Narrative Opinion Summary
The case involves an appeal by a claimant, who sustained an injury resulting in hair loss, against the denial of her medical benefits claim for Rogaine, deemed experimental by the Judge of Compensation Claims (JCC). The employer/carrier (E/C) refused to cover Rogaine, citing its experimental status under Florida Statutes section 440.13(1)(c), which requires medical treatments to be non-experimental and widely accepted. During the proceedings, it was revealed that both parties mistakenly believed Rogaine was not FDA-approved for women. The JCC, after confirming its approval for female androgenetic alopecia, still ruled it experimental without assessing medical necessity or causation. The appellate court reversed this decision, referencing a precedent in *Arizona Chemical Corp. v. Hanlon* where the E/C's failure to refer a treatment to the Division for determination of its experimental status was deemed a waiver of defense. The court emphasized that medical necessity must be based on specific case facts, not solely FDA determinations, and remanded the case for further proceedings to evaluate the medical necessity and causation, along with reconsideration of attorney's fees and costs. The ruling clarified that Rogaine is not experimental, requiring further exploration of the claimant's specific condition and needs.
Legal Issues Addressed
Experimental Treatment under Florida Statutes Section 440.13(1)(c)subscribe to see similar legal issues
Application: The JCC initially deemed Rogaine experimental, thus not covered, but the appellate court reversed this, emphasizing that Rogaine is not experimental due to its FDA approval.
Reasoning: The JCC concluded that the use of Rogaine was experimental and did not evaluate its medical necessity or the causal link between the accident and hair loss, ruling that the E/C had no obligation to reimburse for the medication.
FDA Approval and Medical Necessitysubscribe to see similar legal issues
Application: FDA approval of a drug does not solely determine its medical necessity, which must be evaluated by the JCC based on individual case facts, allowing for off-label prescription use.
Reasoning: The court noted that physicians can prescribe FDA-approved products for uses not specifically indicated in the labeling.
Reversal and Remand for Evaluation of Medical Necessity and Causationsubscribe to see similar legal issues
Application: The case was sent back to the JCC to assess the medical necessity of Rogaine and the causation of hair loss, as well as to reconsider attorney's fees and costs.
Reasoning: The case was remanded to the JCC for further hearings on medical necessity and causation, and the prior denial of attorney's fees and costs was vacated, instructing the JCC to reconsider those matters.
Waiver of Defense under Florida Administrative Code Rule 38F-7.021subscribe to see similar legal issues
Application: The E/C's failure to refer the treatment to the Division as potentially experimental constituted a waiver of their defense, precluding them from contesting its status.
Reasoning: The appellate court held that the E/C waived its defense by not adhering to Florida Administrative Code Rule 38F-7.021, which requires the E/C to refer any potentially experimental treatments to the Division before a hearing.