US Pharm. 2006;1:38-42.

It used to be that courts reviewing pharmacy malpractice claims routinely dismissed complaints if the pharmacist had correctly filled the prescription. A simplistic but logical outcome. If you fill the prescription the way the prescriber ordered, why would you expect a lawsuit if something else goes wrong and the patient suffers harm related to use of the medication? You followed orders, and the patient got what the doctor ordered. It can't be your fault for doing exactly what you were asked to do, right? Of course not. If life were this easy, armies of lawyers would be looking for alternate employment. Instead, there are numbers of attorneys who believe their true calling is to push the liability envelope as hard and far as they can to find new and untried areas of liability potential. There have been at least two cases decided in 2005 involving attempts to argue for new theories of legal accountability.

Failure to Discover Allergy
The plaintiffs are the adult children of their elderly mother who died from an anaphylactic reaction to cephalexin, which was prescribed by a registered nurse practitioner who had diagnosed cellulitis in the patient's arm in December 2001, just before the holidays.1 The nurse knew the patient was allergic to penicillin but claimed there was a low incidence of cross-sensitivity between the two drugs. She also claimed that she consulted with a physician before deciding which drug to prescribe.

The patient took the prescription to a community pharmacy which had on record the majority of the medications she had taken since 1997. The standard operating policy for this pharmacy was to have new patients fill out a form indicating their medication history; this form included questions about drug allergies. The information was entered into the pharmacy's computer database, and the profile was accessed every time a pharmacist filled or refilled a prescription for that patient.

This patient's medication profile contained a coded number in the allergy section that meant she had no known medication allergies. When the pharmacist went to fill the cephalexin prescription, no allergy warning was displayed. Neither of the adult children remembered telling any of the pharmacy personnel that their mother had a history of anaphylactic sensitivity to penicillin products. Likewise, neither of them could recall hearing their mother relate such information to the pharmacy staff.

The medication was delivered to the home shared by the patient and her son. Soon after taking it, the patient called to her son on an intercom and told him she had just taken a dose of the drug and was feeling terrible. The son spoke briefly to his mother and called 911 just before she stopped breathing. The medics were unable to resuscitate her. Intubation was not possible because her airway was blocked by a swollen tongue and vocal cords. The autopsy concluded that the cause of death was due to an "anaphylactoid drug reaction."

The pharmacy asked the court to dismiss the malpractice claims that had been made against it. The judge reviewed the applicable state law and concluded that a "pharmacist has only a limited duty to warn a customer about a physician's prescription, for example, if the prescribed medication is obviously fatal or the dosage is unusual." The policy embodied in this account of the scope of a pharmacist's duty to a patient has its origin in a case decided in 1932. In that decades-old opinion, the judges wrote:

If the law is going to require, as plaintiffs would have it, that the physician be second-guessed by the pharmacist, only danger could result. A pharmacist who advised a patient not to take a drug prescribed by a physician might easily cause death or serious injury, and we think the practice of medicine by pharmacists is not a field in which we should even encourage them to engage, much less require it, as plaintiffs would have.2

This is about as narrow a view on the obligations of pharmacists as exists in any jurisdiction. To see it expressed in a modern era case is unusual. However, in light of the allegations made by these plaintiffs, perhaps the judge felt the need to send a strong message.

The plaintiffs claimed that the pharmacy "has an ongoing and continual duty to inquire about a customer's allergies." In support of this assertion, the plaintiffs obtained the services of an expert witness who asserted there were "national" standards adopted in 1979 by the American Pharmaceutical Association3 and the American Association of Colleges of Pharmacy. These standards direct pharmacists to obtain a customer's drug allergy information and to update it regularly. The judge interpreted this claim to mean that the plaintiffs would require the pharmacist to inquire about a patient's possible allergies every time a new prescription was presented. The judge rejected this argument because the plaintiffs offered nothing to show that such guidelines have been adopted in that state or by federal law, or that they were otherwise applied to govern the practice of pharmacies in this state. The judge also intimated that the opinion of the expert witness may have been dubious since he had never practiced pharmacy in the state hosting this lawsuit.

Furthermore, the judge rejected the breadth of the pharmacy duty advocated by the plaintiff because the prescriber of cephalexin already knew the patient was allergic to penicillin and would not have changed the prescription based on a telephone call from the pharmacist. For these reasons, the judge granted the pharmacy's motion requesting dismissal of the case.

Contraindicated Drugs
In another case, the plaintiff had a prescription for Depakote (valproic acid) filled at a community pharmacy. Six months later, the patient took a new prescription to the same pharmacy for Lamictal (lamotrigine).4 The labeling for Lamictal includes warnings that severe and even fatal rashes may occur with the use of this drug, and the risk increases when valproic acid and lamotrigine are used simultaneously. Soon after beginning Lamictal, the plaintiff developed a drug-induced, life-threatening rash that has left her permanently disabled. According to the pharmacy's records, there was no indication that the plaintiff ever had the Depakote prescription refilled or even transferred to a different pharmacy. On the day that the Lamictal prescription was presented, there was nothing in the patient's records indicating she was still using a drug prescribed six months earlier.

Unbeknownst to the pharmacist, the patient had a prescription drug benefit program that allowed her to fill an initial prescription at a local community pharmacy but required her to obtain refills from a mail-order pharmacy.

The patient sued the pharmacy, alleging that its staff was negligent for giving her the new seizure medication when they knew, or should have known, of a potentially serious interaction with another drug the plaintiff was taking. Put a different way, the plaintiff was urging the court to adopt a rule that would have required the pharmacist to ask the patient if she was still taking Depakote when she presented the Lamictal prescription.

The circuit court granted the defendant's motion for summary judgment, finding that the defendant owed the plaintiff no duty under the circumstances. In a 2–1 split decision of a three-judge panel in the Michigan Court of Appeals, the majority voted to affirm the trial court judge's decision. These two judges cast this case as one where the plaintiff alleged negligence for the pharmacist's failure to warn her of the side effects of a properly prescribed and dispensed drug. Looking to the controlling precedent in that state, these judges noted that "pharmacists are held to a high standard of care in correctly filling prescriptions but they are generally not liable for damages resulting from a properly filled prescription."5 This court had also ruled in the past that "a pharmacist has no duty to warn the patient of possible side effects of a prescribed medication where the prescription is proper on its face and neither the physician nor the manufacturer has required that any warning be given to the patient by the pharmacist."

However, in a more recent case, the same court did find that the pharmacy had breached its duty by not following a drug-interaction warning that had been generated by its computer software. The impact of that decision was limited to the facts surrounding the duty because the pharmacy specifically advertised its drug-interaction system and thus voluntarily assumed a function it was not legally required to have. 6 The judges wrote that the current case was factually distinguishable from the other case, where a warning had been missed. They also read the earlier cases to mean that a pharmacist does not have a duty to inquire about or monitor a patient's drug history.

The majority elected to follow the narrower scope of a pharmacist's duty to warn because they believed that "the pharmacist had no reason to think that plaintiff was on Depakote. The pharmacy's record of her prescriptions for that drug indicated that she discontinued use of it six months earlier. [The] defendant had no way of knowing that she had ordered more from a mail-order source. Indeed, its drug-interaction system indicated no red flags because there was no reason to assume that [the] plaintiff was on Depakote."

The lone dissenting judge displayed exasperation with the opinion of the other two judges. He wrote:

My position is that a pharmacist has a legal duty to act in situations where the pharmacist is asked to fill two incompatible or contraindicated prescriptions under circumstances in which there is an unacceptable, recognized, and medically significant risk of serious harm or death to the customer should the customer take both medications in the dosages prescribed. This duty arises when the dangerously incompatible or contraindicated prescriptions are filled in a single transaction or in separate transactions handled by the same pharmacy sufficiently close in time such that it could be reasonably contemplated that the customer may still be taking the earlier prescribed and filled medication. Additionally, if the pharmacist has actual knowledge that a customer is taking a particular medication, although not filled or purchased at the pharmacy at which the pharmacist is employed, the pharmacist has a legal duty to act when filling a new prescription where there is an unacceptable, recognized, and medically significant risk of serious harm or death to the customer should the customer take both medications in the amounts prescribed.

He called the period between the dispensing of the Depakote and Lamictal prescriptions "a short six months" and characterized it as "a short time frame." He went on to write a detailed analysis of the facts that he determined were critical to his point of view:

In my opinion, the case before us today presents a close call because [the] plaintiff would have apparently finished taking the Depakote prescription, filled in June 2000, sometime in July 2000 in light of the quantity and dosage, and the Lamictal prescription was first filled in December 2000. However, in today's age, it is not uncommon for patients to obtain and continue taking medications through alternative, less expensive sources, such as mail order, or even through samples handed out by their own doctor, and dosages are not necessarily completed in timely fashion where situations often arise in which a patient temporarily stops taking the medication and then resumes the medication for any number of reasons, e.g., a person forgets to pack the medication on a week-long trip.

Considering that the pharmacist here had information at his fingertips showing that [the] plaintiff had recently been taking Depakote, and viewing the documentary evidence in a light most favorable to [the] plaintiff which lends support to her claim that dangerous or fatal interactions often occur when taking the two medications as prescribed, a duty to act arose on [the] defendant's part that would not have been overly burdensome, where [the] defendant's personnel could simply have asked [the] plaintiff whether she was still taking Depakote.

Moreover, I do not believe that applying the duty I have suggested would interfere with the physician-patient relationship, open the floodgates to litigation against pharmacies, overburden pharmacies, hamper pharmacy operations, or inconvenience customers who patronize pharmacies.7

Analysis
Whether one agrees with the majority or the dissent in this case or the allegations of the plaintiffs in the penicillin allergy case, it should be clear that judges are closely scrutinizing the roles that pharmacists have in our drug-delivery system. In both cases, the plaintiffs were urging the courts to push the envelope of pharmacy liability a bit further than has been seen in prior cases. Sometimes these newly advanced arguments work, and sometimes they do not.

In a very recent edition of this column, a case was discussed where a court had to do a significant amount of dodging and distinguishing of state precedents, to the effect that a pharmacist cannot be held liable for correctly filling a prescription.8 This was an addiction case where the pharmacist allegedly filled prescriptions for controlled substances at a rate that he knew, or should have known, could lead to the patient's narcotic dependency. Those judges, in antithesis to the cases discussed in this column, wrote: "We are unwilling to hold that under no set of alleged or discoverable facts could [the patient] sustain negligence claims against the pharmacies' motions to dismiss under [applicable state law]." Take this statement as something of a shot across the bow: Do not be taken by surprise if someday someone sues a pharmacist and wins a liability award, even when the prescription is filled exactly as requested by the prescriber.

REFERENCES
1. Podurski v United States, Slip Op No CCB-0303180 (September 21, 2005), USDC Maryland, 2005 US Dist Lexis 20952.
2. Moore v. Wyeth-Ayerst Labs., 236 F. Supp.2d 509, 512-513 (D. Md. 2002) (citing People's Service Drug Stores v. Somerville, 161 Md. 662, 158 A. 12, 13 [Md. 1932]). See also Hofherr v. Dart Indus., Inc., 853 F. 2d 259, 263-264 (4th Cir. 1988).
3. The organization changed its name to the American Pharmacists Association but still uses the APhA abbreviation.
4. Saukas v Walker Street Pharmacy, Slip Op No 260560 (August 4, 2005), 2005 Mich App Lexis 1847.
5. Stebbins v Concord Drugs, 164 Mich. App. 204; 416 N.W.2d 381 (1987).
6. Baker v Arbor Drugs, 215 Mich. App. 198, 201, 206; 544 N.W.2d 727 (1996).
7. The plaintiffs in the Saukas case (see reference 4 above) have requested leave from the Michigan Supreme Court to appeal the majority decision from the Court of Appeals. The author of this article is also General Council to the Michigan Pharmacists Association (MPA) and, at the time of the article's writing, was reviewing whether or not an Amicus Curiae (friend of the court) brief was going to be filed on behalf of the members of the MPA.
8. Vivian JV. Precedent: the failure to warn. US Pharm. 2005;30(7):52-56. Available at: www.uspharmacist.com/index.asp?show=article&page=8_1526.htm. Accessed November 6, 2005.

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