STATE OF VERMONT
DEPARTMENT OF LABOR
Travis Weston v.Velan Valve Corporation Opinion No. 17-16WC
- By: Phyllis Phillips, Esq.
Administrative Law Judge
For: Anne M. Noonan
Commissioner
State File No. EE-53319
OPINION AND ORDER
Hearing held in Montpelier on November 6, 2015
Record closed on April 4, 2016
APPEARANCES:
Christopher McVeigh, Esq., for Claimant
Keith Kasper, Esq., for Defendant
ISSUE PRESENTED:
Does the use of compounded ketamine cream constitute reasonable medical treatment for
Claimant’s August 30, 2012 compensable work injury?
EXHIBITS:
Joint Exhibit I: Medical records
Joint Exhibit II: Stipulation
Claimant’s Exhibit 1: Preservation deposition of Timothy Lishnak, M.D. (with exhibits),
January 14, 2016
Defendant’s Exhibit A: Connolly, S. et al., A Systematic Review of Ketamine for Complex
Regional Pain Syndrome, Pain Medicine 2015; 16:943-999
Defendant’s Exhibit B: Lynch, M. et al., Topical 2% Amitriptyline and 1% Ketamine in
Neuropathic Pain Syndromes, Anesthesiology 2005; 103:140-6.
CLAIM:
Medical benefits pursuant to 21 V.S.A. §640(a)
Costs and attorney fees pursuant to 21 V.S.A. §678
2
FINDINGS OF FACT:
- At all times relevant to these proceedings, Claimant was an employee and Defendant was
his employer as those terms are defined in Vermont’s Workers’ Compensation Act.
- Judicial notice is taken of all relevant forms and correspondence contained in the
Department’s file relating to this claim.
- Claimant worked for Defendant, a manufacturer of industrial valves. His duties included
working at a “lapping machine,” polishing and deburring the insides of twenty-ton valves
used at nuclear power plants.
Claimant’s August 2012 Work Injury, Medical Course and Current Status
- On August 30, 2012 Claimant was working at the lapping machine when a heavy steel
rod fell on his right (dominant) hand. As a result, he sustained a soft tissue crush injury
to the metacarpophalangeal (MCP) joint – in layman’s terms, the second knuckle – of his
right middle finger. Defendant accepted this injury as compensable and began paying
workers’ compensation benefits accordingly.
- Within just a few weeks after the injury, Claimant complained of symptoms that
prompted concern among his treating providers that he might be developing complex
regional pain syndrome (CRPS). Over the ensuing months, these came to include
excruciating pain out of proportion to objective findings, swelling, sweating, color and
temperature changes and allodynia (hypersensitivity to light touch) in his right hand.
- Claimant treated for his injury with a variety of providers, including Dr. Lishnak, his
primary care provider, Dr. Durant, a hand surgeon, and Dr. Roberts, a pain management
specialist. Given his CRPS symptoms, he was determined not to be a surgical candidate.
Instead he underwent multiple courses of physical therapy and a series of stellate
ganglion blocks. None of these treatments provided completely effective, long-term
relief of his symptoms.
- Concurrent with treatment for his hand injury, Claimant also continued to treat for a
lower back injury he had suffered in 2003 while working for a previous employer. In
2004, his treating pain specialist, Dr. Erickson, had prescribed ketamine cream to be
applied topically to his lower back, following which Claimant reported a noticeable
decrease in his symptoms. Claimant was forced to discontinue this treatment in early
2005, because the responsible insurance carrier refused ongoing payment.
3
- Ketamine has a somewhat controversial history. Approved by the federal Food and Drug
Administration in 1970, it was first used by forward medical units in the Vietnam war as
a “battlefield anesthetic.”1 Today it is commonly used in hospitals to initiate and
maintain general anesthesia, and in sub-anesthetic dosages to provide pain relief while
surgically treating burns and other wounds. Particularly when dispensed orally or
intravenously, the medication poses a risk of serious side effects, including liver toxicity,
nausea and hallucinations. As discussed infra, Finding of Fact Nos. 20 and 26, in its
topical application ketamine appears not to cause any such adverse effects.
- Dr. Lishnak again prescribed ketamine cream for Claimant’s low back pain in 2011, but
as was the case previously, without insurance coverage he was unable to afford it on an
ongoing basis. As a result, he relied on narcotic pain medications to manage his low back
pain.
- In April 2013 Claimant expressed to Dr. Lishnak his interest in trying ketamine cream as
treatment for his right hand CRPS symptoms. Ketamine inhibits the action of the same
neurotransmitters that are thought to trigger CRPS-type pain, and for that reason
researchers have sought to evaluate its efficacy as a treatment option for the condition.2
Thus, noting that in its topical application the medication “has been reported as useful for
these types of cases before and is something [Claimant] has taken, did well on and
tolerated before for his back,” Dr. Lishnak prescribed a trial of ten-percent compounded
ketamine cream.3 Concurrently, he maintained Claimant on Percocet to address his
ongoing low back pain.
- Claimant used the ketamine cream for approximately two months thereafter. He credibly
testified that while the Percocet prescribed for his low back pain helped his right hand
pain “to a certain extent,” the ketamine cream was far more effective at providing
focused symptom relief and improved function. He could tie his shoes, for example, and
was able to manage using his hand for other daily living activities as well. The
improvements were short-lived, however; after Defendant discontinued payment for the
cream in July 2013, his symptoms returned.
- Claimant treated with Dr. Lishnak for both chronic low back pain and chronic CRPSrelated
pain in his right hand at various times throughout 2013 and 2014. For his low
back pain, Dr. Lishnak continued to prescribe narcotic pain medications, including
Percocet, buprenorphine, morphine and fentanyl. For his right hand, for a time Claimant
reported some limited symptom improvement with medical marijuana derivatives.
Although he still exhibited CRPS-type symptoms in his hand, including swelling, pain,
discoloration and sweating, these were less severe than they had been in the past.
1 Connolly, S. et al., A Systematic Review of Ketamine for Complex Regional Pain Syndrome, Pain Medicine 2015;
16:943-999, at p. 943.
2 Id. at p. 944.
3 The medical record for this office visit includes a journal abstract of a study involving the use of topical ketamine
in twenty CRPS patients. The researchers concluded that the study “shows promise for use of topical ketamine as
opposed to parenteral and oral forms which often result in undesirable side effects.” Finch, PM et al., Reduction of
Allodynia in Patients with Complex Regional Pain Syndrome: A Double-Blind Placebo-Controlled Trial of Topical
Ketamine, Pain 2009 Nov; 146 (1-2), 18-25. Presumably this is the report to which Dr. Lishnak referred in his
office note.
4
- In December 2014 Dr. Lishnak wrote an additional prescription for compounded
ketamine cream, but lacking insurance coverage Claimant was unable to fill it.
- Dr. Lishnak’s office notes reflect that his treatment in 2015 has been directed primarily at
managing Claimant’s chronic low back pain. In his deposition testimony, he
acknowledged that Claimant hadn’t complained of hand pain since February 2015, and
that the condition “hasn’t been the topic of conversation at recent visits.” He agreed that
Claimant no longer exhibits sufficient CRPS symptoms to justify the diagnosis. Instead,
he now characterizes Claimant’s condition as chronic pain due to the sequelae of his
crush injury.
- Regardless of the current diagnosis, Dr. Lishnak still expects that ketamine cream will
decrease Claimant’s chronic neuropathic pain to a level where his ability to function will
improve. I find this analysis credible.
- Claimant credibly testified that while his right hand symptoms have abated somewhat,
they have never completely resolved. As was demonstrated at the formal hearing, the
second knuckle of his right third finger remains visibly swollen, “to the size of a golf
ball,” even three years later. He still experiences a constantly pulsating, burning pain in
his hand, “like somebody is taking a knife and just dragging it through tendons and bone,
it’s horrifying.” Occasionally his right palm and fingers sweat excessively. His ability to
use the hand for routine tasks – starting his car, for example – varies, with periods of
waxing and waning symptoms and corresponding increases and decreases in function.
Claimant testified that if ketamine cream was made available to him, he would
“absolutely” use it in the hopes of ameliorating these symptoms.
Expert Medical Opinions Regarding Reasonableness of Ketamine Cream Treatment
(a) Dr. Lishnak
- As noted above, Finding of Fact No. 10 supra, Dr. Lishnak initially prescribed ketamine
cream as treatment for Claimant’s CRPS-related hand symptoms in April 2013. He did
so based first on the medication’s reported efficacy when Claimant had used it previously
for his low back pain, and second, on his review of medical literature indicating that it
was a potentially useful adjunctive treatment for his hand injury.
- Central to Dr. Lishnak’s analysis was his determination that, in contrast to its oral or
intravenous applications, topical ketamine is very well tolerated, with a low risk of side
effects. From a safety perspective, he thus views it as a treatment alternative that is
unlikely to cause harm. In his opinion, where, as here, the risk of harm is fairly low, the
question whether it is reasonable then becomes whether and to what extent it might
benefit a particular patient. This is a determination that can only be made by trying it. I
find this analysis credible.
5
- Claimant having already derived relief of his low back symptoms by using topical
ketamine in the past, in Dr. Lishnak’s opinion it is medically reasonable for him to do so
again, in the hopes that it will provide similar benefit in the context of his right hand pain.
This is true even if the most appropriate diagnosis for his symptoms is no longer CRPS
specifically, but rather a more generalized chronic pain condition referable to his August
2012 crush injury. I find this analysis credible.
- To support his opinion regarding the efficacy of topical ketamine for treatment of chronic
pain conditions such as Claimant’s, in his deposition testimony Dr. Lishnak referenced a
2015 medical journal review of 34 studies, 12 of which involved randomized controlled
trials.4 The studies involved widely varying compounded formulations, in different
concentrations, with different cream bases, co-analgesics and application frequencies. As
a result, direct data comparison was difficult. Despite this variation, none of the studies
described any systemic side effects. This finding was critical to the reviewers’
conclusion:
Topical use of . . . ketamine cream or gel up to 20% [concentration] has
been successfully used in the treatment of chronic pain with few or no side
effects when used according to prescription and medical supervision . . .
Topical ketamine seems to be a valuable therapeutic option in the
treatment of various chronic pain syndromes, especially in localized
neuropathic pain. Further clinical trials . . . are recommended, as well as
comparator trials.5
(b) Dr. Ensalada
- At Defendant’s request, in May 2013 and October 2014 Claimant underwent independent
medical examinations with Dr. Ensalada, a board certified pain management specialist.
In conjunction with his clinical exams, Dr. Ensalada reviewed Claimant’s pertinent
medical records. He also researched the medical literature concerning the use of
ketamine as treatment for CRPS.
- On the basis of his May 2013 examination, Dr. Ensalada concluded that Claimant met the
so-called “Harden” criteria for a diagnosis of CRPS. In this regard, he thus concurred
with the diagnosis proffered by Claimant’s treating providers at the time, including Dr.
Lishnak.
- Dr. Ensalada disagreed with Dr. Lishnak’s suggestion that ketamine cream was a
reasonable treatment option, however. In his opinion, because ketamine has not been
shown to be a safe and effective treatment for CRPS regardless of the form in which it is
administered, its use in Claimant’s case is not medically reasonable.
4 Kopsky, DJ, et al., Analgesic effects of topical ketamine, Minerva Anestesiologica 2015; 81:440-9.
5 Id. at 447.
6
- Dr. Ensalada cited two medical journal articles in support of his opinion. In one, a
double-blind, randomized, placebo-controlled three-week study evaluated the efficacy of
topical two-percent amitriptyline, one-percent ketamine and a combination of both in
treating patients with neuropathic pain.6 The results revealed no difference among the
three groups. Notably, however, the researchers qualified their findings with reference to
another study, in which higher concentrations of the two drugs combined produced
significant pain relief with no additional risk of side effects.7 Thus, they concluded,
“Optimization of doses may be required.”8
- In the second study, researchers reviewed 45 journal articles in which various
methodologies (other reviews, randomized placebo-controlled trials, observational
studies and case reports) had been used to test ketamine’s effectiveness as a treatment for
CRPS.9 In general, the reviewers rated the studies as moderate to low quality. Largely
for that reason, they determined that the evidence regarding the medication’s efficacy is
inconclusive, and therefore that it “cannot be considered a first line option” for treating
CRPS symptoms.10
- Only five of the articles reviewed in the second study involved the use of topical (as
opposed to oral, subcutaneous or intravenous) ketamine. Unlike oral or intravenous
usage, the utility of which was “limited by its side effect profile,”11 none of the topical
ketamine studies reported any side effects. The researchers concluded that the risk-tobenefit
ratio militated against experiments with high-dose protocols, but weighed in favor
of additional topical application trials.
- Dr. Ensalada again examined Claimant in October 2014. This time, Claimant reported
marked improvement in his ability to perform daily living activities – he could make a
full fist, start his car and operate an automatic shift, and he had less difficulty sleeping.
Although he was not entirely asymptomatic, his condition had improved to the point
where Dr. Ensalada concluded that he no longer met the criteria for a CRPS diagnosis.
As noted above, Finding of Fact No. 14 supra, Dr. Lishnak has since reached the same
conclusion.
6 Lynch, M. et al., Topical 2% Amitriptyline and 1% Ketamine in Neuropathic Pain Syndromes, Anesthesiology
2005; 103:140-6.
7 The referenced study involved a combination of four-percent amitriptyline and two-percent ketamine. Dr.
Lishnak’s prescription called for a significantly higher (ten percent) concentration, but still well below the outer
range of the formulations tested in the study upon which he relied in his deposition testimony, Finding of Fact No.
20 supra.
8 Id. at 146.
9 Connolly, S. et al., A Systematic Review of Ketamine for Complex Regional Pain Syndrome, Pain Medicine 2015;
16:943-999.
10 Id. at 950.
11 Id. at 949.
7
- As was the case with Dr. Lishnak, the change in Claimant’s diagnosis has not impacted
Dr. Ensalada’s analysis of ketamine’s usefulness in any respect. Dr. Lishnak continues to
believe it is medically reasonable to trial a topical application as treatment for Claimant’s
ongoing symptoms, given the low risk of side effects and the positive results he
experienced previously. Dr. Ensalada continues to believe there is no basis for doing so
absent high quality evidence establishing that the medication is both safe and effective
for this purpose.
CONCLUSIONS OF LAW:
- The disputed issue in this claim is whether the use of compounded ketamine cream as
prescribed by Claimant’s treating physician constitutes reasonable medical treatment for
the symptoms he continues to experience in his right hand as a consequence of his
August 2012 work-related crush injury.
- Vermont’s workers’ compensation statute obligates an employer to pay only for those
medical treatments that are determined to be both “reasonable” and causally related to the
compensable injury. 21 V.S.A. §640(a); Cahill v. Benchmark Assisted Living, Opinion
No. 13-12WC (April 27, 2012); MacAskill v. Kelly Services, Opinion No. 04-09WC
(January 30, 2009). The Commissioner has discretion to determine what constitutes
“reasonable” medical treatment given the particular circumstances of each case. Id. A
treatment can be unreasonable either because it is not medically necessary or because it is
not related to the compensable injury. Baraw v. F.R. Lafayette, Inc., Opinion No. 01-
10WC (January 20, 2010).
- The determination whether a treatment is reasonable must be based primarily on evidence
establishing the likelihood that it will improve the patient’s condition, either by relieving
symptoms and/or by maintaining or increasing functional abilities. Cahill, supra; Quinn
- Emery Worldwide, Opinion No. 29-00WC (September 11, 2000). An injured worker’s
subjective preferences cannot render a medically unreasonable treatment reasonable. See,
Britton v. Laidlaw Transit, Opinion No. 47-03WC (December 3, 2003). As is the case
with many aspects of medical decision-making, however, there can be more than one
right answer, and thus more than one reasonable treatment option for any given
condition. Lackey v. Brattleboro Retreat, Opinion No. 15-10WC (April 21, 2010).
- The treatment issue here revolves solely around the medical necessity question. Both
parties’ experts agree that Claimant’s current condition is causally related to his
compensable injury. Where they disagree is as to whether topical ketamine is a
medically appropriate treatment option for his chronic pain and other symptoms.
- Where expert medical opinions are conflicting, the Commissioner traditionally uses a
five-part test to determine which expert’s opinion is the most persuasive: (1) the nature of
treatment and the length of time there has been a patient-provider relationship; (2)
whether the expert examined all pertinent records; (3) the clarity, thoroughness and
objective support underlying the opinion; (4) the comprehensiveness of the evaluation;
and (5) the qualifications of the experts, including training and experience. Geiger v.
Hawk Mountain Inn, Opinion No. 37-03WC (September 17, 2003).
8
- Considering these factors here, I conclude that both experts were well qualified, by
training and experience, to express an opinion on the disputed issue. Both adequately
familiarized themselves with Claimant’s pertinent medical history and conducted
comprehensive evaluations. As the treating physician, Dr. Lishnak has been better
positioned to observe Claimant’s symptoms over time and evaluate his response to
previously recommended treatments. Both experts made good use of the available
medical research to support their opinions.
- I have carefully reviewed the medical journal articles submitted by both experts.
Notably, the articles upon which Dr. Lishnak relied dealt specifically with the use of
ketamine in its topical application, while the ones that Dr. Ensalada cited encompassed
oral, intravenous and subcutaneous delivery systems as well. As to these, I acknowledge
that more high quality research is necessary to determine if the medication’s efficacy in
treating neuropathic pain and CRPS-type symptoms outweighs the risk of troubling side
effects.
- As all of the studies concluded, however, no adverse side effects have yet been associated
with the use of topical ketamine. As Dr. Lishnak credibly explained, the risk/benefit ratio
weighs differently, therefore. In its topical application, the medication appears to be safe.
That being the case, the medically necessary next step is to determine whether it will
benefit the patient. According to Dr. Lishnak, the only way to do that is to try it. I
concur, and for that reason I conclude that his opinion is the most persuasive.
- Dr. Ensalada’s analysis began and ended with his determination that the research on
ketamine’s efficacy is not yet of sufficiently high quality to justify its use as a treatment
for chronic neuropathic pain conditions such as Claimant’s. His opinion reflects an
approach to medical practice commonly referred to as “evidence based medicine,” but
only in part. The intent of evidence based medicine is to optimize medical decisionmaking
by emphasizing the use of evidence from research studies that are both well
designed and effectively conducted. As Dr. David Sackett, who is widely regarded as a
“pioneer” of evidence based medicine, described it:
Evidence based medicine is the conscientious, explicit, and judicious use
of current best evidence in making decisions about the care of individual
patients. The practice of evidence based medicine means integrating
individual clinical expertise with the best available external clinical
evidence from systematic research.12
12 Sackett, et al., “Evidence based medicine: what it is and what it isn’t,” BMJ 312 (7023): 71-2.
9
- The concept of evidence based medicine thus incorporates not only the best scientific
research into a doctor’s decision-making process, but also “the proficiency and judgment
that individual clinicians acquire through clinical experience and clinical practice.” As
Dr. Sackett explained:
Evidence based medicine is not “cookbook” medicine. Because it requires
a bottom up approach that integrates the best external evidence with
individual clinical expertise and patients’ choice, it cannot result in
slavish, cookbook approaches to individual patient care. External clinical
evidence can inform, but can never replace, individual clinical expertise,
and it is this expertise that decides whether the external evidence applies
to the individual patient at all and, if so, how it should be integrated into a
clinical decision.13
- Dr. Ensalada’s opinion focused exclusively on the strength of the external clinical
evidence as to ketamine’s efficacy as a treatment for neuropathic pain, and not at all on
how that evidence might reasonably have been integrated into a clinical decision. Dr.
Lishnak’s analysis was far more discriminating, and in that sense it more fully adhered to
the concept of evidence based medicine as Dr. Sackett has described it. For that reason, I
conclude that it is the most persuasive.
- I conclude that the use of topical ketamine cream as treatment for the chronic neuropathic
pain associated with Claimant’s August 2012 work-related right hand crush injury is
medically necessary, and therefore reasonable under 21 V.S.A. §640(a).
- As Claimant has prevailed on his claim for benefits, he is entitled to an award of costs
and attorney fees under 21 V.S.A. §678. In accordance with 21 V.S.A. §678(e), Claimant
shall have 30 days from the date of this opinion within which to submit his itemized
claim.
13 Id.
10
ORDER:
Based on the foregoing findings of fact and conclusions of law, Defendant is hereby ORDERED
to pay:
- All medical and prescription drug costs associated with the use of compounded ketamine
cream as treatment for Claimant’s August 30, 2012 compensable work injury, in
accordance with 21 V.S.A. §640(a); and
- Costs and attorney fees in amounts to be determined, in accordance with 21 V.S.A. §678.
DATED at Montpelier, Vermont this 20th day of October 2016.
____________________
Anne M. Noonan
Commissioner
Appeal:
Within 30 days after copies of this opinion have been mailed, either party may appeal questions
of fact or mixed questions of law and fact to a superior court or questions of law to the Vermont
Supreme Court. 21 V.S.A. §§670, 672.