US Pharm. 2010;35(2):40-45.
A patient presents a prescription to a pharmacy for a psychotropic drug.1 The pharmacist fills the prescription and later the patient, under the influence of the medication, causes an accident while driving a motor vehicle that leaves another driver injured. Should the pharmacy that dispensed the medication be held liable for the other driver’s (the third party) damages? The usual answer by the courts has been “No.”2 The rationale is that the third party is “unforeseeable,” meaning that the relationship between the pharmacy and the third party is too tenuous to constitute the necessary legal connection between the pharmacy’s conduct and the harm inflicted by the conduct of the patient of the pharmacy.
What happens if a little twist occurs to the facts of the above scenario? Assume that before the central nervous system–altering drug is dispensed, the pharmacy receives notice from the state—using a computerized tracking system to determine how many controlled substances a patient is getting from a variety of physicians and pharmacies—that this particular patient may be a drug abuser. Now, using the same facts above, does this added knowledge somehow create a duty on the part of the pharmacy to have protected the third party from the patient’s presumably altered state of consciousness that caused the accident to occur?
This question, before it was answered by the Nevada Supreme Court in December 2009, sent shockwaves of fear throughout the pharmacy practice community.3 The case was characterized as asking whether pharmacies must use available information to protect the public from potentially dangerous patients and was billed as “part of a broader movement under way to place more responsibility for patients’ prescription-drug use on pharmacies.”4,5 The argument goes something like this: Community pharmacies dispense upward of 200 million prescriptions for opiates such as hydrocodone and oxycodone each year (up from about 40 million prescriptions in 1991).6 Pharmacies have much more information available about the history of drug use by patients through medication profiles kept by individual pharmacies. Since 2002, approximately 35 states do online tracking of patients’ controlled-substance prescriptions, and these data are available, in varying degrees, to the pharmacies.7 Consequently, consumers, government officials, and even the pharmacy industry question what a pharmacy should do, both ethically and legally, with this relatively new information.
Facts of the Case
A 35-year-old receptionist working in a physician’s office was determined by the Nevada Controlled Substance Task Force to have obtained 4,500 units of opiates in a single year, all in or near Las Vegas. The Nevada Board of Pharmacy sent letters to 14 pharmacies in the area warning that this patient could be abusing drugs. A year later, after continuing to obtain opiates from several pharmacies, the receptionist was seen driving her sport utility vehicle (SUV) erratically, weaving in and out of a three-lane highway in relatively heavy traffic. Moments later she crashed into and killed a delivery van driver who had pulled off to the side of the road to repair a flat tire. She also severely injured another man who had stopped to help the delivery van driver. The receptionist walked away from the accident unhurt; witnesses reported that she appeared to be laughing. The driver was declared dead at the scene of the accident, and later, during an autopsy, the coroner noted tire tracks covering the victim’s lower back.
When the police arrived, they discovered 167 pills in the receptionist’s SUV, including the painkillers hydrocodone and carisoprodol. The police report indicated that the woman was confused, could not remember the name of one of her two children, and was unable to walk in a straight line. She admitted that she had taken some medicine for a migraine earlier in the day. A blood test revealed the presence of hydrocodone. She was charged with driving while intoxicated, reckless driving, and being involved in a fatal traffic accident. She pleaded guilty and served 9 months of imprisonment. The state of Nevada revoked the license of the physician who wrote the majority of controlled-substance prescriptions for the receptionist.
Lawsuit
The families of the dead and injured men sued the receptionist, her physician, and several pharmacies that filled her prescriptions after having received notice from the state that she was a potential drug abuser. This trial court judge dismissed the pharmacies from the lawsuit, noting that the legislation that created the Nevada Controlled Substances Task Force did not specify what actions, if any, a pharmacy is supposed to take after receiving a warning notice. The plaintiffs appealed to the Nevada Supreme Court. They argued that because the pharmacies had knowledge of the woman’s prescription-filling activities, the pharmacies owed the injured parties a duty of care to not fill the woman’s prescriptions. Important to the rationale for the court’s decision, the complaint did not allege any irregularities on the face of the prescriptions themselves, nor did it allege that the prescriptions presented by the patient to the pharmacies were filled by the pharmacies in violation of the prescriptions’ language, were fraudulent or forged, or involved dosages that, individually and if taken as directed, were potentially harmful to the patient’s health.
The court considered two determinative questions: 1) whether pharmacies owe a duty of care to unidentified third parties injured by a pharmacy customer or whether public policy creates a duty of care for pharmacies, which when breached, supports a common-law negligence claim; and 2) whether Nevada’s pharmacy statutes and regulations create a statutory duty to support the plaintiffs’ negligence claim against the pharmacies.
As a threshold matter, in any negligence case, the injured party must demonstrate that the offending party owes a duty of care to prevent the harm from occurring. Under long-standing principles of common law in Nevada, no duty is owed to control the dangerous conduct of another or to warn others of the dangerous conduct.8 The court, however, noted that there is an exception to this general law, establishing an affirmative duty to aid others when: 1) a special relationship exists between the parties or between the defendant and the identifiable victim, and 2) the harm created by the defendant’s conduct is foreseeable.9 The court stated that “to determine whether the plaintiffs can maintain a common-law negligence claim against the pharmacies for the patient’s criminal act of driving while under the influence of controlled substances, we must consider the relationship between the parties and if a legal obligation can be imposed upon the pharmacies for the third-party appellants’ benefit.” This particular issue had never been addressed by the Nevada courts.10 Thus, absent binding precedent in the state, the court looked to other jurisdictions for guidance. It found a Florida Court of Appeals case with similar facts to be persuasive in deciding what Nevada law should be on these questions.11
In the Florida case, a motorist was involved in a collision with a pharmacy patient who drove while under the influence of prescribed medication and fell asleep at the wheel, causing injuries to the other motorist. The injured party filed a negligence action against the pharmacy, alleging that because the pharmacy voluntarily undertook the duty of warning the patient about the prescription drug’s effect on driving, the pharmacy owed a duty of care to the injured motorist. The pharmacy asked the trial court to dismiss the action on the basis that it owed no duty to an unidentified third party. The trial court agreed and dismissed the complaint. The Florida Court of Appeals recognized that in the context of professional relationships, the duty element of negligence could be established in one of two ways: 1) by a plaintiff having a direct relationship with the defendant, or 2) by showing that the plaintiff is a known or identifiable third party to whom the defendant owes a legal duty. That court determined that no duty of care was owed to the plaintiff because she had no direct relationship with the pharmacy; the pharmacy merely filled its customer’s prescription and warned the customer of the medication’s side effects. The court concluded that the plaintiff was an anonymous member of the driving public and was therefore not a known or identifiable third party. The pharmacy had no control over whether its customer would take the medication and then drive, or even take the medication at all. Therefore, the Florida court held that if it held that the plaintiff was a known or identifiable third party to whom the pharmacy owed a legal duty, this would create a “zone of risk that would be impossible to define.”12 Thus, in the Florida case, the pharmacy’s actions did not create a legal duty in favor of the motoring public.
Using the reasoning of that case, the Nevada Supreme Court concluded in the matter at hand that the pharmacies did not owe a duty to the plaintiffs because the pharmacies had no direct relationship with them. In addition, as in the Florida case, the plaintiffs in this matter were determined to be unidentifiable members of the general public who were unknown to the pharmacies. Thus, the pharmacies’ acts of dispensing prescription drugs to the patient did not create a legal duty to the plaintiffs.
Insofar as pharmacies across the nation are concerned, this should have been a satisfying conclusion to a potentially scary liability threat. However, in a footnote, the Nevada Supreme Court left open a potential loophole that should demand the attention of pharmacies still concerned about the effect of state operated controlled-substance tracking systems and how this information might affect liability questions in the future. The size of this escape clause is subject to debate.
The accident that started this case happened in 2004. At that time, the statute establishing the Nevada Controlled Substances Task Force did not address what, if anything, a pharmacy was supposed to do with information it received about potential drug abusers.13 The court noted that “at the time that the underlying accident occurred, the pharmacies had no obligation to do anything after receiving the task force letter and only limited authority to refuse to fill any prescriptions.”14
However, in 2006, 2 years after the accident, the Nevada Board of Pharmacy amended its regulations, which, according to this court, “may have created a special relationship that could justify imposing a duty in favor of third parties.” The court noted that Board of Pharmacy regulation NAC 639.753(3)(a)-(d) provides: “[I]f a pharmacist declines to fill a prescription, because in his professional judgment the prescription is: 1) fraudulent, 2) potentially harmful to the customer’s health, 3) not for a legitimate medical purpose, or 4) filling the prescription would be unlawful, the pharmacist must in a timely manner contact the prescribing physician to resolve the pharmacist’s concerns. The amendment further provides that after speaking with the physician, the pharmacist may fill the prescription if ‘the pharmacist reasonably believes, in his professional judgment, that the prescription is’ not fraudulent or harmful to the patient’s health or is lawful or for a legitimate medical purpose. If one of these conditions is not met, after discussing the prescription with the physician, the pharmacist is mandated not to fill the prescription and must retain the prescription.”15
The court specifically declined to make a determination as to whether this amended regulation imposes a different duty on pharmacies or creates a special relationship with their customers. In a future case, the court could easily decide otherwise. This possibility aside, the court did carefully examine the statutes and their legislative history to determine that they, in and of themselves, do not establish the duty of care sought by the plaintiffs. The relevant statute states that information provided to a pharmacy by the Controlled Substances Task Force is confidential and cannot be disclosed to any person.16 Further, noted the court, nothing in that statute requires pharmacies to take action to protect the general public after receiving a task force letter. Accordingly, it is evident that the legislature did not intend to create a policy that requires pharmacies to protect third parties from a pharmacy customer’s actions. The legislative history also indicates that the statute was intended to enhance record keeping by permitting more thorough and accurate information to be available to enforcement and regulatory authorities and for transmission by the task force to physicians, pharmacies, and others. The court therefore rejected the plaintiffs’ argument that the statute creates a public policy duty for pharmacies to protect third parties.
It should be noted that this was a 5-2 decision, meaning five justices agreed with the decision while two justices filed a dissenting opinion that would have reinstated the complaint against the pharmacies. The dissenters would have found that pharmacies have a “special relationship” between a pharmacy and a patient that would create a duty to take measures to protect foreseeable victims from foreseeable harm. These justices reasoned that pharmacists possess an expertise in the dispensation of prescription drugs,17 and pharmacists must ensure that the drugs sought by a customer are “dispensed only for medically necessary purposes and according to prevailing standards of care for practitioners practicing in the specialty claimed or practiced by the dispensing practitioner.”18
Nevada’s legislature has recognized that pharmacists are trained to recognize potential drug abuse based on the frequency of a drug’s refill and dosages.19 Before filling a prescription, a pharmacist must review a customer’s records to determine the prescription’s therapeutic appropriateness by considering possible drug abuse, overuse of a particular drug, adverse side effects, or improper dosages or treatment durations.20 If a pharmacist reasonably believes that a prescription for a controlled substance was not issued in the normal course of a professional’s practice, a pharmacist is prohibited from filling the prescription.21 These principles could be used to develop an argument that members of the general public should be protected from the negligence of a pharmacy in dispensing drugs to known or suspected drug abusers.
Analysis
As noted, there was much rejoicing in the pharmacy industry halls when this decision was handed down on Christmas Eve 2009.22 Once again, pharmacies and pharmacists escaped liability and were given near immunity should something go wrong after a facially legitimate prescription is properly filled. Harbor no doubt, this case was correctly decided for the right reasons. Had the majority bought into the argument that pharmacies owe a specific duty to protect the general public from the actions of a drug-abusing patient, this would have created, in the words of the Florida Court of Appeals, a “zone of risk that would be impossible to define.”23 Refusing to do so, the Nevada court avoided the “slippery slope” of tort liability that would have opened the door to unimaginable negligence claims against pharmacies.
Yet there is a bothersome aspect to this case. Why did the pharmacies keep filling opiate prescriptions without question after they received notice from the Nevada Board of Pharmacy that this patient might be a drug abuser? Surely there could be plausible reasons to do so. Maybe the pharmacies verified the prescriptions with the prescriber (the opinion does not tell us one way or another). Maybe the pharmacies questioned the patient and made a professional judgment that she suffered from a painful condition warranting the use of large quantities of controlled substances (again, the opinion is silent on this point). One way or another, the Nevada court chose to ignore the long-standing gatekeeper function of pharmacists, focusing instead on the extent of duty owed to the public.24 It is easy to speculate that this accident would have occurred even if the involved pharmacies took any measures to examine the patient’s medication history, with or without the notice from the state expressing concern about her drug use. Even so, it would have been more professionally satisfying, at least from an ethical perspective, to think that the pharmacies expressed some concern for her well-being before dispensing additional psychotropic drugs.
REFERENCES
1. Psychotropic drug. “Any drug capable of affecting the mind, emotions, and behavior.” www.medterms.com. Accessed January 13, 2010.
2. Stebbins v. Concord Wrigley Drugs, 164 Mich App 204; 515 NW 2d 381 (1987).
3. Merrick A. Case spurs pharmacies’ fears of lawsuits over drug abuse. Wall Street Journal. October 29, 2009. http://online.wsj.com/article/SB125668736789811845.html. See also: Nevada case raises question of pharmacies’ liability in drug abuse accidents. Kaiser Health News. October 28, 2009. www.kaiserhealthnews.org/Daily-Reports/2009/October/28/Pharmacy-case.aspx. Weiss DC. Nevada Supremes consider pharmacy liability for painkiller customer’s accident. ABA Journal. October 28, 2009. www.abajournal.com/news/article/nevada_supremes_consider_pharmacy_liability_for_accident_by_painkiller_cust/. Accessed January 13, 2010.
4. Sanchez v. Wal-Mart (Slip Op No 47851, December 24, 2009), 2009 Nev Lexis 80, 125 Nev Adv Rep 60.
5. See Note 2, supra.
6. See Note 3, supra.
7. See Note 3, supra.
8. Mangeris v. Gordon, 94 Nev 400, 402, 580 P2d 481, 483 (1978).
9. Lee v. GNLV Corp., 117 Nev 291, 295, 22 P3d 209, 212 (2001); Elko Enterprises v. Brovles, 105 Nev 562, 565-66, 779 P2d 961, 964 (1989); Mangeris, 94 Nev at 402, 580 P2d at 483.
10. In common law parlance, this is often called an “issue of first impression.”
11. Dent v. Dennis Pharmacy. Inc., 924 So 2d 927 (Fla Dist Ct App 2006).
12. Cheeks v. Dorsey, 846 So 2d 1169, 1173 (Fla Dist Ct App 2003).
13. NRS 453.1545
14. See Note 3, supra, footnote 3 of the Opinion.
15. NAC 639.753(4).
16. NRS 435.1545(5).
17. NRS 639.213; NRS 639.0124(4).
18. NAC 639.742(3)(h).
19. NRS 639.0124; NAC 639.707(4).
20. NAC 639.707(4).
21. NRS 453.381(4).
22. Merrick A. Nevada high court says pharmacies can’t be sued for death. Wall Street Journal. December 24, 2009. http://online.wsj.com/article/SB126168631995004765.html. Accessed January 14, 2010.
23. See Note 8, supra.
24. Erosion of the “learned-intermediary doctrine”: what every pharmacist (and his malpractice insurer) needs to know about expanding pharmacist liability. Presented at: Annual Meeting of the American Pharmaceutical Association; March 29, 2003; New Orleans, LA. www.mdmlaw.com/PharmacistLiability_Parsells_Vaughan.pdf. See also: Brushwood DB. A case study of Jones v. Walgreen. Pharmacy in History. 1996;38:3-14. http://cms.pharmacy.wisc.edu/aihp/information/excerpts/pih. Accessed January 14, 2010.
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