999 U.S. 999

U.S. FOOD AND DRUG ADMINISTRATION 
v. 
BONDIT CO. INC.

Argued February 29, 2028 
Decided April 1, 2028

[by Terry Sanville]


Bondit Co. petitioned to review and set aside an order of the Food and Drug Administration (FDA) prohibiting the manufacture, distribution or sale of “Lockjaw,” a denture adhesive produced by Bondit Co. Inc. The Science Court of Appeals for the Fifth Circuit (Texas) reversed the order (69 S.C. 007) holding that FDA has not demonstrated that the public health, safety and welfare were at risk. FDA petitioned for certiorari. The U.S. Supreme Court, Ms. Chief Justice Oliva Wendy Helmes, held that the cease and desist order prohibiting the manufacture, distribution or sale of “Lockjaw” was not improper and was consistent with statutory requirements of the Food and Drug Act of 2012.

Reversed and Remanded.

Mr. Justice Toothless dissented in part.

 

Syllabus

In July 2020, the Center for Disease Control (CDC) in Atlanta, Georgia, began receiving reports concerning the spontaneous growth of an extra set of genitalia on male subjects. The extra genitalia were fully functional and not vestigial, were strategically located just below the birth set, and of significantly greater dimensions than the birth set.

By January 1, 2024, the CDC had compiled detailed records for 301 cases of spontaneous genitalia growth. On March 1, 2024 the CDC initiated computer correlation analysis of all reported cases. The results of this analysis were published in the New England Journal of Medicine in November, 2024 (Dr. Arthur Shushnard, “Are Two ______ Better Than One??,” p. 24).

CDC’s computer analysis considered 85 personal and environmental factors. The analysis showed a positive correlation of 0.89 for males reporting spontaneous genitalia generation and using “Lockjaw.” Excepting gender and the lack of teeth, the only other factor showing a positive correlation (0.65) was subjects’ affiliation with the Republican Party.

Subsequent to the publication of these initial correlation studies, the CDC contracted with the Harvard School of Medicine to conduct laboratory and electron microscopy analysis of the use of “Lockjaw” using white rats, armadillos, and orangutans as subjects. Analysis began in February 2025 under the direction of Dr. Armondo Stelleto, formerly of Tehran University. In December 2025, Dr. Stelleto transmitted the results of the analysis to CDC. Dr. Stelleto’s research concluded:

“When used in a regular program of dental hygiene, ’Lockjaw’ has proven effective in causing chromosomal shifts of the Z26 “Y” chromosome of male subjects affecting mucus membrane areas of the anatomy. No such chromosomal shifts were detected in female or politically liberal subjects.

Subjects experiencing chromosomal shifts later grew an extra set of fully-functional male genitalia. Analysis of this study findings, taking into account variance within subject populations, indicates a statistical error factor of less than four percent.”

(Harvard School of Medicine, Medical Brief #122243566.)

CDC transmitted Dr. Stelleto’s research to FDA and on March 12, 2027, FDA issued Order #1066 to Bondit Co. Inc. directing Bondit to cease and desist the manufacture, distribution, or sale of “Lockjaw.”

Ms. Chief Justice Olivia Wendy Helmes delivered the opinion of the Court:

In June, 2021, Congress acted to create the U.S. Science Court of Appeals (485 U.S.C. 222) to assist this Court with cases involving complex issues of science. Congress realized that in many scientific areas, there might be significant dispute concerning the facts and the implications of scientific information. Congress realized that the traditional court system was ill-equipped to resolve litigation involving complex scientific matters. It was for the purpose of assessing scientific information, and determining its effects on human populations and the environment in general, that the Science Courts were established.

Neither the Science Court nor Bondit Co. dispute the findings of Dr. Stelleto’s research or the correlation analysis conducted by the CDC. Bondit maintains, however, that the incidence of spontaneous genitalia growth occurs within approximately two (2) percent of the world’s male population. Bondit maintains that Dr. Stelleto’s research could only indicate that this percentage would “in the worst case” expand to four (4) percent and that a four percent incidence rate does not represent a “significant adverse effect on the public health” as specified by Section 223 (d) of the Food and Drug Act of 2012 (767 U.S.C. 222).

The Science Court appears to have agreed with Bondit’s conclusions concerning the significance of the scientific effect of “Lockjaw” on male Republican subjects and determined that the FDA’s cease and desist order failed to meet statutory requirements. This Court finds the Science Court’s holding repugnant to the basic sanctity of the human form. While the facts are undisputed in this case, the implications of the scientific information and the Science Court’s gauging of significance are not consistent with the judgment of reasonable people.

The Science Court and Bondit are willing to accept a four percent deformity rate among male toothless Republicans who use “Lockjaw.” The Science Court’s holding demonstrates that the scientific community is no better equipped to determine the acceptability of scientific implications than is the man on the street.

Bondit argues that the scientific community often uses a 96% threshold figure to determine the acceptability of a scientific outcome. While this Court will not dispute scientific practice, we take exception to the generalization that the norms of science represent the norms of the general populace. While the Science Court has proven helpful in developing a consensus on the facts of this case, its final judgment is flawed in determining the value of human health. (If you were one of the males with two ____, how would you feel?)

As a concluding statement, this Court finds no merit in Bondit’s argument that having two sets of genitalia does not constitute a health hazard to those affected and that certain male Republican subjects benefit from actually growing a pair. We find that under the implied rules of contract, those purchasing and using “Lockjaw” want their false teeth to stay in their mouth and nothing more.

The mumbled dissent of Justice Toothless is omitted.

About the author…

Terry Sanville lives in San Luis Obispo, California with his artist-poet wife (his in-house editor) and two plump cats (his in-house critics). He writes full time, producing short stories, essays, poems, and novels. Since 2005, his short stories have been accepted by more than 280 literary and commercial journals, magazines, and anthologies including The Potomac Review, The Bitter Oleander, Shenandoah, and The Saturday Evening Post. He was nominated twice for Pushcart Prizes and once for inclusion in Best of the Net anthology.  His stories have been listed as “The Most Popular Contemporary Fiction of 2017” by the Saturday Evening Post. Terry is a retired urban planner and an accomplished jazz and blues guitarist – who once played with a symphony orchestra backing up jazz legend George Shearing.