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:
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.
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,
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
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,
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
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
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.
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 (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. ¶ 20.
Privity and Related Problems.
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  [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 [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
From the foregoing, it should appear obvious in the instant case that privity presents no bar to recovery.
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:
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 causes of action.
The package insert (Plaintiffs' Exh. 1) which was apparently sent to the administering physician with his purchase of Quadrigen stated that:
Whether this statement establishes an express warranty and a breach thereof need not be reached herein, for it is clear, as will be hereinafter developed, that the defendant has breached a warranty implicit in the package insert. However, certain of the problems which need be considered in express warranty causes of action will be briefly discussed. Discussion of the sufficiency of the warning will be reserved for that portion of this opinion wherein the negligence issues are considered.
The unique characteristic of drug-product-liability litigation is that while the product is actually meant for the patient, the sales pitch is made to the physician in an attempt to get him to prescribe a particular product or course of treatment to the ultimate consumer. Rheingold at 976. Thus, advertising will take the form, among other things, of promotional literature to the physician, statements of "detail" men who solicit purchases by the physician, package inserts, labels and the like, and/or articles in medical journals. Id. at 965. Can liability of the manufacturer be sustained even though the consumer has not relied on any representation? One New York decision has held that the physician is an agent of the patient for the special purpose of receiving statements from the manufacturer. Wechsler v. Hoffman-La Roche, Inc., 198 Misc. 540, 99 N.Y.S.2d 588 (Sup.Ct.1950). A number of commentators have expressed the view that the representation need not be made directly to the injured consumer. See, e. g., 2 Frumer & Friedman § 16.04; 2 Harper & James, Torts § 28.7 (1956); Rheingold at 976-77. Nevertheless, if direct communication is dispensed with, it would appear that a plaintiff must still prove reliance by the physician. See id. at 977.
Dr. Feinberg, the administering physician, testified that he had read the package insert (TR 610, 616). According to him, it presented no more than he had already been taught in his formal medical education and in his practice (TR 460-63, 617). But, as will be discussed infra, the evidence clearly indicates the greater incidence of febrile reactions resulting with the use of Quadrigen, so that the statement as it appears in the package insert is incorrect. Moreover, the statement regarding encephalitic reactions is, at the very least, an ambiguous one (TR 610-18).
However, whether these statements can be properly characterized as express warranties which were breached need not be reached in light of my subsequent decision with respect to the implied warranty of merchantability.
In Picker X-Ray Corp. v. General Motors Corp., 185 A.2d 919, 922 (D.C.Mun. Ct.App.1962), it was stated that:
The critical problem, then, becomes the meaning of the word "defective". One
Another commentator suggests a more reasonable test: "[T]he issue as to whether a substance not intended to be present is natural or foreign is completely immaterial on the ground that a product is to be regarded as defective if a reasonable man would not have sold it had he known of the presence of the substance in the product. Keeton, Products Liability—Liability Without Fault and the Requirement of a Defect, 41 Texas L.Rev. 855, 861-62 (1963). (Emphasis added.)
The commentary to the Torts Restatement provides perhaps the best working definition of a defect: "the product is, at the time it leaves the seller's hands, in a condition not contemplated by the ultimate consumer, which will be unreasonably dangerous to him." Restatement (Second) of Torts § 402A, comment g at 351 (1965).
Whatever definition is used, in my opinion the proof amply sustained the fact that Quadrigen was defective and that the defect was the proximate cause of the injury sustained by Eric Tinnerholm. Compare Stromsodt v. Parke-Davis & Co., 257 F.Supp. 991 (D. N.D.1966). I need not discuss the evidence with respect to the biological and clinical testing of Quadrigen by Parke-Davis and the National Institutes of Health at this time although such matter has been fully considered by me in reaching conclusions on the warranty issues. The matter of testing will be amply discussed in the negligence portion of this opinion. However, certain of the articles that have been written in the field and received in evidence, the deposition of Dr. Margaret Pittman of the Division of Biologics Standards (hereinafter referred to as "DBS") of the National Institutes of Health (hereinafter referred to as "NIH"), and testimony elicited at the trial are all important, have been considered by me in reaching this conclusion and will be discussed at some length herein.
The occurrence of encephalopathies following administration of vaccines containing a pertussis component has been long known but the specific element that causes this explosive assault to the brain has not been discovered. See Berg, Neurological Complications of Pertussis Immunization, British Medical Journal 24 (July 5, 1958); Byers & Moll, Encephalopathies Following Prophylactic Pertussis Vaccine, 1 Pediatrics 437 (1948). However, the fact that an encephalopathy can be caused by pertussis vaccine would not mean that liability would be incurred for breach of warranty in the instant case. Rather, the finding of an implied warranty breach is predicated on the fact that by manufacturing Quadrigen in the method chosen by defendant, the chances of contracting an encephalopathy were enhanced.
Aside from the clinical and laboratory studies of the benzethonium chloride preserved Quadrigen which, in my opinion, indicate a defect in defendant's product, the earliest literature which noted a problem with Quadrigen was published in 1960. Massachusetts Department of Public Health, Pertussis Immunization, 263 New England Journal of Medicine 410
In 1964, a study was made with bordetella pertussis cells which showed that various substances influenced leakage from the bacterial cell. Niwa, Yamadeya & Kuwajima, Leakage of Cell Components of Bordetella Pertussis, 88 Journal of Bacteriology 809-10 (1964). Although benzethonium chloride was not used in that study, certain chemical substances similar thereto were employed (TR 1529-30).
Finally, in 1965, in an article co-authored by Dr. Pittman, it was stated:
When testifying at her deposition, Dr. Pittman attempted to water down her statement by contending that she considered this statement to be a mere hypothesis (Pittman deposition of Nov. 17, 1967, at 83 (hereinafter referred to as "Pittman I")), but that it was based on scientific experimental data (id. at 8384). The statement in her article, written when she was not involved in the instant litigation, seems far more significant than her later attempt to diminish its importance. Dr. Pittman, throughout her testimony, appears to consider the instant litigation a personal attack and an indictment of DBS as well (Pittman deposition of Nov. 27, 1967, at 214-15 (hereinafter referred to as "Pittman II")).
Dr. Pittman also testified that leakage would be immediately ascertainable in the toxicity tests conducted by the defendant and DBS (Pittman I, at 79-80). However, she later stated she had absolutely no idea as to the extent of leakage or how long it would take (Pittman II, at 79-81), so it is most difficult to see how she could predict with any certainty that the toxicity tests would reveal the leakage phenomenon.
The foregoing documents lend significant credence to the testimony of one of plaintiffs' expert witnesses, Dr. Lapin, who stated that in his opinion Quadrigen was toxic and that the administration of the vaccine to the infant plaintiff caused the injury involved in this litigation. Coupled with this is the complete failure of defendant to offer any reasonable alternative cause of Eric Tinnerholm's injury.
The "defect" involved was, in my opinion and as already stated hereinbefore, the leakage of endotoxins from within the bacterial cell and it has been shown by a preponderance of the credible evidence that such defect was the proximate cause of the injury.
Nor can defendant argue that this was a marked improvement over Triogen so that it should be shielded from liability even if the above finding is correct. I will state now, and will have occasion to reiterate later that no need justified a risk of marketing Quadrigen at an early
Accordingly, it is my opinion that the defendant has breached its warranty of merchantability to the plaintiff. In view of this discussion, the issues involving liability for breach of the warranty of fitness for a particular purpose need not be considered.
The finding of implied warranty liability does not preclude this Court from finding the defendant liable in negligence. Stromsodt v. Parke-Davis & Co., supra, 257 F.Supp. at 995. However, it is fundamental law that plaintiffs will be limited to one recovery.
Defendant herein is chargeable with negligence in failing to adequately test its product, for thereafter releasing the product for commercial distribution in the face of certain danger signs emanating from the test results, and in failing to adequately warn the medical profession of the risks inherent in its use.
It is established law that where a drug manufacturer develops a new drug subsequently found to produce harmful side effects which the manufacturer failed to discover in the course of testing the product, the manufacturer is liable in negligence where it appears that the drug in fact was inadequately tested or that the manufacturer failed to exercise due care in the development of the product prior to its release on the market for commercial distribution. 3 Frumer & Friedman § 33.01; Roginsky v. Richardson-Merrell, Inc., 378 F.2d 832 (2d Cir. 1967); Stromsodt v. Parke-Davis & Co., supra.
The tests which the various lots of vaccine had to undergo prior to their release on the market were generally biological and/or clinical in nature. Not only was it required that each lot fall within the acceptable standards of potency and toxicity established by DBS, but also the reports from the doctors in the field as well as those testing the vaccine under clinical conditions had to indicate that the drug was safe for use and that it produced no untoward adverse reactions in the recipients.
Both the potency and toxicity tests were first performed in the laboratories of the manufacturer. Once satisfactory results were achieved, the manufacturer would send the lot to DBS which, in turn, would conduct its own independent study. If the DBS test results confirmed the manufacturer's report or protocol, the lot would be approved for release on the market. If, on the other hand, the DBS results conflicted with the results set forth in the manufacturer's protocol, the lot would be returned to the manufacturer for re-testing.
As hereinbefore stated, the potency test was performed by injecting groups of mice with varying dilutions of vaccine, and, after a period of time, challenging the mice with virulent organisms. The protective activity of the vaccine was judged by the number of mice which survived the challenge at the various dilution levels. In addition, it was required that the pertussis vaccine component have no greater potency than 12 protective units per total human immunizing dose (THD).
The standard toxicity test was performed by weighing a group of ten mice, injecting them with a test dose of vaccine and weighing them again at the end of periods of 72 hours and 7 days. A vaccine was accepted as being free from toxicity if at the end of 72 hours the group weight of the mice was no less that it had been at the initial weighing, and at the end of 7 days was greater than it had been initially. A lot automatically failed the test if it was determined that a mouse had died from the vaccine.
Although Parke-Davis found no problem in meeting the potency requirements in the testing of its triple antigen vaccine, Triogen, it is apparent from the correspondence between Parke-Davis and DBS during the year 1959 that beginning with the very first experimental lots of Quadrigen submitted to DBS for testing, i. e., Lots X-7513 and X-7514, Parke-Davis was having difficulty obtaining satisfactory potency values. On January 9, 1959, Dr. Workman of DBS wrote to Parke-Davis that:
Letters of a similar nature were written concerning Lots 049033, 059294, 049032, 049034, 054044, 055961, 051639, 058836 and others, which lots initially produced test results between 2.7 and 7.25 protective units per THD. Some of these lots were re-tested and eventually withdrawn from processing.
Evidencing Parke-Davis' dilemma, on March 5, 1959, only 4 months prior to the time Quadrigen was commercially marketed, George D. Brigham, Director of the Biological Division of Parke-Davis, wrote a letter to Dr. Workman regarding Lot X-7514:
In a follow-up letter dated March 13, 1959, from Dr. Brigham to Dr. Workman, it was further stated:
It seems significant to this Court that Parke-Davis, realizing the inherent potential of the pertussis component for causing fatal reactions, and faced with the unique problem of exceptional deficiencies in the potency values of its pre-market lots, simply sought to strengthen the pertussis component without considering the possible existence of a defect in the combination itself. This proposed solution, however, also presented problems. On June 4, 1959, Dr. Brigham
It appears clear to this Court that Parke-Davis in its rush to commercialization of its product either overlooked or neglected to consider the possibility that Quadrigen was too unstable a vaccine and therefore too unpredictable to be released on the market at that time.
Parke-Davis was equally negligent in failing to test its product under market conditions. Inasmuch as it was well known that variations in temperature could have marked effects on the safety and effectiveness of a vaccine, and it was also known, as testified to by Dr. McLean of Parke-Davis, that many of the lots could not be shipped under refrigerated or storage conditions, it was incumbent upon Parke-Davis to subject their pre-release lots to those foreseeable variations in temperature to which their product would be exposed prior to the point of inoculation so as to insure that this exposure would not produce deleterious effects. This was not done. As it developed, tests taken in 1960 by the Massachusetts Department of Health and subsequently by DBS, indicated that although samples of the quadruple antigen vaccine which were held in storage under refrigerated conditions showed no perceptible loss of potency, those purchased on the market revealed a loss of potency below the minimum requirements for a pertussis vaccine. Although events subsequent to the injury herein cannot be considered in determining the manufacturer's negligence, it could not have been clearer during 1959 that tests under market conditions were necessary and that the defects subsequently discovered in 1960 were foreseeable.
Similarly, Parke-Davis was experiencing difficulty in its attempt to meet the minimum standards of toxicity. Even as late as August 1959, one month after Quadrigen had been released to the commercial market, certain lots which had been submitted by Parke-Davis to DBS for toxicity testing were being rejected. On August 25, 1959, a letter from Dr. Workman to Dr. Brigham, regarding Lot 054043, indicated:
In a letter dated September 16, 1959, Dr. Brigham replied that Parke-Davis' own re-test of Lot 054043 resulted in the deaths of 4 of the 40 mice inoculated. Defendant admitted that although this lot passed a 10-mouse test given earlier, the lot "appears upon more extensive testing to have enough toxicity to fail to pass the Minimum Requirements test in a certain percentage of cases." Plaintiffs' Exh. 3.
Clinical trials of Quadrigen prior to marketing were conducted by Dr. Clarence D. Barrett, Director of the Division of Maternal and Child Health of the City of Detroit, beginning in 1956 and
Because of the nature of the vaccine used in the Barrett study and the lack of controls placed on the diagnostic and reporting procedures, it was negligent for Parke-Davis to have used this study as its basis for making the above representation. The pertussis component which Dr. Barrett used had been in cold storage for the two-year period immediately preceding the inoculations. It had been discovered that during this period of time the potency of the pertussis component had fallen below the NIH's minimum requirements for an acceptable vaccine. Nevertheless, it was used in the study. Although in the standard commercial production lots the benzethonium chloride is combined with the pertussis component at the point of manufacture and allowed to remain in combination throughout the entire storage period, such was not the case with the vaccine used in the Detroit study. There, the preservative was not combined with the pertussis component until the time that the children were to be inoculated. Consequently, the clinical trial could not validly test the extent to which the addition of the benzethonium chloride (one of the few important changes being made in the quadruple antigen product) increased the reactivity of the product. Although the vaccine used may have been sufficient to determine the antibody response in the children tested, never having been subjected to market conditions and representing a quadruple antigen of lesser strength and of a different manufacturing process than the one eventually to be released on the market, it should not have been used as a barometer for judging local and febrile reactions.
Even had the vaccine used been an acceptable one for this purpose, the absence of controls over the diagnostic and reporting procedures made any conclusion with regard to the nature and extent of the reactions an invalid one. Mothers, most of whom came from the lowest socio-economic stratum of urban Detroit, had been asked to report, by telephone, all illnesses or reactions suffered by the children following their inoculations. No doctor or medical assistant at any time took the temperatures of the children either on the day that the vaccine was administered or subsequent thereto unless a mother, suspecting a reaction, brought her child back to the clinic. Needless to say, it was somewhat presumptuous to assume the mothers' ability to recognize a "reaction", to assume their possession of thermometers with which to determine whether their children were experiencing febrile reactions, to assume the availability of telephones with which to communicate the fact that a reaction had been suffered, and hypothesizing the fact that telephones were available, to assume the dependability of the mothers to make the requested reports. To allow any implication to be derived from this study with regard to the incidence of reactions following the inoculation of the children was negligence on the part of the defendant herein.
Of particular note was Parke-Davis' cursory attempt to investigate the cause of a reported death attributed by the treating physician to his use of Quadrigen. Although the autopsy report, received subsequently by Parke-Davis, stated that the immediate cause of death was bronchial pneumonia, the hospital record revealed that the patient had exhibited high fever, convulsions, opisthotonus, vomiting and lethargy several hours after a Quadrigen inoculation. The conclusion of the autopsy report is not necessarily inconsistent with a finding that the child experienced a pertussis encephalopathy prior to his death in that although bronchial pneumonia may have been the immediate cause of the infant's expiration, such condition can frequently be brought about by some other condition, which, in this case, in light of the small hemorrhages found in the subarachnoid portion of the brain, could well have been the vaccinal encephalopathy as was originally diagnosed. Nevertheless, there should have been an immediate and thorough investigation conducted by Parke-Davis into the possible connection between the Quadrigen inoculation and the infant's death two days subsequent thereto, especially in view of the fact that the quadruple antigen was soon to be released on the commercial market. This was not done nor did Parke-Davis attempt to notify the NIH of the possible
In considering the above discussion, it should be understood that the entry of Quadrigen on the market in July 1959 was not a response to a situation in which an epidemic or need existed justifying the risk of premature marketing since products were already available to the medical profession which satisfactorily accomplished that which Quadrigen was designed to do. Stromsodt v. Parke-Davis & Co., supra 257 F.Supp. at 996-997.
In addition to defendant's negligence in failing to further test its product in the face of evidence that the quadruple antigen was unstable, and in the absence of a public need justifying its premature release on the market, defendant was similarly negligent in not adequately warning the medical profession of the dangers inherent in its use.
It is the opinion of this Court that a drug manufacturer is under a duty to warn the medical profession of dangers inherent in its biological drugs which, in the exercise of reasonable care, it knew or should have known to exist. Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 84-85 (8th Cir. 1966); Stromsodt v. Parke-Davis & Co., supra, 257 F.Supp. at 997; Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr. 183 (1964); Alfieri v. Cabot Corp., 17 A.D.2d 455, 235 N.Y.S.2d 753 (1st Dep't 1962), aff'd, 12 N.Y.2d 1098, 240 N.Y.S.2d 163, 190 N.E.2d 535 (1963); Marcus v. Specific Pharmaceuticals, Inc., 82 N.Y.S.2d 194 (Sup.Ct.1948); Frumer & Friedman, supra § 33.01; Restatement (Second) of Torts § 388 (1965); Rheingold at 993, 994. "Watering down" the substance of a warning so as to give false assurance to the medical profession that a drug or biological can be safely administered, thereby minimizing the danger which exists in the use of a product, amounts to an inadequate warning. Love v. Wolf, supra, 38 Cal.Rptr. at 193, 197; Alfieri v. Cabot Corp., supra; Rheingold at 993, 994. Inasmuch as doctors have the right to and in fact do rely on the brochures sent to them by the manufacturers regarding safety in the use of their products, Gielskie v. State, 18 Misc.2d 508, 191 N.Y.S.2d 436, 439 (Ct.Cl.1959), rev'd on other grounds, 10 A.D.2d 471, 200 N.Y.S.2d 691 (3rd Dep't 1960), aff'd, 9 N.Y.2d 834, 216 N.Y.S.2d 85, 175 N.E.2d 455 (1961), a manufacturer is negligent who, after reporting the results of its tests to the FDA, and on the strength of those reports markets its products, discovers new harmful side effects produced by the drug, yet fails to send out warnings of this new development to the foreseeable users, i. e., doctors and dispensaries. Sterling Drug, Inc. v. Cornish, supra, 370 F.2d at 85; De Vito v. United Airlines, Inc., 98 F.Supp. 88, 96 (E.D.N.Y. 1951); Gielskie v. State, supra; Rheingold at 995.
Since the relevant portions of the warning which Parke-Davis issued in the form of a package insert are specifically set forth in the express warranty portion of this opinion, there is no need to recite them at this time.
Knowing that the only advantage in administering Quadrigen rather than the trivalent vaccine was the reduction from two to one of the number of inoculations required for each immunization, it is reasonable to assume that had the doctors been informed that greater reactivity could be expected from the quadruple antigen, they would not have subjected their patients to needless risk by using this product. Fully realizing this, Parke-Davis, employing the technique of ambiguity and a shrewd use of descriptive adjectives, was able to gloss over those facts which would have dissuaded the doctors and dispensaries from using their product, thereby lulling the medical profession into a false sense of security.
The brochure states that "[t]he incidence [of reactions with Quadrigen] is usually no greater than is normally
As hereinbefore stated, a study conducted by Dr. Sauer, submitted for publication in June 1959, revealed that 7 per cent of the children inoculated with Quadrigen suffered fevers of 104 degrees and above. Parke-Davis alleges that the reason such study was not mentioned in its brochure was that the Sauer report had not been published until after Parke-Davis had written its package insert. However, it would appear from the evidence that Parke-Davis was fully familiar with the contents of this report in light of Dr. Sauer's continuing association with defendant since the early days in the development of the pertussis vaccines. As the cases cited above hold, it was Parke-Davis' duty timely to amend its brochure to inform the medical profession of any significant new developments or information which could reasonably be expected to affect a doctor's decision to use the product. Had Parke-Davis promptly amended its literature to include the results of the study conducted by Dr. Sauer, the medical profession would have been apprised prior to the day that the infant plaintiff was inoculated of the unusual reactivity produced by Quadrigen.
Having raised the possibility at trial that plaintiff's injury could have been caused by an allergic reaction and therefore due to plaintiff's own particular hyper-sensitivity (a possibility rejected by me herein), it would appear sufficient to note in passing that defendant was under a duty in 1959 to warn the medical profession of this possibility, especially in view of the fact that such an etiological theory had been recognized since 1947. Berg, Neurological Complications of Pertussis Immunization, British Medical Journal 26 (July 5, 1958). Inasmuch as Parke-Davis did see fit to warn of a possible allergic reaction to penicillin and streptomycin, the two antibiotic residuals from the poliomyelitis vaccine, it similarly should have warned of that possibility with regard to the pertussis component.
Finally, the warning that "[l]ocal reactions have been known to be more severe when the child is in the incubative stage of pertussis" was ambiguous in that it reasonably could have misled the members of the medical profession to believe that only in cases where the child was in the incubative stage of pertussis would encephalitic symptoms occasionally occur. Stromsodt v. Parke-Davis & Co., supra, 257 F.Supp. at 997. This was Dr. Feinberg's interpretation and, in the opinion of this Court, could reasonably have been followed by others.
After due consideration and for the reasons set forth herein, it is the opinion of this Court that the defendant was negligent both in its failure to adequately test its product prior to releasing it on the commercial market and for its failure to adequately warn the medical profession of the dangers inherent in its use.
Finally, as to the damages claimed, I have been guided by the principle enunciated by the New York courts that damages are compensatory, not punitive. Little purpose would be served by further detailing the catastrophe irrevocably visited on this infant child.
The plaintiff father is, of course, entitled to recover for the loss of the child's services and for medical attendance and expenses. Kalina v. General Hospital, 31 Misc.2d 18, 20, 220 N.Y.S.2d 733, 735 (Sup.Ct.1961), aff'd, 18 A.D.2d 757, 235 N.Y.S.2d 808 (4th Dep't 1962), aff'd mem., 13 N.Y.2d 1023, 245 N.Y.S.2d 599, 195 N.E.2d 309 (1963). The parties have stipulated that his out-of-pocket payment for hospital and medical expenses for the infant total $3,470.55 and payments made by him to the State hospitals total $2,812.97, for which he is entitled to recover herein. Eric has been confined to State institutions since January 30, 1962 and will require institutional care, either of a public or private nature, for the rest of his life.
Defendant suggests that since the infant plaintiff might be cared for at State expense, the doctrine of Drinkwater v. Dinsmore, 80 N.Y. 390 (1880) should be applied. Such "collateral source" doctrine, however, has been severely limited in recent years in its application. Klein v. United States, 339 F.2d 512 (2d Cir. 1964); Feeley v. United States, 337 F.2d 924 (3rd Cir. 1964); Cunningham v. Rederiet Vindeggen A/S, 333 F.2d 308 (2d Cir. 1964). Moreover, it is inapplicable in the present case since liability for such expenses may be asserted herein against plaintiff father and plaintiff infant. The present cost of maintaining the infant at Suffolk State School is $6,000, which the State may recover from the father. New York Mental Hygiene Law, McKinney's Consol.Laws, c. 27, § 24. Even though it has accepted lesser payments in past years, it may recover the full reimbursement rates less the payments already made, § 24(9) (b), which potential recovery for the past period of institutionalization is fixed at $33,000. Such sum is subject to the lien of the State under § 24(5) (b). Defendant may, for its own protection and if so advised, move to have such lien determined.
I have not included any amount to cover the nursing services rendered by the infant's mother during the period from December 1, 1959 to January 30, 1962, for lack of proof that such services were other than would normally have been rendered by a mother to her child. I do award the plaintiff father $2,500 for the loss of the child's services during minority.
The damages properly awarded to the infant are to cover future
The defendant contends that since the infant will be permanently confined to an institution he will have little need for damages attributed to loss of earnings. The only authority cited for this proposition is Scolavino v. State, 187 Misc. 253, 263, 62 N.Y.S.2d 17 (Ct.Cl.), modified, 271 App.Div. 618, 67 N.Y.S.2d 202 (3rd Dep't 1946), aff'd, 297 N.Y. 460, 74 N.E.2d 174 (1947), and is clearly inapposite since the condition of the infant in that case prior to the accident made his future employment impossible, i. e., loss of future earnings was not attributable to the accident. Accordingly, taking into account a 5 per cent discount factor and making the valid assumption that Eric would not have commenced to work until age 21, I award him $50,000 for loss of future earnings.
To the out-of-pocket losses suffered by this infant must be added the general damages for pain and suffering. Little purpose would be served in further dwelling on the various aspects of his past, present and permanent condition. He has undergone two spinal taps and a craniotomy, is partially paralyzed and subject to seizures. He is not comatose, however; he is not a vegetable. Accordingly, after careful consideration of this case and of others in which somewhat similar injuries were involved,
In summary, I find as follows:
I. For plaintiff Carl F. Tinnerholm— (a) Reimbursement for medical expenses paid ........... $ 6,283.52 (b) For Past medical expenses for which liable ........ 33,000.00 (c) Loss of Services .................................. 2,500.00 II. For the infant plaintiff Eric Tinnerholm— (a) Future medical expenses ........................... $160,000.00 (b) Loss of future earnings ........................... 50,000.00 (c) Pain and suffering ................................ 400,000.00
The foregoing represents the Court's findings of fact and conclusions of law.
A judgment shall be entered for plaintiffs in conformity herewith.