Abortion Pill

Legal minds say some states – and the abortion pill’s maker – might be in a sticky situation

Supreme Court

Abortion pill manufacturer Danco Laboratories — and multiple states that commit a large number of abortions — could be unprotected from a Washington State District Court ruling which barred the U.S. Food and Drug Administration (FDA) from “altering the status quo and rights as it relates to the availability of mifepristone,” a drug known as the abortion pill.

David S. Cohen, a Drexel University School of Law professor, made the interesting observation in a tweet thread following a petition by Danco to the U.S. Supreme Court, requesting that the High Court stay a lower Court ruling in the case of Alliance for Hippocratic Medicine (AHM) v. FDA. Last week, Justice Samuel Alito agreed to issue the stay until Wednesday, April 19, 2023.

Competing court rulings on abortion pill

Alliance for Hippocratic Medicine (AHM) v. FDA centers on a ruling by U.S. District Court Judge Matthew J. Kacsmaryk on behalf of AHM that suspended the FDA’s 2000 approval of the abortion pill mifepristone, and all decisions made thereafter.

Then, a Fifth Circuit Court of Appeals panel partially upheld the previously mentioned Kacsmaryk ruling on behalf of AHM. And, while the court chose to hear the merits of the request that the 2000 abortion pill approval was illegal, the Appeals Court decision would force the FDA’s safety regulations to be moved back to pre-2016 safety requirements.

At that point, Danco issued a petition to the Supreme Court requesting a stay in the AHM case and Justice Samuel Alito agreed to issue the stay until April 19. Despite Danco claiming potential harm in its petition to the Supreme Court, the generic abortion pill maker, GenBioPro, previously admitted they had already “captured a significant share of the nationwide market for mifepristone.”

Meanwhile, Washington State v. FDA was filed by pro-abortion politicians from several states who requested the judge remove the abortion pill from the FDA’s REMS safety system.

But before hearing the merits of the full request, U.S. District Judge Thomas O. Rice granted a preliminary injunction to bar the FDA from “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.”

Danco and major states not protected by Washington State ruling

These competing cases have garnered interest from the legal community, prompting Professor Cohen to tweet, “Unfortunately, because they didn’t join the Washington case, New York, New Jersey, Massachusetts, and California are not covered by the ‘status quo’ injunction from that case. Those are four of the largest abortion-providing states, and New York is home to Danco.”

Danco claims to be a pharmaceutical company, but it manufactures just one drug: Mifeprex (mifepristone), the abortion pill.

Cohen is pointing to is the fact that the plaintiff states listed in the Washington State lawsuit only include Washington, Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.

Plantiff states potentially protected by the Washington State ruling do not include New York (where Danco is reportedly headquartered) nor states like California, which commit a majority of abortions.

Previous research published at Live Action News indicated that the abortion pill company is currently manufacturing the drug in Europe.

Image: Abortion pill company Danco Laboratories headquartered in New York medication guide pamphlet

Abortion pill company Danco Laboratories headquartered in New York medication guide pamphlet

While Danco appears to be outside any protections ruled in the Washington State case, GenBioPro may be covered, since Nevada is a plaintiff in that lawsuit, and that generic abortion pill manufacturer is headquartered in Las Vegas. Dun and Bradstreet puts the location of GBP inside commercial office suites located at 3651 Lindell Rd (Ste D1041), while patient guides published in 2023 at the company’s website reveal it is using PO Box 3211 in Las Vegas, NV, as its contact address.

Ramifications

If the Supreme Court sends the appeal in the AHM case back to the Court of Appeals, Danco — along with states like New York, California and other heavily invested pro-abortion states — could be subject to pre-2016 abortion pill restrictions, while GenBioPro and the states named as plaintiffs in the Washington State case may not be.

This is merely speculation, as no higher Court has yet ruled in the Washington State case.

Simutaneously, these legal maneuvers are playing out as members of the pro-life community place a greater focus on the federal Comstock Law, which prohibits the mailing of abortion drugs and abortion related paraphernalia, among other things.

Comstock was mentioned in the AHM lawsuit, and it is speculated that enforcement of Comstock could have national implications, not just for the abortion pill but for the legality of abortion generally.

Follow the money 

Meanwhile, a DOJ False Claims Act settlement fined Danco just under $800,000, alleging that the company illegally withheld information about Mifeprex’s manufactured country of origin — which, according to Life Legal Defense Foundation’s release, was China at that time.

The settlement was signed by W. Bradley Daniel on behalf of Danco.

Image: Danco False Claim Act settlement signed by W Bradley Daniel

Danco False Claim Act settlement signed by W Bradley Daniel

In addition, a report published by Mother Jones (MJ) just weeks ago unveiled a January 2023 court document, which appears to describe a shareholder power struggle happening within Danco. Both the DOJ Settlement as well as MJ’s piece have identified W. Bradley Daniel as a leading Danco invester, who Mother Jones claimed “earned about $10.3 million in fees alone.”

This has caused some to speculate whether the latest petition by Danco to the U.S. Supreme Court is less about “protecting women” and more about the bottom line for Danco’s investors.

According to Mother Jones, the “[]average return on investment for everyone who invested in Danco about 452% over 23 years.”

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