Massengill Files Demurrer to Federal Indictment; 54 of 166 Counts Dismissed

On September 7, 1938, attorneys for Samuel E. Massengill filed a demurrer, or formal objection, to each of the 166 charges of adulteration or misbranding of Elixir Sulfanilamide, which were filed in the Greeneville, Tennessee, federal court. The demurrer overtly capitalized on the inadequacies of the Pure Food and Drugs Act of 1906.

With respect to charges of adulteration, the government contended that the "purity" of Elixir Sulfanilamide "fell below the professed standard or quality under which it was sold." Specifically the product's name indicated that the antibiotic was dissolved in a nonpoisonous solvent, which was, in reality, poisonous. Massengill responded that the charges did not violate the Pure Food and Drugs Act, because "adulteration...is not anywhere so defined under said Act, nor by any interpretation thereof..." The doctor was evidently drawing on the Act's nonspecific definition of drug adulteration, which was described as differing "from the standard of strength, quality, or purity as determined by the test laid down in the United States Pharmacopoeia or National Formulary official at the time of investigation."

On the counts of misbranding, specifically with respect to the use of the name "Elixir Sulfanilamide," the government charged that Massengill had used the term "elixir" in a misleading fashion by failing to dissolve sulfanilamide in a nonpoisonous solvent. The doctor, however, rebutted that the Pure Food and Drugs Act did not specify such a definition for misbranding—an argument that could be floated with some merit. The Act defined a misbranded drug as one that was "an imitation of or offered for sale under the name of another article," or if the contents of an original package were replaced by other contents. The government, however, could cling to legislative wording that also defined misbranding as failing to label a product with "the quantity or proportion of any alcohol, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis indica, chloral hydrate, or acetanilide, or any derivative or preparation of any such substances contained therein." Diethylene glycol could be loosely construed as an alcohol derivative (although this rebuttal was contrary to the basis for the FDA's seizure of Elixir Sulfanilamide).

Last, Massengill countered the government's charges of misbranding on the basis of the sticker pasted to the elixir bottle's stopper, which read "Quality Pharmaceuticals." Massengill argued that the words have "no reference to the contents of the bottle to which it was attached," and added, "It referred solely and alone to the S. E. Massengill Company as pharmacists, and is a sort of slogan."

The federal judge, George Caldwell Taylor, evidently agreed with Massengill's third argument and, on September 30, dismissed all of the government's charges, 54 in total, relating to the doctor's use of the "Quality Pharmaceuticals" sticker. The decision left 112 counts of adulteration or misbranding, concerning 56 interstate shipments of Elixir Sulfanilamide, for Massengill to defend at trial.

Massengill's partial victory in federal court was dampened by civil action brought in a Fresno, California, superior court on September 19. A $25,000 damages complaint was filed by Mr. and Mrs. Orvin C. Kutz, parents of the deceased 5-year-old Orvin Kutz, Jr., against Samuel E. Massengill, the manager of Massengill's San Francisco branch, the Fresno druggist who sold the elixir, and 2 drug wholesalers. Counsel for the Kutz parents included California Congressman Bertrand W. Gearhart.

Sources:

United States v Massengill (ED TN 1938).

Death elixir is basis for big damage action. Fresno Bee. September 20, 1938; p 1, col 8.