Stromsodt v. Parke-Davis and Company

Citation257 F. Supp. 991
Decision Date28 September 1966
Docket NumberCiv. No. 3992.
PartiesShane STROMSODT, a minor, by Robert M. Stromsodt, his guardian ad litem, Plaintiff, v. PARKE-DAVIS AND COMPANY, a corporation, Defendant.
CourtUnited States District Courts. 8th Circuit. United States District Courts. 8th Circuit. District of South Dakota

Melvin M. Belli, of Belli, Ashe, Gerry & Ellison, San Francisco, Cal., Mart R. Vogel, of Wattam, Vogel, Vogel, Bright & Peterson, Fargo, N. D., Carlton G. Nelson, and Jerome J. Mack, of Nelson & Mack, Grand Forks, N. D., for plaintiff.

Harold D. Shaft, of Shaft, Benson, Shaft & McConn, Grand Forks, N. D., for defendant.

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 Welfare (HEW). Commercial marketing of the drug under the trade name "Quadrigen" commenced in July of 1959 with Quadrigen having an expiration dating period of twelve months after manufacture, and six months after issue.

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 nor see him again until November 4, 1959, when the baby was taken to Dr. Graham's office for a third shot. Shane slept most of the next two days following the initial seizure, but he had two more convulsive attacks after the first one, both of which were prior to November 4, 1959.

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.

Breach of Implied Warranty
"The liability in negligence of a manufacturer or other supplier for damage caused by his product is based on the supplier's failure to exercise reasonable care. Hence, negligence is a tort concept based on fault.
"Although the courts are occasionally confused about the matter, warranty, on the other hand, is not a concept based on fault or on the failure to exercise reasonable care. But this does not mean that warranty is
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