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Mistake or Wanton Disregard?

The standard for showing wanton disregard is much higher than for a negligent mistake.

T here should be no doubt that pharmacists and pharmacies will be held liable in a civil lawsuit when a dispensing error causes patients to be harmed. The damages usually awarded to the patient are for compensation of the injuries actually suffered and may include an amount for pain and suffering. In some states, patient-plaintiffs may also seek punitive damages if there is evidence that the defendant did something willful or wanton in reckless disregard for the plaintiff’s safety. Two recent cases demonstrate the distinction.

Case #1

The plaintiff entered a weight-loss treatment program in 1995 and was given prescriptions for Verelan (antihypertensive), Profast and Pondamin (commonly called the Fen/Phen diet). At the pharmacy, she agreed to have the prescriptions filled with generic drugs. The pharmacist misread the Pondamin prescription, thinking it called for prednisone, and dispensed Deltasone. The pharmacist testified that because it was during the cold and flu season it would not be unusual for a doctor to prescribe a steroid, which often causes weight gain, along with a diet drug. Although the plaintiff left the prescription with the pharmacist, her physician had also given her a list of the drugs he was prescribing for her. Based on that list, she knew that the pharmacist gave her Deltasone rather than Pondimin, but she did not ask if there was any difference between the two.

The physician had given her prescriptions for 30 days’ worth of each medication, with refills. When she returned to the pharmacy for refills, all of the prescriptions were correctly filled. Within days after this, she began to experience blurred vision and lethargy. After consulting with her physician, the pharmacy error was detected. She claims to have suffered several physical and mental ailments as a result of the mistake. She sued the pharmacy and the pharmacist for negligence and wantonness. A claim of wanton disregard for the plaintiff’s well-being would, if proven, entitle the plaintiff to seek punitive damages.

The plaintiff testified that when she stopped taking the steroid and began taking the correct medication, her system went into withdrawal, causing the blurred vision and lethargy. After the mistake in prescriptions was discovered, she was put back on the steroid and gradually weaned off the drug. The plaintiff claimed that as a result of taking the steroid, she had difficulty in concentrating and had memory loss, hair loss, night sweats, joint pain, and swollen glands. She also stated that she became severely depressed and suicidal. Two physicians diagnosed the plaintiff as suffering from depression and Epstein-Barr virus. One mental health professional determined that her depression and anxiety stemmed from steroid use.

The pharmacy’s expert witnesses contradicted the plaintiff’s experts as to causation and the extent of damages suffered. They testified that the problems experienced by the plaintiff were related to the long-term use of the prescribed diet medications, use of the antidepressant Serzone, and the adenosine injections she received in conjunction with her weight-loss program. These experts also disputed whether the active Epstein-Barr virus was present in her system. According to them, the plaintiff’s test results indicated the presence of the Epstein-Barr antibody in her system, and its presence would indicate that she may have been exposed to the virus at some time in the past. In any event, they claimed that the presence of the Epstein-Barr virus or antibody in her system was not related to her use of the steroid Deltasone.

A state statute requires that malpractice claims against “healthcare providers” be proven by substantial evidence. The trial court judge ruled that pharmacists are healthcare providers and therefore come within the substantial evidence mandate. The judge ruled that the plaintiff had failed to submit substantial evidence that the pharmacy or pharmacist had acted with wanton disregard and dismissed the claims. The plaintiff agreed and voluntarily dismissed the pharmacist from the law suit. After a jury trial against the pharmacy on the negligence claim, the jury returned a verdict in favor of the pharmacy. The plaintiff appealed to the state’s Supreme Court. This Court upheld the finding that a pharmacist is a healthcare provider because the dispensing of drugs is an integral part of healthcare services. The Court also upheld dismissal of the wantonness claim. The pharmacist’s mistake in reading the prescription does not rise to the level of reckless disregard necessary to sustain a wantonness claim. The Court, however, remanded the case for a new trial on the negligence claim because it found the jury instructions to be confusing.

Case #2

PepcidThe plaintiff was diagnosed with pancreatic cancer in 1995. She underwent radical surgery to remove her stomach, parts of her small intestine and her pancreas. In 1997, after she underwent further surgery, her physician prescribed fluorouracil chemotherapy and radiation. Upon release from this hospitalization, she had prescriptions for Diflucan, Kytril and Pepcid taken to the defendant pharmacy. The prescription for Pepcid 20 mg was erroneously filled with Paxil 20 mg. The normal starting dose for Paxil is 10 mg. She consumed the Paxil as directed, twice daily, for approximately one month. During this time she exhibited increased irritability, weakness, confusion and inattention to hygiene. Approximately two weeks after the prescription was erroneously filled, and without knowing about the error, her physician prescribed Zoloft to address the signs of depression displayed by the patient. However, within five days, the doctor stopped the Zoloft because the patient presented with very low blood pressure. A few days later, she got up to go to the bathroom and she fell, causing her to fracture her leg and foot. Testimony indicated that her loss of equilibrium was due to the Paxil. She was admitted to a nursing home. Her daughter brought all of her medications from home and the nurses continued to administer them, including the Paxil. The error was discovered by a nurse five days after admission to the nursing home. Her physician discontinued the Paxil immediately upon learning of the error. When her daughter told the pharmacy about the mistake, the pharmacy indicated that it would fill out an incident report. No one at the pharmacy discussed any of the side effects associated with Paxil or the dangers of abrupt withdrawal. Ten days after the error was discovered, the patient was to be released from the nursing home. However, she fell, causing injuries to her head, back and pelvis. Testimony indicated this fall was caused by abrupt withdrawal of the Paxil.

She sued both the pharmacy and the pharmacist. The jury returned a general damages verdict of $100,000 against both defendants and $150,000 in punitive damages against the pharmacy only. The pharmacy appealed the punitive damages award, claiming there was insufficient evidence to submit the claim to the jury. The pharmacy asserted that this was a simple mistake, not willful and wanton disregard for another’s safety. It also disputed the jury instructions on punitive damages and challenged evidentiary rulings allowing the submission of incidence reports and licensee disciplinary proceedings associated with this incident. The Court found that there was enough evidence to submit the punitive damages question to the jury.

The pharmacist who made the error was on duty alone during the noon rush hour when the mistake occurred. The pharmacist admitted that she had asked for extra technicians to help her during busy times. The evidence showed that during a preceding three-year period, 34 mistakes of a similar nature occurred at this pharmacy. All involved dispensing the wrong drug with the same first alphabetical letter as the prescribed drug. The Supreme Court of Iowa concluded that the jury could have reasoned from this evidence that the pharmacy knew it had a problem and did not take adequate steps to correct it. The Court stated that the pharmacy’s conduct was “particularly egregious” because it failed to warn the plaintiff or her physicians about the adverse consequences of using Paxil or dangers associated with its abrupt withdrawal. The pharmacy knew of the error 12 days before the plaintiff fell in the nursing home, yet, in violation of its own written policy manual, neglected to tell the plaintiff, her family or her physicians what signs or symptoms should be watched for. A jury could have concluded that warnings of this type could have prevented the last fall. Failing to take action after it learned of the error could be taken as evidence of obvious indifference in support of the punitive damage award. Therefore, the trial court did not err in submitting the punitive damages question to the jury. There was also no error in the jury instruction, which indicated “punitive damages are intended to punish the defendant…and protect the public by deterring the defendant and others from doing such wrong in the future.” Nor did the trial court err in admitting evidence of the pharmacy’s financial worth for purposes of calculating the punitive damage award. Likewise, the trial court correctly admitted the reports of 34 other incidents involving misfilled prescriptions as evidence of the existence of a dangerous condition. The fact that 30 of the incidents did not involve the pharmacist who misfilled this prescription is not relevant to the claim for punitive damages against the pharmacy; these incident reports are evidence that the pharmacy corporation knew there was a problem at this particular pharmacy and did not take any corrective action.

The Supreme Court did, however, find that the trial court committed reversible error in admitting evidence regarding the Board of Pharmacy investigation and administrative proceedings about this incident. The trial court erroneously admitted a stipulation and consent order agreed to by the state and the pharmacy. The consent order specifically stated that the parties entered into it for the purpose of settling the charges without a hearing and that the pharmacy did not admit the charges were true or that it was guilty of any wrongdoing. The charges in the Board of Pharmacy complaint “convey an atmosphere of criminality” against the pharmacy and did carry the threat of criminal penalties. This evidence was not probative and its admission caused harm to the pharmacy’s rights. For this reason, the Supreme Court of Iowa remanded the case for retrial only on the issue of punitive damages against the pharmacy. The compensatory damages award against both the pharmacist and the pharmacy were affirmed.

One judge dissented, finding there was insufficient evidence of willful misconduct on the part of the pharmacy to submit the issue of punitive damages to a jury. This judge reasoned that the pharmacy justifiably relied on the plaintiff’s treating physician to render appropriate care after the error was discovered. This judge noted the fact that the pharmacy took no action when it learned of the mistake may be “egregious conduct” but believed the lack of action does not amount to willful or wanton misconduct, where the pharmacy could reasonably assume that the physician would take whatever steps were necessary to protect the patient.

Analysis

Taken together, these cases show that there is significant controversy in how claims against pharmacies are handled in the courts. In the first case, the evidence showed that the pharmacist made a mistake that resulted in harm to a patient. The Supreme Court of Alabama concluded that this evidence was not sufficient to meet the standards of wantonness to sustain a punitive damage claim. Instead, the mistake should serve as a basis for compensatory damages under an ordinary negligence standard.

Although the case has to be retried because the Board of Pharmacy proceedings should not have been admitted, on retrial, the 34 incident reports will still be available as proof on the wanton disregard claim. It is almost ironic that this pharmacy may again face punitive damages because its own incident reports will be used against it. Had similar incident reports been available in the first case, a very different result likely would have occurred.

Pharmacists should take these cases to mean that they are responsible for their work environment. If a simple negligent mistake harms a patient, they will be held accountable for at least compensatory damages. But if they work in situations where errors are continually made and do not take corrective action, they may very well face much greater liabilities.

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