learned intermediary rule and the policy of strict liability.
Siding with the majority of jurisdictions that have considered the question,88 the court applied the learned intermediary rule to find that the duty to warn patients of the dangers of prescription drugs properly lies with the physician, not the pharmacist.89 In so finding, the court relied on the reasoning set forth by the Pennsylvania Supreme Court in Coyle v. Richardson -Merrell, Inc.90
In Coyle, the court first noted the special policy protections afforded prescription drugs in comment k of 402A of the Restatement (Second) of Torts.91 The court then isolated four pertinent factors in comment c of the Restatement "which support the rule of strict product liability":
(1) supplier liability makes a member of the marketing chain available to the injured plaintiff for redress; (2) strict liability provides an incentive to safety; (3) a supplier is in a better position to prevent the circulation of the defective products; and (4) the supplier can distribute the cost of compensating for injuries resulting from defects by charging for it in his business.92
When it applied these factors to pharmacists, the Coyle court found the policy reasons supporting application of strict liability to pharmacists to be lacking.93 First of all, the court pointed out that "it is not the pharmacist on whom the public `is forced to rely' to obtain the products they need."94 Rather, the court said, it is the "[p]hysicians [who] act as exclusive intermediaries."95
Furthermore, the Coyle court found that "holding pharmacists to strict liability [would not] serve as an incentive to safety, for the pharmacist presented with a prescription ordered by a duly licensed physician is not at liberty to substitute his judgment of the product's
safety for the patient for that of the physician."96 The court sought to balance the minimal effect such a duty could have on preventing the circulation of defective products with patients' need to acquire drugs that are "necessary and appropriate for ... their treatment," concluding that the needs of the public would be "ill-serve[dJ" by imposing a duty that would encourage pharmacists to refuse to fill a physician-authorized prescription in an effort to avoid liability.97
In adopting the reasoning of the Coyle court, the Kohl court was unconvinced by the plaintiffs argument that pharmacists are better able to distribute the cost of liability through insurance or indemnification.98 Instead, the court found that "[r]eliance on costshifting . .would result in absolute liability rather than strict liability."" Based on the learned intermediary doctrine and the underlying policies of strict liability, the Kohl court "decline[d] to extend the rule of strict supplier liability to pharmacists."IOo
b. Service vs. product. While the Kohl court based its strict liability holding on the above rationale, the defendants advanced an additional and entirely different argument; namely, that strict liability is inapplicable to pharmacists because they provide a service rather than a product.lol In support of this argument, the pharmacists invoked an Arkansas statute providing that in order to prevail on a strict liability claim, the plaintiff must prove: "(1) the defendant pharmacies are engaged in the business of selling a product; (2) the product was supplied in a defective condition which rendered it unreasonably dangerous; and (3) the defective condition was a proximate cause of the harm. ,112 The pharmacists therefore maintained that because they were not "engaged in the business of selling a product," but rather providing a service, the first prong of the three-part test was not satisfied and the plaintiffs claim must fail.103
Despite the pharmacists' attempt to distinguish services from
products, the Kohl court remained unconvinced. While the court acknowledged that pharmacists do indeed provide a service, it also found that it is indisputable that pharmacists' "main function" is to provide a product?44 Furthermore, the court was influenced by the fact that "the [pharmacists'] service is not separately billed from the product." The court concluded that the defendants' argument was "rather shaky in the pharmacy context," but that nevertheless the learned intermediary rule precluded application of strict liability to the pharmacists.'6
While the Kohl court precluded application of strict liability to pharmacists, it nevertheless found that a negligence claim against the defendant pharmacies was cognizable based on the pharmacist's failure to "supply Kohl and/or her doctor" with the manufacturer's labeling information and because "the pharmacies knew, or should have known, that the labeling information that was supplied was inaccurate."'
The court began by noting the current tension between the traditional and modern views of pharmacist liability.18 Recognizing that the question before it was one of first impression in Arkansas, the court set out both sides of the argument in detail?'9 In the end, the court purported to side with the traditionalists in ruling that "pharmacies generally have no common-law or statutory duty to warn customers of the risks associated with the prescription drugs they purchase."110 The court was persuaded to adopt the traditional view by the policies supporting the learned intermediary rule."' For example, the court pointed out that it would be "incongruous" to hold a pharmacist to a duty to warn individual consumers when such a duty is not even imposed on the manufacturer.la Rather, such warnings are provided "to the person who most needs and can best
evaluate it-the physician-to be shared with and explained to the patient in the context of his or her individual medical circumstances." 113
Despite the above language, the court maintained that the defendant pharmacies could nevertheless be held liable in negligence under Arkansas law.114 While the court declined to impose a "generalized" duty to warn, it noted that pharmacists "must be held to a duty to fill prescriptions as prescribed and properly label the prescriptions."ils Even though the court agreed that it would be "incongruous" to hold pharmacists to higher duty than manufacturers, the court still found that the defendant pharmacies could have breached their duty by failing to supply warnings in labeling information directly to the patient or her physician.le Moreover, the court found that the defendant pharmacies could have breached that duty by failing to question the adequacy of the warnings... supplied by the manufacturer.lis
In short, the outcome in Kohl was surprising given the court's endorsement of the traditional view of pharmacist liability.
A. Strict Liability and Unavoidably Unsafe Drugs
1. The Kohl court correctly ruled that pharmacists should not be held strictly liable for failure to warn
The Kohl court's unwillingness to extend strict liability for failure to warn to pharmacists is unsurprising, for with the exception of patent prescription errors, virtually every court that has passed on the question has also refused to impose such liability.n9 While such decisions suggest that the imposition of strict liability is not an immediate threat to the pharmacist profession, it is worthwhile to
emphasize the policies supporting these decisions, because the same policies support the traditional view of pharmacists' liability in negligence.12 Specifically, the overwhelming authority agrees that holding pharmacists to a strict liability duty to warn would (1) undermine the patient-physician relationship, (2) jeopardize the standard of patient care, and (3) ill serve the policies of strict liability-to encourage safer products.121
2. Strict liability should not be applied to hold pharmacists liable in other fenfluramine cases
Relatively few jurisdictions have addressed the issue of whether pharmacists should be held strictly liable for failure to warn of the dangerous defects of prescriptions drugs,122 and the Kohl case is the only case in the country to address these issues specifically in light of fenfluramine. Therefore, it is helpful to examine the likely scenario should one of the pending fenfluramine cases come before a court.
In Utah, for example, any strict products liability claim must meet a three-prong test. The plaintiff must show: "(1) that the product was unreasonably dangerous due to a defect or defective condition, (2) that the defect existed at the time the product was sold, and (3) that the defective condition was a cause of the plaintiff's injuries."lza
In 1991, the Utah Supreme Court raised the bar for strict liability actions pertaining to prescription drugs by holding that "all FDA-approved prescription medications . . . [are] `unavoidably unsafe."124 This meant that "a drug approved by the United States Food and Drug Administration . . . , properly prepared, compounded, packaged, and distributed, cannot as a matter of law be 'defective' in the absence of proof of inaccurate, incomplete,
misleading, or fraudulent information."' The 1991 holding was a logical extension of the statutory language of the Utah Product Liability Act, which provides that plaintiffs must overcome a rebuttable presumption that the product is free from defects if manufactured according to industry standards.lzb
When the above standards are applied to fenfluramine, it is apparent that plaintiffs are fighting an uphill battle because fenfluramine was FDA-approved until its official withdrawal on September 15, 1997. Consequently, most plaintiffs point out that while fenfluramine was FDA-approved, the combination of fenfluramine with phentermine was not. 117 This logic fails, however, in light of the fact that, in the official news release of the withdrawal of fenfluramine, the FDA specifically pointed out that phentermine was not being withdrawn.'28 It is therefore apparent that, according to the FDA, it was not the "Fen-Phen" combination that was dangerous, but the use of fenfluramine alone.'29
The protection afforded prescription drugs by comment klao and legislative provisions like the Utah Product Liability Act lead most plaintiffs to make the alternative argument that fenfluramine was rendered unreasonably dangerous because of "inaccurate, incomplete, misleading or fraudulent information."131 These allegations seem particularly inapplicable to fenfluramine, because it is undisputed that even the FDA was unconvinced of the dangerous propensities of the drug until its official withdrawal in September 1997. To hold pharmacists responsible for knowing something that even the FDA did not know or acknowledge is highly suspect under a negligence standard, and to hold pharmacists strictly liable for
failing to provide such information directly to consumers borders on the absurd.
Notwithstanding the absurdity of requiring pharmacists' knowledge to exceed that of the FDA, holding pharmacists to strict liability would also significantly undermine the physician-patient relationship. In the typical fenfluramine scenario, a patient would seek the medical advice of her physician for help losing weight. After a consultation, the physician would prescribe the weight-loss drug to be filled at the patient's pharmacy. After this point, it would be counterproductive for a pharmacist to second-guess the physician's orders or substitute her judgment for that of the physician. The learned intermediary rule was implemented to prevent such a situation. Under that well-accepted rule, "information about the risks of medicines is provided to the person who most needs and can best evaluate it-the physician-to be shared with and explained to the patient in the context of his or her individual medical circumstances."132 Requiring pharmacists to evaluate independently individual medical circumstances, such as a patient's weight or eating and exercise habits, would wreak havoc on the assignment of responsibilities in the health care system.
Aside from the practical ramifications outlined above, requiring pharmacists to exercise independent judgment would ill serve the policy of strict liability-to encourage safer products. While holding manufacturers strictly liable for failure to warn of the dangerous propensities of their drugs that they knew or should have known may prevent the circulation of defective products, such a standard would be ineffective if applied to pharmacists. Pharmacists do not have the means to conduct independent tests and research on drugs to determine their dangerous effects. Instead, pharmacists might be left with only one option to protect themselves: to refuse to fill prescriptions "notwithstanding decisions by licensed physicians that a particular drug was necessary and appropriate for their patients' medical treatment."133
In Kohl, the plaintiff urged the court to adopt the strict liability standard in Arkansas because pharmacists are better able to distribute the cost of liability through insurance or indemnification." While such an argument may be applicable to a large pharmaceutical chain,
it lacks teeth when applied to the small neighborhood pharmacy. Many of these pharmacies are family-owned and operated and lack the resources to distribute the cost of the landslide of litigation resulting from fenfluramine.
3. It is unhelpful to distinguish between "services" and 'products" in the strict liability context
While the pharmacists in Kohl were unsuccessful in convincing the court that strict liability was inapplicable to them because they provided a service and not a product, other defendant pharmacists have had better luck with the theory. For example, in Murphy v. E.R. Squibb & Sons,' the California Supreme Court declined to apply strict liability to pharmacists in part because it found that pharmacists are "engaged in a hybrid enterprise."136 The court pointed out that "those who sell their services for the guidance of others... are not liable in the absence of negligence or intentional misconduct,"137 but also acknowledged that "it cannot be disputed that a sale in fact occurs." 138
However, the Murphy court also discussed the policy reasons that prohibit application of strict liability to pharmacists. In addition to those discussed above, the court was persuaded by a policy consideration discussed in the amicus curiae brief filed by the California State Board of Pharmacy: "in order to assure that a pharmacy receives the maximum protection in the event of suit for defects in a drug, the pharmacist may select the more expensive product made by an established manufacturer" rather than a generic brand.139
Because the Murphy court intermingled its policy discussion with its distinction between products and services, it is difficult to determine whether the "hybrid enterprise" argument standing on its own would have been enough to save the defendant pharmacist from strict liability. In any case, it is difficult to see the utility of such an argument, because regardless of the pharmacists' other duties, it is undisputed that pharmacists are indeed in the business of selling
products as required by state products liability statutory law. 140 In the end, the product vs. service argument is unnecessary because the policies supporting the learned intermediary rule, combined with the policies of the strict liability doctrine, are sufficient to preclude application of strict liability to pharmacists.
1. The Kohl court adopted the traditional view in theory but the modern view in practice
While the Kohl court adopted the traditional view in theory, the court's result reflected the modern view. Without doubt, the court granted itself some leeway because it was merely required to decide whether joinder of the two pharmacies was fraudulent. 141 However, because Kohl is the only case in the country so far to address the issue of a pharmacist's duty to warn of the dangerous effects of fenfluramine, the court's reasoning could have ramifications that extend beyond the actual result.
a. The duty to warn vs. the duty to label. While the Kohl court stated that it rejected a "general duty to warn customers of potential drug side effects or to give advice on the efficacy of the drug absent the presence of some contraindication," it nevertheless agreed with the plaintiff that a pharmacist could be held to a duty to supply the manufacturer's labeling information to the patient or her doctor and to second-guess the manufacturer's labeling information that it "knew, or should have known" was inaccurate.142 Although such language reveals the court's attempt to distinguish between the duty to warn and the duty to label, such a distinction is illogical in light of the facts of Kohl.
The facts clearly demonstrate that Kohl contracted valvular heart disease as a result of taking fenfluramine.'43 Thus, Kohl sued the pharmacy under the belief that her injury could have been prevented had the pharmacy provided her with information about the risks of fenfluramine.144 Regardless of whether the court requires pharmacists
to provide such information in warnings or labels, the court is still asking the pharmacist to provide the patient or her doctor with information the pharmacist did not know and had no reason to know. 145
While a valid distinction could be drawn between the duty to warn and the duty to label in a theoretical sense,146 the circumstances of Fen-Phen litigation suggest that, as long as the plaintiff alleges heart-related injuries, the duty to warn and the duty to label will remain synonymous because pharmacists had no reason to know of such dangers until the FDA's withdrawal of the drug.
Thus, semantic distinctions fail to change the heart of the matter: despite the court's pointed rejection of the modern view of pharmacist liability, the suggestion that pharmacists are responsible for the accuracy of manufacturers' labeling information cannot be reconciled with the traditional view the court purported to employ.
b. The learned intermediary rule and a pharmacist's duty. Perhaps the court's most egregious inconsistency was its unqualified endorsement of the learned intermediary rule while at the same time validating the plaintiffs allegations that (1) pharmacies have a duty to supply individual consumers or their physicians with the manufacturers' labeling information, and (2) that pharmacies have a duty to second-guess manufacturers' labels that they "knew, or should have known" were inaccurate.147 Such suggestions corrode the very core of the learned intermediary doctrine. The court's first suggestion-that pharmacists may have a duty to supply individual consumers with the manufacturer's warnings-can be attacked on many levels, not the least of which is practicality. In Leesley v. West, the Illinois Court of Appeals pointed out that many drugs are shipped to pharmacies in bulk from the drug manufacturer and contain only a single package insert with labeling and/or warning information.148 The court concluded that it would be "unreasonable" to require a pharmacist to provide "every customer whose prescription was filled from that bulk container with a copy of the information contained in that single package insert."149
Even putting aside the practical arguments, requiring pharmacists to pass on warning information to individual consumers is in excess of what is required of manufacturers, who by law are required only to warn physicians of the dangerous propensities of their drugs. 150 The Leesley court called such a scheme "illogical," "inequitable," and unduly burdensome.lsi However, the burden on pharmacists is not as disturbing as the disastrous effect such a scheme could have on patient care-the very thing the learned intermediary rule was designed to protect. The Leesley court pointed out that the reason manufacturers are relieved of the duty to inform individual consumers about the hazards of their products is not to protect the manufacturers, but to protect the patients.152 Similarly, pharmacists should not be required to warn individual consumers-not only because such a duty is unduly burdensome, but also because it is the physician, not the pharmacist or the manufacturer, who can best evaluate and explain the dangers of prescription drugs "to the patient in the context of his or her individual medical circumstances."153 Moreover, the Washington Supreme Court reasoned that it would be counterproductive for pharmacists to replicate the manufacturers' package inserts for patients because such inserts are "written for the physician, are detailed and technical, and may confuse and frighten the patient."'54 It is thus perplexing that, while the Kohl court clearly indicated that it felt bound to preserve the physician-patient relationship,lss it fashioned a duty that would erode the very relationship it sought to protect.
Along with suggesting pharmacists have a duty to pass along manufacturers' warnings to individual consumers, the court also suggested that the defendant pharmacists have a duty to secondguess manufacturers' warnings that they "knew, or should have
known" were inaccurate.isb In the context of fenfluramine, it is easy to see the injustice of such a position from a pharmacist's perspective: the court is suggesting that the pharmacists should have known something that not only the FDA did not yet know, but that the manufacturers did not know either.157
Furthermore, although the facts in Kohl are unclear as to what information the pharmacy's labels actually contained, it is evident from the plaintiff's complaint that she thought the pharmacy's label should have warned her of fenfluramine's propensity for causing heart disease.158 Of course, whether or not fenfluramine actually causes heart disease is immaterial. The pertinent question is how much, if anything, pharmacists are required to know about the dangerous side effects of prescription drugs. Requiring them to know anything outside of patent prescription errors creates a slippery slope to limitless liability on the pharmacists' side and substandard patient care on the consumers' side.
Unfortunately, the question of what a pharmacist's duty exactly entails is left open by the Kohl opinion. After the court stated that "a generalized duty to warn is inappropriate given the role of the physician in determining the appropriate drug to be prescribed," it went on to characterize the pharmacists' duty as "a duty to fill prescriptions as prescribed and properly label the prescriptions.'59 Not even the staunchest advocates of the traditional rule could find fault with such a characterization of a pharmacist's duty. However, if the court believes its own language, it is difficult to see how the above duty translates into passing on the manufacturer's labeling information to doctors or individual consumers and second-guessing the manufacturer's warnings.16
c. Exceptions to the clerical accuracy rule. One possible explanation for this anomaly is that while the court perhaps aligned itself with the traditional view in characterizing a pharmacist's duty as clerical accuracy only, the court also suggested the pharmacies in Kohl breached that duty. However, this explanation fails under closer
scrutiny. The authority is clear that the duty of clerical accuracy is limited to correctly filling the prescription as written by the physician and to be alert for patent prescription errors"' such as overdoses or contraindications. Thus, not only does the Kohl court base its holding upon the speculation that the pharmacies could have breached their duty of clerical accuracy, it also seems to suggest that the clerical accuracy duty itself should be expanded.
Another possible explanation is that the court thought the pharmacy's actions fit into one of the established exceptions to the learned intermediary rule. The court peppered its opinion with exceptions to the general rule that pharmacies have no duty to warn, including "where there is evidence the pharmacy compounded.. or changed the drug in some manner after receiving it from the manufacturer,"162 or in the presence of some "contraindication."163 However, neither of the above permutations seem to fit within the exception the court suggested: that pharmacists may have a duty to supply consumers with the manufacturer's label or second-guess the content of such labels.l`' Indeed, while there is ample authority to support the view that the clerical accuracy rule has exceptions, none of this authority extends the exceptions as far as the Kohl court suggested.
For example, in McKee, the Washington Supreme Court limited the patent prescriptions errors exception to "obvious lethal dosages, inadequacies in the instructions, known contraindications, or incompatible prescriptions."' In that case, the defendant pharmacy dispensed weight-loss medications to the plaintiff as prescribed by her physician." After taking the medication for over ten years, the plaintiff subsequently became addicted to the drug and sued the pharmacy in negligence and strict liability.' The court found that despite the plaintiffs allegations, the pharmacy had fulfilled its duty
"to be alert for clear errors or mistakes in the prescription," holding that such a duty did not extend to "warn[ing] customers of the hazardous side effects associated with a drug, either orally or by way of the manufacturer's package insert."les
Likewise, in Adkins v. Mong, the Michigan Court of Appeals declined to find a patent prescription error when a pharmacy dispensed over 116 narcotic prescriptions over a period of six years to a patient who subsequently became addicted and sued the pharmacy in negligence.169 The court held that the pharmacy's duties did not extend to warning the patient of the addictive propensities of the narcotic.l'o
Thus, it seems clear that the Adkins and McKee courts would disagree with the possible suggestion of the Kohl court-that the duty to pass along manufacturers' labeling information to consumers and the duty to exercise independent judgment regarding such labels should be incorporated as exceptions to the clerical accuracy rule.
d. State statutory provisions. Another possible way to reconcile the Kohl court's dicta with its holding is that it relied on the Arkansas state statutory provisions to define the pharmacist's duty. However, the extent to which the court relied upon such provisions is unclear. Initially, the court quoted the following provisions from the Arkansas Code:
The "practice of pharmacy" means the learned profession of: [i]nterpreting prescriptions for drugs, medicines, poisons, or chemicals issued by practitioners authorized by law to prescribe drugs, medicines, poisons, or chemicals which may be sold or dispensed only on prescription...
[a]dvising and providing information concerning utilization of drugs and devices and participation in drug utilization reviews...
[p providing pharmacy care ....171
Then, without ffirther elaboration on the above provisions, the court stated, "[g]iven the statutory provisions discussed"' above, we
disagree with the defendant manufacturers' assessment of Arkansas law and believe a cause of action against the pharmacies is cognizable."'3 The court further held that "[w]hen faced with the issue [of whether the pharmacies were fraudulently joined], we believe Arkansas courts would hold that a pharmacy has a legal duty to exercise due care and diligence in the performance of its professional duties."174 Therefore, the Kohl court suggested that the above Arkansas statutory provisions could impose a duty on pharmacies to pass a manufacturer's warnings on to individual consumers or provide such warnings to a patient's physician, as well as a duty to second-guess the accuracy of a manufacturer's warnings.l'S
Despite the Kohl court's willingness to interpret the Arkansas code as imposing a legal duty on pharmacists, some courts have taken the opposite view. In McKee v. American Home Products, the Washington Supreme Court declined to impose a duty to warn on pharmacists based on the state's "practice of pharmacy" statute.176 Despite the plaintiffs contention that under the state statutory provisions the pharmacy had a duty to warn her of the addictive propensities of the weight-loss drug Plegine, the court determined that the statute "is definitional and does not purport to set forth duties."' The court then offered a conservative interpretation of several of the statutory provisions. First, although the state statute requires pharmacists "to orally explain the directions for use and give any additional information necessary to assure proper use of the drug," the court interpreted this requirement to include "nonjudgmental information, not affecting a decision to take or continue using a drug, such as: whether to take the drugs on an empty or full stomach, substances to avoid while using the drug, or not to drive or use heavy machinery while taking the drug."'
Secondly, although the state pharmacy act requires pharmacists to maintain a record on each patient, the court recognized that "a pharmacist typically does not have the patient's complete medical history and there may be occasions where the pharmacist is unaware a drug is contraindicated."179
If one takes the view that the Kohl court was attempting to enforce the traditional view of pharmacist liability, both of the McKee court's observations should have been applied in Kohl. Although the Kohl court neglected to specify which Arkansas provisions in particular it relied on in its holding, the logical conclusion is that it thought "[a]dvising and providing information concerning utilization of drugs and devices"' imposed a duty to supply the consumer with the manufacturer's warnings or inform the consumer of inadequate information. Under the McKee analysis, such a duty would require a pharmacist to exercise his independent judgment and would therefore be inappropriate.
Moreover, although the Kohl court stated that a "general duty to warn" is inappropriate "absent the presence of some contraindication,"181 it neglected to temper such a statement with the McKee court's recognition that pharmacists have limited access to patient information and cannot be responsible for every contraindication?12
In light of these observations, it should be noted that the Kohl court did not admit that it was aligning itself with either the traditional or the modern view. The fairest reading of the Kohl opinion suggests that the court was attempting to make up its own rule; while it agreed with the traditional view in theory, it was uncomfortable with the unqualified suggestion that pharmacists have no duty to warn. Therefore, the court tried to temper that rule with its own exceptions.'83 However, the court's exceptions cut too far into the substance of the traditional view, thereby enlarging the potential scope of pharmacist liability and threatening patient care. The section below outlines exceptions to the general rule that pharmacists have no duty to warn, which exceptions can be
employed without threatening patient care.
2. Negligence should be applied to pharmacists only in certain circumstances
The principal argument of this Note is that pharmacist liability should be limited in or this to protect not only pharmacists, but liability patients and the health care system as a whole. However, even the most conservative to protect not only pharmacists agree that the general rule prohibiting and to w rn necessarily includes some exceptions.
ca. Limited duty re system as a whole. The "limited duty" rule could also the most conservative cler cal accuracy tempered with exceptions. Surprisingly,'s4 even die Kohl court accurately summarized that the general rule generally recognized e ceptions inherent in the limited duty rule. Under this rule, liabili could attach includes some exceptions.
the pharmacist alte 'd the product, dispensed duty" rule could also be drug,... Limited duty ispensed a drug that was inkrior or defective, characterized additional information about the plaintiffs condition from which a trier of fact could conclude a duty tempered Mth existed and/or a duty to inquire of he prescribing physician whether such drugs were appropriate.185
Several cases have applied the limited duty rule while remaining within the scope of the traditional view. However, the few cases that have recognized such a duty are easily distinguished from the case at hand. In Hand v. Krakowski, the Supreme Court of New York held that the trial court had Improperly granted summary judgment in the defendant pharmacy's vor.186 In that case, the pharmacy dispensed 728 units of psychotropic drugs to the plaintiff's decedent, who was an alcoholic. 117 Because the pharmacy's own records identified the decedent as an alcoholic, and because the psychotropic drugs were "commonly recognized to be contraindicated with alcoholism," the court held the pharmacy "may have had a duty to warn decedent of the grave danger involv d," which precluded summary judgment. 188
Similarly, in Riff v. Morgan Pharmacy, the court affirmed
judgment against the defendant pharmacy.189 In that case, plaintiffs physician prescribed rectal suppositories for the plaintiff's migraine headaches.Iv The pharmacy dispensed the medication to the plaintiff despite the fact that the physician's prescription contained a clear overdose and "patent inadequacies in the instructions."191 The pharmacy also refilled the prescription twice, even though the physician had not authorized any refills.?2 Both Hand and Riff are readily distinguished from Kohl because they both involve the type of patent prescription errors described in the "limited duty" rule.?3
It is important to note that courts have conservatively construed the exceptions in the limited duty rule. For example, the majority of jurisdictions have held that even if the pharmacists had actual or constructive knowledge of a drug's dangerous side effects, the pharmacists still had no duty to warn. For example, in Raynor ro. Richardson-Merrell, Inc., the court noted that "even assuming for the purpose of this [summary judgment] motion that [the pharmacy] knew Bendectin was teratogenic,194 it had no duty to warn [the plaintiff]."'9s
Likewise in Leesley v. West, the court held the defendant pharmacy was under no duty to warn the plaintiff of peptic ulceration and gastrointestinal bleeding, even though such incidents were "known ... side effects of Feldene."196 The Leesley and Raynor decisions emphasize the futility of trying to determine what the pharmacists "knew, or should have known" as applied to the duty to warn. While the modern view advocates a case-by-case analysis to determine whether a pharmacist "knew, or should have known" of the dangerous effects of a drug it prescribed, the traditional view recognizes that even in those situations where a pharmacist actually knew of the dangerous side effects of a given drug, those side effects should be properly discussed with the patient by her physician and not the pharmacist. Furthermore, as the McKee court recognized, a patient's full medical record is often unavailable to the pharmacist,
therefore creating a risk of inaccurate or incomplete advice."' The very purpose of the learned intermediary rule is to bypass the difficulties, inequities, and dangers of imputing knowledge to a pharmacist.
b. The limited duty rule and fenfluramine. Under the reasoning of Raynor and Leesley, the Kohl decision clearly expands the scope of the limited duty rule to an unacceptable extent. When the Kohl court suggested that a pharmacist may have a duty to question a manufacturer's warnings that it "knew, or should have known" were inaccurate,' what it really suggested was that pharmacists have a duty to independently warn consumers if the pharmacists "knew, or should have known" that fenfluramine caused heart disease.
Even under a liberal reading of the limited duty rule, it is difficult to see how a pharmacist should be held responsible for the dangerous side effects of fenfluramine that were not made known by the FDA. Such a suggestion would imply that even a neighborhood pharmacist has means of testing and research at his disposal that surpass one of the government's largest administrative agencies.
Moreover, a conservative reading of the limited duty rule would recognize that whether or not fenfluramine really does cause heart disease is immaterial, for even assuming a pharmacy knew of the dangerous side effects of the drug, a pharmacist should still be protected under the learned intermediary rule.
The pharmacy in Kohl did none of the things that would qualify as an exception under the limited duty rule as it is generally understood. Specifically, it did not "alter the product, or dispense the wrong drug,"199 and it could not have known that fenfluramine was "inferior or defective"too until after the FDA's withdrawal. Furthermore, the pharmacist did not have "additional information"aol about the plaintiffs particular condition within the meaning of Hand v. Krakowski... that would require it to "inquire of the prescribing physician whether such drugs were appropriate."'23
While the fact that the Kohl court was merely trying to determine
whether joinder of the defendant pharmacies was fraudulent prohibits the case from being the smoking gun that it otherwise might have been, the opinion could still be dangerous when read for all it is worth. The court's analysis cannot be cabined in traditional, modern, or limited duty doctrines. As such, it is something of a loose cannon that could be interpreted to expand pharmacist liability to an unacceptable extent and thereby endanger patient care.
The traditional view, tempered with the exceptions of the limited duty rule, is the best mechanism to protect the values fostered under the learned intermediary rule. In contrast, the modern view endangers patient care, undermines the learned intermediary rule, and threatens to supplant the physician's role in the health care system with that of the pharmacist, who is ill-equipped for such responsibility. The court's opinion in Kohl, while paying lip service to the traditional view, encourages an expansive view of pharmacist liability without taking responsibility for the implications. If the Kohl opinion is followed, pharmacists likely will not survive the Fen-Phen feeding frenzy.
Questia, a part of Gale, Cengage Learning. www.questia.com
Publication information: Article title: A Weighty Issue: Will Pharmacists Survive the Fen-Phen Feeding Frenzy? Kohl V. American Home Products Corporation and a Pharmacist's Duty to Warn of the Dangers of Prescription Drugs. Contributors: Fox, Karina - Author. Journal title: Brigham Young University Law Review. Volume: 2001. Issue: 3 Publication date: January 1, 2001. Page number: 1349+. © Brigham Young University, Reuben Clark Law School 2008. Provided by ProQuest LLC. All Rights Reserved.