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In 1962, the DBS brought suit against John P. Calise and the Westchester Blood Bank for intentionally altering the expiration dates on whole blood so that the product dating would exceed the 21-day requirement. He pleaded guilty and was convicted in 1964 on three counts of misbranding, three counts of false labeling, two counts of shipping an unlicensed biological product, and one count of conspiracy. Calise was placed on probation for five years and forbidden to engage in the manufacture, distribution, or sale of any biological, plasma, or blood products. The case marked the first court confirmation that blood is a drug under the definition of the Food, Drug, and Cosmetic Act. The case also marked the first litigation brought against a biologics manufacturer.
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Sidney Steinschreiber, owner of Sidcaps Laboratories Vial of Human Plasma and Water for Injection from the Calise court case in Westchester, NY., used the expired human plasma provided by John Calise to manufacture dried plasma intended for export, employed an irradiation process that did not comply with DBS standards, and labeled his products with an invalid license number. He was found guilty and sentenced to three months in jail. |
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FDA History Office |
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