Understanding “Lost Chances to Recover” (and Looney v. Moore)

By Alex Stein

My colleague, Professor Tony Sebok, drew my attention to an important recent decision, Looney v. Moore, 2015 WL 4773747 (N.Dist.Ala. 2015, by Chief United States District Judge Karon O. Bowdre). This decision adjudicated a textbook lost-chance case that involved the effects of oxygen saturation levels (SpO2) in premature infants with extremely low birth weights (ELBW). For any such infant, high SpO2 levels involved (among other complications) the risk of blindness caused by retinopathy of prematurity (ROP). On the other hand, low levels of SpO2 could lead to life-threatening neurodevelopmental impairments (NDI). The neonatologists’ customary practice was to maintain SpO2 levels in ELBWs between 85% and 95%. The effects of variations within that nationally accepted range were hitherto unknown.

To find out what those effects are, the defendants conducted a clinical trial. They divided the nationally accepted range of SpO2 levels into a high range (90%- 95%) and a low range (85%-90%). Infants whose parents agreed to participate in that trial—all having an extremely low birth weight—were randomly placed in either of the two groups. By making that division, the defendants tracked the infants’ rates of NDI, on one side, and ROP, on the other side.

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TOMORROW, 11/4! Reflections in Honor of the Life and Influence of Professor Alan Wertheimer

Wertheimer_teaching_slideReflections in Honor of the Life and Influence of Professor Alan Wertheimer
November 4, 2015, 1:00 – 5:30 PM
NEW LOCATION:
Wasserstein Hall, Milstein West B (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

Please join us for an afternoon of reflection on the life, work, and enduring influence of Professor Alan Wertheimer (1942-2015). Professor Wertheimer was a leading philosopher of law and bioethics, making critical contributions to clinical research ethics; theories of coercion, undue influence, and exploitation; consent in a variety of contexts, and much more. This tribute event will feature leading scholars discussing and engaging with Professor Wertheimer’s many contributions, and exploring how he influenced their own work.

At the time of his death in 2015, Alan Wertheimer was Senior Research Scholar in the Department of Bioethics at the National Institutes of Health. Continue reading

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

By Ameet Sarpatwari 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, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of October. The selections feature topics ranging from the use of superlatives in cancer research, experience with the priority review voucher for neglected tropical and rare pediatric diseases, to a decision-making framework for gatekeepers of pragmatic clinical trials. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Abola MV, Prasad V. The Use of Superlatives in Cancer Research. JAMA Oncol. 2015 Oct 29. [Epub ahead of print].
  2. Downing NS, Krumholz HM, Ross JS, Shah ND. Regulatory watch: Characterizing the US FDA’s approach to promoting transformative innovation. Nat Rev Drug Discov. 2015 Oct 5. [Epub ahead of print].
  3. Ioannidis JP, Fanelli D, Dunne DD, Goodman SN. Meta-research: Evaluation and Improvement of Research Methods and Practices. PLoS Biol. 2015 Oct 2; 13(10):e1002264.
  4. Kesselheim AS, Maggs LR, Sarpatwari A. Experience With the Priority Review Voucher Program for Drug Development. JAMA. 2015 Oct 27; 314(16):1687-8.
  5. Kim C, Prasad V. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals. JAMA Intern Med. 2015 Oct 19. [Epub ahead of print].
  6. Langedijk J, Ebbers HC, Mantel-Teeuwisse AK, Kruger-Peters AG, Leufkens HG. Licensing failure in the European decentralised procedure. Eur J Pharm Sci. 2015 Oct 19. [Epub ahead of print].
  7. Luo J, Kesselheim AS. Evolution of insulin patents and market exclusivities in the USA. Lancet Diabetes Endocrinol. 2015 Oct 6. [Epub ahead of print].
  8. Whicher DM, Miller JE, Dunham KM, Joffe S. Gatekeepers for pragmatic clinical trials. Clin Trials. 2015 Oct; 12(5):442-8.

House of Reps v. Burwell: A Case Worth Following

By Matthew Ryan, Harvard Health Law Society

With the final judgment in King v. Burwell this summer upholding federal subsidies for health insurance, many legal analysts believed that lawsuits against the Affordable Care Act had ended. But the House of Representatives had other plans. In July of 2014, the House of Representatives voted on partisan lines to sue President Obama for overstepping his constitutional bounds. The House alleged that the President did not faithfully execute the Affordable Care Act with regard to two executive actions. First, the Obama Administration authorized payments to insurance companies to assist with cost sharing. The House argued Congress never appropriated these funds. Second, the House alleged that the Obama Administration unlawfully delayed the employer mandate at a $12 billion cost to taxpayers.

In September, the United States District Court for the District of Columbia cleared a major hurdle for the House: the court granted standing to the plaintiffs for their challenge to the Administration authorizing cost sharing funds without Congressional appropriation. The court did not grant standing with regards to the employer mandate implementation. Continue reading