SCOTUS Watch Update: Oral Arguments for the Coming Week

The Court will hear arguments in two important health-law-related case this week:

• Monday, 12/2: E-cigarettes and the FDA.
  The Court will consider "[w]hether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious." Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, reviewing the en banc decision of the 5th Circuit Court of Appeals, which vacated the FDA's orders as arbitrary and capricious.  
  
  
• Wednesday, 12/4: Gender-affirming care for minors.
  The Court will consider "[w]hether Tennessee Senate Bill 1, which prohibits all medical treatments intended to allow 'a minor to identify with, or live as, a purported identity inconsistent with the minor’s sex' or to treat 'purported discomfort or distress from a discordance between the minor’s sex and asserted identity,' violates the equal protection clause of the 14th Amendment." United States v. Skrmetti, No. 23-477, reviewing the decision of the 6th Circuit Court of Appeals, which reversed the preliminary injunctions issued by the district courts and remanded them for further proceedings.

"Climate change is the most significant threat to human health in the 21st century"

That's the bottom line from Admiral Rachel L. Levine, M.D., the U.S. Assistant Secretary for Health. She's the guest on a podcast hosted by the Commonwealth Fund. Here are a few examples of what she is talking about:

Levine, who oversees the federal Office of Climate Change and Health Equity, talks about how weather-related events are already having a serious impact on our fragile health system supply chain, even though those effects can go unnoticed by the broader public. [1] In communities repeatedly ravaged by storms or heat waves, a lack of blood donations is leading to delays in surgeries and treatment for diseases like sickle cell. [2] In rural Alaska, where the melting permafrost is wreaking havoc on wildlife populations, native tribal communities are forced to rely on shipments of food items that are typically high in sugar and salt — a diet contributing to rising rates of hypertension, diabetes, and heart disease.

Adding injury to more injury, "[w]hen the ground thaws, microbes begin feasting on organic matter in soils that have been frozen for millennia.

These microbes release carbon dioxide and methane, potent greenhouse gases. As those gases escape into the atmosphere, they further warm the climate, creating a feedback loop: Warmer temperatures thaw more soil, releasing more organic material for microbes to feast on and produce more greenhouse gases. [source]

We usually think of weather-related catastrophes in terms of storm surges, killing winds, floods, and similar threats to life, limb, and property. Admiral Levine provides a valuable and often-overlooked  perspective on the effects of climate change on human health.

New England Journal of Medicine: "The Failing U.S. Health System"

It should come as a shock to no one that our health care "system" is only a "system" in the loosest sense of the word. "System" implies a set of common goals, a comprehensive design, and coordination of effort toward achieving the system's purposes. The result is about what you would expect with a largely profit-based set of arrangements among participants who are often working at cross-purposes.

The recent report from the Commonwealth Fund ("Mirror, Mirror 2024: A Portrait of the Failing U.S. Health System") paints a dismal picture. The website has the report and useful chartpacks in PowerPoint and PDF. Here's the executive summary:

• Goal: Compare health system performance in 10 countries, including the United States, to glean insights for U.S. improvement.
• Methods: Analysis of 70 health system performance measures in five areas: access to care, care process, administrative efficiency, equity, and health outcomes.
• Key Findings: The top three countries are Australia, the Netherlands, and the United Kingdom, although differences in overall performance between most countries are relatively small. The only clear outlier is the U.S., where health system performance is dramatically lower.
• Conclusion: The U.S. continues to be in a class by itself in the underperformance of its health care sector. While the other nine countries differ in the details of their systems and in their performance on domains, unlike the U.S., they all have found a way to meet their residents’ most basic health care needs, including universal coverage.

Three of the authors provide an expanded version of this abstract in this week's edition of the New England Journal of Medicine (apparently for free). Here are some of the main points:

• We can be proud of our process for delivering care. Compared to nine peer countries, we are ranked #2, quite close behind New Zealand.
• But the cost of this care is astronomically high and the results place our health outcomes dead last among this peer group:
  
  
  
  
  
  
• "Many of the U.S. health system’s shortfalls result from persistent economic barriers to obtaining essential care. The Affordable Care Act and related policies reduced the proportion of uninsured people to its current level of 7 to 8%. But 26 million Americans still lack insurance. . . . Substantial progress toward this goal could be made by building on existing programs, such as the Affordable Care Act, Medicare, and Medicaid." Note to self: This strategy requires political will and adequate financing at the state and federal levels. I'm not optimistic.
• "The U.S. health care delivery system has profound problems that result in huge inefficiencies and excessive costs that would limit the benefits of expanded coverage. One such problem is the country’s worsening shortage of primary care clinicians . . . . Improved compensation and reductions in administrative burdens for primary care clinicians would help the health system recruit and retain such clinicians and build desperately needed capacity." See Note to self above.
• "A second delivery-system failure is the high prices charged by U.S. health care facilities and professionals, which far exceed prices in other health systems. These high prices largely account for the extraordinary costs of care in the United States, which would make expanded coverage less affordable and which drive employers, who purchase insurance for more than half of Americans younger than 65 years of age, to impose high deductibles and copayments." The authors suggest scrutiny of the extensive consolidation of providers -- institutional and individual -- underway. But: The the premium-price train left the station far earlier than the consolidation boom. Consolidation may be exacerbating the problem, but the problem goes back decades, is cultural,  and it runs deep.
• "Improvements in coverage and the delivery system will need to be complemented by policies targeting critical influences on health outside the health sector. The United States lags behind comparator countries when it comes to addressing the social determinants of health, such as poverty, homelessness, inequality, and hunger. . . . The toll of gun violence in the United States also demands policy attention." See Note to self above.

This report gives us a good differential diagnosis and then prescribes the policy equivalent of "lose weight, exercise more, cut back on meat and dairy, reduce stress in your life, and start getting enough sleep." We all know this is the Path to Enlightenment (or at least to health maintenance), but how many patients take this advice? 

Settlement Off in Bankruptcy Case Involving Purdue

Let's set the stage with the first paragraph from Thursday's majority opinion in the Purdue Pharma bankruptcy case:

The opioid epidemic represents “one of the largest public health crises in this nation’s history.” In re Purdue Pharma L. P., 69 F. 4th 45, 56 (CA2 2023).  Between 1999 and 2019, approximately 247,000 people in the United States died from prescription-opioid overdoses. In re Purdue Pharma L. P., 635 B. R. 26, 44 (SDNY 2021).  The U. S. Department of Health and Human Services estimates that the opioid epidemic has cost the country between $53 and $72 billion annually. Ibid. 

The history in this case is a little complicated, but the Syllabus's description can be boiled down to this:

Owned and controlled by the Sackler family, Purdue began marketing OxyContin, an opioid prescription pain reliever, in the mid-1990s.  After Purdue earned billions of dollars in sales on the drug, . . .thousands of lawsuits followed.  Fearful that the litigation would eventually impact them directly, the Sacklers initiated a “milking program,” withdrawing from Purdue approximately $11 billion—roughly 75% of the firm’s total assets—over the next decade. Those withdrawals left Purdue in a significantly weakened financial state.  And in 2019, Purdue filed for Chapter 11 bankruptcy.  

During that process, the Sacklers proposed to return approximately $4.3 billion to Purdue’s bankruptcy estate.  In exchange, the Sacklers sought a judicial order releasing the family from all opioid-related claims and enjoining victims from bringing such claims against them in the future.  The bankruptcy court approved Purdue’s proposed reorganization plan, including its provisions concerning the Sackler discharge.

The Court held (5-4) "that the bankruptcy code does not authorize a release and injunction that, as part of a plan of reorganization under Chapter 11, effectively seeks to discharge claims against a nondebtor without the consent of affected claimants." Meaning? 

1. The Sackler family's assets aren't protected, which seems only fair since they were plundered from Purdue in the first place. That's the good news. 

2. But that's the only good news, and it's not really good news at all, not if you were one of the claimants who stood to receive compensation pursuant to the settlement agreement. The truly awful news is that the settlement agreement, which was going to pay out billions to the claimants, is now kaput. This is the opening paragraph of Justice Kavanaugh's dissenting opinion:

Today’s decision is wrong on the law and devastating for more than 100,000 opioid victims and their families.  The Court’s decision rewrites the text of the U. S. Bankruptcy Code and restricts the long-established authority of bankruptcy courts to fashion fair and equitable relief for mass-tort victims.  As a result, opioid victims are now deprived of the substantial monetary recovery that they long fought for and finally secured after years of litigation.

Friday's Firearms Decision from SCOTUS: A Few Thoughts

Following up on my two Father's Day posts (here and here) despairing the Supreme Court's tendency to favor gun ownership over gun registration. In their 6-3 Bruen decision two years ago, the Justices struck down a New York firearm regulation. The test, in a majority opinion by Justice Thomas, held:

that when the Second Amendment’s plain text covers an individual’s conduct, the Constitution presumptively protects that conduct.  To justify its regulation, the government may not simply posit that the regulation promotes an important interest. Rather, the government must demonstrate that the regulation is consistent with this Nation’s historical tradition of firearm regulation. Only if a firearm regulation is consistent with this Nation’s historical tradition may a court conclude that the individual’s conduct falls outside the Second Amendment’s “unqualified command.” (emphasis added)

Lower courts since 2022 have struggled to apply the Bruen test. Part of the confusion arises from the fact that generalist judges aren't necessarily good historians. Beyond that, the historical record is often unclear, especially when it is over 300 years old, and many histories across many disciplines illustrate that there is often for debate about mean even among trained historians. Finally, and perhaps most fundamentally, the Bruen majority didn't explain what justifies making this nation's historical tradition the ultimate test of constitutionality in Second Amendment cases. What's wrong with strict scrutiny and a compelling-state-interest test? 

Last Friday the Court handed down its opinion in the Rahimi case, upholding 18 U.S.C. § 922(g)(8), the federal statute that prohibits gun possession by anyone who is subject to a domestic violence restraining order and as to whom "the order . . . either contain[s] a finding that the defendant 'represents a credible threat to the physical safety' of his intimate partner or his or his partner’s child, or 'by its terms explicitly prohibit[s] the use,' attempted use, or threatened use of 'physical force' against those individuals. (citations omitted). 

A few things to note:

1. Liberal and conservative justices alike joined the majority opinion, 8-1.
2. The majority's test for constitutionality was a watered-down version of Bruen. Unfortunately, this nation's history and tradition are still the defining inquiry, but an analogous law or policy will suffice. The majority rejected the idea that there must be an historical "twin" in order for the government to prevail.
3. The lone dissenter was Justice Thomas, the author of Bruen. If you want to know how cock-eyed the Bruen test is, his dissenting opinion in Rahimi is a good place to start. A legal test that forbids states or the federal government to keep firearms out of the hands of a person who is an on-going threat to the physical safety of his intimate partner or to a child of either of them -- a policy that is so sensible that it hardly needs to be litigated -- is a deeply flawed legal test.

COVID-19 Vaccine Fraud: The Worst of the Worst?

Here's the case summary from USDOJ (Office of Public Affairs, June 17, 2024):

A New York woman pleaded guilty today to fraudulently destroying over 2,600 COVID-19 vaccines and issuing a corresponding number of fraudulent COVID-19 vaccination record cards.

According to court documents, Kathleen Breault, 66, of Cambridge, a midwife at Sage-Femme Midwifery PLLC (Safe-Femme), an authorized COVID-19 vaccine administration site in Albany, New York, conspired to obstruct the government’s distribution of COVID-19 vaccines by providing COVID-19 vaccination record cards to individuals who were not vaccinated, including to minors who were at the time ineligible to be vaccinated and to Canadian citizens who were not present in the United States when they were purportedly vaccinated. In addition to destroying COVID-19 vaccines and issuing fraudulent vaccination record cards, Breault and her co-conspirators made over 2,600 false entries into a New York State database that tracked COVID-19 vaccine distribution. Breault agreed to pay more than $37,000 in restitution for the destroyed vaccines.    

Breault pleaded guilty to conspiring to defraud the United States and its departments and agencies. She is scheduled to be sentenced on Sept. 18 and faces a maximum penalty of five years in prison. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors. 

The worst of the worst? It's up there. 

Most health care fraud is about money -- ill-gotten gains obtained by billing for services that were never rendered or that were not medically necessary and appropriate. Individual patients are sometimes harmed in these schemes (denied care they actually needed or exposed to treatment risks that were unnecessary), and then there are the addiction cases that -- in addition to the risk of death or serious injury -- often harm not only individuals but also families and contribute to the harm to whole communities. Even "pure financial fraud" harms insurance programs by taking away funds that could otherwise pay for the provision of medical care to patients in need of it.

This case adds another dimension to fraud-based community harms: public health and safety. Falsely documenting vaccinations and diverting thousands of doses of vaccine to the trash is doubly harmful. It allows unvaccinated individuals to work and play within communities that depended on the widest possible rate of vaccination. And many communities at times throughout the worst of the pandemic experienced vaccine shortages. This case isn't only about money. It's about a kind of depraved indifference to communal well-being that is hard to fathom.

The Bump Stock Case: Is SCOTUS a Public Health Menace (Part II)?

The latest blockbuster decision from SCOTUS is "the bump stock case," Garland v. Cargill, U.S. No. 22-976 (June 14). There isn't much to add to the voluminous media coverage of this case, in which the six conservatives on the Court struck down a 2018 BATF regulation that banned bump stocks because they turned semiautomatic rifles into machineguns, which Congress severely restricted in 1934 (see definition of machinegun in National Firearms Act of 1934, 26 U. S. C. §5845(b)). The majority (in a highly technical and narrow decision by Justice Thomas*) disagreed with BATF and held that bump-stock-equipped rifles are not machineguns. To be fair, the Obama administration came to the same conclusion when it decided against a regulation that would have classified bump-stock-equipped rifles as machineguns. 

Writing for the three liberal justices in dissent, Justice Sotomayor wrote:

A machinegun does not fire itself.  The important question under the statute is how a person can fire it.  A weapon is a “machinegun” when a shooter can (1) “by a single function of the trigger,” (2) shoot “automatically more than one shot, without manually reloading.”  26 U. S. C. §5845(b).  The plain language of that definition refers most obviously to a rifle like an M16, where a single pull of the trigger provides continuous fire as long as the shooter maintains backward pressure on the trigger.  The definition of “machinegun” also includes “any part designed and intended . . . for use in converting a weapon into a machinegun.”  Ibid.  That language naturally covers devices like bump stocks, which “conver[t]” semiautomatic rifles so that a single pull of the trigger provides continuous fire as long as the shooter maintains forward pressure on the gun. 

This is not a hard case.  All of the textual evidence points to the same interpretation.  A bump-stock-equipped semiautomatic rifle is a machinegun because (1) with a single pull of the trigger, a shooter can (2) fire continuous shots without any human input beyond maintaining forward pressure.  The majority looks to the internal mechanism that initiates fire, rather than the human act of the shooter’s initial pull, to hold that a “single function of the trigger” means a reset of the trigger mechanism.  Its interpretation requires six diagrams and an animation to decipher the meaning of the statutory text.  Then, shifting focus from the internal mechanism of the gun to the perspective of the shooter, the majority holds that continuous forward pressure is too much human input for bump-stock-enabled continuous fire to be “automatic.” [emphasis added]

Justice Sotomayor rejects the majority's technical analysis with her customary flair:

Today, the Court puts bump stocks back in civilian hands.  To do so, it casts aside Congress’s definition of “machinegun” and seizes upon one that is inconsistent with the ordinary meaning of the statutory text and unsupported by context or purpose.  When I see a bird that walks like a duck, swims like a duck, and quacks like a duck, I call that bird a duck.  A bump-stock-equipped semiautomatic rifle fires “automatically more than one shot, without manual reloading, by a single function of the trigger.”  §5845(b).  Because I, like Congress, call that a machinegun, I respectfully dissent. 

At a minimum, doesn't the 6-3 split in this case suggest that it's plausible -- even reasonable --  to define bump-stock-enhanced rifles as machineguns, even if there is a plausible -- even reasonable -- contrary argument? Given the room for argument, isn't this just the sort of case in which generalist judges, with or without technical drawings and a video, should defer to the expertise of the agency (with or without Chevron)?

Last Father's Day, I posted about the Supreme Court's obstinate Second Amendment jurisprudence ("2nd Amendment thoughts -- The Constitution is not a suicide pact (or is it?)" (June 18, 2023).) Breaking no new ground whatsoever, I wrote that gun violence is not only a criminal-justice matter, it's also a matter of public health law. The statistics are stunning. So far this year, there have been 225 mass shootings in this country. Granted, few if any involved a bump-stock-equipped rifle, but the 2017 shooting at a Las Vegas music festival (in which 58 people were killed and over 500 injured by a shooter using weapons enhanced by bump stocks) demonstrates the lethality of bump stocks. And with over 700,000 of these things already in circulation (ABC News (June 14, 2024)), to build on Justice Sotomayor's analogy, we are all sitting ducks. 

So this Father's Day, I revisit the issue of gun violence and ask last year's question one more time: Don't we owe more to our children (and their children) than a world in which assault rifles are legal in 40 states and anyone with a driver's license can turn their assault rifle into a machinegun?

____________________

* There is a random connection between machineguns (especially the Thompson machinegun) and Dallas. The father of the late Cary Maguire -- Dallas oilman and philanthropist par excellence -- supplied Allied forces with the Tommy gun during WWII:

NY Times, Nov. 11, 1966 (obituary, J. Russell Maguire, (behind a paywall)).

New Study Confirms Public Health Policy and Tools Were Weakened by Judicial Decisions During COVID Pandemic

Health Affairs has "pre-posted" the most detailed and insightful study I've seen that shows how court decisions -- including those from SCOTUS and various state supreme courts -- undermined traditional public-health policies and tools. The study was headed by Michelle M. Mello, David H. Jiang, and Wendy E. Parmet and deserves close study of the dismantling of a public-health regime that has, by and large, served this country well since its founding. Here's the authors' conclusion:

Our analysis of 112 COVID-19-era judicial decisions revealed areas of profound instability in how courts analyze challenges to exercises of public health legal powers. Based on our understanding of prepandemic case law, the decisions also represent surprising departures from how courts had previously analyzed similar claims, especially those concerning religious liberty and statutory authority.

Public officials come in for some of the criticism, particularly for their occasional failure to explain the rationale for their decisions, which left those decisions vulnerable to attack through litigation. The lesson is unmistakable: the courts, the regulators, and the rest of us need to do better the next time. And there will be a next time.

Biden's State of the Union Address: 13 Health Care Take-aways

Becker's Hospital Review takes a look at "13 healthcare takeaways" from President Biden's State of the Union address last evening. They include:

1. Expanding Medicare's drug price negotiation scope
2. Limiting drug costs
3. Expanding rebate requirement
4. Closing Medicaid coverage gap [for 10 states, including Texas, that haven't expanded eligibility]
5. Capping the cost of insulin
6. Abortion access
7. COVID-19
8. Affordable Care Act
9. Women's health
10. Taxes
11. Gun violence
12. PACT Act [Resources for Veterans]
13. ARPA-H (Advanced Research Projects Agency for Health ) 

Healthiest & Unhealthiest Counties in the U.S.: Texas is Tops on One of These Lists

Market Watch's latest report (January 5) ranks 576 counties based on "14 key metrics that capture the individual, environmental and structural aspects of health for a given community. This includes measures such as life expectancy and health insurance coverage, water and air quality, and food insecurity and healthcare access." Here are the high- and low-lights:

Healthiest counties:

1. Marin County, Calif.

2. Gallatin County, Mont.

3. San Francisco County, Calif.

4. Arlington County, Va.

5. Maui County, Hawaii

6. New York County, N.Y.

7. Boulder County, Colo.

8. San Mateo County, Calif.

9. Chittenden County, Vt.

10. Bergen County, N.J. 

Unhealthiest counties: 

1. Harris County, Texas

2. Apache County, Ariz.

3. Pinal County, Ariz.

4. Webb County, Texas

5. Hidalgo County, Texas

6. Navajo County, Ariz.

7. Cameron County, Texas

8. Orange County, Texas

9. Livingston Parish, La.

10. Jefferson County, Texas 

No state appears on either list more than three times except for one: Texas. And it's the list no self-respecting government (at the state or county level) should want to be on.

If I were of a statistical bent, I'd compare these lists with three other metrics: per capita income, per capita governmental expenditures, and a map of cancer "hot spots." Interestingly, Medicaid expansion does not seem to play as great a factor as one might expect. Louisiana and Arizona share space on the "Unhealthiest" list, and both are states that expanded Medicaid eligibility. But is it a coincidence that the state with six out of ten counties on that list has not expanded Medicaid eligibility? I believe it has to be a factor. Compare the map at the top with the Kaiser Family Foundation's map of expanded-eligibility states (click to expand the images):

JAMA: Increased Depression & Anxiety in Trigger States After Dobbs Decision

In a free article in the Journal of the American Medical Association (JAMA. 2024;331(4):294-301. doi:10.1001/jama.2023.25599) (PDF), researcher report that "[l]iving in states with trigger abortion bans compared with living in states without such bans was associated with a small but significantly greater increase in anxiety and depression symptoms after the Dobbs abortion opinion." The authors conclude:

The findings provide new evidence about the relationship between the changing abortion policy landscape and mental health following the Dobbs opinion. Although there were increases in symptoms of anxiety and depression for the general population after the opinion, changes in symptoms of anxiety and depression were greater among those living in states with trigger abortion bans, and in particular, among females within the age range generally used to compute lifetime abortion incidence. This finding could be related to many factors, including fear about the imminent risk of abortion denial; uncertainty around future limitations on abortion and other related rights, such as contraception; worry over the ability to receive lifesaving medical care during pregnancy; and a general sense of violation and powerlessness related to loss of the right to reproductive autonomy.

Donald Trump and the Perils of Practicing Medicine Without a License

Hydrochloroquine for COVID? Remember when that was a thing?

From The Messenger (Jan. 4):

In a study published this week in the journal Biomedicine & Pharmacotherapy, French researchers found that 17,000 people died across six countries because they depended on [the] drug. Researchers say this is because the drug was used in lieu of more effective treatments, and the potential cardiovascular issues it can cause as a side effect.

That number includes 12,000 deaths in the U.S. alone. Politico adds: "In fact, they say the figure may be far higher given the study only concerns six countries from March to July 2020, when the drug was prescribed much more widely."

You may recall that hydrochloroquine was then-President Trump's treatment of choice (along with household bleach). Here's the history reminder from The Messenger:

It was quickly shown to be ineffective. However, in a situation The Lancet describes as a “comedy of errors”, many political figures continued to endorse the drug as a legitimate COVID treatment. According to one report, Donald Trump, who was president at the time, was among the most prominent advocates of the medication as a treatment for COVID, mentioning it on Twitter and in press briefings.

“What do you have to lose? Take it,” Trump said during a White House briefing in 2020. “I really think they should take it. But it’s their choice. And it’s their doctor’s choice or the doctors in the hospital. But hydroxychloroquine. Try it, if you’d like.”

How Much Does the Fifth Circuit Care About Public Health?

The 5th Circuit Court of Appeals has handed down a couple of decisions this week that surprised me a lot (except that this 5th Circuit is the most conservative federal appellate court in the country):

1. Abortion. The Texas Tribune has a good story on the history of this litigation and Tuesday's ruling (State of Texas et al. v. Becerra, No. 23-10246  (Jan. 2, 2024). The court upheld a permanent injunction against an HHS injunction against DHHS's post-Dobbs guidance that the Emergency Medicine & Active Labor Act (EMTALA) requires Medicare providers to perform an abortion when that is necessary to stabilize a pregnant woman's emergency (life- or limb-threatening) condition. The court concluded that Congress did not intend for the statute to require performance of a procedure that was forbidden by state law. The court went on, asserting that Texas law provides plenty of protection for procedures, including abortion, when continuing the pregnancy poses a threat to the pregnant woman's life or a major bodily function. This is the same line taken by the Texas Supreme Court in its opinion that denied Kate Cox's bid for an abortion under the same exception to the state's abortion ban. 

Meanwhile, according to Kate Riga at TalkingPointsMemo.com, the same issue is in front of the 9th Circuit Court of Appeals. Depending on the outcome of that case, the issue may land at SCOTUS's doorstep soon.

2. E-cigarettes. The case is Wages and White Lion Investments, L.L.C. v. Food & Drug Administration, No. 21-60766 (Jan. 3, 2024). This was an en banc proceeding of the Court of Appeals, with a majority opinion by Judge Oldham (and joined by nine others) and a dissenting opinion by Judge Haynes (joined by four others). The result of the case is that the FDA is ordered to review over 1 million pre-market tobacco applications (PMTAs) against the backdrop of clear and convincing evidence that e-cigs represent a serious health threat, especially to minors, with no countervailing health benefits. 

This is Judge Haynes' take on the majority opinion (emphasis added):

It is against this backdrop that the FDA reviewed the PMTAs of Wages and White Lion Investments, LLC, d/b/a Triton Distribution (“Triton”) and Vapetasia LLC (“Vapetasia”) (collectively, “Petitioners”) and issued marketing denial orders (“MDOs”) to Petitioners.  The FDA denied Petitioners’ PMTAs because they did not contain any reliable evidence suggesting the benefits of Petitioners’ flavored products outweighed the significant risks to youth—an outcome that aligned with both the guidance the FDA had given to applicants and its statutory mandate under the TCA.  But the majority opinion erroneously concludes that the FDA changed the evidentiary standards applied to Petitioners’ PMTAs and wholly ignored Petitioners’ marketing plans, and thus acted in an arbitrary and capricious manner.  Unfortunately, based on a misreading of the law and a misconstruing of the relevant facts, the majority opinion supersedes the FDA’s work by remanding instead of denying the petition, which cuts the FDA’s legs out from under it in the middle of a dangerous and constantly evolving public health crisis.  

In so doing, the majority opinion also departs from all but one of our sister circuits that have addressed the same issue.  See, e.g., Magellan Tech., Inc. v. FDA, 70 F.4th 622 (2d Cir. 2023) (unanimous denial); Liquid Labs LLC v. FDA, 52 F.4th 533 (3rd Cir. 2022) (unanimous denial); Avail Vapor, LLC v. FDA, 55 F.4th 409 (4th Cir. 2022) (unanimous denial), cert. denied, No. 22-1112, 2023 WL 6558399 (U.S. Oct. 10, 2023); Gripum, LLC v. FDA, 47 F.4th 553 (7th Cir. 2022) (unanimous denial), cert. denied, 143 S. Ct. 2458 (2023); Lotus Vaping Techs., LLC v. FDA, 73 F.4th 657 (9th Cir. 2023) (unanimous denial); Prohibition Juice, 45 F.4th 8 (unanimous denial); see also Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021) (denying motion for stay), app. for stay denied, 142 S. Ct. 638 (2021).  The only circuit that granted a petition for review in a comparable context did so on much narrower grounds than the majority opinion embraces today.  See Bidi Vapor, 47 F.4th at 1195 (remanding based on the FDA’s failure to consider marketing and sales-access-restriction plans); but see id. at 1208–18 (Rosenbaum, J., dissenting).  Despite the Eleventh Circuit’s opinion, however, it is telling that the Supreme Court recently denied certiorari for two cases in which other circuits considered similar facts to those before us and denied the petition for review.  See Gripum, LLC v. FDA, 143 S. Ct. 2458 (2023) (mem.); Avail Vapor, LLC v. FDA, No. 22-1112, 2023 WL 6558399 (U.S. Oct. 10, 2023) (mem.); see also Breeze Smoke, LLC v. FDA, 142 S. Ct. 638 (2021) (mem.) (denying application for stay of FDA’s denial, without any recorded dissent). 

Reevaluating this case en banc, I would reach the same determination that the merits panel did and deny the petitions for review before us.

I concur. 

RFK, Jr., Public Health Law & Policy

Robert F. Kennedy, Jr. is running for the Democratic Party's 2024 presidential nomination. He is a prominent member of one of this country's most prominent political families, at least since the Adamses, the Roosevelts, the Buckleys, and . . . oh, we do love our dynasties, don't we?

In a past life, he was an environmental activist (although Dan Farber, whose work I admire, is a skeptic on that count, as well). But RFK, Jr. is also a prominent spreader of misinformation about Covid, vaccines, and Covid vaccines in particular. If his dangerous positions on these public health basics had been the official government policy, countless more people in this country would have died than the 1,137,057 who have died so far. Period. (Interestingly, there isn't a whisper about these issues on his official campaign website. Perhaps because media coverage has been dominated by questions about these issues to exclusion of much else on his issues list, and because just about the entire Kennedy family seems to be opposed to his positions. NYT, Aug. 6, 2023; Politico, April 19, 2023.)

FactCheck.org's SciCheck team has a three-part series on Kennedy's Covid and vaccine errors:

In our first article, Jessie addresses several of Kennedy's key talking points about vaccines in general. (See "FactChecking Robert F. Kennedy Jr.")

In a second article, Staff Writer Kate Yandell goes deep into some of his go-to arguments about vaccines and autism. (See "What RFK Jr. Gets Wrong About Autism.")

[In] the third and final article, Staff Writer Catalina Jaramillo and Kate tackle Kennedy's numerous claims about the COVID-19 pandemic, many of which we’ve written about before and may be familiar to you already.

All three articles can be found on this page. 

Physician Discipline: Covid Denier's License Suspended, but Not For Lying

Sherri Tenpenny, D.O., testified before the Ohio legislature that the Covid vaccine "magnetizes" recipients and interfaces with 5G cellphone towers. Soon after, her medical license came up for renewal and the Ohio Medical Board renewed it, no muss, no fuss, despite the good doctor having been named as "one of the 12 most prolific spreaders of COVID-19 misinformation on social media, according to research from the Center for Countering Digital Hate." (Becker's Hospital Review, Sept. 20, 2021).

At the time of the renewal, the Board said that renewal was an automatic process and did not foreclose a future investigation. After receiving approximately 350 complaints, the Board did start an investigation. Dr. Tenpenny, however, unwisely blew off the Board's discovery requests and a subpoena to testify, and for that she got her license suspended until she starts to cooperate with the Board's investigation. (Becker's Hospital Review,  Aug. 9, 2023).

This case offers two teaching points: (1) many licensing boards are slow to react to quackery, and (2) turning your back on a board’s investigation never pays off  

Meanwhile, Dr. Tenpenny's anti-vaccine and conspiracy-spewing firm rakes in an estimated $4.04 million in annual sales. There's gold in them thar lies!

Public Health Law Priorities to Pursue While Congress Recesses

The American Public Health Association (APHA) sent out its call to action during the current Congressional recess. In addition to providing advice on how to press your views on public-health issues while the Senators and Representatives are away, the APHA missive provides links to a wealth of policy papers, reports, and the like across a broad spectrum of public health. And its not only about Congress. As the APHA suggests, state and local officials -- traditional wielders of "police powers" -- also need to be educated about public health, about which so much misinformation and disinformation emerged during COVID. And there are op-ed opportunities. The list goes on . . . .

Congressional recess is here (July 31 – Sept. 11 for the House and July 31 – Sept. 4 for the Senate) which makes this month the perfect time to raise your public health voice and urge your members of Congress to take action. Join the Speak for Health campaign with APHA’s suggested advocacy activities:

•  Got a minute? Head over to APHA’s action alerts and send a quick message to your elected officials on a variety of topics including environmental health, reproductive rights, gun violence and public health funding.
• Schedule a meeting with your members of Congress, virtually or in person, to discuss public health priorities. You can call their local offices for details on scheduling a meeting.
• When speaking to elected officials, point to APHA’s 2023 advocacy priorities as key areas for action.
• Boost your advocacy efforts with issue fact sheets that summarize priority advocacy issues and state fact sheets that break down public health in each state.
• Write and submit an op-ed to your local paper. APHA offers op-ed writing tips and sample op-eds on gun violence, climate change, public health funding and reproductive health which you can request by emailing speakforhealth@apha.org.
• Engage elected officials on social media about their support for public health. You can include social media shareable images found on the Speak for Health page, and make sure you use the hashtag #SpeakForHealth!
• Attend a town hall and ask your elected official key questions about their commitment to supporting public health. You can contact their office to ask when the next town hall is scheduled.

Your voice helps shape how members of Congress view critical public health issues, and your community’s public health concerns deserve to be heard by our nation’s leaders. Join us and Speak for Health — for today and for future generations.

The APHA 2023 advocacy priorities cover a lot of territory and offer something for everybody:

• Increase and protect funding for vital public health agencies and programs and strengthen the nation’s public health infrastructure. 
• Uphold the Affordable Care Act and expand access to health coverage and services. 
• Address the health impacts of climate change. 
• Protect access to reproductive health care. 
• Pass a 2023 Farm Bill to protect nutrition security. 
• Protect nutrition standards for children. 
• Uphold and strengthen critical public health laws and regulations and reverse damaging rollbacks. 
• Address the nation’s gun violence epidemic.

For more information on APHA’s advocacy priorities, visit https://www.apha.org/advocacy or contact Don Hoppert at Donald.Hoppert@apha.org or Jordan Wolfe at Jordan.Wolfe@apha.org.   

U.S. Child and Teen Firearm Mortality is Off the Chart. Literally.

Following up on my Father's Day post about firearms.  The Kaiser Family Foundation has released a new issue brief: "Child and Teen Firearm Mortality in the U.S. and Peer Countries". One graphic tells the story:

It's the #1 cause of death (by a pretty wide margin) for minors (ages 1-17), ahead of motor vehicles, cancer, and all other causes.

It's a short paper with an important message. The concluding paragraph raises an issue that doesn't get a lot of coverage in the popular press:

Exposure and use of firearms also have implications for mental health. Research suggests that youth may experience symptoms of post-traumatic stress disorder and anxiety in response to gun violence. Specifically, survivors of firearm-related injuries, including youth survivors, may be at increased risk of mental health conditions and substance use disorders. Furthermore, gun violence disproportionately affects many children of color, particularly Black children, and children living in areas with a high concentration of poverty.

This is a public health issue and ought to be understood as a public health law issue as well. When will legislatures wake up?

2nd Amendment thoughts -- The Constitution is not a suicide pact (or is it?)

Some random thoughts on Father's Day about gun violence in the United States.  

According to the authoritative Gun Violence Archive website,  there were 125 shootings on Father's Day (July 18) resulting in 149 victim injuries and 49 victim deaths. Six  shootings involved 4 or more victims being injured or killed (the commonly accepted criterion for a "mass shooting"), including 22 injured and 1 killed in a shooting at a Juneteenth celebration in Willowbrook, Illinois, and 9 injured and 1 killed in St. Louis.  Today.

All gun deaths are horrible, but surely it is worth noting that it seems a disproportionate number of victims appear to be young people, the age of our kids (or, in my case, my grandkids).

As parents, it is our responsibility to try to make the world reasonably safe for our kids. We try to protect them from the consequences of choices and conduct that could kill or maim them. It is admittedly impossible to eliminate all risk from the world, but we do our best to manage that risk. Except when it comes to guns.

I am writing this in HealthLawBlog because gun violence is not only a criminal-law issue but also a public-health issue. As the American Public Health Association (APHA) has written:

Gun violence is a leading cause of premature death in the U.S. Guns kill more than 38,000 people and cause nearly 85,000 injuries each year. As a longtime advocate for violence prevention policies, APHA recognizes a comprehensive public health approach to addressing this growing crisis is necessary.

The biggest obstacle is the number of politicians who are beholden to the gun lobby for secure and well-financed primaries. There are plenty of voters who have been sold an absolutist interpretation of the Second Amendment, and politicians are scared of alienating them, too.

The question posed in the title of this post deserves an answer. 

My SMU Law colleague Eric Ruben argues persuasively that Second Amendment absolutism is based upon a serious -- dare I say fatal? -- misreading of that amendment (click here for links to most of his writings; click here for his latest article, forthcoming in the Yale Law Journal). His work is well worth reading. Suffice it to say that gun-rights absolutists base their position on an ahistorical reading of the Second Amendment, an error that is compounded in the Court's most recent Second Amendment decision by what Ruben and his co-author, Joseph Blocher, in their Yale piece call "originalism-by-analogy," a unique version of originalism, seemingly invented to produce a particularly virulent reading of the Second Amendment.

Justice Robert Jackson wrote in his dissent in Terminiello v. City of Chicago:

There is danger that, if the Court does not temper its doctrinaire logic with a little practical wisdom, it will convert the constitutional Bill of Rights into a suicide pact.

The current Court would do well to heed the wise words of Justice Jackson. 

Bad news for transgender kids: Genecis program is no more

A story in the Dallas Morning News (Dec. 6) by reporters Marin Wolf and Lauren McGaughy provides extremely useful details and context for the decision to shutter the Genecis ("Gender Education and Care, Interdisciplinary Support") program that was jointly run by UT-Southwestern Medical Center and Children's Health. Transgender and gender-diverse minors will now have a harder time than ever getting "health care, including mental health counseling and hormone therapy":

Last month, the hospitals said they would no longer be taking on new patients for hormone or puberty suppression therapy. They also removed all online references to the program, saying the care previously provided through the program will now be managed and coordinated through different specialty departments at the two hospitals.

According to the DMN article, the Genecis clinic was "the only program specifically for transgender children living in Texas and its surrounding states."

UT-Southwestern hasn't commented on the decision to shutter Genecis, but others haven't been so reticent. The article quotes Steve Rosenthal, medical director of the child and adolescent gender center for the University of California, San Francisco Benioff Children’s Hospitals: “It almost goes without saying that this seems inequitable and flatly wrong. Where are these patients going to go? And what’s the reason you’re not going to do it anymore?”

The latest surge: It's real and it was avoidable

Paul Krugman's N.Y. Times newsletter today (not posted yet, but it should be soon) has two altogether unsurprising but very revealing graphs that neatly summarize where we are with the latest surge in COVID-related deaths:

The delta variant is everywhere, but not every country is experiencing the surge that we are. Something other than infectivity is at work here. As Krugman points out, "the systematic refusal to get vaccinated, refusal to wear masks, etc., is very clearly tied to the unique way that common-sense public health measures have been caught up in the culture war. . . . According to a recent NBC poll, 91 percent of Biden voters have been vaccinated but only 50 percent of Trump voters. Or look at death tolls: Blue states look more like Canada or Germany than like Florida or Texas".

Can anyone seriously doubt that the non-policies of Govs. DeSantis and Abbott are unnecessarily killing people in their states?