Liability for Failure to Remove Recalled Product from Inventory

Pharmacy TimesMarch 2016 Central Nervous System
Volume 82
Issue 3

When a hospital fails to respond to a medication recall notice and a patient allegedly suffers major bodily damage as a result, do the statutory requirements in the state's medical malpractice act apply?


When a hospital fails to respond to a medication recall notice and a patient allegedly suffers major bodily damage as a result, do the statutory requirements in the state’s medical malpractice act apply, specifically those requiring notification to the defendant hospital prior to the filing of the lawsuit?


A patient in a southern state was admitted to the hospital to undergo cardiac bypass surgery. He left as a double amputee (his left leg and right foot were amputated), allegedly because he was administered contaminated heparin while receiving care at the hospital. That led to a severe bacterial infection that ultimately necessitated the amputations.

The patient sued the hospital, alleging that it failed to establish and implement adequate procedures to respond to the recall notice from the manufacturer. The cardiac surgery during which the patient received the heparin occurred more than 4 months after the manufacturer of the product had issued the recall notice.

When the trial court was considering the case during pretrial activities, the hospital made a motion to have the lawsuit dismissed. In support of that motion, the hospital argued that the case arose out of the rendering of, or failure to render, medical care or services, thereby calling into play the state’s medical malpractice statute that requires pretrial notification to the defendant, which did not occur.

The attorneys representing the injured patient argued that this was not really a medical malpractice case; rather, it was a case based on the legal theories of product liability and ordinary negligence. From their perspective, the pretrial notification requirement contained in the statute did not apply. The trial court denied the motion of the hospital to dismiss the case, holding the case over for trial, and the institution filed a request with the state court of appeals to hear the case, seeking to have that ruling overturned.


The appellate court denied the hospital’s request for a hearing in order to reverse the decision of the trial court, thereby allowing the case to proceed to trial. The appellate court agreed with the trial court that the expectations contained in the state medical malpractice statute did not apply to this situation and the resulting lawsuit.


After reviewing the facts that led to the lawsuit, the appellate court disagreed with the defendant hospital, concluding that this was not a matter based on negligence in providing health care services, which is the focus of the state statute. Rather, this claim was centered on the administrative policies and actions, or lack thereof, of hospital employees in responding to the recall notification.

The court distinguished negligent performance during a medical procedure (eg, activities associated with the cardiac bypass surgery) from administrative decisions and actions. The latter involve no medical judgment or skill. The court further emphasized that the error that led to the amputations—failure to remove the offending heparin from active inventory— had occurred months before the patient arrived at the hospital for the medical services.

The court noted that the allegation of negligence was not tied to the decision to administer heparin during the surgical procedure. The court stated, “Indeed, failure to administer a blood thinner during the procedure would undoubtedly fall below the acceptable standard of care.”

The court drew a parallel between what had transpired, or failed to transpire, at the hospital to failure by a grocery store to remove a tainted product from its shelves after having been notified of a recall. It concluded that the hospital’s “allegedly wrongful act is not unique to the hospital setting and does not involve professional medical judgment or skill.”

The pretrial notification required by the statute in question here is one example of the myriad approaches adopted by state legislatures, under the heading of “tort reform,” designed to address the “medical malpractice crisis” that has evolved over past decades. As seen in this court decision, the mandate regarding pretrial notification applies to medical malpractice actions alleging negligence in the performance of services under its ambit, but that expectation is not applicable to a “standard” negligence claim. There are many other examples of special procedural requirements when the claim is based on an allegation of medical malpractice.

Dr. Fink is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.

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