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CASE NO. 5308 CRB-8-07-12
COMPENSATION REVIEW BOARD
WORKERS’ COMPENSATION COMMISSION
DECEMBER 8, 2008
STATE OF CONNECTICUT DEPARTMENT OF CORRECTION
GAB ROBINS OF NORTH AMERICA
The claimant was represented by Daniel B. Scott, Esq., Attorney at Law, 22 Pine Street, Bristol, CT 06010.
The respondent was represented by Lawrence G. Widem, 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 5, 2007 Finding and Award of the Commissioner acting for the Eighth District was heard August 29, 2008 before a Compensation Review Board panel consisting of the Commission Chairman John A. Mastropietro and Commissioners Ernie R. Walker and Charles F. Senich.
JOHN A. MASTROPIETRO, CHAIRMAN. The respondent State of Connecticut has taken this appeal from the December 5, 2007 Finding and Award in which the Commissioner acting for the Eighth District ordered the respondent to pay all reasonable and necessary costs for surgery recommended by Dr. James Yue. Dr. Yue recommended the claimant undergo a fusion at L5/S1 spine level and a two level disc replacement at L3/4. It is the trial commissioner’s authorization of the two level disc replacement which is challenged by the respondent.
The pertinent facts giving rise to this appeal are as follows. The claimant was employed by the respondent as a correction officer and had achieved the rank of Lieutenant. On October 18, 2005 the claimant was injured while working at the Webster Correction Institution. The claimant was initially treated by Dr. Gerald Becker and referred to Dr. James Yue, Co-Chief of Orthopaedic Spine Service at the Yale University School of Medicine. Dr. Yue opined that the claimant has not reached maximum medical improvement and is a candidate for spinal fusion surgery and the two level disc replacement.
At the request of the respondent the claimant was examined by Dr. Howard Lantner, a neurosurgeon who opined “[i]t is certain that lumbar fusion or disc replacement at multiple levels, which is presently not FDA approved, would leave him significant residual discomfort as well.” (Claimant’s Exhibit E.) It was Dr. Lantner’s opinion that the claimant reached maximum medical improvement in November, 2006.
Thereafter, upon the request of the Commissioner the claimant was seen by Dr. Anthony Spinella. Dr. Spinella examined the claimant on May 23, 2007 and opined that disc replacement is an accepted method of treatment. However, Dr. Spinella stated that the surgery may or may not help the claimant, as his prognosis was guarded with or without surgery and the claimant was overly optimistic as to his potential for recovery following the surgery.
The issue raised on appeal is controlled by this tribunal’s opinion in Vannoy-Joseph v. State/DMHAS, 5164 CRB-8-06-11 (January 29, 2008).1 In Vannoy-Joseph, we were asked to consider whether the trial commissioner’s approval of a three–level spinal disc replacement procedure was inappropriate while in the instant matter our inquiry concerns the legal appropriateness of the trial commissioner’s approval or a two–level spinal disc replacement. At the time of the trial commissioner’s approval in the instant matter and Vannoy-Joseph,2 only single level disc replacement was approved by the FDA.
In Vannoy-Joseph, the respondent argued that the trial commissioner exceeded his authority in approving the three level multiple disc replacement because (1) the three level multi disc replacement was not FDA approved, and (2) the procedure carried significant cost and health risks and a private health insurer would be permitted to deny this procedure on the basis of its experimental status. We noted that § 31-294d C.G.S. requires an employer to furnish medical and surgical aid and referenced established precedent defining reasonable and necessary medical care as, “that which is curative and remedial. Curative or remedial care is that which seeks to repair the damage to health caused by the job even if not enough health is restored to return to work.” DeFelippi v. Wal-Mart Stores, Inc., 4349 CRB-5-01-1 (January 15, 2002)(citation omitted). Vannoy-Joseph, supra.
Additionally, we held the fact that the proposed surgery was not approved by the FDA did not render the proposed multi disc replacement surgery unreasonable per se, nor was a particular surgical modality’s characterization as experimental by private individual or group health insurance plans as controlled by §§ 38a-483c(b) and § 38a-513b(b) binding authority for determining the reasonableness and necessity of the proposed surgery under § 31-294d C.G.S. We acknowledged this commission’s recognition and occasional reliance on commonly accepted standards utilized by the health care industry, but noted that we were not bound to follow same. We stated:
The reasonableness of treatment also depends on the circumstances. Given the invasiveness, novelty, cost and degree of risk inherent in a three-level disc replacement, a commissioner should weigh the evidence carefully before approving it as “reasonable” and “necessary.” “Whether a proposed surgical procedure is reasonable . . . is a question of fact for the commissioner to resolve.” Pagliarulo v. Bridgeport Machines, Inc., 20 Conn. App. 154, 158 (1989). “Though medical evidence takes center stage in making that decision . . . the trier may also consider surrounding circumstances, such as the claimant’s age, medical history, the effectiveness of prior treatment, and as stated in [Acquarulo v. Botwinik Bros., Inc., 139 684, 690 (1953)], whether the procedure involves real danger and suffering without fair assurance of improved or restored health.” Jolicoeur v. Duncklee, 5150 CRB-2-06-10 (November 8, 2007).
We acknowledged that “off–label” uses for medical devices is an accepted practice as it is “the FDA’s mission to regulate . . . without directly interfering with the practice of medicine.” Id., quoting Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 350 (2001). Thus, concluding that “off-label” use does not bar the proposed surgery, we held:
A commissioner is best able to decide whether an innovative surgical procedure is reasonably assured to restore a claimant’s health when the record contains a detailed evidentiary foundation. We therefore articulate this standard: 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. . . . Just as trial courts are expected to do more than merely rely on an expert witness’ belief that a methodology is reliable; . . . 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. . . . (emphasis ours)(citations omitted).
We then suggested:
[M]ethodological issues that are relevant to the scientific validity of evidence might include the quality of testing and peer review given to the reasoning or technique, its known and potential rate of error, to what degree conclusions rely on subjective assessments rather than objectively verifiable criteria, and the background and reputation of the doctor. This is not a checklist. Other factors may be relevant in addition to, or in lieu of, these factors, depending on the specific context. Of course, it is up to the parties to provide evidence supporting, challenging, or comparing proposed theories of treatment in order to establish a factual record. (emphasis ours) (footnotes and citations omitted.)
Here in addition to the medical evidence already referenced, this matter reflects the written report of claimant’s original treating physician, Dr. Gerald Becker, (Claimant’s Exhibit F), the August 16, 2006, April 23, 2007, and September 10, 2007 reports of the surgeon to whom the claimant was referred, Dr. James Yue (Claimant’s Exhibit C, G, H), and the live testimony of the claimant.3
Dr. Becker’s report provided an assessment of the claimant’s ongoing back pain and, inter alia, Dr. Becker’s recommendation that the claimant be evaluated by Dr. James Yue for a possible combination of fusion and disc replacement surgery. (Claimant’s Exhibit F.) We do not believe the evidence proffered in this matter meets the criteria suggested in Vannoy-Joseph, supra. The record is devoid of evidence providing the trial commissioner with the “concepts and methods” supporting the procedure, why the trier might anticipate the surgery would be effective for the claimant here, as well as the other evidentiary sources suggested by Vannoy-Joseph.
The failure of the parties to provide the trial commissioner with such evidence is understandable as our opinion in Vannoy-Joseph was not rendered until after the trial commissioner issued his decision in the matter. However, in light of our opinion in Vannoy-Joseph we believe a remand is appropriate so as to give the parties an opportunity to provide evidence sufficient with the standards suggested in Vannoy-Joseph, supra.
We therefore remand the instant matter for additional proceedings consistent with this opinion.
Commissioners Ernie R. Walker and Charles F. Senich concur.
1 Vannoy-Joseph v. State/DMHAS, 5164 CRB-8-06-11 (January 29, 2008) provides an insightful and extensive discussion on the issue of disc replacement surgery and offers guidance as to what a trial commissioner might consider as he/she weighs evidence in the course of making a determination. BACK TO TEXT
2 The respondent-employer is the same in the instant matter as in Vannoy-Joseph. Further, the surgeon who will be performing the surgery is also the same as here, Dr. James Yue. BACK TO TEXT
3 The evidence one might think most relevant to the claimant’s request for approval is that of Dr. Yue. The only evidence proffered that addressed the proposed multi-level disc surgery was as follows.
Claimant’s Exhibit C
September 10, 2007 Letter to Atty. Anthony Famiglietti from Dr James Yue (in pertinent part)
At the moment, I believe he is a candidate for a fusion at L5/S1 and a 2 level disc replacement at L3/4 and L-4/5. His time out of work following this surgery would be 6 months. He would be able to do clerical to moderate duty work after these 6 months.
Claimant’s Exhibit G
8-16-06 Office Visit Notes of Dr. James Yue (in pertinent part)
RADIOGRAPHS: He has had plain x-rays performed as well showing no severe scoliotic deformities and no spondylolisthesis. I reviewed his CT scan and diskogram, there is no spondylolysis. He has diffuse leakage of the dye at L3-4, L4-5, and L5-S1. The CT scan also shows evidence of some osteopenia.
PLAN: As a result of this, I would like him to go ahead and get a bone density test. With regards to the timing of surgery, this is going to be a multifactorial decision. At this point in time, our ProDisc disk replacement has been approved by the FDA. I am not sure how he is on Worker’s Compensation at this point in time. I would like to have the patient get his bone density test. I would also like him return with his MRI again for my review and we will see him back in the office following these two tests for appropriate surgical counseling.
Claimant’s Exhibit H
4-23-07 Office Visit Notes of Dr. James Yue (in pertinent part)
Mr. Carnes is here today to follow-up status post his new MRI-of the lumbar spine. The new MRI shows consistent changes compared to his last MRI in 2003 showing predominately L4-5 disk degeneration. He also has evidence of 3-4 and 4-5 or 5-1 changes. At L5-S1, he has a rather marked type 2 end plate at L5 that will necessitate a possible, fusion with bone graft instrumentation depending on whether or not a lumbar artificial, disk prosthesis would fit properly. The patient was made aware of this in the office today. At L4-5; a lumbar prosthesis most likely could be performed as well as at L3-4. This is a Workers’ Compensation matter. This will most likely need to be precertified through his insurance company first. Today in the office, we obtained an. informed consent history and physical for L3-4, L4-5, L5-S1 disk replacement or possible fusion at any or all of the levels. Risks and benefits including, but not limited to infections, bleeding, pain, nerve damage, paralysis, re-operation, hardware failure, retrograde ejaculation, need for blood transfusion, sympathetic dystropy, soft tissue injury such as ureteral injury, viscous injury were discussed with the patient.
PLAN: We will notify him when the FDA approves multilevel disk replacement hopefully, this will be in the next 3-4 months. BACK TO TEXT