About the Author
Joseph L. Fink III, JD, DSc (Hon), BSPharm, FAPhA, is professor emeritus of pharmacy law and policy as well as former Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.
Each of the 4 pharmacy defendants filed separate motions with the trial court judge to dismiss the lawsuits. The judge accepted one of the arguments, known as the learned intermediary doctrine, and ruled that it governed the matter and applied to all 4 pharmacies. The cases against the pharmacies were dismissed, and the attorneys for the deceased’s father appealed. However, the judge of the state court of appeals viewed the learned intermediary doctrine as inapplicable to the facts of this case.
THE COURT’S REASONING
The learned intermediary doctrine is usually encountered in lawsuits against manufacturers of health products, ie, pharmaceuticals or medical devices. The doctrine states that a manufacturer of a product that injured a patient has fulfilled its legal duty to the patient when it provides all the information necessary for the safe and appropriate use of the item to the “learned intermediary,” usually a physician, who then discusses those matters with the patient who will be the ultimate user. It is most commonly encountered in lawsuits based on claims of negligence or product liability.2
The judges at the court of appeals level agreed that the learned intermediary doctrine was inapplicable in this case and should not serve as basis for dismissal. The father’s lawsuit did not allege product liability or failure to warn. Rather, it was a malpractice case based on the prescriber “not noticing that the amount and frequency of prescriptions was outside reasonable practices.”1
The appellate court ruled that “these professional malpractice claims were sufficiently distinct from product liability and failure to warn claims to preclude application of the learned intermediary doctrine to bar their consideration.”1 The matter was returned to the trial court level for further proceedings.
REFERENCES
1. Shamy v Gamao, A-3331-20 (NJ Super Ct App Div 2023).
2. Thornton RG. The learned intermediary doctrine and its effects on prescribing physicians. Proc (Bayl Univ Med Cent). 2003;16(3):359-361.doi:10.1080/08998280.2003.11927929