Tinnerholm v. Parke Davis & Co.

• Decision Date: 15 May 1968
• Docket Number: No. 62 Civ. 4006.,62 Civ. 4006.
• Citation: 285 F. Supp. 432
• Parties: Eric R. TINNERHOLM, an infant under the age of fourteen years, by his Guardian ad Litem, Carl F. Tinnerholm, and Carl F. Tinnerholm, Individually, Plaintiffs, v. PARKE DAVIS & CO., Defendant.
• Court: U.S. District Court — Southern District of New York

285 F. Supp. 432

Eric R. TINNERHOLM, an infant under the age of fourteen years, by his Guardian ad Litem, Carl F. Tinnerholm, and Carl F. Tinnerholm, Individually, Plaintiffs, v. PARKE DAVIS & CO., Defendant.

No. 62 Civ. 4006.

United States District Court S. D. New York.

May 15, 1968.

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Fuchsberg & Fuchsberg, New York City, Jacob D. Fuchsberg Richard E. Shandell, New York City, of counsel, for plaintiffs.

Costello, Ward, Tirabasso & Shea, New York City, Joseph M. Costello, New York City, David C. Dethmers, Detroit, Mich., of counsel, for defendant.

TENNEY, District Judge.

This product liability case, which was tried to this Court without a jury, involves the ethical drug Quadrigen, made by defendant Parke Davis & Co., and administered to the infant plaintiff herein. Quadrigen contains four antigens:¹ diphtheria toxoid, tetanus toxoid, pertussis (whooping cough) vaccine and poliomyelitis vaccine. The action has been brought on behalf of the infant plaintiff by his father, and by the father individually, charging negligence in various respects and breach of an express and implied warranty. There is no dispute that the injuries suffered by the infant plaintiff are catastrophic.

The plaintiff, Eric Tinnerholm, was born on August 30, 1959, in Huntington Station, Long Island, New York. He was the third child born to his parents, the plaintiff Carl F. Tinnerholm and Mrs. Tinnerholm, the other two children then being five and four years of age. His birth was normal, as was his mother's pregnancy, and at the end of the first and second months of his life he was taken to the family physician, Dr. Gerald Feinberg, for routine check-ups. The infant was apparently a big, healthy boy who ate and slept well and was active and alert.

Some time between 11:00 A.M. and noon on Saturday, November 28, 1959, Mrs. Tinnerholm, by prearrangement, took Eric to Dr. Feinberg's office for his first immunization injection. She was informed that this immunization was not the usual 3-in-1 that her other children had received, but that it was a 4-in-1 which added poliomyelitis vaccine to the antigens with which she was already familiar. Eric suffered no immediate side-effects following the injection and continued in apparent good health through that Saturday and Sunday. On Monday he appeared extremely quiet and seemed to look toward the wall most of the day, although the parents apparently thought nothing of this at that time. On Tuesday morning, December 1, 1959, at about 4:00 A.M., the child was found tangled up in his bedclothes and whimpering, but on being picked up and patted he quieted down and presumably went back to sleep. There was no indication of temperature at that time. However, some time later, between 6:30 and 7:00 A.M., the child was found by his mother huddled under the covers, lethargic and bathed in perspiration. His temperature at that time was 108°, he was very white, his lips were blue, and he was limp. While Mrs. Tinnerholm gave the child an alcohol bath, Dr. Feinberg was summoned by the boy's father.

When the doctor arrived around 7:30 A.M. he confirmed the 108° temperature which was shortly reduced to 106° by the alcohol bath. The doctor's examination further disclosed a small amount of emesis and some coughing. The remainder of the examination was negative.

Eric was admitted to Huntington Hospital at 8:45 A.M. where he was again examined by Dr. Feinberg who found the child's neck supple, an absence of masses, and a negative Brudzinski.² Dr. Feinberg's original diagnosis was fever of unknown origin. Eric remained in Huntington Hospital until December 18th, during which period he was cared for by two pediatricians, Doctors Gordon and Kagan, and also examined by a neurologist, Dr. Sengstaken. Dr. Kagan examined the boy on the day of his admission to the hospital and found him to be pale, hyperpneic,³ the eyes dull and apathetic, with focal seizures and twitching of the right side. There was a dullness and loss of landmarks in the ears and some redness at the back of the throat. On the basis of his examination, Dr. Kagan believed that the boy had either a bacterial infection of the bloodstream (sepsis) or meningitis. However, subsequent laboratory testing ruled out both the sepsis and meningitis, for a spinal culture revealed clear fluid with only three cells, a normal finding indicating the absence of infection. There was, however, an elevated protein content of 100 milligrams per cent, indicating some abnormality attacking the brain. A repeat lumbar puncture ten days after admission again showed an absence of cells and a protein content of 56 milligrams per cent, lower than the previous 100 milligrams per cent, but still above normal. During this first hospitalization Eric developed recurrent seizures, and on the fifth day a flaccid paresis or paralysis of the right arm and leg was noted and which persisted until his discharge on December 18, 1959. Since that time he has been retarded in his mental development, being classified in the imbecile-idiot range. He is unable to stand or walk or talk, is incapable of toilet training, and in order for him to be able to sit he must first be propped up. There is a spasticity in posturing of the right upper limb and the right lower limb, indicating a spastic weakness of these extremities. He still suffers occasional seizures and has a mental age in the range of five months.

Is it possible to determine, with reasonable medical certainty or reasonable medical probability, that something peculiar to Quadrigen was the proximate cause of the injuries suffered by the infant plaintiff? The question must be answered affirmatively. Dr. Charash, one of plaintiffs' experts, concluded that the child suffered a pertussis-vaccine encephalopathy,⁴ basing his conclusion on the temporal relationship between the immunization and the onset of illness; the unusual and spectacular sudden rise and subsequent rapid reduction in temperature; the appearance of unilateral seizures and weakness; the essentially extraordinary discrepancy between the very high protein and the absence of white cells in the spinal fluid; and the flatness of the fontanel. For the same reasons, he discounted the possibility of a viral encephalitis,⁵ one of the possible alternatives raised by defendant. Likewise, the suggestion that the infant may have developed a brain abscess from otitis media is not supported by the evidence. What was it, then, that was peculiar to Quadrigen that it can be stated, with reasonable medical certainty or probability, caused the injuries already described? In order to answer this question it is necessary to discuss in some detail pertussis and pertussis vaccine as incorporated in Quadrigen.

Pertussis, or whooping cough, is a communicable respiratory disease caused by a bacterial organism. The disease may attack the brain to the extent that convulsions, high fever, and occasionally hemorrhages in the brain are produced. Sometimes this is accompanied by hemiplegia or paralysis of half the body, and not infrequently there is a resultant mental retardation. The disease is particularly dangerous for children during their first year of life, since little or no maternal immunity is passively transferred to the newborn. Immunity, however, may be obtained through the injection of a vaccine.

A vaccine, by introducing an antigenic factor into the body of the recipient, is intended to stimulate the production of antibodies, which antibodies confer protection against the disease. In the process, lymphocytes, a form of cell contained in the lymph glands, absorb the antigenic factor and produce an antitoxin against the particular disease. With some infectious diseases, such as diphtheria and tetanus, it has been possible in developing a vaccine to isolate the soluble toxin or poison excreted by the bodies of these bacteria, and to inactivate this toxin with formaldehyde, thus converting the toxin into what is called a toxoid. This toxoid preserves the ability to immunize against the disease by stimulating the production of antibodies in the recipient, but it has lost its poisonous qualities.

The pertussis organism, however, is a unique, very complex one containing many different factors. There is an exotoxin, an endotoxin, a protective antigen, a factor that gives the Schwartzman phenomenon,⁶ a factor sensitizing to histamine, yeast, protein extracts, vaccines and endotoxin, to infection by gram negative bacteria and by influenza, to X-rays, pressure, the stress of cold, and to a marked degree sensitizing to ceretonium, one of the important neuro-hormones of the brain. The exotoxin in the pertussis organism is thermo labile, i. e., it is destroyed by heat, and all vaccines with which we are concerned are heated during preparation and the thermal labile exotoxin destroyed. However, the endotoxins inside the cell are not destroyed by heat. It is this endotoxin, also called a lipopolysaccharide, to which febrile reaction following administration of pertussis vaccine is usually attributed. In addition to the protective antigen already mentioned, there are some fourteen or fifteen different antigens, and nobody knows which, of all these antigens, is the one which stimulates production of the antibodies conferring protection against pertussis (whooping cough).

By reason of the complexity and mystery of the pertussis organism, it was impossible to isolate the toxin conferring protective activity and make a toxoid out of it, as in the case of diphtheria and tetanus. Therefore, it was necessary to administer the entire bacteria organism, treating it in some way by heat or otherwise to kill the organism but preserve the antigenicity. As a result, whereas there were practically no reactions to diphtheria or tetanus toxoids, there were not uncommonly reactions to pertussis vaccine such as a swollen injection area and some...