Drugs - Liability

Brief - What is the standard for a pharmacist's duty to warn? - Morgan v. Wal-Mart Stores, Inc., No. 03-99-00700-CV (Tex.App. Dist.3 08/10/2000)

This case deals with implications of the Texas statute creating a duty for pharmacists to counsel patients.  The Texas law, as with those in most other states, was passed in the wake of federal legislation on counseling.  Pharmacists lobbied for these laws to try to establish a professional identify as being expert in the clinical use of drugs, rather than being relegated to their traditional role of preparing and packaging drugs on physician's orders.  Most legal commentators predicted that this law would have the unintended consequence of increasing pharmacists' liability by explicitly creating a duty to counsel and warn patients of the risks of drugs.  The cases arising under these counseling laws are now being tried and reviewed by appeals courts.  This case has been reported in the news media as holding that a pharmacist has no duty to warn of side effects of drugs.  While the plaintiff did lose on appeal, the holding of the case is more complex and should give less comfort to pharmacists.

Plaintiff's decedent was 12 years old when a physician started him on Desipramine for attention deficit hyperactivity disorder.  The prescription was filled at Wal-Mart and the pharmacist did not warn the parents about any risks of the drug.  After about 2 years on the drug, the child died of hypereosinophilic syndrome, which was attributed to an idiosyncratic effect of the drug.  During the period he was using the drug he has several bouts of illness and none of the physician's inquired as to the underlying cause of his problems, so there were several defendants in the case.  After some defendants settled, the case went to trial on a theory of negligence per se, i.e., that the state law required the pharmacist to warn the patient's parents that the drug was not recommend for children and that it had potentially serious side-effects.  The jury found Wal-Mart liable under this theory and awarded in excess of $600,000 in damages against Wal-Mart.  Wal-Mart appealed, arguing that the statute did not create a strict duty to warn and that in the absence of this statutory duty to warn, there was insufficient standard of care testimony to establish that the defendant's conduct fell below that of a reasonably prudent pharmacist.

The appeals court's reasoning was driven by deference to the physician patient relationship and the rationale that requiring pharmacists to warn patients about the risks of drugs, beyond the applicable professional standards, would interfere with the physician patient relationship.  The court reviews a substantial body of cases to this effect.  It is notable that they arose before the current pressures on the physician patient relationship from managed care, and the court was silent on continuing validity of the assumption that the physician patient relationship is sacred and that perhaps the pharmacist could help protect the patient from poor decisionmaking by physicians.  The court then examined the Texas law creating a duty to counsel.  It found that while there might be a statutory duty to counsel, that duty did not include any specific components, such as warning about adverse side-effects of drugs.  The court essentially found that the statute did nothing more than codify the requirement that a pharmacist do what reasonable pharmacists do, nothing that the statute and regulations were couched in terms of behaving reasonably, rather than delineating specific tasks that had to be performed.  The court saw the duty of a reasonable pharmacist, absent special factors identified by expert testimony, as controlled by the learned intermediary, i.e., the physician is the who must warn: "Nonetheless, in light of the learned intermediary doctrine, which we find applicable to the relationship among physician, patient, and pharmacist, we hold that pharmacists have no generalized duty to warn patients of potential adverse reactions to prescription drugs absent some special circumstances not present here."

The problem for the plaintiff is that plaintiff's expert did not provide adequate testimony of the necessary special factors to support a verdict of common law negligence.  The expert even questioned whether a 12-14 year old was a child for the purposed of the label recommendations against given the drug to a child.  Based on this lack of evidence, the court reversed and entered judgment for Wal-Mart, rather than remanding.  This case, if it stands further appeal, reduces the liability of pharmacists in Texas.  Politically, however, it may be a setback to the push by pharmacists to be given more extensive authority to recommend drugs and even to do medical management of patients because, under this court's analysis, such powers would clearly be the unauthorized practice of medicine.