On The Docket
David B. Brushwood, BSPharm, JD
Lawsuits brought by patients against pharmacists usually allege harm caused by a drug that was dispensed to the plaintiff by the defendant. Courts may be asked to decide whether a case based on allegations of this sort should be litigated as a “product liability” case or as a “professional malpractice” case.
Because there are substantive and procedural differences between these two types of cases, it may be more beneficial for one party to advocate for the application of one approach to liability and to urge that the other approach be rejected.
Two recent cases, one from California and the other from Tennessee, decided on the same day (April 3, 2020), addressed this issue within the context of two significantly different sets of facts.
The Tennessee case
The plaintiff in the Tennessee case sued the pharmacy that had dispensed his liraglutide, which allegedly caused him to suffer from “necrotizing pancreatitis and severe malnutrition.”
He asserted that the drug was the subject of an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) that required a MedGuide to be distributed with the drug. He alleged that he never received a MedGuide from the defendant pharmacy, and that this “failure to warn” fell below the standard of care of a pharmacist.
The pharmacy asserted the “seller shield” defense, arguing that the case was actually one of product liability and not of professional malpractice. Under the seller shield defense, a product liability action cannot be maintained against a product seller, other than the manufacturer, except in certain limited circumstances.
The lower court denied the pharmacy’s motion to dismiss and the pharmacy appealed. The appellate court noted that “a pharmacist or pharmacy owes a professional duty of care to a patient to act in compliance with the standard of care required by the pharmacy profession.”
The court also noted that the Tennessee Medical Malpractice Act was amended in 2011 to remove the phrase “medical malpractice” and replace it with “health care liability.” A pharmacist is included in the statutory definition of “health care provider.”
The court concluded that the plaintiff had filed a case of health care liability, rather than a case of product liability, and that the seller shield defense did not apply. Therefore, the denial of the pharmacy’s motion to dismiss was affirmed.
The California case
The plaintiff in the California case alleged that the defendant pharmacy had incorrectly reconstituted a pediatric antibiotic, causing adverse effects for the child that led to hospitalization.
The lawsuit alleged secondary liability of the pharmacy for its employee’s error, as well as primary liability of the pharmacy for “negligent hiring, retention, and supervision of staff,” and also strict liability as the seller of a defective product. The pharmacy moved to dismiss the case.
The court dismissed the strict liability claim, citing prior case law that had established “pharmacies, as a general matter, cannot be held strictly liable for the sale of prescription medication because pharmacists are primarily in the business of providing a service, as opposed to being in the business of selling products to patients.”
The court refused to dismiss the secondary liability claim, which had been labeled only as “negligence” in the plaintiff’s lawsuit, rather than as “professional negligence.” The court ruled that this “imperfect statement of the legal theory” did not require dismissal of the lawsuit.
The court also refused to dismiss the primary liability claim. The pharmacy argued that the primary and secondary liability claims were essentially the same.
The court disagreed. The secondary liability claim was “an indirect claim, i.e., the employees were negligent in filling the prescription.” The primary liability claim was “a direct claim, seeking to hold the pharmacy liable based on its own conduct or lack thereof.”
These two cases support the position that pharmacists and pharmacies are legally considered to be service providers and not product sellers. Pharmacy liability must be based on a breach of the pharmacy standard of care, not on the existence of a drug product defect.