CASE NO. 5416 CRB-8-09-1
COMPENSATION REVIEW BOARD
WORKERS’ COMPENSATION COMMISSION
MARCH 3, 2010
STATE OF CONNECTICUT DEPARTMENT OF MENTAL HEALTH AND ADDICTION SERVICES
GAB ROBINS OF NORTH AMERICA
The claimant was represented by Kevin W. Coombes, Esq., McCarthy, Schuman & Coombes, 61 Russ Street, Hartford, CT 06106.
The respondent was represented by Philip Schulz, Esq., Assistant Attorney General, Office of the Attorney General, 55 Elm Street, P.O. Box 120, Hartford, CT 06141-0120.
This Petition for Review from the December 22, 2008 Remanded Decision of the Commissioner acting for the Eighth District was heard September 25, 2009 before a Compensation Review Board panel consisting of the Commission Chairman John A. Mastropietro and Commissioners Randy L. Cohen and Christine L. Engel.
JOHN A. MASTROPIETRO, CHAIRMAN. The instant appeal arises from the trial commissioner’s ruling on a matter that was the subject of a remand order set out in Vannoy-Joseph v. State/DMHAS, 5164 CRB-8-06-11 (January 29, 2008) [hereafter Vannoy-Joseph I].1 In Vannoy-Joseph I,2 this board considered the respondent’s appeal of former Commissioner A. Thomas White’s November 6, 2006 Finding and Award in which he authorized a three-level disc replacement surgery for the claimant. In this board’s rather lengthy opinion we considered the respondent’s objections and challenges to the trier’s conclusion. Among the respondent’s challenges in that appeal were that the three-level disc replacement surgery proposed was not approved by the Food and Drug Administration [FDA] and thus it was error for the trial commissioner to authorize the procedure.
In our consideration of Vannoy-Joseph I, we, in essence, held that the proposed use of a particular medical device and procedure that has not yet been approved by the FDA did not, per se, disqualify it as reasonable or necessary medical treatment under our Act. We advised that “in the case of a contested surgical procedure that is not well-established in the medical community, the evidence must include enough information for the trier to grasp the concepts and methods that support the procedure, and to anticipate that it will be effective for individuals comparable to the claimant.” Id. We then ordered a remand “for the limited purpose of addressing the scientific validity of three-level disc replacement surgery for individuals comparable to the claimant. . . .” Id.
Proceedings were then held before Commissioner Jack Goldberg acting in the capacity as trial commissioner. See id., note 17. A formal hearing was held June 25, 2008 in the course of which the trial commissioner accepted evidence consistent with our remand order and at the request of the respondent allowed the evidentiary record from the prior hearings to be included as part of the record before the trier. See June 25, 2008 Transcript, p. 7. These proceedings resulted in the December 22, 2008 Remanded Decision of the Commissioner acting for the Eighth District. It is from that decision that the respondent has taken this appeal.
The respondent presents two issues for our review; whether the trial commissioner erred in authorizing the triple level disc replacement surgery in which the Prodisc prosthesis would be utilized as the claimant failed to establish the scientific validity of the proposed surgery and whether the trial commissioner erred in concluding that the proposed surgery was medically reasonable as to the claimant.
We first consider whether, as the respondent contends, the claimant failed to establish the scientific validity of the surgery proposed by the treating physician. At the outset we note that as this matter is inextricably linked to our earlier opinion in Vannoy-Joseph I, we therefore incorporate by reference our opinion and our legal analysis. In Vannoy-Joseph I we provided a rather comprehensive review of the evidentiary bases upon which a trial commissioner might rely in evaluating the appropriateness of an arguably, cutting edge, medical procedure. We stated in Vannoy Joseph I:
Evaluating the appropriateness of a proposed medical treatment is a delicate task. . . [A] workers’ compensation commissioner must assess the credibility of the evidence supporting the various treatment options and decide which is the most reasonable under all of the circumstances. In doing so, the trier has a lot of latitude. The ordinary rules of evidence are not binding in this forum, allowing a commissioner to make inquiry through testimony and records in the manner most likely to ascertain the parties’ rights. Section 31-298. .[I]in the case of a contested surgical procedure that is not well-established in the medical community, the evidence must include enough information for the trier to grasp the concepts and methods that support the procedure, and to anticipate that it will be effective for individuals comparable to the claimant. [A] commissioner must also take steps to verify that a physician’s methodology is reliable, and relevant to the case. The novelty of an unconventional and controversial suggestion for treatment will not render the underlying medical opinion incompetent if it is derived from a valid scientific method, even if other valid methodologies lead to contrary recommendations.(Citations omitted.)
Dr. James Yue, the treating physician who was to perform the multi-level disc transplant, provided testimony by deposition. Claimant’s Exhibit P. We note the trial commissioner’s findings included both Dr. Yue’s expert opinion in a form that is familiar to this forum as well as the scientific evidentiary inquiry suggested in our opinion in Vannoy-Joseph I. Id.3 We believe that the findings reflect that the trial commissioner’s consideration of the evidence was consistent with the remand order of Vannoy-Joseph I.
As to the respondent’s second issue, whether the trial commissioner erred in concluding that the proposed surgery was medically reasonable in this case, we find no error. Our Workers’ Compensation Act requires that a respondent provide medical care that is reasonable or necessary. Section 31-294d. Whether the medical care is reasonable or necessary is a factual finding to be determined by the trial commissioner. See e.g., Anderson v. R & K Spero Co., 107 Conn. App. 608 (2008); Vannoy-Joseph I, supra; Cirrito v. Resource Group Ltd. of Conn., 4248 CRB-1-00-6 (June 19, 2001). Therefore, our review is limited to whether the trial commissioner’s conclusion results from a misapplication of law, is without evidence or based on unreasonable or impermissible factual inferences. See e.g., Blades v. Redman & Turnquist, 5163 CRB-2-06-11 (February 26, 2008). Applying this standard of review to the trial commissioner’s December 22, 2008 Remanded Decision of the Commissioner acting for the Eighth District reveals no such error.4
However, the underlying factual circumstances in this case are somewhat reminiscent of our recent opinion in Chimblo v. Connecticut Light Power, 5417 CRB-7-09-1 (December 30, 2009). In paragraph ll of the December 22, 2008 Remanded Decision of the Commissioner acting for the Eighth District the trial commissioner concluded, “[t]he claimant can benefit from a multi-level disc replacement assuming her weight, MRI, CT, and bone density have not changed, and will require less narcotic medication for a shorter period of time.” In Chimblo, the trial commissioner approved surgery for the claimant and included a requirement that the claimant successfully complete a narcotic detoxification program as well as a weight reduction program and other ancillary diagnostic measures. The respondents appealed, contending that the trier’s authorization of the surgery was unreasonable as it was predicated on an authorization and related evidence from ten years earlier. We concluded that the trial commissioner’s authorization was an approval of the surgery contingent upon certain events relating to the claimant’s fitness as a surgical candidate generally. We think the instant matter is analogous. At the time that the surgical procedure suggested by Dr. Yue is undertaken, the claimant will need to follow whatever pre-surgery regimen is prescribed by Dr. Yue. Dr. Yue will then evaluate the claimant’s medical fitness to undergo the disc replacement surgery.
We therefore affirm the December 22, 2008 Remanded Decision of the Commissioner acting for the Eighth District.
Commissioners Randy L. Cohen and Christine L. Engel concur.
1 We note that a postponement and extension of time were granted during the pendency of this appeal. BACK TO TEXT
2 For a review of the factual circumstances surrounding the claimant’s injury and other particulars we refer to our opinion in Vannoy-Joseph v. State/DMHAS, 5164 CRB-8-06-11 (January 29, 2008). BACK TO TEXT
3 We generally refrain from a broad re-uttering of a trier’s findings. But in this instance we believe providing direct reference to some of the trier’s findings will permit a better understanding as to the inquiry made by the trial commissioner and the evidence proffered following our remand order in Vannoy-Joseph I. These selected factual findings include the following:
8. Dr. Yue testified he participated in one study, entitled “Results of Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of ProDisc-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of one-Level Degenerative Disc Disease,” that dealt with one-level disc replacement surgery with the ProDisc device that was an FDA level one study. (6/25/08 Tr. at pages 62-64, 101, Defendant’s 6)
9. Dr. Yue testified the Multicenter study had a cohort of 286 patients among 16 hospitals with more than 40 doctors contributing, with a conclusion that the “ProDisc-L has been found to be safe and efficacious. In properly chosen patients, ProDise-L has been shown to be superior to circumferential fusion by multiple clinical criteria.” (6/25/08 Tr. at page 63)
10. Dr. Yue testified the other six studies he presented as evidence dealt with studies of smaller cohorts of between 16 and 118 patients who underwent one-level and two-level Pro-Disc device surgery and that are distinguishable from the multicenter study and were not FDA level one studies. (6/25/08 Tr. at page 63-64, Defendant’s 1-5, 7)
11. Dr. Yue testified that workers’ compensation claimants were excluded from the non-FDA level one studies out of a concern the claimants might have secondary gain issues or incentives to remain disabled after the surgery, explaining the FDA set the exclusionary criteria for the Multicenter study and chose to include the workers’ compensation claimants. (6/25/08 Tr. at page 65, Defendant’s 1-7)
12. Dr. Yue testified that he has done seven more studies including seven workers’ compensation claimants and that six are doing great and one is not back to work and that those studies are one year old. (6/25/08 Tr. at page 92)
13. Dr. Yue testified that there are other studies on two-level disc replacements that have been done that he not part of and that he did not produce them for insertion into the record because he was not asked to, adding they support the results his own studies have found. (6/25/08 Tr. at page 76)
14. Dr. Yue testified that a two-level randomized study was done and completed and is under review right now and was presented at a national meeting in Miami in May 2008, with identical results to the single-level study that has been published. (6/25/08 Tr. at pages 72, 101)
15. Dr. Yue testified the FDA-approved study has the same high quality level-one data analysis, randomized prospective analysis of a two-level lumbar Pro-Disc replacement versus a two-level fusion, but said the FDA will not allow the publishing of the results until the two-level product is approved because it does not want people to think the two-level product is approved for sale now. (6/25/08 Tr. at page 72)
16. Dr. Yue testified that he believes multilevel disc replacement in the lumbar spine is safe and efficacious for patients suffering from multilevel degenerative disc disease, particularly in view of the multilevel disc replacement FDA study results. (6/25/08 Tr. at page 101)
17. Dr. Yue testified that his research papers, all of which were published in Journal of Neurosurgery Spine Magazine, were sent out by the magazine editor for comment and peer review to independent physicians he doesn’t know, explaining the reviewers are called reviewer one, reviewer two, etc. These reviewing doctors - all of them spinal doctors -- make their own conclusions separate and independent from each other and send them back to the editor with comments to be answered, he testified, adding the editor sends the comments back to him and he tries to answer them, at which time the process is repeated. (6/25/08 Tr. at pages 74-75)
18. Dr. Yue testified that he performed 10 surgeries at three or more levels of artificial disc replacement at Yale and observed an additional 25 to 30 surgeries at three or more levels in Germany. (3/27/08 Tr. at page 37)
19. Dr. Yue testified that he has been able to follow five of those 10 patients for eight years and that he has not had to perform additional surgeries to revise the prosthesis, although one patient had an adjacent level change below the replacement that was due to a congenital defect and required additional surgery. One patient sustained a broken back in the Avon Mountain accident several years ago with the prosthesis remaining fine and not having moved or shifted, he testified. (3/27/08 Tr. at pages 14, 39-40)
20. Dr. Yue testified that the recovery time for a multilevel lumbar fusion is at least six months to a year while a patient can return to work as early as three weeks with a multilevel artificial disc replacement, and that he averages return to work times of eight to ten weeks depending on the size of the patient. (3/27/08 Tr. at page 18)
23. Dr. Yue testified that the Multicenter study could not prevent doctors and patients from knowing what group they were assigned to. The physicians had to know whether to do a fusion or a disc replacement, while the patients learned upon waking because if they had one incision than they had a disc replacement while two incisions meant they had a fusion. (6/25/08 Tr. at page 71) BACK TO TEXT
4 We also note the respondent did not file a Motion to Correct. Arguably, our review is limited to the trier’s application of the law. See e.g., David v. Beloff Billiards, 4843 CRB-4-04-8 (August 15, 2005) BACK TO TEXT