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WHITTLE v. UNITED STATES

April 30, 1987

Charles E. Whittle, Plaintiff,
v.
United States of America, Defendant



The opinion of the court was delivered by: PRATT

John H. Pratt, United States District Judge

FINDINGS OF FACT AND CONCLUSIONS OF LAW

 This is an action under the Federal Tort Claims Act, charging medical malpractice on the part of physicians at the Walter Reed Army Medical Center, which plaintiff claims resulted in the death of his wife, Joan A. Whittle. A non-jury trial was held on October 27 through 30, 1986.

 Pursuant to Federal Rules of Civil Procedure 52(a), the court enters the following Findings of Fact and Conclusions of law.

 FINDINGS OF FACT

 1. Plaintiff's wife went to Walter Reed Army Medical Center (Walter Reed) in August, 1981, for treatment of depression and chronic headaches. She had been troubled for many years by serious headaches and had sought treatment from a number of military and civilian facilities close to the Army posts where her husband was assigned. She brought with her the medical records of her treatment from at least some of these facilities. All previous efforts to determine the source of her pain and to relieve her symptoms were largely unsuccessful. It is clear from the records that Mrs. Whittle's problems were complex and of long duration. Hers was not a routine case.

 2. Upon arrival at Walter Reed, she was first examined at the neurology clinic, which revealed no physical bases for her distress. She was then referred to the outpatient psychiatric clinic, where she came to be treated by Antonio Blanco, M.D., a second year resident in psychiatry. Dr. Blanco, 32 years old, had received his medical degree from the University of Madrid, Spain.

 3. Dr. Blanco reviewed her history at the first meeting on August 13, 1981 and diagnosed her to be suffering from dysthymic disorder or atypical depression, hystrionic personality with obsessive traits, and possible authentic migraine headaches aggravating emotional illness. He prescribed Nardil and Norgesic, an analgesic.

 4. On September 2, 1981, Mrs. Whittle again saw Dr. Blanco who prescribed a drug regimen of 75 mg. per day (5 tablets) of Nardil, an anti-depressant monoamine oxidase inhibitor (MAOI) which improves the psychological condition and acts as a mood elevator. Dr. Blanco also prescribed up to six tablets per day of Fiorinal, a barbiturate consisting of butalbital, caffeine and aspirin. The maximum recommended dosage of Nardil was 75 - 90 mg. per day. See Modern Drug Encyclopedia, 636 (13th ed. 1975)(75 mg. per day); Physicial's Desk Reference (PDR), 1981 ed. at 1375 (90 mg. per day). The maximum recommended dosage of Fiorinol was six tablets per day. PDR at 1574. On occasion, physicians prescribe dosages in excess of the recommended dosages.

 5. There is substantial documentary evidence, which is largely undisputed, that warn of the prolongation and/or potentiation of the effects of barbiturates when used in combination with MAOI's. See e.g., PDR, 1981 ed.; Goodman & Gilman, The Pharmacological Basis of Therapeutics, 6th Ed., 1980. This is because the MAOI interferes with the ability of the liver to metabolize barbituates, allowing the barbituates to remain in the blood stream at higher levels for a longer period of time. As a result of this "prolongation" effect, taking Nardil in combination with a barbituate such as Fiorinal increases the possibility that a second, supplemental ingestion of Fiorinal will push the barbituate level in the blood to toxic levels. The MAOI can convert the non-toxic Fiorinal regimen into a potentially toxic one. Because of the "prolongation" or "potentiation" effect, the pharmacological literature recommends that barbituates should be administered at a reduced dose when taken concurrently with Nardil. See e.g., PDR at 1375. Even defendant's psychiatric expert admitted that these drugs should be used cautiously and that he himself never used Nardil and Fiorinal in combination. Defendant's expert witnesses do not dispute this well known and adverse relationship.

 6. Dr. Blanco's office chart and memorandum (Pltf. Exs. 6, 7 and 18) reflect his knowledge and concern about the potential, adverse interactions of the two drugs. Dr. Blanco testified that it was his intention, as approved by his supervisors, that the Fiorinal would be discontinued when Nardil reached its proper therapeutic level. None of these supervisors, with exception of Dr. Donley, was identified by name, and none testified.

 7. Mrs. Whittle saw Dr. Blanco on October 2, 16 and 28 and November 13 and December 2, 1981 and on one other occasion, the date of which is not noted in the medical record. She saw him a total of eight times over a period of more than 3 1/2 months. On some of these occasions, Mrs. Whittle reported her condition as improved and that she was feeling better. During this period, Mrs. Whittle was continued on the same regimen of Nardil and the maximum recommended dosage of Fiorinal (up to 6 tablets per day). Specifically, she was given 30 pills of Fiorinal on October 28, 180 pills on November 13 and 120 pills on December 2. Although Mrs. Whittle initially took Nardil less frequently than prescribed in order to avoid adverse side effects, during this period, at the urging of plaintiff and Dr. Blanco she took Nardil more regularly, as prescribed, despite the unpleasant side effects she had experienced. (R. at 49, 77).

 8. Mrs. Whittle's informed consent as to the course of treatment prescribed by Dr. Blanco was not obtained on September 2, when the regimen of Nardil and Fiorinal was first prescribed. Dr. Blanco testified that he and Mrs. Whittle had had such a discussion, but the chart for September 2 indicates only that Dr. Blanco warned of possible abuse of analgesics. The chart of the same date does not list any discussion about the interaction of Nardil and Fiorinal. In addition, the medical record shows that Mrs. Whittle signed a "Patients Rights" form on December 2, 1981, three days before, her death and three months after the original prescription for the combined use of Nardil and Fiorinal. This form stated that each patient over the age of 12 "shall be informed of . . . the risks, side effects, and benefits of all medications and treatment procedures used, especially when the medications and treatment procedures are unusual or experimental." Patients Rights para. 4(e), in Pltf Ex. 6. The form also provides that the patient must give written, dated, and signed informed consent to "the utilization of any unusual medication or hazardous assessment or treatment procedure." Id. at para. 5(e). The Patients Rights form, however, only purports to be a recitation of rights. It does not purport to list the "risks, side effects, and benefits of all medications and treatment procedures" nor does it purport to be a written, informed consent to any course of treatment. The treatment chart for the December 2 visit does not reflect any supplemental discussion of treatment risks between Dr. Blanco and Mrs. Whittle. Furthermore, the plaintiff testified that his wife never passed on to him any knowledge on her part of the risks associated with the use of these drugs. In the complete absence of corroborating evidence, we cannot accept Dr. Blanco's contention that plaintiff and his wife were informed of the potential for central nervous system depression and barbiturate toxicity.

 9. Mrs. Whittle had suffered headaches on December 2, 3, 4 and 5 and had taken Fiorinal each day for relief. On December 5, shortly after 10:00 p.m., plaintiff found his wife on the floor of their bedroom unconscious and unresponsive to efforts to resuscitate her. He never observed any indications of life from the time he discovered her. Previously, she had spent most of the afternoon of December 5 in bed. She was also nauseated and incoherent. In the early evening, perhaps around 6:30 p.m., plaintiff helped her get out of bed and took her downstairs for a short period of time. She appeared groggy and sluggish and required plaintiff's help in negotiating the stairs. After 45 minutes, plaintiff helped her back upstairs and into bed. He checked on her two or three times during the evening, the last time being between 9:00 p.m. and 9:30 p.m. before finding her unconscious on the floor. When plaintiff's ...


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