Massengill's Elixir Sulfanilamide: The Aftermath

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Elixir_Sulfanilamide.pngJanuary 10, 1939
: Three months after Dr. Samuel E. Massengill pleaded guilty to 174 counts of adulterating and misbranding Elixir Sulfanilamide, he was elected president of the Bristol Chamber of Commerce in a show of municipal confidence [1].

January 17, 1939: Former Massengill chemist and creator of Elixir Sulfanilamide, Harold Cole Watkins, 58, shot himself in the heart with a .38 caliber automatic pistol at 7:30 am in the kitchen of his Bristol home. Watkins had "retired" from the Massengill company 6 months earlier; the circumstances of his departure from the firm, whether voluntary or by request, were not clear. Although the death was reported a suicide, Watkins's wife claimed that the self-inflicted gunshot was accidental. In addition to his widow, Watkins was survived by 2 sons [2-4].

January 19, 1939: Massengill sales manager Gordon Fletcher reported that the company had paid out more than $500,000 in injury claims regarding Elixir Sulfanilamide [4].

April 14, 1939: In the District Court for the Northeastern Division of the Eastern District of Tennessee (at Greeneville), judge George C. Taylor* ordered Massengill to pay $8500** and court costs for the wrongful death of Earl L. Beard, who had died in a Tulsa hospital on October 16, 1937, after consuming Elixir Sulfanilamide. The suit was brought by the deceased's mother, Mrs. Norris T. Beard of Oklahoma City [5]. (The plaintiff, represented by Swingle and Hardin of Greeneville, originally filed the suit in September 1938 and asked for $50,000.)

April 19, 1939: A civil suit brought by the widow and heirs of John W. Gibbons of Mt. Olive, Mississippi, against Massengill was dismissed without prejudice in the same federal court. Gibbons, 71, had died October 9, 1937, after consuming 2.5 ounces of a 4-ounce elixir prescription, which had been written by his physician, Archie Calhoun. (The civil complaint, originally filed on October 1, 1938, asked for a total of $45,000 in damages and a jury trial.) The plaintiffs moved for a voluntary nonsuit, most likely on the basis of deposition testimony. One of the deceased's physicians testified that Gibbons had died of coronary thrombosis, which was believed to be independent of diethylene glycol toxicity. A treating urologist also suspected prostate cancer. The plaintiffs were required to pay court costs [5].

April 20, 1939: A civil complaint was filed against Massengill in the same federal court by Claire B. Williams, widow of Fred L. Williams, a Florida resident who had died October 12, 1937, after consuming probably 6 ounces of Elixir Sulfanilamide. The plaintiff, represented by Caldwell, Brown, and O'Dell of Bristol, Tennessee, demanded $10,000 and court costs. Three months later, the case was settled out of court for an undisclosed amount [5].

November 3, 1939: A civil complaint was filed against Massengill in the same federal court by Sylvia Cauley, who alleged the wrongful death of her husband, Emanuel Cauley. Cauley, a Florida resident, had died October 16, 1937, after consuming 5 ounces of Elixir Sulfanilamide. The plaintiff, also represented by Caldwell, Brown, and O'Dell, demanded $10,000 and court costs. Massengill defended the suit by arguing that the 1-year Tennessee statute of limitations applied, not the 2-year limit in Florida. Judge Taylor agreed, and the suit was dismissed in March of 1940. The plaintiff was ordered to pay court costs [6].

Also in November, Theodore Klumpp, Chief Medical Officer of the FDA, and Herbert Calvery published their report on the Elixir Sulfanilamide deaths, which included information from 353 persons who consumed the drug. Data were "sufficient" to conclude that Elixir Sulfanilamide was the primary cause of 105 deaths; although in "several" cases, concomitant illness may have contributed to mortality. The drug was most often prescribed for the treatment of gonorrhea (39% of deaths) or sore throat (23% of deaths). The average time of survival from the first elixir dose to death was 9.4 days (range, 2-22 days) [7].

The most common, initial symptoms were nausea and vomitingsymptoms which may have been life saving for some by prompting discontinuation of the drug. Headache was also frequently experienced. These symptoms were followed by a progressive decrease in urine output, which was often associated with considerable back, flank, and/or abdominal pain. Signs of uremic encephalopathy then emerged, leading to coma, convulsions, and death. In only a few cases were laboratory studies performed (eg, South Carolina case report).

The average elixir dose taken by the deceased, both children and adults, was somewhat higher than that taken by the 248 survivors, although there was considerably overlap in the range of doses taken by the 2 groups.

Group

Mean Dose, cc

Minimum Dose, cc

Maximum Dose, cc

Deceased

 

 

 

   7 months-16 years
   (n = 34)

52.7 ± 32.8

5

120

   17-78 years
   (n = 71)

98.6 ± 37.9

20

240

Survivors

 

 

 

   1-14 years
   (n = 48)

44.2 ± 30.2

3

105

   ≥15 years
   (n = 200)

83.7 ± 57.5

1

240

March 8, 1940: A civil complaint was filed against Massengill in the District Court for the Northeastern Division of the Eastern District of Tennessee (at Greeneville) by the administrator for Pearl Locklair. Locklair died October 4, 1937, in Charleston, SC, after consuming an unknown quantity of Elixir Sulfanilamide. The plaintiffs asked for $35,000 in total damages. Massengill defended the complaint by arguing that the 1-year Tennessee statute of limitations applied, not the 6-year limit in South Carolina. Judge Taylor agreed, and the suit was dismissed on August 7, 1940. The plaintiff appealed to the US Court of Appeals for the Sixth Circuit [5,8].

January 9, 1942: The US Court of Appeals for the Sixth Circuit reversed the lower court's decision, and the wrongful death suit for Pearl Locklair was remanded for trial [8]. 

May 25, 1942: Massengill's petition to the US Supreme Court in the wrongful death suit for Pearl Locklair was denied [9].

September 2, 1942: In a settlement with the administrator for Pearl Locklair, Massengill agreed to pay $1500, plus $150 in expenses and court costs [5].

* The same judge who presided over the government's adulteration and misbranding case against Massengill. The Beard judgment was the result of a non-jury decision.

** $7500 for loss of support and other pecuniary loss and $1000 for pain and suffering.

1. Massengill heads Bristol chamber. Bristol Herald Courier. January 11, 1939; p 5, cols 1-3.

2. H. C. Watkins victim wound. Bristol News Bulletin. January 17, 1939; p 1, col 6.

3. Harold Cole Watkins victim of gunshot. Bristol Herald Courier. January 18, 1939; p 2, col 2.

4. Maker sulfanilamide formula is suicide. Greeneville Sun. January 19, 1939; p 1, col 6.

5. Greeneville, TN, court records; obtained from NARA. 

6. Cauley v S. E. Massengill Co. 35 F 371 (TN Dist 1940).

7. Klumpp TG, Calvary HO. The toxicity for human beings of diethylene glycol with sulfanilamide. South Med J. 1939;32:1105-1109.

8. Wilson v Massengill. 124 F2nd 666 (US App 1942).

9. Massengill v Wilson. 316 US 686; 62 S Ct 1274; 86 L Ed (US SC 1942).

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2 Comments

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