NC Court Approves Medical Claim for Non-FDA-Approved Compound Cream

A North Carolina appellate court recently held that non-FDA-approved drugs could not be categorically excluded from medical compensation under the state’s workers’ compensation system [Davis v. Craven County ABC Bd., 2018 N.C. App. LEXIS 368 (Apr. 17, 2018)]. The court noted that the text of the Workers’ Compensation Act did not limit the types of drugs that might reasonably be required solely to those that are FDA-approved. The court stressed that instead, the statute indicates that whether a particular medical treatment “may reasonably be required to effect a cure or give relief” is a fact question that must be individually assessed in each case [N.C. Gen. Stat. § 97-2(19)]. The court concluded that were the court to create a categorical exclusion for non-FDA-approved medical treatments, it would, in effect, be adding an exception to the Act where one does not exist in the text.

Background

Davis injured his right ankle in a work-related accident and began to receive workers’ compensation benefits. A physician at a pain clinic prescribed a compound cream to treat the condition. While the compound itself was not approved by the FDA, the component drugs that were compounded to create the cream had been separately approved by the FDA.

A deputy commissioner concluded that the cream was reasonably necessary to effect a cure, provide relief, or lessen Davis’ period of disability. The Full Commission affirmed and the employer and carrier appealed.

Appellate Court Decision

The appellate court stressed that it had no authority to create exceptions to the plain text of statutes on policy grounds. It added that if requiring workers’ compensation providers to compensate injured workers for non-FDA-approved drugs was bad policy, it was up to the state’s General Assembly to change that law. As to the risk-reward ratio argued by the employer and carrier—that the compound drug provided limited relief and came with risks, the court said such a resolution was an issue of fact to be resolved by the Commission. The physicians who testified reported no substantial side effects. Competent evidence supported the Commission’s findings.