Sabatier v. State Farm Mutual Automobile Insurance

MURPHY, Chief Judge. The primary question presented is whether thermography is a valid diagnostic tool for medical use in the diagnosis and treatment of musculoligamentous injuries, musculoskeletal disease, or nerve root impingement and is therefore compensable as a “necessary” medical service within the coverage of Maryland Code (1991 Repl.Vol.), Article 48A, § 539 (the Personal Injury Protection or PIP statute). This section of the Maryland Insurance Code provides that, unless waived by the insured, every policy of motor vehicle liability insurance shall afford, inter alia, medical benefits for the named insured and family members residing in the household who are injured in an automobile accident. The medical benefits under this section, are in an amount up to $2,500, and must be for “reasonable” expenses for “[njecessary medical ... services.” I. Dr. Henry S. Sabatier, a physician licensed to practice in Maryland, sued State Farm Mutual Automobile Insurance Company in the District Court, sitting in Baltimore City, to recover for thermography services rendered to a number of State Farm’s policyholders who were covered for PIP medical benefits. 1 State Farm denied payment, claiming that thermography examinations in the diagnosis and treatment of musculoligamentous injuries, musculoskeletal disease and/or nerve root impingement, as performed by Dr. Sabatier, were not necessary medical treatments as defined in § 539 and, therefore, were not reimbursable under the PIP statute.

Upon demand for a jury trial filed by State Farm, the cases were removed to the Circuit Court for Baltimore ²³⁵ City. Subsequently, State Farm filed a counterclaim seeking a declaratory judgment that the services in question were not within the coverage of § 539. 2 By order dated September 14, 1989, the trial court bifurcated the issues before it. The order provided that the “threshold issue [concerned] the validity of [the] thermographic examinations” performed by Dr. Sabatier and that this issue would be decided in a separate trial. The order further provided “that only in the event that this court determines that thermography is valid ... shall the other issues presented by this case be tried.” The court said that if validity is shown by a preponderance of the evidence, it would then consider thermography in the context of the “reasonable and necessary” language of § 539.

At the trial, evidence was adduced that clinical thermography is a medical diagnostic technique that measures and maps infrared radiation emanating from the skin surface to show skin temperature. There was evidence that in a normal patient’s thermogram, one side of the patient’s body will match the other side, reflecting a symmetry of temperature, while patients with an injury or pathology will show an asymmetrical measurement of the injured body part with its corresponding side. Eleven medical expert witnesses testified and approximately 200 exhibits were received in evidence. The proponents of thermography testified that it is a reliable, objective, non-invasive diagnostic test, while its detractors testified that it is virtually useless as a diagnostic aid.

The court made detailed factual findings from the evidence before it. In weighing the validity of thermography, the court followed the criteria for admissibility of scientific evidence as articulated under the so-called Frye-Reed test. ²³⁶ While noting that this standard governed the admissibility of scientific evidence in criminal cases, the court nevertheless found it to be instructive in the present case. It explained that Frye v. United States, 293 F. 1013 (D.C.Cir. 1923), held “that expert testimony on the proof of scientific results would not be admitted in criminal cases unless the underlying principle was ‘sufficiently established to have gained general acceptance in the particular field in which it belongs.’ ” Frye, supra, 293 F. at 1014 . The court noted that this Court later adopted the Frye test in Reed v. State, 283 Md. 374 , 391 A.2d 364 (1978), a criminal case involving the admissibility of spectrograms, commonly described as “voiceprints.” Relying upon Windmere, Inc. v. International Ins.

Co., 105 N.J. 373, 379 , 522 A.2d 405 (1987), the trial court looked to three sources to determine the general acceptability required under the Frye-Reed standard. It first considered the expert witness testimony. It then reviewed the scientific literature presented at trial. Finally, it evaluated other persuasive judicial authority that considered the general acceptability of thermography.

As to the expert testimony, the court concluded: “The testimony presented favors the defendants under the Reed/Frye general acceptability standard..., The defendants established (and the plaintiffs concurred) that thermography was not widely accepted within the relevant medical community. Moreover, through a preponderance of the evidence, the testimony offered by the defendants’ experts was of greater persuasive value. Thus, under the Reed/Frye test, the first leg of the analysis, the expert testimony, is satisfied. Second, even without Reed/Frye, the balance of the evidence presented by the witnesses decisively favors the defendants.” The court further found: “The general acceptability of thermography is not demonstrated by the available scientific literature.

Plaintiff has offered some evidence of valid testing. However, ²³⁷ because the testing was outside reliable protocol ..., the results are suspect. The testing offered by the defendants, while certainly not conclusive, has the benefit of a measure of objectivity. As such, this literature is afforded greater weight.” Finally, after considering the relevant judicial decisions of other jurisdictions, the court stated that “the opportunity to consider thermography has not arisen for the majority of states.

The few jurisdictions that have adjudicated the issue of admissibility of thermography are split. Thus, the persuasive value of these cases, within the Windmere parameters, is inconclusive as a result.” Based on these findings, the court concluded: “[Tjhermography, as a medical diagnostic procedure for the treatment of musculoligamentous injuries, musculoskeletal disease and nerve root impingement, is an invalid medical procedure. Pursuant to a review of the relevant evidentiary standards as presented at trial, this Court finds that the plaintiff has failed to meet his threshold burden of validity. Accordingly, this Court does not reach the questions of whether thermography, under Section 539, is a necessary service or involves a reasonable expense.” Dr. Sabatier appealed to the Court of Special Appeals.

We granted certiorari prior to consideration of the case by the intermediate appellate court to consider the significant issue of public importance presented in the case.

II

Dr. Sabatier contends that the Frye-Reed standard for determining the admissibility of scientific evidence in a criminal case is not an appropriate standard by which to ascertain whether a particular diagnostic technique is fundamentally valid and constitutes a reasonable and necessary medical procedure compensable under § 539. He argues that the standard of proof as to the medical efficacy of ²³⁸ thermography as a diagnostic test ought to be reasonable medical proof by medical practitioners. Specifically, he suggests, that this Court adopt a standard which gives credence to the acceptance of a medical procedure by physicians who are (1) trained and knowledgeable in the procedure, its intended use and clinical benefit; (2) familiar with the literature and procedure; and (3) accepted by sufficient physicians utilizing the procedure so as to demonstrate that said procedure has probative medical value and efficacy. Dr. Sabatier, alternatively, suggests that even if the Frye-Reed test is applicable, the evidence is sufficient to satisfy that standard.

He also contends that the lower court improperly discredited the testimony of his expert witnesses based on their personal and financial stake in the use of thermography. Moreover, he says that the fact that State Farm’s witnesses were not trained and skilled in the clinical use of thermography entitles their testimony to little weight. State Farm maintains that the trial court’s reliance on the Frye-Reed test was appropriate. It asserts that while this standard is typically applied in an evidentiary context, its purpose—the determination of whether a scientific technique is of such general acceptance as to permit the trier of fact to rely upon it in resolving an issue before it—coincides with its fact-finding function in the present case.

State Farm further argues that adoption of Dr. Sabatier’s test, with its reliance upon the views of only those practitioners who utilize a procedure, rather than establishing any sort of objective standard of general acceptance, provides an almost fool-proof means of establishing validity. Thus, it urges that failure to consider the testimony of knowledgeable experts who do not utilize the procedure is to limit the court’s determination to those with only favorable views as to a technique’s purported validity.

III

In a forty-one page memorandum opinion supporting its resolution of the case, the trial court (Kaplan, J.) chronicled ²³⁹ the evidence adduced before it. It first observed that, as early as 1938, researchers recognized a possible relationship between breast cancer and skin temperature. Referring to an article published in 1957 concerning “thermographic imaging,” 3 the court related that the article claimed tKat the skin of malignant breast tumors is usually 1 to 3 degrees centigrade warmer than the other areas of the breast, and that with appropriate measurement of skin temperature, these tumors could be diagnosed. This report, as Judge Kaplan stated, “spawned additional research and other areas of the body were gauged and studied”; that in the thirty years since that initial report, numerous thermal scanning devices have appeared; and that the “standard accuracy of these devices show a variance of 0.1 degree Centigrade in the measurement of surface skin temperature.” Judge Kaplan observed that the focus of the evidence was upon thermography in the medical context of nerve and soft tissue injuries and was based upon the body’s continual emission of heat.

He concluded from the evidence that the pictures obtained by the thermographers (called “thermograms”) reflect the heat given off by the blood flow on the surface of the skin and that thermography “scans and records the surface of the body to a depth of between six to ten millimeters to measure that heat emission.” The court explained: “The principal theory of thermography involves the symmetrical pattern through which this heat is released. That is, a normal patient’s thermogram will show heat which is constant. Thus, one side of that patient’s body will match the other side creating a symmetry of temperature. Conversely, patients with a pathology have a restricted blood flow beneath the skin’s surface.

This causes an asymmetrical measurement of the injured body part with its corresponding side. Thermography is prem ²⁴⁰ ised on the concept of comparable anatomical zones of the body with asymmetrical patterns being indicative of disorder. Thermography seeks to measure and graph those potential disorders.” From the evidence before him, Judge Kaplan determined that the most popular means to measure skin temperature is through the use of an infrared camera, the imaging process being called Electronic Infrared Thermography (EIT); the process senses skin temperature and translates it into colored images reflecting corresponding heat emission. In his memorandum opinion, Judge Kaplan related that the camera’s pictures “are then transmitted to a television monitor and 35mm slides are produced,” and that temperature changes are represented by a color coded picture of the patient’s affected areas, the different colors representing a one degree centigrade variance in skin temperature.

Judge Kaplan summarized the evidence describing the procedure for conducting a clinical thermographic examination. He stated: “Several days prior to conducting a clinical thermographic exam, the patient is instructed on how to minimize outside influences on skin temperature. These instructions would include a restriction on smoking, the limited use of cosmetics or lotions, and an avoidance of excessive sun, for a period of time before the exam. “On the day of the examination, the patient is then requested to complete a medical history form which specifies the area of injury. Other factors such as prior fractures or surgery are noted.

The body area to be examined is sponged with water and dried with cool air. The patient is then put in a draft-free room for 30 minutes to allow the patient’s body temperature to equilibrate to the ambient room temperature. The room temperature is usually set at 68 to 74 degrees Fahrenheit with a low relative humidity. Following the stabilization of the patient’s temperature, the patient is led to the instrument room for thermographic examination.

The examination room is set to the same ²⁴¹ temperature as the previous room. A standard thermographic exam consists of three series of pictures taken at 15 minute intervals. These pictures are then evaluated and interpreted by the diagnosing physician. The technician that is responsible for administering the thermograms is often a person without formal medical training.

The technician is required, however, to complete coursework through the designated thermographic institutions.” There was evidence before the court that with the proper protocol a patient undergoing a thermographic examination “is believed incapable of manipulating body temperature,” an essential factor in “identifying and treating trouble spots that conventional diagnosis has overlooked.” There was evidence that thermography reduces the need for other more intrusive diagnostic testing, thereby relieving the need to subject a patient to other potentially hazardous diagnostic procedures. Judge Kaplan noted that Dr. Sabatier had the burden of proving, consistent with the Frye-Reed standard, that “thermography has achieved a certain degree of acceptability among its Peers.” Considering first the testimony of knowledgeable experts, Judge Kaplan said that the testimony at trial revealed a sharp difference of opinion, with Dr. Sabatier relying only on experts actively engaged in the clinical practice of thermography. As to their testimony, Judge Kaplan said that Dr. Sabatier “did not produce a single witness that was not intricately (and financially) tied to thermography,” a factor to be taken into account in determining whether their testimony was “derived from scientific fact, and not motivated by bias.” Specifically, Dr. Sabatier, in addition to his own testimony, offered expert testimony from Dr. Jacob Green and Dr. Jack Hubbard, both board certified neurologists; Dr. Bernard Filner, a board certified anesthesiologist; and Dr. Joseph Uricchio, a board certified orthopedic surgeon. They testified that thermography is a valid diagnostic test for musculoligamentous injuries, musculoskeletal disease and nerve root damage, and is also useful for reflex sympa ²⁴² thetic dystrophy, myofacial pain, and peripheral nerve entrapment syndromes (carpal tunnel syndrome).

Judge Kaplan acknowledged that these experts were well acquainted with the “theoretical underpinnings” of thermography as well as its factual basis. He said: “The experts recounted numerous clinical episodes where the use of thermography located a pathology that was missed by other procedures. Slide shows were presented that graphically illustrated the asymmetrical-symmetrical distinction. They noted that thermography detects ‘trigger points’ in the body which generate heat caused by muscle constrictions.

The experts concluded, that through the appropriate protocol, thermography, either as a primary or as an adjunctive technique, is reliable. Their individual clinical success stories were offered, in part, as proof of the value of the procedure.” According to the evidence, Dr. Green conducts 600 thermograms per year in his private medical practice. He also acts as a medical director for a manufacturer of thermographic equipment, for which he is paid approximately $10,000 annually. Dr. Filner completes approximately 700 thermograms per year at an average cost of $325.

The evidence showed that thermographic equipment necessary for producing thermograms costs $40,000, while equipment used for a CT scan and a Magnetic Resonance Imager, two primary medical imaging services, costs in the millions of dollars and requires highly trained personnel for its operation. By contrast, the evidence showed that thermography technicians need only scant training to operate the equipment, thereby resulting in low overhead costs, and greater profitability to the physicians utilizing thermography. Expert testimony introduced by State Farm was to the effect that thermographic examinations were a useless diagnostic tool. The testimony of these experts, Judge Kaplan said, was superior to that of Dr. Sabatier’s experts and their explanations “as to thermography’s ineffectiveness were factually, based, graphically demonstrated and uncontroverted by the plaintiff’s witnesses.” Judge Kaplan ²⁴³ found, as to these experts, that they had a collective wealth of experience and expertise to establish their credibility and were not biased.

He first recounted the testimony of Dr. Charles Ash, a board certified orthopedic surgeon with thirty-five years of medical experience, who took issue with the central theme of thermography, as follows: “Advocates of thermography claim that it objectively pictures a pathology because the skin temperature is controlled by the flow of blood to the nerve endings. Additionally, the proponents note that specific changes in thermal temperature also occur at ‘trigger points,’ areas of the body said to initiate pain or nerve root irritation. However, Dr. Ash has noted, in recent experiments, that there are inherent errors involved in imaging a curved surface such as the human body. To demonstrate, Dr. Ash showed slides of a thermogram that was taken of a balloon filled with two liters of water heated to 80 degrees Fahrenheit.

The heat loss was factored and the balloon was stated to be comparable to a bald human head. Then, the balloon was rotated 90 degrees, 180 degrees and 270 degrees and thermographically imaged in each position within 30 seconds. No appreciable heat loss was experienced from the balloon in a 30 second window. The result showed four distinct colors on each rotation.

The area closest to the camera was the warmest spot on each rotation. Because a thermogram shows diverse colors for each one degree Centigrade, the balloon represented a four degree Centigrade range. The relatively uniform temperature of the balloon should have reflected only one color. Dr. Ash believes that thermographic imaging equipment with its two dimensional depictions does not accurately measure the rounded surface of a patient.

The three degree Centigrade margin of error is, as Dr. Ash reported, prohibitively high. “Dr. Ash also has conducted an informal polling of practicing orthopaedic surgeons. In a random sample of 405 Active Fellows in the American Academy of Orthopaedic Surgeons, Dr. Ash received 316 responses to a questionnaire on the use of thermography. Of these, 293 Fellows ²⁴⁴ affirmatively replied that they had treated neck and back pain. Eighteen of this group (6.1%) noted that they had performed or prescribed thermography.

Fourteen of these eighteen (4.8%) found thermography a valid test.” Another witness testifying for State Farm was Dr. William Deyerle, a board certified orthopedic surgeon who had been in practice for almost fifty years. He had guest lectured throughout the country on orthopedic surgery, had taught medical school and post-graduate courses, and published over fifty articles on the subject. He testified that he was acquainted with thermographic procedures and stated that thermography was not generally accepted by orthopods and had no diagnostic value. He said that thermography is not included in any medical school curriculum and is not mentioned by the American Academy of Orthopedic Surgeons as even an evolving procedure.

State Farm’s most convincing witness, according to Judge Kaplan, was orthopedic surgeon, Dr. John McCulloch, board certified in both the United States and Canada. He had published twenty-nine papers, authored four textbooks, and lectured on numerous occasions throughout the world. In his twenty-year career, Dr. McCulloch estimated that he had performed some 12,000 to 14,000 operations and had diagnosed triple that number. His orthopedic speciality involved the spinal regions, including musculoligamentous injuries, musculoskeletal disease, or nerve root impingement.

Judge Kaplan summarized his testimony (footnotes omitted) as follows: “Dr. McCulloch noted the role of a spinal surgeon is to consider the scientific validity of any test used and verify clinical impressions. He is responsible for examining patients, arriving at a diagnosis, then attempting to prove the diagnosis by ordering tests. To that degree, Dr. McCulloch has ‘carefully’ considered various modalities of testing to evaluate the sensitivity and specificity of the tests. Again, Dr. McCulloch, like all of defendants’ witnesses, is not an expert in thermography by means of a regular clinical contact with the procedure.

Rather, as an expert in the ²⁴⁵ field, Dr. McCulloch is compelled to pass judgment on the validity of thermography to verify his clinical diagnosis. “Dr. McCulloch, in conjunction with Dr. Leo Mahoney, has conducted one of the only blinded studies of thermography that exists. Twenty-three patients were selected with known disc herniation resulting in nerve root impingement. Additionally, twenty-five normal control subjects were selected. The patients had a ‘clear-cut’ clinical diagnosis verified by the ‘gold standard’ at that time [meaning a diagnostic test most widely regarded as sensitive and specific].

All of the study patients were tested by thermography. The individual that interpreted the thermogram was unaware of any previous diagnoses, i.e., the study was blinded. Of the normal group, symmetrical back and leg thermograms occurred in less than 25% of the patients. In the study group, the lumbar thermograms had a sensitivity (ability to identify the disorder) of 35% Thermograms taken of the legs had a sensitivity of 48%.

As Dr. McCulloch observed: ‘[W]hat we showed was that there were almost as many patients with a clear-cut diagnosis who had normal thermograms and there were some supposedly normal patients who had abnormal thermograms and thus the sensitivity and specificity of thermography in terms of a valid investigative tool was no better than the flip of a coin.’ * * # * * * “On cross-examination, Dr. McCulloch was questioned on the false positives that his normal patients showed. Was it not possible that these normal patients had some hidden problems, such as varicose veins, infections, tumors? Dr. McCulloch replied: ‘[0]ne of the problems with thermography is the claim to its specificity is so broad that by definition of the thermographers it’s a non-specific test. It shows not only varicose veins but neuropathies,