Judicial Watch Files Supreme Court Brief in Battle to Protect Pregnant Mothers from Abortion Drug


 

The judiciary’s default position of bestowing undue deference on federal agencies has led to the rise of an unelected fourth branch of government that touches every aspect of our lives. These federal agencies wield budgets in the hundreds of billions of dollars with little to no oversight….

In 2000, the FDA harnessed the executive power from a political administration with a personal agenda bent on approving the drug mifepristone (“Mifeprex”), which intentionally ends the life of a prenatal human. In approving Mifeprex, the FDA violated its own unambiguous regulation and relied on pretext…. The FDA’s actions in 2016 and 2021 were arbitrary and capricious and violated the Administrative Procedures Act (“APA”).

[T]he FDA significantly revised the Mifeprex labeling and REMS [risk evaluation and mitigation strategy] in 2016 and reduced the safety requirements. These changes included significantly altered dosage, removal of the follow-up medical visit, removal of the requirement to take the drug in a doctor’s office, and expansion of the use through 70 days gestation. Also of significance and concern, the FDA modified the REMS to require reporting of only deaths attributable to the drug. No longer would hospitalizations, transfusions, or other serious adverse events need to be reported.

The FDA’s asserted rationalization for these significant changes was that it was “following the science.” The FDA has not, however, provided the science it followed that could reasonably explain the changes.

In 2021, using the COVID-19 pandemic as a tool, abortion proponents, led by the American College of Obstetricians and Gynecologists (“ACOG”), sued the FDA to dispense with the REMS in-person medical visit as a prerequisite for obtaining Mifeprex and permit the drug to be mailed.

Of the 32 reported adverse events, two were 15-day reports (the others were not serious and/or not unexpected). One of the 15-day reports was reported as “hemorrhage due to a ruptured ectopic pregnancy and death.” [Emphasis added] The other was reported as “post abortal parametritis/endometritis, adult respiratory distress syndrome and bilateral pneumonia.” This latter 15-day report and one case where fever was reported represent the total reports on the marketed drug suggesting infection. In addition, one infection was reported in the Population Council's 200 mifepristone study and one death [Emphasis added] due to clostridium sordellii infection was reported in the Canadian study.

We have received a small number of reports of ruptured ectopic pregnancies (including one death [Emphasis added] from hemorrhage due to a ruptured ectopic pregnancy). As you will recall, Mifeprex* and misoprostol are not an effective treatment of ectopic pregnancy. Confirmed or suspected ectopic pregnancy is a contraindication for the use of Mifeprex and should be ruled out prior to initiating Mifeprex treatment. Because ectopic pregnancy may be present despite your best efforts to rule it out before starting Mifeprex treatment, you should be mindful of the possibility of an ectopic pregnancy throughout the treatment period and have a plan for its management.

Two cases of serious systemic bacterial infection (one fatal) [Emphasis added] following treatment with Mifeprex and misoprostol have been reported.

We have also received a report of a myocardial infarction [heart attack] occurring in a 21-year-old woman three days following use of Mifeprex and misoprostol.

[T]he Medical Department of Exelgyn recorded from health professionals and authorities 23 spontaneous reports (of which 12 cases of serious adverse events, 11 non serious events and no case from clinical trials) in association with Mifepristone.” [Emphases in original]

The 12 cases of serious events reported during the period of review are classified as follows:

3 serious unlabeled. In which 1 case of unintended pregnancy with fetal malformation, 1 case of death [Emphasis added] and 1 case of thoracic pain (ischaemic accident).

9 serious labeled with 5 cases of unintended pregnancy, 2 cases of allergic reaction, 1 excessive bleeding and 1 septicaemia to Streptococcus.

In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it. It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those “major” and “interrelated” changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.

Plaintiffs allege that all ballots received after Election Day pursuant to the Illinois Receipt Deadline are illegal and invalid. These ballots are as invalid as if they were received one year after Election Day, because they violate the federal Election Day statutes. [Emphasis in original]

Plaintiffs allege three claims. First, they claim Defendants’ receipt and counting of late, illegal ballots dilutes the value of Plaintiffs’ lawfully cast votes, thereby infringing on their right to vote under the First and Fourteenth Amendments ... Second, Plaintiffs claim the Receipt Deadline injures them as federal candidates, infringing on their right to stand for office under the First and Fourteenth Amendments ... Third, Plaintiffs claim the [14-day extension] violates their federal statutory rights …

The Board … advised that the number of ballots received after Election Day through November 17, 2020, could materially affect the unofficial election results.

[Illinois’ own data indicates that] Illinois received as many as 266,417 ballots during the period between November 3 (Election Day) and November 17, 2020 (Receipt Deadline) …. This tranche of ballots totaled as much as 4.4% of the total ballots cast in the 2020 election. The record includes unrebutted, contemporaneous statements by Defendants that this tranche could change electoral outcomes after Election Day.

By counting untimely and illegal ballots received after Election Day and diluting Plaintiffs’ timely cast and received ballots, Defendants … are depriving Plaintiffs of rights protected under the First Amendment and 14th Amendment” and 42 U.S.C. § 1983.

In an apparent effort to fly under the radar, the Biden administration strategically launched a controversial gun control initiative that is receiving millions of taxpayer dollars on a Saturday instead of a weekday when it is more likely to receive news coverage and social media scrutiny. The program is called National Extreme Risk Protection Order (ERPO) Resource Center and it will train a broad range of the population—law enforcement officials, prosecutors, attorneys, judges, clinicians, social service providers, behavioral health professionals and community organizations—to help keep guns out of the hands of people who pose a threat to themselves or others. It will function under the Department of Justice (DOJ), which has dedicated millions of dollars to get it going. The investment demonstrates the DOJ’s commitment to addressing the gun violence crisis in the United States, according to an agency official quoted in the weekend announcement.

Biden Attorney General Merrick B. Garland claims the multi-million-dollar initiative will provide partners across the country with valuable resources to keep firearms out of the hands of individuals who pose a threat to themselves or others, a key phrase repeatedly used throughout program documents. “The establishment of the Center is the latest example of the Justice Department’s work to use every tool provided by the landmark Bipartisan Safer Communities Act to protect communities from gun violence,” Garland said. ERPO laws are modeled after domestic violence protection orders and create a civil process that allows police, family, medical professionals, and others to petition a court to temporarily prohibit someone at risk of harming themselves or others from purchasing and possessing firearms for the duration of the order. Assistant Attorney General Amy L. Solomon asserts that the nation’s gun “crisis” cannot be solved at one level of government and therefore there must be a collaboration of federal, state, local and holistic solutions to keep American communities safe.

Judicial Watch has filed a Freedom of Information Act (FOIA) request with the DOJ’s Office of Justice Programs (OJP) to uncover records involving the millions in ERPO grants that have been doled out by the agency, including solicitations, requests for proposals, contracts, memoranda, work plans, budgets, purchase orders, meeting minutes, audits and other correspondence. The American public deserves to know what, if any, politically connected entities received taxpayer money to conduct the mission of this questionable gun control program largely crafted in secret. Specifically, Judicial Watch is seeking records for three ERPO grants and the umbrella Biden administration endeavor known as Byrne State Crisis Intervention program that funds the creation and implementation of gun violence reduction initiatives in states around the nation and has distributed over $238 million in the last two years.

An ERPO program called Firearm Crisis Intervention Training and Technical Assistance Initiative has received the largest chunk of money, a total of three awards for $4 million, and Judicial Watch is seeking records that could shed more light on the award process and how the money is spent. The program claims to provide expert guidance, training, and technical assistance to state, local and tribal judges and courts in support of coordinated and effective state crisis intervention court proceedings and related gun violence reduction initiatives. A mystery “advisory committee” provides expertise on assessing and responding to individuals who may pose a risk to themselves or others with a firearm and develops training for court staff and judicial officers regarding firearms laws and best practice as they apply to individuals in crisis. The secret committee also develops and disseminates a “Judicial Toolkit” on firearms and crisis intervention, among other things.

The other two projects funded under the administration’s ERPO initiative and listed in Judicial Watch’s FOIA request are called Implementing Safer Communities Training and Technical Assistance and the John Hopkins ERPO Resource Center (ERC): Maximizing Impact Through Evidence, Equity, and Implementation, which have received $1 million and $2 million respectively. The first aims to advance data collection to help develop and administer tools to ascertain crisis intervention gaps and needs. The second is hub based at a private university in Maryland designed to support states and localities with the implementation of programs to reduce gun violence by providing research, technical assistance and other educational materials.