US Pharm. 2007;32(9):68-72.

Articles discussing the liability of pharmacists or pharmacies for failing to warn patients about risks associated with the use of medications abound. It seems like just about every court has weighed in on the issue. Most unfortunately for practicing pharmacists, there does not seem to be any one predominant line of thinking about the beginning and ending of responsibility when pharmacists fail to counsel patients appropriately. A recent case law decision, however, offers to shed some new light on the subject.1

Facts of the Case
The parties agreed on the facts underlying this litigation. On November 10, 2003, the mother of a child complaining of allergies and sinus-related problems took her child to a pediatrician. The physician told the mother that he would be issuing a prescription for Omnicef (cefdinir) and gave her directions on how to use the medication. It appears that the physician changed his mind when he discovered that the office did not have any Omnicef samples, because he gave her a prescription for Septra DS (sulfamethoxazole and trimethoprim). The physician did not tell the mother that he had changed the prescription.

On the same date, the mother took the prescription to a pharmacy in Zachary, Louisiana, where it was filled with the generic equivalent of exactly what the physician prescribed. At the time, Louisiana had a Board of Pharmacy rule requiring pharmacists to provide counseling on medication use, including "common severe side or adverse effects."2

In court, the pharmacy stipulated that it did not provide the counseling mandated by this rule. It also admitted that the pharmacist on duty should have called the prescriber to clarify why a pediatrician was prescribing Septra DS to a child. It was also undisputed that the child developed Stevens-Johnson syndrome that progressed to toxic epidermal necrolysis subsequent to ingesting the generic version of Septra DS.

The pharmacy, however, denied that its acknowledged failure to counsel was a direct or proximate cause of the harm suffered by the child. In essence, it claimed that Stevens-Johnson syndrome and epidermal necrolysis are rare and uncommon conditions not normally associated with use of the prescribed antibiotics. An expert witness for the patient testified in a deposition that prescribing Septra DS for a young child was "not a prudent choice." Other evidence was offered that the brand name or generic equivalent for Septra DS, though not the drug of first choice, was nevertheless appropriate under the circumstances. Furthermore, there was evidence that the child had ingested this medication on prior occasions without incident. Finally, other experts testified that the conditions exhibited by the patient are "extremely rare" and unexpected. Upon the request of the pharmacy, the trial court judge dismissed the complaint. The mother, acting on behalf of her daughter, filed an appeal with the state's Court of Appeals.

Appellate Decision
The Court of Appeals characterized the claims against the pharmacy as negligently failing to counsel as required by an applicable Board of Pharmacy Rule, which resulted in the harm suffered. In Louisiana, negligence is defined as "conduct which falls below the standard of care established by law for the protection of others against an unreasonable risk of harm."3 Under the state's laws, liability for negligence requires that five specific elements be present:

1. Proof that the defendant had a duty to conform his conduct to a specific standard (the duty element);
2. Proof that the defendant's conduct failed to conform to the appropriate standard (the breach element);
3. Proof that the defendant's substandard conduct was a cause-in-fact of the plaintiff's injuries (the cause-in-fact element);
4. Proof that the defendant's substandard conduct was a legal cause of the plaintiff's injuries (the scope of liability or scope of protection element); and
5. Proof of actual damages (the damages element).4

For purposes of resolving the dispute, the pharmacy admitted that it did not meet the standards of the first two elements. It also admitted that the patient suffered damages. While this would have left the court to discuss the third and fourth elements, in reality, only the fourth element was in contention. Put another way, the only issue was whether the pharmacy's "substandard" conduct was a legal cause of the injuries sustained.

In the Appeals Court analysis, legal causation is measured by how foreseeable the consequences of a particular conduct are. In this case, the Board of Pharmacy rule sets forth the parameters of the duty in question. As "minimum requirements," pharmacists are required to counsel on each of the following items:

1. The name and description of the medication;
2. The dosage form, dosage, route of administration, and duration of drug therapy;
3. Special directions and precautions for preparation, administration, and use by the patient;
4. Common, severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;
5. Techniques for self-monitoring drug therapy;
6. Proper storage;
7. Prescription refill information; and
8. Action to be taken in the event of a missed dose.5

The primary dispute here was whether the failure to perform the duties required under point 4 had anything to do with the problems allegedly suffered by the child. Despite the admitted fact that the pharmacist on duty undertook none of these minimum mandates, the pharmacy contended that there was nothing in the record to suggest it was dangerous or improper to fill the prescription as ordered for this patient. The allegation that selection of this drug for this patient was not a "prudent choice" did not, according to this court, render the pharmacy's misconduct as the legal cause of the damages incurred. In a glimmer of judicial clarity, the court stated:

While complications are foreseeable from taking any medication, it does not seem to be reasonably foreseeable that the rare harm suffered here would result from the failure to counsel a patient, which resulted in the dispensation of an apparently appropriate antibiotic. This is particularly so where [the pharmacy's] regulated duty was to inform the patient of "common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur." 6

In light of these findings, the court went on to state that it could not easily associate the pharmacy's failure to warn with the injuries incurred. The court determined that the Board of Pharmacy rule does not mandate warnings by pharmacists about "rare" or "remotely possible" side effects.

The court went on to analyze the "public policy" issues implicated by this ruling. The stated purpose of the counseling mandate is set forth in the Board's rule: "to improve therapeutic outcomes by maximizing proper use of prescription medications and devices."7 The mother argued that had she been counseled, she would have been alerted, and the pharmacist would have called the doctor, who would have realized his mistake and corrected the prescription to prescribe Omnicef.

Disagreeing, the court stated: "While we recognize that a jury could believe this scenario, it does not appear to us that the purposes underlying the regulated duty for pharmacy counseling encompass this factual scenario in which [the mother] would have been alerted to a possible error." It would appear that this court did not think the mother of the injured child would have acted any differently had she been told of these very uncommon adverse reactions to this medication. The judges noted that the mother had given this child the drugs in question on prior occasions and that she did not question their appropriateness at that time. Nor did she tell the pharmacist that any adverse consequences happened to the child in the prior exposures to the drugs. The judges concluded that the public policy embodied in the rule would not be enhanced by finding the pharmacy liable under these circumstances.

The bottom line was that without showing the foreseeability of the injuries suffered, without evidence that the injuries could easily be associated with this medication, and absent any public policy to the contrary, the mother of the child could not establish a proximate cause between the pharmacy's failure to warn and the injuries suffered by the child. Therefore, absent the causation element, the pharmacy could not be held liable.

Analysis
Before jumping to the conclusion based on this one case that pharmacists can escape liability even when we do not counsel as required by law, consider that there are a number of jurisdictions where the courts go the other way. For example, the Missouri Court of Appeals reversed a summary judgment of the trial court granted in favor of the defendant pharmacist where the lower court had ruled that the pharmacist's "only obligation was to fill (sic) the prescriptions accurately." The case involved a strong hypnotic drug prescribed at three times the normal dose. There, the court stated, "Pharmacists are trained to recognize proper dose and contraindications of prescriptions, and physicians and patients should welcome their insights to help make the dangers of drug therapy safer." Summary judgment was overruled, and the case was returned to the trial court for a decision on whether the pharmacist met his legal duty under the facts of the case.8

In another case, the Court of Appeals of Georgia ruled that a pharmacist has no duty to warn a patient or to refuse to dispense a medication in light of a potentially severe side effect arising from excessive dosage. Summary judgment entered for the defendant pharmacy was upheld on appeal. However, the court noted that the state had passed a mandatory counseling law that went into effect after the events giving rise to the litigation occurred. The court stated this holding "would not be controlling precedent for cases involving pharmacists' duties arising after 1/1/1993."9 The date mentioned was the day that the OBRA-90 statute mandating counseling for some federal prescription drug programs went into effect. That date was also when the Georgia law requiring pharmacy counseling became effective.

This court could have easily come out the other way. Here, the defendant admitted that a breach in the standard of care occurred. There are some jurisdictions where an admitted unlawful act gives rise to a presumption of liability.

So, what to think about this case? The outcome is good for those who oppose pharmacy liability, such as stockholders or investors, as an unnecessary and wasteful corporate expense. Just as surely, there are a number of pharmacists who will applaud the result reached here. Patient advocates will just as likely cry foul and declare the court as anticonsumer and protectional of business interests. Where then should practicing pharmacists come out on liability issues when this kind of situation occurs?

Counseling takes time and effort, factors that do not seem so pressing when there is a big backload of prescriptions to fill and long lines of people are waiting, or there are just not enough bodies available to get the prescriptions finished in a timely manner. Counseling can become very expensive. Paying a pharmacist to talk to patients does not result in larger profits, and the dispensing fees offered by many third-party payors does not increase when a pharmacist counsels. Counseling takes time away from the one part of dispensing that does pay: "counting and pouring and licking and sticking."

As practical as all of these considerations are, it seems very shortsighted to adopt policies or procedures whereby a pharmacist is forced to make a choice between counseling as required by law or just ignoring the law and fill the prescriptions as fast as possible. It is somewhat like the question embodied in the cliché: Do you want it done right or do you want it done right now?10

Part of the answer must come from pharmacists who will not compromise legal or ethical standards. We all know that communication with patients is the bedrock of the pharmacy practice. Cutting corners is not just illegal; it violates the ethic of protecting the patient from harm. How hard would it have been for the pharmacist to recognize that this was an unusual drug for a pediatric patient and make the call to the doctor's office? Letting the pharmacy skip on liability here is not as good for our profession as it might seem at first blush. Accepting responsibility when something goes wrong is part and parcel of being a professional.

References
1. McKee vs Wal-Mart Stores, Slip Op No 2006 1672 (La App 1 Cir, June 8, 2007); 2007 La App Lexis 1176.
2. Louisiana Administrative Code Title 46, Professional And Occupational Standards Part LIII, Pharmacists, Chapter 11, Pharmacies, § 1115, Patient Counseling.
3. Detraz v. Lee, 05-1263, p. 8 (La. 1/17/07), 950 So.2d 557
4. Citing Detraz, note 2 supra, 950.2d  at 562.
5. See note 2, supra, La. Admin Code 46: LIII.1115 Section D.
6. La Admin Code 46:LIII.1115D(4).
7. La Admin Code 46:LIII.1115A. It is interesting, though not directly relevant, that the rule was modified to take effect after the situations giving rise to this litigation. The January 1, 2004 version simplistically states that the purpose of patient counseling is "to ensure proper use of drugs and devices." See also La. R.S. 37:1164(31).
8. Horner v. Spalitto , 1 S.W.3d 519 (Mo App 1999).
9. Walker v. Jack Eckerd Corp, 434 S.E.2d 63 (Ga App 1993).
10. See: www.goodproductmanager.com/ 2006/12/22/the-difference-between-right-and-right-now for an article on being a good product manager. Accessed August 21, 2007.

To comment on this article, contact editor@uspharmacist.com.