Hixenbaugh v. United States

• Decision Date: 16 September 1980
• Docket Number: Civ. A. No. C79-692.
• Citation: 506 F. Supp. 461
• Parties: Karen HIXENBAUGH et al., Plaintiff, v. UNITED STATES of America, Defendant.
• Court: U.S. District Court — Northern District of Ohio

506 F. Supp. 461

Karen HIXENBAUGH et al., Plaintiff, v. UNITED STATES of America, Defendant.

Civ. A. No. C79-692.

United States District Court, N. D. Ohio, E. D.

September 16, 1980.

Michael Shafran, Bruner & Shafran, Cleveland, Ohio, for plaintiff.

Patrick M. McLaughlin, Dennis P. Zapka, Asst. U. S. Attys., Cleveland, Ohio, for defendant.

MEMORANDUM AND ORDER

KRUPANSKY, District Judge.

This is an action initiated by the plaintiff Karen Hixenbaugh (Hixenbaugh) pursuant to the Federal Tort Claims Act, 28 U.S.C. § 2671 et seq., and the National Swine Flue Immunization Program Act, 42 U.S.C. § 247b wherein plaintiff seeks compensatory and punitive damages for permanent injuries assertedly resulting from an acute polyradiculoneuropathy identified in this action as Guillain Barre Syndrome (GBS) proximately caused by the alleged negligence and breach of express and implied warranty of the United States in the administration of a swine flu innoculation on or about October 24, 1976.

Plaintiff's husband Robert Hixenbaugh joins in the action seeking damages for the loss of affection, companionship, services and consortium of his wife.

The jurisdiction of the Court is properly invoked. The Complaint herein was filed on June 23, 1979. Pursuant to 28 U.S.C. § 1407, the action was transferred by the Judicial Panel on Multi-District Litigation to the United States District Court for the District of Columbia for consolidated and coordinated pretrial proceedings. Subsequent to a final pretrial Order issued by the transferee court, In Re Swine Flu Immunization Products Liability Litigation, Misc. No. 78-0040 (D.D.C. November 15, 1979), the within cause was remanded to this Court for final disposition upon stipulations and evidence adduced at trial.

It is conceded by the Government that Hixenbaugh received a monovalent Swine Flu vaccination on October 24, 1976 at the Randall Park Mall in North Randall, Ohio which was administered by the Government as a part of the National Influenza Immunization Program undertaken in 1976. She experienced an immediate painful reaction in her arm in the area of the innoculation which subsided by the following morning. Approximately three weeks after receiving the innoculation, Hixenbaugh developed stomach pains, diarrhea and nausea, which symptomology was alleviated by medication prescribed by Dr. Charles G. Zegiob, M.D., on November 24, 1976. In January of 1977 plaintiff contracted influenza, and the condition ran its course and she recovered without complications.

During the intervening months Hixenbaugh displayed no symptomology and enjoyed excellent physical health. On Sunday, January 22, 1978 she manifested generalized pain and muscle twitching in the calves and thighs of both legs. The muscular "flicking" accompanied by increased pain continued until January 25, 1978 when she was admitted to Marymount Hospital with a slight fever.

Dr. Cornelio B. Deogracias, M.D. (Deogracias), her treating physician in his admission notes recorded:

Painful calves for three days which started while house cleaning. Calve pain aggravated by walking. No related trauma to the legs. Has cold. Eyes, ears and throat negative. Heart and lungs normal. No swelling of legs. Mild viscosities of the right thigh and leg ...

Bilateral calve tenderness, Homan's sign suggestively positive.

Plaintiff's temperature was recorded as 100.2 degrees orally. The doctor's impression was possible thrombophlebitis right and left lower legs. (Tr. pgs. 226-27)

Deogracias engaged in consultation with doctors Edward M. Zucker, M.D. (Zucker), a neurologist, and Edward W. Shannon, M.D. (Shannon), a neurological surgeon. A diagnostic venogram ruled out the initial diagnosis of thrombophlebitis and plaintiff, within a short period of time, developed a bilateral "foot drop". Shannon's consultation notes disclosed:

The examination at this time revealed the patient to be a friendly, pleasant, well-developed 28-year-old white female with unsustained nystagmus on lateral gaze in both directions. There was questionable temporal pallor of both optic discs. The tendon reflexes were moderately hyperactive, moreso in the lower extremities than in the upper. The Babinski responses were absent. There was no evidence of any sensory disturbance. She had a severe bilateral foot drop ....

This patient may have a Guillain-Barre syndrome or this may be an acute onset of multiple sclerosis.

Shannon performed a lumbar puncture. Subsequently, the spinal fluid was reported as being negative. More specifically, the fluid was clear and colorless. Sugar level was 65 mg. per cc. The total protein was 21 mg. per cc.

Zucker's diagnosis of the patient's disorder was a peripheral neuropathy ... "of which I did not know the etiology. I really didn't have any evidence to say what the cause of it was." Zucker also recorded that his neurological examination of the plaintiff disclosed that the cranial nerves were normal; that the reflexes in her arms were active and equal. An inconsistency in his notes states "... the Achilles reflexes were active and equal ... ankle reflexes were absent." The Doctor explained the inconsistency from recollection and stated that the Achilles reflexes were absent the first time he examined the plaintiff. (Zucker appears to contradict his recollection concerning the absence of Achilles reflexes and the significance of such clinical findings between pages 85 and 99 of the transcript of testimony.) He found no sensory impairment, but noted some weakness in the patient's legs and the bilateral foot drop, together with some weakness of her hands.

Subsequent to the plaintiff's discharge from the hospital on February 7, 1978, her physical condition continued to deteriorate to a point where she could not raise her legs. She developed "wrist drop" and was unable to extend her fingers. Approximately seven to eight weeks from the onset of the neurological symptoms she reached a plateau after which her condition began to slowly improve with the aid of physiotherapy. During the ensuing eleven months she regained the full and complete use of her arms, hands and fingers, which prompted Zucker, on September 14, 1979, to report:

She (Hixenbaugh) still has weakness of both legs and especially of dorsiflexion. There is no sensory loss and little muscle atrophy. She is confined to a wheel chair but walks with crutches at home. She does much of her household duties. Neurologic exam —

... reflexes in arms 2 + equal reflexes in legs ... 3 equal reflexes in ankle jerks 1 + equal Babinski — withdrawal bilaterally.

(Government Exhibit G)

On March 17, 1980, Hixenbaugh was admitted to Highland View Hospital for programed physical therapy at which time she was examined by Dr. Asikin Mentari, M.D. (Mentari), a specialist in physical medicine and rehabilitation and Dr. Yun Jen Sheen, M.D. (Sheen), a resident in physical medicine and rehabilitation. At that time a neurologic examination disclosed active tendon reflexes and an "upgoing" or positive Babinski sign bilaterally. Mentari's impression of the plaintiff's neurological disorder resulting from the examination was a "chronic, generalized motor neuropathy of the lower extremities with the distal muscles affected more than the proximal". (Tr. p. 268) Sheen noted "that GBS should be ruled out". (Gov't Ex. P) Dr. Winkelman, a neurologist, upon examination of the plaintiff "found evidence of a central nervous system lesion with spasticity, increased reflexes, and up-going plantar responses." Id.

The initial issues joined by the pleadings, testimony and exhibits presented for resolution by the Court are twofold, namely:

1. Identification of the plaintiff's neurological disorder; and

2. The causal relationship, if any, between said disorder and the innoculation of monovalent Swine Flu Vaccine administered by the Government as a part of its National Influenza Immunization program to the plaintiff Hixenbaugh on October 24, 1976.

Guillain Barre syndrome is an inflammatory neurologic disorder of unknown etiology which affects the peripheral, as opposed to the central nervous system. The syndrome is characterized by neurologic symptoms rather than a specific organic disorder. The National Institute of Neurological Communicative Disorders and Strokes (NINCDS) has defined the clinical, laboratory and electrodiagnostic criteria for diagnosis of GBS. As stipulated by the parties, features required for the diagnosis under the NINCDS criteria are a progressive motor weakness of more than one limb, and areflexia (loss of tendon jerks). Variants indicative of a different disease process include fever at the onset of neuritic symptoms, severe sensory loss with pain, progression of the disease beyond four weeks, cessation of progression without recovery or with major permanent residual deficit remaining, and central nervous system involvement. Elevated cerebrospinal fluid protein is "strongly supportive" of the GBS diagnosis.

Although the exact etiology of GBS is unknown, it has been associated with a variety of antecedent events most common of which is a viral infection either respiratory or gastroenteric. Other antecedent events temporally associated with the onset of GBS include bacterial infections, malignant diseases, vaccines and surgery.

The interval between the prodromal infectious episode and the ensuing symptomology is a variable. The infectious symptomology has usually subsided by the time the neuropathic manifestations surface. To date, no biochemical procedure has evolved capable of isolating the organic cause, if any, of GBS. Accordingly, causal connection can be established only from reported clinical observations and studies and the inferences drawn therefrom. Recorded elevated protein levels in the cerebrospinal fluid, progressing from accepted norms during the initial few days of the onset of the clinical findings with peaking within four to six weeks provide critical laboratory support for the more...