Lassiter v US Federal

Immunization Info

N.B.
A copy of extracts from the 11 page original text. I have not intentionally altered one word, or underlined any passages. I have excluded certain passages and page numbers.

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In the United States Court of Federal Claims
Office of Special Masters
90 -2036V
Filed: December 17, 1996

Petitioner: Eric Lassiter, an incompetent,
By his mother, and next friend,
Mary Lassiter
v.
Secretary of the Department of
Health and Human Services
Respondent.

Clifford J. Shoemaker, Vienna, Virginia for petitioner.
Caroline Elmendorf, U.S. Department of Justice, Washington, D.C., for respondent
French, Special Master.
Decision on Entitlement
This case arises under the National Vaccine Injury Compensation Program....
Petitioner's mother, Mrs. Mary Lassiter, filed this claim on behalf of her son on September 28, 1990 alleging that as a result of the administration of a diphtheria-pertussis-tetanus (DPT) shot on April 19, 1972, petitioner sustained an injury set forth on the Vaccine Injury Table, namely an encephalopathy, with permanent neurological damage. Respondent defends by arguing that because no contemporaneous medical records exist that document conclusively that the onset of the injury occurred within the requisite time frame, petitioner has not established a Table injury. Respondent argues further, that petitioner's condition more likely than not, is due to autism and is unrelated to the DPT vaccine. Following a careful review of the record in its entirety, the court concludes that Eric Lassiter is entitled to compensation.

Procedural Background (OMITTED)

ISSUES

The controversy can be framed by two questions: First, is the evidence sufficiently reliable to establish the onset of encephalopathic symptoms within the specified time frame (three days)? If the answer to this question is in the affirmative, petitioner enjoys a presumption of causation. If not, petitioner must establish his case by the causation in fact method required in traditional tort litigation. Second, is a diagnosis of idiopathic autism sufficient to establish a factor unrelated thereby defeating petitioner's claim? The evidence supports an affirmative answer to the first question and a negative answer to the second.

FACTS

.....................Eric was born on September 15, 1970, the apparently healthy product of an uncomplicated pregnancy and delivery. Until his DPT booster shot given at 19 months of age, he was progressing very well and reaching developmental milestones as expected. Medical records of well baby checks at Morningside Health Station verify that he was "doing well". Fact witnesses claim that at 12 months he was "very smart" walking, eating well, had a good vocabulary, and played games with his cousin. By fifteen to eighteen months he was fully potty trained and was a happy, pleasant child.
Everything changed after his DPT booster shot administered on April 19, 1972. Office records for that visit note "no problems", and his physical examination showed " a well developed, well nourished male who was active and alert."
Approximately four hours after the inoculation, he began to convulse, foam at the mouth, and roll his eyes back in his head (1). For several days Eric exhibited bizarre symptoms; he developed fever, screamed "off and on" for extended periods, would not feed nor drink, could not swallow(2), and lost immediate those milestones already achieved. He lost his potty training skills, lost his vocabulary, and screamed "like a wild person." Thereafter he no longer was able to follow commands and never returned again to his normal behavior. In the words of his maternal aunt(3), "after that needle, Eric never spoke again."(4)
At present, Eric is profoundly retarded, cannot care for himself, and is completely dependent on others. He exhibits repetitive stereotyped movements, is incontinent of feces, and perseverates, cannot name any objects, rarely smiles, and has a significant lack of verbal communication.

-----------------------------------------------------------------------------------------------------------------------------------------Footnotes:
*Dr Spiro states that this event could possibly be a seizure, but it might be simply a "shaking" due to fever. Dr. Lichtenfeld's opinion is that the event was in fact a seizure and constitutes evidence of brain dysfunction. Mrs. Lassiter testified that she had seen seizures before and recognised it. Based on her description at the emergency room, the treating doctor also concluded that it was a seizure.
*Difficulty in swallowing led Mrs. Lassiter to believe that the DPT "caused him to have a sore throat". Her complaint of a sore throat is documented in medical records.
*Ethyl Floyd, Eric's aunt, and her own small child were living with the family. Eric's father died in 1987.
*Following the shot all speech stopped apparently. According to the testimony he tried to communicate, but the speech was garbled-- "did not come out normal" Eric is now 25 years old and speaks some words but no sentences.

MEDICAL RECORDS
(OMITTED)
except........
St Lukes Hospital 1978 medical history. Diagnosis of "static encephalopathy.....(Follow up)
Of pertussis encephalopathy" with retardation and hyperactivity.

CREDIBILITY ISSUE

The court finds that the symptoms claimed are supported by a preponderance of evidence and may be relied upon as credible account of events. In reaching its conclusion the following arguments were considered.
Respondent argues that mother is guilty of exaggeration, and that the court should discredit her entire testimony. The court disagrees. The tendency to exaggerate was duly noted at the hearing and was noted also in the medical records by one treating physician who took a medical history.(5) Her exaggerations are noted primarily when she boasts about Eric's achievements. She is proud of her son and very supportive. She can be excused in this regard. The trier of fact has the unique prerogative to assess credibility of fact witnesses as well as weight to be given expert testimony. Throughout these proceedings, and throughout the medical records, Mrs. Lassiter and Mrs. Floyd are consistent about basic events -- Those facts that are most relevant to the court's decision. The symptoms described in 1974 , are the same described to every medical doctor since 1974, and the same described during case proceedings. Dr. Lichtenfeld came to the same conclusion and considers the eyewitnesses to be reliable as to basic facts.
(SUMMARY OMITTED)

THE NATURE OF THE INJURY

Having found the facts favourable to petitioner's claim, the larger question concerns their significance. Dr. Lichtenfeld is confident that Eric sustained a vaccine-related encephalopathic event following his vaccination and "he was never okay after that." He bases his opinion on the constellation of symptoms observed, the screaming, seizure, anorexia, the sudden loss of developmental skills, failure to recover those skills, and lack of any evidence of a progressive neurological disease. It is his opinion that Eric's present deficits are related directly to that encephalopathic event.
Respondent's expert believes otherwise, based not only on his opinion that the factual testimony and supporting documentation of onset are inconclusive, but also on what he considers a lack of neurological signs or symptoms:
Q then the mother's description of what occurred did not, in your mind, constitute an encephalopathy.
A That's correct.............and no other contemporaneous doctor states that it was a DPT encephalopathy.
Deposition of Dr, Alfred Spiro:

It is the court's opinion that Dr. Spiro dismisses too cavalierly the sudden loss of milestones, sudden changes in behaviour and personality, and abrupt loss of skills, all of which are recorded throughout Eric's care and treatment and constitute compelling signs of unresolved central nervous system dysfunction. The court finds Dr. Lichrtenfeld's opinion to be better reasoned, more persuasive, and more in keeping with the facts.

Based on the court's own findings of fact and the reasons proffered by Dr. Lichtenfeld, the court concludes that Eric, more likely than not, sustained an encephalopathy and that the first manifestation of onset of the injury occurred within the Table time frame. Petitioner is thus entitled to a presumption of causation. Pursuant to the statutory scheme, a petitioner is entitled to a presumption of causation. Pursuant to the statutory scheme, a petitioner is entitled to receive compensation upon such findings unless respondent successfully establishes that a factor unrelated is more likely the cause of petitioner's injuries. In this case, respondent claims that Eric is autistic and that autism is not caused by DPT.

AUTISM AS A FACTOR UNRELATED

MEDICAL TESTIMONY

Respondent argues that Eric's current behavioural manifestations and retardation "fit the pattern of autistic spectrum disorders with severe mental retardation". Dr. Spiro summarises.

This child had a DPT related febrile reaction following his DPT booster, but, it is clear that he currently fits into the autistic spectrum disorder with retardation. His group of disorders is totally unrelated to DPT, it usually constitutes a group of genetically determined or idiopathic disorders (without a clear known etiology)(9)
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Footnote
(9) The term etiology is a synonym for cause or origin.
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Dr. Spiro cites the following symptoms on which he bases his autism diagnosis: stereotypical movements, lack of eye contact, perseveration. Speech/language disorder and lack of verbal communication, hands in constant motion, and the fact that onset was unnoticed during the first year or so...... a not uncommon occurrence in autism.

Dr. Spiro argues that he has never seen any individual autistic children where there was a causal link between the autism and the administration of DPT vaccine. He cites the 1991 Institiute of Medicine Report "adverse Effects of Perttussis and Rubella vaccines.....page 152 which concludes that "there is no evidence to indicate a causal relation between DPT vaccine or the pertussis component of DPT vaccine and autism."

Petitioner on the other hand, argues that autism cannot be considered a cause of Eric's condition because autism is not a disease but a syndrome (group of symptoms) with multiple causes. " An encephalopathy, whatever its cause or etiology, can produce brain damage which
results in autistic-like symptoms or behaviors."

Petitioner relies upon recent medical literature to support his theory. Five articles were submitted as petitioner's exhibits and will be discussed briefly. These articles do not challenge the possibility that in any individual case autism may be caused by a genetic factor, but they support the claim that other causes have been implicated as well:

Textbook of Neurology....
Autism is one of the developmental disorders of brain function, as in the others, there are several causes. In most cases, the cause is unknown.... There may be an inherited susceptibility to some environmentally determined stress. In few cases, there is evidence of tuberous sclerosis, hypomelanosis of Ito, fragile X, phenylketonuria,, congenital rubella, neonatal herpes simplex, hydrocephalus, malformation or other static encephalopathy... Perinatal brain injury does not cause autism as an isolated deficit.
Doctors "Steffenburg and Gillberg list many disorders, 22 in all, which have been associated with autism. They conclude that autism is not a disease but " represents a behavioral
syndrome with multiple etiologies............Autism can be the final common expression of various contributory/etiological factors." They explain further that genetic factors are in operation in some cases "disease entities or pre- and perinatal damage leading to destruction/dysfunction in certain brain areas can cause autism in others." " The Etiology of Autism".

Dr. Gerhard Bosch states in his treatise on "Infantile autism" that various factors or noxae working together can cause autistic symptoms, either triggering the autistic behavior or intensifying the effect. He explains further that as a result of "cerebral affections suffered in early childhood a clinical picture could develop that would be indistinguishable from that of infantile autism." He cites case reports in which insults to the brain were followed by onset of infantile autism. " Autism can occur or be closely simulated in children with known organic brain damage." Other etiologic factors include complications at birth, prenatal damage, infectious diseases, encephalitis. "In one case the development of the child is said to have changed.....Symptomatologically equivalent cases of autism can be caused by cerebral-organic damage."

In his treatise entitled "Recent Neurobiological Finding in Autism" Luke Y. Tsai also lists a similar variety of established neurologic disorders reported in autism including viral infections and other toxic environmental causes of brain damage. He explains that it is now well accepted that autism results from dysfunction in certain parts of the central nervous system that affect language, cognitive and intellectual development, and the ability to relate. He believes autism may be " the common pathway of a diverse range of organic brain conditions" including both prenatal and post-natal infections or injuries, the latter accounting for those whose autism is manifested "after a period of apparently normal development."

Dr. Suzanne Steffenburg states in her article entitled "Neuropsychiatric Assessment of Children with Autism: A Population Based Study " that the majority of children with autism and autistic-like conditions have overt signs of brain dysfunction" The implication is " that brain damage or dysfunction causes autism..... that autism and autistic-like conditions are neurobiologically very similar.... And that autism is likely to be a biological disorder with multiple aetiologies.. She concludes that "gene disorders, chromosomal abnormalities, certain hereditary traits and structural brain anomalies caused by environmental hazards, singly or in combination, clearly coincide with the autistic symptomatology. Rather than deciding that autism is "the cause" it should be understood that it is a symptom of an underlying disorder.

DISCUSSION
(ABRIDGED)

If in a proceeding on a petition it is shown by a preponderance of the evidence then an encephalopathy was caused by infection, toxins, trauma, or metabolic disturbances the encephalopathy shall not be considered to be a conditions set forth in this table.

As applied to this case, these sections require no more than a showing that there was a metabolic disturbance and that more likely than not it caused the encephalopathy... the fact that respondent has not identified a specific metabolic disorder by name, therefore, in and of itself, is irrelevant. But even so, respondent is required to establish that a metabolic disorder exists. That requirement has not been met in this case.

A careful interpretation of the literature indicates that autism can be mirrored by a condition that includes "autistic-like" signs or symptoms. Eric's condition has never been diagnosed conclusively as autism according to the medical records. The predominating diagnosis refers instead to "static encephalopathy" with autistic tendencies in addition to delayed development."

Deposition of Spiro . The diagnosis of autism proposed by Dr. Spiro is explained only briefly and is without adequate foundation. Based on a review of the medical literature, it appears that some term other than autism is probably more accurate... Petitioner quotes........
The term " pervasive developmental disorder is preferred to "autism" because it stresses variability in symptoms and severity and denies that autism is a disease with a single cause" PDD is used in the Revised Diagnostic and Statistical Manual of the American Psychiatric Association as an umbrella term for frankly autistic children and for other children with similar but fewer, less severe symptoms.

Dr. Spiro has not explained clearly why he believes, first, that Eric meets the criteria for autism, or second, why he believes that Eric suffers a metabolic disturbance... other than for the reason that many autistic conditions are so related. Respondent did not attempt to address the articles submitted by petitioner to support petitioner's theory nor has respondent explained why the articles are not relevant to this case. Respondent's theory in defense, therefore, is not only undocumentable, unknown and inadequately supported, it is also speculative'

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Footnote:
Dr Spiro acknowledges that the onset of autism is usually insidious rather than, as in this case, an acute event, and that the description of onset in this case is not completely typical of autism. He speculates that perhaps Mrs. Lassiter merely attributed a longstanding event (autism) to something that happened suddenly (the DPT shot) which, he states, is not uncommon among parents who are in denial. Deposition of Dr. Spiro. The court finds this an unlikely explanation.
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CONCLUSIONS

In summary, respondent's evidence and proffered explanations are weak, unconvincing, and insufficient to support a finding of an underlying metabolic or genetic disorder as the cause of Eric's affliction. Petitioner has presented a better case in support of a Table injury.

The court concludes that a preponderance of the evidence requires a finding for petitioner. The parties are directed to pursue discussions and negotiation for determining the appropriate amount of compensation to which petitioner is entitled.
IT IS SO ORDERED

E. LaVon French
Special Master.