Public Health and The First Amendment – AID v. Alliance for Open Society

By Wendy Parmet

The Supreme Court’s decision last week to grant cert in AID v. Alliance for Open Society International, demonstrates anew the importance of First Amendment jurisprudence to public health protection. In recent years, it has sometimes seemed as if the First Amendment has become the most significant legal obstacle to effective public health protection through law. In cases such as Lorillard Tobacco, Thompson v. Western States Medical Center (the compounding pharmacy case), and Sorrell v. IMS Health, Inc., the Supreme Court has found that First Amendment protections for commercial speech trump public health protection, a view that the D.C. Circuit seemed to endorse when it ruled last summer in R.J. Reynolds that the graphic warning labels required by the Tobacco Control Act violated the First Amendment Rights of cigarette companies.

Yet sometimes the First Amendment helps to advance the cause of public health, particularly by limiting the reach of laws that are designed to restrict an open and informed approach to sexual and reproductive. US AIDS offers one such example. In that case, plaintiff NGOs challenged a provision in the federal Leadership Act, 22 U.S.C. § 7631(f),  that required them to adopt a policy explicitly opposing prostitution in order to receive federal funds available to fight HIV/AIDs, tuberculosis, and malaria.  The plaintiffs argued that the Act constituted an unconstitutional condition and violated their First Amendment rights by compelling them to adopt the government’s viewpoint regarding prostitution. The Second Circuit, in an opinion by Judge Parker, concluded that the plaintiffs were likely to prevail on the merits and granted them a preliminary injunction.

Now the Supreme Court will reconsider the issue. Public health advocates are likely to weigh in and argue for the widest possible protection for their own advocacy.  In doing so, they might want to keep in mind the threat that the First Amendment poses for public health in other contexts, especially in commercial speech cases.  And they will certainly want to think about how they can convince courts to value public health when deciding First Amendment cases. Figuring out how to do that — how to develop a First Amendment jurisprudence that is respectful of public health — just may be the most pressing challenge facing public health lawyers today.

Where Are We Now: Post 3, The Agony (and Potential Ecstasy) of Defeat

By Scott Burris

Law has been an extremely effective mode of public health intervention in the last thirty years, which means that proponents of its use have won more than a few tough political battles.  Nonetheless, it is hard to escape the fact that, in recent years, the public health side has been getting killed wherever law is made. The First Amendment turns out to create a right to mine prescription records for data (Sorrell v. IMS Health), advertise liquor prices (44 Liquormart), keep warning labels off cigarette packs (RJ Reynolds v FDA)  – even operate a tattoo parlor in a city that lacks the resources to regulate its safety.  With the Heller case, the strictest forms of gun control were taken off the table, and there is a lot more litigation ahead to define what can be done. The ACA case raises the possibility of future limits on federal regulation via the spending clause. In the latest and most chilling development, the DC Circuit panel in the FDA label case laid the foundation for questioning whether there is even a rational basis for regulations aimed at discouraging people from using “lawful” but dangerous products:

We are skeptical that the government can assert a substantial interest in discouraging consumers from purchasing a lawful product, even one that has been conclusively linked to adverse health consequences.

Things aren’t a whole lot better over in the elected parts of government.  State and local health departments have been experiencing steady budget strangulation ever since (and even before) the Great Recession. The federal life-line, the Prevention and Public Health Fund, was raided once already by Congress, and remains a tempting target. Using the money we do get to promote legal interventions for health is under attack: with the help or acquiescence of Democrats, the long-standing restriction on lobbying in the HHS appropriations bill was changed. Despite legal analysis concluding that the old lines – educating public and policy makers is OK, just don’t push for specific legislation – are still in place, broad language about “future” legislation and threatening letters from an outfit called “Cause of Action” has reportedly chilled a lot of funding recipients.

For many of us, the succession of reverses and cuts looks like public health as usual: public health is usually the underdog whatever the topic. On the other hand, there are arguments that things are different now, ranging from the simple claim that the cuts have now reached bone to the belief that there is an active effort to put the “new public health” entirely out of business. So what is happening?

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Who Pays? The Wage-Insurance Trade-off and Corporate Religious Freedom Claims

By Elizabeth Sepper

Happy new year to all and thanks to the Bill of Health for the opportunity to blog this month!

The first day of 2013 saw yet another ruling in the contraception coverage controversy.  And yet another private corporation—this time a real estate management company owned by the billionaire founder of Domino’s pizza—won a temporary injunction against the mandate on religious freedom grounds.  The company’s claim boils down to this:  the Affordable Care Act forces it to pay, through its insurance plan, for healthcare (in this case contraception) to which it objects as a matter of religion.  Let’s bracket, for the moment, the question of whether an artificial entity can have religious beliefs, let alone a conscience, and ask “what wrong with this argument?”

At heart, it misses a basic fact of health economics:  health insurance, like wages, is compensation that belongs to the employee.  Study after study shows that employers pay in wages whatever they don’t pay in health insurance premiums.  Most recently, a study of Massachusetts’ health reform found that firms offering health insurance pay wages lower by an average of $6,058 (nearly exactly the cost of annual health insurance premiums).  Each employee’s actual “salary” is wages plus the employer share of the health insurance premium.  So, when a corporation purchases a health insurance plan that its employees (and their family members) may or may not use to buy contraception, it is no more paying for contraception than it does when employees use their wages to buy it.

Unfortunately, this basic fact about employer-sponsored insurance is invisible to the public.  Employees are ignorant of the effects of insurance on wages and see insurance as a gesture of goodwill with employers reaping the benefits.  This year for the first time, W-2s must list the total annual premium paid toward health insurance (thanks to the Affordable Care Act).  It’s a first step.  But I suspect that it will do little to change our societal perception of employer-sponsored insurance.  In the litigation over contraceptive coverage, I fear that courts may continue to overlook the fact that insurance (and the healthcare it buys) is paid for by employees, not employers.  If so, the courts will only open the door to future challenges to employees’ healthcare decisions, whether paid for with insurance or wages.

BU Law Conference on New Legal Challenges to Global Tobacco Control, Jan. 25, 2013

Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).

The BU Law conference  (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements.  Speakers include some of the world’s leading public health experts on this topic:

  • Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
  • Micah Berman, New England School of Law
  • Scott Burris, Temple University Beasley School of Law
  • Julien Chaisse, The Chinese University of Hong Kong
  • Richard Daynard, Northeastern University School of Law
  • Samantha Graff, NPLAN
  • Jane Kelsey, University of Auckland Faculty of Law
  • Lara Khoury, McGill University Faculty of Law
  • Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
  • Jonathan Liberman, Cancer Council Victoria
  • Benn McGrady, Georgetown University Law Center
  • Ted Mermin, Public Good Law Center
  • Kevin Outterson, BU School of Law
  • Robert Stumberg, Georgetown University Law Center
  • Allyn Taylor, Georgetown University
  • Tania Voon, University of Melbourne Law School
  • George Annas, BU School of Law and BU School of Public Health
  • Leonard Glantz, BU School of Law and BU School of Public Health
  • Wendy Mariner, BU School of Law and BU School of Public Health
  • Alexandra Roberts, BU School of Law
  • Keynote Speaker: Dr. Michael Siegel, BU School of Public Health

The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.

Bad to the Bone

By Christopher Robertson

I just came across this excellent story by Mina Kimes, which gives a detailed chronicle of how the lines between physician discretion, off-label promotion, and human subjects research can be blurred by an aggressive manufacturer, in a context where life or death is on the line (bone cement used in spine surgery).  The article also suggests themes about medical malpractice, products liability, and physicians’ conflicts of interest too.

First Amendment & Pharma: Taking Freedom of Information Seriously

By Frank Pasquale

Back in 2011, the AJLM had a symposium issue anticipating major issues in 1st Amendment limits on FDA restrictions on off-label marketing. It was a prescient move, as Prof. Robertson’s post shows. Just as it did in Sorrell, the Second Circuit is using free speech jurisprudence to significantly expand pharmaceutical companies’ freedom of action to promote drugs:

The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomniafibromyalgia and other conditions. . . .

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Court Says Off-Label Promotion is Legal, and the Difference Between Warrant and Truth

By Christopher Robertson

Invoking the First Amendment protection of speech, the Second Circuit today reversed a criminal conviction for a drug salesman’s promotion of a drug beyond its FDA-approved uses.  The case in U.S. v. Caronia; the opinion is here, and here’s the Reuters story.

In First Amendment cases like Western States Medical Center and Sorrell v. IMS, the Supreme Court has been nibbling around the edges of the FDA’s regulatory regime, but nobody — not the industry, the FDA, or the Supreme Court — has seemed eager to really take it on directly.  For decades the FDA has relied on the regulation of speech as a primary tool.  Those regs turn on the distinction between drugs’ on-label uses (for which companies can promote) and off-label uses (for which companies are not allowed to promote, since the companies have declined to prove to the FDA that the drug is safe and effective for those uses).  Physicians are free, however, to use drugs off-label, so the crux of the FDA regulation really is about whether the company can talk about (promote) a transaction that is otherwise perfectly legal.  With Caronia, the Second Circuit is striking right at the heart of this regulatory regime.

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Tobacco Companies Must Punch Selves in Face, Court Orders

By Christopher Robertson

The Washington Post covers a new order by DC district court judge Gladys Kessler, arising out of an old RICO case brought by the federal government, requiring that the tobacco companies publish advertisements to confess publicly that they previously lied about the safety of smoking and manipulated cigarettes to make them more addictive.  I have pulled the district court order and posted it here, along with this appendix.  The order provides the exact language of the mandated advertisements, but no analysis.  Below the fold, I trace the convoluted path this case and a related case have taken through the compelled speech doctrine around the First Amendment, all thanks to a single judge on the Court of Appeals.

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