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3/22/2001

Knowing Patient's Allergies, Pharmacist Had Duty to Warn, Says Illinois Court

Nancy Tarleton Landis

When a pharmacist knows that a prescribed drug is likely to injure a patient, it is that pharmacist’s responsibility to intervene, an Illinois appellate court found in a recent case.

Facts of the case. A trial court had dismissed charges brought in 1994 against Wal-Mart Stores Inc. by Heidi and Kent Happel concerning a prescription for the nonsteroidal anti-inflammatory drug (NSAID) Toradol (ketorolac tromethamine) filled in 1993. Despite information in the pharmacy’s computer system that Heidi was allergic to aspirin, acetaminophen, and ibuprofen—and despite a handwritten note about these allergies on her prescription for Toradol—the pharmacy failed to contact the physician and patient and filled the prescription.

After taking one dose as prescribed for menstrual cramps, the patient began to have respiratory distress and was subsequently treated for anaphylactic shock. In the negligence action against Wal-Mart and the physician, she testified that her asthma episodes had since worsened and become more frequent and that she had also had seizures and an exacerbation of multiple sclerosis.

The Wal-Mart pharmacist testified that it would have been necessary to override a computerized contraindication alert to complete filling of the prescription. The physician testified that he did not know the drug was contraindicated for patients with an allergy to aspirin or another NSAID.

The Happels settled with the physician in March 1999. In September 1999, the trial court granted a motion by Wal-Mart for summary judgment (i.e., dismissal of the case). Wal-Mart argued that it neither owed the plaintiff a duty to warn of the allergic reaction nor voluntarily assumed that duty. The Happels appealed, and in September 2000 the appeals court for the second district of Illinois reversed the trial court’s granting of summary judgment. This sent the case back to the trial court level.

Basis for the opinion. In rendering their decision, the appellate court judges considered an amicus curiae ("friend of the court") brief from the National Association of Boards of Pharmacy (NABP) and several previous cases concerning the scope of pharmacists’ duty. Other courts have concluded that imposing upon pharmacists a generalized duty to warn the physician or patient about adverse effects or excessive quantities of a prescribed drug would, in effect, insert pharmacists into the physician–patient relationship, requiring them to exercise medical judgment about prescribing.

Happel v. Wal-Mart "is not a case in which the plaintiff is asking the pharmacist to exercise any modicum of medical judgment or to interject himself into the doctor–patient relationship," states the opinion. In this case, "both the foreseeability and likelihood of injury strongly favor imposing a duty to warn on defendant," and the burden to warn either the patient or the physician is minimal. "Under the circumstances here, where defendant knew of Heidi’s allergies, where defendant knew that Toradol was contraindicated for a person with Heidi’s allergies, and where defendant knew that injury or death was substantially certain to result, defendant had an affirmative duty to disclose, either to [the physician] or to Heidi, the information that Heidi should not take Toradol."

The court found NABP’s brief, which suggested that the duty to warn in this case was consonant with the professional practices and standards expected of a pharmacist, to be persuasive. The National Association of Chain Drug Stores had filed a brief supporting Wal-Mart’s arguments.

Change in Illinois? Happel v. Wal-Mart is noteworthy because of the many cases establishing precedent that pharmacists do not have a duty to warn, said Karl G. Williams, a pharmacist for McKessonHBOC MedManagement who has a private law practice and teaches at the University of Wyoming pharmacy school. Although some court cases in other states have imposed on pharmacists a duty to warn, Williams considers this position by an appellate court in Illinois to be "really remarkable" in view of the Illinois courts’ long history of not imposing a duty to warn. If the case were to reach the state supreme court, he is skeptical about whether the finding of a duty to warn would survive.

In particular, Williams pointed to the Illinois case of Frye v. Medicare-Glaser Corp., in which the patient died after drinking alcohol while taking a barbiturate. The plaintiff had alleged that, because the pharmacy had affixed a "drowsiness" sticker to the container, the pharmacist had undertaken a duty to warn but had failed to warn of all potential dangers. The state supreme court reversed an appellate court finding of a duty to warn. In the 2000 case of Kasin v. Osco Drug, Inc., an Illinois appellate court held that, if a pharmacist voluntarily undertakes a duty to warn about potential adverse effects of a drug, that duty extends only to the information the pharmacist provides; the choice to warn of a few specific effects does not require the pharmacist to warn about all possible adverse effects.

Proceeding with caution. Gary G. Cacciatore, another pharmacist–attorney who is director of regulatory affairs for Cardinal Health, said the Happel v. Wal-Mart case is interesting because, while courts are starting to recognize the expanded duties of pharmacists, "they’re doing it cautiously. They’re not recognizing a generalized duty to warn for pharmacists. Their argument is that it would cause a pharmacist to question everything the doctor does. But there are certain situations—and this court does a good job of pointing out those situations—in which the pharmacist does have responsibility beyond accurately filling the prescription….In this particular case, they say not only was it foreseeable but it was nearly certain that the patient was going to have an adverse reaction. And in those cases, it makes sense to hold the pharmacist responsible for taking action to prevent harm to the patient."

Cacciatore compared Happel v. Wal-Mart with a recent case in Texas, Morgan v. Wal-Mart Stores, Inc. In that case the trial court upheld pharmacists’ duty to warn, but in August 2000 the court of appeals for the third district reversed the decision.

In 1993, 14-year-old Cameron Pettus, the son of Jacquelyn Morgan, died of hypereosinophilic syndrome, a rare adverse reaction to desipramine. He had begun taking the drug at age 12 for attention deficit hyperactivity disorder. In 1995 Cameron’s parents sued several defendants, including physicians who had failed to diagnose the problem and Walgreen’s, where the original prescription was dispensed. Morgan stated that she had received no information about the drug from pharmacists at either Walgreen’s or Wal-Mart. By the time the trial began in 1999, the plaintiffs had settled or dismissed their claims against all defendants except Wal-Mart.

The appellate court based its judgment on the facts of that case, said Cacciatore, but it did say that under different circumstances there may have been a duty to warn. "I think both courts were correct," he said, but the facts in the Texas case were different. The appellate court opinion on Morgan v. Wal-Mart states, "We hold that pharmacists have no generalized duty to warn patients of adverse reactions to prescription drugs absent special circumstances not present here."

What was missing, said Cacciatore, were those special circumstances that did apply in the Happel case: "that it was not only foreseeable but nearly certain that the patient would have an allergic reaction."