Harborth v. State ex rel. Dep't of Workforce Servs., Workers' Comp. Div., 424 P.3d 1261

Harborth injured her thoracic/lumbar spine at work (2006) and underwent conservative care and a prior lumbar discectomy; symptoms persisted leading to proposed extensive fusions by a U.S. surgeon.
Concerned about loss of mobility from fusion, Harborth sought treatment in Germany from Dr. Karsten Ritter‑Lang, who recommended fusions at T12–L1 and artificial disc replacements (M6) at L4–5 and L5–S1; M6 was not FDA‑approved but approved in EU and other countries.
Harborth traveled to Germany, paid part of the cost herself, and had the surgeries (including adjacent‑level M6 implants); she recovered well and returned to full duty.
The Wyoming Division denied coverage, classifying the non‑FDA device/procedure as off‑label, experimental/alternative medicine lacking required objective evidence under Division Rules, ch. 10.
The Medical Commission and the district court upheld the denial, finding (1) implantation of a device that has no FDA approval is not an "off‑label" use under the Division Rule, and (2) Harborth failed to produce objective, reliable documentation of safety/effectiveness to overcome the Division Rule's presumption against alternative medicine.

Issue	Harborth's Argument	Division's Argument	Held
Whether the M6 adjacent‑level implants were an "off‑label" use	The M6 use should be treated as off‑label and could be authorized if supported	M6 has no FDA label to deviate from; thus not "off‑label" under Rule ch.10 §19	Not off‑label; no FDA approval means no label to deviate from
Whether substantial evidence supported characterization as "alternative medicine" requiring documentation	Harborth argued the surgery's success, patient testimony, website data, and surgeon statements showed safety/effectiveness	Division argued there was insufficient objective, verifiable literature/studies to meet Rule ch.10 §3 requirements	Substantial evidence supports finding it was "alternative medicine" and Harborth failed to meet documentation burden
Whether outcome of Harborth's individual successful surgery was controlling	Harborth argued her positive outcome proves safety/effectiveness	Division argued single success does not substitute for objective population‑level evidence required by the Rules	Court: individual success is not a substitute for required objective documentation
Whether the Medical Commission acted arbitrarily or capriciously	Harborth claimed the Commission ignored/discounted admissible evidence and thus was arbitrary	Division contended the Commission considered evidence and reasonably weighed it	Held: decision was not arbitrary or capricious; evidence could reasonably support the outcome

Morris v. State ex rel. Dep't of Workforce Servs., Workers' Comp. Div., 403 P.3d 980 (Wyo. 2017) (standard of review of agency decisions and burden of proof reminders)
Guerrero v. State ex rel. Dep't of Workforce Servs., Workers' Comp. Div., 352 P.3d 262 (Wyo. 2015) (agency review principles)
Walton v. State ex rel. Wyo. Workers' Safety & Comp. Div., 153 P.3d 932 (Wyo. 2007) (definition of substantial evidence)
Hildebrant v. State ex rel. Dep't of Workforce Servs., Workers' Safety & Comp. Div., 345 P.3d 875 (Wyo. 2015) (agency given latitude to weigh medical evidence)
Rodgers v. State ex rel. Wyo. Workers' Safety & Comp. Div., 135 P.3d 568 (Wyo. 2006) (reviewing whole record for substantial evidence)
Cooper v. Smith & Nephew, Inc., 259 F.3d 194 (4th Cir. 2001) (physician may use cleared device off‑label; court discusses distinction between FDA clearance/approval and physician use)