Travis Weston v. Velan Valve Corporation Opinion No. 17-16WC

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STATE OF VERMONT

DEPARTMENT OF LABOR

Travis Weston v.Velan Valve Corporation  Opinion No. 17-16WC

  1. 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:

  1. 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.

  1. Judicial notice is taken of all relevant forms and correspondence contained in the

Department’s file relating to this claim.

  1. 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

  1. 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.

  1. 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.

  1. 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.

  1. 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

  1. 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.

  1. 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.

  1. 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.

  1. 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.

  1. 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

  1. In December 2014 Dr. Lishnak wrote an additional prescription for compounded

ketamine cream, but lacking insurance coverage Claimant was unable to fill it.

  1. 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.

  1. 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.

  1. 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

  1. 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.

  1. 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

  1. 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.

  1. 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

  1. 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.

  1. 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.

  1. 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

  1. 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

  1. 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

  1. 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.

  1. 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

  1. 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:

  1. 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.

  1. 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).

  1. 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

  1. 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).

  1. 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.

  1. 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

  1. 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.

  1. 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.

  1. 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.

  1. 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

  1. 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

  1. 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.

  1. 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).

  1. 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:

  1. 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

  1. 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.

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