HealthLawProf Blog

Guest Blogger Professor Rebecca Dresser: When Research Subjects Don’t Follow the Rules

Research participants don’t always do what they are supposed to do. When their personal interests conflict with the demands of study participation, some participants surreptitiously break the rules. Rule-breaking participants don’t normally intend to compromise the study process; they simply see their own interests as more important than study rules aimed at generating good data.

Some participants have written about their rule-breaking and others have disclosed it to reporters and scholars writing about human trials. Researchers also report discovering various forms of rule-breaking that participants tried to hide. But because not many studies use techniques that can uncover rule-breaking, much of the behavior isn’t detected.

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Information Blocking and Interoperability

Cross-Posted from Bill of Health

The “Cromnibus” spending bill signed by the President on December 16 rightly upset Senator Warren and not just for providing luxury cars to a feckless Congress. However, in general the bill ignored healthcare. There was no new money for those ACA “villains” CMS and IRS and only a little more for NIH (resulting in net reductions all around given inflation). Of course constituencies have to be pandered to, so there was a symbolic $10 million cut from the moribund IPAB. Meanwhile, the CDC did well, HRSA picked up a few telemedicine dollars, but ONC didn’t get everything it wanted. However, look closer and it seems that during the convoluted legislative process someone threw a meaty wrench into the gears of an already flailing meaningful use program.

As I have discussed at length here and here the meaningful use subsidy program for EHRs may have delivered hundreds of thousands of mediocre electronic health records systems into provider offices but has failed to deliver effective data sharing. ONC knows this is an issue, is aware of and discussed the JASON report, has its own “10-year vision” and emphasizes interoperability in its recently released Health IT Strategic Plan (Disclosure: I serve on the HIT Committee Consumer Workgroup, but these views are mine alone). But, some kind of showdown has been brewing for a while. Have the HITECH billions been wasted? Was the regulatory problem in meaningful use or in certification? Are the HIT developers to blame or health care providers? (Answer: Yes). And, the AMA being “appalled” aside, what happens now that the meaningful use carrots have begun morphing into sticks?

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Employer Liability for Privacy Torts

It's been almost a year since the publication of the HIPAAA Omnibus Rule. Since then then the regulatory mavens have been quiet. And that's not surprising. Solutions for our contemporary health privacy challenges such as big data and information collected by mobile apps generally lie outside the scope of HIPAA. In the interim some state courts have been showing surprising vitality in filling HIPAA’s remedial gap, the absence of a private right of action.

In Walgreen Co. v. Hinchy, 2014 WL 6130795 (Ind. Ct. App.), Withers, the defendant's employee-pharmacist, viewed the prescription records of the plaintiff-customer. Withers then divulged the information she learned from those records (including that the plaintiff had failed to fill her oral contraception prescription) to her husband, the customer’s ex-boyfriend and the father of the plaintiff’s child. Plaintiff brought breach of privacy claims agains the pharmacist and alleged both vicarious liability and direct negligence against the employer pharmacy chain. The jury returned a verdict for $1.8 million.

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Published This Week

Marshall B. Kapp, Getting Physicians and Patients to Choose Wisely: Does the Law Help or Hurt?, 46 U. Tol. L. Rev. (Forthcoming 2015).

Michael Ashley Stein, Christopher P. Guzelian, Kristina M Guzelian, Expert Testimony in Nineteenth Century Malapraxis Actions, 55 Am. J. Legal Hist. 284 (2015).

Natalia Silva, Mental Insanity at the International Criminal Court: Proposal for a New Regulation, SSRN.

Omar Ha-Redeye, New Tort of Intrusion Upon Seclusion and Electronic Health Records, SSRN.

I. Vivas-Tesón, Bioresearch, Biobanks and Informed Consent from Vulnerable Donors in Spanish Law, SSRN.

Mark A. Rothstein, Ethical Issues in Big Data Health Research, 43 J. of Law, Med. & Ethics (Forthcoming 2015).

Aliza Y. Glasner, Erin E. Wilhelm, Lawrence O. Gostin, Ira Shoulson, Facilitating Medical Product Development Through Voluntary Data Sharing: A Look at the Legal Issues, SSRN.

Daniel James Sheffner, Fatal Medical Negligence and Missouri's Perverse Incentive, 7 St. Louis U. J. Health L. & Pol'y 147 (2013).

Guest Blogger Professor Rebecca Dresser: The Value of Role Reversal

Not so long ago, medical researchers had a habit of using themselves as guinea pigs. Many scientists saw self-experimentation as the most ethical way to try out their ideas. By going first, researchers could test their hypotheses and see how novel interventions affected human beings. In his book Who Goes First? Lawrence Altman reports that my own institution, Washington University, was nicknamed the “Kamikaze School of Medicine” because of its self-experimentation tradition.

Today we rely on a more systematic process to decide when to begin human testing, with experts and ethicists evaluating when a trial is justified. But a modified version of self-experimentation still makes sense.

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Published This Week

David Bardey, Philippe De Donder, Cesar Mantilla, Adverse Selection vs Discrimination Risk with Genetic Testing. An Experimental Approach, SSRN.

Bernadette M. McSherry, Mental Health Laws: Where to from Here?, 40 Monash U. L. Rev.175 (2014). 

Guest Blogger Professor Rebecca Dresser: Inclusive Research Oversight

Professionals like researchers, doctors, ethicists, and lawyers are largely responsible for the regulations and ethical guidelines that govern human subject research. Nearly everyone appointed to the groups that develop and apply research ethics standards is a professional. Although ordinary citizens are sometimes included in research ethics deliberations, they play a minor role.

Most surprising, and to me, disturbing, is the omission of people who know what it is like to be a research subject. Few people with direct experience as subjects have been involved in the creation and application of human research rules and guidelines. I believe their exclusion has deprived the oversight system of morally relevant information.

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Thank You to November's Guest Bloggers

HealthLawProf Blog would like to thank our wonderful November guest bloggers, Professor Jean Macchiaroli Eggen, Assistant Professor Marc D. Ginsberg, Associate Dean and Professor of Law Joan H. Krause, Professor Maya Manian, and Assistant Professor Jessica L. Roberts. Here is a short recap of their posts:

Professor Jean Macchiaroli Eggen posted the following: Is Nanotech the Next Asbestos?, Low-Level Exposures to Chemicals in Drinking Water: Are They Actionable?, In Honor of Veterans Day: Resolving the Complex Legal Issues of the Iraq and Afghanistan Burn Pit Litigation, and Will the Neuroscience Revolution Change Tort Law?: Some Thoughts on the Mental Disabilities* Rule in Negligence Law.

Assistant Professor Marc D. Gnsberg posted the following: The Locality Rule And A National Standard Of Care, Enforceability of Voluntary Binding Arbitration of Medical Negligence Claims, Admissibility of Forensic Autopsy Reports in Homicide Prosecutions, and Informed Consent.

Associate Dean and Professor of Law Joan H. Krause posted the following: United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part I), United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part II), The Complicated Relationship Between Integration and Health Care Fraud, and The Right to Try Meets the Reality of Drug Approval.

Professor Maya Manian posted the following: The 2014 Midterm Elections and Access to Reproductive Healthcare, The Criminalization of Pregnant Women, Health Exceptions in Anti-Abortion Legislation, and Young v. UPS: Will the Supreme Court Deliver a Healthy Ruling for Pregnant Workers?.

Assistant Professor Jessica L. Roberts posted the following: Healthism? The EEOC, Employer Wellness Programs, and Discrimination on the Basis of Health Status, Executive Power and the Employer Mandate, and Turkey for Me, Turkey for You: The FDA Kicks Off the Holiday Season by Finalizing Two Anti-Obesity Rules.

Guest Blogger Associate Dean and Professor of Law Joan H. Krause: The Right to Try Meets the Reality of Drug Approval

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

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Guest Blogger Professor Rebecca Dresser: When the Professional Becomes Personal

Most of the time, we teach and write about health issues from a distance. We don’t deal with matters like access to health care and enrolling in clinical trials ourselves. But every so often, a personal event disrupts this situation. We find ourselves facing the very issues we are used to considering from a comfortable, professional point of view.

This happened to me and six of my medical ethics colleagues, Dan Brock, Norman Fost, Arthur Frank, Leon Kass, Patty Marshall, and John Robertson. After many years of writing and teaching about serious illness and ethics, serious illness and ethics became something personal. Five of us were diagnosed with life-threatening cancers and three had spouses in that situation (one of us faced both situations).

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Introducing Guest Blogger Professor Rebecca Dresser

HealthLawProf Blog is very pleased to welcome our first guest blogger for the month of December, Professor of Law Rebecca Dresser. The following is her short bio:

Rebecca Dresser is the Daniel Noyes Kirby Professor of Law and Professor of Ethics in Medicine at Washington University in St. Louis. Since 1983, she has taught medical and law students about legal and ethical issues in end-of-life care, biomedical research, genetics, assisted reproduction, and related topics. Before coming to Washington University, she taught at Baylor College of Medicine and Case Western Reserve University. In 2003, she was a Visiting Research Scholar at the University of Tokyo, where she taught a short course in law and bioethics. Dresser received her law degree from Harvard Law School. Her book, When Science Offers Salvation: Patient Advocacy and Research Ethics, was published by Oxford University Press in 2001. She also edited and contributed to Malignant: Medical Ethicists Confront Cancer (Oxford University Press, 2012). She is a co-author of The Human Use of Animals: Case Studies in Ethical Choice (Oxford University Press, 2d Edition, 2008) and Bioethics and Law: Cases, Materials and Problems (West Publishing Co., 2003). Dresser has written numerous journal articles, as well as commissioned papers for the National Academy of Sciences and National Bioethics Advisory Commission. She is Chair of the Hastings Center Fellows Council and an “At Law” columnist for the Hastings Center Report. From 2002-2009, she was a member of the President’s Council on Bioethics. In 2011, she was appointed to a four-year term on the National Institutes of Health Recombinant DNA Advisory Committee.

Guest Blogger Professor Jean Macchiaroli Eggen - Will the Neuroscience Revolution Change Tort Law?: Some Thoughts on the Mental Disabilities* Rule in Negligence Law

Over the past several decades research in neuroscience, through the use of functional neuroimaging and other techniques, has sought to explain a vast array of human thought processes and behaviors, and the law has taken a keen interest in these studies. Neuroscience has offered tantalizing insights into human cognition and decision making. Criminal law has been the most frequently discussed area of the law to take an interest in and incorporate neuroscience research, most notably in matters related to juvenile sentencing. E.g. Miller v. Alabama, 132 S. Ct. 2455, 2464-65 (2012) (noting that neuroscience has demonstrated a fundamental difference between juvenile and adult brains and holding that mandatory life imprisonment without parole for persons under the age of eighteen was unconstitutional); Roper v. Simmons, 543 U.S. 551 (2005) (prohibiting the death penalty for older juveniles based, in part, on brain development studies). 

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Guest Blogger Professor Maya Manian - Young v. UPS: Will the Supreme Court Deliver a Healthy Ruling for Pregnant Workers?

In Young v. United Parcel Service, argued before the U.S. Supreme Court on December 3, 2014, the Court will decide whether the federal Pregnancy Discrimination Act (PDA) protects pregnant workers from suffering economic harms due to pregnancy-related health conditions. The PDA provides that pregnant women “shall be treated the same for all employment-related purposes … as other persons not so affected but similar in their ability or inability to work.”

In 2006, Peggy Young became pregnant while working as a delivery truck driver for UPS. Her healthcare provider recommended that she not lift more than twenty pounds, but Young’s job description required hauling much heavier packages. Based on the medical advice she received, Young requested a temporary accommodation of a lightened load similar to accommodations UPS already granted other workers. Young’s supervisor denied her request and sent her on an unpaid leave, during which she lost her healthcare benefits.

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Hamline University Health Law Institute - reception at AALS 2015

Are you attending AALS 2015? The Hamline University Health Law Institute cordially invites you and a guest to a reception honoring members of the Association of American Law Schools (AALS) Section on Law, Medicine and Health Care.  

When: Friday, January 2, 2015, from 6:30 to 8:00 p.m. at:

Where:  Lebanese Taverna
              2641 Connecticut Avenue NW
              Washington, DC 20008
              (202) 265-8681 

Please RSVP here by December 20.

We look forward to seeing you,

Thaddeus Pope
Jonathan Kahn
Laura Hermer
Jean Holloway
David Larson
Barbara Colombo
Kim Dayton

Guest Blogger Assistant Professor Jessica L. Roberts - Turkey for Me, Turkey for You: The FDA Kicks Off the Holiday Season by Finalizing Two Anti-Obesity Rules

Last Thursday was Thanksgiving, the gateway meal to the notoriously high-fat, high-sugar, high-calorie American holiday season. One recent estimate speculates that Americans consume approximately 4500 calories during Thanksgiving dinner, with about 45% of those calories coming from fat. While traditional wisdom holds that most Americans gain between seven and ten pound over the holidays, several studies have indicated that on average we gain only one pound. However, that happy news comes with a few qualifiers: one, overweight people gain about five pounds over the holidays (instead of the average one) and two, once we gain that extra pound, we never lose it, leading to gradual weight gain over the course our lifetimes. Thus, maintaining a healthy weight is more of a marathon than a sprint. Although countless websites are replete with tips for avoiding holiday bloat, the real battle happens long after the menorahs and wreaths go back into the closet.

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Published This Week

Larissa Lee, Let the Hospital's Conscience Be Your Guide: How Institutional Policies are Eroding 'Death with Dignity', SSRN.

David Orentlicher, Aging Populations and Physician Aid in Dying: The Evolution of State Government Policy, 48 Ind. L. Rev. 111 (2014).

Edward Williams, Federalism, the Federal Tort Claims Act, and Statutes of Repose: Maintaining the Balance, SSRN.