The D.C. Circuit has affirmed a lower court's decision barring the Pilchuck Nation from securing tribal recognition, saying the group located in Washington state failed to go through a formal process as overseen by the U.S. Department of the Interior.
The federal appellate court said in its Tuesday per curiam judgment that the issues raised by the Pilchuck Nation and its chairman, Kurt Kanam, do not warrant a published opinion and ordered that the district court's decision be affirmed. Pilchuck and Kanam failed to apply for acknowledgment to the DOI under the U.S. government's so-called Part 83 regulations, under which tribes may be federally recognized, the D.C. Circuit said.
"DOI regulations set forth a process for putative Indian tribes to seek federal recognition," the judgment said. "This court has long held that tribes seeking recognition must pursue the Part 83 process. It is undisputed that the Pilchuck Nation failed to do so, which dooms this lawsuit."
The D.C. Circuit cited its 2016 decision in Mackinac Tribe v. Jewell, its 2013 decision in Muwekma Ohlone Tribe v. Salazar , and its 1987 decision in James v. U.S. Department of Health and Human Services .
Last year, on June 28, U.S. District Judge Richard J. Leon rejected the Pilchuck Nation's latest attempt to gain formal recognition, saying it had not exhausted its nonlegal options because it never sought tribal status through the official process overseen by the DOI's Bureau of Indian Affairs.
In his ruling, Judge Leon found that the Pilchuck Nation and Kanam have "not even attempted to comply with the procedural requirements established in Part 83."
Kanam's efforts to revise his June 2021 lawsuit confirmed his failure to follow the Part 83 process, according to Judge Leon. The judge said Kanam initially claimed that the federal court must endorse a putative order by the Karluk Tribal Court of the Native Village of Karluk, Alaska, which recognized the Pilchuck as party to an 1855 treaty with the U.S. government.
Citing "substantive contradictions" in Kanam's later filings, the judge declined to extend leave to amend the suit, which he called the Pilchuck Nation's fourth bid for federal recognition.
Requiring tribes to follow the Part 83 rules, he said, "is appropriate because it is consistent with congressional direction, leverages agency expertise, creates an administrative record ripe for judicial review and allows for the possibility that the matter will be resolved administratively without need for judicial intervention."
Kanam sued U.S. Interior Secretary Deb Haaland and top BIA officials last year, saying the government has ignored multiple requests by the Pilchuck Nation for federal recognition.
That disregard violated the tribe's due process rights and the Administrative Procedure Act, according to Kanam, who has claimed that he descends via adoption from a signatory to the 1855 Treaty of Point Elliott. Kanam's past attempts to secure formal recognition largely stem from a March 2012 ruling by the Karluk Tribal Court, which declared the Pilchuck Nation to be a "treaty tribe" recognized by the U.S. government, his lawsuit says.
Judge Leon declined to give any deference to that conclusion, however, saying the tribal court "exceeded any authority it may hold in issuing that order." Even if valid, the judge added, the Karluk Tribal Court ruling is not binding on federal courts.
"Congress has not delegated the authority to regulate the relationship between Indian tribes and the United States to any tribe," he wrote.
Declining to let Kanam amend his suit, Judge Leon noted that the Pilchuck Nation chairman sought to file a revised version claiming a Seattle federal court had already registered the Karluk Tribal Court's ruling from a decade ago. That assertion, the judge found, "is not mere semantics: Kanam's theory of the case rises and falls with the deference a federal court — or the secretary — should accord the tribal court's order."
"Denial is thus also warranted in light of Kanam directly contradicting his original complaint in an attempt to defeat the secretary's motion to dismiss," he wrote.
On Tuesday, the D.C. Circuit commented that Kanam contends that the tribal court judgment is a decision of a "United States court," but that term "plainly references" the federal courts.
"Moreover, plaintiffs do not explain how a congressional finding in the List Act — describing how tribes previously were recognized — could impose any mandatory duty on Interior," the appeals court said.
Kanam's lawyer did not respond immediately to a request for comment Tuesday. The U.S. Department of the Interior and the BIA also could not be reached.
U.S. Circuit Judges Karen LeCraft Henderson, Gregory G. Katsas and Justin R. Walker sat on the panel for the D.C. Circuit.
Kanam is represented by Margaret Farid of Roy Farid LLP and J. Nelson Happy.
The federal officials are represented by Mary G. Sprague and John L. Smeltzer of the U.S. Department of Justice's Environment and Natural Resources Division, and by Samuel E. Ennis and John-Michael Partesotti of the Interior Department's Office of the Solicitor.
The case is Kurt Kanam et al. v. Debra Haaland et al., case number 22-5197, in the U.S. Court of Appeals for the District of Columbia Circuit.
The underlying case is Kanam et al. v. Haaland et al., case number 1:21-cv-01690, in the U.S. District Court for the District of Columbia.
Former U.S. Food and Drug Administration officials who served under Republican and Democratic administrations urged the U.S. Supreme Court to reverse a Texas federal judge's order invalidating the agency's approval of a widely used abortion medication, saying "judicial second-guessing of FDA's safety determinations would have serious negative consequences for the public health."
On Friday, shortly after U.S. Supreme Court Justice Samuel Alito issued a five-day stay while reviewing lower court orders blocking access to mifepristone, 10 former FDA officials and 20 food and drug law scholars warned the U.S. Supreme Court of "catastrophic consequences" that may result if inexpert judges undo agency approvals of the drug, saying in amicus briefs that the judge's actions could deprive patients of life-saving medication.
The justices should "refrain from interfering with FDA's determinations of drug safety and efficacy rationally supported by scientific evidence for at least two reasons: congressional intent and agency expertise," the former agency officials said.
The officials — including Rachel Sherman, who served in five administrations beginning in 1989, most recently as principal deputy commissioner of food and drugs during the Trump administration — explained that the agency's modern authority over drug approvals came about in response to a series of public health crises, including a tragic incident involving a raspberry-flavored toxic elixir that killed more than 100 people in the 1930s.
In response, Congress passed the Food, Drug, and Cosmetic Act of 1938, empowering the FDA to create a premarket approval system to prevent dangerous drugs from reaching the market.
As a result, drug manufacturers today must prove, through rigorous studies and reliable data, that their products are safe and effective, the former FDA officials told the justices, assuring them that the agency's approval process is "thorough and science-grounded at every stage."
The district court's order "is the first time that any court has second-guessed FDA's determination that a drug is safe and effective," the former officials said, urging the justices to grant the U.S. Department of Justice and Danco Laboratories' applications for a stay and, after full briefing on the merits, undo the Texas court's preliminary injunction.
If the Supreme Court allows the lower court's rulings undoing the FDA's approvals of mifepristone to stand, the former agency officials warned that it would undermine Congress's chosen scheme, "opening the door to endless re-litigation of FDA's decisions with potentially disastrous consequences."
"Patients who suffered from rare side effects could seek to pull drugs from the market notwithstanding the proven benefits of the drug to vast numbers of other patients. Drug companies could try to pull their competitors' drugs from the market based on a supposed mismatch between clinical trial conditions and the recommendations listed on the label," they told the court. "And companies that invested millions of dollars into a drug that FDA rejected could seek a second opinion from the courts."
The courts don't have the expertise to make the scientific and clinical determinations to evaluate new drugs' safety and efficacy, the former FDA officials said.
"These cases would require inexpert judges to be proficient in exactly what FDA's experts have spent their lives training to do. And as history shows, getting it wrong could lead to catastrophic consequences, whether it were to result in allowing an unsafe or ineffective drug to be sold to the public or depriving critically ill patients of access to a safe and effective remedy," they said.
The FDA approved mifepristone about 23 years ago for use in tandem with the drug misoprostol to end early-stage pregnancies.
In November 2022, anti-abortion groups and physicians sued the FDA in Amarillo, Texas, just months after the U.S. Supreme Court — in a majority opinion penned by Justice Alito — overturned Roe v. Wade .
The plaintiffs sought to undo the agency's approvals of mifepristone, which is available as a generic and under the brand name Mifeprex. It accounts for more than half of all abortions in the U.S. and is routinely prescribed for miscarriage treatment.
U.S. District Judge Matthew Kacsmaryk, who was appointed by then-President Donald Trump in 2019, ruled in an April 7 order that the abortion pill opponents had a substantial likelihood of success on the merits and blocked the effective date of the FDA's 2000 approval and subsequent approvals of mifepristone while the lawsuit plays out.
Almost immediately after the Texas order came down, however, a Washington federal judge issued a conflicting order in a separate case.
U.S. District Judge Thomas O. Rice, who was appointed by former President Barack Obama in 2011, preliminarily enjoined the FDA from limiting the availability of mifepristone in 17 states and the District of Columbia — jurisdictions that had sued the agency to preserve access to the drug.
The Biden administration and Danco, which is the brand name manufacturer of mifepristone, filed emergency motions to the Fifth Circuit seeking to stay the Texas court's ruling. The plaintiffs, who "neither take nor prescribe" mifepristone, had shown no irreparable harm would befall them if the FDA approval remained intact and therefore lack standing, they told the Fifth Circuit.
The Fifth Circuit issued a midnight order on April 12 partly upholding Judge Kacsmaryk's ruling. The panel's order would not have revoked FDA approval of mifepristone entirely but would have reinstated pre-2016 restrictions on it.
Judge Kacsmaryk's injunction was set to partially go into effect beginning at midnight on April 14.
But the DOJ and Danco submitted emergency applications to the Supreme Court that day taking aim at what they called flawed standing analysis by the Fifth Circuit in its late-night ruling.
If the Fifth Circuit ruling stays in place, Danco would be unable to conduct its business, it said, asking the high court to either fully stay the Texas court's injunction or to grant certiorari, expedite briefing and hear argument in the case before its summer recess.
The DOJ likewise urged the Supreme Court to stay the district court's "destabilizing order in full" in order to preserve "a status quo that has been settled for years."
The DOJ further told the Supreme Court that the Fifth Circuit had "fundamentally misunderstood the record," and that even a decision limiting the district court's order to the FDA's pre-2016 restrictions on the drug, as the Fifth Circuit intended to do, would block mifepristone from being introduced into interstate commerce, until the drug's labeling can be updated.
The Fifth Circuit's decision would reinstate pre-2016 restrictions on the drug, cutting off access to telehealth abortion care and barring the distribution of the pill by mail. It also would reinstate three mandatory in-person doctor visits and reduce the gestational limit for dispensing from 10 weeks to seven.
"And it is unclear how FDA could take those steps without risking contempt under the Washington injunction," the DOJ said.
When Justice Alito paused the Texas decision, he ordered that any response to the application be filed by Tuesday.
Counsel for the anti-abortion groups and physicians, Alliance Defending Freedom's senior counsel Erin Hawley, said in a statement Friday that the district court decision would "restore the critical safeguards for women and girls that were unlawfully removed by the FDA."
Twenty food and drug law scholars affiliated with various U.S. universities ripped into the lower courts for second-guessing the FDA's mifepristone approvals, saying in their own amicus brief Friday that the lower courts' orders "rest on critical misunderstandings of federal food and drug law and the underlying regulatory history for mifepristone."
The experts argue that the lower courts' orders upend the drug regulatory scheme established by Congress by replacing the FDA's scientific and medical expertise with "the courts' own interpretations of the scientific evidence."
The food and drug law experts pointed to instances where, they say, lower courts have erred in their rulings based on fundamental misunderstandings of the law.
For instance, the lower courts had failed to grasp that clinical trials are conducted under more restrictive conditions than those for approved labeling, nor did they understand that "whether a particular drug product is well-suited for a particular patient is generally a practice of medicine question that is outside FDA's purview," they told the justices.
The experts further noted that the lower courts' did not acknowledge that FDA regulations impose robust post-marketing adverse-event reporting requirements on new drug application holders for all drugs, including mifepristone.
The lower courts' remedies are "statutorily improper," the experts said, warning that such rulings would undermine drug development and public health.
Circumventing the drug approval process created by Congress could upend the pharmaceutical industry and chill research and development, with dire consequences, they said.
"Patients who rely on medications for their health and well-being could see their drugs removed from the market," the experts warned.
The food and drug law scholars are represented by Lewis A. Grossman, Denise Esposito, Robert A. Long, Julia F. Post, Beth Braiterman and Emile Katz of Covington & Burling LLP.
The ex-FDA officials are represented by Jordan D. Segall and Jerry Yan of Munger Tolles & Olson LLP.
Danco is represented by Jessica L. Ellsworth, Catherine E. Stetson, Philip Katz, Lynn W. Mehler, Kaitlyn A. Golden, Danielle D. Stempel, Marlan Golden, Delia Scoville and Eva M. Schifini of Hogan Lovells.
The DOJ is represented by Elizabeth B. Prelogar of the DOJ.
The anti-abortion groups are represented by Erik C. Baptist and Erin M. Hawley of the Alliance Defending Freedom.
The cases are Danco Laboratories LLC v. Alliance for Hippocratic Medicine et al., case number 22A901, and U.S. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al., case number 22A902, before the Supreme Court of the United States.
An Oregon federal judge affirmed a $5.3 million jury win for nearly 5,000 Jack in the Box employees alleging minimum wage, overtime and late pay violations, saying given the company's systemic failures the damages were reasonable, but amended the verdict correcting errors in the jury's penalty wage calculations.
U.S. District Judge Marco A. Hernandez in a Thursday order denied the motion to reduce the damages award the company called "unconstitutionally excessive" in the workers' Fair Labor Standards Act class action, saying to do so would be diverging from state wage and hour law.
"The public policies underlying Oregon's wage-and-hour laws are of fundamental importance to individual employees and to the public welfare because the delay or nonpayment of wages results in deprivation of the necessities of life, including the inability to meet just obligations to others," Judge Hernandez wrote in the order. "The court, therefore, finds this factor does not favor reducing the penalty-wage award."
Jack in the Box had objected to a jury verdict in October awarding $5.3 million to nearly 5,000 employees who each received around $2,000 in penalty wages, saying it was too large of an award. The jury had found that the class members were not paid minimum wages, sufficient overtime and did not receive timely payment of final wages and that they were entitled to penalty wages for those violations.
The workers argued, and the judge agreed Thursday, that employees in Oregon regularly recover penalty wages within that range and have never been found to be unconstitutionally large. The Oregon legislature ensured that by enacting a law capping penalty wages at the employee's hourly rate times eight hours times not more than 30 days, the judge added.
"Defendant's violations occurred against every Oregon employee in every paycheck for years. In addition, many of the employees impacted by defendant's violations were minimum wage workers," the judge said in denying the company's motion. "Oregon's need to secure uniform compliance with its wage-and-hour laws is fundamental and important."
Jack in the Box had been over-withholding contributions to the Oregon's Workers' Benefit Fund from every paycheck of every state worker for nearly a decade and only corrected the issue after it no longer had any workers in the state, the judge said. The individual over-withholdings were only a few cents per hour, but Judge Hernandez said that did not excuse the fact that the violations occurred thousands of times and affected thousands of workers.
"These violations were not isolated incidents or the result of a few managers engaging in violative behavior, but rather the result of a state-wide, company-driven system that persisted from 2004 through 2012," the judge wrote.
Jon Egan of the Egan Legal Team, who is representing the workers, said that in addition to the $5.3 million jury award, Jack in the Box owes $993,400 in damages for the WBF over-deductions. That brings the total damages to $6,373,453, plus over $6.5 million in pre-judgment interest.
However, Judge Hernandez shaved $1,908 off the $2,690,544 penalty wages owed to the WBF class, because the jury had misunderstood how to calculate something with respect to one named plaintiff who had settled his claims and should not have been included in the total calculation.
Judge Hernandez also granted Jack in the Box's request to remove penalty wages attributable to the named plaintiffs' shoe deductions, noting that the jury had not found there were improper shoe deductions, knocking the plaintiffs' $21,112 total penalty wages to $11,500.
The case began in 2010 as a proposed class and collective action seeking unpaid overtime and minimum wages for workers at corporate-owned Jack in the Box restaurants in Oregon. After some claims were trimmed, the suit now centers on late paychecks and deductions the company took to pay into the state worker's benefit fund and to supply workers with nonslip shoes.
The state fund and shoe deduction subclasses had been certified in 2017, as well as a subclass alleging the chain didn't promptly give workers their last checks when it transferred restaurants to franchisees between 2006 and 2011.
In November 2019, U.S. District Judge Anna Brown had ruled on several summary judgment motions and rejected the company's bid to send the suit into arbitration.
Jack in the Box argued that the named plaintiffs signed arbitration agreements that would normally compel their suits into arbitration, but Judge Brown in 2019 found that the chain waived its right to use these agreements by not trying to enforce them until several years into the lawsuit.
Judge Brown also in 2019 found Jack in the Box violated state wage law by diverting too much employee pay to the benefit fund, finding it acted carelessly, and that it had unlawfully failed to give workers their last paychecks during the franchisee takeover, saving the damages calculation for later.
Judge Brown at that time additionally denied the workers' motion for summary judgment on their shoe-related claims, finding it was unclear whether the workers had consented to the company's deducting the shoes' cost from their paychecks.
Representatives of the parties did not immediately respond to requests for comment Friday.
The workers are represented by Jon Egan of the Egan Legal Team and Jim W. Vogele.
Jack in the Box is represented by Douglas Parker, Heather St.Clair and Ian Maher of Lane Powell PC and by David P. R. Symes of Symes Law Office LLC.
The case is Jessica Gessele et al. v. Jack in the Box Inc., case number 3:14-cv-01092, in the U.S. District Court for the District of Oregon.
The Oregon Health Authority has announced that it has issued the first three licenses for facilitators in its psilocybin program, who will help patients receive therapy through the use of the psychedelic found in mushrooms.
In a statement Tuesday, the state said it issued licenses to David Naftalin, Alexander Polvi and Jeanette Small, who will work within the regulatory framework outlined under the Oregon Psilocybin Services Act, which voters passed by referendum in 2020 and which is now taking effect after two years of rulemaking.
"We want to congratulate the first facilitators to be licensed in Oregon," Oregon Psilocybin Services Section Manager Angie Allbee said in the statement. "As your work in providing non-directive psilocybin services takes shape, we thank you for your dedication to client safety and access as we move closer to opening service centers."
Psilocybin, like cannabis, is considered a Schedule 1 substance in the federal Controlled Substances Act, and according to the statement, administration sessions can only happen at licensed service centers.
The facilitators' role is to be present with clients in preparation sessions, administration sessions and integration sessions, and take a "non-directive" approach to the services, meaning that facilitators support clients without directing their experience, according to the OPS website.
According to the statement, service centers provide psilocybin products made and tested by licensed manufacturers and labs, and there are currently two manufacturers in the state with licenses to produce psilocybin.
The state said it anticipates issuing licenses to laboratory and service center applicants in the coming months.
Representatives for the state could not immediately be reached for comment Wednesday.
Oregon is one of two states to have decriminalized psilocybin with a referendum, with 53% of Colorado voters approving a bill to decriminalize plant- and fungi-based psychedelics late last year.
The Colorado referendum, called the Natural Medicine Health Act of 2022, goes further than Oregon's by decriminalizing the use and possession of mushroom-derived psilocybin and psilocin; DMT, an alkaloid found in many plants; the root-derived psychedelic ibogaine; and the cactus-derived mescaline, not including mescaline derived from the peyote cactus.
American Bar Association Hit With Data Breach Class Action Alleging 'Knowing Violation' of Security Standards
The complaint alleges that the ABA's knowing violation of its obligations to abide by best practices and industry standards in protecting customers’ personal information resulted in giving the hacker access to the personal and financial information of up to 1.4 million ABA members.
On Thursday, April 20, the American Bar Association (ABA) notified its members of a March 6, 2023, data breach that resulted in an unauthorized third party gaining access on March 17 to certain usernames and hashed and salted passwords.
The next day, Troy Law PLLC, a New York-based employment firm, filed a class action complaint against the ABA for damages resulting from the breach, alleging that the ABA “allowed widespread and systematic theft” of member information, and that its “actions did not come close to meeting the standards of commercially reasonable steps that should be taken to protect customers’ personal identifying information.”
The April 21, 2023, class action complaint, filed in the United States District Court for the Eastern District of New York, was brought by named plaintiff Tiffany Troy. It alleges that “the March 17, 2023, breach gave the hacker access to the personal and financial information of up to 1.4 million ABA members.”
“The Breach was caused and enabled by Defendant’s knowing violation of its obligations to abide by best practices and industry standards in protecting customers’ personal information,” the compliant states. “Defendant grossly failed to comply with security standards and allowed its customers’ financial information to be compromised, all in an effort to save money by cutting corners on security measures that could have prevented or mitigated the Breach.”
The complaint alleges that the breach exposed both personal and financial information of the affected members, and that “the hackers continue to use the information they obtained as a result of Defendant’s inadequate security to exploit and injure Class members across the United States.” The complaint does not specify how the illegally acquired information allegedly has been or continues to be used. In its initial email notifying members of the data breach, the ABA stated that it had received no reports that anyone’s information had been misused.
The complaint further alleges that the ABA was untimely in alerting members to the breach: “Defendant failed to uncover and disclose the extent of the Breach and notify its affected customers of the Breach in a timely manner. Defendant failed to take other reasonable steps to clearly and conspicuously inform its customers of the nature and extent of the Breach. Furthermore, by failing to provide adequate notice, Defendant prevented Class members from protecting themselves from the Breach.”
Among other things, the plaintiff contends that the ABA members affected by the data breach were injured in the form of “opportunity cost and value of time” associated with monitoring financial and bank accounts following the breach, and costs of obtaining replacement credit and debit cards.
The plaintiff seeks relief in the form of actual, punitive and statutory damages, at least three years’ worth of credit-monitoring fees, attorney’s fees, litigation costs, and pre- and post-judgment interest.
Legaltech News reached out to the ABA for a response. “We do not comment on pending/ongoing litigation,” a spokesperson said in an email.
Regarding the breach itself, the spokesperson noted that “the bad actor obtained only user names and encoded (salted and hashed) passwords—not other personal information and no financial data.”
Contemporary American judges have more in common with medieval monks than just wearing robes.
Today's courts are dominated by formalists. After reviewing decisions from the last several months — about guns, abortion and industrial pollution — they remind me of work by the 13th and 14th century scholastics, dominated by the monks who dictated thinking in Europe prior to the Renaissance.
Scholastics believed they could find truth using formal exercises handed down from Aristotle through men like St. Thomas Aquinas. They typically began their work by studying a book on the topic at hand by a renowned scholar.
Scholastics might then study documents related to that book. They would debate snippets of competing text. They would scrutinize minutely the meaning of individual words and then use formal logic to show that contradictions were merely mistakes of subjectivity by the reader.
This should sound familiar to readers of opinions by contemporary court formalists who prefer labels like "textualist" and "originalist." Read U.S. Supreme Court Justice Clarence Thomas' 2022 opinion holding that requiring license applicants to show the need for a handgun violated the Second Amendment in New York State Rifle & Pistol Association Inc. v. Bruen.
Justice Thomas' approach intentionally did not consider the relevant human condition — mass shootings, out-gunned police officers and the like — and a concurring opinion by Justice Samuel Alito said the dissent erred by considering them.
Instead, Justice Thomas focused on the structure and definition of the words in the Constitution and then invoked scholarship from the "founding era" and the 19th century while laboring over the precise relevance of English history, only to have this antique scholarship disputed and contradicted by the ancient manuscript studies invoked by former Justice Stephen Breyer in dissent.
Indeed, to Justice Thomas it was not appropriate to consider whether the ruling might lead to more shootings. Instead, he wondered whether the court should give more weight to thinking from 1791 when the Second Amendment was adopted or to 1868 when the Fourteenth Amendment that applied to the states was adopted.
Like the scholastics, Justice Thomas focused on this process of scholarship as a way to weed out the subjectivity from his decision and gave us a "true" answer. Justice Alito used a similar approach in his 2022 decision in Dobbs v. Jackson Women's Health Organization where the court held that women had no constitutional right to an abortion.
Justice Alito studied sources about women's historical rights to abortion while noting that it was not appropriate to consider what the court's ruling meant to specific women or the general public.
This other worldliness may dissatisfy many of us in the same way Renaissance humanists were dissatisfied with the pronouncements of church scholastics 700 years ago. It's because, when we look closely, we can see that the writer's preferences decided the issues more than logical compulsion.
In his Second Amendment decision, Justice Thomas continued the practice of giving no force to the words "well-regulated militia," which are often labeled a merely "prefatory clause" to the actual rule — its "operative clause."
He continued to discount the predominately military origins of what it meant to "bear arms." Instead, he echoed earlier rulings giving decisive weight to "the right of the people to keep … arms" and to his selective history.
In Dobbs, Justice Alito chose to rely on the Supreme Court's 1997 ruling in Washington v. Glucksberg that assisted suicide wasn't protected under the Constitution because it wasn't deeply rooted in American history and tradition.
By choosing this precedent over the forward-looking reasoning of cases like the Supreme Court's 1954 Brown v. Board of Education where the court overturned school segregation, he guaranteed that he would find, as was historically the case, that a woman had no rights, including to an abortion.
It's hard to credit claims of objectivity when we can see the decisive personal choices being made. It was no surprise that medieval scholastic monks usually sided with Catholic orthodoxy.
Was anyone surprised that Justice Thomas and Justice Alito voted against gun control and abortion rights? Wouldn't the justices have been more convincing if they admitted they were using personal judgment and then justified that judgment against current realities?
This isn't to criticize such conservatism in any century or to praise it either. It's to say that judges are more credible when they are open about their judgments and defend them in terms we can understand.
In favor of gun rights, Justice Thomas might have argued that the right to self-defense today is as vital as it ever was in a country of vast spaces and limited law enforcement.
Justice Alito might have argued that granting women a constitutional right to abortion strikes the balance between two lives, or one real and one potential life, too strongly in favor of the one over the other. It's the failure to place the real human issues at the center of the discussion that's the problem, even for those who agree with Justices Thomas' and Alito's views.
Today, the formula in the formalist approach dominates most legal opinions, including in business litigation.
Consider Judge Michelle Friedland's 2023 opinion about the Clean Water Act for the U.S. Court of Appeals for the Ninth Circuit in American Rivers v. American Petroleum Institute.
There's nothing sinister about it. It's just typically inaccessible contemporary judicial reasoning. First, despite the ease of finding this information from the court's online docket, readers must slog through eight pages of information about the numerous parties and their status in the case.
The staff-created summary takes up three pages, and then three pages are needed to list all the lawyers. Is it helpful to readers to take up 14 pages before we see what the court has to say?
Mercifully, Judge Friedland begins her opinion by summarizing the holding: Courts remanding to an agency a challenge to a regulation can't vacate the regulation during the remand without finding the regulation unlawful. This is helpful, except we don't know why they can't, and why is what matters.
To know why, the court then takes us through the usual formula. The text of the law at issue and its background are described at needless length. While reading it we have no idea of why it's important. It's more of an incantation.
About 20 pages in, we get back to where the court started — can it vacate a regulation during a remand.
Like many opinions, but later than most opinions, the court then detours again to address challenges to the court's jurisdiction — now needlessly common in most cases. This takes another four pages, and, 25 pages in, we still haven't heard anything about the core matter — why the court can't vacate a regulation while it's remanded.
When the issue is finally joined, it's back to the sacred manuscripts. Precedent says that the court's equitable powers are limited by those of the English equity courts at the time of separation.
Thankfully, the court makes no deep dive in this subjective direction, but then it does something worse. It leans mostly on the fallacy that because a court hasn't vacated a regulation on remand before, the court can't do it. Why is that a bar? There is a first for everything.
Next, the opinion jumps to a scholastic favorite, the canon expressio unius est exclusio alterius — the law says we can set aside unlawful regulations, therefore we can't set aside regulations not held unlawful.
Of the opinion's 31 pages, only about five address the main issue. They are filled mostly by quotations from other courts. There are five or six sentences reflecting the court's own thinking. They rely mostly on dogma.
The least attention is given to what matters to the people and businesses involved in the case. Remanding the case leaves a potentially unlawful regulation in place — probably for years.
Perhaps the court should have thought more seriously about ruling on the legality of the regulation rather than spending years litigating precisely how to avoid the question by sending it back to the agency.
The decision records that the challenged regulation was adopted by the Trump administration. The Biden administration wants the remand to potentially remove the regulation.
By the time it gets around to doing it, there may be another Trump administration, DeSantis administration, or what have you. Courts decide what is law. Avoiding the task, delaying the task, often makes the courts useless.
Likewise, vacating a regulation without finding anything wrong with it is as unfair to businesses relying on it as it is to assume a person is guilty until proven innocent. The court's equitable powers certainly embrace finding at least this much common sense.
In short, the court would have done better to address the human values and consequences at stake then to spend most of its opinion on collateral matters only to resolve the case with a fallacy and a canon of construction.
Courts haven't always acted this way. Justice Oliver Wendell Holmes and Justice Louis Brandeis were perfect opponents of scholasticism and formalism. Justice Holmes declared that the law was alive, not "a brooding omnipresence in the sky," and that "the life of the law has not been logic but experience."
Similarly, Justice Brandeis understood that human values and consequences matter most in arguing that: "If we desire respect for the law, we must first make the law respectable." Where did we go wrong?
Perhaps it has just become easier for us to point to mechanical means of reaching a decision rather than dealing with the flesh, bones and blood of a living controversy. We say: "It's just the law talking, not me." But this should worry us. The triumph of formalism in American decision writing has coincided with an historic decline in respect for the courts.
To reverse this trend, courts should place humanism above scholasticism and formalism in decision making. Trial courts should say who wins and why under the basic legal principle at stake and the facts of the case before them — not the facts of some other case.
Appellate courts should develop understandable legal standards and justify them in human terms — how will they affect the fortunes of the parties in the case and the parties who come after them. Appellate courts should have the courage to speak in their own voices and not speak principally through disembodied quotations from decisions they have chosen to quote over other contrary decisions.
It's not hard. Indeed, decisions are easier to write when a judge sees them for what they are — their opinions. Matters of judgment. By a human. About other humans — standing alone or gathered in a business. Whatever a judge's perspective, we all have a stake in judges writing credible opinions for the sake of a credible judiciary and a more stable nation.
Judges should take this to heart. They should throw off formalism and speak to the parties in front of them and the nation at large as people trying earnestly to sort out the troubles of litigants using principles embodied in law and wisdom.
It's fine for judges to wear robes, but we would all profit if they would throw off their cowls and look us in the eye.
Thomas G. Moukawsher is a judge on the Connecticut Superior Court. He is the author of the forthcoming book, "The Common Flaw: Needless Complexity in the Courts and 50 Ways to Reduce It"
More Than 2,650 Women Partners From 190 Firms Issue Call to Action Post-'Dobbs'
"Our presence and leadership within the bar is without question a byproduct of the freedom each of us has had to make reproductive decisions for ourselves," the thousands of signatories from about 190 firms wrote.
Now that the Supreme Court has overturned Roe v. Wade with its decision in Dobbs v. Jackson Women’s Health — negating almost 50 years of precedent and effectively taking away a once-constitutional right to choose — many lawyers are incensed. Law firms have pledged to defend abortion rights for people, and some have even joined forces with the Legal Alliance for Reproductive Rights to do so. Now, thousands of individual partners from some of the largest law firms in the world have signed onto calls of action to support reproductive rights in America.
More than 2,500 women partners from some of the most prestigious Biglaw firms across the country have joined together “with sorrow and a call to action” in our post-Dobbs nation to defend the right to choose. From their letter:
In sum, with the Supreme Court’s decision in Dobbs, women’s fundamental rights to liberty and equality have been drastically abridged. Women’s right to make choices about our reproductive health and when and if to have or expand a family is now subject to the control of state legislatures. The court has failed to uphold the promise at the very core of the Constitution: the promise of liberty and dispassionate, fair and equal treatment for all under law.
We cannot let that failure stand. As lawyers, and officers of the courts, we know we have unique abilities and responsibilities in the wake of this decision. To honor that responsibility and our oath to support the Constitution, we each commit ourselves to offering our pro bono legal services to organizations that defend and support women’s rights to autonomy, equality and safe access to reproductive care, including abortion.
These organizations have waged the battle for reproductive freedom for decades. Now more than ever, they are in need as they support women across the country who will find themselves in the crosshairs of the law. This commitment is personal, but we call upon members of the bar across the country to make similar commitments, including and importantly the men of the bar, who we need as our allies in the fight for equal citizenship.
Shortly there after, more than 1,400 male Biglaw partners penned their own call to action, in solidarity with their female colleagues. From their letter:
We refuse to remain silent. Too often, reproductive health care is framed as a “women’s issue.” While women are clearly affected most significantly and directly, this is a human rights issue. It is imperative that men speak up and stand up as reproductive justice affects us all. This is not just about abortion, although abortion is health care and should be treated as such.
As members of the bar, we took an oath to uphold the Constitution and its promise of liberty and equality for all. Dobbs breaches that promise and hands women’s right to make their own reproductive decisions over to the whims of state legislatures. It is our duty to join our women colleagues and also offer our pro bono services to organizations that defend and support women’s rights to autonomy, equality and reproductive care. We are committed to offering those services and also to making a donation now to support such organizations.
Attorney and cannabis policy advocate Amber Littlejohn recently announced her departure as executive director of the Minority Cannabis Business Association, an organization she joined in 2019 that focuses on policies aimed at redressing the harms caused by cannabis prohibition.During Littlejohn's tenure, the MCBA released the National Cannabis Equity Report, which marked the first comprehensive effort to examine the social equity programs in states that have implemented them to gauge their impact and offer policy recommendations for bringing those adversely affected by the war on drugs into the regulated industry.
Littlejohn spoke to Law360 just a few days before leaving the MCBA to discuss the state of social equity policies, the systemic challenges faced by small operators and the proposals on Capitol Hill to end federal prohibition. This interview has been edited for clarity and length.
What do you think are some of the biggest misconceptions that the public has about cannabis?
I think first and foremost [the idea] that people who have consumed or use cannabis as medicine are criminals, or somehow are not law-abiding citizens. From the beginning of prohibition in this country, they've really tied cannabis — a plant that, if you look around, I think very much does the opposite of instill anger and aggression in people — to criminal behavior. It's disappointing. So getting people away from the idea that if you smell cannabis or see somebody consuming cannabis, that they are somehow a criminal or a bad person. And that stigma unfortunately still exists as much as cannabis support has grown around the country.
What does the public misunderstand about the cannabis industry?
I think it's a misunderstanding that equity really is out front and an integral part of the cannabis industry. And while we'd like it to be so, there are only 15 state-level social equity programs, and those programs have to date been minimally effective in actually creating equity within the industry. We are not seeing the level of community reinvestment that was promised. We are not seeing the level of criminal justice reform that was promised. So I think it's important for people to understand that while the rhetoric is strong around equity and reform in the cannabis industry, the reality of those endeavors is really different.
How do you define equity in the cannabis space?
I would just say that equity should be woven throughout every element of cannabis policy. But generally speaking, I look at cannabis equity in four pillars.
[First], an equitable industry: creating equity and diversity within the industry, ensuring that people who have been most impacted by prohibition, folks existing in the legacy market, have the opportunity to participate meaningfully in the legal market
Second, an equitable community: helping to restore power to communities that have been most harmed by cannabis prohibition.
Third, equitable justice. This is getting people out of prison and jail. This is limiting cannabis-related contact with people that have been historically disproportionately policed concerning cannabis
And then lastly, equitable access: ensuring that veteran status, housing benefits status, disability status, none of these things would impede people's access to safe cannabis products.
If you could wave a policy wand, what would you like to see instituted in this country as far as cannabis policy?
First and foremost, I'd like to end federal prohibition, which was implemented contrary to the recommendations of experts. And now we have been stuck with a policy that was intended to wreak havoc and create harm in the Black community. So I would love to see the end of prohibition. Not only would this be great for those sitting in jail, and for those communities still being overpoliced, but it would create a real meaningful pathway to success for small cannabis businesses as well. The dual system of state-legality/federal-illegality is difficult for even large, well-funded firms to navigate. It's nearly impossible for small firms to navigate.
What are the major challenges for small businesses trying to get on their feet in this industry?
First, I would point to inequitable access to capital. Because of the federal banking situation and federal prohibition continuing to exist, most people that start cannabis businesses started through either personal wealth or friends and families. And then when you get into the individuals that have either been justice-involved or otherwise seriously impacted by the war on drugs and cannabis prohibition, that becomes even more inaccessible.
Next would be the limited licensing schemes. Arbitrarily limited and capped licenses at the state level have really created an overinflated value for licenses and a scarcity that has priced most people and most small businesses out of the running. You have some states where you have only a handful or not even a handful of licensed operators that are diverse firms.
And then lastly, I would say it's taxes, both state-level taxes and federal taxes are extraordinarily punitive. At the federal level, we have [Section 280E of the U.S. Tax Code] that treats state-legal cannabis businesses like criminal enterprises and taxes them accordingly.
And even on the state level, the excise tax and the sales tax are set at a punitive rate that often create a situation where small businesses can pay an effective tax rate of 70% to higher when you combine state and federal. And this makes it really impossible for the legal cannabis industry to compete with the unregulated market that doesn't have to pay taxes.
I'm glad you brought up the unregulated market, which continues to persist in states where cannabis has been legalized. What do you think is causing that, and what do you think is the most productive way to talk about it?
I think there are a few factors. As I mentioned, taxes are a big factor. Unnecessary burdens to entry are another. Creating licensing frameworks that really don't address the skill set of the legacy market for instance. Many legacy operators in communities, for example like New York, operate their businesses exclusively on a distribution and delivery system. And so to offer them a large storefront may not be the best path to success for them or even the best utilization of the market that they've developed. So it makes it challenging to incorporate them into the legal system.There has to be effort invested in understanding who exists in the unregulated market. I think there is a tendency of law enforcement agencies and sometimes regulators to lump the unregulated market into the cartel gang member bucket when you have an entire spectrum of people: people that have come from families that have for generations sold and grown cannabis, people who are peacefully selling it to raise their family. There are also the opportunists that pop up at the beginning or before the inception of a legal market and create, you know, "gifting" shops. They really run the spectrum.
And so I think it's really important to figure out who's there and to create pathways for those who would like to transition into the legal space, and to identify ways to enforce cannabis laws against opportunists trying to exploit gray areas, or people that are organized crime entities that are preying on individuals and communities and engaging in labor trafficking. That is something that we all collectively, I think, agree does not belong in a lawful and responsible industry.
But on the flip side of that, we don't want to re-criminalize people that are otherwise law-abiding citizens, but for the fact that they have failed to complete the licensing process for an otherwise peaceful cannabis business.
What are some of the biggest divisions within the legalization movement or within the cannabis industry at this point?
I would point to the interstate versus anti-interstate [camps]: those who want to limit or delay interstate commerce to protect existing state markets, and those who want to open up an interstate market even before federal legalization. Again, I often think that both camps are taking somewhat extreme positions, and the likely solution exists in the middle, as it often does in arguments like this.Another division that I don't think folks talk about enough is that legalization doesn't actually benefit everyone. Companies that are doing OK within their states haven't really aggressively pushed or done the work to get us to the point of federal legalization. In the anti-legalization camp are people also who have seen the legal market crush their generations-old cannabis business that was otherwise thriving under the weight of really burdensome taxes and regulation.
And then lastly, something that we're really seeing emerging right now is equity versus nonequity. And you know, very few will come out and say, "Hey, we don't care about equity." But when it comes to actions and being willing to do meaningful work, to create equity within the cannabis industry, that is something that we see waning. There are companies that are doing away with their social equity departments and firing staff and scaling back investment in that area, really failing to recognize that social equity is a component of [environmental, social, and governance principles] and the impact that that can have on your valuation from long-term sustainability. I think, unfortunately, sometimes the industry behaves a little shortsightedly as it concerns that.
What are your thoughts on the three major pieces of federal legislation trying to end cannabis prohibition? These are the MORE Act in the House, the CAO Act in the Senate, and GOP Rep. Nancy Mace's States Reform Act.
So the MORE Act and the CAO Act were actually very similar to each other in that they put equity and criminal justice reform at the forefront. Both things that I am hoping continue throughout federal legalization efforts.
I think the CAO Act took an additional step of attempting to build out a legal framework for cannabis. I do have concerns [about U.S. Food and Drug Administration] involvement and [U.S. Alcohol and Tobacco Tax and Trade Bureau] involvement and ensuring that whatever regulatory burden is created is going to actually support small businesses and not completely eliminate them. As both those are written right now, it would be a very difficult if not impossible transition for a lot of small businesses.
We would definitely like to see the breadth of provisions that concern small businesses and small minority businesses expanded in both of those proposals, because again, while I think the spirit is there, we are hoping to see a lot more meat on the bones as it concerns actually how we would get it done.
The States Reform Act is an interesting proposal. I will definitely start by saying outside the expungement provisions, there are no equity provisions. Not incredibly surprising understanding that it came from the other side of the aisle. So to support something like that, I would definitely need to see a robust effort to incorporate addressing the harms of an intentional war on people of color that goes right through federal cannabis policy.
I will say though, when it comes to small business, the SRA actually has the least burdensome regulatory framework, and probably the most small-business-friendly framework that I've seen to date. So that is encouraging, because I think regulatory burdens are the little-discussed equity issue that I think the SRA was very thoughtful in addressing. So while the absence of equity essentially renders that proposal a nonstarter in its current iteration, I am definitely encouraged by the thoughtful approach to regulation.
What do you think were the missteps or missed opportunities as far as states trying to implement their equity policies?
Especially states that have implemented [legalization] over the last four years, they had the opportunity to learn from the mistakes of the past. One of the challenges is not actually reaching out and engaging small businesses enough when developing policy. Because what we've seen over and over again is cannabis policy essentially becoming a compromise between industry and criminal justice reform organizations, neither of which have any investment or concern about the viability and sustainability of small minority businesses in the space.
Another big misstep is the failure to provide funding and technical support before markets open. Only six state-level social equity programs provide direct funding to social equity applicants or licensees and none of them have provided that funding at the time that the market opened or the applications opened.
So while there may be, you know, licensing fee waivers, it doesn't waive the hundreds of thousands of dollars that it may cost to submit an application in a competitive market, and it doesn't necessarily provide the funding to stand the business up. When your social equity support dollars are coming from adult-use revenues, it may take months or years for it to get to the people that need it. The funding in Illinois for social equity applicants that was supposed to come from the early adult-use revenues is still not making it into the hands of equity operators in the system years later.
Do you have any thoughts about some of the states that are coming online now in the Northeast — New Jersey, New York and Connecticut — and some of the proposals that they have on the table right now?
Connecticut is another place where the proposals that are absolutely exclusionary are dressed up as equity. It would take millions of dollars to be part of the first round of licenses, and then I think everybody else was fighting for, I think, 12 licenses. So that becomes a near impossible uphill battle and just whether you can buy enough balls in the lottery to be successful. It's disappointing.
In New York, I think the [Marijuana Regulation and Taxation Act] did a fantastic job of prioritizing equity and the [Office of Cannabis Management] has stayed focused on creating equity. I think it is yet to be seen how many successful applicants can come out of this first round, whether the first round of applications and licenses are tied up in litigation, and really how the fund is going to work.
You know, to date, we don't have a single social equity program that is rolled out without being delayed due to litigation. So I am hopeful that we can get these businesses up and running for these justice-involved individuals and really get to looking at what the next few rounds of licenses look like and making sure that the legal supply chain is sufficient to support legal businesses competing with the unregulated market.
What is your take on the SAFE Banking Act?
I wholeheartedly support the SAFE Banking Act. MCBA has offered some clarifying amendments on things we think could improve both access to capital and equity. SAFE Banking isn't the magic fix-all, but it is an incredible first step that could provide relief. I think folks who are in mature cannabis states fail to recognize that as these markets open up, so few banks bank cannabis, that it's nearly impossible for a brand-new cannabis business to get a bank account. It means you're in a position where you're taking the risk of starting your initial account at a bank that very likely will freeze your funds. And people don't want to take that risk. On the ongoing situation with robberies, anything that we can do to remove cash from these premises is really something that I will continue to support. So I will definitely continue to keep working with lawmakers to push this through.
Is marijuana is a bad word?
I mean, in truth if you look back at so many words, in the English language, in a country with a history as troubled as ours, there are a lot of words with troubled history. I use the term cannabis. I don't use the term marijuana, but I frequently engage in policy, and the term marijuana is used in those settings. In the multitude of battles that I fight on a given day, I'm going to prioritize basic human rights and supporting struggling businesses. I will save the fight for that for someone else
New Mexico Governor Michelle Lujan Grisham signed the New Mexico Civil Rights Act — also known as House Bill 4 — advancing fair and equal treatment under the law on Wednesday.
The legislation effectively bans qualified immunity — a judicial doctrine that shields state actors, including law enforcement officials, from liability, even when they knowingly break the law. New Mexico is now the second state to ban qualified immunity, following Colorado which enacted legislation to end the practice in June 2020.
Under New Mexico’s new law, a person has the right to sue the state, a city, or county, when their rights under the state’s constitution have been violated, such as in cases involving police misconduct. With the passing of this law, residents of New Mexico will finally be able to hold officials who engage in wrongdoing accountable.
“We will soon have a clear path to justice and a meaningful way to hold government accountable,” New Mexico Speaker of the House Brian Egolf, who introduced the bill, tweeted after the bill’s passage. “This is a bright day for the New Mexico Constitution.”
Police officers rarely face criminal charges or even internal disciplinary measures when they engage in misconduct. When misconduct goes unchecked, officers may continue to abuse their powers. Often, when police misconduct is discovered in one case, several more instances of misconduct committed by the same officer are uncovered in other cases. For example, several convictions in cases investigated by former Chicago officer Jon Burge and his team have been overturned due to repeated misconduct that went unpunished for many years. Nearly 37% of exoneration cases since 1989 involved police misconduct, the National Registry of Exonerations reported.
“The new law puts a price tag on police misconduct and creates a strong incentive for agencies to adopt and enforce policies that prevent abuses which can lead to wrongful convictions,” said Innocence Project State Policy Advocate Laurie Roberts. “It also provides exonerees with the financial justice they deserve after having their rights violated by government officials and having their freedom unjustly taken away.”
A bipartisan coalition of organizations including the Innocence Project, Americans for Prosperity, American Civil Liberties Union, Institute for Justice, National Police Accountability Project, and Ben Cohen and Jerry Greenfield — co-founders of Ben & Jerry’s — championed the bill.
Qualified immunity has prevented New Mexicans from holding police officers who commit misconduct accountable through civil lawsuits for too long. Such avenues for remedy are crucial for wrongfully convicted people and everyday citizens to seek justice for violations of their rights.
Ron Keine, for example, was wrongfully convicted in Bernalillo County, due to police misconduct so egregious it actually did lead to the firing of several sheriff’s deputies. Mr. Keine came within nine days of being executed for a murder he didn’t commit. Later, despite the fact that he was exonerated and officers involved in his case were fired, Mr. Keine’s lawsuit against the county and the sheriffs who helped secure his wrongful conviction were dismissed.
“Eliminating the legal doctrine of qualified immunity not only provides financial justice to victims of police abuse, including people who have been wrongfully convicted, but it also incentivizes police agencies to properly hire, train, and supervise law enforcement to prevent abuses from occurring in the first place,” said Rebecca Brown, the Innocence Project’s director of policy. “While Congress must end qualified immunity nationwide, many states — recognizing the urgency of this reform — are taking action on their own.””
By passing the New Mexico Civil Rights Act, the state has adopted a reform that assures accountability while preventing harm — a major step toward more equal justice for all.
A Texas federal judge on Friday ruled that the U.S. Food and Drug Administration "stonewalled judicial review" of its decades-old approval of the abortion drug mifepristone and agreed to stay the effective date of the drug's approval, in a watershed ruling that could dramatically restrict abortion access in the U.S., where medication abortion has become the most common method to terminate pregnancies.
U.S. District Judge Matthew J. Kacsmaryk stopped short of granting the preliminary injunction sought by the anti-abortion advocacy groups against the FDA's 23-year-old approval of mifepristone — the pill used in tandem with misoprostol to end an early-stage pregnancy. The judge agreed "to stay the effective date of FDA's September 28, 2000 approval of mifepristone and all subsequent challenged actions related to that approval."
However, he stayed the applicability of his opinion and order for seven days "to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit."
Almost immediately after the Texas ruling came down, a Washington federal judge issued an order preliminarily enjoining the FDA from "altering the status quo and rights as it relates to the availability of Mifepristone."
Judge Kacsmaryk, who was appointed in 2019 by former President Donald Trump, found that the anti-abortion advocacy groups had a substantial likelihood of success on the merits and stayed the FDA's 2000 approval while a lawsuit brought against the agency by anti-abortion groups including the Alliance for Hippocratic Medicine plays out.
The groups sued the FDA in November 2022, just months after the U.S. Supreme Court overruled Roe v. Wade, seeking to undo the agency's approvals of the brand-name drug Mifeprex and the generic version of the drug, mifepristone.
The anti-abortion groups, along with a handful of individual physicians, claim that medication abortions are dangerous, that the FDA should not have approved mifepristone and that the agency has removed safeguards once in place to protect women and girls.
The group not only sought to block an FDA January 2023 rule change that permanently lifted a restriction requiring in-person dispensing of the abortion pill and permitted pharmacies to fill mifepristone prescriptions for customers directly, it also sought to overturn all FDA approvals of mifepristone dating back to the agency's initial decision to greenlight the drug back in 2000.
The FDA, for its part, has repeatedly said mifepristone is safe and effective.
The agency has argued that serious adverse events associated with the drug are a "rarity" and that plaintiffs have provided no evidence that, in the absence of a preliminary injunction, mifepristone's continued availability on the market would cause them any harm.
In its briefs, the FDA further argued that a preliminary injunction threatens to cause significant harm to patients and would upend the status quo relied on by businesses and workers involved in mifepristone's manufacturing and distribution.
In a hearing on the motion for a preliminary injunction, held on March 15 in Amarillo, Texas, counsel for the government told Judge Kacsmaryk that a preliminary injunction could have a broader impact on the U.S. pharmaceutical industry.
Julie Straus Harris, counsel for the FDA, told the judge a preliminary injunction in the case "would leave pharmaceutical companies unable to confidently rely on FDA approval decisions to develop the pharmaceutical drug infrastructure that Americans depend on to treat a variety of health conditions."
The anti-abortion groups are represented by Erik C. Baptist, Erin Morrow Hawley, Matthew S. Bowman, Erica Steinmiller-Perdomo, Julie Marie Blake and Denise M. Harle of the Alliance Defending Freedom and Christian D. Stewart of Morgan Williamson LLP.
The government is represented by Noah T. Katzen of the U.S. Department of Justice's Civil Division's Consumer Protection Branch.
The case is Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., case number 2:22-cv-00223, in the U.S. District Court for Northern District of Texas.