Findings Of Fact At all times material hereto, Respondent has been a physician licensed to practice in the state of Florida, having been issued license number ME 0044173. She practiced medicine in Key West, Florida, from 1985 through June 1993 when she closed her office as a result of a family problem and moved to West Virginia. She is licensed as a physician in West Virginia and currently practices medicine in that state. Respondent is Board-certified in internal medicine. In April 1993, Petitioner's pharmacy inspector responded to telephone calls from pharmacists in Key West concerning Respondent's prescribing practices by traveling to Key West and reviewing pharmacy records of Respondent's patients. One of Petitioner's investigators thereafter collected and compiled copies of computer printouts from six pharmacies listing prescriptions filled for seven of Respondent's patients. Respondent had worked at a clinic where she experienced approximately 15,000 patient visits per year. After determining that Respondent had prescribed what he considered to be an inordinate amount of controlled substances, Schedule II narcotics, the investigator wrote to Respondent advising her that an investigation had been commenced. In July, Respondent telephoned him and advised him that she had relocated to West Virginia. The investigator asked her for the medical records for the seven patients he questioned, and Respondent advised him that in conjunction with her closing her practice and relocating, she had given their medical records to approximately 500 of her patients so they could take them to other physicians and continue receiving their medical care, and those records not picked up by patients had been sent to a Dr. Garriques to be the custodian of those records. Of the seven medical records requested by the investigator, six of them had been given to the patients, and the seventh had been transferred to Dr. Garriques. Respondent admitted that she had not personally kept either the originals or copies of the medical records of her patients. The investigator subsequently telephoned Sun Belt Clinic where Respondent had worked and was told that Respondent's medical records were not there because she had given them to her patients. In December 1993, the investigator issued a subpoena to Sun Belt Clinic for Respondent's medical records and received nothing. Petitioner has made no further effort to obtain the medical records of the patients involved in this proceeding. Controlled substances are categorized by the Drug Enforcement Agency in five different schedules according to their potential for abuse. Schedule I substances are illegal. Schedule II substances, although considered highly addictive, can be prescribed by licensed physicians for medical purposes. Schedule II substances can be narcotic (opiates administered for pain) or non- narcotic. Schedule II narcotics include morphine (morphine sulfate), methadone (dolophine), dilaudid (hydromor-phone), and oxycodone (percodan and percoset). Dexedrine is also a Schedule II controlled substance. Although morphine is the most potent narcotic available in the United States, only approximately 10-20 percent of it is absorbed, when ingested. Methadone is available in government-run clinics for the treatment of heroin addiction. Methadone is also a bona fide treatment for pain. Pursuant to the statutes regulating the conduct of registered pharmacists in the state of Florida, pharmacists are not permitted to dispense methadone for addiction; rather, pharmacists can only dispense methadone as a pain medication. At least one doctor in Key West, other than Respondent, prescribes methadone for pain, and a local hospital there has begun using methadone to treat pain on an in- patient basis. L.P., one of Respondent's patients, is a narcoleptic. Narcoleptics need a stimulant, such as dexedrine or ritalin, to function normally. Before seeing Respondent, L.P. had been "worked up" at Stanford and was taking a maintenance dosage of dexedrine. Between September 11, 1992, and June 1, 1993, Respondent prescribed dexedrine, 15 mg., for L.P., the same dosage L.P. was on before and after being Respondent's patient. The amount and frequency of dexedrine prescribed by Respondent for L.P. is within the range recommended by the Physician's Desk Reference and was an appropriate treatment for L.P.'s narcolepsy. Persons suffering from chronic pain (as opposed to acute episodes of pain) for which there is no cure or treatment available that can alleviate the person's pain are said to suffer from "intractable pain." There are two types of patients who suffer from intractable pain. The first group are patients with terminal, irreversible illnesses, such as cancer patients. Physicians generally give those patients whatever narcotics they need to alleviate the pain during the end stage of their lives. The second group is composed of patients who suffer from non-terminal disease processes who have tried different specialists and treatments available without achieving relief from their chronic pain. Those persons are generally not treated in family practice settings but rather are referred to pain management centers or pain clinics, in locations where such are available, to have their pain alleviated by treatments such as receiving morphine implants or having doctors perform nerve blocks. Many physicians avoid caring for patients who require Schedule II controlled substances to alleviate their suffering. The United States Department of Health, Education and Welfare, through its Agency for Health Care Planning and Research, has established national guidelines for treatment of moderate to severe pain in cancer patients, using Schedule II narcotics. The guidelines are written as a starting dose for opiate-naive adults, i.e., adults who have never before taken opiates. The guidelines further indicate that adults who are not opiate-naive may need a stronger dose. Although none of Respondent's other five patients involved in this proceeding were cancer patients, they suffered from intractable pain. Respondent prescribed narcotics for them within the guidelines recommended to relieve intractable pain in cancer patients. The Agency for Health Care Planning and Research recommends for moderate to severe pain a starting dose of dilaudid of 6 milligrams every three to four hours with a maximum recommended dose of 24 milligrams a day. It recommends a starting dose for moderate to severe pain for methadone or dolophine of 20 milligrams every six to eight hours with a maximum of 80 milligrams a day. For morphine, Agency guidelines recommend a starting dose of 30 milligrams every three to four hours. As to those five patients discussed hereinafter, Respondent saw each of them two times a week when they came to her for their prescriptions. In that way, she was able to monitor them closely and write prescriptions for limited quantities of medication. Sometimes, she saw those patients more often since the pharmacies in Key West were not able to stock supplies of narcotics as easily as non-narcotic medications. If a patient brought a prescription for such narcotics to a pharmacy and the pharmacy had an insufficient quantity in stock to fill that prescription, the patient could go elsewhere or could take the quantity the pharmacy had in stock. Under that circumstance, the prescription for the full quantity would be cancelled, and the patient would return to Respondent to get an additional prescription in order to have the full dose prescribed by Respondent. Respondent treated J.P. for six years for migraine headaches on an indigent basis. J.P. could not afford a CAT scan, and there were no other resources in Key West available to him for further work-up at no cost. Respondent based her treatment plan on her best clinical judgment and a complete physical examination. She tried Midren and other anti-inflammatory medications first. She prescribed percoset for three or four years. She then tried dilaudid. She prescribed dilaudid, 2 mg. from March 19, 1992, through April 23, 1992. She then prescribed dilaudid, 4 mg., from April 30, 1992, through August 17, 1992. From September 3, 1992, through November 30, 1992, she prescribed dolophine, 10 mg. On December 4, 1992, she changed J.P.'s treatment, prescribing morphine, 30 mg., through January 29, 1993. Pharmacy records reflect other medications thereafter, with a prescription for 15 dilaudid, 4 mg., on March 24, 1993, followed by 8 morphine sulfate tablets, 30 mg., on May 21, 1993; 5 percoset tablets on May 31, 1993; 15 morphine sulfate tablets, 30 mg., on June 4, 1993; and 5 percodan tablets on June 7, 1993. Although J.P. filled Respondent's prescriptions at several pharmacies, for example using three different pharmacies during the month of January 1993, the total amount of medication prescribed by Respondent was within the federal Agency guidelines. Respondent's prescribing practices as to J.P. were appropriate and not excessive. Over the course of her treatment of J.P., Respondent observed him change from a "non-functional" person to a functional person who was able to hold a job as a chef when his pain was relieved. Respondent treated M.G. for AIDS-related cluster headaches, which are very intense. He was also grieving for his girlfriend who had died of AIDS. Respondent treated him with dilaudid, which made him pain-free most of the time, and, in addition, he learned relaxation techniques to help deal with his pain. Respondent maintained him on a dosage of dilaudid, 4 mg., from December 28, 1992, through early March 1993. The quantity of dilaudid prescribed by Respondent was within the federal Agency guidelines, and was appropriate and not excessive. While taking dilaudid, M.G. was able to work four days a week as a taxi dispatcher. Respondent treated C.D. for chronic severe pain resulting from connective tissue disease. C.D. also suffered from intermittent gland swelling. Respondent unsuccessfully tried numerous anti-inflammatory medications in treating C.D., and he was treated by a rheumatologist in Miami without benefit. Respondent placed him on a maintenance treatment plan of 100 mg. a day of morphine and kept him at that level. Pharmacy computer printouts reveal C.D.'s morphine treatment commencing in February of 1992 and continuing into mid-June 1993. His functioning improved so that he was able to obtain a job as a taxi driver and once again start playing his guitar in a band. The maintenance program Respondent instituted for C.D. was within the federal Agency guidelines and was appropriate. Respondent treated J.B. for six years for multiple orthopedic problems and back pain. J.B. was not opiate-naive. He had been severely abused as a child and started taking narcotics at the age of two when he suffered a broken arm and severe burns to his hand as a result of his father's behavior. Respondent wrote alternating prescriptions for methadone, dolophine, and morphine for J.B. from December of 1991 through mid-June 1993. He remained on the same dosage. When seen in the community, J.B. was clean, spoke coherently, walked in a straight line, and dressed appropriately for Key West. Although the mixture of prescriptions and the dosage amounts Respondent prescribed for J.B. were substantial, her prescribing practices for J.B. were within the federal Agency guidelines and were appropriate. Respondent treated P.P. from 1986 through 1993 for severe sinusitis. P.P. also developed severe low back pain (sciatica). Respondent took a back x- ray, administered physical therapy, and referred P.P. to a hypnotist. Respondent wrote on prescriptions which she gave to P.P. that her diagnosis was a herniated disc. Respondent started her on dilaudid, 2 mg., in February 1992 and continued that regimen through January 1993. She also prescribed percoset and valium, 5 mg., for the severe back pain and muscle spasm. She also prescribed an anti-inflammatory for the stomach upset resulting from the narcotic. Respondent's prescribing practices as to P.P. were within the federal Agency's guidelines and were appropriate. In her treatment and prescribing practices for L.P., J.P., M.G., C.D., J.B., and P.P., Respondent kept detailed records, in part due to her concern that she might become the subject of criticism by Petitioner. Such records were not, however, offered at hearing by either party. The prescribing of controlled substances to the patients involved in this proceeding was done in the course of Respondent's professional practice.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a Final Order be entered finding Respondent not guilty and dismissing the Administrative Complaint filed against her in this cause. DONE and ENTERED this 1st day of June, 1995, at Tallahassee, Florida. LINDA M. RIGOT, Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 1st day of June, 1995. APPENDIX TO RECOMMENDED ORDER Petitioner's proposed findings of fact numbered 1-3 and 22 have been adopted either verbatim or in substance in this Recommended Order. Petitioner's proposed findings of fact numbered 4-21, 23, and 24 have been rejected as not being supported by the weight of the credible evidence in this cause. Respondent's fifth unnumbered paragraph has been adopted either verbatim or in substance in this Recommended Order. Respondent's fourth unnumbered paragraph has been rejected as being irrelevant to the issues involved herein. Respondent's first, second, third, sixth, and seventh paragraphs have been rejected as containing only argument. COPIES FURNISHED: Steven Rothenburg, Esquire Agency for Health Care Administration Suite 210 9325 Bay Plaza Boulevard Tampa, Florida 33619 Katherine Anne Hoover, M.D. Route 2 Box 203 Lost Creek, West Virginia 26385 Dr. Marm Harris, Executive Director Board of Medicine Agency for Health Care Administration 1940 North Monroe Street Tallahassee, Florida 32399-0770 Tom Wallace, Assistant Director Agency for Health Care Administration Suite 301 The Atrium 325 John Knox Road Tallahassee, Florida 32303
The Issue The issues are whether Respondent is guilty of: 1) failing to practice medicine within the applicable standard of care, as required by section 458.331(1)(t), Florida Statutes, by inappropriately and excessively prescribing one or more controlled substances and 2) failing to keep medical records that justify the course of treatment for prescribing one or more controlled substances, as required by section 458.331(1)(m), Florida Statutes, by failing to document patient histories, examination results, test results, results of drugs prescribed, dispensed or administered, or reports of consultations or hospitalizations, or failing to justify the amount and dosage of pills prescribed.
Findings Of Fact Introduction At all material times, Respondent has been a physician licensed to practice medicine in Florida. His license number is ME 33389. His practice is located in Delray. Respondent is not Board certified in any specialty. He appears to have practiced for many years. In 1987, Respondent was disciplined for a failure to keep medical records. The Board of Medicine reprimanded Respondent, imposed $2000 of costs and one year's probation, required 30 hours' coursework in risk management and recordkeeping, and restricted Respondent's license by requiring the submission of quarterly reports covering prescribing activities, among other things. In 2007, Respondent was disciplined for a violation of the requirements imposed on a dispensing practitioner. The Board of Medicine imposed a fine and probation. The Board also required a drug course, a law and rules course, ten hours' coursework in the responsibilities of dispensing practitioners and 25 hours' community service. This case involves Respondent's use of chronic opioid therapy for chronic and breakthrough pain not associated with cancer or other terminal disease. As detailed in the Conclusions of Law, the issues require consideration of whether Respondent's medical records are adequate to justify these prescriptions and whether these prescriptions are inappropriate, excessive, or otherwise unjustified, so as to violate the applicable standard of care. In attempting to prove these two sets of violations, Petitioner has limited its allegations to Respondent's prescriptions of five Schedule II controlled substances and one Schedule III controlled substance. The five Schedule II controlled substances are oxycodone, roxicodone, Oxycontin®, Oxyfast®, and Percocet®. The lone Schedule III controlled substance is Norco®. A Schedule II controlled substance has a high potential for abuse and has a currently accepted, but severely restricted, medical use in treatment in the United States. Abuse of a Schedule II controlled substance may lead to severe psychological or physical dependence. A Schedule III controlled substance has a lower potential for abuse and a currently accepted medical use in treatment in the United States. Abuse of a Schedule III controlled substance may lead to moderate or low physical dependence or high psychological dependence. People have used opium for pain relief for thousands of years. The pharmacological production of opioid drugs started after the identification of the morphine alkaloid in 1806. By the end of the 19th century, in the United States, legal controls were imposed on opioids. By the 1940s, opioids could be legally used only if prescribed by physicians, pursuant to strict regulatory controls. By the end of the 20th century, tension had emerged between physicians reluctant to prescribe opioids due to professional-liability considerations and advocates of pain control. Particularly contentious issues are whether and how to prescribe opioid therapy for chronic pain not associated with terminal disease. Oxycodone and hydrocodone are short-acting opioids with an onset of 30-90 minutes and duration of 4-6 hours. Roxicodone is oxycodone hydrochloride. In controlled-release form, such as Oxycontin®, oxycodone hydrochloride is a long-acting opioid with an onset of 1-12 hours and duration of 8-72 hours. With a quicker onset than oxycodone in pill form, Oxyfast® is a liquid containing 20 mg of oxycodone hydrochloride in a one-ml bottle. Percocet® is oxycodone and acetaminophen: a dosage of "10/325" is 10 mg of oxycodone and 325 mg of acetaminophen. Norco® is hydrocodone and acetaminophen: a dosage of "10/325" is 10 mg of hydrocodone and 325 mg of acetaminophen. Methadone is an inexpensive synthetic opioid with long- acting effect. The half-life of methadone typically ranges from 15-60 hours, but may extend to 120 hours. The long, variable half-life of Methadone discourages its wider use in pain control because of difficulties in maintaining not more than therapeutic levels. During the time in question, Oxycontin® was relatively expensive among the opioids listed in the preceding paragraph. At that time, one 30-mg roxicodone pill cost an uninsured patient about $0.70-$1.00, one 40-mg Oxycontin® pill cost an uninsured patient about $8.00, and one 80-mg Oxycontin® pill cost an uninsured patient about $14.00. The record does not reliably establish street values for these drugs, but all of them were traded and consumed at high rates illegally on the street. Short-acting opioids are more appropriate for breakthrough pain, which is a temporary spike in pain above chronic-pain levels due, for example, to physical exertion. A short-acting opioid is well-matched to the relatively short duration of breakthrough pain. This record does not permit resolution of the dispute over whether long-acting opioids are more effective than short-acting opioids for the relief of chronic pain. Generally, prescribed opioids pose distinct risks of consumption and diversion by the patient. For the opiate-naïve patient, doses of opioids that may be easily tolerated by the opiate-tolerant patient may cause potentially life-threatening side effects, including respiratory depression. For the opioid- tolerant patient who is consuming opioids not prescribed by the practitioner--from other, undisclosed practitioners or from street purchases--additional doses of prescribed opioids may cause the same life-threatening side effects as those faced by the opiate-naïve patient, although, with controlled dosing among opioid-tolerant patients, opioids typically may be increased until pain control is attained. Pain medicine practitioners may manage these risks, in part, by administering periodic urinalyses to their patients. The urinalyses administered to the ten patients in this case were threshold tests that would detect the presence of various substances above a certain level. Such tests would uncover opioid-naïve patients and patients consuming other controlled substances, but not the level of any controlled substance detected by the test. Sometimes, opioid rotation may achieve the desired analgesic effect at relatively low doses. Otherwise, chronic pain may require increasing doses of the same opioid to obtain the same relief originally obtained by lower doses, although some patients may find effective relief for extended periods at a dosing level that is not increased. Less frequently, higher opioid doses may produce hyperalgesia. Optimally, effective pain management is multifaceted, including such disciplines or techniques as psychotherapy, cognitive behavioral therapy, biofeedback, relaxation techniques, physical therapy, and reliance on nonopioid analgesics. But limits on insurance coverage or lack of insurance and the relatively high costs of most of these alternative disciplines or techniques may legitimately require the practitioner to rely more on the relatively inexpensive opioids. Even Petitioner's expert witness admitted, "Sometimes I have self-pay patients who are on opiates only because they can't afford anything else." (Pet. Ex. 4, p. 7.) Petitioner's expert acknowledged that roxicodone "is something you tend to give people who have no insurance." (Tr., p. 85.) Cost considerations may also require that the practitioner break down what would be a single prescription of, say, 100 pills into two prescriptions of 50 pills each, so the patient can effectively pay for his prescription in two installments. Again, Petitioner's expert witness admitted that there was nothing wrong with this practice. (Pet. Ex. 4. p. 41.) None of the ten patients addressed in this case had insurance during the relevant period. (One patient potentially had COBRA coverage that would have expired long before the period in question.) Although at least a couple of patients were employed in professions in which at least moderate earnings might be expected, the record does not reliably describe the financial resources of any of the ten patients. The record contains no evidence of injury to the patients discussed below in terms of the care, including prescribed opioids, that they received from Respondent. Excessive consumption of prescribed or diverted opioids is dangerous and can be fatal. But, as Respondent's expert witness testified, the fatal combination seen "excessively" in the eight deaths per day in Florida from prescription drug abuse is opioids; benzodiazepines, such as Xanax®; and muscle relaxants, such as Soma®. Although Respondent prescribed medications in all three categories, Petitioner has not alleged any violations arising from Respondent's prescriptions of any drug besides the opioids discussed above, so Respondent's prescriptions of benzodiazepines and muscle relaxants to these ten patients are generally omitted from the Findings of Fact. As Petitioner's expert testified, there is no quantitative criterion for the standard of care in prescribing opioids. (Tr., pp. 29 and 108.) The standard-of-care determination is dependent on the facts. Two facts of importance are the achievement of pain relief and the restoration or maintenance of function in the patient. The record contains ample evidence of the extent of pain relief, although nearly all of it is in the form of reports from patients, whose credibility is difficult to assess. The record contains relatively little evidence of functionality for most patients. As discussed in the Conclusions of Law, contrary to the testimony of Petitioner's expert, a standard-of-care violation is not established, per se, by a medical-records violation. The record is problematic in several other respects. Most notably: 1) Petitioner's expert witness stated in his initial report to Petitioner that Respondent's medical records were adequate and justified the course of treatment (Tr., pp. 111-22); but 2) Respondent's expert witness stated that Respondent's medical records were inadequate, at least based on present practices. (Depo. Tr., Forest S. Tennant, Jr., pp. 51- 52.) Also, in what probably came as a surprise to Petitioner, its expert witness three times opined that, under certain conditions, a physician may lawfully deviate from the applicable standard of care in the prescription of opioids. (Tr., pp. 65, 90, and 95-96.) The testimony of each expert witness was uneven. Most of the flaws of Petitioner's expert are listed above, but he repeatedly tended to agree with the attorney asking him questions. Neither expert displayed an over-familiarity with the details of the medical records; sometimes, Respondent seemed somewhat unfamiliar with them too. Petitioner's expert is Board certified in the subspecialty of pain medicine and practices in Orlando; Respondent's expert is not Board certified in any specialty or subspecialty and has never practiced in Florida. But Respondent's expert thoughtfully explained how a higher blood pressure and pulse rate might be associated with under- medication, and a lower blood pressure and pulse rate might be associated with over-medication. Respondent's expert also recognized the difference between a medical-records violation and a standard-of-care violation. During the time in question, Respondent saw 15 patients daily, not 60 or more patients daily, as are seen by some high-volume opioid-prescribing physicians. The ten patients in this case are all residents of Florida, not residents of other states drawn to the opioid-prescribing practices of a compliant Florida physician. (One of the ten patients appears to have been a resident of Mississippi, but had a Florida driver license--tending dispel an inference that he was in Florida briefly for the purpose of obtaining opioids.) Almost always, Respondent obtained patient records from the physician who had been treating the patient immediately before he or she began seeing Respondent. And, at a time when the practice was not required by statute or rule, Respondent used urine screens to determine whether his patients were consuming the opioids that he was prescribing them. For none of the ten patients has adherence to the dosing practice of a preceding physician, per se, constituted compliance with the applicable standard of care. Except for a relatively brief period after acquiring the patient, Respondent could only satisfy the applicable standard of care by appropriate treatment, regardless of the dosing practice of the preceding physician. In large part, the purpose of administering urinalyses was to detect aberrant behavior by the patient. In this context, aberrant behavior means patient diversion of opioids or consumption of other opioids or other controlled substances without disclosure to Respondent or, in the case of illegal consumption of such substances, even with disclosure to Respondent. W. C. From February 12, 2007, through July 16, 2009, Respondent prescribed to W. C. 150 30-mg roxicodone pills and 120 15-mg roxicodone pills each month. Respondent first saw W. C. on June 20, 2001, when Respondent served as the medical director of the Pain Management Center in Miami. At the time of this initial visit, according to Respondent's medical records, Respondent complained of rheumatorial arthritis of the left knee, on which he had had surgery, two years earlier, to repair a tear of the medial collateral ligament. W. C. also complained of lower back pain and tendonitis in the left elbow and shoulder. The patient's situation was exacerbated by his job, which involved moving refrigerators. The initial note states that the patient's general practitioner, Dr. Martin Coleman, had prescribed him 5-mg pills of Roxicet®, and the patient had taken some Xanax® from his wife to relieve spasms and stress. The next office visit took place on July 16, 2001, at which time Respondent brought a "note," not medical records, from Dr. Coleman. According to Respondent's medical records, Dr. Coleman's note stated that the degenerative arthritis was of the right knee, not the left knee, which had been treated with Percocet®, which is similar to Roxicet®. Evidently relying on the patient's statement that he had tried his wife's Xanax®, the July 16 record states: "His anxiety is helped tremendously with Xanax®." At this time, Respondent saw W. C. for seven or eight months. These medical records are missing, but they are not at issue in this case. At some point, W. C. transferred to the Delray office of the Pain Management Center while this office was staffed by Drs. Morency, Rabinsky, and Weed. In November 2005, W. C. suffered a wedge fracture of the T12 vertebra, which caused him severe back pain, as a result of an automobile accident. On February 14, 2007, Respondent saw W. C. in the Delray office of the Pain Management Center, to which Respondent had since transferred. Among the records that Respondent reviewed was a neurological consultation dated September 7, 2006, in which the neurologist, Dr. Perry Hoeltzell, described cervical, left arm, left lower back, and left leg complaints since the November 2005 accident. Respondent also examined an MRI of the spine taken on September 7, 2006, that showed a T12/L1 collapse of the disc with chronic anterior wedging of the T12 vertebra. The appearance was of a flexion trauma. These conditions supported the finding or complaint of cervical radiculopathy of C3 through C6 and lumbar radiculopathy of L4-5/L5-6. W. C. informed Respondent that he liked the flexibility of his current prescription of 150 pills of 30-mg roxicodone and 120 pills of 15-mg roxicodone monthly, so he could decide which dose to take when. However, W. C. did not appear to be an uncritical consumer of every controlled substance that he could get. The July 16, 2009, medical note reports that W. C. declined a renewal of Cymbalta®, saying that it did not work and, "I didn't think I needed it." At the time of the February 14, 2007, office visit and through the final office visit of July 16, 2009, W. C. was able to work and suffered no side effects. Each month, Respondent saw W. C. in the office and typically spent 15-30 minutes talking with him. The medical records over this period are inadequate and do not justify the opioid prescriptions that Respondent gave W. C. during this time. For two and one-half years, Respondent prescribed the same two prescriptions of roxicodone with medical records consisting of monthly reports of blood pressure, pulse, general appearance, patient history, and complaints, such as level of pain, the extent of pain relief, side effects, sleep, and mood. As tended to be his practice with all ten patients, Respondent never filled in the bottom of the medical-record form, which prompted insertion of the "plan." Respondent never recorded any diagnosis or general assessment of W. C., or recorded how he was managing the patient. For over two and one-half years, Respondent failed to document these important elements of medical records. This was too long for Respondent to claim that he was merely maintaining the prescription regime of the preceding physician until Respondent had the opportunity to assess the patient, discuss with the patient treatment alternatives, and develop a pain- management plan. In this timeframe, Respondent should have documented these tasks multiple times. The absence of this critical patient assessment and treatment information from the medical records means that the records fail to justify the course of treatment. Petitioner's expert witness opined that Respondent violated the applicable standard of care due to the excessive prescription of medications. But when asked why the prescribed medications were excessive, the expert responded, "the medical records," which, he explained, failed to provide an understanding of how the patient was managed, failed to provide a diagnosis, assessment, or treatment plan, and omitted any description of level of functioning, clinical exams, or physical exams. (Tr., p. 23.) Petitioner's expert witness described Respondent's medical records as "poor." (Tr., p. 27.) If there were any doubt that the basis of the expert's standard-of-care opinion was the inadequate medical records, he dispelled it in the following exchange: Q: Dr. Gerber, this prescribing of roxicodone 30 mg of 150 pills in conjunction with roxicodone 15 mg of 120 pills, what is your opinion about the appropriateness and whether or not the prescribing of those two--that combination is within the standard of care and why? A: Well, without medical records justifying it, if falls below the standard of care. There's no explanation of why these two potent opioids are being prescribed together. . . . (Tr., pp. 24-25.) Obviously, where the patients, other than W. C., do not testify, the ability of Petitioner's expert to opine as to the standard of care is limited to what he has learned of their care from the medical records and the testimony of Respondent, which supplies very little in addition to what is contained in the medical records. After an extensive discussion of the inadequacies of the medical records, in response to a standard- of-care question, the expert admitted that the lack of medical records left him "not able to formulate an opinion as to how this patient was managed." (Tr., p. 23.) Immediately after this statement, Petitioner's expert twice testified that the standard-of-care violation was due to the problems with the medical records. (Tr., pp. 23-24.) The frustration of Petitioner's expert witness, although understandable, does not justify elevating a medical-records violation to a standard-of- care violation--again, as explained in the Conclusions of Law. The sole attempt of Petitioner's expert to predicate a standard-of-care violation on something besides the inadequate medical records was unsuccessful. Although he elsewhere disclaimed reliance merely on the quantity of prescribed opioids as the sole basis of a standard-of-care violation, Petitioner's expert complained about Respondent's prescription of "these two potent opioids . . . together." (Tr., p. 25.) Of course, there is only one potent opioid at issue in the W. C. counts-- roxicodone. (Xanax®, which Respondent also prescribed to W. C., is not an opioid and, as noted above, is not alleged as a basis of any liability in this case.) If the two opioids were the two dosages of roxicodone, the expert's complaint appears to be a back-door attempt to object to the quantity of prescribed opioids--in isolation from other relevant factors. Significantly, Petitioner's expert testified that, with acceptable documentation, "one [of the roxicodone prescriptions] by [itself] might be acceptable" (Tr., p. 25)--implying that his underlying problem is with the quantity of this opioid that Respondent has prescribed. But, as Petitioner's expert witness conceded, "patients can have a lot of pain and require high doses of opioids even with minimal diagnostic studies." (Tr., p. 26.) Petitioner's expert eventually admitted that a monthly prescription of 120 pills of a hypothetical 45-mg roxicodone, which is slightly less than Respondent's prescription of 120 pills of 15-mg roxicodone and 150 pills of 30-mg roxicodone, might have met the standard of care, if "there was good documentation of physical functioning [and] the notes and records clearly documented an assessment and plan." (Tr., p. 31). For W. C., clinical reports amply documented injuries that could have accounted for the pain that W. C. consistently reported during the period in question. The record establishes sustained function during the course of treatment--and even beyond. Alone among the patients, W. C. testified to his extensive orthopedic problems in his back and to the role of Respondent and his medication regime in preserving W. C.'s functionality. Respondent's treatment of W. C. left one question unanswered. In general, Petitioner's expert rightly asked why Respondent did not offer or explore nonopioid treatments. (Tr., p. 27.) The absence of any consideration of nonopioid treatments is a deficiency in the medical records, but also relevant in determining whether Respondent met the standard of care. Respondent's usual explanation--the prohibitive costs of such alternative treatments--may not apply to W. C., who was continuously employed throughout his treatment, possibly even as the owner of the company for which he worked. Respondent testified: "He was a laborer, he had his own moving company." (Tr., p. 209.) But, standing alone, this question does not establish a standard-of-care violation. There is less, if any, value in the suggestion of Petitioner's expert that a standard-of-care violation may be based on Respondent's failure to prescribe methadone. As noted above, this record fails to establish that the standard of care requires the use of long-acting opioids for chronic pain, and this repeated suggestion by Petitioner's expert fails to account for the difficulties, noted above, in the use of this persistent opioid, which even Petitioner's expert admitted must be used "carefully." (Tr., p. 32.) Petitioner proved a medical-records violation, but not a standard-of-care violation. D. M. From January 8, 2007, through July 18, 2007, Respondent prescribed to D. M. a monthly regime of roxicodone and Oxycontin®. The sole exception to the monthly office visits with Respondent is an office visit dated February 5, 2007, which, judging from the handwriting on the note, involved another physician at the Pain Management Center. Respondent's prescriptions for January 8 and March 5 were for 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. On April 2, Respondent increased the monthly prescription to 180 30-mg roxicodone pills while maintaining the number and dose of Oxycontin® pills. On April 30, Respondent increased the number of roxicodone pills to 200 monthly, but decreased the dosage to 15 mg, while maintaining the number and dose of Oxycontin® pills. On May 24, Respondent issued a prescription for 200 15-mg roxicodone pills, 100 30-mg roxicodone pills, and 180 40-mg Oxycontin® pills. On June 21, Respondent prescribed 200 15-mg roxicodone pills and 180 40-mg Oxycontin® pills. On July 18, Respondent prescribed 100 30-mg roxicodone pills and 180 40-mg Oxycontin® pills. D. M. is unique among the ten patients in two regards. She has the shortest treatment period at six months, and she is the only patient to have received Oxycontin® monthly for the duration of her treatment under Respondent. Another unusual aspect of D. M.'s case is Respondent's clear confusion about his treatment of her. Respondent testified that he first saw her on May 24, 2007. This testimony is contrary to the stipulation, and it is not borne out by the medical records. The medical notes for January 8 (Joint Ex. 2, p. 159), March 5 (Joint Ex. 2, p. 157), April 2 (Joint Ex. 2, p. 156), and April 30 (Joint Ex. 2, p. 155) all appear to be in the handwriting of the physician who filled out the medical note for May 24 (Joint Ex. 2, p. 346). D. M. bore a diagnosis of fibromyalgia, which is a diagnosis of a condition whose existence divides the medical community. However, associated with the diagnosis is widespread pain involving the muscles and soft tissues and sleep disturbances, both of which D. M. reported. Although the disease is not like a fracture or herniated disc in its ability to be confirmed by some form of imaging technology, the present record provides an inadequate basis to disregard the existence of this condition or dismiss the potential severity of the pain associated with this condition. In 1995, D. M.'s physician, Thomas Fitzpatrick, M.D., referred D. M. to John H. Gridley, Jr., M.D., who specialized in internal medicine and rheumatology. After an examination of this 35-year-old patient, Dr. Gridley diagnosed D. M. with what is now referred to as fibromyalgia. She has borne this diagnosis ever since. D. M. had been a patient of the Kendall office of the Pain Management Center since 2003. Her condition had deteriorated since 1995; she had spent two years in bed. During this time, she had received the opioids that Respondent later maintained. When D. M. first saw Respondent nearly 12 years later, she had gained 70 pounds, and her systolic blood pressure had increased 34 mm to 144/72. D. M. advised Respondent that the only medication that relieved her pain was Oxycontin®, so, after discussing diet and exercise, Respondent continued her existing prescription of Oxycontin® with roxicodone for breakthrough pain. On D. M.'s next visit, on March 5, no vital signs were taken. On her next visit, on April 2, her blood pressure had dropped to 102/78, although her pulse was 78. Her pain, which was reported as "6" on her first visit, was down to "5" on this visit. In addition to his confusion over when he started treating D. M., Respondent seemed confused by his own treatment plan for this patient. Alluding to his much-used explanation of financial constraints precluding the prescription of Oxycontin®, Respondent testified that, due to "financial reasons," "we converted one Oxycontin® to Roxy 30s, giving her exactly the same dosage. The patient was having financial problems. I remember that." (Tr., p. 227.) However, the record reveals no reduction in the relatively expensive Oxycontin® prescription, only an increase in the roxicodone prescription on April 30 and again on May 24. Later, Respondent testified that his office mistakenly increased the roxicodone prescription on April 30 from "100 to 180 milligrams." (Tr., p. 228.) However, this increase amounted to only 20 30-mg pills for the month or about 20 mg daily. The increase on May 24 was much larger--from 6000 mg/month of roxicodone to 9000 mg/month of roxicodone. This was also a mistake, but a much bigger one. D. M. never informed Respondent of the prescription error, which Respondent "didn't like." (Tr., p. 228.) Respondent reduced the June 21 prescription, probably to allow D. M. to use some of the extra roxicodone that she had on hand. (Tr., p. 228.) However, Respondent never attempted to explain how these two dosing mistakes happened or, if they were not mistakes, what justified these dramatic increases in opioids being prescribed to the patient. Respondent probably did not attempt a justification of these increased dosages because no justification existed: D. M. reported a small increase in pain from April 30 to May 24, but only from a "5" to a "6." Consistent with his refusal to predicate a standard- of-care violation strictly on the quantity of opioids prescribed, Petitioner's expert witness admitted, "counting pills is not the best way of managing a patient." (Tr., p. 43.) But his standard-of-care analysis regarding Respondent's care for D. M. includes the quantity of pills in the context of patient complaints, the underlying diagnosis, and the existence of alternative means of treating the patient's pain, such as a fentanyl patch. (Tr., pp. 40 and 45.) The standard-of-care violation for D. M. relies on this broader record of Respondent's care for this patient, not on the following testimony of Petitioner's expert: "So, the whole case boils down to, you shouldn't be putting patients with fibromyalgia on this much medication." (Tr., p. 44.) Neither in May 2007 nor three and one-half years later at the hearing did Respondent have any idea why he dramatically increased D. M.'s roxicodone prescription on May 24. To the extent that Respondent claimed a "mere" mistake, his explanation would have carried more weight, if he had not also offered his well-worn financial argument that the patient could not afford the additional cost of the long-acting opioid, Oxycontin®. This argument did not apply to D. M., who was already paying for Oxycontin® each month. This makeshift defense, the unjustified increase of opioids, the mistaken recollection of the substitution of roxicodone for Oxycontin®, and the failure to recall when Respondent's treatment of this patient started combine to make Respondent's brief treatment of D. M. appear random and chaotic. On these facts, Respondent's prescription of opioids was inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. R. H. From January 29, 2007, through July 7, 2009, Respondent prescribed to R. H. a monthly regime of 30-mg roxicodone and 10/235 Norco®. For January 29 and March 2, the dosages were 60 roxicodone pills and 240 Norco® pills. On March 27, Respondent raised the roxicodone prescription to 90 pills. This prescription continued through visits on April 24, May 22, June 20, and July 18. On August 2, which was only two weeks after the preceding office visit, Respondent doubled the number of roxicodone pills to 180. On September 28, Respondent increased the roxicodone by one-third, from 180 to 240 pills. On November 30, Respondent increased the roxicodone prescription to 300 roxicodone pills and, for the first time, changed the Norco® prescription, raising it from 240 pills to 300 pills. Respondent maintained these prescriptions through 14 "monthly" visits in 2008--actually, 13, as the last is on December 23, 2008--and visits on January 21 and February 17, 2009. On March 17, Respondent decreased the Norco® to 280 pills. On the final visit, on July 7, 2009, Respondent decreased the roxicodone to 270 pills and Norco® to 240 pills. Respondent first saw R. H. in 2001 due to failed-back syndrome following a car accident three or four years earlier and a micro-discectomy of L5/S1, which had resulted in additional complications. R. H. had been wheelchair-bound for eight months and was learning to walk again; she was in intractable pain. A psychiatrist later diagnosed her with severe anxiety disorder and post-traumatic stress disorder. R. H. visited the Pain Management Center after a referral by her physician, who was no longer comfortable prescribing her Vicodin ES®. R. H. disclosed in her 2001 initial office visit that she had recently had another automobile accident, for which she had been charged for driving under the influence. R. H. reported that epidural injections had failed to control her pain, and she had gained 50 pounds in the past couple of years. An unsettling consultation note is in R. H.'s medical records. On January 31, 2001, Anjan K. Ghosh, M.D., of the Anesthesia Pain Care Consultants, Inc., saw R. H. in consultation. Dr. Ghosh concluded the R. H. suffered from lumbar post-laminectomy pain syndrome "with conflicting physical signs on examination," mechanical lumbar axial pain, severe anxiety disorder, and gastroesophagael reflux disease. In a detailed plan of treatment, Dr. Ghosh proposed a caudal catheter neuroplasty and nerve root decompression to treat R. H.'s recurrent lumbar radiculitis. Based evidently in part on an adverse surgical experience, R. H. refused this treatment, saying, "the reason I was sent to see you [was] for only pain medication." After Dr. Ghosh explained that he would continue her Vicodin ES® only for two weeks, R. H. asked again if she could consider the surgical intervention later, but, for now, obtain prescriptions for an opioid regimen, which Dr. Ghosh declined to do. R. H. was an unusual patient because, even though she was in her mid-thirties when she first saw Respondent, she often brought her mother, who, according to Respondent, "doled" out her prescribed opioids. (Tr., p. 242.) In contradictory statements, Respondent testified: "She did well. She was able to function. She lost jobs constantly." (Tr., p. 243.) Respondent's testimony about this patient is surprisingly brief based on the lengthy two and one-half years that he saw her, as covered by this case; the dramatic increase in roxicodone from 1800 mg monthly to 9000 mg monthly, with a smaller increase in Norco®; and the instability of the patient, as reflected by her dogged pursuit of opioids, her DUI arrest five or six years earlier, and the role of her mother as the gatekeeper to her prescribed opioids. Petitioner's expert witness noted that the March 27, 2007, medical note, in which Respondent raised the roxicodone from 60 pills to 90 pills monthly, contained no explanation for the increase. Likewise, Petitioner's expert found no justification in the medical records for the doubling of the roxicodone from 90 pills to 180 pills monthly in August 2007, the increase from 180 pills to 240 pills monthly two months later, or the increase of the Norco® from 240 pills to 300 pills monthly one month later. Petitioner's expert noted these increases in opioids were not accompanied by physical exams, physical findings, or any consideration of alternative therapies, such as nonsteroidal anti-inflammatory drugs. Respondent's medical records reveal a "4" for reported pain on March 1, 2007, but no vitals, and no pain report or vitals on March 27, 2007, when Respondent hiked the roxicodone by 50% and prescribed Neurontin®, which Respondent testified at the hearing he did not "even know what it is." (Tr., p. 240- 41.) The medical note for April 24, 2007, consists of a few scribbled lines without any vitals or pain report. On May 22 and June 20, 2007, the medical records contain vitals, but no pain report. Finally, on July 18, the medical note contains a pain report, but it is still a "4." Two weeks later, when Respondent doubled the roxicodone from 90 to 180 pills monthly, the medical note reflects that the pain is still only a "4." During this period of time, R. H. had had a molar surgically removed on April 7, 2007, and had been passing out weekly since that event. In mid-September 2007, R. H. was admitted to a local hospital one week after an automobile accident. In the followup to the automobile accident, a CT scan of the brain revealed vascular abnormality, which required a followup hospital admission that did not reveal anything especially serious. However, the accident had resulted in some upper extremity pain and some back pain. At the time of the hospital admission in connection with this accident, R. H. admitted only to the use of Soma® and Valium®, as well as occasional marijuana, but not the extensive opioids that Respondent was prescribing. All of this information is in Respondent's medical records. R. H. reported a pain level of "8" on the September 28 medical note, despite the large increase in roxicodone prescribed two months earlier. If there was a discussion of the recent automobile accident, it does not emerge from the nearly illegible notes, and Respondent did not testify to any analysis of the effect of this recent accident. At this time, Respondent increased the roxicodone by 50%--from 180 pills to 240 pills monthly. On November 1, 2007, the medical note reveals that R. H. reported pain at a level of "5." On a patient questionnaire, R. H. reported that pain had not interfered at all in the past month with her mood, walking, sleeping, concentrating, appetite, work, or relationships, and she denied any side effects. Despite this information, one month later, on November 30, with the pain reported at only a "4," Respondent increased the roxicodone by 60 pills monthly. While Respondent maintained this prescription through 2008, R. H. reported pain at only a "4." On February 17, 2009, in a medical review, Respondent noted that R. H.'s urine had tested positive for THC. This note records R. H.'s difficulty in keeping a job. This note describes a treatment plan to continue the present pain medications, possibly taper benzodiazepines, and continue to refer R. H. to psychotherapy. There is little connection between the medical records--most notably, the self-reported pain levels--and the amount of opioids that Respondent prescribed. Given the obvious difficulties that this patient was experiencing and the large increases in opioids that Respondent prescribed her, the treatment plan described in the preceding paragraph was insufficient. These facts do not depict merely a failure of the medical records to justify the course of treatment. Even without regard to the single indication of marijuana use, R. H. was a substance abuser who lied to health-care providers about what she was taking and required her mother to control her access to the opioids that Respondent prescribed. Respondent's treatment "plan" was to give R. H. exactly what she wanted, including one drug with which Respondent was completely unfamiliar. This patient needed help, and Respondent, for two and one-half years, failed to practice in accordance with the applicable standard of care by continuing to supply her with an increasing supply of opioids--essentially, failing to treat her. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. K. L. From March 15, 2007, through July 16, 2009, Respondent prescribed to K. L. a monthly regime of mostly 30-mg roxicodone with occasional 10/325 Percocet®, 80-mg Oxycontin®, and 15-mg roxicodone. On March 15, 2007, Respondent prescribed 420 30-mg roxicodone pills (all roxicodone prescriptions for K. L. are for 30 mg unless otherwise stated) and 120 Percocet® pills. This prescription continued through office visits on April 11, May 9, and June 6, at which time Respondent dropped the Percocet® prescription. From July 2, 2007, through November 14, 2007, which covers five and one-half months, Respondent prescribed "monthly"--on six occasions--420 pills of roxicodone. On December 12, 2007, Respondent reduced the prescription to 400 pills of roxicodone, but added 60 Percocet® pills. This prescription continued through office visits on January 8, 2008, and February 7. On March 5, 2008, Respondent dropped the Percocet® from the prescription, but raised the roxicodone to 420 pills. This prescription continued until January 5, 2009--so as to cover 11 months with 12 "monthly" prescriptions. On January 30, 2009, Respondent reduced the roxicodone from 420 pills to 360 pills. On February 26, 2009, Respondent effectively increased the prescription by reducing the 30-mg roxicodone from 360 pills to 280 pills, but adding 200 pills of 15-mg roxicodone. On March 5 and 6, 2009, Respondent prescribed 90 roxicodone pills, 30 Percocet® pills, and 26 Oxycontin® pills (in two prescriptions). Four days later, on March 10, Respondent prescribed 120 roxicodone pills. Fifteen days later, on March 26, Respondent prescribed 390 roxicodone pills. On April 22, Respondent prescribed 360 roxicodone pills. On May 20, he prescribed 330 roxicodone pills. And on June 17 and July 16, 2009, Respondent prescribed 300 roxicodone pills each office visit. At the initial visit, K. L. informed Respondent that he had been seeing another pain physician, Frederick Swartz, M.D., but was required to visit every three weeks and found the office hours inconvenient. One may safely infer that the frequency of visits was part of Dr. Swartz's attempt to restrict K. L.'s aberrant behavior. Dr. Swartz had prescribed, every three weeks, 84 Percocet®, 284 roxicodone, and 84 Xanax®. On a monthly basis, the 84 pills translate to about 121 pills, and the 284 pills translate to about 410 pills. Respondent's initial prescription thus maintained the levels of Percocet® and roxicodone that the preceding physician had prescribed. During the initial interview, K. L. advised Respondent that he had suffered orthopedic injuries from being struck in the face with a baseball bat many years earlier, as well as two automobile accidents more recently. Having previously worked as a personal trainer, according to the notes, K. L. "works now in the New York State Business." The meaning of this statement remains known only to its author, but does not necessarily mean that K. L. was an out-of-state patient. K. L. informed Respondent that he obtained adequate pain relief from the 14 roxicodone that he took daily. K. L. stated that he had tried Oxycontin® for a couple of days, but did not like it due to cognitive impairment. His only surgical history involved the repair of the eye socket following the baseball bat injury. K. L. rated his pain as a "6." Respondent testified that, after four months, he eliminated the Percocet® because there was no need for K. L. to be taking two short-acting opioids simultaneously, and Respondent was concerned about potential acetaminophen toxicity. These were prudent concerns. A major issue in this patient's treatment developed when, on March 15, 2007, he took a urinalysis, and it tested positive for opiates, in addition to the oxycodone and benzodiazepine that Respondent had been taking, as prescribed. The test results distinguish between the oxycodone present in the roxicodone and Percocet® that had been prescribed for K. L., and other, nonprescribed opiates, such as heroin and codeine. K. L. failed subsequent urinalyses administered by Respondent. On May 9, 2007, his urine tested positive for oxycodone and other opiates, but not benzodiazepines. On February 7, 2008, January 30, 2009, and February 26, 2009, K. L.'s urine tested positive for oxycodone, morphine (another opiate that evidently is disclosed separately from opiates), and benzodiazepines. Respondent's contradictory testimony confirms his mishandling of the patient. Initially, Respondent testified that he had concluded, when K. L.'s urinalyses first disclosed opiates, that K. L. suffered from some sort of rare condition in which the liver failed to metabolize the oxycodone and caused the urinalyses to detect the oxycodone as other opiates. This explanation is discredited because Respondent failed to order additional lab work on liver function at the time and failed generally to proceed to rule out or otherwise deal with any liver problems. Respondent later admitted, in cross- examination, that he was not concerned about K. L.'s liver in 2007 (Tr., p. 339.), but only became concerned about it in 2009. (Tr., p. 340.) The actual explanation for the failed urinalyses was K. L.'s consumption of other opiates that he was not disclosing to Respondent. And Respondent was aware of this aberrant behavior. Undermining his testimony about a later suspicion of liver dysfunction, Respondent, reading from a medical note dated January 30, 2009, testified: "I even put [K. L.] on probation because I thought he was lying to me." Obviously, he would not have put a patient on probation for impaired liver function. Even if Respondent were telling the truth that he did not realize, until January 30, 2009, that K. L. had been lying to him about other opiate use--which he was not--two facts nonetheless undermine Respondent's attempted explanations. First, from March 15, 2007, through January 30, 2009, Respondent prescribed to K. L. over 10,000 roxicodone pills. After Respondent claimed to have concluded that K. L. was lying about other opiate use, Respondent prescribed, from February 26, 2009, through July 16, 2009, over 2000 more roxicodone pills plus 200 15-mg roxicodone pills. As was the case with R. H., these facts do not depict merely a failure of the medical records to justify the course of treatment. K. L. is also a substance abuser, engaging in the especially dangerous behavior of combining his prescribed opioids with unprescribed opioids. For almost two years, Respondent joined K. L. in an elaborate rationalization process designed to avoid confronting the patient's urgent problem. K. L. needed help, and Respondent, for two years, failed to practice in accordance with the applicable standard of care by continuing to supply him with an increasing supply of opioids-- essentially, failing to treat him. Under these circumstances, Respondent's opioid prescriptions were inappropriate, excessive, and otherwise unjustified. Petitioner proved a medical-records violation and a standard-of-care violation. J. K. From May 22, 2007, through July 27, 2009, Respondent prescribed to J. K. a monthly regime of 30-mg roxicodone plus Oxyfast® occasionally. (All roxicodone prescriptions for J. K. are for 30 mg.) On May 22, 2007, Respondent provided J. K. with two prescriptions of 120 roxicodone pills each. On June 19, Respondent wrote J. K. two roxicodone prescriptions--one for 150 pills and one for 170 pills. On July 16, Respondent wrote J. K. a prescription for 150 roxicodone pills, a prescription for 120 roxicodone pills, and one bottle of Oxyfast®. On August 13, Respondent wrote J. K. a prescription for 300 roxicodone pills, five roxicodone pills, and two bottles of Oxyfast®. On September 10, Respondent wrote J. K. a prescriptions for 295 roxicodone pills, five roxicodone pills, and one bottle of Oxyfast®. On October 8, Respondent reduced the numbers of roxicodone pills by giving J. K. prescriptions for 190 roxicodone pills, 140 roxicodone pills, ten roxicodone pills, and one bottle of Oxyfast®. On November 2, Respondent maintained these prescriptions, dropping only the prescription for ten roxicodone pills. But, three days later, Respondent gave J. K. a prescription for ten roxicodone pills. On December 3, 2007, Respondent greatly increased the prescription, raising it to 410 roxicodone pills and two bottles of Oxyfast®. On January 4, 2008, Respondent reduced the prescription to 330 roxicodone pills in one prescription and ten roxicodone pills in the other, as well as two bottles of Oxyfast®. Again, on February 1, 2008, Respondent increased the prescription, raising it to 380 roxicodone pills, but dropping the Oxyfast®. Respondent repeated this prescription on February 28 and raised it to 410 roxicodone pills on March 28. Respondent lowered it to 380 roxicodone pills on May 22. Then, on May 22, June 19, July 17, and August 13, Respondent prescribed 450 roxicodone pills each month. Respondent did not see J. K. for the next five months. On January 19, 2009, Respondent gave J. K. separate prescriptions of 200 and 250 roxicodone pills. On February 13, Respondent issued J. K. a single prescription for 450 roxicodone pills. On March 12, Respondent issued five roxicodone prescriptions for 200 pills, 100 pills, 100 pills, 50 pills, and 70 pills--for a total of 520 pills. Six days later, on March 18, Respondent gave J. K. another roxicodone prescription--this time for 30 pills. On April 7, Respondent gave J. K. two roxicodone prescriptions--one for 100 pills and one for 250 pills. Six days later, on April 13, Respondent gave J. K. two more roxicodone prescriptions--one for 200 pills and one for 50 pills. On May 5, Respondent gave J. K. a roxicodone prescription for 250 pills. On June 1, Respondent gave J. K. roxicodone prescriptions for 250 and 200 pills each. And on June 29 and July 27, Respondent gave J. K. roxicodone prescriptions for 450 pills each. J. K. had been a semi-professional hockey player who retired prematurely due to back pain. He exacerbated his back problems when he was involved in an automobile accident on April 19, 2004. On July 16, 2007, J. K. reported a pain level of "7," but this increased to a "9" on August 13, 2007. At this time, Respondent increased the roxicodone prescription. However, the medical records do not reveal escalating pain reports during the first half of 2008 when Respondent twice ramped up the roxicodone levels. The complaints of Petitioner's expert witness are that Respondent prescribed short-acting opioids for chronic pain, and Respondent prescribed excessive opioids for the injury at issue, which Petitioner's expert first identified as the older hockey injury, not the newer injury from the car wreck. These complaints appear ungrounded. As noted above, this record fails to reveal the superiority of long-acting opioids over short-acting opioids for the treatment of chronic pain, and Petitioner's expert acknowledged that a practitioner must sometimes prescribe roxicodone, rather than a long-acting opioid, such as Oxycontin®, due to cost considerations. Obviously, in suggesting that J. K.'s pain was disproportionate to his injury, Petitioner's expert would have enjoyed greater credibility if he had not first based his testimony on the much- older hockey injury to the face, rather than the newer injuries to the back from the automobile accident. In her cross-examination of Respondent, Petitioner's counsel tried to suggest that Respondent violated the standard of care by resuming the roxicodone prescription, after a five- month hiatus in visits between August 2008 and January 2009. However, Respondent first confirmed that J. K. was positive for oxycodone and, thus, not opioid-naïve. Respondent also explained that J. K. had seen a doctor in New Jersey while he was there visiting his mother. Essentially, for J. K., the standard-of-care opinion of Petitioner's expert witness is based entirely on inadequate medical records. The expert noted correctly that Respondent's medical records, which span two years, lack assessments, diagnoses, and treatment plans. At times, the medical records fail to support changes in medications. But Petitioner has failed to prove that Respondent's treatment of J. K. itself violates the standard of care because there is some correspondence between pain reports and prescription quantities. Petitioner proved a medical-records violation, but not a standard-of-care violation. K. G. From June 19, 2007, through July 27, 2009, Respondent prescribed to K. G. a monthly regime of 30-mg roxicodone pills. (All roxicodone prescriptions to K. G. are for 30-mg doses, unless otherwise indicated.) For the first four months, Respondent prescribed 300 roxicodone pills monthly. For the next four months, Respondent prescribed 280 pills monthly. For the next year, Respondent did not see K. G. When K. G. returned on December 19, 2008, Respondent prescribed 280 roxicodone pills, which he maintained for the next two months' prescriptions. On April 6, 2009, Respondent maintained the prescription at 160 30-mg roxicodone pills plus 240 15-mg roxicodone pills, which is the equivalent of 280 30-mg pills. On April 30, 2009, Respondent provided two prescriptions of 160 and 120 roxicodone pills, and, on May 26, June 24, and July 27, 2009, Respondent prescribed 280 roxicodone pills each month. K. G. presented to Respondent with complaints of lower back pain, probably resulting from two automobile accidents. An MRI of the lumbar spine showed a herniated disc at L5/S1, causing impingement of the right and left S1 nerve root, and a herniated disc at L4/L5. Dr. Deluca, who was no longer practicing, had been prescribing K. G. 120 80-mg Oxycontin® pills and 420 30-mg Oxycontin® pills, presumably monthly. K. G. had been switched to Suboxone®, which is used to withdraw a patient from opioids, but K. G. admitted to buying and using Oxycontin® on the street. The initial note contains a treatment plan. Claiming a pain level of "9," K. G. asked to resume Oxycontin®, but Respondent declined, based in part of K. G.'s history of high intake of opiates. Respondent instead suggested interventional pain management. A urinalysis administered on the initial visit was negative as to "everything." Respondent then prescribed ten roxicodone pills daily, perhaps revealing a belief that K. G. was not, in fact, opioid-naïve at the time. On K. G.'s next visit, on July 17, 2007, he tested positive for THC. In a medical note dated October 22, 2007, Respondent noted that K. G. had not seen the orthopedist, to whom he had referred him. Respondent found K. G. difficult to manage because he traveled a lot, working as a market maker for stocks. K. G. took Suboxone®, but only to avoid withdrawal symptoms from interruptions in his roxicodone regime while he was in other countries, where he presumably could not take his roxicodone. On January 4, 2008, Respondent placed K. G. on probation due to unspecified aberrations in behavior. K. G. promptly discontinued seeing Respondent for over ten months between January 4 and November 21, 2008. On his return, K. G. again tested positive for THC. Respondent testified that he counseled him not to continue to use marijuana, but his records do not document this fact. Respondent continued treating K. G. for another eight months without administering another urinalysis. Again, the medical records reveal no assessment, diagnosis, or treatment plan. Petitioner's expert witness pursued some false trails in trying to establish a standard-of-care violation. He complained about a split prescription on April 30, 2009, but there were only three such prescriptions over two years, and this record fails to reveal a sinister purpose in splitting prescriptions. About the worst thing that Petitioner's expert has to say about the practice is that he is "not sure of the purpose for that." (Tr., p. 70.) Petitioner's expert witness raised the issue of short-acting versus long-acting opioids, but this has already been addressed. Petitioner's expert objected to Respondent's prescription of Xanax® and Soma®, but, as already noted, Petitioner did not plead these matters. Petitioner's expert witness mentioned the polysubstance use of benzodiazepines and oxycodone--both prescribed--with marijuana. Petitioner's expert opined that patients who persist in using marijuana "need to be tapered off their [opioids] and referred for [substance abuse] counseling." (Tr., pp. 72 and 145.) Respondent's expert opined that practitioners are divided in what to do with patients whose aberrant behavior involves exclusively marijuana use. The standard of care as applied to marijuana use is discussed in the Conclusions of Law. Petitioner's expert finds firmer footing when he ties in the other aberrant behavior of K. G., including obtaining Oxycontin® on the street and K. G.'s on-again, off-again misuse of Suboxone® as a opiate-substitute, not as an agent to assist in opiate detoxification. When K. G. ignored Respondent's referral to an orthopedist, K. G. blatantly ignored Respondent's lone attempt to initiate a reexamination of the patient's underlying condition. There were one or more unspecified aberrant behaviors, and, when Respondent finally placed the patient on probation, K. G. quit seeing Respondent for ten months: on his return, he promptly tested positive for marijuana again. These facts are the grounds of the standard-of-care violation. As was the case with R. H. and K. L., so it is with K. G. By continuing to prescribe opioids and not treating the underlying condition, or tapering him off and then dismissing K. G. as a patient, if he refused to stop his aberrant behavior, Respondent essentially deprived K. G. of the treatment that he required. Petitioner proved a medical-records violation and standard-of-care violation. D. D. From June 30, 2008, through June 3, 2009, Respondent prescribed to D. D. a monthly regime of 290 30-mg roxicodone pills. And, in this case, a one-year span produced only 12 prescriptions. At his initial visit on June 30 or July 1, 2008, D. D., a diabetic in his 50s, presented with pain in both knees. His left knee had been replaced two years earlier and was doing well, but he was awaiting replacement of his right knee. D. D. had an abscess at L5/S1. He was on SSI disability. Although taking 30-mg and 15-mg roxicodone, D. D. wanted to get off the 30-mg pills because he had no insurance. Obese at 192 pounds, D. D. reported his pain to be an "8." The treatment plan involved converting D. D.'s 15-mg roxicodone pills for 30-mg roxicodone pills, despite his interest in dropping the 30-mg pills, but Respondent maintained the same dosage as had been prescribed by the preceding physician. Otherwise, the treatment plan consisted of discussing the rules of the Pain Management Center. Petitioner's expert witness complimented Respondent on his initial medical record: he called it a "well presented medical record, a good history there. I think this is an appropriate medical record." (Tr., p. 85.) And it is. Petitioner's expert also testified that the patient required opiate management. Laboring under a misunderstanding as to the amount of roxicodone that Respondent had prescribed on the first visit, Petitioner's expert was alarmed by what he thought had been a doubling on the second visit; in fact, the quantity had remained unchanged. In this case, given the short time of treatment and the extensive medical difficulties of the patient, whom Respondent described aptly as "one of the saddest patients I have" (Tr., p. 230), Petitioner's expert lacked support in the record for his opinion that Respondent was required to address eliminating pain medications from D. D.'s life. D. D. was a low-functioning person when he presented to Respondent, and the standard of care did not require, within one year, that Respondent either get D. D. off opioids or substantially improve his function. However, toward the end of the treatment period, D. D. enjoyed greater functionality, as he was able to help raise his grandson. Petitioner failed to prove a medical-records violation or a standard-of-care violation. J. M. From October 1, 2007, through July 3, 2009, Respondent prescribed J. M. a monthly regime of 30-mg roxicodone pills and Oxyfast bottles. (All roxicodone prescriptions to J. M. are for 30-mg doses, unless otherwise indicated.) On October 1, 2007, Respondent prescribed 240 roxicodone pills and one bottle of Oxyfast.® On October 23, Respondent maintained the roxicodone, but doubled the Oxyfast® to two bottles. Respondent maintained this prescription level the next month. On December 21, Respondent essentially maintained the same prescription level by prescribing 105 30-mg roxicodone pills and 273 15-mg roxicodone pills, as well as two bottles of Oxyfast.® On January 18, 2008, Respondent again maintained the same prescription level by prescribing 70 30-gm roxicodone pills and 340 15-mg roxicodone pills, plus two bottles of Oxyfast.® But four days later, Respondent prescribed another 70 roxicodone pills. On February 18, Respondent prescribed 240 roxicodone pills in two prescriptions--one for 70 pills and one for 170 pills--but no Oxyfast.® On March 25, Respondent prescribed 240 roxicodone pills--in separate prescriptions of 110 and 130 pills--and two bottles of Oxyfast®. Respondent repeated this prescription, but with a single roxicodone prescription each month, for the next nine months. The only exceptions were split prescriptions of 140 pills each on June 17 and the discontinuation of visits between June 17 and September 8. On February 24, 2009, Respondent reduced the prescription to 60 pills of 15-mg roxicodone. On March 23, he raised it to 300 pills of roxicodone--split into prescriptions of 120 pills and 180 pills--and two bottles of Oxyfast.® On April 17, Respondent prescribed two bottles of Oxyfast®, and, on April 23, Respondent prescribed 70 roxicodone pills. On May 15 and June 10, 2009, Respondent prescribed 300 roxicodone pills--divided into two prescriptions of equal amounts--and two bottles of Oxyfast®. On July 3, 2009, Respondent prescribed 300 roxicodone pills--divided into prescriptions of 80 and 220 pills--and two bottles of Oxyfast®. In the initial visit in 2002, J. M. presented as a 32-year-old male with lower back pain. He reported that he had injured his back a few months earlier picking up an object. Unable to lift, J. M. had had to quit working as a gardener. He had been taking four or five Percocet 10/325's daily. The treatment plan, which was prepared by Respondent, was to help J. M. quit smoking tobacco and convert him from Percocet, with the potential acetaminophen toxicity, to roxicodone. J. M. told Respondent that his girlfriend had let him try some of her Xanax®, which had helped him with spasms and sleeping, so Respondent prescribed that too. They also discussed that J. M. should exercise his COBRA rights on his insurance because he was going to get some evaluations, as well as epidural injections. An MRI of the lumbar spine performed on February 6, 2008, revealed multilevel central disc herniations at L2/L3, L3/L4, L4/L5, and L5/S1 with annular tears in the herniations at L3/L4, L4/L5, and L5/S1. The MRI disclosed mild spinal stenosis at L4/L5. None of the ten patients involved in this case displayed the same extent of objective bases for the pain of which he or she complained. In August 2007, while being seen by Dr. Morency at the Pain Management Center, J. M. expressed a desire to be seen by a different physician, but the medical record fails to reveal why. On October 1, 2007, when first treating J. M., Respondent continued the level of opioids that Dr. Morency had been prescribing. Respondent prescribed Oxyfast® with roxicodone because the former, as a liquid, has a faster onset than the pill, which can take 45 minutes to take effect. Respondent testified that he doubled the Oxyfast® on October 23 because the pain was worse. But, according to the medical records, J. M. reported pain of "5" on October 1, 2007, and, three weeks later, reported pain of only "3." On July 3, 2009, a urinalysis revealed THC. Respondent discussed with J. M. his aberrant behavior and placed him on probation, warning him not to test positive for marijuana again. However, J. M. had tested positive for marijuana on April 17, 2006, August 7, 2007, and October 23, 2007--each time he had been tested. Respondent did not test J. M. again for nearly two years. Petitioner's expert faulted Respondent for his handling, or lack of handling, of J. M.'s apparently ongoing marijuana use during treatment. This is addressed in the Conclusions of Law. Petitioner's expert witness faulted Respondent for using short-acting opioids rather than long-acting opioids, but this has been dealt with already. Except for the doubling of the Oxyfast® early in the period of treatment, the medical records fail to establish a correspondence between pain reports and prescription levels of roxicodone on three occasions: the two months during which Respondent supplemented the roxicodone prescription with 70 pills and the 25% increase in roxicodone in early 2009. The medical records lack assessments, diagnoses, and treatment plans. In particular, the medical records are deficient because they do not justify the three increases in prescribed opioids. But there is insufficient evidence of a standard-of- care violation as to J. M. There is insufficient evidence of aberrant behavior that would require Respondent to taper off J. M. from pain medications--despite well-documented sources of pain--while he obtained counseling to help him stop using marijuana. And the three instances in which increased prescriptions were not justified in the medical records prove a medical-records violation, not a standard-of-care violation, as discussed in the Conclusions of Law. No other evidence in the record establishes a lack of justification for the prescribed opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. L. From April 26, 2007, through March 3, 2009, Respondent prescribed to M. L. a monthly regime of 30-mg roxicodone pills, except for a single prescription of oxycodone and two prescriptions of Percocet® 10/325. (All roxicodone prescriptions to M. L. are for 30-mg doses.) On April 26, 2007, Respondent prescribed 440 mg of roxicodone pills in two prescriptions--one for 200 pills and one for 240 pills. Respondent repeated this prescription monthly for seven months--eight times--when, on December 6, 2007, he raised it to 540 mg in two prescriptions--one for 290 pills and one for 250 pills. Starting January 8, 2008, Respondent returned to his initial pattern of prescribing 440 pills of roxicodone in two prescriptions. This continued through 2008--again, counting January 8, this amounted to 13 prescriptions, not 12, over the year. Respondent continued this prescription pattern on January 6 and February 2--the latter incorporating 40 15-mg roxicodone pills to achieve the same total prescription in dosage. On March 3, 2009, Respondent prescribed 150 roxicodone pills, 210 5-mg oxycodone pills, and 210 Percocet® 10/325 pills. In 1999, David Buchalter, M.D., referred M. L. to the Pain Management Center with a report stating that an MRI suggested that the patient had a small herniated disc at C3/C4, a mild disc bulge at C4/C5, and degenerative disc space narrowing at C5/C6. By the time that Respondent saw M. L., he had been complaining of neck and lower back pain for many years. M. L. could not afford Oxycontin®, but a urinalysis confirmed that he was taking his prescribed short-acting opioids. M. L. had been seen by the Pain Management Center for several years, and he had never exhibited aberrant behavior. Nothing stands out in the record concerning the care received by M. L., although, again, two years of medical records contain no assessment, diagnosis, or treatment plan. Petitioner proved a medical-records violation, but not a standard-of-care violation. M. P. From February 12, 2007, through July 7, 2009, Respondent prescribed to M. P. a monthly regime of Oxycontin and methadone initially and, later, mostly roxicodone. (All roxicodone prescriptions for M. P. are for 30 mg, unless otherwise indicated.) M. P. had been seen by the Pain Management Center since at least 2002. He was operating a forklift in 1999 when boxes fell on him, injuring his neck. An MRI revealed a ruptured disk at C3/C4, a disc bulge at C4/C5, and degenerative disc disease at C5/C6. At the time of the office visit, M. P. was still employed driving a forklift, but was taking 120 mg of Oxycontin® daily. Despite a medical record dated January 5, 2006, stating that M. P. could not afford Oxycontin®, he was still on this relatively expensive, long-acting opioid at the start of the period in question. During his years of treatment at the Pain Management Center, M. P. had never displayed any aberrant behavior, as periodic urinalyses revealed that M. P. was taking his prescribed opioids and nothing else. The medical records during the period in question contain no patient assessments or treatment plans, nor do they explain the switching of medications. Of particular interest, as to the standard of care, is the relatively long period that Respondent prescribed two long-acting opioids, methadone and Oxycontin®. As Petitioner's expert testified, such overlapping is appropriate during a dosage-transition phase, as the practitioner transitions the patient from one such opioid to another. But here, Respondent prescribed methadone and Oxycontin for five months. At the end of this period, Respondent discontinued the Oxycontin®, but there is no constant tapering off of Oxycontin® during this period. From February to July 2007, the monthly prescriptions for Oxycontin® are for 14,400 mg, 14,400 mg, 14,400 mg, 14,400 mg, 0 mg, and 4800 mg. As noted above, methadone is difficult to use for analgesic purposes. Doubtlessly, this difficulty is increased by adding another long-acting opioid, even if its half life is much shorter than the half-life of methadone. But this is really all that Petitioner presents for a standard-of-care violation. Although it is a close question, Petitioner's evidence fails to convince that five months' dual prescribing of two long-acting opioids was inappropriate, excessive, or unjustified. Petitioner's expert questioned the amount of roxicodone prescribed, in conjunction with methadone, for back pain. This criticism was less well-founded, as Respondent eventually discontinued the methadone also. Additionally, M. P. tended to report high pain levels during the period in question. Again, during the two and one-half years of relevant treatment, the medical records fail to include an assessment, diagnosis, or treatment plan, including any guide to the transitioning of the patient off of two long-acting opioids. Petitioner proved a medical-records violation, but not a standard-of-care violation.
Recommendation It is RECOMMENDED that the Board of Medicine enter a final order finding Respondent guilty of nine counts of medical-records violations and four counts of standard-of-care violations and imposing $107,500 in administrative fines, four years' suspension from the practice of medicine, 200 hours' community service, six years' probation after completion of the suspension, restrictions upon Respondent's license after it is reinstated, coursework, and costs. DONE AND ENTERED this 23rd day of June, 2011, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 23rd day of June, 2011. COPIES FURNISHED: Shirley L. Bates, Esquire Grace Kim, Esquire Department of Health 4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-1701 Sean Michael Ellsworth, Esquire Ellsworth Law Firm, P.A. 1501 Collins Avenue, Suite 208 Miami Beach, Florida 33139 Renee Alsobrook, Acting General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Larry McPherson, Jr., Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399
The Issue The issue in this case is whether Everett Luis Northup sustained a birth-related neurological injury.
Findings Of Fact Katrina Northup (formerly Katrina McGuff) and Richard Northup are the natural parents of Everett Luis Northup. At all times material to this proceeding, Katrina Northup was an obstetrical patient of Wayne Blocker, M.D., and Dr. Blocker was a "participating physician" as defined in section 766.302(7), Florida Statutes. Dr. Blocker provided obstetrical services in the course of labor and delivery at the birth of Everett. Ms. Northup did not experience any significant problems during her prenatal course. On August 21, 2009, she presented to Brandon Regional Hospital, which is a licensed Florida hospital. She was 34.1 weeks pregnant. Beginning at 8:58 a.m., Ms. Northup was started on Pitocin. By 2:23 p.m., the baby's station was -1. At 3:50 p.m., Ms. Northup's membranes ruptured. At 4:41 p.m., the baby was experiencing increasing fetal tachycardia, and the mother's efforts at pushing were nonproductive. A decision was made to use vacuum extraction to facilitate the delivery. Dr. Blocker applied a KIWI vacuum extractor to the baby's head, but a seal could not be achieved. A soft cup vacuum extractor was used to deliver the baby's head to the perineum so that Ms. Northup could push the baby out. Four pulls, two of which were pop offs, were used. Ms. Northup was able to push the baby out after the use of the vacuum extractor. The baby experienced shoulder dystocia during delivery. This means that there was a delay in descent because the baby's shoulder was impinged on the mother's pubic bone. The shoulder dystocia was corrected using a MacRoberts maneuver, which is flexing the mother's hips to give more room in the pelvis. The shoulder dystocia did not require additional force from the vacuum extractor. Everett was born live on August 21, 2009, at 4:45 p.m. He weighed 3,875 grams at birth. Everett was large for his gestational age. The hospital's admission summary for Everett described his condition at time of delivery as follows: Infant was delivered pale, floppy, and with a poor respiratory effort. Infant was suctioned PO and nasally and stimulated . The initial HR was <100 but exceeded 100 by 1 minute of age. Respirations became more regular and color became ruddy with a rapid HR. Tone remained poor and there was bruising of the left arm and ballotable fluid in the scalp. After delivery, Everett's mouth, nose and pharynx were suctioned and he was given blow-by oxygen for two minutes. Everett's Apgar score at one minute of age was recorded as seven and, at five minutes of age, was eight. Apgar scores are designed to define a baby's responsiveness and cover five different categories: heart rate, respiration, color, reflex activity or reflex responsiveness, and muscle tone. Each of the categories can be scored a zero, a one, or a two. At one minute of life, Everett's heart rate was greater than 100 beats per minute; he had a good cry; there was some flexion of the extremities; he had a grimace; and his body was pink and extremities were blue. At five minutes of life, Everett's heart rate was greater than 100 beats per minute; he had a good cry; he had active motion; he had a cry or active withdrawal; and he was blue/pale. Everett's initial blood gases were recorded as a pH of 7.20, which is considered a mild to moderate metabolic acidosis. Everett was admitted to the Neonatal Intensive Care Unit (NICU). His admission summary describes the findings of the admission physical examination as follows: CONDITION: Pink, quiet and responsive. HEENT: Anterior fontanelle soft, open, and flat, red reflexes present bilaterally, subgaleal bleed with ballotable fluid, nares patent and palate intact. CARDIAC: Normal sinus rhythm with tachypnea, weak pulses and poor perfusion, CRT -5 seconds, precordium quiet and no murmur. Abdomen: Soft and nondistended abdomen, good bowel sounds, 3-vessel cord and liver edge palpable at the costal margin. GU: Normal male features for gestational age, testes descended bilaterally and patent anus. NEUROLOGIC: Quiet and responsive with fair muscle tone and reflexes for age. SPINE: Neck supple without masses, spine straight and intact, no sacral dimple noted and no clavicular fracture palpated bilaterally. EXTREMITIES: Symmetrical movements and no hip clicks. SKIN: Bruising over left arm. Everett's heart rate was recorded on August 21, 2009, as 208 at 5:00 p.m., 166 at 5:30 p.m., 172 at 6:00 p.m., and 168 at 8:30 p.m. Blood pressures taken at the same time intervals were 55/20, 48/20, 45/28, and 70/47. The initial glucose level for Everett was 29. This hypoglycemia was corrected with a DIOW bolus of 3 ml/kg. Everett had a respiratory distress syndrome, which was attributed to his premature lungs. This syndrome was corrected with intubation and the use of surfactant. He was intubated for approximately nine hours and then placed on room air. On August 27, 2009, Everett was discharged from the NICU. When Everett was 11 months old, his parents expressed concerns to his pediatrician that Everett was not meeting his developmental milestones. The pediatrician referred Everett to a pediatric neurology specialist, who prescribed an MRI. The MRI showed a "symmetric increased T2 signal within the periventricular white matter with associated atrophy of the corpus callosum, likely related to leukomalacia secondary to prematurity." On February 1, 2012, pediatric neurologist, Francis Filloux, M.D., notes her diagnostic impressions: Cerebral palsy with a spastic diplegia pattern or possible spastic triplegia, with the best function in the left upper extremity. Periventricular leukomalacia, by report from the prior MRI scan. Associated neurodevelopmental impairments. History of very mild prematurity. Everett is permanently and substantially mentally and physically impaired. Everett did not suffer an injury to the brain during resuscitation in the immediate post delivery period in a hospital. Petitioners retained Jeffrey Koren, M.D., and Stephen Glass, M.D., as expert witnesses. Respondent retained Donald Willis, M.D., and Michael Duchowny, M.D., as its expert witnesses. Dr. Glass is board-certified in neurology with a special competence in child neurology, and he is board-certified in pediatrics. He has been practicing as a pediatric neurologist for 32 years. Dr. Glass is currently an associate professor of neurology and pediatrics at the University of Washington. Dr. Glass opined that Everett sustained an injury to the brain caused by mechanical injury, due to the multiple vacuum extractions which occurred in the course of labor which rendered Everett permanently and substantially physically and mentally impaired. He believes that the injury to the brain caused by the use of the vacuum extraction device used during the delivery process caused a reduction of blood flow to the periventricular areas of the brain which caused periventricular leukomalacia (PVL), which led to cerebral palsy. Dr. Koren is board-certified in gynecology and has been practicing obstetrics and gynecology for over 30 years. He opined that the use of the vacuum extraction caused a traumatic injury to the scalp of Everett causing a subgaleal bleed and a diminished blood flow to the periventricular areas of the brain, which caused the PVL. Dr. Willis is fellowship trained in maternal fetal medicine and board-certified in obstetrics and gynecology and maternal fetal medicine. He began in private practice in 1980 and has taught at several universities. Since 2000, he has been doing consultations in maternal fetal medicine. Dr. Willis is of the opinion that Everett did not suffer a brain injury which was mechanical or due to oxygen deprivation during labor and delivery. Based on his readings of Everett's fetal heart-rate monitor, there was no evidence of fetal distress. Everett's Apgar scores were normal with a score of seven at one minute and eight at five minutes. The umbilical cord pH was not consistent with acidosis or hypoxia that would be significant enough to cause significant brain injury. The subgaleal hematoma caused by the use of the vacuum extractor was not clinically significant. Everett did not require a transfusion, and he was not anemic. By the second day of Everett's life, he had a hematocrit of 53, which is normal for a newborn. Dr. Duchowny is a pediatric neurologist who directs the neurology training program at Miami Children's Hospital. He is a professor of neurology and pediatrics at the University of Miami School of Medicine and is a full professor at the Florida International University School of Medicine. His clinical practice is based out of Miami Children's Hospital. Dr. Duchowny is board-certified in pediatrics, neurology with special qualification in child neurology, and clinical neurophysiology. He performed an independent medical examination of Everett on December 12, 2011. Dr. Duchowny opined that Everett did not suffer a brain or spinal cord injury caused by oxygen deprivation or mechanical injury during the course of labor, delivery or resuscitation in the immediate post delivery period. He explained the basis for his opinion as follows: [A]lthough Everett's neurological problems were substantial in both, the mental and motor domains, a review of his medical records did not support the belief that these abnormalities were, in fact, acquired during the labor or delivery. Everett was a pre-term infant. He was large for gestational age, but he was born at 34 weeks gestation, but if you look through the neonatal course, it's clear that his was relatively benign. For example, Everett's Apgar scores seven and eight at one and five minutes of life. These scores were quite good. His cord blood gases also were mildly abnormal, but really very little evidence of any significant problem. His cord pH was 7.18. He had a base excess of minus 10.3, and these are mild findings, and consistent with his overall neonatal course, during which he actually did very well. For example, there was no evidence of overall systemic involvement, apart from some transient hypoglycemia that was adequately treated, and he did not have multi-organ system failure, liver involvement, cardiovascular collapse. He certainly wasn't comatosed. He was transiently intubated but did not require a prolonged course of ventilator support. Sepsis was suspected, and he was treated with antibiotics, but ultimately his cultures were negative, and he went home without any significant problems or complications in the newborn period. Given the fact that his MRI scan of the brain ultimately revealed damage in the form of periventricular leukomalacia, and thinning of the corpus callosum, it would appear that his deficits could not have been acquired in the course of labor, delivery or the immediate post-partum period. Rather, I believe that Everett's brain injury was acquired prior to birth, likely as a consequence of his prematurity. Had it been acquired during labor and delivery, I would have expected a much more severe postnatal course, given the MRI findings and his neurological examination. The opinions of Dr. Willis and Dr. Duchowny are credited. Everett did experience a subgaleal hematoma during the birthing process. In order for a subgaleal hematoma to cause brain damage, it would have to be a substantial loss of circulating blood volume which would lead to hypovolemic shock. Everett did not have hypovolemic shock nor did Everett experience any seizures. If the subgaleal hematoma had been clinically significant, Everett would have been given a blood transfusion. He was not given a blood transfusion and he was not anemic. The subgaleal fluid collection was small and easily reabsorbed. Both Dr. Glass and Dr. Koren opined that the Apgar scores were incorrect and should have been substantially lower. However, their opinions are based on the descriptions of Everett at the time of delivery, which were pale, floppy, and with poor respiratory effort. At delivery, Everett's heart rate was less than 100 beats per minute. After he was suctioned and stimulated, Everett's heart rate was greater than 100 beats per minute and his color was ruddy. Everett had a difficult birth, which was reflected in the descriptions of him at delivery. However, within a minute of delivery he had bounced back and had a normal Apgar score. The greater weight of the evidence establishes that Everett did not suffer an injury to the brain during labor and delivery due to oxygen deprivation or mechanical injury. More likely than not the PVL and thinning of the corpus collosum are findings associated with Everett's prematurity and not a result either directly or indirectly of the vacuum extraction delivery and the resultant subgaleal hematoma.
The Issue The issue in this case is whether Layton Maloy suffered an injury for which compensation should be awarded under the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact Jessica and Josh Maloy are the natural parents of Layton Maloy. Layton was born on September 4, 2012, at Lakeland Regional Medical Center, Inc. (Lakeland Regional), which is a hospital located in Lakeland, Florida. Layton was a single gestation and weighed in excess of 2,500 grams at birth. Obstetrical services at Layton’s birth were provided by Dr. Jeffrey L. Puretz, who was a physician participating in the NICA program. Notice of NICA participation was provided to Petitioners by Dr. Puretz and by Lakeland Regional. Petitioners contend that Layton suffered a birth-related neurological injury and seek compensation under the NICA Plan. More specifically, Petitioners contend that Layton suffered a stroke during labor and delivery, which resulted in a brain injury, rendering Layton permanently and substantially mentally and physically impaired. Respondent contends that there was no event during labor and delivery which resulted in oxygen deprivation to Layton, and that any medical conditions suffered by Layton are not birth-related neurological injuries as defined in section 766.302(2), Florida Statutes. Respondent further contends that Layton is not permanently and substantially mentally and physically impaired. Intervenors take no position as to whether Layton suffered a birth-related neurological injury. Layton was born at approximately 9:22 p.m., via cesarean section secondary to non-reassuring fetal heart rate tracing following six hours of labor. Following receiving an epidural, Mrs. Maloy experienced hypotension for which she received two doses of Ephedrine to raise her blood pressure. Following the second dose of Ephedrine, the baby’s fetal heart tracing became non-reassuring and the mother and baby’s heart rate became tachycardic. Mrs. Maloy also received an amnioinfusion during labor. Layton was born crying, pink and vigorous. Layton’s one- minute Apgar score was 8, and his five-minute Apgar score was 9. He did not require resuscitation at birth, and was sent to the regular newborn nursery with “routine NB orders” where he was noted to be active, awake, with normal rooting and sucking reflexes. Layton was discharged from the hospital with his mother on day two of life. After returning home, Mrs. Maloy noticed what she believed to be Layton having abnormal movements described as episodes of arms and/or legs shaking. His two-week old check-up was normal. However, two or three days after that check-up, she returned to the pediatrician’s office where “Layton had an episode in front of Dr. Leviten.” Dr. Leviten admitted Layton to Lakeland Regional for evaluation and a neurological consultation. A VEEG obtained was interpreted to reveal frontal central spike and wave on a few occasions from the left hemisphere suspicious for seizure activity. Layton was subsequently placed on Phenobarbital. Layton was noted at this time to be clinically very stable, doing well, eating well, happy and alert, and interactive. Layton was transferred to All Children’s Hospital. Upon admission, he was noted to be bottle feeding, had normal tone and no focal deficits. Dr. Ena Andrews, a pediatric neurologist, first saw Layton on September 26, 2012, at All Children’s Hospital, where she reviewed his medical records from Lakeland Regional. Her impression included a history of focal seizures and a finding on MRI that “is suspicious for intrauterine stroke.” She conducted a neurological examination of Layton. There were no abnormal findings from her neurological examination. She also reviewed a CT performed at Lakeland Regional that was read as normal by a radiologist. However, she ordered an MRI to rule out an intrauterine stroke. The MRI was conducted and Dr. Andrews reviewed the results with Mrs. Maloy on September 27, 2012: IMAGING STUDIES: I reviewed images of the MRI with mom at the bedside. As suspected, after reviewing the head CT, there is an area on the right frontal lobe with hypodensity on T2 weighted images. The area is also hypodense on diffusion, indicating it is not an acute ischemic lesion. Ventricles enlarged on the left compared to the right. There is also a hypodense area on the right parietal. Finding appears to be limited to the white matter without clear involvement of the cortex. There is no enhancement. LABORATORY STUDIES: Phenobarbital level is 22.9 this morning. IMPRESSION: History of focal seizures, doing well without seizure recurrence. Phenobarbital is in low-therapeutic range. Hypodense lesion in the right frontal and parietal white matter, unclear etiology. Given prior investigations at outside hospital, including blood cultures and CSF cultures, infection is unlikely. No evidence of diffusion change to suggest acute stroke; however, this does not rule out the possibility of prenatal stroke. Differential also includes some other type of inflammatory lesion with edema. In her deposition which was taken on June 23, 2015, when Layton was less than 3 years old, Dr. Andrews explained that her use of the word “prenatal” referenced a stroke occurring before birth, and her use of the term “acute stroke” referenced a stroke occurring within 14 days of the September 26, 2012, MRI. Dr. Andrews was asked about the comments she wrote in her September 27, 2012, notes: Q: So by “acute stroke” in your September 27th note, do you mean no stroke occurring within 14 days? A: Yes. Q: Is that 9/26 MRI? A: Correct. Q: Is that your testimony? A: Yes. Q: Now, you have -- you did not -- you did not diagnose Layton Maloy with having suffered a stroke during labor and delivery, correct? A: That’s correct. Q: Based on your notes here, would you agree with me that the imaging that you looked at was suggestive potentially for -- or rather you weren’t able to rule out a stroke occurring just before -- sometime before birth, correct? A: Correct. I was not able to rule that out. * * * Q: So one -- you actually reviewed not only the MRI that was done on September 26, 2012, but you also reviewed the CT scan that was done prior to that, correct? A: Yes. Q: Okay. And when you reviewed the CT scan, even though the radiologist didn’t note some abnormality, you felt that there was a possible abnormality on that CT scan, correct? A: Correct. Q: And you felt there was an area on the right frontal lobe that caused you some concern, correct? A: Yes. Q: And . . . you felt that the area is also hypodense on diffusion, indicating it is not an acute ischemic lesion; is that correct? A: Yes. Q: And so by that you mean that it wasn’t an ischemic event, whether it’s a stroke or something else, that caused this lesion occurring within two weeks of the study being done, correct? A: Correct. Q: And so that acute ischemic lesion that you saw on the CT scan and then correlated on the MRI, that is something that could have occurred during labor? Ms. Gaffney: Form A: Yes. Layton was discharged from All Children’s Hospital on September 29, 2012, but Dr. Andrews and another pediatric neurologist, Dr. Joseph Casadonte, followed up the medical management of Layton’s seizures in their offices beginning on October 10, 2012. Layton continues to see Dr. Andrews for management of his seizures, and has had additional brain diagnostic testing and imaging through the years. A November 28, 2012, brain MRI was read to reveal the following findings in pertinent part: Findings: The previously seen signal abnormality in the right frontal and right parietal lobes is no longer identified. Lateral ventricles and third ventricle are mildly prominent, more so then on prior examination. There is persistent asymmetry with the left lateral ventricle being larger than the right lateral ventricle. The subarchachnoid spaces are increased in size when compared to prior examination. There is no mass effect or midline shift. No abnormal fluid collections are identified. The pons is decreased in size. The vermis also appears smaller than expected. It is also noted that the corpus callosum is thinned in appearance. Layton was admitted to St. Joseph’s Hospital in January 2013, for acute vomiting and rash, with a history of seizures. Radiology results from an MRI conducted at St. Joseph’s Hospital revealed the following: IMPRESSION: Generalized volume loss in the brain with prominence of the subarachnoid space in the lateral ventricles. No transependymal fluid migration to suggest increased intracranial pressure. No intracranial hemorrhage or mass effect. While at St. Joseph’s Hospital, Layton had an 18-hour video EEG monitoring which was normal. He also had a consultation with Dr. Jose Ferreira. Dr. Ferreira’s impression included history of suspected neonatal seizures; mild degree of hypotonia of unclear significance; suggestion of mild volume loss on MRI which he believed was borderline; and the possibility of disorders associated with seizures of continued concern. He noted that the MRI showed no signs of ischemia or hemorrhage. Dr. Andrews attributes Layton’s balance and coordination issues to his mild to moderate developmental delay. Her records reflect that Layton continues to improve with function overall, and her testimony is consistent with her records. Significantly, Dr. Andrews testified that she has not seen evidence of a mental impairment, but that he suffers from physical or motor impairment for which physical therapy was prescribed. She further explained that some of the factors, e.g., social interactions, language development, and higher cognitive functions, which she would use to evaluate any mental impairment cannot be determined until he is older. She also testified that he is improving from physical therapy. When asked whether Layton’s physical impairments were permanent, she answered that she “wouldn’t be able to say whether his impairment is permanent” at this time, as she does not know to what extent he will continue to make progress and at what point he may or may not plateau. Layton also has had difficulty feeding and is being seen by a gastroenterologist for that. Layton’s most recent brain MRI was conducted on February 9, 2015. The report from the MRI contained the following: IMPRESSION: Continued somewhat slightly dysmorphic appearance of the brain as discussed in detail with mildly prominent ventricles, left greater than right. The findings may suggest some degree of volume loss, potentially involving the left basal ganglia and thalamus with question for decreased white matter volume. While nonspecific, these may be the sequela of prior insult. Dr. Andrews agrees with the above impression. She believes that his epilepsy to be symptomatic from brain abnormalities that were seen on MRI. However, when specifically asked whether the seizure disorder that Layton has is consistent with a perinatal stroke, she responded, “his epilepsy, we believe to be symptomatic from brain abnormalities that we’ve seen on MRI.” She did not specifically testify that these brain abnormalities were consistent with a perinatal stroke. Petitioners retained James Balducci, M.D., to review Layton’s medical records. Dr. Balducci practices in obstetrics and gynecology and maternal fetal medicine in Arizona. In his deposition taken on April 13, 2015, Dr. Balducci stated his opinion that Layton did sustain a brain injury caused by oxygen deprivation during labor. Specifically, Dr. Balducci is of the opinion that Layton suffered oxygen deprivation to his brain shortly after a second dose of ephedrine was administered to his mother during labor and delivery, and that this caused Layton to have a stroke. He reached this opinion by examining the fetal heart tracings. Dr. Balducci explained the basis for his opinion as follows: A: This baby suffered oxygen deprivation to the brain shortly after the second dose of Ephedrine. So the effects of the Ephedrine caused a vasoconstriction in the fetal vessels in the brain, caused an intrapartum stroke to the baby’s brain, which was the source and the cause of this baby’s neurologic sequela which the baby suffers from today. Q: And is the basis for that opinion, Dr. Balducci, the fetal heart tracings that you’ve just gone over with me? A: Yes. The fact that the baby was completely reassuring prior to the two doses of Ephedrine, and the fact that the baby became completely non-reassuring after the second dose of the Ephedrine, with the maternal pulse raising up to 140, trying to get the mother’s blood pressure up, the Ephedrine had the effect, in the fetal physiology, of causing a fetal stroke in the kid’s brain. Q: And sir, are you able to say within a reasonable degree of medical probability that that is diagnosable from these fetal heart tracings? A: Yes, ma’am. And the reason is -- Q: And the timing of the -- I’m sorry. I didn’t mean to speak over you. A: Yes ma’am, because the tracing prior to the second dose of ephedrine was reassuring, and the -- the fetal heart rate tracing post Ephedrine was completely non-reassuring, and nothing else had changed. Q: Sir, would you agree with me that you can have a non-reassuring tracing and still deliver a viable infant with no hypoxic brain injury? A: Yes, ma’am. That happens a lot. Dr. Balducci is of the opinion that a local area of Layton’s brain was devoid of oxygen secondary to the administration of Ephedrine to his mother. According to Dr. Balducci, the effects of this type of stroke may not show up until a week or two later so the baby is not depressed at birth. At the request of Petitioners, Paul Kornberg, M.D., reviewed Layton’s medical records and performed a medical examination of Layton. Dr. Kornberg is a specialist in physical medicine and rehabilitation, specifically pediatric rehabilitation. He serves as Medical Director for Tampa General Hospital’s Pediatric Rehabilitation Program and works in an outpatient clinic. His practice includes treatment of children with Cerebral Palsy and who have had intrapartum strokes. He examined Layton and evaluated him on April 7, 2015, when Layton was approximately 2 1/2 years old. Dr. Kornberg believes that Layton is permanently and substantially neurologically and physically impaired. This opinion is based on Layton’s daily seizures and that, at the time of his examination, Layton was dependent on a feeding tube. Based upon the history he was given, he noted that Layton dragged his left leg when fatigued. Upon examination, however, Dr. Kornberg found that Layton’s tone and strength appeared to be normal. At the time of his examination, Layton was walking and putting words together at the level that would be expected at his age at the time of the examination. Dr. Kornberg has no opinion as to whether Layton’s impairments are related to oxygen deprivation occurring during labor and delivery. He noted that there are causes other than an event during labor and delivery that could cause Layton’s symptoms (e.g., seizures, functional neurologic impairments, sensory processing issues), including a variety of developmental abnormalities of the brain. Layton’s school records from the Polk County Public Schools contain an initial Individualized Education Plan (IEP) which was developed at an IEP meeting on September 1, 2015, just three days before Layton’s third birthday. In the domain of Curriculum and Learning, Layton scored in the mild developmental delay range in cognitive development and scored average in communication development. In the Social Emotional Behavior domain, Layton scored in the mild developmental delay range in personal-social development. In the Independent Functioning domain, Layton scored in the significant delay range in adaptive developmental quotient and average in the motor development quotient. The initial IEP indicates that the educational setting for Layton would be in an ESE Pre-K classroom. The IEP noted that he needed a health care plan but did not need assistive technology devices or strategies and did not need specially designed or adaptive physical education (PE). A physical therapy (PT) evaluation was performed by Polk County Public Schools on November 12, 2015. It reveals that Layton’s ESE teacher reported that, at that time, Layton was able to go up and down the steps to the portable classroom with one railing and close supervision; he pedaled a small tricycle on the playground sidewalk; and he was able to drink a can of Pediasure from a straw. The physical therapist notes that although a wooden chair with armrests was available in the classroom, Layton was sitting in a standard classroom chair at the time and appears to have functional balance. He was noted to walk independently within the classroom and needed verbal cuing to remind him not to run in the classroom which, apparently, he liked to do. By observation and teacher report, Layton was noted to want to run in the classroom and to need verbal cuing to slow down. Although observed to be mildly off balance at times, falls appeared to be rare. He was reported to be able to put away his lunchbox and was eating well. He was observed walking and running on the playground without falling. Nonetheless, the PT report recommended that Layton continue to wear his soft helmet for safety when playing on the playground or transitioning on campus, due to his history of seizures and falling. Layton’s most recent PT report, dated August 30, 2016, from his school states in pertinent part: Layton should be watched closely when he is outdoors to be sure he does not get overheated. Mother had previously noted that he had a high incidence of falling (greater than 10x) per day, however by teacher report, and undersigned therapist’s observation, his falls are currently rare. Layton has been wearing a soft helmet when he is outdoors at school (on the playground and in the halls). Layton has been able to walk with the undersigned PT from his classroom, to the far end of school and back, with supervision to handheld assistance. Layton is able to walk on the yellow lines (with helmet on) with minimal verbal cuing. He is able to walk at a good pace, and has only had rare stumbles (primarily when he stumbled on a doormat, but did not fall). Layton is able to ascend steps to the portable reciprocally with one railing, and is emerging in ascending the steps reciprocally without using the railing. He is able to descend the steps in a step to fashion, both with and without the railing. Layton is able to ascend and descend the ramp without the railing with verbal cuing to slow down by teacher report for ascent and observation of PT for descent. By Mrs. Stambaugh’s report, he is able to ride the tricycle independently with the helmet on. She reported that he has not had falls on the playground. Within the classroom, Layton does not wear the helmet. He sits in a wooden toddler chair with armrests to give some additional protection if he should have a seizure while sitting in his chair in the classroom. By teacher report, Layton is potty trained, and uses the standard toilet. She noted that he wears regular underwear, but still needs assistance with hygiene. Mrs. Stambaugh reported that he feeds himself with utensils. By report, Layton is a car rider in the am and pm, and does not currently need to negotiate bus steps. By Mrs. Stambaugh’s report, they go to the field at the front of the school for fire drills, and they hold Layton’s hand when they walk there. Mrs. Stambaugh reported that Layton only climbs on playground equipment with direct, close adult supervision. The PT report suggested that Layton continue to wear his soft helmet when on the playground or walking on campus, that he should be closely supervised on any playground equipment, and that he should not get overheated. His most recent IEP dated September 7, 2016, notes that Layton loves to dress up as a police officer or fireman, and loves to play with Legos and blocks. The IEP reflects that Mrs. Maloy has Layton on a waiting list for a regular Pre-K program. It also reflects that he no longer receives G-tube feedings at school because he is eating well. However, school staff has been trained to provide G-tube feedings to him in case Layton will not eat or drink his Pediasure. Testimony of Layton’s parents is consistent with the mental and physical abilities detailed in the school records. Mrs. Maloy is able to understand Layton and attend to his needs when he communicates with her. Although Layton tends to prefer a certain food repetitively for breakfast, lunch, and dinner, he eats regular food and his G-tube is used as a supplemental feed. Layton continues to have a seizure disorder for which he continues to be followed by Dr. Andrews and continues to take medicine. Mr. Maloy plays catch with Layton, and takes him to the water park. Mr. Maloy sometimes feeds Layton food from his own plate including meats and vegetables. NICA retained Dr. Donald Willis, a physician who is board-certified in maternal fetal medicine and obstetrics and gynecology. Dr. Willis reviewed the medical records related to Layton’s birth to determine whether Layton sustained an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury in the course of labor, delivery, or resuscitation in the immediate post-delivery period. In a report dated September 2, 2014, Dr. Willis referenced relevant parts of Layton’s records and stated in pertinent part: The mother was admitted at 39 weeks in labor with spontaneous rupture of the membranes. Amniotic fluid was clear. The fetal heart rate (FHR) monitor during labor was reviewed. The FHR had a normal baseline rate of 130 bpm on admission and normal heart rate variability. Late and variable FHR decelerations began about 90 minutes prior to delivery. This pattern was followed by a period of exaggerated FHR variability with some improvement in the overall pattern prior to delivery. Cesarean section was done for “intolerance to labor.” Birth weight was 3,319 grams (7 lbs 5 oz’s). The baby was not depressed at birth. Apgar scores were 9/9. The baby came out crying and required no resuscitation. The baby was taken to the normal newborn nursery after delivery. Umbilical cord blood gas was not done. Newborn hospital course was uneventful. The baby was discharged home with the mother two days after delivery. The baby apparently did well until about two weeks after birth, when some twitching movements were noted. Seizure activity was diagnosed. Head MRI at four months of age showed generalized volume loss. In summary, Cesarean section was done for a non-reassuring FHR pattern during labor. The baby was not depressed at birth and had a normal hospital course with discharge home two days after birth. Medical records suggest the baby did not suffer a birth related injury. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical injury to the baby’s brain during labor, delivery or the immediate post delivery period. In a deposition on February 24, 2015, Dr. Willis testified as to typical findings in an infant who suffered oxygen deprivation. If a stroke is caused by hypoxic injury to the baby during labor and delivery, then the entire brain is going to be affected by the hypoxia. “I mean, we don’t see an isolated stroke in a baby like of one small, little area in the brain due to hypoxic injuries during labor and delivery.” Normally, babies born with hypoxic brain injury are depressed at birth. Layton’s Apgar score was 9 at one minute and 9 at 5 minutes, and was not depressed at birth. He noted that the hospital progress notes stated that the baby came out crying and was vigorous, and went to the normal nursery. Two days after birth, the hospital notes stated that the newborn was progressing as expected. And, he noted that the baby was discharged home after two days, which is a routine time for discharge. When asked whether the fetal heart tracing was consistent with an in utero stroke, Dr. Willis testified that “well I don’t know that a tracing can tell me if a baby had a stroke in utero.” He further explained: A: I have been reviewing cases for NICA for 14, 15 years, and what I look at is oxygen deprivation that occurs during labor or delivery that results in brain injury. And those babies, as we said, are going to have problems at birth and be depressed. I have not considered a stroke that occurs spontaneously during labor as a hypoxic event resulting in brain injury. Q: Well -- A: I am not the judge. I’m just -- I’m just the doctor that’s reviewing the cases here, but that’s how I review them and that’s what -- and that’s how I reviewed the NICA case and that’s my interpretation of what it means by oxygen deprivation with brain injury. Q: Well, I want to go over that again then. An ischemic stroke occurring in utero during labor will cause oxygen deprivation to the part of the brain that’s affected by the ischemia, correct? A: That’s correct. Q: Okay. And as you sit here today, you’re not familiar with any such pathology, an intrauterine stroke occurring during labor not caused by hypoxia? A: I’m sure all things can occur, but for NICA, I read it as I stated. I mean, if you had a stroke due to the -- that wasn’t due to oxygen deprivation, again, where would you place when that stroke occurred if there’s no event to show you that here’s where the stroke occurred? I can’t say that the baby had a stroke during labor because an MRI afterwards shows the baby had brain injury. I don’t know where that stroke occurred. The only thing I can do is look at the fetal heart rate tracing and the baby after birth and the newborn course and try to determine if that baby had oxygen deprivation sufficient enough to cause brain injury. And that’s what I’ve done on my report. If baby had a stroke that you’re talking about, who knows -- you know, how would you -- I have no way of telling where or when that would have occurred if you have a stroke that leaves a baby without symptoms, because all the ones we see due to oxygen deprivation, those babies are depressed at birth. When asked whether Ephedrine poses a risk of harm to a baby, he replied “no.” When asked whether tachycardia can cause a stroke, he replied, “Tachycardia does not cause stroke as far as I’m aware.” When asked whether there is any way from reviewing an MRI to be able to tell when an injury occurred, he replied, “no.” Dr. Willis’ opinion that there was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby’s brain during labor or delivery is credited. NICA also retained Dr. Michael Duchowny to evaluate Layton. Dr. Duchowny is board-certified in pediatrics, neurology, with special qualifications in child neurology, and in clinical neurophysiology. He is a senior staff attending at Nicklaus Children’s Hospital, and directs the neurology training program. Dr. Duchowny reviewed Layton’s medical records and performed an independent medical examination on Layton on January 7, 2015. In a medical report dated January 11, 2015, Dr. Duchowny expressed the following opinions: In Summary, Layton’s neurological examination is only significant for mild generalized hypotonia with oromotor dysfunction and an indwelling G-tube. His motor and cognitive development are both in the 18-24 months range which places him at a mild level of disability. He is doing well from the social and behavioral domains with no specific focal or lateralizing findings of significance. This examination therefore does not provide support for the presence of either a substantial mental or motor impairment. Review of the medical records reveals that Layton was born at 39 weeks gestation at Lakeland Regional Medical Center. He weighed 3320 grams at birth and had Apgar scores of 8 & 9 at 1 and 5 minutes. He was ultimately discharged in stable condition on day 3 of life. As documented by his mother, he was diagnosed with neonatal seizures which have persisted to the present time. Most of his current issues are related to a chronic medically resistant seizure disorder. Of note, Layton has never received pyridoxine, pyridoxal-5-phosphate or biotin. Layton’s MRI scan on January 3, 2013 was significant for prominent extra-axial spaces and generalized volume loss. There is no mention of a right frontal infarct pattern. I have not personally reviewed the scan. In view of Layton’s overall developmental progress, I do not believe he should be considered for inclusion within the NICA program. Dr. Duchowny routinely reviews and interprets brain imaging studies as a daily part of his practice. He explained that the MRI is the gold standard in terms of diagnosis of stroke, and that FHR tracings are of no clinical significance in diagnosing a stroke. Had Layton suffered a stroke during labor and delivery or at any time, Dr. Duchowny would expect to see findings of that on the neuroimaging studies performed on Layton’s brain. He did not see any clinical evidence of a stroke on any of the brain MRIs he reviewed. Dr. Duchowny attributes Layton’s seizure disorder to developmental abnormalities in his brain which were acquired in utero. He attributes Layton’s mild generalized hypotonia (low muscle tone) and oral-motor dysfunction (which has necessitated a G-tube for supplemental feeding) to prenatally acquired Cerebral Palsy. When asked about Dr. Ferreira’s use of the term “volume loss” regarding the January 2013 MRI, Dr. Duchowny disagrees that there was volume loss and noted an asymmetry of the ventricles. “It certainly is not a stroke.” Regarding his physical examination of Layton, Dr. Duchowny described Layton’s motor and cognitive development to be in the mild range of delay. He noted that there were “no local or lateralizing findings as one might expect to see in a stroke.” He described his findings to be consistent with a toddler with developmental delay. Dr. Duchowny described Layton as very sociable, noting his behavior to be “appropriate.” He described Layton as a “very cute boy” who is very interactive and progressing well in the social and behavioral domains. He noted that while Layton was poorly coordinated, he could take steps and walked into the examination room. He had a “button” on the left side of his abdomen for the G-tube. He also noted that in reviewing Dr. Andrews’ records, she initially noted “suspicion of perinatal or prenatal stroke” but that notation did not carry throughout her notes over time. That is, while she considered it, she did not diagnose Layton with a stroke. This is consistent with Dr. Andrews’ testimony. Moreover, when asked about Dr. Casadonte’s notation of “concern for intrauterine stroke,” Dr. Duchowny understands that to mean prenatally acquired. When asked if it is medically probable that based on his records review, his examination of Layton, and his review of the imaging studies, whether Layton suffered a stroke during labor and delivery, Dr. Duchowny replied, “No, I don’t believe so.” Dr. Duchowny’s opinion in this regard is credited. Dr. Duchowny wrote a supplemental report dated September 19, 2016, which addressed Layton’s February 9, 2015, MRI study. This report was one page in length and reads as follows: Pursuant to your request, I reviewed the MR imaging study on Layton Maloy performed on February 9, 2015, at All Children’s Hospital. As you know, Layton has been imaged extensively in the past including head CT studies on September 24, 2012, March 7, 2013, and September 13, 2013, brain MR Imaging on Sept. 26, 2012, November 28, 2013 and February 9, 2015, and head ultrasound on October 18, 2012. The brain MR imaging study of February 9, 2015 is the most recent imaging performed to date and was obtained when Layton was 2 ½ years old. This study reveals no areas of abnormality in the cerebral cortex or subcortical white matter. The deep gray matter structures (basal ganglia and thalami) are also normal. The hippocampi demonstrate no abnormality. The lateral ventricles are enlarged and dysmorphic in appearance. The occipital horns are larger than the frontal horns and evidence a colpocephalic configuration. There is a ventricular asymmetry favoring greater enlargement on the left. The corpus callosum is borderline thin. The posterior fossa contents are abnormal and reveal ponto-cerebellar hypoplasia and vermian hypoplasia with compensatory enlargement of the fourth ventricle. In summary, these imaging findings are consistent with prenatally acquired brain malformations and provide no evidence for acquired brain injury due to either intra- partum mechanical injury or oxygen deprivation. In response to Dr. Duchowny’s one-page supplemental report, Petitioners requested Dr. Daniel Adler review the February 9, 2015, MRI report, as well as his earlier imaging reports. Dr. Adler is a pediatric neurologist who practices in New York City. It is Dr. Adler’s opinion that the images from the February 9, 2015, MRI report demonstrate a progressive loss of tissue in the white matter of Layton’s brain and are not the result of a congenital problem. He concludes that the images reflect brain injury that happened to the fetus due to intrauterine hypoxia, of a type not manifested by encephalopathy. At NICA's request, Jay Goldsmith, M.D., reviewed Layton’s medical records and the reports of all diagnostic and neuroimaging studies performed on Layton, as well as Mrs. Maloy’s labor and delivery records. Dr. Goldsmith is a neonatologist who is board-certified in Pediatrics and Neonatal-Perinatal Medicine. He practices neonatology and is a professor of pediatrics at Tulane University Medical School. He diagnoses strokes in babies as part of his clinical practice and has been practicing neonatology for approximately 40 years. In his deposition which took place on September 26, 2016, Dr. Goldsmith noted that at birth, Layton was a fairly vigorous baby with good Apgar scores. No abnormal brain function, or encephalopathy, was noted in the newborn period, and Layton went home with his mother after two days. Dr. Goldsmith explained: That’s, probably, the most important thing to rule out; an intrapartum deprivation of oxygen; if there’s no encephalopathy, for the most part, there’s no injury that occurred during labor and delivery; the person who is injured, or a baby who is injured in -- a fetus who was injured in labor and delivery will, certainly, in the overwhelming number of cases, show signs of that injury as a newborn; and demonstrate it as an encephalopathy. The one exception to that is perinatal arterial stroke; and so that’s what, basically, this case has come down to; Layton came back at two to three weeks of age with seizures; had a work-up; and subsequently, I think, seven brain imaging studies, none of which showed arterial stroke. Now, perinatal arterial stroke is a neuroradiological diagnosis, pure and simple; you can think about it; you can put it on your differential diagnosis; but if you don’t see a stroke on the images, there’s no stroke; and, in fact, as this process evolved, over two and a half years or so, the MRIs showed that Layton has a developmental, or genetic, anomaly of his brain that has, certainly, defined itself on the brain imaging. Dr. Goldsmith considers MRI to be the gold standard in diagnosing a stroke, which is consistent with Dr. Duchowny’s testimony. He further noted that Layton transitioned well from intrauterine to extrauterine, and explained that babies injured in the womb during labor and delivery do not make this transition well, would not be vigorous at birth, would be acidotic, and may need resuscitation. Dr. Goldsmith is also of the opinion that the findings of the 2015 MRI suggest a developmental anomaly of the brain, showing that his brain was slightly dysmorphic with no evidence of stroke. When asked whether he would expect to see evidence of a stroke on the MRI findings, he answered, “Yes; unfortunately, the brain does not regenerate,” noting that with an ischemic stroke, that area of the brain will die and will not regenerate. “We will see a hole in the brain in that area.” It is Dr. Goldsmith’s ultimate opinion “to an extraordinary high degree of certainty” that Layton did not suffer a stroke during labor and delivery, and that his injuries were not a result of a neurological injury caused by oxygen deprivation that occurred during labor and delivery. Dr. Goldsmith’s opinion in this regard is credited. While Dr. Goldsmith is of the opinion that Layton is permanently and substantially mentally and physically impaired, he would defer to a neurologist, especially one who has examined Layton, to make that determination. The dispute in this case centers on what, more likely than not, was the primary cause of Layton’s impairments. That is, did Layton suffer a stroke during his mother’s labor that resulted in oxygen deprivation to a specific portion of Layton’s brain which caused his disabilities or is it more likely than not that they were caused by a prenatally acquired congenital or genetic disorder acquired in utero. Secondly, did any such injury result in Layton becoming permanently and substantially mentally and physically impaired. The undersigned finds the testimony of NICA’s experts to be compelling. The greater weight of the evidence establishes through the opinions of Dr. Willis and Dr. Goldsmith, together with Dr. Duchowny, that there was not an apparent obstetrical event that resulted in loss of oxygen to Layton’s brain during labor and delivery that resulted in brain injury. Moreover, the record evidence does not support a finding that Layton is permanently and substantially mentally and physically impaired. His treating physician, Dr. Andrews, noted Layton’s improvements over time and was not of the opinion that Layton has a mental impairment. Moreover, Dr. Kornberg’s opinion that Layton is substantially impaired, while deferring to the pediatric neurologists, was based in large part on Layton’s required use of the G-tube for feeding. He has clearly improved in this regard and now uses the G-tube to supplement his eating and use of Boost or Pediasure. Dr. Duchowny’s opinion that Layton’s disabilities are in the mild range, and not considered to be substantial, is consistent with Dr. Andrews’ assessment, and is credited.
