In re Worker's Compensation Claim of Harborth

          Appeal 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.

          Before DAVIS, C.J., and BURKE ^[†] , FOX, KAUTZ, and BOOMGAARDEN, JJ.

          FOX, Justice.

         [¶1] 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.

         ISSUES

         [¶2] We rephrase the issues as follows:

         1. Did the Medical Commission erroneously determine that Ms. Harborth's non-FDA-approved medical procedure was an "off-label" use of medical services?

         2 Did 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?

         3. Was the Medical Commission's decision arbitrary and capricious?

         FACTS

         [¶3] 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.

         [¶4] 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.

         [¶5] 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.

         Second, 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."^[1] 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.

         [¶6] The Division eventually preauthorized Dr. Rajpal's proposed surgery in October 2014. In the meantime, however, Ms. Harborth had become apprehensive about undergoing the procedure:

[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 accept.

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.

         [¶7] 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.

         [¶8] 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.

         Dr. 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."

         [¶9] 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."^[2] 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.

         [¶10] 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, ^[3] 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.

         [¶11] In February 2015, the Division denied compensation for the surgery, finding that it was not reasonable and necessary medical treatment.^[4] 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.

         [¶12] 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."

         [¶13] 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 disc implantations.

         [¶14] 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 appeal.

         STANDARD ...