Thank you for 3 great years!

Three years ago today, we launched the Bill of Health blog to create a one-stop-shop for readers interested in news, commentary, and scholarship in the fields of health law policy, biotechnology, and bioethics. We have been thrilled at the blog’s success and reach so far.

A few quick stats:

  • We have 90 contributors from 49 institutions around the globe.
  • More than 350,000 unique visitors from more than 200 countries have visited the blog since it was first launched.
  • The blog gets more than 17,000 page views per month.
  • We’ve clocked in over 2,000 blog posts covering a wide range of topics:
    • Health insurance, health care finance, health care reform
    • Reproductive health and rights
    • Pharmaceutical regulation
    • Food safety and regulation
    • Human subjects research
    • Personhood and animal rights
    • General health law, policy, and bioethics

As a sample, here are the top five most viewed posts from each academic year:

2012 – 2013

  1. The High Cost of Health Care: Why Some Pay $240 for a $9 Bottle of Pills, by Jonathan Darrow
  2. Finasteride as an FDA-Approved Baldness Remedy: Is It Effective?, by Jonathan Darrow
  3. Liability for Failure to Vaccinate, by Arthur Caplan
  4. Discrimination in the Doctor-Patient Relationship, by Holly F. Lynch
  5. At $28,000 a Dose, How Effective Is Acthar?, by Jonathan Darrow

2013 – 2014

  1. Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON, by Jonathan Darrow
  2. Taking China’s Food Safety Problem Seriously (I), by Ching-Fu Lin
  3. Medical Marijuana Delivery May Not Be As “Eazy” As It Seems, by Arielle Lusardi
  4. Taking China’s Food Safety Problem Seriously (II), by Ching-Fu Lin
  5. Ethical Concerns, Conduct and Public Policy for Re-Identification and De-identification Practice: Part 3, by Daniel Barth-Jones

2014 – 2015

  1. Highlights from the 21st Century Cures Act, by Rachel Sachs
  2. Savior Siblings in the United States, by Zachary Shapiro
  3. New browser app shines light on conflicts of interest, by Christine Baugh
  4. A New Cholesterol-Lowering Drug at What Price?, by Kate Greenwood
  5. Pain on the Brain: A Week of Guest Posts on Pain Neuroimaging & Law by Amanda C. Pustilnik

Thanks to our many contributors – and to our readers!  We look forward to many more years of growth.  And always, if you have any comments or suggestions, make sure to send them our way: petrie-flom@law.harvard.edu.  Happy reading!

Glenn and Holly 
Bill of Health Co-Editors

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Malpractice at the Front Desk

By Alex Stein

Georgia’s Court of Appeals recently categorized a clinic’s front-desk person’s failure to communicate a patient’s complaints to the doctors as ordinary negligence rather than medical malpractice. Wong v. Chappell, 773 S.E.2d 496 (Ga.App. 2015).

This categorization has four important implications:

First, it allows an aggrieved patient to file her suit and proceed to trial without obtaining expert testimony and a preliminary affidavit (or certificate of merit) from a qualified physician.

Second, it frees plaintiffs from the stringent limitations and repose rules that apply in medical malpractice actions. Continue reading

Ohio State Seeks Founding Director of New Program on Data, Law, Ethics and Policy

By:  Efthimios Parasidis

The Ohio State University Moritz College of Law seeks a mid-level to senior tenured professor to serve as Professor of Law and founding director of the Program on Data, Law, Ethics and Policy (“DLEAP”) at the College, part of the Ohio State University’s Translational Data Analytics Discovery Theme initiative. The successful candidate will demonstrate excellence in scholarship and a commitment to outstanding teaching.   The position, a 51% FTE appointment, will begin in the 2016-17 academic year.

As a faculty member the successful candidate will be expected to teach core and specialized courses in the law curriculum. The research and teaching interests of the successful candidate will likely focus on privacy law and regulation, information- and cyber-security, big data and data mining, and/or related health law and intellectual property issues.   As the director of DLEAP, he or she will be responsible for building the research program, with a small staff and an assortment of affiliated faculty. A successful candidate must be capable of leading DLEAP in employing legal, regulatory, and policy expertise to focus on the social and ethical impact of big data and in serving as a complement and resource for other Translational Data Analytics initiatives at Ohio State and to the broader data analytics community. Continue reading

Worth Reading This Week

By Nicolas Terry

Call for Papers: Designing Ethical Review Processes for Big Data Research

The Future of Privacy Forum is hosting an academic workshop supported by the National Science Foundation to discuss ethical, legal, and technical guidance for organizations conducting research on personal information. Authors are invited to submit papers for presentation at a full-day program to take place on December 10, 2015. Papers for presentation will be selected by an academic advisory board and published in the online edition of the Washington and Lee Law Review. Four papers will be selected to serve as “firestarters” for the December workshop, awarding each author with a $1000 stipend. Submissions, which are due by October 25, 2015, at 11:59 PM ET, must be 2,500 to 3,500 words, with minimal footnotes and in a readable style accessible to a wide audience. Publication decisions and workshop invitations will be sent in November. Details here.

‘The Week in Health Law’ Podcast

By Nicolas Terry

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Nic welcomes studio guests law professor Barbara Evans & bioethicist Eric Meslin. The primary topic is the future of research and its regulation, leading to a broad-ranging discussion that includes the future of the FDA, emerging research models, and how consent & autonomy fit into this changing ecosystem. Eric mentioned an interesting article by Neal Lane and you should check out some excellent contributions by Barbara dealing with the FDA and Genomic Tests and other regulatory issues.

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 iTunes, listen at Stitcher RadioTunein and 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

Doubling Down on Prosecutorial Discretion

By Zack Buck

Health care entities should be “on high alert” following the Southern District of New York’s decision in Kane v. Continuum Health Partners that I blogged about here earlier this month.

The case, which serves as the first and most consequential interpretation of when an overpayment is “identified” for purposes of False Claims Act (FCA) liability, provides a measure of much-needed guidance for attorneys and compliance officers in an area that is rife with confusion. But not too much.

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New DTCA Guidance — Enough to Empower Consumers?

Bill of Health contributor Christopher T. Robertson has a new Op-Ed out in the New England Journal of Medicine:

As one of only two countries that permit direct-to-consumer advertising (DTCA) of pharmaceuticals, the United States tasks the Food and Drug Administration (FDA) with regulating that advertising to ensure that it doesn’t mislead consumers. When a drug maker publishes or broadcasts a claim that its drug has benefits in a particular disease, the FDA requires it to include information on the product’s risks as well. Since it’s not feasible for companies to include all the important information about their products in a television ad, the FDA requires them to refer viewers to more complete information, such as that in a printed magazine ad. Companies have tended to comply with this requirement by supplementing colorful, persuasive ads with one or two pages of dry text providing the required disclosures, often simply using language that the FDA has approved for other purposes, such as package inserts for prescribers. But research shows that most patients who attempt to read these disclosures find them difficult to understand, and many don’t even try to make sense of them.1 Now, the FDA is in the process of adjusting its DTCA rules, aiming to provide greater assurance that patients receive due warning of the most significant risks — but its tweaks probably don’t go far enough to really empower consumers to make smart decisions about the drugs they put into their bodies. […]

Read the full article here.

(UPDATED) Defendants’ Motion for Summary Judgment Granted in Looney v. Moore (SUPPORT trial lawsuit)

UPDATE: Plaintiffs have filed an appeal in the U.S. Court of Appeals for the Eleventh Circuit. Their brief is due on October 19.

The district court has granted summary judgment (opinion pdf) for all remaining defendants as to all of plaintiffs’ remaining claims in Looney v. Moore, the lawsuit arising out of the controversial SUPPORT trial, which I last discussed here. This therefore ends the lawsuit, pending possible appeal by the plaintiffs.

Plaintiff infants include two who were randomized to the low oxygen group and survived, but suffer from “neurological issues,” and one who was randomized to the high oxygen group who developed ROP, but not permanent vision loss. In their Fifth Amended Complaint (pdf), plaintiffs alleged negligence, lack of informed consent, breach of fiduciary duty, and product liability claims against, variously, individual IRB members, the P.I., and the pulse oximeter manufacturer. What unites all of these claims is the burden on plaintiffs to show (among other things) that their injuries were caused by their participation in the trial. Continue reading

Fetal Personhood and the Constitution

By John A. Robertson

The Rubio-Huckabee claim that actual and legal personhood start at conception has drawn trenchant responses from Art Caplan on the medical uncertainty of such a claim and David Orentlicher, drawing on Judith Thomson’s famous article, that even if a fetus is a person, woman would not necessarily have a duty to keep it in her body.

Their debate claim that the fetus is already a legal person under the constitution also deserves a response, for it has no basis in positive law.  In Roe v. Wade all nine justices agreed that the use of “person” in the Constitution always assumed a born person, and therefore that the 14th Amendment’s mention of person did not confer constitutional rights until after a live birth.  In the years since Roe, when the make-up of the court has changed, no justice has ever disagreed with that conclusion, including those who would overturn Roe and Casey. Continue reading

Bioethicist Art Caplan: Marco Rubio And The GOP’s Dangerous Misconception On When Life Begins

Bill of Health Contributor Art Caplan has a new piece up on Forbes:

Does human life begin at conception? For Marco Rubio and some other politicians now running for the presidential nomination in the GOP herd, the answer is yes. There is no doubt in their mind about when life begins. Amazingly despite indifference to science regarding other matters like evolution and climate change, they invoke science on behalf of their advocacy of what might best be called “conceptionalism.” And given what science shows the law must protect every new life.

Those lobbying for conceptionalism aim to outlaw all abortions, no matter how an embryo is conceived. Even if a mentally ill 12-year-old woman is raped by her predatory father, killing an embryo, if one results, ought not be a legal option in their view. When life begins at conception murder is never an option, Rubio and his fellow-travelers aver. [..]

Read the full article here.

Bioethicist Art Caplan: All Hat, No Cattle—The False Hope of Right-to-Try Laws

Bill of Health contributor Arthur Caplan and Alison Bateman-House have a new piece up in Harvard Health Policy Review:

Are right-to-try laws a good idea? In 2014, they began appearing throughout the United States, first in Colorado and now in 23 states, with several more considering passing versions of this popular legislation.

At first glance these bills may seem worth enacting. Right-to-try (RTT) laws promise terminally ill patients that they can obtain experimental drugs or medical devices in their quests to save or extend their lives. These investigational medical products are still in development and have not yet met the requirements set by the Food and Drug Administration (FDA) in order to be approved for sale or use in the United States. In some cases, the products are still being tested and patient access would primarily be by enrolling in a clinical trial – something terminally ill people may be too unwell to do. Less commonly, the products have completed clinical testing and are waiting for an approval verdict from the FDA. In either case, RTT laws are about providing terminally ill patients access to unapproved drugs or devices. […]

Read the full article here.

Journal of Law and the Biosciences: Call for Harvard Student Submissions

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish the Journal of Law and Biosciences  (Oxford University Press), an online, open-access, peer-reviewed journal. JLB includes a Notes & Developments section, comprised  of  brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools. The Petrie­Flom Center is responsible for providing the Notes & Developments for one issue per annual volume.

We are currently seeking Harvard graduate students to contribute papers to be published in JLB’s Notes & Developments section in early 2016. In previous years, Notes & Developments have been generated from scratch specifically for JLB, based on selection from submitted proposals. This year, we are taking a different approach by publishing already complete (or to-be-completed by the deadline) original student papers (such as student notes, course papers, etc.) written by graduate students from any Harvard school.  Notes & Developments are limited to 5000 words, including footnotes and references,  and  should  be  on  a  topic  of  relevance  to  law  and  the  biosciences,  in particular a topic of relatively recent concern, controversy, or change. They should focus on  describing  the  issue  at  hand,  explaining  why  it  is  relevant to scholars and practitioners, and providing analysis and questions for further consideration.

Interested students should submit their papers and CVs for consideration no later than September 7, 2015 (earlier  is  welcome). Up to four papers will be selected for publication in the New Developments section of JLB. Applicants will be notified by the end of September. Selected students will receive comments on their papers by the end of October, and will also be responsible for providing comments to the other selected students. Revisions will be due by the end of November, and final submissions to JLB will be due by the end of December 2015.

Please send all application materials, and direct all questions, to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Affective Forecasting and Genetics

by Zachary Shapiro

Psychological research on “affective forecasting,” studying individuals’ ability to predict their future emotional states, consistently shows that people are terrible at predicting their ability to adapt to future adversity. This finding has particular significance for medical decision-making, as so many serious health decisions hinge on quality-of-life judgments, generally made by an individual balancing risks and benefits they perceive of a future state that is likely to result from a given therapeutic regime.

Much of the research on affective forecasting has focused on high-stakes events, restricting study participation to those likely to find the study event particularly significant, such as tenure-track faculty, registered voters, or sports enthusiasts. Despite a growing body of research on forecasting biases in the medical domain, little work has previously systematically considered such biases in clinical genetics. However, as the prevalence of genetic testing has increased, scholars have noticed forecasting deficiencies with increasing regularity.[1]

While evidence suggests that those who receive genetic testing, whether they are non-carriers or carriers of specific genes, differ in terms of short-term general psychological distress, their long-term distress levels do not differ significantly. Results of research into the affective reactions of patients undergoing predictive genetic testing suggest that, in general, psychological outcomes are not as negative as one may expect.

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Bureaucracy Can Save Lives – The Legacy of Dr. Frances Kelsey

By Robert Field

What adjective would most people associate with the word “bureaucrat”? For many, it would be “inefficient,” “inept,” or “incompetent.” But another that is just as descriptive is “lifesaving.”

Dr. Frances Kelsey, who died this month at the age of 101, was celebrated as an American hero for her work as a medical officer at the Food and Drug Administration (FDA). She saved thousands of lives and prevented untold suffering by using techniques that earn bureaucrats a bad name, delay and obstruction, to keep the drug thalidomide from reaching the market in the United States in 1961.

Thalidomide is a sedative that had been approved for sale in Europe four years earlier and was prescribed for morning sickness during pregnancy. The American manufacturer, Richardson-Merrell, saw a large potential market in the United States. However, Dr. Kelsey, who was assigned to review its application for marketing approval, was troubled by questionable safety data. The law in effect in 1961 required that she issue a decision within 60 days, but she was able to buy more time by asking for additional information.

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Interpreting Fiorina’s Comments on Vaccination Law

I’ve started writing for Forbes as a regular contributor. My first piece, Carly Fiorina Says Her Views On Vaccines Are Unremarkable; For Better Or Worse, She’s Right, analyzes GOP presidential candidate Carly Fiorina’s recent ad hoc remarks on the relative rights of parents and schools with respect to vaccinations and to some of the hyperbolic reactions to those remarks. Fiorina’s remarks are ambiguous, in ways that I discuss. But, as the title of the article suggests, and for better or worse, I think that the best interpretation of them places her stance squarely in the mainstream of current U.S. vaccination law. I end with a call for minimally charitable interpretations of others’ views, especially on contentious issues like vaccination.

A Very Special ‘The Week in Health Law’ Podcast

By Nicolas Terry

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TWIHL presents its first Back to School Special. We asked some wonderful health lawyers what were the compelling additions to this Fall’s health law curriculum. The answers are diverse and fascinating. To hear their explanations look for episode 22 when you subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app.

We are extremely grateful to the following (with links to their recommended topics):
Micah Berman – PBS Unnatural Causes
Erin Fuse Brown – Physician Self-Referral Updates (STARK)
Glenn Cohen – Egg freezing and egg banking: empowerment and alienation in assisted reproduction
Brietta Clark – Pickup v. Brown
Nicole Huberfeld – Armstrong v Exceptional Child Center Inc. 
Elizabeth Weeks Leonard – King v. Burwell
Frank Pasquale – Narrow Networks
Ross Silverman – Should childhood vaccination against measles be a mandatory requirement for attending school? Yes
Norman G. Tabler, Jr.–  Can an Arbitrator Rule Against a Hospital for Not Violating the Anti-Kickback Statute?
Nicolas Terry – North Carolina State Board of Dental Examiners v. Federal Trade Commission

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.

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

Akamai v. Limelight: Implications for Medical Method Patents (Redux)

Yesterday, the Court of Appeals for the Federal Circuit issued a unanimous en banc ruling in Akamai v. Limelight, altering the reach of patent liability for induced infringement of a method claim under 35 U.S.C. § 271(b).  This is the second time the en banc court has considered Akamai.  Three years ago, in a splintered decision, a majority of the court had ruled that liability for induced infringement was possible where no single entity had performed all the steps of a claim, but where those steps were divided between two or more parties, one of whom had induced the other(s) to infringe.  In 2014, the Supreme Court reversed, essentially reinstating this single entity rule, and after a panel opinion largely adopting the Supreme Court’s reasoning, a unanimous en banc court has now broadened – at least somewhat – the scope of divided infringement liability, relative to the Supreme Court’s decision.

More specifically, the Federal Circuit concluded that an entity may be held liable for others’ performance of steps of a method claim “in two sets of circumstances: (1) where that entity directs or controls others’ performance, and (2) where the actors form a joint enterprise.”  Noting the court’s prior holdings that these circumstances are met where there is an agency relationship between the relevant actors or there are explicit contractual duties to perform the steps of the method claims, the en banc court added another such circumstance in which liability may be found: “when an alleged infringer conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.”  Because this third condition was present in the case under consideration, the Federal Circuit deemed Limelight liable for infringement.

Exactly thirteen months ago, after the Supreme Court’s decision but before the Federal Circuit had considered the case on remand, I had blogged here about the case’s potential implications for diagnostic method patents.  (For those interested in this field, I then wrote a longer article about diagnostic technologies more broadly, which features a more detailed explanation of this issue.) Essentially, my argument was that the increasing restrictions the courts have placed on patentable subject matter under 35 U.S.C. § 101 would interact with these new divided infringement rules.

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Clarity for an “Unforgiving” and “Potentially Unworkable” Rule

By Zack Buck

In a case previously blogged about here, last week, the Southern District of New York denied Defendants’ motion to dismiss in U.S. ex rel. Kane v. Continuum Health Partners, No. 11-2325, in a major decision for health care entities unclear on the parameters of overpayment liability under the False Claims Act (FCA).

The case centers on Continuum Health Partners, Inc. (Continuum)—which operated three New York City area hospitals—and its erroneous receipt of overpayments from the New York Medicaid program based on a software glitch. The overpayments began in 2009; by September 2010, the New York State Comptroller had notified Continuum. Continuum tapped Robert Kane, an employee, to review the billing data and identify all claims that were incorrect. On February 4, 2011, Kane emailed a spreadsheet to superiors that contained 900 claims that may have been erroneously billed. The spreadsheet was “overly inclusive” and “approximately half of the claims listed therein were never actually overpaid.” On February 8, Kane was terminated.

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