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May 15, 1968

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,
PARKE DAVIS & CO., Defendant

Tenney, District Judge.

The opinion of the court was delivered by: TENNEY

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: *fn1" 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 degrees, 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 degrees temperature which was shortly reduced to 106 degrees 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. *fn2" 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, *fn3" 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, *fn4" 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, *fn5" 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, *fn6" 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 fever. Occasionally, there was severe pain from the site of the injection, and on rare occasions convulsions, high fever and the neurological sequelae of brain hemorrhage, hemiplegia and mental retardation, just as with the disease itself. The cause of these neurological manifestations following the use of pertussis vaccine is not definitely known either on a pathological, histological or clinical basis. These manifestations, however, were first brought to the attention of the medical profession in April of 1948. Thereafter there were developed additional controls over the production of pertussis vaccine. Under the new regulations the encephalopathic type of reaction was minimized. The use of phosphate adjuvants *fn7" made possible a decrease in the amount of pertussis in the formula; new maximum as well as minimum potency standards were set; and the toxicity of the pertussis component was reduced by extra heating and by the toxicity test. The potency test is performed by injecting groups of mice with varying dilutions of vaccine and, then, after a period of time, challenging the mice with virulent organisms. The toxicity test was performed by injecting a group of ten mice of specified weight with a specified dose of vaccine and weighing the group at specified intervals. I will have further occasion herein to discuss in greater detail the matter of tests as to their adequacy in the present case. Mention has been made above of the use of phosphate adjuvants which permitted a reduction of the amount of pertussis in the formula. Today, at least in American vaccines, an aluminum salt is used as an adjuvant. An adjuvant serves as a depot or button which will slow the release of the antigen rather than having it released all at once when the vaccine is merely suspended in a liquid. When aluminum phosphate was first used, there was some apparent increase in toxicity and the amount of the aluminum phosphate was reduced approximately one-half with a resultant substantial reduction in toxicity. Thereafter vaccines with the aluminum phosphate were no more toxic than other adsorbed vaccines.

 One other aspect of the manufacture of pertussis vaccine should be mentioned at this time. All vaccines packed in multi-dose vials require a preservative to keep them sterile (not to preserve their potency). In the development of pertussis vaccines up until the development of polio vaccine the universal preservative used was merthiolate. At the time there was no information that the merthiolate affected the vaccine for better or for worse, but it has recently been discovered that merthiolate acts as a stabilizer of the vaccine, that in its presence the vaccine tends to decrease in toxicity in storage at the same time as its potency is stabilized at a level at least for the first six months.

 In the early 1940's, there was developed the method of combining pertussis vaccine with diphtheria and tetanus toxoid into a combined antigen product colloquially known as "DTP". No apparent increase in toxicity or reactivity was noted as a result of such combination. Defendant marketed such a product under the trade name "Triogen".

 After the Salk poliomyelitis vaccine was developed, it was decided by defendant to attempt to mix the polio vaccine with the "Triogen" in order to develop commercially a quadruple antigen product. In connection with the development of polio vaccine it had been learned that merthiolate had a deleterious effect upon the polio virus, caused by the action of released mercury ions. Eli Lilly & Company incorporated Versene within its vaccine, which prevented the release of the mercury ions. However, Versene was incompatible with the aluminum phosphate used as an adjuvant by defendant in Triogen, and since defendant anticipated that it would want to develop a vaccine combining the polio vaccine with Triogen, it decided to use benzethonium chloride, or Phemerol, which was defendant's trade name for this product.

 Unknown to defendant, the benzethonium chloride had an unusual effect on the pertussis vaccine contained therein. It appears that there was a loss of potency, a reduction in the protective activity of the pertussis vaccine when benzethonium chloride rather than merthiolate was used as the preservative, which loss occurred only when the vaccine was exposed to variations in temperature. While there is no knowledge as to the manner in which benzethonium chloride affects the unidentified protective antigen of the pertussis vaccine, considerable knowledge has been accumulated as to the physical effects of benzethonium chloride on pertussis bacteria placed in a solution including benzethonium chloride. It has been demonstrated that benzethonium chloride partially disappears from the solution during storage, coming down from twenty-five parts per million to only seven parts per million. Benzethonium chloride is a quartenary ammonium compound and has a positive charge, whereas the bacterial cell wall has a negative charge. By attraction, the benzethonium chloride is adsorbed to the cell. Such adsorption on the bacterial cell wall may cause its denaturation and favors the leaching of the toxin from the bacterial cell, resulting in the leakage of the contents of the organism. Certainly, it is reasonable to conclude that the effect of the use of benzethonium chloride was to release the endotoxin from the bacteria cell into the fluid that was injected. One such endotoxin, the lipopolysaccharide, causes fever, and fever can produce convulsions and brain damage. Indeed, fever is one of the recognized etiologies or causes of post-pertussis vaccine encephalopathies.

 It is reasonable to conclude, as I do, with reasonable medical certainty or probability that the release of the endotoxin into the fluid injected into the infant plaintiff was the cause of the unusually high fever which, in turn, caused the severe and permanent brain damage. I find defendant's suggestion that the cause of such damage was a viral encephalitis caused by some unspecified virus, or a sepsis or meningitis, or an allergic reaction, totally unconvincing. It is not plaintiffs' burden to disprove every possible ground of causation suggested by defendant nor must the findings of the Court meet the standards of the laboratorian. Plaintiffs' experts have furnished impressive evidence to support the conclusions reached herein, evidence which has clearly withstood the attack of defendant's experts. Having found Quadrigen to have been the causative factor, I turn now to the question of warranty, express and implied, and the further question of negligence.

 Warranty Generally.

 Liability for breach of warranty arises where persons or property are damaged because of a product's failure to live up to an express or implied representation by the manufacturer or other supplier. It is distinguished from negligence liability in that it is not based upon fault or upon the failure of such manufacturer or supplier to exercise reasonable care. 2 Frumer & Friedman, Products Liability § 16.01[1] (1967) (hereinafter referred to as "Frumer & Friedman"); cf. Rheingold, Products Liability - The Ethical Drug Manufacturer's Liability, 18 Rutgers L.Rev. 947, 977 (1964) (hereinafter referred to as "Rheingold").

 An express warranty will arise where a manufacturer, supplier or other seller positively represents a fact concerning the goods he sells. 2 Frumer & Friedman § 16.02; cf. Uniform Commercial Code § 2-313. In the instant case, plaintiffs allege that defendant warranted Quadrigen as "safe, effective and free from harmful side effects * * *." Amended Complt. P20. *fn8" An implied warranty, on the other hand, is imposed by operation of law. 2 Frumer & Friedman § 16.02. The implied warranties allegedly breached in the case at bar are the warranties of merchantability and fitness for a particular purpose. Amended Complt. P28. The warranty of merchantability is that "the thing sold is reasonably fit for the general purpose for which it is manufactured and sold." Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358, 161 A.2d 69, 75 A.L.R.2d 1 (1960); 2 Frumer & Friedman § 16.04[2][d]; see Burr v. Sherwin Williams Co., 42 Cal.2d 682, 268 P.2d 1041 (1954); Twombley v. Fuller Brush Co., 221 Md. 476, 158 A.2d 110 (1960); Ryan v. Progressive Grocery Stores, 255 N.Y. 388, 175 N.E. 105, 74 A.L.R. 339 (1931); Rheingold at 978 (reasonable fitness for ordinary purpose for which sold). The implied warranty of fitness for a particular purpose is virtually self-explanatory, the major distinction from the merchantability warranty being reliance on the particular seller's skill and judgment. 2 Frumer & Friedman § 16.04[2][d]; see Henningsen v. Bloomfield Motors, Inc., supra.

 Privity and Related Problems.

 a. Privity.

 The last decade has seen a vigorous frontal assault on the previously near impregnable "citadel of privity" so that in many states the insulation of the manufacturer of defective goods from direct liability for breach of warranty, express or implied, is a thing of the past. See generally the excellent state-by-state analysis of the privity problem in 2 Frumer & Friedman § 16.04; Kessler, Products Liability, 76 Yale L.J. 887 (1967); Prosser, The Assault Upon the Citadel (Strict Liability to the Consumer), 69 Yale L.J. 1099 (1960).

 The decision which provided the impetus for the collapse of privity was Henningsen v. Bloomfield Motors, Inc., supra, wherein the New Jersey Court held that public policy demanded the extinction of the privity doctrine because of mass marketing conditions causing the manufacturer to become remote to the ultimate consumer, sales being accomplished through intermediaries, and product demand being created by use of advertising media. It was obvious, indicated the Court, that the manufacturer contemplated the cultivation of the ultimate consumer and that at least with respect to the purchase of a car, the implied warranty of merchantability should extend to the ultimate purchaser of such vehicle and those persons who would reasonably be anticipated to use it, such as members of the purchaser's family and those occupying or using the vehicle with his consent.

 Of course, no extended discussion is necessary to show that this Court is bound by the New York law of warranty. And it is clear that if the requirement of privity is not dead in this jurisdiction, it has at least been dealt a debilitating blow by the New York Court of Appeals in Greenberg v. Lorenz, 9 N.Y.2d 195, 213 N.Y.S.2d 39, 173 N.E.2d 773 (1961); Randy Knitwear, Inc. v. American Cyanamid Co., 11 N.Y.2d 5, 226 N.Y.S.2d 363, 181 N.E.2d 399 (1962); and Goldberg v. Kollsman Instrument Corp., 12 N.Y.2d 432, 240 N.Y.S.2d 592, 191 N.E.2d 81 (1963). See generally 2 Frumer & Friedman § 16.04[2][b][x]. In Greenberg v. Lorenz, supra, the Court held that a retailer impliedly warrants the wholesomeness of food and household goods to all members of the buyer's household since a presumption should arise that the purchase was made for all such persons. Randy Knitwear, Inc. v. American Cyanamid Co., supra, dispensed with the requirement of privity in an express warranty case. Frumer & Friedman point out that the real importance of Randy Knitwear was that it paved the way for the New York Courts to abrogate privity as a requirement in implied warranty cases since the Court noted (1) a trend away from privity; (2) privity was an outmoded technical rule; (3) that the separate indemnity actions required by the privity rule were a waste of time spent in litigation (obviously both on the part of the courts and the various parties who would be involved); and (4) that warranty was historically a tort action. Id. at § 16.04[2][b][x]. Finally, in Goldberg v. Kollsman Instrument Corp., supra, the New York Court of Appeals went about as far as Henningsen by holding that an airplane assembler could be liable for the death of an airplane passenger under an implied warranty theory. It was held, however, that the manufacturer of a component part was not liable since "adequate protection is provided for the passengers by casting in liability the airplane manufacturer which put into the market the completed aircraft." 12 N.Y.2d at 437, 240 N.Y.S.2d at 595, 191 N.E.2d at 83. *fn9" It is apparent that the refusal to hold the component part manufacturer was not because of lack of privity. 2 Frumer & Friedman § 16.04[2][b][x].

 From the foregoing, it should appear obvious in the instant case that privity presents no bar to recovery. *fn10"

 b. Necessity of a Sale.

 In Perlmutter v. Beth David Hospital, 308 N.Y. 100, 123 N.E.2d 792 (1954), the Court held that a hospital administering a blood transfusion is rendering only a service and is not making a sale. Whether a sale is necessary to impose warranty liability today is questionable (see 1 Frumer & Friedman § 19.02; Rheingold at 974), but even assuming such a requirement, it is submitted that Perlmutter would not bar a recovery in the instant case. Faced with the argument that cases such as Perlmutter would prevent recovery, in Gottsdanker v. Cutter Laboratories, 182 Cal.App.2d 602, 6 Cal.Rptr. 320 (1960), the live-polio vaccine case, the California Court stated:

"Clearly it is the patient, and not the doctor, who is the ultimate consumer of the vaccine. While a sale is essential to impose liability under the implied warranties, the initial sale to distributor or retailer of pharmaceuticals is sufficient to impose upon the manufacturer the responsibility of fulfilling the implied warranties which run to the benefit of the persons whom the manufacturer intended to be, and who in fact became the 'consumers'." Id. at 605, 6 Cal.Rptr. at 324.

 The Cutter rationale is a sound one. Moreover, the case at bar is distinguishable from Perlmutter (as was Cutter). Similarity would have been present if the physician who had administered the vaccine to Eric Tinnerholm had been sued for breach of warranty. See 3 Frumer & Friedman § 33.02[b]. Under the law as it existed at that time, plaintiffs would possibly have been denied any recovery. But the later decisions of the New York Court of Appeals in Greenberg v. Lorenz, Randy Knitwear, Inc. v. American Cyanamid Co., and Goldberg v. Kollsman Instrument Co. would allow a direct recovery against the manufacturer, a result not inconsistent with Perlmutter. Accordingly, I find that even if the technical requirement of a sale is necessary, such requirement has been fulfilled under the Cutter Laboratories decision and Perlmutter presents no obstacle to recovery.

 With these hurdles cleared, I turn to a consideration of the warranty ...

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