On March 26, 2024, the U.S. Supreme Court heard oral arguments for the case FDA v. Alliance for Hippocratic Medicine, which has its origins in Judge Matthew Kacsmaryk's ruling in March 2023. The Supreme Court's ruling on whether the Food & Drug Administration improperly approved mifepristone for medication abortions in 2000 is due in June.
Late on Wednesday, April 12, 2023, the U.S. Court of Appeals for the 5th Circuit issued a partial stay of Judge Matthew Kacsmaryk’s ruling suspending the Food and Drug Administration’s approval of mifepristone, one of the two drugs used in medication abortions and a drug used in miscarriage care. The decision will allow mifepristone to remain on the market, but it will keep changes the FDA made to the drug’s approved use in 2016 blocked, as well as the agency’s 2021 finding that the drug could be distributed by mail.
Kacsmaryk’s opinion was riddled with historical inaccuracies and distortions — none more egregious than his reference to the 1936 decision by the U.S. Court of Appeals for the 2nd Circuit in United States v. One Package. Kacsmaryk states that the decision affirmed the illegality of shipping abortion-related devices by quoting two short passages.
But this is wrong: One Package did not concern mailing devices that the recipient could use for an abortion — instead, the case centered on the legal right of physicians to import devices for research and prescription, when the well-being of their patients was at stake. The case was a win for medical research on contraception and women who wanted control over their fertility. The case’s background and history expose how Kacsmaryk fundamentally misinterprets the case, and why his reliance upon it to impede the use of mifepristone is ill-informed.
In June 1932, Margaret Sanger, then the best-known advocate for contraception, set in motion what would become United States v. One Package.
After decades of advocacy, Sanger was frustrated with the slow progress toward passing legislation to enable unfettered access to contraception for women (diaphragms and cervical caps, specifically). So, she and free-speech advocate and attorney Morris Ernst set up a test case to assess the medical legitimacy of contraception and the rights of doctors to research medical devices.
The medical director of the Sanger-led Birth Control Clinical Research Bureau, Dr. Hannah Stone, agreed to receive a package of pessaries (a.k.a. diaphragms) from a Japanese doctor, Sakae Koyama, whom Sanger had befriended on her travels to Japan. Section 305a of the U.S. Tariff Act of 1930 had recently extended the 1873 Comstock Act to foreign imports of materials perceived as obscene. And so, Sanger and Stone anticipated that the U.S. Customs Office would seize the shipment of pessaries under this law. Then, Ernst would defend Stone and the right to import contraceptives in court.
And that is precisely what happened.
Initially, their legal strategy to dispute the seizure of the pessaries worked. In January 1936, U.S. District Judge Grover M. Moscowitz decided in Stone’s favor, finding that she had “imported the libeled articles for experimental purposes to determine their reliability and usefulness as contraceptives to cure or prevent disease” — which was “a lawful purpose.” Therefore, Moscowitz held that “the libeled articles do not come within the condemnation of the statute.”
Despite that clear affirmation that Stone was in the right, the government appealed, and the case came before the U.S. Court of Appeals for the 2nd Circuit in New York.
In December 1936, the 2nd Circuit panel affirmed the lower court’s ruling. Reflecting on the Comstock Act, from which the Tariff Act of 1930 was derived, Judge Augustus Hand wrote, “Its design, in our opinion, was not to prevent the importation, sale, or carriage by mail of things which might intelligently be employed by conscientious and competent physicians for the purpose of saving life or promoting the well being of their patients.” Hand was no fan of abortion, but found it puzzling “that no measures may be taken to prevent conception,” which in his mind would result in more pregnancies being terminated “by means of an operation.” In short, the wider the availability of contraception, the fewer abortions. The ruling clearly affirmed the right of physicians to prescribe contraceptives for their patients’ well-being.
Stone gathered her thoughts in a January 1937 article in the Nation headlined “Birth Control Wins,” proclaiming that the ruling “once and for all establishes contraception as a recognized part of medical practice and removes the legal barriers to the dissemination of contraceptive knowledge.”
The One Package decision had a lasting impact on the accessibility of contraception. As a result, physicians could legally prescribe contraception without their patients needing to have a condition for which pregnancy would be a health risk. Additionally, manufacturing companies invested more research funding into spermicide and diaphragm research and design, and the range of diaphragm sizes and types available to doctors increased. Two decades before the birth control pill came onto the U.S. market, diaphragms were the main contraceptive available to women, and researchers were now able to design and to test more secure and better-fitting versions thereof.
Kacsmaryk, however, has a very different reading of One Package — one not supported by the historical context or the totality of Hand’s opinion. Kacsmaryk wrote in his ruling that “the Second Circuit interpreted the statute to embrace articles the 1873 Congress ‘would have denounced as immoral if it had understood all the conditions under which they were to be used …’” Kacsmaryk then asserted that the 2nd Circuit “observed that ‘the word “unlawful” would make this clear as to articles for producing abortion.’”
The problem with this interpretation is that it omits the sentence in between the two quotations — the line on “conscientious and competent physicians” — which makes Hand’s actual meaning quite clear.
Not only does Kacsmaryk’s interpretation misrepresent what Hand actually wrote, his reliance on One Package to invalidate the FDA’s long-standing approval of mifepristone makes little sense for three reasons. First, the 2nd Circuit’s decision concerns only articles that could have been used for contraception, not for abortion, and there was little overlap between them at the time.
Second, even if the decision covered instruments used for abortion, doctors conducted the procedure in the 1930s with standard medical instruments, and it would be difficult, if not impossible, to prosecute physicians for purchasing the instruments that they would use for a range of operations. Even people attempting self-abortions would have used commonly available household objects such as rubber bulbs and syringes.
Finally, Hand identified the availability of contraceptives as critical to public health: They are instruments needed for “saving life or promoting the well being” of patients. That characterization would apply to mifepristone, which is used to provide health- and lifesaving care during miscarriages.
This history lends credence to the argument that Kacsmaryk’s ruling is based on misleading legal interpretation in service of political ends.
Stone stated in her Nation article that “laws which define moral behavior cannot remain static. They must be swept aside from time to time by the newer currents of thoughts which spring from human needs.” In his ruling on mifepristone, however, Kacsmaryk tried to revert the United States back to a time when the federal government punished physicians and women for purchasing and receiving contraceptives in the mail. But his need to rely on a dubious interpretation of a long-dormant law indicates just how much currents of thought have changed.
Originally published for Made By History on the Washington Post on April 13, 2023. Updated for Bunk on March 26, 2024.