Department of Justice Requires Chemical Abortion Pill Distributor to Pay $765,000 on the Heels of Pending U.S. Supreme Court Decision in Chemical Abortion Drug Case
During the midst of heated litigation over the U.S. Federal Drug Administration’s (“FDA”) approval and deregulation of chemical abortion drugs, the Department of Justice (“DOJ”) quietly announced last week that Danco Laboratories, LLC (“Danco”) has agreed to pay $765,000 to settle a lawsuit alleging violations of the False Claims Act.[1] This announcement was published on the DOJ’s website only a day after the Fifth Circuit Court of Appeals blocked, in part, a district court judge’s ruling that suspended the FDA’s original 2000 approval of the chemical abortion drug mifepristone – Danco’s only product.
Despite being the distributor of the first “FDA-approved” chemical abortion drug, little is known about Danco. From its inception, Danco has cloaked its operations in secrecy, keeping its location and investors undisclosed.[2] What is known about the company is that it is privately owned and was formed solely to import the chemical abortion drug mifepristone under the brand name Mifeprex.
Danco has largely managed to stay under the radar over the years, but recently the company has been thrust into the public eye due to its involvement in high-profile lawsuits. In January 2021, Life Legal Defense Fund filed a lawsuit against Danco alleging that it failed to label Mifeprex boxes with the country of origin and failed to pay marking duties on Mifeprex, as required by the Tariff Act, 19 U.S.C. §1304(i).[3] Under the Tariff Act, companies that import foreign products into the United States are required to mark products with the country of origin.[4] Products that are not properly marked with their country of origin are subject to a tax that is 10% of the product’s assessed value.[5]
Danco has been importing the drug Mifeprex since at least 2002. However, Danco allegedly failed to mark the imported pharmaceutical products with the appropriate country of origin and, according to the lawsuit, violated the False Claims Act by knowingly avoiding the marking duties it owed to the United States for their imports.[6] The False Claims Act imposes liability on those who knowingly avoid obligations owed to the United States.[7]
These allegations against Danco were resolved through a civil settlement with the DOJ, under which Danco agreed to pay $765,000. The settlement included resolution of claims brought by the Life Legal Defense Foundation under the whistleblower provisions of the False Claims Act that allow private parties to file an action on behalf the United States. The whistleblowers will receive around $115,000 from the settlement.
Although Danco has resolved the False Claims Act lawsuit, it is still litigating a contentious case that is currently before the United States Supreme Court on emergency applications. In November 2022, four national medical associations and four doctors filed a lawsuit against the FDA for its approval and deregulation of the chemical abortion drug.[8] The lawsuit alleges the FDA illegally approved and deregulated chemical abortion drugs and in doing so, failed to abide by its legal obligations to protect the health and safety of women and young girls.[9] Americans United for Life has filed a friend-of-the-court brief on behalf Members of Congress in the case before the district court, Fifth Circuit Court of Appeals, and United States Supreme Court, highlighting how the FDA’s unlawful actions have gravely harmed women and young girls, and continues to do so.
Overall, Danco’s settlement with the DOJ highlights the dangers that arise from a lack of transparency in the abortion industry. The abortion industry should be transparent about its domestic and international operations, especially when it is responsible for the widespread distribution of chemical abortion drugs that have led to life threatening complications for women, and of course, the deaths of millions of unborn lives. It is important for the welfare of women and young girls that players in the abortion industry, like Danco, continue to be held accountable to the highest standards of the law.
[1] Department of Justice, Pharmaceutical Distributer Agrees to Pay $765,000 to Resolve False Claims Act Allegations Relating to Failure to Pay Customs Duties, DOJ (Apr. 12, 2023), https://www.justice.gov/opa/pr/pharmaceutical-distributer-agrees-pay-765000-resolve-false-claims-act-allegations-relating.
[2] Carole Novielli, The Media Once Wanted to End Secrecy Around the Abortion Pill. Today, Transparency is Needed More than Ever, LiveAction (July 26, 2020), https://www.liveaction.org/news/media-secrecy-abortion-pill-transparency-needed-today/.
[3] Complaint at 3-5, U.S. ex rel. Life Legal Defense Foundation v. ASD Specialty Healthcare, LLC, et al., No. 21-cv-0088 (E.D. Tex. filed Jan. 29, 2021).
[4] Id. at 2.
[5] Id.
[6] Department of Justice, supra note 1.
[7] Id.
[8] All. for Hippocratic Med. v. U.S. Food & Drug Admin., No. 2:22-cv-223 (N.D. Tex. filed Nov. 18, 2022).; see also Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, Alliance Defending Freedom, https://adflegal.org/case/alliance-hippocratic-medicine-v-us-food-and-drug-administration (last updated Apr. 19, 2023).
[9] Id.
