Court Ruling Highlights Risks of Improper Dose Adjustments

A recent decision from the Georgia Court of Appeals is a timely reminder of the role of dosage titration in patient safety.

In December 2013, a patient sought treatment for depression and was evaluated by a nurse practitioner (NP) employed by a behavioral health treatment facility and supervised by a licensed physician. The NP decided to prescribe lamotrigine (Lamictal; GSK) for the patient.¹

Severe, life-threatening skin reactions such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) are known adverse effects of lamotrigine, and rapid uptitration is known to increase the risk of these adverse effects. Accordingly, the manufacturer’s product labeling describes initial dosing as 25 mg once daily for weeks 1 and 2, followed by 50 mg once daily for weeks 3 and 4, and 100 mg once daily after 4 weeks, with further uptitration as clinically indicated.² The NP prescribed a dose of 25 mg once daily for week 1, then 50 mg once daily for week 2, and 100 mg daily beginning 19 days after treatment initiation.¹

The patient (plaintiff) indicated that she was not given any medication counseling instructions by the pharmacist regarding dosing or adverse effects. Eight days after starting the 100-mg dose, the patient began experiencing flulike symptoms, and within 3 days, the patient was intubated in intensive care. The patient was diagnosed with TEN and SJS. The patient survived but experienced substantial sequelae, including severe vision problems, scarring over a large body surface area, loss of fingernails and toenails, and loss of hair.¹

THE LEGAL CASE AND PRACTICE IMPLICATIONS

The patient filed a negligence and malpractice lawsuit against multiple parties, including the physician, the health care facility, and the pharmacist. The facility and physician were dismissed, and the physician’s businesses entered an $800,000 consent judgment.¹

At trial, the jury awarded $40.3 million in damages, assigning 2% responsibility ($806,190) to the pharmacist. Both the plaintiff and the pharmacist sought posttrial relief, which the trial and appellate courts denied. The court upheld that liability was appropriately shared and that the pharmacist was not solely responsible for the full damages. The case may be subject to further appeal and further assessment of legal liability. Regardless of additional adjudication, the instructions for uptitration and downtitration of medication dosages can have life-threatening implications.¹

PRACTICE IMPLICATIONS

This case highlights the significant legal risks pharmacists face when involved in medication management, even with relatively limited responsibility. Clear documentation, careful review of prescriber instructions, and proactive communication with the care team are essential safeguards. Pharmacists should remain vigilant in verifying dosing adjustments and counseling patients on titration, as errors or oversights can carry life-threatening consequences and substantial liability.

REFERENCES

1. Shaw v Smith, 374 Ga App 623; 913 SE2d 750 (2025).

2. Lamictal. Prescribing information. GSK; 2015. Accessed September 2, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020241s045s051lbl.pdf