Pharmacy Law: Liability When Dispensing to Allergic Patients

SEPTEMBER 01, 2008
Joseph L. Fink III, BSPharm, JD

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.

Issue of the Case

When a pharmacist dispenses a medication in a category of pharmaceuticals to which the patient is allergic, what legal doctrines, in addition to negligence, may be used in the lawsuit against the pharmacy?

Facts of the Case

A patient in a midwestern state was experiencing severe menstrual cramps and asked that her physician phone in a prescription for her. The physician phoned the pharmacy to request dispensing of a nonsteroidal anti-inflammatory drug (NSAID), although the patient had experienced allergic reactions to that category of medications in the past.

The husband of the patient came to the pharmacy to pick up the prescription, and testimony was presented that neither he nor his wife was aware that the medication was an NSAID. When the wife had presented prescriptions at the pharmacy in the past, she had been approached by staff members to inquire about any drug allergies, and she told them she was allergic to aspirin, acetaminophen, and ibuprofen. The husband testified that the same question was asked with this transaction and that he had reported her history of drug allergies.

In his testimony, the manager of the pharmacy noted that pharmacists were required by policy to inquire about allergies. Moreover, the pharmacy's computer system would have borne information about the hypersensitivity. If a new prescription was entered into the computer, the software would compare that new information with the preexisting information about other medications being used by the patient, as well as history of allergies. If an incompatibility was detected, a warning would have flashed on the computer screen. This warning only could be overridden after calling the prescriber or by an override requiring that the pharmacist enter a security code.

The manager testified that it was improper for the pharmacist to complete an override without contacting the prescriber. In this case, the system reflected neither an indication that the physician had been contacted, nor that a manual override had occurred. The pharmacist who actually dispensed the medication testified that she had no recollection of the entire incident. She did indicate, however, that the patient's history of allergies would have been available to her through the computer system.

After consuming the first dose, the patient began having difficulty breathing. She called the pharmacy to ask if there might be some explanation and was told no. Suffering continuing breathing problems, she consulted a pharmacist-friend who was familiar with her history and told her to go to an emergency room immediately. She was diagnosed as being in anaphylactic shock and subsequently reported increased episodes of asthma, petit mal seizures, and worsening of her multiple sclerosis.

She filed a lawsuit against the pharmacy using several legal doctrines: negligence, loss of society, willful and wanton misconduct, and battery. The case was filed in a federal trial court, and the pharmacy moved for summary judgment on the last 2 claims, requesting that the judge rule they lacked merit and should be dismissed.

The Court's Ruling

The motions to dismiss both claims—willful and wanton misconduct as well as battery—were denied.

The Court's Reasoning

Turning first to the willful and wanton misconduct argument, the judge reviewed a state statute designed to shield some defendants from punitive damages associated with malpractice claims. He concluded that the statute did eliminate the possibility of punitive damages being assessed as punishment for a verdict of willful and wanton misconduct, but the plaintiff still could recover compensatory damages based on negligence.

The second legal theory to be addressed was battery, traditionally defined as offensive touching without consent. The judge stated that in order for the plaintiff to recover damages, she would need to show that (1) the pharmacy intended to cause a harmful contact; (2) harmful contact occurred; and (3) the plaintiff did not consent to the contact.

With regard to 1, the court concluded that the plaintiff need not show that the pharmacy intended the harm; it was only necessary to show that the pharmacy intended to bring about the contact when dispensing the offending medication. On 2, the court determined that the harmful contact occurred when the defendant caused the plaintiff to "come in contact with a substance in a way that may be viewed as offensive"; whereas for 3, the lack of consent existed because the patient did not know she was receiving a medication to which she likely would be allergic.