Parke-Davis and Company v. Stromsodt

Citation411 F.2d 1390
Decision Date31 July 1969
Docket NumberNo. 18743.,18743.
PartiesPARKE-DAVIS AND COMPANY, a Corporation, Appellant, v. Shane STROMSODT, a Minor, by Robert M. Stromsodt, His Guardian ad Litem, Appellee.
CourtUnited States Courts of Appeals. United States Court of Appeals (8th Circuit)

William H. Hillier, of Lord, Bissell & Brook, Chicago, Ill., for appellant, R. R. McMahan, Chicago, Ill., and Harold D. Shaft, of Shaft, Benson, Shaft & McConn, Grand Forks, N. D., and David C. Dethmers, Detroit, Mich., on the brief.

Mart R. Vogel, of Wattam, Vogel, Vogel, Bright & Peterson, Fargo, N. D., and Melvin M. Belli, of Belli, Ashe, Ellison, Choulos, Cone & Harper, San Francisco, Cal., for appellee, Seymour L. Ellison, of Belli, Ashe, Ellison, Choulos, Cone & Harper, San Francisco, Cal., and Carlton G. Nelson, of Nelson & Mack, Grand Forks, N. D., on the brief.

Before BLACKMUN, MEHAFFY and LAY, Circuit Judges.

MEHAFFY, Circuit Judge.

This diversity products liability action, instituted pursuant to the provisions of 28 U.S.C.A. § 1332, involves a multiple antigen product marketed by Parke-Davis and Company under its trade name "Quadrigen." This product was intended for use in simultaneous immunization against four major diseases of children: diphtheria, tetanus, pertussis (whooping cough) and poliomyelitis. Shane Stromsodt, a minor, by amended complaint brought this action by Robert M. Stromsodt, his father and guardian ad litem. Appellee will sometimes hereafter be referred to as plaintiff and sometimes as Shane.

Shane was born in Grand Forks, North Dakota, on May 24, 1959 and was inoculated with Quadrigen by a technician under the direction of Dr. John H. Graham, the family physician, on August 26 and October 1, 1959. Following the second inoculation, plaintiff suffered a convulsion and thereafter suffered other convulsions. There is no dispute that he sustained serious and permanent brain damage, disabling him both mentally and physically to the extent that for his lifetime he will require constant attention and perhaps institutional care.

The case was tried to the United States District Court for the District of North Dakota sitting without a jury. The trial court found that Quadrigen proximately caused Shane's condition; that Parke-Davis breached its implied warranty of fitness and merchantability; and that Parke-Davis was negligent in its testing of Quadrigen and in its warning of possible danger from its use. The trial court rendered judgment in the sum of $500,000.00, and its memorandum and order are published at 257 F.Supp. 991. We affirm.

The issues before this court may be broadly stated as: (1) causation (cause of brain damage sustained by plaintiff); (2) sufficiency of the evidence to justify the trial court's findings of a breach of implied warranty by defendant; and (3) sufficiency of the evidence to justify the trial court's finding that defendant was negligent.

Shane's birth was normal and he developed normally and suffered no unusual reaction from his first inoculation of Quadrigen administered on August 26, 1959. Shane continued to develop normally until the second inoculation which was administered about 5:00 p. m. on October 1, 1959. Immediately thereafter his mother carried Shane from Dr. Graham's office to her automobile and there discovered that his face was covered with a fine rash. Upon arriving at her home she undressed Shane and noticed a fine reddish rash on the upper part of his body and also a redness at the site of the inoculation. Shortly thereafter Mrs. Stromsodt gave Shane his bottle and he vomited the contents. This was the first time he had done this. Shane then had a "spell," his eyes rolled back, his head rolled back, he arched his back and he dug his heels into the bed, whined and turned his head from side to side. Mrs. Stromsodt noticed that Shane had a fever and, being concerned, telephoned Dr. Graham. Shane was listless and slept a lot the next two days. He had two more convulsions before November 4, 1959 when he was taken to Dr. Graham for his final shot. On this occasion Quadrigen was not administered but in lieu thereof a triple antigen product was used.

On January 13, 1960, Shane was taken by his family to Dr. Samuel S. Pettit, a physician and surgeon at the Grand Forks Clinic who limited his practice almost exclusively to pediatrics. Shane suffered additional and numerous seizures and was later taken by his family to the Mayo Clinic but the Mayo report recites Shane's condition and prognosis, but made no diagnosis as to the cause of Shane's difficulty. Shane was subsequently observed and examined by Dr. A. R. Natarajan of Minot, North Dakota in St. Joseph's Hospital from February 4 to February 9, 1966. Dr. Natarajan specializes in neurology and psychiatry. Later Shane was examined on September 25, 1966 at the instance of Parke-Davis by Dr. Blaine McLaughlin, who found that he has serious brain damage, is unable to talk or function normally, has motor difficulty and will be unable to take care of himself. All of Shane's doctors who examined him agreed with the diagnosis of severe brain damage, motor difficulty, difficulties in speech and that he is handicapped to such a degree that he will never be able to take care of himself and will require close supervision for the rest of his life.

In the early 1940's American drug manufacturers combined pertussis (whooping cough) vaccine with diphtheria toxoid and tetanus toxoid, thereby making a three-in-one combination known as D.P.T. (Diphtheria-Pertussis-Tetanus). This product has been generally and successfully used by doctors treating young children and is manufactured by a number of drug companies and public health bodies in the United States. Parke-Davis markets its three-in-one product under the name "Triogen."

Diphtheria and tetanus antigens in D.P.T. are toxoids while pertussis antigen is a vaccine. The difference is that toxoids are toxins produced by living bacteria, separated and treated so as to destroy toxicity while preserving antigenicity. Vaccines are preparations of whole organisms that can be killed or attenuated and suspended in solution. In 1953 Dr. Jonas Salk developed a successful poliomyelitis vaccine, and thereafter Parke-Davis gave consideration to including the poliomyelitis vaccine with its D.P.T. product, Triogen.

Inflammatory reactions involving the central nervous system occasionally follow the injection of various vaccines and serums, including pertussis vaccine, but despite its danger all the medical witnesses agreed that immunization against pertussis was proper and that they would use it or had used it for their own children or for children under their care. Some states even require pertussis vaccinations before a child can be admitted to school. Pertussis vaccine is "biological" as opposed to a drug within the framework of federal statutes and regulations (42 U.S.C.A. § 262 et seq.). Its licensing and regulation are therefore under the Department of Health, Education and Welfare (H.E.W.) rather than through the Food and Drug Administration (F.D.A.). Dr. Margaret Pittman was chief of the Laboratory of Bacterial Products for the Division of Biologics Standards of the National Institutes of Health (D.B.S.) under H.E.W., and reviewed license applications that included pertussis vaccine. Each lot of vaccine had to be specifically released by D.B.S. before it could be placed upon the market. Pertussis vaccine is made of bacteria that has been cultured from bacteria isolated in an actual case of whooping cough and treated to remove its propensity to cause the disease, yet sufficient to cause the formation of antibodies. Thus, a person receiving the vaccine forms antibodies as a reaction against the introduction of the bacteria and thereby obtains immunity against the disease. The substance in the vaccine that causes one to form antibodies is the "antigen." The potency test for pertussis vaccine was standardized by D.B.S. in 1953, and thereafter all lots of this vaccine were tested against this standard. This particular standard remained unchanged until 1961. Additional to the potency test, each lot of pertussis vaccine was given a toxicity test which consisted of injecting massive doses of the vaccine into the bodies of a group of mice and then observing their recovery over a specified period.

Among the many problems in the development of a four-in-one product which included the poliomyelitis vaccine was the selection of an appropriate preservative to protect the final product. Parke-Davis used menthiolate as its preservative in Triogen, but this preservative was not suitable for Quadrigen because it adversely affected the poliomyelitis vaccine, and Parke-Davis ultimately selected benzethonium chloride as its preservative for Quadrigen. Parke-Davis' trade name for this preservative was Phemerol. There were other technical problems involved in the production of Quadrigen which we do not consider relevant and necessary to discuss.

A product license for production of Quadrigen was granted by H.E.W. on March 25, 1959 and the language of the package insert containing the warning was approved. Quadrigen was first marketed in July, 1959. Additional pertinent facts will be discussed hereafter under the specific issues as required.

We are completely aware of the changing law in this era relating to products liability cases, which has been spawned by life in this modern society. This has resulted in a veritable field day for professors, commentators, practicing attorneys and others, all of which constitutes what might be expressed as an explosion of theories. This also includes treatises, statutes and many judicial opinions as well as a section in the Uniform Commercial Code and the Restatement of Law.1 Despite all of this, we think it is not an oversimplification to state that the decision which we reach in this case can be grounded upon settled and elementary rules of law applicable to diversity cases and to the...

To continue reading

Request your trial
41 cases
  • Larkin v. Pfizer, Inc., No. 2002-SC-0746-CL.
    • United States
    • United States State Supreme Court — District of Kentucky
    • June 17, 2004
    ...sophisticated medical man' of the dangerous propensities of the drug." McEwen, 528 P.2d at 529 (quoting Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390, 1400 (8th Cir.1969))." `[I]t is incumbent upon the manufacturer to bring the warning home to the doctor."' Id. (quoting Paul D. Rheingold, P......
  • Wooderson v. Ortho Pharmaceutical Corp.
    • United States
    • Kansas Supreme Court
    • April 27, 1984
    ...drugs of which it knows, or has reason to know. E.g., Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir.1966); Parke-Davis & Co. v. Stromsodt, 411 F.2d 1390 (8th Cir.1969); Stevens v. Parke, Davis & Co., 9 Cal.3d 51, 107 Cal.Rptr. 45, 507 P.2d 653 (1973); Love v. Wolfe, 226 Cal.App.2d 37......
  • Finn v. G. D. Searle & Co.
    • United States
    • California Supreme Court
    • March 29, 1984
    ...(Id., at p. 1274.) 10 Strict liability was also applied to a mixture of four vaccines in Parke-Davis and Company v. Stromsodt (8th Cir.1969) 411 F.2d 1390, 1397-1399. In California, two appellate court decisions have applied strict liability to injuries caused by vaccines. (Grinnell v. Char......
  • Feldman v. Lederle Laboratories
    • United States
    • New Jersey Supreme Court
    • July 30, 1984
    ...should have known in the exercise of reasonable care." Stromsodt v. Parke-Davis & Co., 257 F.Supp. 991, 997 (D.N.D.1966), aff'd, 411 F.2d 1390 (8th Cir.1969); accord Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 658-59 (1st Cir.1981) (when by 1970 oral contraceptive manufacturer had i......
  • Request a trial to view additional results
1 books & journal articles

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT