Pharmacy Law: Criminal Liability for Tampering with Medication Packaging?

A pharmacist facing criminal charges associated with missing fentanyl patches seeks to have federal charges related to tampering with a consumer product dropped.

Issue of the Case

When a pharmacist is facing criminal charges associated with missing oxycodone and fentanyl, may the government also allege additional charges under the federal statute that addresses reckless tampering with a consumer product?

Facts of the Case

The defendant pharmacist was charged with multiple criminal counts related to the missing controlled substances. Two of those criminal charges were based on the fact that boxes for fentanyl patches were found on the pharmacy shelves that contained no patches. The government’ s prosecuting attorneys described the criminal acts as “opening the manufacturer’ s boxes containing fentanyl patches, by removing said fentanyl patches, by regluing said manufacturer's boxes and returning said manufacturer’s boxes and returning said manufacturer’s boxes to a secured narcotics storage...”, all of which was alleged to violate the federal statute outlawing tampering with consumer products.

The relevant federal statute specifies that one can face criminal charges when he or she “with reckless disregard for the risk that another person will be placed in danger of death or bodily injury and under circumstances manifesting extreme indifference to such risk, tampers with any consumer product that affects interstate or foreign commerce, or the labeling of, or container for, any such product...”

Pharmacists who have been in practice for a while will recall that during late September 1982, 7 people died in the Chicago area after consuming Extra Strength Tylenol that had been tampered with by someone who added potassium cyanide. The investigation concluded that this individual had removed the manufacturer’ s packages from the open display shelves, inserted the offensive chemical adulterant, and then returned the products to the shelves to await an unsuspecting consumer. A total of 8 bottles were found to have been thus adulterated. Despite the offer of a $100,000 reward, the perpetrator has never been found.

In the case under consideration here, the defendant pharmacist asked the federal trial court to drop the 2 allegations related to tampering with the medication packaging, arguing that what he had done did not constitute “tampering.” He pointed to 2 cases decided by federal courts in other parts of the country. The first involved a nurse who removed meperidine from syringes and replaced it with saline solution. In the second case, the defendant physician assistant had replaced pre-bottled hydrocodone tablets with other tablets from which the identifying marks had been scratched off.

The Court’s Ruling

The federal court judge denied the motion made by the defendant. The 2 criminal charges associated with application of the product tampering statute were to be continued to be addressed during trial.

The Court's Reasoning

The court first clarified that what the defendant was arguing was that the mere removal of the medication from the packaging did not constitute tampering. The prosecution had responded that the defendant was ignoring the fact that he had also reglued the boxes and returned them to the area for storing controlled substances.

Turning to the 2 decisions from other courts, the judge first examined the matter arising from the actions of the nurse with the syringes. Following conviction the nurse had argued that withholding the narcotic analgesic from the patient did not create danger of bodily injury, so the statute had not been violated. The appellate court in that case concluded that the statute outlaws actions beyond those that convert a medication to a poison—“tampering that reduces the efficacy of the drug designed to save life or alleviate a bodily injury” is also forbidden.

Examining the second appellate decision that might be precedent, the case based on the allegedly illegal acts of the physician assistant, the court identified the central argument of the defendant as being that removal of the hydrocodone tablets was theft but not tampering. The appellate court had rejected that argument, concluding that by replacing the hydrocodone with other dosage forms the defendant had increased the risk that injury from the illicitly substituted medications would occur. That court said the defendant’ s acts had “clearly reduced the efficacy of a bottle of hydrocodone tablets...”

In the instant case the trial court judge concluded that “Removing all of the patches from a box of fentanyl patches clearly ‘reduced the efficacy’ of the box.” He acknowledged that the other 2 appellate cases that involved surreptitious substitution of other substances could be differentiated by the act of switching contents of the container; that did not occur here because the box was empty after the defendant’s actions. Nonetheless, the judge denied the motion to drop the tampering charges because the criminal indictment of the defendant charged him with not only tampering with the patches but also tampering “with the labeling and container for” the patches (emphasis from court opinion).

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