COMMUNITY PRACTICE

Two high courts uphold pharmacists' duty to warn

The highest courts in Illinois and Massachusetts both ruled within days of each other that pharmacists have certain duties to protect patients from potential harm caused by their medications.

In the case of Happel v. Wal-Mart Stores Inc., the Illinois Supreme Court affirmed that if a pharmacy collects information about a patient's allergies, it has a duty to warn of contraindications. In the case of Cottam v. CVS Pharmacy, the Massachusetts high court ruled that if a patient believes that a list of possible side effects is complete, the pharmacy has a duty to make sure that the list is, in fact, comprehensive.

The Massachusetts high court upheld a lower court verdict that awarded Robert Cottam damages of $357,000. The damage amount had been reduced because the jury blamed 49% of the negligence on him and the other 51% on CVS. The plaintiff had settled out of court with his prescribing physician and therapist.

Cottam had alleged that he suffered permanent damage and impotence from priapism triggered by the trazodone he had been prescribed for depression in 1994. He contended that when a CVS pharmacy in Reading, Mass., filled his Rx, the pharmacist gave him only a short list of possible side effects and warned only that the drug could cause drowsiness. He alleged that he was not warned about the risk of priapism.

The Massachusetts decision concerned the scope of duty to warn that's voluntarily undertaken by a pharmacy. The court said that such a duty is based on the pharmacy's entire communications with the patient and the patient's understanding of that communication. For example, if a pharmacy applies only one warning label, such as "take with food," a reasonable patient could not construe it as a comprehensive warning.

However, if the pharmacy provides more information, as in Cottam v. CVS Pharmacy, the court said, "the patient could reasonably interpret the warning form as a complete and comprehensive list of all known side effects, it is appropriate to impose on the pharmacy a duty commensurate with what it appeared to have undertaken. Where a pharmacy provides a more detailed list of warnings or, by way of advertising, promises to provide customers with information, it may thereby undertake a duty to provide complete warnings and information."

Pharmacists and pharmacy owners don't have to hit the panic button because the Massachusetts verdict does not say they have a duty to provide a list of all side effects, said David Brushwood, R.Ph., J.D., professor of pharmacy healthcare administration, University of Florida. He thinks it would be overkill to hand patients a list of all possible side effects, no matter how remote, because patients could be scared away from the medications they need. On the other hand, a knee-jerk reaction to simply stop giving out any warning on side effects would deprive patients of information they need.

"The appropriate reaction to Cottam is if you're not providing a complete list, come out and say it," said Brushwood. "Print on the top of your handouts 'This is not a complete list of side effects,' so the patient doesn't think it is complete. You do need to provide an opportunity for people who want a complete list to get it. You could send them to a Web site or tell them to ask the pharmacist, who could give them the package insert. I think that's all you have to do."

The Cottam ruling is a duty-to-warn case that has "profound" implications for pharmacy, Brushwood said. It charts new territory because it focuses on the consumers' expectations as the basis for the pharmacist's responsibility. Thus, the pharmacy has to be careful to not create expectations that it fails to meet.

The Illinois high court ruled that if a pharmacy keeps patient allergy information on file, it has a duty to act when a prescription is contraindicated. "We do not disapprove of pharmacies' collecting allergy information and recording it in their computers," the justices wrote. "However, if a pharmacy chooses to engage in such a practice, it must also warn of known contraindications. A pharmacy has a duty to warn either the prescribing physician or the patient of the potential danger."

The Illinois high court sent the Happel case back to a lower court for trial. The plaintiff, Heidi Happel, alleges that the defendant, Wal-Mart pharmacy, dispensed her ketorolac script despite having information about her allergy to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) on record in the computer. She further alleges that the pharmacist filled the Rx with no warning about the contraindication. After taking the drug, she suffered anaphylactic shock and has had more frequent asthma attacks and seizures and her multiple sclerosis has worsened.

Carol Ukens

Carol Ukens. Two high courts uphold pharmacists' duty to warn.

Drug Topics

2002;9:42.