MEMORANDUM AND ORDER
RONALD N. DAVIES, District Judge.
This is a product liability case tried to the Court without jury, involving the ethical drug Quadrigen made by the Defendant, Parke-Davis and Company, containing four antigens: diphtheria toxoid, tetanus toxoid, pertussis (whooping cough) vaccine and poliomyelitis vaccine. It was also described as a quadruple antigen with a prophylaxis against diphtheria, pertussis, tetanus and poliomyelitis. Jurisdictional requirements of 28 U.S.C.A. § 1332, have been met.
The Plaintiff was originally shown as "Robert M. Stromsodt, guardian ad litem of Shane Stromsodt, a minor." By ex parte order entered by this Court April 1, 1966, leave was granted Plaintiff to amend the caption of the amended complaint to include "and Robert M. Stromsodt, individually." The Defendant moved the Court to set aside this order, urging that it was given no opportunity to object to it and contending that the North Dakota Statute of Limitations had run as against any claim of Robert M. Stromsodt, individually. A ruling was reserved on this motion.
To make certain that the issues are solidly joined in this cause, and that its ultimate resolution may not be attacked by reason of any real or fancied future claim to which the Defendant may think itself exposed, the Defendant's motion, upon which ruling was reserved, must be and it is hereby granted. The Defendant's motion to dismiss the cause of action as to Robert M. Stromsodt, individually, must be and it is hereby granted, for the reason that the complaint fails to state a cause of action as to Robert M. Stromsodt, individually. This case is ordered captioned as it appears herein, that is, "Shane Stromsodt, a minor, by Robert M. Stromsodt, his guardian ad litem, Plaintiff, versus Parke-Davis and Company, a corporation, Defendant," and as so styled it will be adjudicated.
In 1953 Parke-Davis commenced studies for the purpose of determining the feasibility of combining poliomyelitis vaccine with the company's trivalent antigen sold under the trade name "Triogen," containing diphtheria toxoid, tetanus toxoid and pertussis vaccine. Parke-Davis' product, Quadrigen, which has heretofore been described, was finally developed and licensed March 25, 1959, and its manufacture authorized by the Department of Health, Education and
On April 13, 1961, the Division of Biologics Standards (DBS) of the National Institutes of Health (NIH) issued a memorandum to manufacturers of multiple antigen products containing pertussis and poliomyelitis vaccines that the products could contain no less than 14 units of pertussis potency (previously 12) and be labeled with an expiration date of six months after manufacture, and four months after issue. This change was necessitated when studies indicated a significant loss of pertussis potency in quadruple antigen vaccines after marketing. No comparable loss of pertussis potency had been found in triple antigen products not containing poliomyelitis vaccine.
DBS then determined that some lots of inactivated poliomyelitis vaccine contained a live vacuolating agent, (SV 40), from the monkey kidney cells on which poliomyelitis virus was grown. Resultantly, a memorandum was issued May 20th, 1961, requiring the subsequent lots of vaccines containing components grown on monkey kidney cells be free of live SV 40.
On August 23, 1961, DBS issued a regulation or letter placing a new toxicity test requirement on all products containing pertussis vaccines; and on September 21, 1961, provided a new reference vaccine for the pertussis potency test which effected an additional increase in the potency requirement. The new toxicity test required additional treatment of the pertussis component. This treatment adversely affected the pertussis potency to the extent that the potency requirement could not consistently be met. Various articles appearing in medical literature indicated that the poliomyelitis component and the preservative being used might be the cause of the instability in multiple vaccines. Production and marketing of "Quadrigen" was finally halted in November, 1962.
Shane Stromsodt was born in Grand Forks, North Dakota, May 24th, 1959. His mother's pregnancy and his birth were entirely normal and uneventful, according to her physician, Dr. John H. Graham. On August 26th, 1959, Shane was taken for examination to Dr. Graham's office; and on that date Quadrigen was administered to him intermuscularly. The infant seemed to suffer no ill effects, and his mother recalled no reaction which caused her any alarm. On October 1, 1959, some five weeks later, Shane was again taken to Dr. Graham's office, examined and once more Quadrigen was injected into the child's body, between four and five o'clock that afternoon. Mrs. Stromsodt bundled up the child and took him to the family car in which her husband, Robert, was waiting. She reached the car some five or ten minutes after Shane had received the Quadrigen, removed the blankets from about the child, and noticed a fine red rash on his face.
The Stromsodts drove to their home where Shane was undressed, and the rash noticed on his face and the upper part of his body. Mrs. Stromsodt gave Shane his bottle immediately after the family had their meal. Shane promptly vomited the bottle's contents, something he had never done before. Mrs. Stromsodt laid the child on the bed and testified the baby had a "seizure." She described his eyes as rolling back in his head, his heels and head dug into the bed, his back arched and his fingers grasping. Mrs. Stromsodt believes the convulsion may have lasted five minutes. Having no idea of what was happening, she watched Shane and when the seizure was over, telephoned Dr. Graham. She described to the Doctor what had happened to Shane and added that she thought the baby had the measles. The Doctor, however, thought it was a reaction from the shot given Shane and instructed Mrs. Stromsodt to watch him and to telephone next morning if the child was no better. Shane seemed normal the next morning, and Mrs. Stromsodt did not call the Doctor
When Shane was taken to Dr. Graham's office November 4, 1959, Mrs. Stromsodt recited his condition to the Doctor. She told him the baby had suffered from two "spells" since the last Quadrigen shot, that he had been sleeping more and "it seemed like he wasn't doing anything any more." In short, the child was not progressing normally. The Doctor concluded that Shane should not be given Quadrigen because of the severe reaction suffered by the infant following the October 1 injection of that drug, and thus, on his third trip Shane was given Triogen which contained diphtheria toxoid, pertussis vaccine and tetanus toxoid (DPT). Poliomyelitis vaccine was not given on this date.
Shane continued to have difficulties which stemmed from the October 1st introduction of Quadrigen into his body and repeatedly had seizures until January, 1960. Mrs. Stromsodt testified the baby was making no progress. On January 13, 1960, the Stromsodts sought the advice of a specialist in pediatrics and took Shane to Dr. Samuel L. Pettit in Grand Forks. The Doctor prescribed phenobarbital for the child and testified that he finally prescribed a conventional dosage of one-quarter grain phenobarbital three times a day for Shane, which amounts he continues to receive.
When trial of this case began Shane was nearly seven years old. The record shows he walks unsteadily, lacks coordination, speaks but a few words, has none of the basic childhood skills normally possessed by children of his age and can neither read nor write. Uncontraverted medical testimony disclosed that he has damage to the brain and central nervous system. Shane is definitely, permanently and irreversibly injured, and in all probability his parents shortly will be unable to give him the necessary care and the boy will have to be institutionalized.
A careful weighing of all the credible medical testimony in this case leads this Court to the inescapable conclusion that the competent producing cause of Shane Stromsodt's condition was Quadrigen, and that chronologically and etiologically Shane's condition is traced directly to the Quadrigen administered to him October 1st, 1959.
Of the several theories under which the Plaintiff seeks to recover in this action, only two are sustainable and require discussion here. They are breach of an implied warranty and negligence.
None of the experts called by either party could or would state which particular ingredient in Quadrigen caused the damage to Shane Stromsodt. Plaintiff's witness, Dr. Ronald Okun, testified that there was evidence to show that pertussis endotoxin made the other components of Quadrigen more liable to cause an anaphylactic sort of reaction in a patient. Other evidence indicated that the product was rendered defective by the instability of potency in the pertussis vaccine. The evidence justifies the conclusion that the Plaintiff's injuries and damages were caused by a defect in the Quadrigen, and that such defect constitutes a breach of the implied warranty of merchantability.
The asserted lack of privity is not a defense in North Dakota to a claim based upon breach of an implied warranty. See Lang v. General Motors Corporation, 136 N.W.2d 805 (N.D.1965). This apparently would be particularly true in actions by the ultimate consumer against a manufacturer for breach of implied warranties where "through advertising or other media of education and information defendant has convinced and persuaded the medical profession to prescribe its drug, since it is in the very competitive field of supplying drugs and medicines for the alleviation of human suffering as well as for its own pecuniary advantages." Bennett v. Richardson-Merrell, Inc., D.C., 231 F.Supp. 150.
The finding that Parke-Davis breached the implied warranty of merchantability and that Plaintiff's injuries were caused thereby does not preclude a finding that the Defendant is also chargeable with negligence in failing adequately to test the product and adequately to warn of the dangers inherent in its use.
Clinical trials of Quadrigen prior to marketing were conducted by Dr. Clarence D. Barrett of Detriot beginning in 1956 and terminating in 1959. These tests used Quadrigen considered "fresh" in that the product was less than six months of age from the date of "pooling" of the poliomyelitis component with the DPT fraction. The trials were designed to determine antibody response and the earliest age in infancy at which immunization against poliomyelitis, diphtheria, tetanus and pertussis would be started, using a multiple antigen against all four diseases. No clinical reactions of any serious consequence were reported or observed.
Quadrigen was then made available to selected members of the medical profession who were requested to comment on their use of the product. These "field trials" indicated a marked increase in reactions among patients given Quadrigen over those being given DPT and poliomyelitis vaccine. Of the severe reactions reported the first apparent instance in which death resulted was in March of 1959. It does not appear that Parke-Davis made any effort to determine the cause of the high incidence of reactions, and only a cursory attempt was made to investigate the cause of a death attributed to the use of Quadrigen.
It appears to this Court that adequate tests performed prior to marketing would have disclosed the product's potency instability as well as the cause of greater incidence of reaction, especially in view of the number and seriousness of the reactions being reported. This was not a situation where an epidemic
Although all of the Government regulations and requirements had been satisfactorily met in the production and marketing of Quadrigen, the standards promulgated were minimal. The Defendant still owes a duty to warn of dangers of which it knew or should have known in the exercise of reasonable care. Love v. Wolf, 226 Cal.App.2d 378, 38 Cal.Rptr. 183. See also Ebers v. General Chemical Co., 310 Mich. 261, 17 N.W.2d 176; Brown v. Globe Laboratories, 165 Neb. 138, 84 N.W.2d 151; Gonzalez v. Virginia-Carolina Chemical Company, 239 F.Supp. 567 (DC, SC, 1965).
The danger must be reasonably foreseeable and the injury must be proximately caused by the failure to warn. The Defendant knew or should have known that Quadrigen might cause encephalopathies in some users and to warn of the danger.
Though this may have been the first case in which encephalopathy
The warning "Local reactions have been known to be more severe when the child is in the incubative stage of pertussis" on the insert accompanying the product, not only would not have warned members of the medical profession, but might have misled them to believe that only in cases where the child was in the incubative stage of pertussis would encephalitic symptoms occasionally occur.
There is no competent evidence in the entire record, medical or otherwise, to show that Shane's condition arose out of or from any susceptibility or predisposition, nor that the child had any congenital disease or disorder or defect of any kind, nor that he had any allergy or idiosyncrasy, nor that heredity was a factor that might account for his present condition.
This Court being of the opinion that the Defendant is liable both for breach of an implied warranty and for negligence, it becomes unnecessary to forecast whether the Supreme Court of North Dakota would apply Sec. 402 A of the Restatement of Torts in a situation such as is here presented.
As pointed out in 2 Frumer-Freidman, Chapter 3, Sec. 16A :
The Plaintiff has sustained the burden of proving, by a fair preponderance of the credible evidence adduced upon trial, that Parke-Davis has breached an implied warranty, and in addition, has been guilty of tortious negligence. The verdict which this Court reaches, and the damages awarded, are supported by either one or both of these theories.
It is my conclusion that the sum of $500,000.00 constitutes a fair, just and adequate award to Shane Stromsodt, considering the totality of circumstances in this lawsuit.
Counsel for the Plaintiff are directed to prepare and submit through the Clerk of this Court findings of fact, conclusions of law, order for judgment and judgment with the least practicable delay.