The opinion of the court was delivered by: ACKERMAN
This is an action brought pursuant to the Federal Tort Claims Act, 28 U.S.C. § 2671, et seq., and the Swine Flu Act, 42 U.S.C. § 247(b). Plaintiffs, Mrs. Miriam and Dr. Ernest Stich, seek to recover damages allegedly suffered as a result of a swine flu inoculation which Mrs. Stich received on November 18, 1976, pursuant to the national immunization program undertaken by the federal government. See The National Swine Flu Immunization Program of 1976, Pub.L. 94-380, 90 Stat. 1113. Specifically, Mrs. Stich contends that she contracted either Guillain-Barre Syndrome ("GBS") or some other condition as a result of this immunization which, in turn, caused her to suffer her injuries. Her husband, Dr. Stich, seeks recovery for loss of consortium and loss of services.
Under the Federal Tort Claims Act, as incorporated in the Swine Flu Immunization Act, this action is governed by the law of the forum state, here New Jersey, except as otherwise provided. 28 U.S.C. § 1346(b); 42 U.S.C. § 247b(k)(2)(A); Richards v. United States, 369 U.S. 1, 7 L. Ed. 2d 492, 82 S. Ct. 585 (1962).
This action was filed on April 12, 1978. On May 18, 1978, it was transferred by the Judicial Panel on Multidistrict Litigation to the United States District Court for the District of Columbia for coordinated and consolidated pretrial proceedings pursuant to 28 U.S.C. § 1407 before the Honorable Gerhard A. Gesell. The case was thereafter remanded to this court on February 5, 1980. The Final Pretrial Order of the transferee court, dated November 15, 1979, provides that if plaintiffs establish that Mrs. Stich contracted GBS, they need not establish any theory of liability. If, however, it cannot be established that she has GBS, then plaintiffs must prove negligence or another appropriate theory of liability.
The Final Pretrial Order also limits the litigants herein to local discovery, meaning only that which is specifically related to her condition. Over seventy depositions were taken during the course of national discovery, many of which were introduced into evidence at trial in this action.
The trial of this nonjury case was trifurcated. The three phases contemplated in the pretrial order are: Phase I -- Diagnosis and Causation of Miriam Stich's condition; Phase II -- Foreseeability of Risk and Informed Consent; Phase III -- Damages. After thirty-nine days of testimony comprising some 6,390 pages of trial transcript, the trial of Phase I has been completed. The plaintiffs have presented medical testimony through the following witnesses:
Dr. Joseph Gluck, internist and a treating physician of Mrs. Stich
Dr. Howard Medinets, neurosurgeon and specialist in forensic medicine
Dr. Robert Lisak, neurologist
Plaintiffs also presented testimony by deposition of certain doctors drawn from the multi-district discovery proceedings in the consolidated swine flu cases. See In re Swine Flu Immunization Products Liability Litigation, 89 F.R.D. 695, (D.C.D.C.).
The United States presented medical evidence through the following witnesses:
Dr. Peter Tsairis, neurologist and electromyographer
Dr. Richard Price, neurologist and virologist
Dr. Richard Whitley, virologist and Director of the National Institute of Allergy and Infectious Diseases ("NIAID") Collaborative Anti-Viral Study Group
Dr. Neal Nathanson, epidemiologist and microbiologist
Defendants also presented testimony through the multi-district depositions, including the following witnesses:
Dr. Barry Arnason, Dr. Paul Wehrle, Dr. Stephen Schoenbaum, Dr. Peter Dyck, Dr. Larry Schonberger, Dr. Henry Retailliau, Dr. Alexander Langmuir, Dr. Jonas Salk, Dr. Frederick Davenport, Dr. Harry Meyer, Dr. David Karzon, Dr. Gordon Meiklejohn, Dr. D.A. Henderson, Dr. David Sencer, Dr. Charles Hoke, Dr. J. Donald Millar, Dr. John Seal, and Dr. E. Russell Alexander.
The court has carefully considered the live testimony, the deposition testimony, the exhibits submitted, and the arguments of counsel. This memorandum constitutes the court's decision and includes the court's findings of fact and conclusions of law pursuant to Federal Rules of Civil Procedure 52(a). I find that Mrs. Stich has failed to establish by a preponderance of the credible evidence that the condition she is suffering from is GBS, or that it is causally related to the swine flu inoculation which she received. I find instead that the most probable diagnosis of Mrs. Stich's condition is herpes simplex encephalitis ("HSE") of a viral etiology unrelated to the swine flu inoculation she received. See Caputo v. United States, 157 F. Supp. 568, 571 (D.N.J. 1957); Szczytko v. Public Service Coordinated Transport, 21 N.J. Super. 258, 264, 91 A.2d 116 (App. Div. 1952).
MRS. STICH'S MEDICAL HISTORY
It is undisputed that Mrs. Stich received a swine flu inoculation at Brookdale Community College on November 18, 1976.
That afternoon she flew to California on a pleasure trip, where she stayed for five days. On November 22, 1976, towards the end of her stay in California, she began to feel ill. She returned home to New Jersey the next day. At that time she had a fever, muscle aches, a headache and noted a general malaise. Her physician husband put her to bed and gave her Keflex and aspirin. The following day, November 24, 1976, she remained ill with a fever of 102 degrees and was in bed, and on November 25, 1976, she was not well enough to prepare the Thanksgiving dinner.
On November 26, 1976, Mrs. Stich was seen at her home by the family's physician, Dr. Joseph Gluck. Although she still had a fever and complained of a headache and a general loss of well-being, her physical examination at that time was otherwise unremarkable. Her urinalysis and complete blood count were normal, and Dr. Gluck prescribed rest and aspirin.
On November 27, 1976, Mrs. Stich was taken to the Emergency Room of Riverview Hospital in Red Bank, New Jersey, where she was admitted at 12:00 p.m. Upon examining Mrs. Stich, Dr. Gluck found her condition dramatically changed. He noted that she now had convulsions as well as a fever. She was totally unconscious, and the muscles of all her extremities were in spasm. Her neck was supple, her eyes were roving horizontally without focusing, although they were deviating mainly to the left. Her pupils were equal, small and reacted normally to light. The Babinski and Hoffman reflexes, which are indicative of Central Nervous System ("CNS") pathology, were both abnormal. Mrs. Stich appeared to have normal power in her extremities and she was continent. During her convulsive state, Dr. Gluck noted that Mrs. Stich showed physical signs of decerebration. The family history, which was taken on November 27, 1976 and dictated by Dr. Gluck, indicates the following:
Examination in the past has been without any significant abnormalities other than residual polio affecting both lower extremities, mainly to the left; approximately five days ago, while in California, she noted the onset of malaise, muscle aches, headache and then fever. She flew home and by the next day, had temperature to 102 degrees with marked loss of well-being. There were no other specific symptoms. The illness had the character of a typical acute febrile viral infection.
Diagnosis on admission by Dr. Gluck was meningo-encephalitis of unknown etiology. Dr. Gluck was unaware until December 10, 1976, that Mrs. Stich had received a swine flu inoculation on November 18, 1976. Dr. Gluck had, however, himself given her an influenza B inoculation on October 25, 1976.
For the three or four days following her admission to Riverview Hospital, Mrs. Stich's level of consciousness varied substantially, although she never regained full normality. By December 2, 1976, she was totally unconscious and unresponsive, and she remained comatose or semi-comatose for the next three to four months.
On February 14, 1976, Mrs. Stich was transferred to the Neurological Institute at Columbia Presbyterian Hospital in New York, New York. This transfer was apparently made for the purpose of seeking assistance with the diagnostic treatment of Mrs. Stich's condition, and perhaps to facilitate the performance of a brain biopsy. The medical records from her stay at Columbia Presbyterian Hospital indicate that during this period her vital signs were stable and normal. Although she did not respond to external stimuli, she did occasionally open her eyes and look around her room. No verbalization took place.
On March 8, 1977, she was again re-hospitalized at Riverview Hospital. By April or May her coma had lightened to the point that she was awake. On June 6, 1978, she was transferred to Morris Hall Rehabilitation Center and remained there until August 15, 1978, when she was again returned to Riverview Hospital. Mrs. Stich currently remains at Riverview.
GUILLIAN-BARRE SYNDROME -- GBS
Guillian-Barre Syndrome is a neurologic disorder, inflammatory in nature, which was first described in 1859 by Dr. Landry. It was again described in 1916 by Drs. Guillian, Barre and Stohl. The syndrome characterizes a set of neurologic symptoms, rather than defining a specific organic disorder. To date, medical science has not established the syndrome's exact etiology or cause.
The extent to which GBS may encompass any ("CNS") involvement remains a controversy within the medical community. As classically defined, GBS is a peripheral neuropathy which results from the demyelination of the peripheral nervous system.
This demyelination results in a progressive motor weakness of the limbs which ranges from mild weakness to paralysis of every motor muscle. Most typically GBS involves the lower extremities initially, progressing (normally over the course of between a few days and two weeks) upward to affect the upper limbs, face and bulbar muscles. This progressive weakness affects both proximal and distal muscles, and it reaches a plateau in the second or third week after onset as the affected muscles begin to re-myelinate. Over the course of a period ranging from three months to one year, GBS patients generally regain full use of the affected muscles, although there are permanent residual effects in approximately 10% of all GBS cases.
Plaintiffs urge this court to adopt a much broader clinical definition of GBS. Their position is that GBS may embrace a wider spectrum of neurologic or CNS involvement than suggested by the classical definition, and that GBS does not represent any specific neurologic picture. They argue that GBS properly includes central nervous system disease as well as peripheral nervous system disease, and may affect any or all, or any combination of the parts, of the nervous system.
While the precise nature of the syndrome may be in dispute, the criteria established for the diagnosis of GBS by the National Institute of Neurological and Communicative Diseases and Stroke ("NINCDS") have been generally accepted by the medical profession, and particularly by neurologists, as an authoritative and accurate description of GBS.
See 3 Annals of Neurology, (June 1978). Under these criteria, clinical, laboratory and electrodiagnostic data are together evaluated in a non-mechanistic manner to determine whether a diagnosis of GBS is appropriate in a specific case. I find the NINCDS criteria to be an appropriate standard against which to measure the plaintiffs' proofs and adopt them as controlling herein.
Under the NINCDS criteria, the two features required for diagnosis are:
B. Areflexia (loss of tendon jerks). Universal areflexia is the rule, though distal areflexia with definite hyporeflexia of the biceps and knee jerks will suffice if other features are consistent.
I have previously discussed the characteristic monophasic course of progressive motor weakness, plateau, and then gradual improvement that is a diagnostic hallmark of GBS. Areflexia, the second required finding in GBS, is the absence or depression of deep tendon reflexes ("DTRs"). The type of reflex loss finding required to substantiate a diagnosis of GBS is a value less than one-plus or two-plus, which are considered to be in the normal range. This loss of DTRs must occur within days or, at most, a few weeks of the onset of the illness.
It follows as a corollary to this required absence or depression of DTRs that the related pathological reflexes or signs, such as the Babinski and Hoffman, would be similarly absent. The presence of either these pathological reflexes or of increased DTRs (hyperreflexia) would be an indication of central nervous system disease. Other signs of an overwhelming central nervous system involvement, such as a history of mental confusion, dementia, loss of memory and congnitive functions, delirium and agitation, would suggest a diagnosis other than GBS.
The NINCDS criteria next list seven clinical features which are strongly supportive of a diagnosis of GBS. Ranked in order of importance, these are:
1. Progression. Symptoms and signs of motor weakness develop rapidly but cease to progress by four weeks into the illness. Approximately 50% will reach the nadir by two weeks, 80% by three weeks, and more than 90% by four weeks.
2. Relative symmetry. Symmetry is seldom absolute, but usually, if one limb is affected, the opposite is as well.
3. Mild sensory symptoms or signs.
4. Cranial nerve involvement. Facial weakness occurs in approximately 50% and is frequently bilateral. Other cranial nerves may be involved, particularly those innervating the tongue and muscles of deglutition, and sometimes the extraocular motor nerves. On occasion (less than 5%), the neuropathy may begin in the nerves to the extraocular muscles or other cranial nerves.
5. Recovery. It usually begins two to four weeks after progression stops. Recovery may be delayed for months. Most ...