Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

Social Distancing, Social Protest, and the Social Constitution of a New Body of Law

By Lindsay F. Wiley

COVID-19 mitigation orders, court decisions adjudicating challenges to them, and legislation adopted to constrain similar orders in the future are constituting a new body of law governing social distancing.

The emerging law of social distancing is vital to the future of public health. It also offers more general lessons about how law interacts with individual behavior, social norms, and social contestation of what we owe each other as members of a community.

Social protests — including massive protests for racial justice and against police violence as well as much smaller anti-lockdown protests — are playing an important role in these developments.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Person smoking cigarette.

Graphic Warnings on Cigarettes: Public Health vs. Corporate Speech

By Laura Karas

The latest attempt of the U.S. Food and Drug Administration (FDA) to make a dent in the country’s intractable tobacco problem is a set of color graphic warnings that will appear on cigarette packages and advertisements beginning in June of 2021.

The legal battle surrounding the graphic warnings and other attempts to regulate commercial speech in the food and drug context illustrate the courts’ enduring failure to appreciate the full extent and substantiality of the government’s interest in promoting public health.

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U.S. Supreme Court building

The Artifices of Corporate Speech: Video Preview with Nathan Cortez

The Health Law Policy, Bioethics, and Biotechnology Workshop provides a forum for discussion of new scholarship in these fields from the world’s leading experts.

The workshop is led by Professor I. Glenn Cohen, and presenters come from a wide range of disciplines and departments.

In this video, Nathan Cortez gives a preview of his paper, “The Artifices of Corporate Speech,” which he will present at the Health Law Policy workshop on October 26, 2020. Watch the full video below:

lady justice.

When Health Advice Is Hard to Come by, BIPOC Suffer the Consequences

By Claudia E. Haupt

The COVID-19 pandemic has highlighted the tradeoffs at stake for Black, Indigenous, and people of color (BIPOC) seeking reliable health advice.

While there are legal safeguards to ensure reliable health advice within the confines of the doctor-patient relationship, outside of that relationship, the First Amendment protects bad advice just as much as good advice.

Courts continue to interpret the First Amendment in an expanding, deregulatory manner and the health context is no exception. For example, one novel judicial interpretation challenges previously accepted applications of the police power in furthering public health. In a forthcoming article, “Public Health Originalism and the First Amendment,” my colleague Wendy Parmet and I explore some of the dangers associated with this deregulatory approach.

Overall, the beneficiaries of these recent developments tend to be powerful speakers. The costs have largely fallen on women, as seen for example in NIFLA v. Becerra, and those who lack access to reliable medical advice, who are disproportionately BIPOC. Current First Amendment doctrine thus has the dangerous potential to further exacerbate existing racial disparities in health.

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Photograph of a person holding an e-cigarette in one hand and traditional cigarettes in the other hand.

FDA’s Warning Letter to Juul & the First Amendment

By Daniel Aaron

On September 10, 2019, the Food and Drug Administration (FDA) issued a warning letter to Juul asserting that the vaping manufacturer had violated federal law by illegally marketing its e-cigarettes as safer than other products. Citing evidence uncovered at a July 2019 House Subcommittee hearing as well as industry documents, FDA claims that Juul marketed its products as modified-risk tobacco products (MRTPs) without an FDA order allowing the product to be marketed as such. Therefore, FDA concluded, Juul’s products are adulterated.

At first blush, this seems like a heavy-hitting letter. FDA warning letters are an effective enforcement tool because they intimidate regulated entities and carry the threat of further enforcement. FDA likely hopes Juul will bring itself into compliance with federal law by ceasing to market its products as lower-risk.

However, enforcement letters carry no legal weight in and of themselves. Should Juul continue to market its products as lower-risk, there may be a long legal battle implicating the First Amendment.

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How the FDA Produces Knowledge (and Is Not So Weird)

Credit: SalFalko

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech regulations are especially worrisome when motivated by paternalism.  This argument has received some traction in the courts, and is now getting a favorable look by the Trump administration.

I have argued (here, here, and here) that this law is not actually a speech regulation.  Nor is it paternalistic.  Instead, it is simply a vanilla regulation of a behavior (shipment of product in interstate commerce), which depends on various sources of evidence (including speech) as revealing whether the actor has an illicit intent (an unapproved use of the product).  The pre-market approval system, which requires that companies prove safety and efficacy for all intended uses, solves a collective action problem to produce information as a public good.  This is our key social mechanism for producing knowledge about safety and efficacy.  If this law is unconstitutional in the off-label context, the entire pre-market approval system would seem to be as well.

In a new piece out on SSRN, my physician co-author Victor Laurion develops the example of the drug Seroquel XR, to show how a federal prosecution for off-label promotion caused the company to perform scientific research on two new indications (general anxiety disorder and major depression).  A detailed discussion of the regulatory record shows how physician prescribing was improved by this public information, regardless of whether the FDA approved the new indication.  In this way, the FDA protects the liberty of physicians and patients to try drugs for new uses, even while holding companies to the proof of any uses that they actually intend.  The fact that the company’s intention is shown by speech evidence is immaterial. Read More

Is it legal for Trump to punish health insurers that do not support repeal of Obamacare?

By Christopher Robertson

In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:

At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.

For what its worth, the Trump administration denied that she had done so.  But if she did, is that legal?  Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)?  If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Read More