Plaintiff George Shamy was the father of Deanna D. Shamy. In 2017, Deanna died from an overdose of prescription medications. Two years after her death, George, individually and as administrator of Deanna’s estate, sued four
pharmacies he alleged negligently filled Deanna’s prescriptions for addictive medications and controlled dangerous substances (CDS) far in excess of reasonable practices. George alleged the pharmacies’ malpractice in filling Deanna’s prescriptions, despite knowing she had been overly and carelessly prescribed addictive medications, exacerbated the risk of harm posed by her preexisting addiction, which resulted in her death. The trial court granted summary judgment to the pharmacies, and George appealed.

The Superior Court of New Jersey Appellate Division (“New Jersey Appellate Court”) held in its October 20, 2023 opinion, “We conclude the trial court erred when it applied: (1) the learned intermediary doctrine to preclude George’s malpractice claims; and (2) the incorrect proximate cause standard to conclude that one of the pharmacies was entitled to summary judgment even if the claims against it were not barred.”

Learned Intermediary Doctrine

With respect to drugs and medical devices, New Jersey has adopted the “learned intermediary” doctrine, under which a pharmaceutical manufacturer generally discharges its duty to warn the ultimate user of prescription drugs by
supplying physicians with information about the drug’s dangerous propensities. The rationale behind the doctrine is that the prescribing physician, acting as a learned intermediary between the manufacturer and the patient as the product consumer, is in the best position to relay to the patient the warnings of the pharmaceutical manufacturer. The doctrine recognizes that a prescribing doctor has the primary responsibility of advising the patient of the risks and benefits of taking a particular medication. Thus, it is the physician’s responsibility to pass on to the parties the information that enables the patient to use the product safely.

The learned intermediary doctrine in New Jersey is codified at N.J.S.A. 2A:58C-4, which provides, in relevant part:

“In any product liability action the manufacturer or seller shall not be liable for harm caused by a failure to warn if the product contains an adequate warning or instruction or, in the case of dangers a manufacturer or seller discovers or reasonably should discover after the product leaves its control, if the manufacturer or seller provides an adequate warning or instruction. An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the person by whom the product is intended to be used, or in the case of prescription drugs, taking into account the characteristics of, and the ordinary knowledge common to, the prescribing physician. If the warning or instruction given in connection with a drug . . . has been approved or prescribed by the federal Food and Drug Administration under the “Federal Food, Drug, and Cosmetic Act,” 52 Stat. 1040, 21 U.S.C. § 301 et seq. or the “Public Health Service Act,” 58 Stat. 682, 42 U.S.C. § 201 et seq., a rebuttable presumption shall arise that the warning or instruction is adequate.”

The New Jersey Appellate Court stated in the case it was deciding, “George argues, however, that the learned intermediary doctrine is inapplicable to his claims because he does not allege either product liability or a failure to warn Deanna about the inherent dangers of the prescription medications and CDSs dispensed to her by the pharmacy defendants. Instead, George alleges that the pharmacies engaged in professional malpractice by not noticing that the amount and frequency of Gamao’s prescriptions for Deanna for addictive medications and CDS was outside reasonable practices and refusing to fill those prescriptions. We agree that George’s professional malpractice claims are sufficiently distinct from product liability and failure to warn claims to preclude application of the learned intermediary doctrine to bar their consideration.”

“Because the trial court applied the learned intermediary doctrine to bar George’s claims, it did not define the contours of the standard of care the pharmacy defendants owned Deanna and whether genuine issues of material fact exist with respect to whether they deviated from that standard. We leave those decisions to the trial court in the first instance.”

Proximate Cause

“In the event the trial court finds that George has raised a genuine issue of material fact with respect to whether the pharmacy defendants deviated from the standard of care they owned to Deanna, it shall consider the defendants’
arguments that they are entitled to summary judgment on the question of proximate cause. We agree with George’s argument that the trial court erred when it applied a “but for” proximate cause analysis to the claims alleged against
Walgreen … In some circumstances, however, a plaintiff may recover if he establishes that professional negligence increased the risk of harm posed by a preexisting condition and the increased risk was a substantial factor in producing the harm … the professional defendant is responsible only for the damages attributable to the role the defendant’s negligence played in the ultimate outcome … it would not be necessary for Walgreen to have dispensed one of the medications that caused Deanna’s death, provided George could prove that Walgreen’s failure to stop dispensing Oxycodone to Deanne exacerbated the risk of Deanne preexisting addiction and was a substantial factor in her suffering and death.”

Source Shamy v. Gamao, M.D., Docket No. A-3331-20.

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