FDA Learns of Proposed Massengill Defense in 1938 Federal Adulteration/Misbranding Case

Several weeks after Samuel E. Massengill pleaded not guilty to federal charges of adulteration and misbranding in the case of Elixir Sulfanilamide, the FDA received word of the company's possible defense [1]. A "confidential informant," who had obtained information from a pharmaceutical chemist and "close friend" of Dr. Massengill, told FDA Assistant Chief Paul B. Dunbar that the firm had acquired at least 660 affidavits from elixir customers who attested to their "entire satisfaction" with the product.

According to Dunbar's source, Massengill would contend that those who suffered elixir-related deaths used the medication "recklessly and in excess of the dosage recommended." When given under competent medical supervision in the advised amounts, the company would argue, the product caused no harm.

In addition, Massengill would attempt to show that sulfanilamide alone could have caused the deaths. A 15% mortality rate with the antibiotic, as quoted by the company, would compare favorably with the firm's calculated elixir-related death rate. The latter statistic would be acquired by dividing the estimated number of reported deaths, approximately 100, by the total number of cases of use per the company (660 + 100, or 760) for a death rate of 13%.

Dunbar also learned that Massengill was worth about $11 million (>$165 million in 2009) and had expended about 5% of his net worth (>$7 million) on the tragedy. Although Massengill regretted the deaths, he believed himself to be "blameless," the chemist reported. Moreover, Massengill and others in the Bristol area considered the doctor to be a public benefactor. Last, while admitting to be a friend of Massengill, the chemist had no respect for the elixir's creator, Harold Cole Watkins, who was described as "unreliable."

1. FDA correspondence. Letter from P. B. Dunbar to Drug Division. July 23, 1938.