Pennsylvania Court: Off-Label Use of CBD Reimbursable Under Workers’ Comp

The Pennsylvania Supreme Court has affirmed a Commonwealth Court ruling that an off-label use of CBD oil prescribed for a workplace injury is reimbursable under the state’s workers’ compensation system, as Stephen McConnell writes in Drug & Device Law.

The unanimous decision in Schmidt v. Schmidt rejected the employer’s argument that off-label use of the cannabis oil is inherently illegal because it lacks the approval of the Food and Drug Administration (FDA).

It is a significant decision in both workers’ compensation and broader pharmaceutical liability contexts, providing a strong precedent for defending off-label uses.

The case involved a lawyer who suffered a work-related injury while loading files into a trial bag. The incident aggravated his degenerative disc disease, resulting in significant and worsening pain.

After exhausting traditional treatments, including frequent opioid use, the claimant’s physician prescribed CBD oil to manage the pain and avoid escalating opioid dependency.

The treatment had positive results, but the employer denied reimbursement, citing the FDA’s disapproval of CBD’s medical use. The workers’ comp board agreed, but the Commonwealth Court overturned that decision, prompting a further appeal.

The Pennsylvania Supreme Court held that FDA approval is not a prerequisite for reimbursement under the state’s workers’ compensation statute.

The Court interpreted “medicines and supplies” broadly to include any treatment prescribed as part of a healthcare provider’s plan for a work-related injury.

It also ruled the claimant was not a provider, and thus not required to submit formal billing documentation.

Schmidt provides a strategic precedent for defending off-label drug use across legal contexts, particularly when FDA status is used to argue illegality. It underscores the importance of statutory interpretation over regulatory approval in healthcare reimbursement disputes.

In a humorous conclusion to the article, McConnell notes that the decision got him thinking about legal work-related injuries.

“We can dimly recall moments in court when we might have torn a meniscus by leaping to a conclusion, or sprained a ligament by stretching an argument,” he writes.