Must non-patients be warned about drug effects

Drug Store News, Nov 19, 1990

Must non-patients be warned about drug effects

OREGON, 1990 - The HMO argued this case should not have even gone to trial because the plaintiff did not establish a breach of the standard of care on the part of the HMO. The plaintiff countered that a jury could determine guilt without the aid of experts based on the fact that a prescription drug is dangerous and requires a pharmacist to independently warn of its hazards, regardless of the instructions of the prescribing physician or any statutory requirements to warn.

In his testimony, the plaintiff proved that an overdose of imipramine was potentially fatal and that there was no warning by the HMO's pharmacist. With this evidence, the plaintiff argued that the jury could find a duty to warn existed and that the pharmacist's duty was breached.

The defendant argued that expert testimony is required to prove the community standard of care for a pharmacist and that the plaintiff provided no evidence that the community standard of care in the professional community required a pharmacist to warn of the hazards of this prescription drug. The defendant concluded that no breach of due care could be found even if the warning were lacking.

While no Oregon appellate court has thus far decided the standard of care for a pharmacist in a negligence action, other Oregon law concludes that, in most cases of negligence against professional persons, expert testimony is required to establish what the reasonable practice is in a community. Without such expert testimony, a plaintiff cannot prove negligence. The reason for the rule is the court's feeling that a panel of jurists is generally not able to discern what is considered reasonable professional conduct for a pharmacist. However, the court points out there are cases where the standard of care is obvious - for example, a surgeon operating without sterilization of instruments.

The court further noted that most jurisdictions have not found any common law that says a pharmacist has the duty to warn patients of the hazards of drugs prescribed by physicians, preferring to leave decisions about warning requirements to legislatures and the prescribing physicians themselves. While these laws vary from state to state and district to district, most courts believe that pharmacists should not be expected to second-guess physicians. While most law cases show that pharmacists do not have a duty to warn, the facts in this case prompted the court to once again make a decision on a pharmacist's duty to warn, and how far that duty extends.

RESULTS - Considering the complex relationship between a physician, a patient, and a pharmacist, the court first concluded that an expert must testify as to the standard of care in the community for warning of the dangers of a prescription drug before a jury could determine that such a standard was breached.

The only expert testimony presented in this case consisted of the fact that it was standard practice for the pharmacist to use a label to warn that an overdose of imipramine was potentially fatal.

While there was conflicting evidence about whether that warning was given in this case, the court decided that the overall standard of care was met and that the plaintiff's case was deficient. However it should be noted that the court refused to comment on the standard of care in other circumstances, such as when a pharmacist sells a non-prescription substance or when a pharmacist has personal knowledge of the customer's medical condition.