Month: June 2017

Keeping an Eye on the Eleventh

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By Zack Buck

A particularly noteworthy health care fraud case—one that could have a major impact on the falsity requirement of the Federal Civil False Claims Act (FCA)—awaits a decision from the Eleventh Circuit as we enter the second half of 2017.  U.S. v. AseraCare, a case that could determine whether “objective falsity” and not only a “difference of opinion” is required for FCA liability, had oral arguments in mid-March in front of the Eleventh Circuit, and has been called a “case to watch” in 2017.  A decision is still forthcoming.

AseraCare was particularly notable because the FCA claim—which was alleged against the corporate hospice provider for allegedly fraudulently certifying individuals for hospice eligibility among other alleged claims—was abruptly dismissed in the Northern District of Alabama in 2016.  Rejecting the claims because the government failed to prove that the claims at issue were objectively false, Federal District Court Judge Judge Karon Owen Bowdre found that the government only proved that a clinical disagreement existed as to whether or not the patients should have been certified as hospice-eligible, which was insufficient to prove a false claim under the FCA.  According to the court, allowing the government to prove that a FCA action could be maintained based only upon the government’s disagreement with the defendant’s clinical judgment would allow the government to “short-circuit” the FCA’s falsity requirement. Read More

Michele Goodwin on ‘The Week in Health Law’ Podcast

Nicolas P. Terry Leave a comment

By Nicolas Terry and Frank Pasquale

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This week, University of California, Irvine Law Professor Michele Bratcher Goodwin offers a detailed and insightful analysis of an increasingly adversarial relationship between women and the state. In a series of articles, Goodwin has demonstrated that pregnancy is being policed by an array of oppressive state laws, many of which are being used in contexts far removed from their legislative intent. She asks in “The Pregnancy Penalty,” “If a woman is fourteen times more likely to die during pregnancy and childbirth than terminating a pregnancy through a legal abortion, why do some lawmakers resist support for contraception and seek to criminalize abortions?” Today’s podcast includes many troubling answers, rooted in historical and social theoretical analysis.Our conversation includes a detailed look at leading abortion cases and their limitations. We end with a disturbing narrative about under-age marriages in the US, often in circumstances that otherwise would be statutory rape. Goodwin describes the failed institutions that have made underage marriage a global problem.

Michele Goodwin is a Chancellor’s Professor at the University of California, Irvine with appointments at the School of Law; Program in Public Health; Department of Criminology, Law, & Society; Department of Gender and Sexuality Studies; and Stem Cell Research Center. Her publications include six books and over 80 articles and book chapters on law’s regulation of the human body, including civil and criminal regulation of pregnancy and reproduction, reproductive technologies, human trafficking (for organs, sex, and marriage), and tissue and organ transplantation.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

FDA v. Opana ER: Opioids, Public Health, and the Regulation of Second-Order Effects

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Earlier this month, the FDA announced that it is asking Endo Pharmaceuticals to remove the opioid Opana ER from the market.  Opana ER is an extended-release pain reliever often abused by those who take it.  While opioid abuse is nothing new, and many opioids leave those who take them addicted to narcotics or heroin, Opana ER is particularly dangerous because of how people misuse it.  The pill was designed to prevent would-be abusers from crushing and snorting it —  a popular means of ingesting prescription opioids.  Without the ability to crush and snort the drug, however, abusers turned to dissolving the pills and injecting them intravenously, leading to outbreaks of Hepatitis C, HIV, and other blood-borne diseases.  In Indiana’s Scott County, for instance, the prevalence of HIV has skyrocketed since the introduction of Opana ER to the local population, with 190 new cases since 2015.

While this foray into public health is somewhat surprising — given the anti-regulatory stance of the current administration and its billionaire backers — it is precisely the type of initiative the FDA should be taking.  Public health is a central part of the FDA’s mission statement, which notes that the agency “is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.”  Traditionally, though, the FDA’s efforts to ensure safety and efficacy have been limited to the narrow context of individual patients taking medications as directed under physician supervision.  As the FDA noted in its Opana ER press release, this is the first time it has requested that an opioid be taken off the market as a result of its susceptibility to abuse and the associated public health consequences.

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Better Care Act Targets Immigrants

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If you need yet another reason to conclude that the Senate Republicans’ proposed health care bill – the so-called Better Care Reconciliation Act (BCRA)– is designed more to appease different parts of the Republican base than improve the health care financing system, look no further than page 2 of the draft. There hiding in plain sight are provisions barring certain classes of documented immigrants from participating in health insurance exchanges. To understand why the bill includes these provisions, and why they make no sense from a health policy perspective, a bit of history is helpful.

As Patricia Illingworth and I document in our recent book, The Health of Newcomers: Immigration, Health Policy, and the Case for Global Solidarity, anti-immigrant sentiment has long distorted health policy. That was the case during the summer of 2009, when opponents of what became the ACA rallied in town hall meetings charging that President Obama wanted to provide coverage to undocumented immigrants. When Obama pledged to a joint session of Congress that undocumented immigrants would not be covered by his plan, Rep. Joe Wilson of South Carolina shouted out “You lie.” Read More

Making Health Care Safer: What Good Looks Like

John Tingle Leave a comment

It’s fair to say that patient safety and health quality reports in recent years have tended to focus on what is going wrong in the NHS and what needs to be done to put things right.We have had some dramatic health care systems failures which have resulted in unnecessary deaths of patients.The naming and shaming of errant health care providers has taken place and we have now through the CQC (Care Quality Commission), a much more open, stronger, intelligent and transparent way of regulating health care quality than we have ever had before.

The health care regulatory system does seem to be making a positive difference to NHS care judging from recent CQC reports with some good examples of health quality and safe care practices taking place. Other trusts can learn from these practices.

The CQC have just published a report which includes several case studies illustrating some of the qualities shown by care providers that are rated good or outstanding overall. These hospitals known as hospital trusts in the NHS have been on a journey of improvement some going from special measures to good (CQC inspection ratings). The views of some of the people involved in the care improvement initiatives are stated in the case studies revealing important insights on improvement strategies and the nature of the problems overcome. Read More

Vaccine Liability in Europe: A New Development

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By Alex Stein

Yesterday, the European Court of Justice has issued an important ruling on vaccine manufacturers liability. N.W. et al. v. Sanofi Pasteur MSD, C‑621/15. This ruling triggered a hailstorm of criticism from different media outlets, including CNN. These outlets, however, have largely misreported the ruling and its underlying reasons, partly because of this misleading Press Release issued on behalf of the Court itself. In this post, I analyze the Court’s actual decision and briefly compare it with the American law.

The case at bar was about an adult patient who developed multiple sclerosis shortly after being vaccinated against Hepatitis B. The vaccination he received was manufactured by Sanofi Pasteur. Following the patient’s death from multiple sclerosis, his family filed a products liability suit against the company. The suit was filed in a French court, whose decision on evidentiary matters triggered a series of appeals that brought the case before the European Court of Justice. The Court was asked to determine whether the French evidentiary rule which allows plaintiffs to prove the vaccine’s defect and causation by “serious, specific and consistent evidence” in the absence of medical research in either direction aligns with the European law of products liability. The Court ruled that it does while making a number of clarifications and setting up conditions for such rules being valid under Article 4 of the European Council Directive 85/374/EEC of 25 July 1985. Read More

Webinar, 6/28: Procedural Aspects of Compulsory Licensing under TRIPS

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Join us at yet another webinar with J. Wested at the University of Copenhagen. This time we will debate procedural issues in compulsory licensing with H. Grosse Ruse-Kahn (University of Cambridge) & M. Desai (Eli Lilly). Further information on our webinar series is available at here, here, and below:

Procedural Aspects of Compulsory Licensing under Trade-Related Aspects of Intellectual Property Rights (TRIPS)

Wednesday 28. June 2017
4-6 p.m (CEST)
Sign-up & questions: Jakob.blak.wested@jur.ku.dk

This webinar on “TRIPS and the life sciences” will approach the question of compulsory licensing by looking at the technical and procedural requirements applied by courts when evaluating a petition for a compulsory license.  

The balancing of the instrumental application of patent rights as a stimulator of innovation and the public interest in having access to these innovations form a controversial trajectory of discourse, which is as old as patent law. Compulsory licenses are one of the means that have been applied throughout the history of patent law, to condition this complex intersection of interests. The TRIPS agreement is no exception and art 31 contains the provision for member states to grant CL. In 2013, the Indian authorities granted a compulsory license to NATCO Pharmaceuticals for Bayers patented pharmaceutical product Carboxy Substituted Diphenyl Ureas, useful for the treatment of liver and kidney cancer. This decision raised several issues regarding the procedures and requirements to be met in order to grant a compulsory license. Furthermore, in January 2017 an amendment to TRIPS agreement entered into force allowing compulsory licensors to export their generic pharmaceuticals to least developed countries, further recalibrating the intersection of the monopoly power of the patent and public interest. Read More

Jaime King on ‘The Week in Health Law’ Podcast

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By Nicolas Terry and Frank Pasquale

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Hastings law professor and antitrust expert Jaime King joins us to discuss competition and consolidation in healthcare delivery. We discussed (apparently) pro-competitive collaborations, price transparency models, the limits of demand-side reforms, Gobeille’s interpretation of ERISA as a major blow to state initiatives, and innovative cross-market merger activity. Be sure to follow Jaime’s scholarly work at SSRN, and to keep up with her Source on Health Care Price & Competition, which has up-to-the-minute aggregators on key issues in health care finance.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Housing Equity Week in Review

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Our latest round-up of the biggest stories in housing law and equity, for the week of June 12-18, 2017:

  • The Joint Center for Housing Studies of Harvard University released the yearly State of the Nation Housing report. The report encourages a renewed national commitment to expand the range of housing options available.
  • A NY State Appellate Court struck down a chronic nuisance ordinance in Groton, NY, because of provisions that led to the eviction of those who seek emergency services. Story via Ithaca.com
  • The Out of Reach report and tool that was published a couple of weeks ago by the National Low Income Housing Coalition is getting press around the country for showing the gap between current wages and rents in most US cities. This article, from CNBC highlights the lack of affordable housing for minimum wage workers.
  • An opinion piece in The Hill makes, again, the case for investment in housing as an investment in childhood development and health.
  • 79 people are presumed dead in the fire at Grenfell Tower in London. Some argue that the tragedy should be a red light for distressed public housing in the US.
  • The Philadelphia Inquirer posted its second article in its Toxic City series. This most recent article investigates lead-poisoned soil in the city’s River Wards neighborhoods. While lead paint is often considered the biggest danger to children, in these areas and others, the soil may be a great danger.

Monthly Round-Up of What to Read on Pharma Law and Policy

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By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of May. The selections feature topics ranging from post-approval safety events among novel drugs approved between 2001 and 2010, to the failure of the Alzheimer’s drug Solanezumab, to the three-year impacts of the Affordable Care Act among low-income adults. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA. 2017 May 9;317(18):1854-1863.
  2. Gellad WF, Kesselheim AS. Accelerated approval and expensive drugs – a challenging combination. N Engl J Med. 2017 May 25;376(21):2001-2004.
  3. Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. BMJ. 2017 May 3;357:j1680.
  4. Sacks CA, Avorn J, Kesselheim AS. The failure of Solanezumab – how the FDA saved taxpayers billions. N Engl J Med. 2017 May 4;376(18):1706-1708.
  5. Sommers BD, Maylone B, Blendon RJ, Orav EJ, Epstein AM. Three-year impacts of the Affordable Care Act: improved medical care and health among low-income adults. Health Aff (Millwood). 2017 Jun 1;36(6):1119-1128.