US Pharm
. 2011;36(2):62-65. 

A pharmacist makes a mistake when filling a prescription. This mistake causes the patient harm that can be measured in monetary and emotional terms. The pharmacist is sued. There is no question that each of the elements of ordinary negligence is present here. There is a duty to fill the prescription accurately; there has been a breach of that duty, the breach caused the patient harm, and that harm is measurable in monetary damages. The pharmacist will likely be held liable to pay a judgment in favor of the injured patient. What liabilities does the pharmacist face? 

The only questions are how much the pharmacist will have to pay and for what kind of damages. In cases of ordinary negligence, often also referred to as malpractice when the negligence is caused by a licensed professional (the words are used interchangeably without any other meaningful distinction), courts have most uniformly held that the defendant, in this case the pharmacist, will be liable to the plaintiff, the patient here, for an amount designed to compensate the plaintiff for ordinary loss of income or value of life and, if appropriate, an amount calculated to pay the plaintiff for emotional damages. The goal of the courts, in a jurisprudence sense, is to make the plaintiff “whole” in monetary terms as if the malpractice never happened. Often it is up to a jury to decide the exact amount of liability damages and, if approved by the judge, that amount will become the judgment the defendant has to pay. 

In more recent years, however, plaintiffs in pharmacy malpractice cases have begun with increasing frequency to ask for extra amounts of money in the form of punitive damages that, in addition to the ordinary compensatory damages, are designed to punish the defendants for such egregious conduct as to correct whatever problem lead to the mistake in the first place. Punitive damages can be double, triple, or sometimes even exponentially higher than compensatory damages and are awarded together with compensable damages. This could be disastrous for organizations that do not typically have insurance coverage for the increased punitive damage amounts. Typically, punitive damages are sought from corporate defendants, such as the owner of the pharmacy where the mistake was made, for “system failures,” or for procedures that are not designed sufficiently to prevent the error from occurring. 

Herein lies the problem: What is the difference between simple human error and system failure? 

Lawsuits

A recent case sheds light on the question and provides some guidance for pharmacists to know what kinds of problems they might face when a mistake is made.1 The opinion issued by the federal Sixth Circuit Court of Appeals involves two different cases that were consolidated because the legal issues were the same. Both cases originated in a Tennessee court against the same defendant and required the court to interpret Tennessee’s law on whether punitive damages were properly allowed under that state’s laws. As a procedural matter, both cases were transferred to a federal district court. 

Case 1: In 2001, a 75-year-old woman presented a handwritten prescription from her urologist for imipramine (an antidepressant) to a pharmacist employed in a national chainstore pharmacy. The pharmacist mistakenly read the drug name as Imuran (azathioprine) and dispensed this powerful immunosuppressant. There is no dispute that the patient did not receive counseling at the time she picked up her prescription. Upon returning home and over a period of several weeks, she took the entire prescribed dose and part of one refill before she went to the emergency room complaining of symptoms of swelling in her legs, feet, and abdomen; weight gain; and shortness of breath. According to the records, the emergency room physician recognized that Imuran was not a drug prescribed for bladder problems, and the patient immediately stopped taking the erroneously dispensed medication. In the complaint, she alleges that her health improved after she stopped taking Imuran and began taking imipramine, but she never fully recovered from the congestive heart failure complications that Imuran caused. The patient died in 2003. 

Case 2: A 93-year-old patient, through his son-in-law, presented a prescription for a manufacturer-created Uro-Pac dosage of Floxin (ofloxacin) to a different pharmacist employed by the same chainstore in 2001. The Uro-Pac was unavailable at that location but the pharmacist offered to create a simulated dose pack. The patient’s son-in-law accepted this option. Unfortunately, the pharmacist miscalculated the number of tablets necessary to simulate Uro-Pac and created a dose pack with dosage directions greater than prescribed. The patient took the medication as directed until another son-in-law recognized that she was taking too large of a dosage after she complained of nausea and vomiting. In her lawsuit, she claims that she never fully recovered prior to her death in 2002. 

District Court

After much legal rambling, the two cases ended up together in front of a federal district court judge sitting in Tennessee. Both of the plaintiffs had asked for compensatory and punitive damages. Germane to this discussion, the federal district judge granted a summary judgment motion on behalf of the defendant pharmacy, holding that neither plaintiff will be able to seek punitive damages once the cases are set for trial. Both plaintiffs appealed that ruling to the Court of Appeals, claiming the district court erred in interpreting Tennessee law on the availability of punitive damages. 

Court of Appeals: The primary issue under review is whether Tennessee law, specifically the Tennessee Medical Malpractice Act,2 permits punitive damages to be sought under the circumstances of these two cases. The Tennessee law, according to this court, “codifies the common law elements of negligence—duty, breach of duty, causation, proximate cause, and damages,” and that “no claim for negligence can succeed in the absence of any one of these elements.” To obtain punitive damages, the plaintiffs would have to offer additional proof, in the form of clear and convincing evidence, of a required mental state of the defendant under Tennessee law. 

The Court of Appeals started its analysis, stating that: “Punitive damages are not available under Tennessee law unless a plaintiff can prove by clear and convincing evidence that the defendant acted intentionally, fraudulently, maliciously, or recklessly.”3 Clear and convincing evidence “leaves no serious or substantial doubt about the correctness of the conclusions drawn.” This means that “in contrast to the preponderance of the evidence standard [for ordinary negligence] clear and convincing evidence should demonstrate that the truth of the facts asserted is highly probable as opposed to merely more probable than not.”4 

Punitive damages are “intended to punish a defendant, to deter him from committing acts of a similar nature, and to make a public example of him”—they are “appropriate only in the most egregious cases.”5 Further, “to prevail on a claim for punitive damages in a negligence case, the plaintiff must show that the defendant’s negligence that proximately caused his or her injury reached a substantially higher level than ordinary negligence” and “was so reprehensible that it must be both punished and deterred.”6 In addition, “a submissible punitive damages claim has been made if the evidence and the inferences reasonably drawn from the evidence are sufficient to permit a reasonable juror to conclude that the plaintiff established with convincing clarity that the defendant’s conduct that caused the plaintiff’s injury was intentional, fraudulent, malicious, or reckless.”7 

On appeal, the plaintiffs limited their claims, alleging only that the pharmacy had acted either intentionally or recklessly. 

Intent: Insofar as the “intentional” part of the standard goes, the plaintiffs urged “that a person can be subject to punitive damages if she intentionally engages in conduct regardless of whether that conduct is meant to be hurtful, benign, or helpful.” Under state law, “a person acts intentionally when it is the person’s conscious objective or desire to engage in the conduct or cause the result.” Trying to claim that their punitive damages allegations meet this standard, the plaintiffs argued that the “or” prior to “cause the result” in this definition negates the need to prove any connection between the required mental state and the result. They argued that the pharmacy’s intentional action in filling the prescriptions is sufficient to satisfy the “intentional” standard for punitive damages. Furthermore, the plaintiffs asserted, the defendant pharmacy acted intentionally because it was the pharmacy’s “conscious objective or desire to engage in the conduct” of filling the prescriptions, knowing that improperly filled prescriptions could be harmful even though the pharmacy had no intent to make mistakes in filling the prescriptions or to cause any resulting injury to the plaintiffs. Thus, they argued that “negligent conduct is reprehensible enough to demand an award of punitive damages.” 

The district court judge rejected this argument, stating: “Such an interpretation would lead to freakish results where almost every act of mere negligence becomes an intentional act subject to punitive damages.” The Appellate Court agreed, stating that the plaintiffs did not offer any case law in support of this interpretation. On the contrary, the court found a case decided under Tennessee law holding that “the issue is not whether [the defendants] intentionally or consciously [engaged in the conduct], but rather the motive for the [conduct].”8 From this the court concluded, “Intentional refers to a person who acts intentionally with respect to the nature of the conduct or to a result of the conduct when it is the person’s conscious objective or desire to engage in the conduct or cause the result.”9 The court then concluded that while a pharmacy is generally cognizant of the fact that an error in filling a prescription could happen, “this is not sufficient to meet the clear-and-convincing-evidence standard” required under state law. 

Reckless: The plaintiffs also claimed that punitive damages should be available because the pharmacy’s conduct satisfies the “reckless” standard. Tennessee law states, “A person acts recklessly when the person is aware of, but consciously disregards, a substantial and unjustifiable risk of such a nature that its disregard constitutes a gross deviation from the standard of care that an ordinary person would exercise under all the circumstances.”10 The court explained that “reckless” can refer to the circumstances surrounding the defendant’s conduct or the result of the defendant’s conduct. The pharmacy admitted that its pharmacists were negligent in violation of the standard of care requiring the accurate filling of prescriptions but denied that “preventable errors” are the equivalent to the “gross deviation” of the standard of care to constitute recklessness. Tennessee courts have defined “recklessly to require” as disregarding a substantial risk such that the person gave no thought to or paid no attention to the known risk.11 The state courts have gone on to explain, “Although the reckless actor intends to act or not to act, the reckless actor lacks the ‘conscious objective or desire’ to engage in harmful conduct or to cause a harmful result…[R]ecklessness contains an awareness component similar to intentional conduct which is not demanded of negligence.”12 This court concluded that none of the pharmacy’s or pharmacists’ acts rose to this level of recklessness. 

Analysis

This case adequately demonstrates the difference in the standards that must be met to prove ordinary negligence (or malpractice) and the extra burden of proving sufficient evidence that the defendant acted so recklessly or intentionally as to have the mental intent that harm be caused to the plaintiff. It’s bad enough to get sued for making a simple mistake, but when punitive damages allegations are made, vigilance is important to make sure the judgment is reasonable and not excessive. 

REFERENCES

1. Beal v. Walgreen Company, Slip Op No. 09-5899, November 10, 2010, 10a0693n.06; 2010 U.S. App Lexis 23304, 2010 Fed App 0693N (6th Cir). www.leagle.com/xmlResult.aspx? xmldoc=In%20FCO%2020101110127. xml&docbase=CSLWAR3-2007-CURR. Accessed January 10, 2011.
2. Tennessee Code Annotated §29-26-115.
3. Goff v. Elmo Greer & Sons Constr. Co., 297 SW3d 175, 187 (Tenn 2009), cert denied, 130 S Ct 1910, 176 L Ed 2d 367 (2010); Hodges v. S.C. Tool & Co., 833 SW2d 896, 901 (Tenn 1992).
4. Nelms v. Walgreen Co., Slip No. 02A01-9805-CV- 00137, 1999 Tenn App LEXIS 437, 1999 WL 462145, at *3 (Tenn Ct App July 7, 1999).
5. See Note 3, supra; Goff, 297 SW3d at 187.
6. Duran v. Hyundai Motor Am., Inc., 271 SW3d 178, 206 (Tenn Ct App 2008).
7. See Note 6, supra; Duran, 271 SW3d at 207.
8. JWT, L.P. v. Printers Press, Inc., No. M2001-02590-COA-R3-CV, 2002 Tenn App Lexis 753, 2002 WL 31397317, at *9 (Tenn Ct App October 4, 2002). Noting there was no dispute, “that it was the conscious objective of [the defendants] to [engage in the conduct].”
9. Tenn Code Ann §39-11-302(a).
10. See Note 3, supra; Goff at 187, n 11.
11. Doe v. Roman Catholic Diocese of Nashville, 154 SW3d 22, 37 (Tenn 2005); quoting Webster’s Third International Dictionary 655 (1971).
12. Id at 38. 

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