Kowalski v. Rose Drugs of Dardanelle, Inc.

ROBERT L. BROWN, Justice,

dissenting.

The majority holds today that pharmacists owe no duty to their customers to warn them of fatal prescriptions. The only duty owed, concludes the majority, is to act as robots in all situations and to properly fill and label prescriptions. This conclusion is totally at odds with the Regulations of the Arkansas Board of Pharmacy and does a disservice to the pharmaceutical profession in general by failing to recognize the high standards observed within the profession itself. Specifically, it belies the fact that pharmacists, on occasion, should consult with prescribing physicians about seemingly errant prescriptions and should counsel their customers about obvious drug interactions and contraindications. Surprisingly, the majority’s discussion acknowledges no circumstances, such as lethal prescriptions or deleterious drug interactions, where a pharmacist should raise questions and consult with the prescribing physician and the customer. That goes way too far in my judgment in nullifying any duty on the part of the pharmacist. For these reasons, I dissent.

I. The Issue

kiFour days before his death, Kevin Allen Curry was prescribed heavy dosages of Oxycodone, Methadone, Diazepam, Trazo-done, Orphenadrine, and Lunesta by Dr. Randeep Mann of Russellville. Several of these drugs were central nervous system depressants, and Methadone was a controlled substance. Curry filled these prescriptions at Rose Drugs in Dardanelle as a first-time patient. He died two days later of mixed drug intoxication combined with alcohol.

Virginia Kowalski, as special administra-trix of Curry’s estate, filed this wrongful-death action against Dr. Mann1 and Rose Drugs and contended that Rose Drugs was negligent in causing Curry’s death by (1) failing to warn Curry of the dangers and adverse effects of this combination of drugs; (2) failing to warn Dr. Mann of the dangerous drug interactions between the combination of drugs prescribed; and (3) failing to check the various prescriptions for drug interactions and contraindications. Rose Drugs moved for summary judgment and urged that Rose Drugs did not owe a duty to warn Curry regarding the risks that might be associated with his prescription medications or to refuse to fill his prescriptions. The only duty owed Curry, according to Rose Drugs, was to fill the prescriptions according to the directions of the physician, Dr. Mann.

The circuit court’s order granting summary judgment concluded that Rose Drugs had no legal duty to reject the prescriptions that were prescribed by Dr. Mann and had no legal l^duty to warn Curry of the risks associated with those prescriptions. The court said: “there are no genuine issues as to any material fact that Rose Drugs complied with the duty announced in [Kohl v. American Home Products Corp., 78 F.Supp.2d 885 (W.D.Ark.1999) ], which was to fill the prescriptions as prescribed and properly label those prescriptions.”

Hence, the issue before this court on appeal is whether a pharmacist ever has a duty to consult with the physician or warn a customer regarding a suspect prescription. The majority thinks not. I could not disagree more.

II. Legal Duty of Care in Arkansas

Arkansas statutory law makes it clear that pharmacists owe a duty of ordinary care and diligence to their customers. For example, the Pharmacy Code defines “pharmacy care” as “the process by which a pharmacist in consultation with the prescribing practitioner identifies, resolves, and prevents potential and actual drug-related problems and optimizes patient therapy outcomes through the responsible provision of drug therapy or disease state management.” Ark.Code Ann. § 17-92-101(13) (Supp.2009) (emphasis added).

The practice of pharmacy is further defined in section 17-92-101(16)(A) as the learned profession of:

(v) Interpreting 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;
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(viii) Advising and providing information concerning utilization of drugs and devices and participation in drug utilization reviews;
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(x) Providing pharmacy care....

hArk. Code Ann. § 17-92-101(16)(A) (Supp.2009) (emphasis added).

The Arkansas Medical Malpractice Act acknowledges that a pharmacist is a “medical care provider.” Ark.Code Ann. § 16-114-201(2) (1987). And, finally, the federal district court in Kohl predicted that ultimately Arkansas, when faced with the issue of whether pharmacists owe a duty of care to their customers, “would hold that a pharmacy has a legal duty to exercise due care and diligence in the performance of its professional duties,” based on these Arkansas statutes. Id. at 892. In short, there is no disagreement, except perhaps from the majority, that pharmacists owe a general duty of ordinary care to their customers. The question is whether this duty of care extends to consulting with the prescribing physician and warning customers when hazardous and dangerous situations surrounding a prescription arise.

III. Exceptions to the General Rule

The rationale advanced by Rose Drugs and adopted by the majority for no duty to warn is that the physician acts as the “informed intermediary” in the chain of distribution of the drugs between the manufacturer and the patient, preempting any discretion on the part of the pharmacist. See Kohl v. Am. Home Prods. Corp., supra. This is the general rule adopted by a majority of jurisdictions, says the majority, but the rule is not absolute, as the majority would have us believe. For example, in the case relied on heavily by the majority, Kohl v. American Home Products Corp., supra, the federal district judge said: “However, we do not believe this duty encompasses 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.” 78 F.Supp.2d at 892 (emphasis added). Thus, an exception is created in Kohl. Certainly, in the instant case, the presence of contraindicating drugs is argued as a cause of Curry’s death.

In several of the cases cited by the majority from other jurisdictions, exceptions are noted to the general rule. See Cottam v. CVS Pharmacy, 436 Mass. 316, 764 N.E.2d 814 (2002) (court expressly did not rule on the situation where pharmacist has specific knowledge of increased danger to customer); Moore v. Mem’l Hosp. of Gulfport, 825 So.2d 658 (Miss.2002) (recognizing that there are exceptions to the learned-intermediary doctrine, as applied to pharmacists, where it was undisputed that the plaintiff had informed the pharmacy of health problems which contraindicated the use of the drug in question or where the pharmacist filled prescriptions in quantities inconsistent with the recommended dosage guidelines); McKee v. Am. Home Prods. Corp., 113 Wash.2d 701, 782 P.2d 1045 (1989) (court noted that under certain circumstances where there is a patent error on the prescription such as an obvious lethal dose, inadequacy of the instructions, known contraindication, or incompatible prescriptions, the pharmacist should take corrective measures); Morgan v. Wal-Mart Stores, Inc., 30 S.W.3d 455 (Tex.App.2000) (recognizing that the courts that have held that pharmacists owe their customers a duty beyond accurately filing prescriptions do so based on the presence of additional factors, such as known contraindications, that would alert a reasonably prudent pharmacist to a potential problem and not disputing that a pharmacist may be held liable for negligently filling a prescription in such situations).

^Furthermore, several jurisdictions have explicitly held that in certain circumstances, a duty to warn exists. See, e.g., Riff v. Morgan Pharmacy, 353 Pa.Super. 21, 508 A.2d 1247, 1252 (1986) (holding that the pharmacy had a legal duty to exercise due care and diligence, and that the pharmacy breached this duty “by failing to warn the patient or notify the prescribing physician of the obvious inadequacies appearing on the face of the prescription which created a substantial risk of serious harm to the plaintiff’); Homer v. Spalitto, 1 S.W.3d 519, 522 (Mo.Ct.App.1999) (where the pharmacist filled a central nervous system depressant along with a high dosage of a hypnotic drug known to interact with the depressant, the Missouri court reversed summary judgment finding that while in some cases the pharmacist’s only duty may be to fill a prescription accurately, “in other eases, a pharmacist’s education and expertise will require that he or she do more to help protect their patrons from risks which pharmacists can reasonably foresee”).

IV. Standard of Care

Several states have endorsed a standard of care for pharmacists that, under certain circumstances, includes a duty to warn. For example, in Dooley v. Everett, 805 S.W.2d 380 (Tenn.Ct.App.1990), the Tennessee Court of Appeals was presented with the question of whether a pharmacist had a duty to warn a customer of the potential interaction between two different prescription drugs which were prescribed for asthma. The Dooley court concluded that “the pharmacist has a duty to act with due, ordinary, care and diligence in compounding and selling drugs.” Id. at 384. Moreover, the court recognized that the plaintiff had presented Inexpert testimony that the pharmacist breached the duty owed his customer by failing to warn the customer or the prescribing physician of the potential drug interactions. And while the question of whether a duty is owed is a question of law to be decided by the court, the Dooley court held that the scope of the duty and whether the standard of care had been breached due to the drug interaction and combined prescriptions of the two drugs was a question to be decided by the trier of fact. For these reasons, summary judgment was not appropriate.

Also, in Lasley v. Shrake’s Country Club Pharmacy, Inc., 179 Ariz. 583, 880 P.2d 1129 (Ariz.Ct.App.1994), the Arizona Court of Appeals initially recognized that a pharmacy owed the customer a duty of reasonable care and then stated that the next question was whether the pharmacy breached the standard of care established because of that duty. The customer had introduced affidavits from experts averring that the applicable standard of care for pharmacists included a responsibility to advise customers of the addictive nature of the drug, to warn of the hazards of ingesting two drugs that adversely interact with one another, and to discuss the addictive nature and long-term effects of the drug with the customer. The court, citing Dooley, concluded that whether the pharmacy failed to warn the patient, and thus breached its duty of reasonable care, presented a question for the jury.

V. Arkansas Standard of Care— Board Regulations

The Arkansas State Board of Pharmacy has adopted a comprehensive regulation on patient care and patient counseling for pharmacists. See Regulation 9 — Pharmaceutical Care/Patient Counseling (2004). This regulation requires the pharmacist to evaluate | ^prescriptions and engage in “effective communication” with the customer concerning the dosage, times of administration, significant side effects, and other questions that the patient might have. Regulation 09 — 00—0001(a)—(d). Regulation 09-00-0001(e) also requires the pharmacy to “maintain a computer program which will identify significant drug interactions.

... The pharmacist will be responsible for counseling the patient on these interactions with verbal and, where appropriate, ■written information.” Regulation 09-00-0001(b)(4) further states that “the ultimate decision to use the medication or not use the medication rests with the physician who has more complete patient information.” However, “[i]t is the pharmacist’s responsibility to monitor the patient’s medication therapy in the areas addressed in this regulation and to inform the physician of a suspected problem.” Id.

It is absolutely clear that Regulation 9 provides a duty as pharmacists to alert physicians to potentially lethal drug combinations and drug contraindications and to counsel and warn customers of the risk. As already noted, the Pharmacy Code defines “pharmacy care” as “the process by which a pharmacist in consultation with the prescribing practitioner identifies, resolves, and prevents potential and actual drug-related problems and optimizes patient therapy outcomes through the responsible provision of drug therapy or disease state management.” Ark.Code Ann. § 17-92-101(13) (Supp.2009) (emphasis added). Regulation 9 of the Pharmacy Board Regulations clearly requires meaningful counseling with the customer about drug dosages and significant side effects. Thus, our own statutes and Board regulations define the role of pharmacists as more than mere order fillers and specifically provide that pharmacists should laswork with physicians to identify, resolve, and prevent potential and actual drug-related problems and also counsel with their customers about the dosages and side effects.

In sum, Arkansas statutes and regulations go in the opposite direction from the majority which seeks to limit a pharmacist’s duty to only properly filling and labeling prescriptions. Regulation 9, in particular, provides the standard of care pharmacists must provide to their customers and imposes in certain situations a duty to warn the customer and alert the prescribing physician of a serious, potentially lethal problem. The question next becomes whether there is proof that the standard was breached in the instant case.

VI. Expert Testimony

In the deposition of Dr. Michael Horseman, Kowalski’s expert and a pharmacist from Corpus Christi, Texas, he testified that the number of prescriptions of central nervous system depressants in the instant case and the combined large dosages more likely than not caused Curry’s death. He further testified that under the standard of care for Dardanelle, it would be inappropriate to fill large dosages of controlled substances and central nervous system depressants together. Dr. Horseman emphasized that Curry was a first-time customer and added that in this situation, the standard of care required the pharmacist at Rose Drugs to question Curry about whether he had taken these drugs before and whether he was aware that these drugs in combination are particularly dangerous drugs.

Dr. Horseman added that the pharmacist should have recognized the fact that there was a contraindication in filling these combined prescriptions and should have called Dr. Randeep |MMann to confirm what was prescribed and the combination in which they were prescribed. If Dr. Mann confirmed the prescriptions, then the pharmacist at Rose Drugs had a choice of either filling them or not filling them. If he felt it was appropriate to fill them, then the pharmacist should have given both handwritten material and verbal counseling to Curry. Dr. Horseman elaborated that even if (1) the pharmacist had called Dr. Mann; (2) Dr. Mann had confirmed orally that the prescriptions were what he intended; and (3) the pharmacist had counseled Curry about the drugs, he still believed the pharmacist failed to comply with the standard of care because he had the obligation to refuse to fill the prescription unless the physician could provide documentation that the prescription was appropriate. Dr. Horseman added that the required computer system, which alerts a pharmacist to potential drug interactions, should have “red flagged” the pharmacist about the interactions involved with the multiple prescriptions.

Dr. Howell Foster, an associate professor of pharmacy at the University of Arkansas for Medical Sciences and Rose Drugs’s expert, agreed that the standard of care in Arkansas requires pharmacists to follow regulations governing pharmacists, including Regulation 9 of the Arkansas State Board of Pharmacy. Dr. Foster further agreed that a pharmacist has discretion to fill or not to fill a prescription.

Dr. Harvey Ham, a pharmacist at Rose Drugs who worked the day that Curry’s prescriptions were filled, testified that he did not remember filling Curry’s prescriptions. He did say that Rose Drugs has a computer program that flags interactions, contraindications, and |onother problems with regard to prescriptions. He opined that Pharmacy Board regulations did allow pharmacists to refuse to fill prescriptions on certain occasions and that this had been done on occasion at Rose Drugs. He had no recollection of seeing Curry or filling Dr. Mann’s prescriptions or knowing of any warning of drug interaction from the computer.

Dr. Lee Roy Parker, the other pharmacist working at Rose Drugs when Curry filled his prescriptions, testified that he counseled Curry for about five minutes about whether he was familiar with the medications since they were potent and advised Curry not to take the prescriptions with other medications or alcohol. He acknowledged that he had the authority to refuse to fill prescriptions. He did not recall any conversation with Dr. Mann on that day. Was Dr. Parker’s conversation a sufficient warning under Regulation 9? Dr. Horseman says no. The majority says no warning was required in any event because the practice of pharmacy carries with it no such duty under any circumstances.

. VII. Conclusion

The majority opinion fails to recognize that, far from being a robot, the pharmacist is a critical link in the prescription chain who owes a duty of due care to customers. Moreover, Pharmacy Board regulations fix a standard of care to be followed by our pharmacists, which include consulting with physicians and warning customers concerning perceived drug problems in certain circumstances. "Whether the standard of care set out in these regulations was breached under these circumstances is a material question of fact that should be left up to .the trier of fact to decide. Certainly, there was ample proof submitted to the court that the [ si standard of care was breached in this case. Summary judgment obviously was inappropriate, and this case cries out for reversal. I respectfully dissent.

. Appellee Dr. Randeep Mann remains a defendant in this cause of action after the circuit court granted summary judgment in favor of Rose Drags. The jury trial against Dr. Mann was continued pending the outcome of this appeal.