Jim was a former milk wagon horse who was used to produce serum containing antibodies against diphtheria toxin. Jim produced over 30 quarts of diphtheria antitoxin in his career, and no doubt saved many lives. However, on October 2, 1901 Jim showed signs that he had contracted tetanus and was killed. After the death of a girl in St. Louis was traced back to Jim's contaminated serum, it was discovered that serum dated September 30th contained tetanus in its incubation phase. This could have easily been discovered, had the serum been tested prior to use. Furthermore, samples from September 30th had also been used to fill bottles labeled August 24th, while actual samples from the 24th were shown to be free of contamination.
These failures in oversight led to the distribution of antitoxin that caused the death of 12 more children. This incident, and a similar one involving contaminated smallpox vaccine, led to the passage of the Biologics Control Act of 1902 which established the Center for Biologics Evaluation and Research. Jim's misfortune, and the ensuing tragedy and reaction thus set a precedent for regulation of biologics and set the stage for the formation of the Food and Drug Administration (FDA).
- Public Health
-  - A brief review of major accomplishments during the first 100 years of CBER
-  - An overview of the incident and conditions surrounding it