Category: Wendy Parmet

In Regulating E-Cigarettes, No Easy Fix For The FDA

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This new post by Wendy Parmet appears on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

Read the full post here.

Vaccine Mandates: Second Circuit Reaffirms their Constitutionality

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By Wendy Parmet

Although the political debate over vaccination rages on, the legal debate is as settled as the science. Last month, in Phillips v. City of New York, the Second Circuit reaffirmed in record time what it and other courts have consistently held: states have the power to mandate that schoolchildren be vaccinated against vaccine-preventable diseases.

The plaintiffs in Phillips included parents of children who had received a religious exemption, but were barred from school during a chicken-pox outbreak, and parents of a child who had been denied a religious exemption. Together they brought just every claim possible against city and state defendants: free exercise, substantive due process, equal protection, and the Ninth Amendment. Last June, District Court Judge William F. Kuntz granted summary judgment for the defendants, relying heavily on an earlier decision of the Second Circuit, Caviezel v. Great Neck Public Schools. Plaintiffs appealed to the Court of Appeals. Read More

Ebola Quarantines: Remembering Less Restrictive Alternatives

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By Wendy Parmet

The heartfelt letter issued by Kaci Hickox, the nurse being held in quarantine in a New Jersey hospital, calls into question the surprising decision by Governors Christie and Cuomo to quarantine health care workers returning from West Africa. It also shines a spotlight on the all-important, but largely unexplored, question of how the less restrictive “alternative test” applies to quarantine. In her letter, Hickox describes being treated in a shockingly harsh and unsupported manner, being kept for hours in isolation at Newark International Airport, and then in a tent outside of University Hospital in Newark, given only a granola bar to eat. Even after she tested negative for Ebola, and her purported fever had vanished, she remains confined in the hospital. How, she asks, will returning health care workers be treated when they return from Africa?  “Will they be made to feel like criminals and prisoners?”

Hickox’s question points to the critical flaw in the decision by Governor’s Cuomo and Christie to quarantine asymptomatic health care workers returning from Africa. By using the “big gun” of quarantine, the most restrictive public health law we have, rather than a less restrictive approach, the Governors seek to show an anxious public that they’re being tough on Ebola. No doubt this is a politically popular stance. But, as many public health experts have noted, the Governors’ approach can only impede efforts to convince health care workers to go to Africa, where they are desperately needed if the world is to be freed of Ebola. The quarantines may also discourage US-based health care workers and first responders from caring for those who are stricken stateside. If 21 days of confinement in a hospital is demanded for those who care for patients in Liberia, why won’t the same approach be used here? And if so, who will answer the 911 call?

The dangers posed by the Governors’ draconian approach demonstrate the public health importance of the basic constitutional principles that guide the law of quarantine: while governments have the right, if not the duty, to impose quarantine in appropriate circumstances to protect the public’s health, individuals can only be detained when doing is the least restrictive alternative. Exactly what that means has not been fully explored by the courts, in part because quarantine cases are relatively rare. Most modern cases concern patients with tuberculosis. These cases, including ones from New York and New Jersey (e.g., City of New York v. Doe, 205 A.D.2d 469, 614 N.Y.S.2d 8 (N.Y. App. Div., 1 Dept. 1994); City of Newark v. J.S., 652 A.2d 265 (N.J. Super. Ct. Law Div. 1993)), suggest that detention is permissible, but only upon a showing that the patient has been non-complaint with less restrictive approaches (such as directly observed therapy). Courts have also made clear that prisons are not appropriate placements for patients, and that decisions must be based on the best medical and public health evidence. And although courts have not explored these issues, it seems clear that states must provide care and support for those are unable to care for themselves due to public health orders. People who are quarantined are serving the public. We need to treat them accordingly.

In the face of Ebola, fealty to the least restrictive means principle as well as sound public health policy requires that policymakers proceed with a far more nuanced approach than we have seen from the Governors of New York and New Jersey. Without question, public health controls are appropriate, indeed necessary, in response to this awful disease. In Dallas, health officials required health care workers to sign documents agreeing to self-monitor and avoid public transportation. Because Ebola cannot be spread before someone becomes ill, even the latter may be excessive. But these measures were far less restrictive and more tailored than those now being employed in New Jersey and New York. Indeed, a wide range of measures lie between the neglect the public fears, and the over-reaction that the Governors have instituted. Both public health and the Constitution demand we explore them.

Expelling Immigrants from the Exchanges

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By Wendy Parmet

[Cross-posted from HealthLawProf Blog.]

The warning by the Centers for Medicare and Medicaid Services (CMS) last month that up to 115,000 people might lose their health insurance under the Affordable Care Act (ACA) unless they can send proof of their citizenship or immigration status was more than a bit ironic. After spending much of the year and millions of dollars trying to boost participation in the exchanges, CMS is now trying to reduce participation. In so doing, it will likely exclude many young, healthy adults, just the type of people that the exchanges need to succeed

The reason for the exclusion lies with the heated politics of immigration, and our ambivalent approach to providing immigrants with health care. Although the ACA’s critics have lambasted the law on many accounts, when the Act was first debated in Congress no charge – not even death panels! — was made more heatedly or drew more attention than the claim that the Act would cover illegal immigrants. It was that charge, after all, that Representative Joe Wilson referred to when he shouted “You lie!” during the President’s speech to a joint session of Congress.

Obama, however, didn’t lie when he promised that the Act would not cover illegal immigrants. The ACA bars from the exchanges immigrants who are “not lawfully present,” a category that includes the so-called Dreamers, the young immigrants who by virtue of an executive order have a right to live and work in the country. It also requires exchange applicants to provide their Social Security number and, in the case of non-citizens, information about their immigration status, which must be verified by the Department of Homeland Security. These are the requirements that CMS is now enforcing.  Read More

King v. Governor of the State of New Jersey: Applying the First Amendment to Laws Regulating Physician Speech

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By Wendy Parmet

[Cross-posted from HealthLawProf Blog.]

Last week’s decision by the U.S. Court of Appeals for the Third Circuit in King v. Governor of the State of New Jersey, provides an insightful addition to the growing body of case law examining the clash between the state’s power to regulate clinical practice andfree speech.

Although the common law of informed consent arguably implicates the First Amendment rights of physicians and other health professionals, the conflict between the state’s power to regulate health care and free speech has become more apparent in recent years as state legislatures have increasingly enacted laws prescribing what physicians and other clinicians can and cannot say. Such laws are especially common with respect to abortion, but state legislatures have also required physicians to provide specific information about breast cancer treatments, or refrain from asking patients about gun ownership.

Not surprisingly, these laws are frequently challenged on First Amendment grounds. Some courts, relying on the Supreme Court’s cursory treatment of a First Amendment claim in Planned Parenthood v. Casey, have held that laws pertaining to what is said in the course of treatment regulate clinical practice rather than speech, and are, therefore, not subject to heightened review under the First Amendment. That was essentially the approach followed by the Ninth Circuit in Pickup v. Brown, which upheld a California law banning sexual orientation change efforts (SOCE) for minors, and the Eleventh Circuit in Wollschlaeger v. Governor of the State of Florida, which upheld a Florida law limiting physicians’ ability to inquire about their patients’ gun ownership.  As a result of these decisions, it became easier for states to regulate the speech of physicians than the speech of commercial purveyors of deadly products.  Read More

Defining Public Health Emergencies

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By Wendy Parmet

[Cross-posted from HealthLawProf Blog.]

What makes a public health threat an emergency? In this week’s New England Journal of Medicine, Rebecca Haffajee, Michelle M. Mello and I ask this question in connection with Massachusetts Governor Deval Patrick’s decision last spring to declare the opioid-addiction epidemic a “public health emergency.”  In our Perspective we do not question the seriousness of the opioid-addiction problem; or the specific policies Patrick implemented. Rather, we ask whether the epidemic warranted the invocation of emergency powers.

In the years since 9/11, in the name of public health legal preparedness, public health officials and scholars have focused much attention on the need for so-called emergency laws to strengthen the response to a public health emergency. Although the exact parameters of emergency laws vary, they typically allow for the suspension of some or most ordinary legal procedures and protections. Thus when an emergency is declared, the rules of the legal system are suspended. Executives can take action without awaiting legislative approval, or following the typical administrative process. Judicial review may also be significantly curtailed. As my co-authors and I discuss, this has enormous costs, not only on the individuals and entities whose interests are affected, but on the credibility of public health officials who must ultimately depend on the public’s trust. If the public comes to believe that declarations are issued too easily, its support for public health may diminish. In addition, in the absence of legislative and judicial checks, executive powers may easily be turned against vulnerable populations, as they have been too often in history.

Yes precisely because emergency laws are designed to give officials flexibility to respond to unexpected crises, for which existing policies are insufficient, public health emergency laws grant officials extremely broad, usually unreviewable, discretion to decide what constitutes a “public health emergency.” For example, the Massachusetts law that Governor Patrick invoked provides no definition of a public health emergency whatsoever, leaving its determination solely to the Governor’s judgment. Likewise no definition appears in the 2005 federal Public Readiness and Emergency Preparedness Act (PREPA), which preempts most state tort claims against and a vaccines and countermeasures once the Secretary of Health and Human Services declares an emergency.  Read More

What Is (or Isn’t) a Public Health “Emergency”?

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By Rebecca Haffajee

In this week’s issue of New England Journal of Medicine, Michelle Mello, Wendy Parmet, and I write about what constitutes — or should constitute — a “public health emergency”. The law provides for emergency declarations, which suspend ordinary legal standards and processes in order to avoid catastrophe, on many levels (international, federal, state, local) and in public health or more general contexts. We focus our discussion at the state level, using Governor Deval Patrick’s declaration of the opioid-addiction crisis as a public health emergency as an opportunity to explore the appropriate parameters of these powers. My co-authors and I don’t debate the public health significance of opioid addiction in the Commonwealth, nor the specific measures ordered pursuant to this declaration. We do question the expanding use of public health emergency powers beyond the traditional arenas of infectious disease outbreaks, natural disasters, and acts of bioterrorism into new territories, such as injuries and chronic disease.

State laws provide governors and their top health officers with considerable latitude in declaring public health emergencies. But the powers available upon such declarations are extraordinary and should be wielded with care. My co-authors and I identify three key criteria that seem to be enshrined in the spirit of public health emergency laws: “the situation is exigent, the anticipated or potential harm is calamitous, and the harm cannot be avoided through ordinary procedures.” In the absence of these criteria, the invocation of such emergencies may raise heightened concerns — for instance, if ensuing orders involve serious infringements on individual and private business rights — and could result in a loss of public trust in health officials and legitimacy in public health laws. We caution against setting such troubling precedent.

Read more in our Perspective, entitled “What Is a Public Health “Emergency”?“.

Ebola and the Return of Quarantine

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By Wendy Parmet
[Ed. Note: Cross-posted from HealthLawProf Blog.]

Last month’s riots in an Ebola-infected slum in Monrovia, Liberia demonstrated anew the perils of relying on quarantine, and similar highly coercive public health laws, to contain highly contagious diseases.

At first blush, Ebola viral disease (EVD) is exactly the type of disease for which broad quarantines (more precisely, sanitary cordons) would seem appropriate. Transmitted through direct contact with the bodily fluids of an infected person, EVD can spread rapidly through a community, as it has done in several West African nations. Although experimental treatments and vaccines offer promise for the future, they have not yet been shown to be effective in humans; nor are they readily available. As a result, health officials are forced to rely on tried and true public health strategies, such as identifying cases, isolating and treating them with strict infection control measures, and monitoring their contacts. Needless to say, doing so is very challenging and very expensive, especially in highly urbanized areas, with weak health systems.

Given the challenges, health officials and government leaders are often tempted to call in the troops, and rely on more heavy-handed measures, such as imposing sanitary cordons around whole towns or neighborhoods, quarantining those who have had contact with patients, and restricting travel into and out of affected regions. Although the impetus for these measures is understandable given the magnitude of the EVD threat, history suggests that such highly coercive tactics frequently backfire. Like the military-style show of force employed by the police department in Ferguson, Missouri earlier this summer, highly coercive public health measures can undermine the public’s trust in authorities. Thus, rather than reduce travel, identify contacts, and come forward if they show symptoms, individuals are more apt to try to leave affected areas and avoid the health care system. Or they riot, as they did in Monrovia and China during the SARS outbreak. In any case, the problem is made worse not better. Read More

McCullen and New York Statewide Coalition: The Erosion of Public Health as a Legal Norm

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By Wendy Parmet

At first glance, last Thursday’s decisions by the Supreme Court in McCullen v. Coakley and the New York Court of Appeals in New York Statewide Coalition of Hispanic Chambers of Commerce v. New York City Department of Health and Mental Hygiene, have little in common. McCullen, which struck down a Massachusetts law establishing a 35 foot buffer zone around reproductive health clinics, was a First Amendment case that dealt with the always contentious issue of abortion. In contrast, N.Y. Statewide Coalition, which upheld a lower court decision striking down a regulation of the New York City Board of Health barring the sale of large portions of sugary soda, was decided on state administrative law grounds, with the court finding that the Board exceeded its authority.

On closer inspection, however, the two cases share several features in addition to their date of decision. One is the failure to give substantial weight to the state’s interest in protection health. In his opinion for the Court in McCullen, Chief Justice Roberts accepted that the buffer zone law was content neutral and therefore not subject to strict scrutiny. Nevertheless, a unanimous Court held that the Massachusetts law was not narrowly tailored to serve the government interests of protecting public safety and access to health care. In reaching this decision, the Court focused on the “toll” that the buffer zone placed on the abortion opponents who tried to dissuade woman from having abortion, rather than the impact of the lack of such a zone on woman seeking reproductive health care. Equally important, the Court showed no willingness to defer to the state’s contentions that alternative regulatory approaches had proved unsatisfactory. Rather the Court insisted that given “the vital First Amendment interests at stake, it is not enough for Massachusetts simply to say that other approaches have not worked.”

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