CASE NO. 5150 CRB-2-06-10
COMPENSATION REVIEW BOARD
WORKERS’ COMPENSATION COMMISSION
NOVEMBER 8, 2007
DUNCKLEE, INC., et al
CNA INSURANCE CO., et al
The claimant was represented by Michael R. Kerin, Esq., Kerin & Canty, P.C., 120 Broad Street, Milford, CT 06460.
The respondents Duncklee, Inc. and CNA were represented by Michael McAuliffe, Esq., Pomeranz, Drayton & Stabnick, 95 Glastonbury Boulevard, Glastonbury, CT 06033.
The respondents Harrington Engineering and Peerless Insurance Co. were represented by Joseph Passaretti, Esq., Montstream & May, L.L.P., Salmon Brook Corporate Park, 655 Winding Brook Drive, P.O. Box 1087, Glastonbury, CT 06033-6087.
The respondents State Technical Services Inc. and Peerless Insurance Company were represented by Jessica Argieros, Esq., Law Offices of Rosenbaum & Vollono, 655 Winding Brook Drive, Glastonbury, CT 06033. They did not appear at oral argument and joined in the briefs submitted by the other respondents.
The respondents State Technical Services, Inc. and CNA were represented by Howard Levine, Esq., Law Offices of Cynthia A. Jaworksi, 55 Capital Boulevard, Suite 210, Rocky Hill, CT 06067. They did not appear at oral argument and joined the briefs of the other respondents.
The respondents State Technical Services, Inc. and National Grange Mutual Insurance Company were represented by Keith E. Marquis, Esq., Law Offices of Keith E. Marquis, 205 Church Street, Suite 626-637, New Haven, CT 06510.
The respondents State Technical Services, Inc. and The Hartford Insurance Group were represented by Laurence P. McLoughlin, Esq., Law Offices of David J. Mathis, 55 Farmington Avenue, Suite 500, Hartford, CT 06105. They did not appear at oral argument and joined the briefs of the other respondents.
This Petition for Review from the October 11, 2006 Finding and Dismissal of the Commissioner acting for the Second District was heard April 27, 2007 before a Compensation Review Board panel consisting of the Commission Chairman John A. Mastropietro and Commissioners Amado J. Vargas and Scott A. Barton.
JOHN A. MASTROPIETRO, CHAIRMAN. The claimant has petitioned for review from the October 11, 2006 Finding and Dismissal of the Commissioner acting for the Second District, challenging the trier’s denial of authorization for four-level disc replacement surgery in his lower back. We affirm the trial commissioner’s decision.1
The claimant sustained a compensable lumbar spine injury on May 12, 1992. When conservative treatment proved ineffective, he was sent to discuss a four-level fusion with Dr. Paonessa, who referred him to Dr. Yue. After a series of diagnostic tests in May 2004, Dr. Yue determined that the claimant was a candidate for a four-level disc replacement procedure using “ProDisc” technology.2 In November 2001, the United States Food and Drug Administration (FDA) had begun a clinical study of the ProDisc for use at one and two levels. Dr. Yue testified that, as part of that study, he has completed 165 single- or dual-disc replacements in approximately 97 patients. Dr. Yue has also traveled to Germany to participate in 65 disc replacements at three levels, seven at four levels, and one at five levels, with the first of those procedures having occurred in July 2003. He was unsure if any four-level procedure had been performed in the United States. The trier found that Dr. Yue stated that 92.4% of patients who underwent one-or two-level replacements were satisfied with the results.3
On August 14, 2006, the FDA approved the ProDisc for use at one level. The two-level study remained ongoing. Dr. Yue testified that the approval of ProDisc at one level allows physicians to use the device for multiple levels, as long as the physician deems the procedure to be medically necessary, and the patient understands the use would be “off label.” Dr. Yue did not anticipate the FDA would conduct a study of ProDisc for approval of use at three or more levels due to cost factors, and the eventual loosening of FDA use restrictions that would occur as the ProDisc becomes established. Claimant’s Exhibit A, Deposition, pp. 49-50. He testified that exclusionary criteria had been developed for the ongoing clinical trial to ensure that extraneous factors would not affect the study of ProDisc’s effectiveness in patients with degenerative disc disease.
In the first of two bone density tests, the claimant had shown signs of osteopenia, an exclusionary factor that might have prevented the FDA from permitting surgery under a “compassionate use” exception. The second test showed improved bone density, which was no longer a contraindication for surgery. As for the alternative of a four-level fusion, Dr. Yue did not think it would give the claimant significant relief. Dr. Yue stated that he would be willing to perform the four-level disc replacement, which would give the claimant a 70-80% chance of returning to work. On a scale of A to F, he rated the proposed disc replacement surgery as having a likely “B” to “B+” result, while the fusion would have a “D” result. If the claimant agreed to the disc replacement, he would be required to sign a waiver so that Yale would allow Dr. Yue to perform the procedure at its hospital facility. There was no evidence presented regarding the terms of this waiver.
The trial commissioner concluded that Dr. Yue’s testimony was credible, and found that he has achieved great success with single and double-level disc replacements. The trier then cited the fact that the manufacturer of ProDisc had requested physicians to use the product close to the FDA label usage for four to six months subsequent to its approval. He also found that there was insufficient evidence to fully assess the waiver that the claimant would have to execute. He concluded, “The proposed four-level disc replacement involves real danger and suffering without fair assurance of effectuating an improvement or restoration of the claimant’s health at this time, and therefore, does not constitute reasonable and necessary medical treatment.” Findings, ¶ K. The trier then made the same finding with regard to the proposed four-level fusion. Findings, ¶ L. The claimant has appealed the denial of the disc replacement surgery to this board.
We first address the claimant’s objection that the trier ignored the opinions of other treating physicians, which buttress Dr. Yue’s recommendation for surgery. As the claimant notes in his brief, the trial commissioner is free to believe all, some or none of an expert’s testimony. Tartaglino v. Dept. of Correction, 55 Conn. App. 190, 195 (1999), cert. denied, 251 Conn. 929 (1999); Walter v. Bridgeport, 5092 CRB-4-06-5 (May 16, 2007). In a workers’ compensation case, the trial commissioner has sole authority to determine the weight and credibility of evidence. Irizarry v. Purolator Courier Corp., 4382 CRB-4-01-4 (May 2, 2002). Even if the medical reports of Drs. Paonessa, Criscuolo and Murphy were not expressly contradicted by other evidence, the trial commissioner did not have to give them weight, or discuss them in his findings. The opinions of other orthopedic surgeons offering cumulative support for multi-level disc replacement surgery do not constitute undisputed evidence, nor are they material to the trier’s decision. See Warren v. Federal Express Corp., 4163 CRB-2-99-12 (February 27, 2001). Thus, the trier committed no error by failing to mention those opinions.
The main issue before us is whether the findings and evidence support the trial commissioner’s conclusion that the proposed four-level disc replacement surgery was not reasonable and necessary medical treatment within the meaning of § 31-294d C.G.S. The trier’s conclusion in ¶ K—that the four-level disc replacement procedure “involves real danger and suffering without fair assurance of effecting an improvement or restoration of health”—refers to a test adopted in Pagliarulo v. Bridgeport Machines, Inc., 20 Conn. App. 154 (1989), which drew language from Justice Baldwin’s concurrence in Acquarulo v. Botwinik Bros., Inc., 139 Conn. 684, 690 (1953). The Acquarulo Court affirmed a trier’s decision to suspend benefits where a claimant refused exploratory back surgery that was recommended by all of the doctors. In his concurrence, Justice Baldwin reasoned that the claimant’s benefits would not have been suspended if he could have demonstrated that “the measure of recovery to be expected from the medical and surgical procedure recommended did not warrant the danger and suffering involved.” Id.
In Pagliarulo, which also involved a refusal of surgical treatment, the Appellate Court confirmed, “Whether a proposed surgical procedure is reasonable . . . is a question of fact for the commissioner to resolve.” Id., 158. Though medical evidence takes center stage in making that decision; see Irizarry, supra; 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, whether the procedure involves real danger and suffering without fair assurance of improved or restored health. Pagliarulo, supra, 159. If a treatment strategy has only a modest chance of succeeding, it falls within the trier’s discretion to decide whether to approve it under the circumstances. Irizarry, supra; Cirrito v. Resource Group Ltd. Of Connecticut, 4248 CRB-1-00-6 (June 19, 2001).
Here, the trial commissioner was not present at the deposition of Dr. Yue, and was left to gauge the credibility of that witness from his deposition and his medical reports. As we review Dr. Yue’s deposition, we identify several areas that may have emerged as concerns regarding the reliability and safety of attempting four-level disc replacement surgery. Dr. Yue acknowledged that the claimant had shown a low bone density in January 2005, which prevented him from being an immediate surgical candidate. Deposition, p. 37. In November 2005, a second test showed a dramatic improvement that Dr. Yue attributed to the claimant’s use of a bone-building regimen involving medication, calcium and/or Vitamin D. Deposition, pp. 73, 95. Dr. Yue did not explain if or how the change in bone density would be maintained long-term. The claimant had also been gaining weight at the time of Dr. Yue’s deposition, which was a concern, as a body mass index in the 30-31 range was a prerequisite for surgery. Id., pp. 73-74. Further, Dr. Yue had not realized that the claimant had been out of work since November 2003, which created a concern that negative psychological or motivational factors might exist that could inhibit recovery and a return to work. Id., pp. 111-12.
Despite Dr. Yue’s optimism regarding four-level disc replacement surgery, the fact remains that the claimant was seeking permission to use the ProDisc differently than the FDA had approved, and beyond what the manufacturer recommended this early in the approval stage of the product. Id., p. 66. This is not insignificant, as the procedure carries with it an additional set of risks. For example, Dr. Yue explained that “the more levels of degeneration, the more difficult it can be with predicting total success,” due to the variations found at each disc level, and because the interspaces would shrink as discs are added. Id., 74. He acknowledged that the claimant might need a fusion at the fourth level if the insertion of discs at two or three levels compressed the spine too much to allow a fourth implant. Id. There was also a risk that he would be unable to insert the prostheses into the disc spaces, requiring fusion at the first two levels. Id., pp. 99-100. Dr. Yue had earlier stated that a fusion would make the claimant’s situation dramatically worse. Id., p. 92. Other, general risks included subsidence of the implant, fracturing of the vertebrae, minor nerve damage, blood clots, stroke, and death. Id., pp. 88-89.
Further, though Dr. Yue did not discuss his role in the multiple disc replacement surgeries performed in Germany, his testimony indicates that other physicians had been involved in that work. Id., pp. 69, 80-81. To that end, in Claimant’s Exhibit C, an April 8, 2005 report by Dr. Yue stated, “This surgery can only be performed in Germany by Dr. Rudolf Bertagnoli and due to FDA restrictions cannot be performed in the USA.”4 The commissioner cited the fact that there was no direct evidence Dr. Yue had performed any of the three-to-five-level surgeries himself, and that only seven of the surgeries in Germany had been at four levels. Findings, ¶ F. Dr. Yue stated that he had participated “intraoperatively” in three of the four-level disc replacements. Id., p. 69. Dr. Yue then acknowledged that he had not performed disc replacement at more than two levels in the United States. He could not be certain that Yale Hospital would allow a four-level procedure, though he thought they would agree if they were reimbursed for the cost of the implant, and the claimant assumed certain risks by signing a waiver. Id., pp. 70, 80.
Given these details, we disagree with the claimant’s assertion on appeal that Dr. Yue’s testimony is devoid of any evidence that the proposed surgery involves danger and suffering without fair assurance of improvement. The trial commissioner may have come away from Dr. Yue’s testimony with numerous doubts, and he was not required to view Dr. Yue’s opinion as being sufficient to justify approval of the surgery under the circumstances. The trier was also not required to set forth each reason for his decision to withhold authorization of the procedure. See Admin. Reg. § 31-301-3. We therefore find no error in the trial commissioner’s denial of the requested disc replacement surgery.
The claimant also asserts that the medical treatment issue described at the outset of the formal hearing was “authorization for a four-level disc replacement,” with no mention of fusion surgery. March 30, 2006 Transcript, p. 3. He thus argues that fusion surgery should not have been addressed in the trier’s decision. The boundary between the two procedures is not so clear-cut, however.
Fusion surgery was discussed during the claimant’s direct examination of Dr. Yue, who explained how multilevel fusion surgery is performed by entering from both the front and back, and using bone grafts to fill the space between vertebrae, with screws or a plate being implanted to secure the graft. Deposition, pp. 10-11. The claimant requested that he compare fusion and disc replacement. Id., pp. 18-19. Dr. Yue explained that fusion surgery is riskier because it requires two surgical approaches, takes more time, places the neurologic structures at higher risk due to the implantation of screws, and demands a longer recovery period, with a risk of bone graft rejection that can worsen a patient’s pain. Id. Other risks include blindness due to blood flow into the eyes while the body is prone. Deposition, p. 107. Dr. Yue also said that fusion results in a complete loss of motion at that vertebrae segment (whereas the artificial disc preserves motion), and stated that fusions have not been very successful in alleviating discogenic low back pain. Deposition, p. 22. The loss of motion also promotes adjacent level degeneration due to the body’s transfer of residual motion to another disc level.
Dr. Yue would advise the claimant to forego surgery rather than having a fusion done. He opined that a four-level fusion would not give the claimant any significant relief; Id., p. 43; and could make the claimant’s condition “dramatically worse.” Deposition, p. 92. He also stated that only 20-25% of people return to any kind of work following a four-level lumbar fusion, because of the disability caused by the approach to the spine, the mental stress of long-term narcotic use, and the risk factors that a future employer would have to consider. Deposition, p. 34. He also explained that, though the discogram showed significant changes at only three levels, a fusion from L3-L4 to L5-S1 would also create problems, as L2-L3 would degenerate and require another operation in the near future. Id., p. 53. There was a further possibility that Dr. Yue would not be able to gain access to L2-L3 due to the placement of the claimant’s rib cage. Deposition, p. 100.
In light of this testimony, the trier reasonably addressed the option of four-level fusion surgery in his decision. Disc replacement surgery was being introduced as a surgical alternative to the more accepted option of fusion, as demonstrated by the FDA study, which required that the results of disc replacement surgery be “noninferior” to fusion surgery in order to approve use of the ProDisc. Deposition, pp. 50-51. The commissioner also found Dr. Yue’s testimony credible, and he expressed strong opposition to fusion surgery. We think it important to note, however, that the trier’s order only denied both disc replacement surgery and fusion surgery “at this time.” The claimant may seek surgical intervention again in the future, as factual circumstances evolve. See Schenkel v. Richard Chevrolet, Inc., 4639 CRB-8-03-3 (March 12, 2004)(claimant retains right to seek medical treatment if circumstances change following previous denial of treatment).
The trial commissioner’s decision is hereby affirmed.
Commissioners Amado J. Vargas and Scott A. Barton concur in this opinion.
1 The claimant in this matter moved for an extension of time to file Reasons of Appeal, which was granted. BACK TO TEXT
2 Dr. Yue testified that the ProDisc implant consists of two metal-alloy endplates coated with titanium sandwiched over a polyethylene plastic core that allows the top endplate to slide over a domed part of the core. The endplates also have “keels,” or ridges, that anchor the endplates into the vertebrae. Implantation is performed anteriorly, by approaching the spine through a stomach incision. The vertebrae above and below the degenerated disc space are notched out, and the artificial disc is inserted, with the keels sliding into the grooves. Claimant’s Exhibit A, Deposition, p. 9. Over a period of eight to ten weeks, the body’s bone will grow into the coarse titanium coating, further securing the device. BACK TO TEXT
3 The transcripts of Dr. Yue’s two-day deposition (which began on January 13, 2006 and was continued on March 1, 2006) actually address patient satisfaction with multiple-level disc procedures. When asked about the results of the three-level procedures he had performed, Dr. Yue stated that he has looked at the multilevel results for three levels and greater, and has seen approximately 93% efficacy from a patient satisfaction and an outcome standpoint, which he reported in a 2005 study that was published in the trade journal “Spine.” Claimant’s Exhibit A, Deposition, p. 29. The article provides a minimum two-year follow-up on 15 two-level and 10 three-level disc replacement procedures. Dr. Yue also testified that “statistically speaking,” 92.4 percent of patients with multilevel degenerative disc disease who received ProDisc implants were completely satisfied with their outcome. Id., p. 98. BACK TO TEXT
4 We note Dr. Yue’s testimony that in Germany the standards for qualifying for a four-level disc replacement procedure are more relaxed than in the United States, in part because surgeons there have been performing disc replacement surgeries for over 20 years. Deposition, pp. 87-88, 104-105. He also stated that there are no liability costs associated with the use of the ProDisc implant in Europe, which reduces the cost of surgery there. Id., p. 70. Dr. Yue had been of the opinion in November 2005 that, if the claimant could not wait any longer for surgery, he should consider having a multi-level disc replacement done in a country where the surgery has been approved by its governmental counterpart to the FDA. Id., pp. 77-78. BACK TO TEXT