1). “Judge Nullifies F.D.A.'s Approval Of Abortion Pill”, Apr. 8, 2023, Pam Belluck, 1,691 words, The New York Times.
3). “Texas judge suspends FDA approval of abortion pill mifepristone”, Apr. 7, 2023, Ann E. Marimow, Caroline Kitchener & Perry Stein, The Washington Post
Introduction by dmorista: Yesterday, the much anticipated Texas Mifepristone ruling was announced. This ruling was made by the well-known Amarillo reactionary ”Forced ,Birth” Operative, Federal District Judge Matthew J. Kacsmaryk. Kacsmaryk has a long history of far-right activism, and his ruling came as no particular surprise.
Forced Birth operatives and other reactionaries have come to rely on Kacsmaryk’s far-right outlook to obtain favorable rulings. Item 1)., “Judge Nullifies F.D.A.'s Approval Of Abortion Pill”, notes that: “In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents, calling medication abortion ‘chemical abortion' and referring to a fetus as an 'unborn human’ or '’unborn child.’ ”
Item 1) also notes that in fact the Amarillo case: “ …. was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members and was incorporated in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the only federal judge covering the Amarillo division in the court's Northern District.” (Emphasis added)
On the day that Kacsmaryk’s ruling was first possible 18 Attorneys General, from the somewhat more civilized Blue States, filed a case in Washington State to prevent the FDA from delisting Mifepristone. In that proceeding: “In a preliminary injunction in that case that he applied to the states that had sued, Judge Thomas O. Rice blocked the agency from taking ‘any action to remove mifepristone from the market or otherwise cause the drug to become less available.’ ”
In Item 2)., “For Texas Judge in Abortion Case, a Life Shaped by Conservative Causes”, the article notes that Kacsmaryk and his wife were “devastated when their first child, a girl they named Tyndale, was stillborn.” Well, that’s tough and all, but the vicious approach of Kacsmaryk is standard authoritarian stuff. We can be sure that a number of women have already died as a result of the disruption of reproductive health care in the fascist / reactionary Red States. We might note that Louisiana and now South Carolina have proposed legislation calling abortion or helping a woman to obtain abortion Murder. Since both of these antediluvian places are “Death Penalty State” that would entail executing women who had obtained abortions. Not quite consistent with the faux stance of caring for women and girls that these operatives try to present as their motivations.
Item 3, “Texas judge suspends FDA approval of abortion pill mifepristone”, notes that there are 12 Attorneys General who brought the case to the Washington State Federal Judge who ruled that the FDA must not delist mifepristone. I have heard that there were 12, 14, and 18 State Attorneys General involved. I don’t really know which number is correct.
The right-wing Evangelical Christians intend to make abortion, and contraception, illegal in the entire U.S. and to return the country, in that and other social policy aspects to the “Dark Ages”. This neatly works, hand in hand, with the policy goals of the Plutocratic Oligarchical Finance Capitalists, who are the most influential actors in the U.S. political milieu. There is only one way to stop this: We have to defeat these people ourselves. No so-called well meaning liberals, duped left-leaning supporters of the Fascist Coup Regime in Ukraine, law and order liberals, or other left-liberal types will save us. We must save ourselves. But the current U.S. Ruling class are the weakest Capitalist rulers in modern U.S. History. We have to challenge them on every level and at every possible occasion.
1). “Judge Nullifies F.D.A.'s Approval Of Abortion Pill”, Apr. 8, 2023, Pam Belluck, 1,691 words, The New York Times.
The Texas judge's ruling was quickly contradicted by another federal judge in Washington State who ordered the F.D.A. to keep mifepristone available.
A federal judge in Texas issued a preliminary ruling invalidating the Food and Drug Administration's 23-year-old approval of the abortion pill mifepristone, an unprecedented order that -- if it stands through court challenges -- could make it harder for patients to get abortions in states where abortion is legal, not just in those trying to restrict it.
The drug will continue to be available at least in the short-term since the judge, Matthew J. Kacsmaryk, stayed his own order for seven days to give the F.D.A. time to ask an appeals court to intervene.
Less than an hour after Judge Kacsmaryk's ruling, a judge in Washington state issued a ruling in another case, which contradicted the Texas decision, ordering the F.D.A. to make no changes to the availability of mifepristone in the 18 states that filed that lawsuit.
The conflicting orders by two federal judges, both preliminary injunctions issued before the full cases have been heard, appear to create a legal standoff likely to escalate to the Supreme Court.
President Biden said his administration would fight the Texas ruling. ''This does not just affect women in Texas,'' he said in a statement. ''If it stands, it would prevent women in every state from accessing the medication, regardless of whether abortion is legal in a state.''
The order by Judge Kacsmaryk, a Trump appointee who has written critically about Roe v. Wade, is an initial ruling in a case that could result in the most consequential abortion decision since the Supreme Court overturned Roe v. Wade last June.
On Friday night, the Justice Department filed a notice that it is appealing the Texas ruling.
''Today's decision overturns the F.D.A.'s expert judgment, rendered over two decades ago, that mifepristone is safe and effective,'' Attorney General Merrick B. Garland said in a statement, adding that the Justice Department would ask that the decision be stayed while the appeal is pending. He said the department is reviewing the ruling in the Washington case.
The lawsuit, filed by a coalition of anti-abortion groups and doctors, seeks to end more than 20 years of legal use of mifepristone, the first pill in the two-drug medication abortion regimen.
The lawsuit in Washington State was filed against the F.D.A. by 18 Democratic attorneys general who were challenging the agency's restrictions on the prescribing and dispensing of mifepristone. In a preliminary injunction in that case that he applied to the states that had sued, Judge Thomas O. Rice blocked the agency from taking ''any action to remove mifepristone from the market or otherwise cause the drug to become less available.''
Medication abortion is the method used in more than half of abortions in the United States. The lawsuit claims that the F.D.A. did not adequately review the scientific evidence or follow proper protocols when it approved mifepristone in 2000 and that it has since ignored safety risks of the medication.
The F.D.A. and the Justice Department have strongly disputed the claims in the lawsuit and said that the federal agency's rigorous reviews of mifepristone over the years had repeatedly reaffirmed its decision to approve mifepristone, which blocks a hormone that allows a pregnancy to develop. In a statement Friday night, the agency said: ''F.D.A. stands behind its determination that mifepristone is safe and effective under its approved conditions of use for medical termination of early pregnancy, and believes patients should have access to F.D.A.-approved medications that F.D.A. has determined to be safe and effective for their intended uses.''
In the 67-page Texas ruling, Judge Kacsmaryk appeared to agree with virtually all of the claims made by the anti-abortion groups and repeatedly used the language of abortion opponents, calling medication abortion ''chemical abortion'' and referring to a fetus as an ''unborn human'' or ''unborn child.''
''The court does not second-guess F.D.A.'s decision-making lightly,'' the judge wrote. ''But here, F.D.A. acquiesced on its legitimate safety concerns -- in violation of its statutory duty -- based on plainly unsound reasoning and studies that did not support its conclusions. There is also evidence indicating F.D.A. faced significant political pressure to forgo its proposed safety precautions to better advance the political objective of increased 'access' to chemical abortion.''
A lawyer for Danco Laboratories, which makes the branded version of mifepristone, called Mifeprex, and had joined the lawsuit on the side of the F.D.A., forcefully disagreed with the judge's characterizations.
''The court's ruling rewrites the facts and the law to tell its preferred narrative -- which is a story line that conflicts with established legal principles and with Mifeprex's well-established safety profile,'' the lawyer, Jessica Ellsworth, said in a statement. Danco filed a notice that it was appealing the ruling.
Erik Baptist, a lawyer for the anti-abortion groups that filed the Texas case called the decision ''a significant victory for the doctors and medical associations we represent, and more importantly, the health and safety of women and girls.'' Mr. Baptist, who is senior counsel for the Alliance Defending Freedom, a conservative Christian legal organization, said, ''by illegally approving dangerous chemical abortion drugs, the F.D.A. put women and girls in harm's way, and it's high time the agency is held accountable for its reckless actions.''
Legal experts said that even if the Texas ruling is ultimately upheld, there would be several legal options that could allow the manufacturers of mifepristone to continue supplying the drug and providers to continue prescribing it to patients.
Shortly after the rulings on Friday night, the chief executive of GenBioPro, one of the two manufacturers of mifepristone in the United States, issued a statement saying the company was reviewing the decisions of both judges.
''We will take any steps necessary to lawfully make mifepristone available and accessible to as many people as possible in the country,'' the statement from the C.E.O., Evan Masingill, said.
And if legal access to mifepristone is blocked, some abortion providers plan to provide only the second abortion medication, misoprostol, which is used safely on its own in many countries where mifepristone is less available. Misoprostol, a drug that is approved for other medical uses, causes contractions similar to a miscarriage and is considered slightly less effective on its own than in combination with mifepristone and more prone to cause side effects like nausea.
In the Texas lawsuit, the plaintiffs also seek to ban the use of misoprostol for abortion, but their request for a preliminary injunction focused on mifepristone.
Since last year's Supreme Court ruling overturning the national right to abortion, the pills used in medication abortions have increasingly become the focus of political and legal battles. Some conservative states, in addition to banning or restricting abortion in general, have begun considering legislation that specifically targets abortion pills. And several recent lawsuits have been filed in efforts to preserve or expand access to medication abortion.
The lawsuit filed in Washington state was intended to be a direct challenge to the Texas case. The Democratic attorneys general filed the case in late February on the first day that Judge Kacsmaryk could have issued a ruling. While its main claims sought to eliminate a framework of extra restrictions that the F.D.A. has long applied to mifepristone, the suit also asked the judge to declare that the F.D.A.'s ''approval of mifepristone is lawful and valid'' and to enjoin the F.D.A. ''from taking any action to remove mifepristone from the market or reduce its availability.''
In a news conference earlier this week, Washington's attorney general, Bob Ferguson, characterized the lawsuit he and the other attorneys general filed as ''the opposite of what's going on in Texas.'' He added ''So the potential is there for two decisions or judges that are, in effect, contrary to one another. In other words, one judge in Texas could potentially say 'Hey I'm issuing a ban on mifepristone nationwide' and a judge in Washington State in the case with 17 other states could say 'no, no, not only is it available, you got to expand access to it.'''
The case has caused a frenzy of concern in the reproductive health community. It was filed by the Alliance for Hippocratic Medicine, an organization that lists five anti-abortion groups as its members and was incorporated in August in Amarillo, Texas, where the case was filed. Judge Kacsmaryk is the only federal judge covering the Amarillo division in the court's Northern District.
The F.D.A. has regulated mifepristone more stringently than many other drugs and has regularly reviewed evidence for its safety and effectiveness.
For a dozen years, the agency has imposed an additional framework of restrictions and monitoring for the drug. Called a Risk Evaluation and Mitigation Strategy, or REMS, that framework has been used for only about 300 other drugs, only 60 of which it currently covers.
In recent years, the F.D.A. has extensively reviewed new data on mifepristone and has lifted several of the restrictions, including the requirement that patients obtain the drug in person from a provider.
Some of the same anti-abortion organizations that filed the Texas lawsuit had previously filed, in 2002 and 2019, citizen petitions opposing the F.D.A.'s actions on mifepristone. Both were rejected by the agency as unfounded. And a 2008 review by the Government Accountability Office found no irregularities in the F.D.A.'s mifepristone approval.
Legal experts said that the ruling appeared to be the first time that a court had acted to order that a drug be removed from the market over the objection of the F.D.A. and that if the ruling stood, it could have repercussions for federal authority to regulate other types of drugs.
In his statement, Mr. Biden said, ''If this ruling were to stand, then there will be virtually no prescription, approved by the F.D.A., that would be safe from these kinds of political, ideological attacks.''
Adam Liptak contributed reporting.
2). “For Texas Judge in Abortion Case, a Life Shaped by Conservative Causes”, Apr. 8, 2023, Abbie VanSickle, 1,119 words, The New York Times.
Judge Matthew J. Kacsmaryk issued a preliminary ruling in a closely watched Texas case that could make it harder for patients to get abortions throughout the country.
Judge Matthew J. Kacsmaryk and his wife, Shelly Kacsmaryk, were devastated when their first child, a girl they named Tyndale, was stillborn.
It was 2006 and a searing, formative experience for Judge Kacsmaryk, then a lawyer at the prominent Texas firm Baker Botts. He became involved in and later served on the board of a Texas Christian organization that provides housing and adoption services to women with unplanned pregnancies as an alternative to abortion.
''Matthew and Shelly's first child was stillborn, and I think that contributed to his interest in wanting to support women in all kinds of ways, but most especially when they are pregnant,'' said Sherri Statler, the president and chief executive of the group, Christian Homes & Family Services in Abilene. ''They often feel pressured into getting an abortion until they find out there is an organization that will support them through their pregnancy.''
Judge Kacsmaryk, now a federal judge in Amarillo, Texas, issued a preliminary ruling on Friday evening invalidating the Food and Drug Administration's approval of a widely available abortion drug in one of the most-watched court cases since the Supreme Court overturned the right to an abortion. A coalition of anti-abortion groups and doctors have sued the Food and Drug Administration, seeking to void the agency's approval of the drug mifepristone.
His ruling clashed with that of another federal court, setting up a legal standoff that is likely to escalate to the Supreme Court.
The case has put a spotlight on Judge Kacsmaryk, 45, a Trump appointee whose conservative views have prompted accusations that anti-abortion groups judge-shopped to find a sympathetic jurist to limit access to medication abortion -- allegations that lawyers for the plaintiffs have denied. The focus only intensified after the judge, in a highly unusual move, asked lawyers in the case not to publicize a hearing. He cited death threats, harassing calls and concerns of a ''circuslike atmosphere.''
Judge Kacsmaryk rose to the federal bench after years litigating at a conservative religious freedom firm, First Liberty Institute. Democrats opposed his 2019 confirmation based on his history of opposing L.G.B.T.Q. rights. Last fall, he found that the Biden administration's guidelines for protections for L.G.B.T.Q. workers went too far. He also recently ruled that a federal program aimed at giving teenagers access to confidential contraception violated the U.S. Constitution and state law.
Activists have demonstrated in front of the federal court building in downtown Amarillo, voicing their fears that this case could prove another devastating blow to women seeking abortions. They worry the judge will bring his personal views to the case, pointing to his previous rulings in other hot-button issues.
''He's advocating a political perspective from his perch on the bench,'' said Rachel O'Leary Carmona, the executive director of the Women's March, an advocacy group. She lives in Amarillo and has been helping to organize protests around the case.
Judge Kacsmaryk did not respond to requests for comment for this article, but several longtime friends and former co-workers described an experienced courtroom litigator shaped by his religious upbringing and faith. They rejected the idea that the judge would let personal views influence a decision.
''He's a real by-the-book stickler,'' said Hiram Sasser, executive general counsel for First Liberty Institute.
Born in Florida in 1977, Judge Kacsmaryk moved to Texas when he was a child. His father worked in the defense industry, and he grew up dreaming of working for the C.I.A., said Ephraim Wernick, a law school friend.
In an email, Mr. Wernick said he felt news media coverage of Judge Kacsmaryk unfairly painted him as an ideologue.
''Matt understands the properly limited role of a judge in our constitutional system,'' he said. ''I am confident that any decisions he makes from the bench will be grounded in careful study of law, facts and precedent.''
Judge Kacsmaryk attended Abilene Christian University, a private college, then the University of Texas law school in Austin.
After graduating in 2003, he joined Baker Botts, stayed for five years, became a federal prosecutor and in 2014 joined First Liberty Institute.
Mike Berry, the vice president of external affairs for First Liberty Institute, said he often sought Judge Kacsmaryk's advice.
''He was a very serious litigator, and he'd been in a lot of courtroom battles,'' Mr. Berry said. ''He knew his stuff. I could go to him and just trust that he had that instant credibility.''
Mr. Berry recalled a conversation with Judge Kacsmaryk about their shared opinion that great attorneys can separate personal emotions from their client's best interest. The conversation then turned to judges.
''A good judge will sometimes reach decisions or conclusions that they don't feel they personally would want but what the law requires,'' Mr. Berry said. ''We both believe that's true.''
Although Judge Kacsmaryk's family members, including his parents, did not respond to requests for comment, records and interviews with friends suggest his conservative views have remained a major part of his identity, both in his professional and personal life. He lists himself in his profile for the federal courts as a current member of the Federalist Society and the Philadelphia Society, a national conservative organization.
He served on the board of Ms. Statler's organization, Christian Homes & Family Services, from 2016 until he became a judge. He and his wife remain donors, Ms. Statler said.
His experience with her group runs deep, she said. Judge Kacsmaryk's sister used Christian Homes & Family Services years ago to put up her son for adoption. Ms. Statler said she could say no more for privacy reasons, and Judge Kacsmaryk's sister, Jennifer Griffith, did not respond to multiple requests for comment from The New York Times.
But Ms. Griffith told The Washington Post earlier this year that her brother had come to support her when she was a pregnant 17-year-old and had fled to Christian Homes. He held her baby in his arms, she said, and that experience, along with leaving the infant with adoptive parents, solidified her brother's belief that every pregnancy should be treasured.
''He's very passionate about the fact that you can't preach pro-life and do nothing,'' Ms. Griffith told The Post.
Ms. Statler agreed about Judge Kacsmaryk. ''I just know he just has a real tender spot for caring for women,'' she told The Times, ''and particularly women who are pregnant.''
Julie Tate contributed research.
3). “Texas judge suspends FDA approval of abortion pill mifepristone”, Apr. 7, 2023, Ann E. Marimow, Caroline Kitchener & Perry Stein, The Washington Post
Byline: Ann E. Marimow, Caroline Kitchener and Perry Stein
A federal judge in Texas blocked U.S. government approval of a key abortion medication Friday, siding with abortion foes in an unprecedented lawsuit and potentially upending nationwide access to the pill widely used to terminate pregnancies.
The highly anticipated ruling puts on hold the Food and Drug Administration's approval of mifepristone, a medication first cleared for use in the United States in 2000. The ruling will not go into effect for seven days, to give the government time to appeal.
U.S. District Judge Matthew J. Kacsmaryk, a nominee of President Donald Trump with long-held antiabortion views, agreed with the conservative groups seeking to reverse the FDA's approval of mifepristone as safe and effective, including in states where abortion rights are protected.
The Biden administration will probably appeal to the U.S. Court of Appeals for the 5th Circuit, and the case could make its way to the Supreme Court. The lawsuit followed the Supreme Court's elimination of the constitutional right to abortion last June, which allowed states to outlaw or sharply restrict the procedure.
Medication-induced abortion - the most common method of abortion in the United States - has become increasingly contentious since the high court overturned Roe v. Wade.
The lawsuit was brought by the legal group Alliance Defending Freedom on behalf of antiabortion medical organizations and four doctors who say they have treated patients with mifepristone. It claims the FDA did not have the power to approve the drug - one of two medications that are used together to terminate a pregnancy - and takes issue with the agency's easing of restrictions on the pill through the years.
Public health professionals and legal experts have denounced the lawsuit as unsupported by scientific evidence. The FDA has repeatedly found the two-step medication abortion protocol to be a safe and effective alternative to surgical abortions. The drug manufacturer, Danco Laboratories, and the Justice Department have called the plaintiff's claims baseless.
But the challengers accused the FDA of choosing politics over science when it approved "chemical abortion drugs," and of purposely ignoring what the plaintiffs claim are potentially harmful side effects.
Both sides made their cases to Kacsmaryk on March 15 during a four-hour hearing that focused on the technical aspects of federal drug regulation and FDA processes. Kacsmaryk seemed aware of the stakes and how historic this case could be, asking the lawyers about legal precedent and his authority to essentially override the FDA's approval of a drug more than 20 years ago.
The plaintiffs alleged that the FDA wrongly approved mifepristone and that the drug has failed to meet the rigorous federal standards necessary to be prescribed to patients in the United States. Erik Baptist, a lawyer with Alliance Defending Freedom, portrayed the drug as dangerous, saying the "harm of chemical drugs knows no bounds."
On the other side, lawyers for the government and Danco defended the approval process and said there is tremendous evidence that the pill is safe. When Kacsmaryk asked if the drug was still safe now that the FDA allows the pill to be administered without a doctor present, Justice Department lawyer Julie Straus Harris said the science is still conclusive.
The government and drug manufacturer also argued that the plaintiffs had no legal standing to proceed with the case because the antiabortion doctors cannot show direct harm from that decision.
"Plaintiffs spent less than one hour describing the irreparable harm to you," Jessica Ellsworth, a lawyer representing Danco, told the judge. "That's for good reason. They don't have any."
In a brief filed before the hearing, leading organizations of physicians and other public health professionals told Kacsmaryk that reversing FDA approval of mifepristone after 23 years would "cause profound and irreparable harm to patients across the country." It would be the first time a court ordered the FDA to remove a medication from the market despite opposition from the agency and the drug's manufacturer.
Most pregnancy terminations in the United States are now brought about by medication and have "an exceptionally low rate of complications," the brief said.
In a two-step medication abortion, a patient first takes one mifepristone pill, which terminates the pregnancy. Approximately 24 hours later, the patient typically takes a four-pill dose of misoprostol, a drug introduced in 1973 to treat stomach ulcers, to soften the cervix and prompt contractions that expel the embryo or fetus. While misoprostol is widely used on its own to perform abortions around the world, studies show it is less effective than the two-step regimen, and usually causes more cramping and bleeding.
Without access to mifepristone, abortion clinics would have to either default to a misoprostol-only medication abortion protocol, or perform only surgical abortions. Providers said either scenario would result in massive upheaval as they try to enact new procedures, which some clinic owners fear may present legal hurdles. A few have been stockpiling mifepristone in anticipation of the ruling, hoping they would be permitted to distribute the pills they already have regardless of Kacsmaryk's decision.
If clinics no longer have access to mifepristone, "there will be a huge amount of congestion and waiting," Amy Hagstrom Miller, chief executive of Whole Woman's Health, a network of abortion clinics, said in advance of the decision. "We may have to do whatever we can outside of the building so the majority of the space can be for procedures."
For abortion providers in states where the procedure is legally protected, the lawsuit is an unsettling reminder that they are also vulnerable to abortion restrictions - from federal legislation, as well as nationwide injunctions.
In briefs filed as part of the challenge, legal scholars warned that any court decision taking mifepristone off the market also would have far-reaching consequences for other drugs considered safe and effective. Patients who rely on lifesaving medications could see their drugs removed from the market with little notice, they said.
"We are not aware of any case in which a court has removed a drug from the market over FDA's objection," said a brief filed on behalf of the FDA legal scholars.
As states have moved to restrict or ban abortion since last June, women have increasingly turned to using pills to terminate their pregnancies. Abortion opponents see the drugs as a threat to their efforts to ban abortion, and have been ramping up efforts to restrict their use, both in the courts and state legislatures.
The lawsuit targeted the FDA's loosening of restrictions on the abortion pill, including the agency's decision in 2016 to say the drug could be used through 10 weeks of pregnancy, up from the seven-week limit in the initial approval. The FDA took steps this year to ease access to the medication in states where its use is legal, allowing retail pharmacies to dispense the pills directly from doctors or by mail.
In a separate legal challenge on the opposite side of the issue, 12 Democratic state attorneys general sued the FDA in February in an effort to loosen restrictions on access to mifepristone, claiming that the agency has imposed "particularly burdensome" limits on distribution of the drug.
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