Opinion ID: 6534446
Heading Depth: 3
Heading Rank: 4

Heading: Dr. Ritter-Lang's Deposition by Written Interrogatories

Text: [¶29] Dr. Ritter-Lang testified via written deposition, providing brief responses to 12 interrogatories jointly propounded by the parties. Dr. Ritter-Lang stated that the information in the Enande website was accurate; that the M6-L disc and its placement at adjacent levels had been approved in all European Union (EU) countries, Australia, South Africa, Russia, Brazil, and Mexico; and that the complication rates for other health care providers' implantation of the M6-L disc lie between 0 and 30%. Finally, Dr. Ritter-Lang agreed that Ms. Harborth's surgery was successful and confirmed that he did not anticipate future complications. [¶30] Our examination of the Medical Commission's decision is confined by our standard of review, which turns not on whether we agree with the outcome, but on whether the agency could reasonably conclude  as it did, based on all the evidence before it. Morris , 2017 WY 119 , ¶ 25, 403 P.3d at 987 (citation omitted); see also Hildebrant v. State ex rel., Dep't of Workforce Servs., Workers' Safety & Comp. Div. , 2015 WY 41 , ¶ 12, 345 P.3d 875 , 879 (Wyo. 2015) (Whether we might reach the same result or not, we will not reweigh the evidence, but instead defer to the [agency's] decision if it is based upon relevant evidence that a reasonable mind might accept.). Considering the evidence before it, the Medical Commission could reasonably conclude that Dr. Ritter-Lang's surgery was alternative medicine and that Ms. Harborth failed to produce sufficient documentation for its safety and effectiveness. [¶31] The testimony of Ms. Harborth and Ms. Gibson did little to document the safety and effectiveness of the M6 disc replacement at adjacent levels of the lumbar spine. Ms. Harborth merely reported having conversations with a number of unnamed former patients who highly, highly recommended Dr. Ritter-Lang, including a rancher from Austin, Texas, who enjoyed outstanding results. The patients were contacted via links on the Enande website and presumably selected by Enande to provide testimonials for the company. Ms. Gibson had personally followed up with thousands of patients after surgery; yet, she was unable to offer any observation as to the overall success rate of their surgeries. She described with specificity only the results of her own surgery, which did not involve implanting M6 discs in her lumbar spine. The testimony of both witnesses was too vague and too subjective to satisfy the requirement for objective and verifiable evidence. [¶32] We also view the information on the Enande website with caution, as the website is a marketing tool directed at potential customers for Dr. Ritter-Lang. It is not unreasonable to question the reliability of information contained in promotional materials and seek corroboration from objective sources. See , e.g. , Birch v. State ex rel. Wyo. Workers' Safety & Comp. Div. , 2014 WY 31 , ¶ 4, 319 P.3d 901 , 904 (Wyo. 2014) (discounting promotional materials generated by the treatment provider and the manufacturer of the device ..., both of which not surprisingly extolled the treatment benefits of [the device]). Objective evidence that would substantiate the claims of Enande and Dr. Ritter-Lang may have been available. The Enande website stated that the M6 disc has been thoroughly investigated biomechanically and studies published internationally in recent years have shown that artificial disc replacement is superior to fusion or conservative treatment. When asked about the complication rate of other providers' implantation of M6 discs, Dr. Ritter-Lang stated that [t]he complication rates in studies lie between 0 and 30% (emphasis added). 6 Indeed, a device and a procedure approved by all EU countries, Australia, South Africa, Russia, Brazil, and Mexico very likely has documentation of its safety and effectiveness which may overcome the lack of FDA approval. But it was Ms. Harborth's burden to introduce it into the record, and none can be found. [¶33] Dr. Ritter-Lang's testimony by written interrogatories barely expanded on the information contained in the Enande website. He listed the countries that have approved the M6 device and its placement at adjacent levels. His remaining responses were cursory. Six of his 12 answers were either yes or no. Other than listing the countries that have approved the M6 device, his longest answer was 15 words. Dr. Ritter-Lang supplied a complication rate of 0 to 30% for the implantation of M6-L discs by  other medical providers. Although his response clearly referred to the implantation of M6-L devices, see supra n.6, it was not unreasonable for the Medical Commission to seek clarification of such a wide-ranging figure, whether by reviewing the studies in which this figure was published or by questioning Dr. Ritter-Lang. As the Medical Commission stated, [u]nfortunately, Dr. Ritter-Lang did not testify in this case and his representative, Colleen Gibson, declined to answer questions concerning complication rates for surgeries performed by Dr. Ritter-Lang. The Medical Commission is given wide latitude to ... ascribe the relevant weight given to the evidence presented[,] including medical evidence and opinion. Hildebrant , 2015 WY 41 , ¶ 13, 345 P.3d at 879 (citations and internal quotation marks omitted). It was not unreasonable for the Medical Commission to find Dr. Ritter-Lang's sparse offering unsatisfactory. 7 [¶34] Ms. Harborth urges us to consider the success of her surgery as documentation of its safety and effectiveness. Under the unusual circumstances of this case, in which Ms. Harborth proceeded with surgery before the Division completed its preauthorization evaluation, it may be tempting to weigh the actual outcome of surgery into the determination of compensability. Because Ms. Harborth underwent surgery costing $340,000 less than Dr. Rajpal's procedure and returned to her previous work duties with no restrictions and no pain medication, the evidence of her outcome is especially compelling. However, even if our standard of review allowed us to reweigh the evidence, it would be unreasonable to view the outcome of a medical procedure as a factor that trumps all others. We keep in mind that the Division's Rules do not award compensation for medical treatments only if they are successful (assuming arguendo that the success of a medical treatment can always be measured); instead, in order to receive medical benefits, a claimant must show that his treatment is reasonable and necessary. A patient might fail to respond to reasonable and necessary medical treatment; and, likewise, a patient may benefit from elective, unnecessary medical treatment. [¶35] Similarly, Chapter 10, § 3 of the Division Rules demands sufficient documentation for safety or effectiveness against specific conditions, which indicates the need to show evidence of a treatment's efficacy in treating the claimant's condition -evidence that is necessarily objective. A claimant's successful surgery is only a single instance of success, and is not a substitute for objective and verifiable medical data demonstrating the procedure's overall record for safety and effectiveness. Where, as here, the record contains very sparse objective, verifiable evidence that Dr. Ritter-Lang's procedure was generally safe and effective against the specific condition of disc degeneration at adjacent levels of the lumbar spine, the success of Ms. Harborth's surgery (or the success of any other individual's surgery) does not shift the overwhelming weight of the evidence in her favor. [¶36] We hold that FDA approval of a medical device or treatment is not required to establish that it is reasonable and necessary; but, under Chapter 10, § 3 of the Division Rules, the Division may require a claimant requesting a non-FDA-approved medical device or treatment to produce reliable documentation of its safety and effectiveness against her specific medical condition. 8 A claimant need not produce, as Ms. Harborth suggests, a complete summary of every  scrap of medical literature that has been printed .... Applying our standard of review, however, we find in the record substantial evidence to support the Medical Commission's determination that, in the absence of FDA approval, Ms. Harborth did not satisfy her burden to document the safety and effectiveness of placing the M6 disc at adjacent levels in the lumbar spine. Having found substantial evidence to support its decision, we will not substitute our judgment for that of the Medical Commission.