IN THE MATTER OF THE WORKER'S COMPENSATION CLAIM OF: LINDA J. HARBORTH, Appellant (Petitioner),
STATE OF WYOMING, ex rel., DEPARTMENT OF WORKFORCE SERVICES, WORKERS' COMPENSATION DIVISION, Appellee (Respondent).
from the District Court of Campbell County The Honorable
Michael N. Deegan, Judge.
REPRESENTING APPELLANT: C. JOHN COTTON, COTTON LAW OFFICES,
P.C., GILLETTE, WYOMING.
REPRESENTING APPELLEE: PETER K. MICHAEL, WYOMING ATTORNEY
GENERAL; DANIEL E. WHITE, DEPUTY ATTORNEY GENERAL; J.C.
DEMERS, SENIOR ASSISTANT ATTORNEY GENERAL; MICHAEL J. FINN,
SENIOR ASSISTANT ATTORNEY GENERAL; KELLY D. MULLEN [*] , ASSISTANT
ATTORNEY GENERAL. ARGUMENT BY MS. MULLEN.
DAVIS, C.J., and BURKE [†] , FOX, KAUTZ, and
Linda J. Harborth underwent artificial disc replacement to
treat her work-related back injury. The Department of
Workforce Services, Workers' Compensation Division, (the
Division) denied benefits for the surgery because the
artificial disc and the surgical procedure had not been
approved by the U.S. Food and Drug Administration (FDA), and
Ms. Harborth had not produced sufficient objective medical
support for their use. After a contested case hearing, the
Medical Commission upheld the Division's decision,
determining that the procedure was both an
"off-label" use of medical services and
"alternative medicine" for which benefits were not
authorized. The district court affirmed the Medical
Commission's decision, and we also affirm.
We rephrase the issues as follows:
the Medical Commission erroneously determine that Ms.
Harborth's non-FDA-approved medical procedure was an
"off-label" use of medical services?
substantial evidence support the Medical Commission's
determination that Ms. Harborth's non-FDA-approved
medical procedure was "alternative medicine" for
which Ms. Harborth did not provide adequate support?
the Medical Commission's decision arbitrary and
In 2006, Ms. Harborth suffered a compensable injury to the
thoracic and lumbar regions of her spine while working as a
driller at the Caballo Mine for the Powder River Coal
Company. For a few years, Ms. Harborth was able to continue
working while treating her injury with physical therapy,
chiropractic manipulation, and various medications, but the
treatments ultimately proved ineffective. In 2009, Robert J.
Benz, M.D., performed a hemilaminotomy and discectomy at
L5-S1. Despite the surgery, the pain returned. Ms. Harborth
again attempted conservative treatment with limited success.
In 2014, Nathan Simpson, M.D., observed severe disc narrowing
at T12-L1 and L4-S1 and recommended a laminectomy.
Ms. Harborth sought a second opinion from Sharad Rajpal,
M.D., of Boulder, Colorado. Dr. Rajpal noted degeneration at
the L4-5 level, "no disc with complete loss of disc
height and bilateral lateral recess and foraminal
stenosis" at L5-S1, and progressive degeneration at
T12-L1. Dr. Rajpal recommended a foraminotomy at L4-5 and
transforaminal lumbar interbody fusions (TLIF's) at both
L5-S1 and T12-L1. Ms. Harborth testified that Dr.
Rajpal's surgery would cost approximately $400, 000.
The Division requested two peer reviews of Dr. Rajpal's
proposed surgery. First, Robert A. Narotsky, M.D., wrote:
It is being recommended that [Ms. Harborth] undergo an L5-S1
TLIF, T12-L1 TLIF and right L4-5 laminotomy and foraminotomy
to treat her current symptoms. This is not unreasonable,
however, I question the need for decompression at L4-5.
Additionally, I would consider obtaining a scoliosis series
and assessing overall sagittal alignment given her
accentuated lumbar lordosis. Lastly, I am concerned that she
has significant degenerative changes at T10-11 and T11-12
that could be contributing to her thoracolumbar pain and
should be investigated further prior to surgery.
Judson H. Cook, M.D., opined that Dr. Rajpal's proposed
fusion of L5-S1 was reasonable, but "it might be more
reasonable to proceed with L4-5 fusion versus simple
decompression given her primary issue as axial low back
pain." Dr. Cook stated that the fusion at T12-L1
was medically reasonable, but he declined to recommend
preauthorization because he believed that the degeneration at
that level was not caused by the initial compensable injury.
The Division eventually preauthorized Dr. Rajpal's
proposed surgery in October 2014. In the meantime, however,
Ms. Harborth had become apprehensive about undergoing the
[Ms. Harborth:] . . . Basically I wanted to know, since all
of this was being told to me, what was my quality of life
going to be in a year, five years or ten years? And [Dr.
Rajpal] just told me not to think about it, we would just
think about today and surgery. And, to me, that was hard to
Q. [Ms. Harborth's counsel:] Did you do some work to find
out what the downstream consequences were of fusions?
A. Yes, I did. As well as working at the mine, seeing other
people who had fusions, overall most of them did not do well,
and I was online as I was looking at all of this, it said the
fusion -- as well as it was backed up by the doctors, is that
the fusion is not your first treatment, it's the very
last treatment you do because it can lead to more problems
since all of it is hinged together, it doesn't move, that
you have extra wear and tear on the joints around it, so in
time, you could end up having a lot more fusions.
Q. What was your understanding of your ability to return to
work . . . [if] you elected to go ahead with the fusions?
A. [Dr. Rajpal] didn't recommend that I return to work,
and I was told by a person here at the Wyoming Workforce or
work office that people undergoing this type of procedure do
not return to work. And at [Dr. Rajpal's] office they
were telling me that I would have to learn to dress
differently, they would show me how because I would not be
very movable, with my hip especially.
While investigating spinal fusions online, Ms. Harborth had
come across Karsten Ritter-Lang, M.D., a German orthopedic
surgeon with the Enande spinal center in Bremen, Germany, who
performed artificial disc replacement surgery using the
"M6" artificial disc. The Enande website promoted
the procedure as superior to fusion, because "the M6
prosthesis . . . can biomechanically mimic the natural
disc" and "a large percentage of patients can lead
a completely normal life." Ms. Harborth contacted
several former patients of Dr. Ritter-Lang via the Enande
website, who "highly recommended" Dr.
Ritter-Lang's disc replacement procedure. Ms. Harborth
submitted her medical records to Dr. Ritter-Lang and, upon
his review, he found a "clear medical indication for
surgical intervention" and recommended a fusion at
T12-L1, implantation of the M6 artificial disc at L4-5, and a
fusion at L5-S1. Dr. Ritter-Lang would perform the surgery in
Germany for approximately $61, 000. However, even though the
M6 device was approved for use in all European Union (EU)
countries, Australia, South Africa, Russia, Brazil, and
Mexico, it was not approved by the FDA. Likewise, the FDA had
not approved the placement of an FDA-approved device adjacent
to a fusion.
Hoping to preserve her mobility and continue working, Ms.
Harborth elected to have surgery with Dr. Ritter-Lang.
Although the Division approved Dr. Ritter-Lang as Ms.
Harborth's new health care provider, it stated:
"This is not a pre approval of the bills. All bills will
be reviewed for reasonable and necessary medical care and the
relatedness to the original injury." Accordingly, the
Division requested Dr. Narotsky and Dr. Cook to update their
opinions to include an assessment of the surgical procedure
recommended by Dr. Ritter-Lang. Dr. Narotsky wrote:
Dr. Rajpal has recommended that [Ms. Harborth] undergo an
L5-S1 TLIF, T12-L1 TLIF and right L4-5 laminotomy and
foraminotomy to treat her current symptoms. Dr. Ritter-Lang
has recommended an L5-S1 anterior-posterior fusion, T12-L1
posterior cemented fusion and L4-5 disc arthroplasty. Neither
approach is unreasonable, however, I question the need for
any surgery at L4-5 at this time whether it be decompression
alone or disc arthroplasty.
Narotsky repeated his recommendation that Ms. Harborth obtain
a scoliosis series to assess overall sagittal alignment, and
to rule out T10-11 and T11-12 as possible pain generators.
Dr. Narotsky concluded: "Although I think both
approaches are reasonable Dr. Rajpal's proposal would
certainly be less invasive. Arthroplasty could still be done
at L4-5 in the future if it became necessary."
Dr. Cook listed three concerns with Dr. Ritter-Lang's
approach. First, "one of the general contraindications
to a total disk arthroplasty is symptomatic facet arthropathy
and it is documented that the patient had positive responses
to L4-5 facet blocks and therefore a disk replacement at this
level would maintain motion at the painful L4-5 facet
joints." Second, Dr. Cook stated, "[t]o my
knowledge, there has been no United States FDA approval of
the M6-L disk replacement system." Third, disc
replacements approved by the FDA "are not indicated to
be placed adjacent to a fused segment of the lumbar
spine." For these reasons, Dr. Cook recommended against
authorizing Dr. Ritter-Lang's surgery.
While the Division was seeking peer reviews, Ms. Harborth was
in "excruciating" pain. Thus, she did not wait for
the Division to preauthorize Dr. Ritter-Lang's surgery.
Paying out of her own pocket,  Ms. Harborth travelled to Germany
and underwent surgery with Dr. Ritter-Lang. On January 8,
2015, Dr. Ritter-Lang performed a fusion at T12-L1 and
implanted the M6 prothesis at L4-5. During surgery, however,
Dr. Ritter-Lang discovered that the condition of the L5-S1
segment was better than he had expected; thus, he also placed
an M6 prosthesis at L5-S1. By implanting M6 discs at the
adjacent levels of L4-5 and L5-S1, Dr. Ritter-Lang avoided
the FDA's nonapproval of, and Dr. Cook's concern
with, performing arthroplasty adjacent to a previous fusion.
However, the implantation of artificial discs at adjacent
levels of the lumbar spine also lacked FDA approval.
In February 2015, the Division denied compensation for the
surgery, finding that it was not reasonable and necessary
medical treatment. The Division noted that both the M6 disc
and the surgical procedure lacked FDA approval. Under Wyo.
Dep't of Workforce Services, Rules, Regulations & Fee
Schedules, Workers' Comp. Div., ch. 10 (2018) (Division
Rules), the Division determined the procedure to be
"alternative medicine," "experimental
care," and "off-label use" of medical
services. Ms. Harborth timely requested a hearing on the
Division's denial of compensation.
Meanwhile, Ms. Harborth's surgery appeared to be a
success. In June 2015, Ms. Harborth was released to work with
no restrictions. She returned to her previous duties of
running heavy equipment and drilling. She was no longer
taking pain medication. She testified that the surgery
allowed her to "do things that I have not been able to
do in years."
Ten months later, in April 2016, the Medical Commission held
a contested case hearing. Dr. Ritter-Lang did not testify at
the hearing. Instead, he was deposed by written
interrogatories, in which he provided short responses to 12
questions. Ms. Harborth also submitted a printout of a few
webpages from Dr. Ritter-Lang's company's website.
Ms. Harborth testified about the injury, her treatment
history, the basis of her decision to undergo surgery with
Dr. Ritter-Lang, and the surgery's apparent success.
Colleen Gibson, a former patient of and current
"international case manager" for Dr. Ritter-Lang,
testified that Dr. Ritter-Lang successfully performed two
artificial disc replacement surgeries on her back. As an
international case manager, she had observed patients who
experienced positive results. However, Ms. Gibson would not
attest to the overall efficacy of Dr. Ritter-Lang's M6
The Medical Commission affirmed the Division's denial of
compensation, concluding that Ms. Harborth failed to prove by
a preponderance of the evidence that Dr. Ritter-Lang's
surgery was reasonable and necessary. The Medical Commission
determined that the M6 disc and its placement at adjacent
levels of the lumbar spine was noncompensable both as
"off-label" use of medical services and
"alternative medicine" under Chapter 10 of the
Division Rules. The district court affirmed the Medical
Commission's decision. Ms. Harborth timely perfected this