US Pharm. 2006;4:65-71.     

In the typical malpractice claim against a pharmacy, the patient-plaintiff has the burden of presenting evidence that shows the pharmacy violated a standard of care and that the violation was a cause of the injuries sustained by the patient. Once these elements of the claim are established, the plaintiff is obliged to show the extent of harm, expressed in a monetary amount. In most states, this amount is called "compensatory damages" because the amount awarded in a verdict is designed to compensate the patient for such things as loss of income, medical expenses, loss of compassion from family members, and for the "pain and suffering" that the patient incurred as a result of the pharmacy's negligence. In legal terms, these forms of compensation are supposed to make the patient "whole" again, i.e., as if the problem had not occurred in the first place. At least that's the theory.

Some (but not all) states also allow patients to seek "punitive damages" in cases where the facts are egregious enough to warrant imposition of an amount of money that will punish the pharmacy for really bad behavior. In a few of the states that do not permit punitive damage awards, the "pain and suffering" element of the compensatory damages verdict may serve as a proxy for punitive damages. However, to keep "runaway jurors" from awarding an amount that far exceeds any imaginary limit on compensation, many states have adopted statutes that set monetary limits on the size of a negligence verdict. If the jury comes back with a number that exceeds the permissible amounts, the judge will enter a verdict at the permissible amount.

In states that do permit verdicts that can include an amount designed to punish the errant pharmacy, the burden that the patient has to meet is much higher than the one for ordinary negligence or malpractice. Depending on the state, to qualify for punitive damages, the patient-plaintiff must show that the pharmacy acted with "wantonness" or with "reckless disregard" for the welfare of the patient. The type of conduct that warrants punitive damages is sometimes difficult to describe. However, in Alabama, a state that has addressed punitive damage awards against pharmacies on at least two prior occasions, the state Supreme Court was recently challenged once again to explain the conduct necessary to sustain a verdict over and above the normal compensatory damage verdict.¹

Facts
On May 21, 1999, a 71-year-old patient who suffered preexisting dementia from Alzheimer's disease fainted while working in his garage. He hit his head on an object in the garage and was unconscious for a period of time. He was transported to an emergency department for initial treatment. Once stabilized, he was transferred, at the request of his primary care physician, to the Baptist Medical Center in Montclair, Alabama, where this doctor practiced. Upon admittance, the primary care physician asked for a neurological consultation, and over the course of the hospital stay, the patient was seen by four neurologists.

On May 23, the senior neurologist determined that the patient was experiencing seizures. He prescribed Dilantin (phenytoin) to be administered intravenously with a loading dose of 1,000 mg, to be followed by 300 mg administered orally at nighttime each day of his hospitalization. On the morning after the loading dose was administered, blood tests showed the level of Dilantin in his blood was 13.1 mcg/mL, well within the therapeutic range of 10.0 to 20.0 mcg/mL expected for this drug. The patient's chart where the nighttime dose was recorded showed the prescription in medical shorthand: "Dilantin 300 mg po qhs."²

The hospital pharmacy has a policy of generating a medication administration record (MAR) every 24 hours. This report shows all drugs administered to all patients as ordered pursuant to the prescriptions issued by each physician. The MAR for this patient and drug was accurately recorded.

During this hospital stay, the patient complained of severe back pain caused by spinal compression fractures of unknown origin. He was confused, especially at night, which was not abnormal for him, as reported by relatives. He received various pain medications, along with Valium (diaze­ pam) and Risperdal (risperidone), to address his confusion and agitation.

On May 25, the patient was transferred to a rehabilitation unit within the hospital. For recordkeeping purposes, the patient was released from the hospital and readmitted into the rehab unit. Accordingly, the patient's hospital medication orders were terminated and reissued as new prescriptions. The record also showed that the patient was receiving 13 different medications in the rehab unit. This MAR continued to reflect that the patient was receiving Dilantin orally. However, the order was recorded in a way not reflecting the prescription issued from the hospital physician. The latter was recorded as "phenytoin 100 mg cap (Dilantin) oral; give = 3 capsules = 300 mg tid anticonvulsant." From May 26 to May 31, the patient received three 100-mg capsules of Dilantin three times a day for a daily total of 900 mg. On June 1, he received 600 mg of Dilantin prior to discharge.

The hospital has a policy designed to catch mistakes like this one. The policy requires that any time a new physician's order for medication was entered, the nurse initially undertaking to administer the medication was responsible for comparing the MAR to the actual order to "reconcile" the two. Thereafter, the nurses successively administering the medication in accordance with the directions appearing on the MAR were not responsible for again reconciling the MAR entry with the actual physician's order. Thus, the reconciliation process was designed to take place only once for any new orders entered within the previous 24 hours.

There was no indication which pharmacist erred in transcribing the chart order onto the MAR system. Likewise, there was no evidence as to why the nursing staff did not cross-check the orders.

Complicating matters even more, the original prescription issued when the patient entered the rehab unit was not available. The state pharmacy law requires pharmacies to keep prescription records only for two years. There were no other redundant systems available to trace the prescription because the computer hardware and software had been upgraded twice in the period from the patient's stay until trial. The hospital's director of pharmacy, who was not employed by the hospital when this incident was recorded, testified that he could not identify the pharmacist or pharmacists involved with this erroneous transcription. When asked by the patient's attorney if the chief pharmacist knew how this incident occurred, the pharmacist stated that he could only guess. He speculated that it is not uncommon to give Dilantin three times a day, nor is it uncommon to give a dose of 300 mg once a day. Because of the similarity in expressing these terms in shorthand, it would not be difficult to become confused.

A nurse who worked in the rehab unit when this incident occurred testified as to her knowledge of the MAR system and what was required of her as a nurse. She did not have any specific knowledge of why the patient's chart was not checked against the MAR. However, she testified that she could not think of any time that the MAR procedures were not followed because "it is just a practice we did."

When the patient was discharged on June 1, this same nurse prepared and signed prescriptions for the patient's discharge. The prescriptions she wrote came from the MAR showing the patient was to receive 300 mg of Dilantin three times per day. While it was a common practice for nurses to write out prescriptions, according to hospital procedures, the physician on duty should have reviewed the prescriptions and signed them at the time of discharge. The neurologist who initially issued the prescription for Dilantin testified that nurses frequently prepared prescriptions, but they would always have to be signed by a physician.

On June 1, the patient's daughter drove him to their local pharmacy, where one of the pharmacists had provided the family with more than 15 years of pharmacy services. Upon being presented with the Dilantin prescription, the pharmacist said he immediately became concerned because, in his experience, he had never seen a dose as high as the one on this prescription. The pharmacist first telephoned the physician whose name appeared on the drug order but was told the physician was not in his office at the time of the call. He waited for an unspecified time for the physician to return the call, but he never did talk to the doctor.

Ultimately, the pharmacist filled the prescription as it was written, but he cautioned the patient's daughter that he should talk to the doctor before a dose of this magnitude was administered. There was no dispute that the patient never took any of the medication supplied by the community pharmacy.

The next day, on June 2, the daughter called the patient's primary care physician and reported that her father could not swallow the medications, and he was not able to verbalize or communicate. The physician told the daughter to immediately call for an ambulance and have her father brought back to the hospital medical center. A battery of tests were performed, including a blood level of Dilantin, which was found to be 54.4 mcg/mL, indicating the patient was suffering from Dilantin toxicity. (Recall that the normal therapeutic range is 10.0 to 20.0 mcg/mL). At trial, this physician testified that the patient's symptoms--difficulty swallowing, inability to talk, and general muscle weakness--were all consistent with a Dilantin overdose. The patient was admitted to the hospital and removed from any further administration of Dilantin. The blood levels were checked daily and came down enough to enable the patient to be transported to a skilled nursing care unit. By July 12, his Dilantin blood level decreased to 10.0 mcg/mL.

Lawsuit
The patient sued the hospital, alleging that the hospital and its employees had "negligently and/or wantonly failed to follow the standard of care and skill of the average qualified member of the profession practicing the specialty by the defendant..." During the trial, the attorney representing the hospital admitted that one of its pharmacists had made an error in changing the Dilantin dosage interval on the MAR from "qhs" (at bedtime) to "tid" (three times a day). The attorney for the hospital asserted in his opening statement that no evidence would be presented during the trial showing that anyone at the hospital had consciously disregarded the patient's safety, so as to warrant an award of punitive damages. In the hospital attorney's closing statement, he asserted that although an error had been made in the MAR, which had been compounded when the MAR was not properly reconciled by a nurse, those failures were simply the result of human error, and that "although it was negligent for them to do that," there was no proof of any consciousness on the part of anyone at the hospital that some act or omission was being done that would likely or probably cause injury.

During a trial recess, after both sides finished their claims, but before the jury was instructed as to the applicable law, the attorney for the hospital argued to the judge that the punitive damages claim should be dismissed. The attorney renewed the hospital's contention that "although the evidence might support a negligence claim, there was not substantial evidence indicating that [the hospital] had acted wantonly, let alone clear and convincing evidence of wantonness so as to allow the recovery of punitive damages." The trial court judge denied the hospital's motion to dismiss the punitive damages claim.

The case was submitted to the jury with instructions that the patient was claiming that the hospital "breached the standard of care required of a hospital," that its breach was the proximate cause of his injury, and that the hospital did "not deny it breached the standard of care in administering Dilantin to [the patient]." The judge instructed the jury that before the hospital could be found guilty of wantonness, "it must be shown that the hospital or its employees acted with reckless indifference to the consequences ... it either consciously or intentionally did some wrongful act or consciously omitted some known duty which produced the injury." Finally, with respect to the patient's claim for punitive damages, the judge instructed the jury that punitive damages could be awarded if the patient had proved by clear and convincing evidence that the hospital "consciously or deliberately engaged in some type of wantonness in regard to [the patient]."

The jury came back with a general verdict in favor of the patient, awarding the patient compensatory damages in the amount of $200,000 and punitive damages in the amount of $800,000. The trial judge entered a judgment for those amounts. The hospital filed a motion for a judgment as a matter of law, saying in essence that the jury should not have been permitted to consider punitive damages, or in the alternative, for a new trial or a remittitur (reduction of the jury award). The trial judge denied the hospital's motion for a judgment as a matter of law as to the wantonness claim and the punitive damages award. The judge acknowl­ edged that the jury could have concluded from the evidence that the hospital "through its agents acted with a conscious disregard for the safety of [the patient] in failing to monitor his medication, knowing that such failure could result in Dilantin toxicity." The judge remarked that certain occurrences at trial had improperly influenced the amount of the compensatory damages award, and that the award should be reduced to $25,000. The judge also found that the punitive damages award should be reduced to $50,000. For those doing the math, the $1 million jury verdict was reduced to $75,000 by the trial court judge. The patient was given 30 days to accept the remittitur, or a new trial would be granted. The patient timely filed a motion to alter, amend, or vacate that judgment. The judge denied that motion. The trial judge also ruled that because the patient had failed to accept the remittitur, the hospital's motion for a new trial would be granted.

Appeal
Both parties appealed the ruling to the Alabama Supreme Court. This group of judges said that the one dispositive issue is "whether there was clear and convincing evidence of wantonness on the part of [the hospital] so as to authorize the imposition of punitive damages." The standard for an award of punitive damages is set by a state statute that provides: "Punitive damages may be awarded in tort actions where it is proven by clear and convincing evidence that the defendant consciously or deliberately engaged in ... wantonness that caused injury to the plaintiff."³

"Clear and convincing evidence" is defined as "evidence that, when weighed against evidence in opposition, will produce in the mind of the trier of fact [in this case, the jury] a firm conviction as to each essential element of the claim and a high probability as to the correctness of the conclusion." Proof by clear and convincing evidence requires a level of proof greater than a preponderance of the evidence or the substantial weight of the evidence but less than beyond a reasonable doubt.⁴

"Wantonness" is defined as "conduct which is carried on with a reckless or conscious disregard of the rights or safety of others."⁵ In earlier cases, this court ruled that "‘wantonness' is not merely a higher degree of negligence; instead, it is a ‘qualitatively different tort concept of actionable culpability.'" ⁶ In terms of burdens of proof, the court stated: "While a party claiming wantonness does not have to prove an intent to injure, this Court has held that wantonness requires proof of some degree of conscious culpability." ⁷ Furthermore, the court has held that wantonness is "the conscious doing of some act or the omission of some duty, while knowing of the existing conditions and being conscious that, from the doing or omitting to do an act, injury will likely or probably result."⁸

The patient argued that he satisfied the "clear and convincing" evidence standard for wantonness by evidence showing that: on the MAR, the hospital pharmacy had erroneously changed the description of the Dilantin interval of dosage; a nurse's reconciliation was not performed or that the reconciliation was improperly performed; none of the nurses administering Dilantin to the patient detected the error due to the fact that there were no additional checks, balances, or other safeguards in place to prevent the repetition of such error; the patient exhibited classic symptoms of Dilantin toxicity, which are well known in the medical profession, but no one monitored the level of Dilantin in his blood; no one ever checked the original physician's order despite the unusually large amount of Dilantin being administered; a nurse illegally signed the doctor's name to the discharge prescription; the community pharmacist attempted to question the amount of Dilantin prescribed but was ignored and treated rudely when he tried to question hospital employees about the problem; and the nurses and other hospital personnel never checked the PDR (Physicians' Desk Reference) or their other computer systems to verify the dosage.

The Supreme Court rebuffed all these arguments. It stated that the director of pharmacy for the hospital had only guessed how the dosage mistake occurred and that his testimony amounted to "nothing more than human error in the form of inattention, thoughtlessness, or heedlessness--the inadvertent omission of a duty." ⁹ As to the MAR comparison with the original order, the court stated, "Whether the nurse's reconciliation was simply not performed or was performed incorrectly, there is no evidence indicating that the nurse responsible consciously performed the reconciliation wrongly, or consciously omitted to perform it, while knowing of the existing conditions and being conscious that from doing or omitting to do an act, injury will likely or probably result."

As to the allegation that the patient's condition should have alerted the health care providers to monitor his Dilantin blood levels, the court noted that one of his neurologists testified that although the patient was exhibiting lethargy, confusion, and difficulty walking, all of which can be signs of Dilantin toxicity, "throughout the time he was on the rehab floor, he was episodically sleepy. And he was taking Valium and getting a lot of pain medicine. So I thought throughout the time he was on the rehab floor, that that was the reason he was lethargic. Plus the fact that he had preexisting dementia and had had a fall. So I thought it was a--mainly a problem with preexisting dementia, plus a lot of pain medicine, plus Valium. And I was never suspicious that he'd had Dilantin toxicity."

Directing attention to the culpability of the pharmacists involved in this incident, the pharmacy director was asked if he would consider a dosage of 300 mg three times a day as being "unheard of" in a hospital setting. He answered, "No, sir. It's not a common dose, but I've seen it on multiple occasions in different hospitals that I have worked." In his opinion, that dosage alone "would not raise a red flag in the mind of a pharmacist that the dosage might be placing a patient in jeopardy." The neurologist testified that there were occasionally people to whom it was necessary to give large amounts of Dilantin, often in the hospital, so that there were times when a prescribed dosage as high as 900 mg daily would be appropriate. He also opined that a dosage of 900 mg daily would be unusual, "but we have had patients take that amount or higher."

After reviewing the evidence, the Supreme Court of Alabama concluded:
Given the state of the record, we cannot say that clear and convincing evidence was presented that any nurse at the hospital was guilty of wantonness in failing to suspect that [the patient's] symptoms represented Dilantin toxicity, or that the nurse was guilty of wantonness in not suspecting the MAR entry was erroneous because of the unusually high daily dosage of Dilantin being administered. There was no expert testimony adduced to the effect that the standard of care would have required [the hospital] to institute checks, balances, or safeguards to detect a Dilantin medication error, other than the reconciliation process, and there was no expert medical testimony to the effect that the standard of care would have required a nurse to have checked the Physicians' Desk Reference or any computer system to verify the dosage reflected on the MAR. Finally, not only was there no expert medical testimony to the effect that one of the nurses at the hospital should have procured a blood test to determine the level of Dilantin in [the patient's] blood, there was affirmative testimony that only a doctor could order such a test.

Analysis
The fact that this court could not find that the errant pharmacist acted with wanton disregard for the patient is somewhat at odds with two prior cases brought against pharmacists in the state where the patient was seeking punitive damages.¹⁰ After comparing the facts of those cases to the facts of the present case, the court stated:

Together, they stand for the principle that if a pharmacist is presented with an illegible prescription that he or she misreads, without careful study, to call for a dangerous drug that would be anomalous to the specialty of the prescribing physician, the pharmacist must investigate further. Failure to do so could represent a reckless disregard for the safety of others generally.¹¹Conversely, an inadvertent misreading by a pharmacist of a legible prescription, under circumstances whereby the medication given to the patient, although representing an unusual choice, was not of such "extreme unusualness" as to cause any competent pharmacist "grave concern," would represent no more than negligence.

Based on this analysis, the judges of the Supreme Court of Alabama concluded unanimously that "the trial court erred in denying the hospital's motion for a directed verdict in its favor as to the issue of wantonness as a predicate for an award of punitive damages." Therefore, that part of the judgment was reversed.

While this discussion may not elucidate any shocking new bright line test between ordinary negligence and willful or wanton disregard for the safety of patients, it should be a good indication for pharmacists that the courts are scrutinizing our profession closely and will hold us responsible when things go wrong that we could have or should have prevented. While the degree of culpability between these two levels of damages may be difficult to articulate, pharmacists should always strive to prevent any and all errors within our abilities.

REFERENCES
1. Ferguson vs. Baptist Health Systems, 910 So 2d 85; 2005 Ala Lexis 19, February 11, 2005.
2. The Supreme Court judges thought it important enough to clarify the meaning of the medical order in the patient's chart by including a detailed analysis of each term in a footnote; presumably, this will help out the lawyers who read the case and do not know much about the health care system. The footnote, in toto, states: "‘Po' is an abbreviation for the Latin phrase ‘per os,' meaning by mouth, orally. Merriam-Webster's Collegiate Dictionary 956 (11th ed. 2003); ‘QHS' is an acronym for the Latin phrase ‘quaque hora somni,' meaning at the hour of sleep, i.e., at bedtime. It apparently is a commonly used blending of two acronyms: ‘QH,' an acronym for ‘quaque hora,' meaning every hour and ‘HS,' an acronym for ‘hora somni,' meaning at bedtime. See Dorland's Illustrated Medical Dictionary, Appendix 2, ‘Selected Abbreviations Used in Medicine' (30th ed. 2003)."
3. Section 6-11-20(a), Ala. Code 1975.
4. Ala. Code 1975, § 6-11-20(b)(4).
5. § 6-11-20(b)(3).
6. Lynn Strickland Sales & Service Inc. v. Aero-Lane Fabricators, Inc., 510 So. 2d 142 (Ala. 1987).
7. Yamaha Motor Co., Ltd. v. Thornton, 579 So. 2d 619, 623 (Ala. 1991). See also, Hamme v. CSX Transportation, 621 So. 2d 281 (Ala. 1993).
8. Fox Alarm Co. v. Wadsworth, [Ms. 1020994, Jan. 14, 2005]  So. 2d, 2005 Ala. LEXIS 17 at *23 (Ala. 2005) (quoting McKenzie v. Killian, 887 So. 2d 861, 871 [Ala. 2004], quoting in turn Alfa Mut. Ins. Co. v. Roush, 723 So. 2d 1250, 1256 [Ala. 1998], and citing Bozeman v. Central Bank of the South , 646 So. 2d 601 [Ala. 1994]).
9. "Evidence ... which affords nothing more than mere speculation, or conjecture, or guess is insufficient to warrant the submission of a case to the jury." Sprayberry v. First Nat'l Bank, 465 So. 2d 1111, 1114 (Ala. 1984). Finley v. Patterson, 705 So. 2d 826, 830 (Ala. 1997).
10. Harco Drugs, Inc. v. Holloway, 669 So. 2d 878 (Ala. 1995), and Cackowski v. Wal-Mart Stores, Inc., 767 So. 2d 319 (Ala. 2000).  The Cackowski case was discussed in this column in an article entitled, "Mistake Or Wanton Disregard?" US Pharmacist, 25:11, November 28, 2000. 
11. 669 So. 2d at 880; 767 So. 2d at 326.

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