Abrams v. ButeAbrams v. Bute
OPINION OF THE COURT
This аppeal and cross appeal require consideration of the duty owed by a pharmacist in filling a prescription issued by a
I. Factual and Procedural Background
On October 17, 2007, the defendant Dr. Brad Bute performed hemorrhoid surgery on the plaintiff’s decedent at North Shore Plainview Hospital. While the decedent was in the hospital, hospital staff administered medications to him, including about six milligrams of hydromorphone, a nаrcotic drug used to treat pain. After the surgery, Dr. Bute wrote the decedent a prescription for hydromorphone. The decedent was instructed to ingest up to eight milligrams of hydromorphone every three to four hours as needed for pain.
The decedent was driven home from the hospital by the plaintiff, his wife. She then filled the decedent’s hydromorphone prescription at a CVS pharmacy located in Hicksville, New York. The plaintiff testified that when she returned home, she gave the decedent a dosage of eight milligrams of hydromorphone. About an hour later, the plaintiff found the decedent “gasping for air.” The plaintiff called for an ambulance, but the decedent died shortly before it arrived. An autopsy report prepared at the request of the plaintiff indicated that the decedent died as a result of acute hydromorphone intoxication.
The plaintiff commenced this action to recover damages for, inter alia, personal injuries. The complaint alleged, among other things, that Dr. Bute was negligent in prescribing eight-milligram doses of hydromorphone to the decedent, since an eight-milligram dose of hydromorphone is dangerous for an opioid-naive patient, such as the decedent, who had not previously been exposed to that narcotic. The complaint further al
The complaint also asserted that the defendants CVS Pharmacy, CVS Albany, LLC, and the individual pharmacist that filled the prescription (hereinafter collectively the CVS defendants) were liable for the decedent’s death. In this regard, the complaint alleged that the dosage of hydromorphone prescribed by Dr. Bute was so high that the CVS defendants had a duty to take steps to confirm that the prescription was appropriate for the decedent under the circumstances.
The CVS defendants moved for summary judgment dismissing the complaint insofar as asserted against them, arguing, inter alia, that they did not breach any duty of care owed to the decedent in filling his prescription. The plaintiff opposed the motion and cross-moved for summary judgment on the issue of liability. Both sides submitted expert evidence in support of their respective positions.
The Supreme Court denied both the motion and the cross motion. The court concluded that there were material issues of fact as to whether the CVS defendants breached a duty owed to the decedent. The CVS defendants appealed and the plaintiff cross-appealed from the order.
On appeal, the CVS defendants contend that they had no duty to warn the deсedent of the dangers of taking the prescribed dosage of hydromorphone or to otherwise take any steps to ensure that the prescription was appropriate for the decedent under the circumstances. The plaintiff contends that the expert evidence that she submitted in support of her cross motion demonstrated that the CVS defendants departed from the appropriate standard of care and that the CVS defendants failed to rebut her showing.
II. Discussion
“A tort obligation is a duty imposed by law to avoid causing injury to others”
(New York Univ. v Continental Ins. Co., 87
NY2d 308, 316 [1995]). “A defendant stands liable in negligence only for breach of a duty of care owed to the plaintiff”
(Sanchez v State of New York,
“The existence and scope of an alleged tortfeasor’s duty is, in the first instance, a legal question for determination by the court”
(Di Ponzio v Riordan,
In this case, the plaintiff alleged that the CVS defendants filled and dispensed the hydromorphone prescription that had been issued by Dr. Bute. In undertaking to perform these tasks for the benefit of the decedent, the CVS defendants entered into a relationship with him. Given the existence of such a relationship, there is little difficulty in concluding that the CVS defendants owed him a duty of care in filling and dispensing the hydromorphone prescription
(see Willson v Faxon, Williams & Faxon,
The CVS defendants nevertheless argue that the scope of this duty, as a matter of law, did not include any obligation to warn the decedent of the dangers of taking the prescribed dosage of hydromorphone or to take any steps to confirm that the prescription was not issued in error. The CVS defendants contend that the prescribing physician is solely responsible for determining whether the prescription is appropriate for any particular patient and that requiring a pharmacist to verify the appropriateness of a prescription would undermine the physician-patient relationship and intrude into the exclusive professional sphere of the treating physician.
“In negligence cases, once a duty is found, the duty, in theory at least, always requires the same [general] standard of conduct, that of a reasonable person under the same or similar circumstances” (Prosser & Keeton, Torts § 37 [4] at 236 [5th ed];
see generally
1A NY PJI3d 2:10 at 219 [2015]). Accordingly, in order to determine whether liability exists, “the jury must compare the defendant’s conduct to that of a reasonable person under like circumstances”
(Reis v Volvo Cars of N. Am.,
However, the Court of Appeals has recognized a “subtle” distinction between this general “reasonable-person standard” and the standard to be applied when a defendant has special training or experience in a trade or profession and is engaged in that capacity
(see Reis v Volvo Cars of N. Am.,
Accordingly, where an individual is alleged to have committed professional negligence, a jury must compare the defendant’s conduct to the degree of skill and care used by others in the community who practice in the same field
(see Reis v Volvo Cars of N. Am.,
Here, the CVS defendants are alleged to have been engaged in the practice of pharmacology. The existence of pharmacists as a distinct professional class has been traced back to ancient Egypt and Babylonia, where “a class of preparers of medicines existed separate from those who prescribed and administered drugs” (David B. Brushwood, The Pharmacist’s Duty to Warn: Toward a Knowledge-Based Model of Professional Responsibility, 40 Drake L Rev 1, 5 n 16 [1991]). Howеver, the specific role played by pharmacists in the distribution of prescription medication has fluctuated in response to changing conditions within the pharmaceutical industry (see id. at 16).
For example, “[t]he ‘apothecary’ of colonial and frontier Aanerica usually functioned as both pharmacist and physician” {id. at 16 n 70). This role shifted “as medicinal preparations became more complex, and as the expertise to prepare them became more difficult to acquire” {id.). In response to this increasing complexity, retail “ ‘druggists’ ” emerged, who specialized in compounding prescription drugs and preparing medication for the public’s consumption {id.). “Following World War II, large pharmaceutical manufacturers assumed the responsibility for formulating and producing drug products,- and the emphasis in pharmacy practice switched from compounding, to the dispensing of already compounded products” {id. at 16 n 71).
In modern times, the means of distributing prescription medication to the public generally involves three principal actors: the manufacturer, the prescribing physician, and the pharmacist
(see generally McKee v American Home Prods. Corp.,
113 Wash 2d 701, 708-712,
The rules governing the liability of those engaged in the manufacture of prescription drugs are distinguishable from those governing the manufacture of other consumer products
(see Cooley v Carter-Wallace Inc.,
The Court of Appeals has thus recognized that “[although a prescription drug is by its nature an inherently unsafe product and would in the usual case impute strict liability to its manufacturer, a defense is provided against such liability when the drug is properly prepared, and accompanied by proper directions and warning”
(Martin v Hacker,
The responsibility of providing information about the potential hazards of a prescription drug “properly falls most heavily on the manufacturer who stands in the best position to recognize and cure defects”
(Baker v St Agnes Hosp.,
However, under the “learned intermediary doctrine” — first enunciated by the Court of Appeals in
Martin v Hacker
(
The pharmacist’s traditional role in this system of distribution is to accurately fill the prescription in accordance with the instructions provided by the prescribing physician
(see generally
Kimberly A. Burns & Alan R. Spies, A
Pharmacist’s Duty to Warn: Promoting the Acceptance of a Consistent Legal and Professional Standard,
47 Duq L Rev 1, 3 [Winter 2009]; R. Paul Asbury, Comment,
Pharmacist Liability: The Doors of Litigation Are Opening,
40 Santa Clara L Rev 907, 910 [2000]). This requirement of technical accuracy obligates a pharmacist tо ensure that “patients receive the correct drug, in the correct dosage, with the correct directions” (David B. Brushwood,
The Professional Capabilities and Legal Responsibilities of Pharma
The need for technical accuracy in filling and dispensing a prescription drug is another product of the inherently dangerous nature of prescription medicine. Indeed, “[p]eople trust not merely their health but their lives to the knowledge, care and prudence of druggists, and in many cases a slight want of care is liable to prove fatal to some one”
(Brown v Marshall,
The view has been expressed that “[a]n unforgiving, ‘no mistakes allowed’ approach to pharmacy law reflects the technical and nonjudgmental nature of the pharmacist’s traditional role and recognizes that an honest error in judgment cannot occur when a pharmacist does not use judgment” (David B. Brushwood, The Professional Capabilities and Legal Responsibilities of Pharmaсists: Should “Can” Imply “Ought”?, 44 Drake L Rev at 444).
This view reinforces the notion that it is the prescribing physician who is responsible for exercising the professional judgment needed to determine whether a particular course of treatment is appropriate for a given patient. Courts have been reluctant to impose a standard of care on pharmacists that would go beyond the need to accurately fill a prescription and require pharmacists to exercise their own professional judgment in a manner that could conflict with that of the prescribing physician
(see e.g. McKee v American Home Prods. Corp.,
113 Wash 2d at 711-716,
The view that a pharmacist does not exercise any professional judgment has been criticized by courts and commentators alike, who have rejected the contention that “a pharmacy is no more than a warehouse for drugs and that a pharmacist has no more responsibility than a shipping clerk who must dutifully and
unquestioningly
obey the written orders of omniscient physicians”
(Riff v Morgan Pharm.,
353 Pa Super 21, 28,
These authorities show the tension that exists between the professional role of pharmacists within the healthcare system
The Court of Appeals has recognized that “[t]he primary duty of a hospital’s nursing staff is to follow the physician’s orders, and a hospital is normally protected from tort liability if its staff follows the orders”
(Toth v Community Hosp. at Glen Cove,
However, a nurse or hospital staff member may nеvertheless be liable for carrying out a doctor’s order “where the hospital staff knows that the doctor’s orders are so clearly contraindicated by normal practice that ordinary prudence requires inquiry into the correctness of the orders”
(Toth v Community Hosp. at Glen Cove,
This Court has previously, in the context of discussing a package insert in a products liability case, stated that a contraindication is “a circumstance under which the drug must never be given” and that it is “absolute and admits of no exceptions”
(Baker v St. Agnes Hosp.,
The language used by the Court of Appeals in
Toth v Community Hosp. at Glen Cove
(
This general standard articulated in
Toth v Community Hosp. at Glen Cove
(
The application of this general standard to pharmacists working under the direction of a prescribing physician is consistent with case law from other states. These courts have indicated, using various formulations, that “pharmacists owe their customers a duty beyond accurately [filling] prescriptions [where] the presence of additional factors, such as knоwn contraindications . . . would alert a reasonably prudent pharmacist to a potential problem”
(Morgan v Wal-Mart Stores, Inc.,
The CVS defendants nevertheless contend that New York case law demonstrates that it is the “long-established rule in New York” that a pharmacist, as a matter of law, has no duty to warn a customer or contact the prescribing physician to inquire about the сorrectness of a prescription. The CVS defendants argue that this rule “bars [the] plaintiff’s claim” and entitles them “to judgment as a matter of law.”
In this regard, the CVS defendants primarily rely upon language from cases issued by the First, Third, and Fourth Departments
(see Burton v Sciano,
Accordingly, these cases are merely instances where the complaint failed to adequately allege that “observations and information known to or readily perceivable” by the pharmacist put him or her on notice of the potential danger such that it “trigger [ed] the duty to protect”
(N.X. v Cabrini Med. Ctr.,
Indeed, earlier cases from two of these same Departments expressly recognized that the scope of a pharmacists’ duty may, under certain circumstances, extend beyond merely filling a prescription with technical accuracy
(see Eberle v Hughes,
In
Eberle v Hughes
(
As these cases illustrate, there is no merit to the CVS defendants’ categorical contention that a pharmacist’s duty will never extend beyond accurately filling a prescription
(see id.; Hand v Krakowski,
In sum, we conclude that, when a pharmacist has demonstrated that he or she did not undertake to exercise any independent professional judgment in filling and dispensing prescription medication, that pharmacist cannot be held liable for negligenсe in the absence of evidence that he or she failed to fill the prescription precisely as directed by the prescribing physician or that the prescription was so clearly contraindicated that ordinary prudence required the pharmacist to take additional measures before dispensing the medication
(see N.X. v Cabrini Med. Ctr.,
In this case, the CVS defendants moved for summary judgment dismissing the complaint insofar as asserted against
In opposition, the plaintiff submitted an affidavit from an expert who stated that an eight-milligram dose of hydromorphone “should only be dispensed to customers who have built up a tolerance to the drug as a result of long-term exposure.” The plaintiff’s expert stated that the decedent had “never been exposed to opioid medication,” and that this information was “reflected in [the CVS defendants’] own records.” Accordingly, the plaintiff’s expert opined that the dosage was “clearly contraindicated” for the decedent and that “it was a departure from safe and accepted pharmacy practice” for the CVS defendants to fill the prescription without first calling Dr. Bute to question the propriety of the prescription’s dosage.
The Court of Appeals has stated that “opinion evidence must be based on facts in the record or personally known to the witness”
(Cassano v Hagstrom,
Here, the opinion of the plaintiff’s expert — that the CVS defendants deviated from safe and accepted pharmacy practice by failing to contact Dr. Bute before filling the prescription— was based on the premise that the CVS defendants were aware of the particular characteristics of the decedent that rendered the dosage contraindicated for him. In this regard the plaintiff’s expert references only the CVS defendants’ “records.” The plaintiff’s expert does not provide any other basis for his conclusion that the CVS defendants knew that the decedent was opioid-naive or otherwise assert that the CVS defendants had a duty to inquire in the absence of any specific knowledge regarding the decedent’s prior opiate use.
The record on appeal does not support the factual assumption relied upon by the expert in reaching his professional opinion. Although certain pharmacy records were submitted by the plaintiff in opposition to the motion of the CVS defendants, these records only show prescriptions filled for the decedent at a single pharmacy over a limited period of time. Furthermore, the defendant pharmacist testified at her deposition that she was unable to tell from the records available to her at the time the prescription was filled what prescriptions the decedent had filled at other pharmacies or hospitals. She did not even have access to prescriptions filled for the decedent at other CVS pharmacy locations. Since the expert’s opinion was based on facts not supported by the evidence, it was insufficient to raise a triable issue of fact as to whether the prescription was so clearly contraindicated that the applicable standard of care required the CVS defendants to confirm that the prescription was not issued in error
(see Cassano v Hagstrom,
III. Conclusion
In light of the foregoing, the order is affirmed insofar as appealed from, and reversed insofar as cross-appealed from, on the law, and the motion of the CVS defendants for summary judgment dismissing the complaint insofar as asserted against them is granted.
Ordered that the order is affirmed insofar as appealed from; and it is further,
Ordered that the order is reversed insofar as cross-appealed from, on the law, and the motion of the respondents-appellants for summary judgment dismissing the complaint insofar as asserted against them is granted; and it is further,
Ordered that one bill of costs is awarded to the respondents-appellants.