The chief chemist at Massengill, Harold C. Watkins, tried one solvent after another before settling on diethylene glycol, a sweetish but largely tasteless fluid. The concoction was checked for flavor and fragrance, and then manufactured in batches totaling hundreds of gallons. The liquid, Elixir Sulfanilamide, was put into bottles of 4 ounces each and shipping began on Sept. 4, 1937.
Tulsa, Oklahoma., was the first city in which reactions were reported. By early October 1937, 10 patients in the practice of James Stephenson, M.D., had died immediately after taking the bright red liquid.
When FDA inspectors reached Massengill's Tennessee plant, they found that Tulsa would not be the only site of the problems. Two hundred forty gallons of "elixir" had been shipped across the country, from California to Virginia.
A short time later, Walter Campbell, the FDA's chief chemist, held a press conference in Washington, D.C., during which he said that 14 people had died after taking the Massengill product. He said that the FDA could not legally investigate or prosecute the matter unless it could be shown that there was something wrong with the label on the bottles. He had, however, begun a national investigation, as his agency was the only one with any possible jurisdiction. Campbell would go on to become Commissioner of Food and Drugs in 1940.
The 1906 law had no prohibition per se of dangerous drugs. Campbell was fortunate in that the medicine was labeled an "elixir," which technically is a liquid containing alcohol, so he went ahead with his investigation in hopes that the technicality would be sufficient cause to investigate.
The full field force of the FDA in the United States, 239 inspectors, began to search out the druggists and doctors who had received the shipments. Massengill proved to be trouble. At the beginning of the crisis, on Oct. 15, 1937, the FDA had asked the company to recall from doctors, druggists, and distributors whatever was left of the shipments. The company sent out a notice that all should send back the preparation, but said nothing about the reason for the return or the emergency nature of the recall. The recall was largely ignored. It wasn't until four days later that the company was told it had to send out a second notice, indicating that the drug was life-threatening.
By the end of November 1937, 107 deaths had been reported, many of them children. Not counted in the statistics was Watkins, the chemist who had caused it all, who died while cleaning his gun. It is unclear how many more victims there were beyond those reported, but the FDA investigators kept the number of deaths down by recovering, within four weeks, more than 90 percent of the original shipment. About 6 gallons, apparently, accounted for all the deaths.
Less than a month later, when it was clear the episode was over, the question of prosecution arose. Samuel Massengill himself wrote to the AMA, staking out the company's position. The deaths were regrettable, he said, "but I have violated no law."
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