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Oakey v. May Maple Pharmacy, Inc.

Court of Appeals of New Mexico

April 13, 2017

KATHLEEN M. OAKEY, Personal Representative of the Estate of TAWANA LUCERO, deceased, Plaintiff-Appellant,
v.
MAY MAPLE PHARMACY, INC., Defendant-Appellee.

         APPEAL FROM THE DISTRICT COURT OF BERNALILLO COUNTY C. Shannon Bacon, District Judge.

          Fine Law Firm Mark Fine Albuquerque, NM Fuqua Law & Policy, P.C. Scott Fuqua Santa Fe, NM for Appellant

          Hatcher Law Group, P.A. Scott P. Hatcher Mark A. Cox Santa Fe, NM for Appellee

          OPINION

          LINDA M. VANZI, Chief Judge.

         {1} This appeal arises from a lawsuit brought by the personal representative of the estate of Tawana Lucero, who died at the age of nineteen from an overdose of physician-prescribed medications, including opioids classified under federal and state law as Schedule II controlled substances because of their high potential for abuse and addiction. As relevant here, the personal representative (Plaintiff) asserts claims of negligence and negligence per se against May Maple Pharmacy, Inc. (the Pharmacy). The Pharmacy moved for summary judgment, contending that it was entitled to judgment as a matter of law because "a pharmacist's standard of care is to dispense appropriately prescribed medications to a patient in accordance with a proper medical doctor's prescription[, ]" and the Pharmacy met that standard in filling the prescriptions at issue. The district court entered an order granting the motion, dismissing all claims against the Pharmacy with prejudice, and awarding costs to the Pharmacy. We reverse.

         FACTUAL BACKGROUND

         {2} The record reveals the following undisputed facts. On December 1, 2009, Lucero died from multiple drug toxicity. The autopsy report identified the drugs in her system as Oxycodone, Oxymorphone, and Alprazolam. At the time of her death, Lucero's Oxycodone levels were 980 ng/mL; her Oxymorphone[1] levels were 26 ng/mL; and her Alprazolam levels were 95 ng/mL.[2]

         {3} As described in the toxicology report, Oxycodone is a "semi-synthetic narcotic analgesic" used to control pain. It has an "addiction liability" similar to that of morphine and should be administered in the smallest dose possible and as infrequently as possible; the usual adult dose is 5 mg every six hours. Oxycontin is an extended-release form of Oxycodone. It can cause adverse reactions, including death, at concentrations well less than 1000 ng/mL, especially when taken in combination with other central nervous system (CNS) depressants. Opioids have a high potential for abuse and addiction and are classified as Schedule II controlled substances under federal and state law. 21 U.S.C. § 812(b)(2), (Schedule II)(a)(1) (2012); 21 C.F.R. § 1308.12(b)(1); NMSA 1978, § 30-31-5(B) (1972); NMSA 1978, § 30-31-7(A)(1)(a), (A)(2)(p) (2007); 16.19.20.66(A)(1)(n) NMAC. Alprazolam is a benzodiazepine with CNS depressant effects used to manage anxiety and related disorders. The recommended dosage is 0.8 to 4 mg for anxiety, and 6 to 9 mg for phobic and panic disorders. When used in conjunction with other CNS depressants, Alprazolam can be toxic even at low concentrations. Alprazolam has a lower potential for abuse than Oxycodone and is classified as a Schedule IV controlled substance. 21 C.F.R. § 1308.14(c)(2) (2015); § 30-31-5(D); 16.19.20.68(A)(2) NMAC.

         {4} Dr. John Tyson of Doctor On Call, LLC, a medical clinic focusing on pain management, wrote prescriptions for Oxycodone, Oxycontin, and Alprazolam to treat Lucero's pain and anxiety, which the Pharmacy dispensed to Lucero from May 28, 2009 through November 16, 2009. Oxycodone was prescribed in 5 mg dosages, and Oxycontin was prescribed in dosages between 20 mg and 80 mg. The Pharmacy sometimes dispensed medication to Lucero "early, " i.e., prior to the time the previously prescribed amount should have lasted if taken as directed.

         {5} The Pharmacy does not dispute Plaintiff's interpretation of the record as showing that the Pharmacy filled Oxycontin prescriptions for Lucero between two and twenty-three days "early" on at least seven occasions between May 28, 2009 and September 21, 2009. At least some of these prescriptions contained the words "OK to fill early" or a similar indication that the prescription could be filled "early." On a few occasions, Lucero paid a substantial amount of cash to purchase Oxycontin from the Pharmacy, and at least once paid $1, 107 for 90 Oxycontin 80 mg pills in September 2009. An October 2009 "addendum" note by Doctor on Call's Dr. Maron with the subject "Rx FRAUD?" indicates receipt of a call from an unidentified pharmacist reporting that Lucero had "presented to pharmacy for early refill" and had offered to pay over $1000 cash, despite that she would have received the medication free via Medicaid three days later.

         PROCEDURAL BACKGROUND

         {6} Plaintiff initially sued Dr. Tyson and Doctor On Call, asserting claims for malpractice, negligence, and wrongful death (among others), based on allegations that Dr. Tyson had prescribed excessive amounts of dangerous medications to Lucero. A subsequent amended complaint also asserted claims against the Pharmacy, as follows: (1) negligence, based on allegations that the Pharmacy breached its "duty of care to apply the knowledge ordinarily used by reasonably well-qualified pharmacists" by dispensing "excessive quantities of Schedule II or other dangerous drugs" to Lucero; and (2) negligence per se, based on allegations that the Pharmacy, by dispensing "excessive quantities of medications" to Lucero "departed from the standard of care, knowledge, and skill of a reasonably trained pharmacist" and breached regulatory duties to "properly and reasonably dispense controlled medications" mandated by 16.19.20.41(A) NMAC and 16.19.4.16 NMAC.

         {7} The Pharmacy moved for summary judgment, dismissal with prejudice, and costs, based on the argument that "[a] pharmacist who accurately fills prescription medication as prescribed by the doctor has no liability exposure to one who is injured by the drugs on claims the amounts were excessive, unless the pharmacist has some reason to know the specific customer will be harmed[, ]" and that the Pharmacy "accurately dispensed what . . . Lucero's doctors prescribed and otherwise met all applicable standards of care." The Pharmacy's motion discussed no standard other than its proffered clerical accuracy standard, for which it relied on case law from other jurisdictions. The motion made no mention of any statutes or regulations applicable to pharmacy practice or controlled substances and no argument concerning Plaintiff's claim of negligence per se, nor did the Pharmacy's reply brief, [3] although Plaintiff addressed these points in opposing the motion. Plaintiff argued that genuine issues of material fact precluded summary judgment because the parties' experts gave contrary opinions concerning the conduct required of a retail pharmacist in these circumstances, pursuant to statutes, regulations, and public policy, and whether the Pharmacy's conduct deviated from the standard of care.

         {8} The parties' expert affidavits reflect differing opinions concerning the standard of care for retail pharmacists dispensing Schedule II drugs and whether the Pharmacy's conduct met that standard. The Pharmacy's expert, Dr. Matthew C. Lee, stated that "[t]he appropriate standard of care for a retail pharmacist is that he or she has a duty to dispense appropriately prescribed medications to a patient" and that if the pharmacist "does not dispense medication in accordance with the medical doctor's prescription, that pharmacist risks interfering with the doctor/patient relationship and may be inappropriately practicing medicine without a license." According to Dr. Lee, there were instances in this case "where the customer presented with an early refill" but Dr. Tyson had approved "those early refills for reasons medically indicated by the doctor[, ]" and physician-approved "early refills" are valid and should be filled by the pharmacist.

         {9} Dr. Lee stated that, "[i]f the retail pharmacist does find discrepancies in either the prescriptions ordered or in fact has evidence of drug abuse, the pharmacist should call the prescribing physician to ensure that the prescriptions presented are in fact what the physician intended to order[, ]" noting but not identifying "certain indications in the record" that the Pharmacy "did consult with personnel at Doctor[]on[]Call[.]" Dr. Lee added,

[T]here is nothing unusual or inappropriate about either the level or amount of narcotic medication prescribed which should have led any retail pharmacist to question or refuse to dispense the prescription. Although the dosages are considered high, specifically for Oxycontin, there is nothing unusual in this dosage level as prescribed for patients with chronic pain. In other words, all prescriptions of Dr. Tyson and filled at the May Maple Pharmacy are valid and legitimate.

         {10} Dr. Lee's affidavit did not explain the basis for his opinions or identify any source materials supporting them, other than his background in pharmacy and his review of certain case documents, including prescriptions, medical records, and deposition transcripts of the medical examiner and a state police officer. Although he cited no authorities-legal or professional-Dr. Lee said he "found no violation of any federal or New Mexico statutory or regulatory requirements dealing with the practice of pharmacy[, ]" and concluded without further explanation that the Pharmacy "accurately filled all prescriptions according to the terms and instructions written by Dr. Tyson" and "met all applicable standards of care which apply to the practice of retail pharmacy."

         {11} Plaintiff's expert, Dr. James T. O'Donnell, relied on his background in pharmacy and review of record materials but also on his review of other materials, including the Standards of Practice for the Profession of Pharmacy, the New Mexico Pharmacy Practice Act, provisions of the federal Controlled Substances Act, and materials addressing the responsibilities of pharmacists under the Controlled Substances Act. Dr. O'Donnell disagreed with Dr. Lee's opinions that the prescriptions at issue were facially valid and that the standard of care for retail pharmacists required nothing more of the Pharmacy in these circumstances than that it accurately fill facially valid prescriptions. He said that prescriptions indicating "OK to fill early" were illegal and could not be filled "no matter what the prescriber has written on the prescription" because they were for Schedule II controlled substances, which cannot be "refilled"[5] or authorized as "OK to fill early." According to Dr. O'Donnell, a pharmacist faced with an "early" request to fill a prescription for a Schedule II controlled substance "has a duty to inquire [of] the patient why, and then speak to the physician and get authorization from the physician."

         {12} Dr. O'Donnell said that such "early" requests are "evidence of excessive use of the [c]ontrolled [s]ubstance, in excess of the prescribed dose." Excess use "places the patient at risk ([of] death or serious injury), increases abuse, dependence, and addiction, and may be evidence of diversion." A pattern of such "early" requests "is highly suspicious of abuse and[/]or diversion, and would preclude the pharmacist" from filling the prescriptions; to do otherwise would violate requirements of "[g]ood [f]aith, [r]easonable [j]udgment, and [c]orresponding [r]esponsibility" imposed by federal and state law. According to Dr. O'Donnell, provisions of the federal Controlled Substances Act, the New Mexico Pharmacy Act, and their respective implementing regulations "require the pharmacist to consider issues beyond the face legality of the prescription" such as abuse, diversion, and whether the prescription is for a legitimate medical need. He concluded that the Pharmacy breached the "[s]tandard of [c]are of the [p]rofession of [p]harmacy" and violated the New Mexico Pharmacy Practice Act, NMSA 1978, § 61-11-1 (1997); 16.19.20.41 NMAC; and the federal and state Controlled Substances Acts, 21 U.S.C. § 829 (2016); 21 C.F.R. § 1306.04(a) (2017); and NMSA 1978, § 30-31-1 (2005).

         {13} At the motion hearing, the district court responded to Plaintiff's observation that no New Mexico case prescribes a standard of care for pharmacists in this circumstance by stating that "there is a standard. It's called the reasonably prudent pharmacist." The court focused heavily on Dr. O'Donnell's opinion that prescriptions indicating "OK to fill early" were illegal because they were for Schedule II controlled substances, which cannot be "refilled" or authorized as "OK to fill early, " inquiring what law supports that opinion, and stating that Dr. O'Donnell's affidavit "needed to be clear on its face" but fell "woefully short" and did not "set forth a standard of care." In the district court's view, "Dr. O'Donnell needed to take on Dr. Lee in order to create that genuine issue of material fact" and failed to do so.

         {14} The district court entered an order dismissing the Pharmacy from the lawsuit and awarding costs to the Pharmacy, stating without further elaboration that there were no issues of material fact and that the Pharmacy was entitled to summary judgment as a matter of law. This appeal followed.

         STANDARD OF REVIEW

         {15} Summary judgment is appropriate where "there is no genuine issue as to any material fact and the moving party is entitled to a judgment as a matter of law." Rule 1-056(C) NMRA. "An issue of fact is 'material' if the existence (or non-existence) of the fact is of consequence under the substantive rules of law governing the parties' dispute." Martin v. Franklin Capital Corp., 2008-NMCA-152, ¶ 6, 145 N.M. 179, 195 P.3d 24. The motion must present "such evidence as is sufficient in law to raise a presumption of fact or establish the fact in question unless rebutted." Romero v. Philip Morris Inc., 2010-NMSC-035, ¶ 10, 148 N.M. 713, 242 P.3d 280 (internal quotation marks and citation omitted). If it does, the opposing party "must adduce evidence to justify a trial on the issues." Id. (internal quotation marks and citation omitted). Nevertheless, "[t]he mere fact that the non-moving party has failed to contravene the assertions of the material supporting a motion for summary judgment does not mean that the moving party is entitled to judgment. The moving party may not be entitled to judgment even if the non-moving party totally fails to respond to the motion." Brown, 1995-NMSC-050, ¶ 8. This is because "the non-moving party is not required to make any showing with regard to factual issues" unless "the moving party has made a prima facie case that it is entitled to summary judgment[.]" Id. (internal ...


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