“Medical Malpractice” vs. General Negligence: The Case of Falling Accidents

By Alex Stein

As I wrote previously – see here, here, here, here, here, here, here, here, and here – whether a tort action sounds in “medical malpractice” as opposed to general negligence, or vice versa, can be crucial. Suits sounding in “medical malpractice” must satisfy special requirements that include shortened limitations periods, statutes of repose, and expert affidavits (or certificates of merit) at filing. In many states, those suits are also subject to special damage caps. Suits sounding in general negligence are free from these constraints. Filing and prosecuting those suits is consequently not as onerous and expensive as filing and prosecuting medical malpractice actions. For that reason, we witness many disputes over this pivotal categorization issue. Continue reading

New from Bioethicist Art Caplan: How State Right-To-Try Laws Create False Expectations

A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:

Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.

Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.

Read the full article here.

New paper on cross-disciplinary collaboration

The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?

Some advice on how to address the particular challenges and opportunities in interdisciplinary research are described in our recent paper “Ten Simple Rules for a Successful Cross-Disciplinary Collaboration” published in the online open access journal PLOS Computational Biology last month. Please find below and abstract of the paper, which has inter alia been discussed and cited by Times Higher Education.

Abstract:

Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020″ EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.

However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.

Proposed citation:

Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214

A needle in a haystack – finding the elusive solution to Indiana’s HIV Outbreak

By Nicolas Wilhelm, JD

Scott County, Indiana, which only has a few thousand residents, has historically had an average of five HIV cases per year. Since December 2014, however, the county has seen an outbreak, with more than 140 newly diagnosed cases. Dr. Jonathan Mermin, the director of the National Center for HIV/AIDs, Viral Hepatitis, STD and TB Prevention at the Center for Disease Control (CDC) calls this “one of the worst documented outbreaks of HIV among IV users in the past two decades.” Dr. Joan Duwve, the chief medical consultant with the Indiana State Department of Health, explained that the abuse of the prescription drug Opana was one of the catalysts for the increase in HIV cases, with some residents injecting it as frequently as 10 times a day, and sharing syringes with other members of their community.

HIV is mainly spread either by sexual contact with another person with HIV, or by sharing needles or syringes with someone who has HIV. One way to reduce the spread of the disease is to implement syringe exchange programs (SEPs) that reduce the transmission of blood-borne pathogens like HIV by providing free sterile syringes and collecting used syringes from injection-drug users (IDUs).

Continue reading

Grading the ACA as Equal Protection Statute

The Affordable Care Act is sprawling.  Some of its myriad provisions may (or may not!) reduce healthcare costs.  Think of accountable care organizations, the hospital readmission reduction program, or even the preventive services mandate.  And so, the Act’s success is often evaluated by asking whether it has helped reduce healthcare costs.  (See, e.g., David Cutler here.)

Other of the ACA’s provisions are intended to promote financial security in the face of illness.  The Act’s most litigated provisions, requiring that people buy insurance, expanding Medicaid, and creating exchanges, can be understood primarily in this light.  And so, the Act’s success is also often evaluated by asking whether it has truly promoted financial security.  (See today’s New York Times piece from Margoret Sangor-Katz on the subject of underinsurance post-ACA, or Aaron E. Carroll’s take from December.)

A third way of understanding the ACA’s reforms–and evaluating its success or failure–too often gets left out (as it was by the NY Times here): The ACA can perhaps most coherently be thought of as an equal protection statute.

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Medical Malpractice and the Middle-Ground Fallacy: Should Victims’ Families Recover Compensation for Emotional Harm?

By Alex Stein

Medical malpractice victims are generally entitled to recover compensation for emotional harm they endure: see, e.g., Alexander v. Scheid, 726 N.E.2d 272, 283–84 (Ind. 2000). But what about a victim’s close family member? Take a person who suffers emotional distress from witnessing a medical mistreatment and the consequent injury or demise of her loved one. Should the court obligate the negligent physician or hospital to compensate that person for her emotional harm?

This question has no uniform answer under our medical malpractice laws. Some states allow victims’ families to recover compensation for their emotional harm, while others do not. Three weeks ago, the Connecticut Supreme Court struck a middle ground between these two extremes. Squeo v. Norwalk Hosp. Ass’n, 316 Conn. 558, — A.3d —- (Conn. 2015). Continue reading

The Robust But Unsatisfying State Of Health Care Fraud Enforcement

By Zack Buck

Earlier this spring, the U.S. Department of Health and Human Services and Department of Justice reported they had recovered nearly $28 billion as a result of anti-health care fraud efforts in FY 2014. The federal False Claims Act played a substantial role in achieving these recoveries: the government recovered $2.3 billion in FCA settlements and judgments, and opened nearly 800 new civil health fraud investigations, in FY 2014 alone. Further, the agencies noted that these anti-fraud efforts—bolstered by increased funding and authority under the Affordable Care Act—are continuing to abandon the “pay and chase” method of fraud enforcement, relying instead on prevention and “real-time data analysis.”

Interestingly, it is no longer just the federal government driving the enforcement regime. Increasingly, facing Medicaid shortfalls, states are getting involved—and, according to practitioners, state enforcement is “exploding.” For example, in New York, its Office of Medicaid Inspector General recovered more than $1.7 billion from FY 2011 to 2013. States have also had success in litigating claims to trial, most recently illustrated by the notable South Carolina Supreme Court verdict against pharmaceutical giant Johnson and Johnson. Further, Vermont is likely to become the newest state to establish its own state false claims act, another wide-ranging and powerful statute that mirrors the federal FCA.

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Two Cheers for Corporate Experimentation

Rubin's vase2I have a new law review article out, Two Cheers for Corporate Experimentation: The A/B Illusion and the Virtues of Data-Driven Innovation, arising out of last year’s terrific Silicon Flatirons annual tech/privacy conference at Colorado Law, the theme of which was “When Companies Study Their Customers.”

This article builds on, but goes well beyond, my prior work on the Facebook experiment in Wired (mostly a wonky regulatory explainer of the Common Rule and OHRP engagement guidance as applied to the Facebook-Cornell experiment, albeit with hints of things to come in later work) and Nature (a brief mostly-defense of the ethics of the experiment co-authored with 5 ethicists and signed by an additional 28, which was necessarily limited in breadth and depth by both space constraints and the need to achieve overlapping consensus).

Although I once again turn to the Facebook experiment as a case study (and also to new discussions of the OkCupid matching algorithm experiment and of 401(k) experiments), the new article aims at answering a much broader question than whether any particular experiment was legal or ethical. Continue reading

New Discussion Draft of 21st Century Cures Act Released (Again)

Earlier today, the House Energy and Commerce Committee released the most recent draft of the 21st Century Cures Act, in time for it to be marked up by the Health Subcommittee tomorrow.  At 300 pages, the new draft adds back in a number of provisions that were excised from the previous, 200-page iteration of the draft.  I haven’t had time to uncover all of the new additions just yet, but given that this is my third blog post on the subject, I wanted to highlight some of the ways in which this version differs (and doesn’t differ) from the last draft.

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LGBT Health: Recognizing Disparities and Increasing Support

by Vadim Shteyler

Amid this week’s disheartening studies highlighting discrimination of LGBT populations, the American College of Physicians (ACP) affirms its support and offers new recommendations for furthering LGBT health.

The bad “news”: is not really news. It is further evidence of how much more effort needs to be placed on ending LGBT discrimination and inequalities. A national survey published in the Ann of Intern Med found that lesbians were significantly less likely to get vaccinated for HPV than their heterosexual counterparts (adjusted prevalence of 8.5% v 28.4%). HPV is easily transmissible through contact and believed to be equally transmissible in gay and heterosexual women. The vaccine can prevent most cases of cervical cancer, which has terrible outcomes if discovered late, indicating that many deaths could have been prevented. An editorial in the same issue describes neglected health concerns affecting LGBT populations and calls for better professional education on LGBT health. The CDC’s and American Congress of Obstetrics and Gynecology’s (ACOG) efforts to inform patients about pap smear rates not been slow and inconsistent in changing medical practice. Combined with markedly lower HPV vaccination rates, cervical cancer remains a big concern. Continue reading

Bioethicist Art Caplan: A Potential Solution to the Shortage of Solid Organs for Transplantation

A new opinion piece by contributor Art Caplan along with Stephen Wall and Carolyn Plunkett, in JAMA:

In the United States, the majority of deaths occur unexpectedly, outside hospitals or in emergency departments. Rarely do these deaths provide opportunities for organ donation. In Europe, unexpected deaths provide substantial numbers of transplantable organs through uncontrolled donation after circulatory determination of death (UDCDD). UDCDD considers decedents candidates for donation even when death is unexpected, regardless of location, as long as preservation begins after all life-sustaining efforts have been exhausted.

More than 124 000 patients are wait-listed for organs in the United States, a number that increases annually despite attrition from 10 500 who die or become too sick for transplantation.1 United States policy currently promotes organ recovery from 3 sources; neurologic deaths, controlled circulatory deaths, and live donors for kidneys and partial livers.

However, these approaches are incapable of meeting increasing US demand for transplants. During controlled donation after circulatory determination of death (CDCDD), the time from cessation of life support to circulatory arrest often exceeds 60 minutes. Prolonged hypotension leads to irreparable organ damage, thus limiting the effect of CDCDD on organ supply. Live donation primarily affects kidney supply; it is unlikely that altruistic donation will ever meet demand. Although many changes in public policy regarding cadaveric donation are debated (markets and presumed consent), none is likely to become law or make substantial differences in organ supply. […]

Read the full article here.

Regulating Wellness Through Employers: Mitigating the Knowledge Gap

Some of the behavioral changes that the Affordable Care Act seeks to bring about are prompted directly by the Act or a federal agency acting pursuant to the Act.  The “individual mandate” that people buy health insurance is one example; individuals who do not change their behavior to comply with that particular provision of the law are subject to a tax penalty imposed by the IRS.

But much of the work of the ACA is done through regulatory intermediaries that are themselves incentivized by the Act to find ways to bring about the end-user behavioral changes that the ACA is really after.  Medicaid expansion is a straightforward example–under the ACA the federal government does not provide insurance coverage to those who make less than 133% of the federal poverty line, rather, it incentivizes states to do so.  Accountable Care Organizations are another somewhat more roundabout example: the Act incentivizes doctors to form organizations that will themselves incentivize doctors to coordinate care and patients to obtain more value-maximizing services.

Like any principal-agent relationship, regulating through an intermediary has benefits and costs.  The intermediary (state, employer, insurer, doctor, etc.) may be differently positioned than the federal government to obtain information about, and influence the behavior of, the actors whose collective behavior we ultimately care about, for better or worse.  And certain intermediaries may be differently responsive to the concerns of those impacted by the policies they enact than the federal government, again for better or worse. Continue reading

Bioethicist Art Caplan: Deep-Fat Fryers in Schools is Business, Not Freedom

A new piece by contributor Art Caplan on NBC News:

How bad is the obesity epidemic among kids in America?

Bad enough that 69 percent of young adults in Minnesota cannot serve in the military due to obesity-related health problems, according to a recent report “Too Fat, Frail and Out-of-Breath to Fight,” from a group of retired generals.

And how is one public official responding to the child obesity crisis? With a call for more fried foods in school. The Texas Agriculture Commissioner, Sid Miller, says he wants to restore deep-fat fryers in Texas school cafeterias. In his mind, this “isn’t about french fries, it’s about freedom.”

The freedom to develop cardiovascular disease?

School cafeterias are the front line on the battleground for childhood obesity prevention. They serve as test kitchens for interventions designed to increase the consumption of fruits and vegetables and decrease the intake of processed and fried foods. In 2012 the USDA and First Lady Michelle Obama announced standards for more nutritious school food. As part of the rules, schools are expected to serve fruits, vegetables and whole grains daily, and limit calories in servings. […]

Read the full article here.

Bioethicist Art Caplan: Rein It In, Dr. Oz

A new piece by contributor Art Caplan on Medscape [Note: free registration required]:

Dr Mehmet Oz is in trouble again. He was accused by 10 physicians in a letter of promoting quackery. They demanded that Columbia University Medical Center fire Dr Oz. Now, I can say with some authority that as “America’s Doctor”—the person who, for many Americans, is the voice of medicine—he is not going to be fired. His show is not going to end. That isn’t going to happen.

Dr Oz has evoked this response from these 10 physicians because he continues to push the border of legitimacy on his shows with respect to touting things for which there isn’t much evidence. And that is a problem. Many doctors tell me that when Dr Oz endorses something—green coffee beans, some neti pot to cure the common cold—whatever it is, they are going to be asked about it, and their patients run out and buy it. He has enormous power when it comes to the platform he has built. And let’s face it: He is an effective communicator. His show is fun to watch. I understand why the American people are paying attention to Dr Oz. […]

Read the full article here.

New Discussion Draft of 21st Century Cures Act Released

Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee.  At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft.  As such, it is perhaps more notable for what it took out of the original draft than for what it added in.  I haven’t had time to digest fully all of the cuts just yet, but in advance of the hearing this morning I wanted to highlight two significant deletions from the first draft and one potentially significant addition.

First, when I blogged in February about the first draft of the Act, I expressed excitement over the idea of a Medical Product Innovation Advisory Commission.  The Commission would have had the ability to oversee the way in which agencies like the NIH, FDA, and CMS all interact with each other to affect the development and dissemination of medical products.  A significant portion of my scholarship focuses on precisely these ideas, and I was hopeful that the Commission would make it into the second draft.  Alas, it did not.

Second, the first draft of the Act contained a series of very controversial exclusivity provisions.  Chief among them may have been the draft provision giving “dormant therapies” (essentially, new drugs for unmet medical needs) the option of 15 years of exclusivity.  Alexander Gaffney’s Regulatory Explainer on the first draft provides a helpful overview, for those who are interested in learning more about this provision.  But interestingly, this and other provisions relating to increased exclusivity are gone from the new draft.  Now, it is possible that some of this language will reappear later, especially as the section of the draft relating to “Repurposing Drugs for Serious and Life-Threatening Diseases and Conditions” has yet to be supplied.  But in the first draft of the document, the sections for “Repurposing Drugs” and “Dormant Therapies” were separate, so it is not clear that this is likely to happen.

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Cassandra C. Goes Home – Connecticut Misses an Opportunity

By Jonathan F. Will

On Monday Cassandra C. was sent home from the hospital.  Her cancer is in remission after responding well to treatments.  Many will recall that those treatments were forced on Cassandra against her wishes and those of her mother.   Back in January, the Connecticut Supreme Court issued a two-page order agreeing with state officials that Cassandra, at seventeen years three months, should be compelled to undergo chemotherapy to treat her Hodgkin’s Lymphoma.

The success of this medical treatment may be viewed by some to vindicate the comments of those like bioethicist Art Caplan and Fox News legal analyst Peter Johnson, Jr., who agreed with the decision.  Indeed, Mr. Johnson, after giving a personal anecdote of his own history with Hodgkin’s Disease, declared this decision to be right on the law, right on the ethics, and right on humanity.

Mr. Johnson gave the impression that a minor should never be permitted to make such a medical decision, while Dr. Caplan at least implied that his conclusion might be different if the refusal was based on religious beliefs.  Then you have a commentator in The Economist who came to the exact opposite conclusion.  He expressed concerns about Cassandra’s liberty and the rights of her mother to make decisions on her behalf.

I’m not so easily convinced by their arguments.

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Exploring The Significant State-To-State Variation In Marketplace Enrollment

A new post by the Petrie-Flom Center’s Academic Fellow Matthew J. B. Lawrence on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

What role did geography, advertising, community, Navigators, and the controversy surrounding the Affordable Care Act (ACA) play in consumers’ decisions whether to purchase health insurance in the individual marketplaces? The percentage of potential exchange marketplace enrollees who actually made use of the marketplace to purchase insurance varied widely from state to state for 2014 and 2015.

As of February 22, 2015, for example, there were eight states with enrollment at 50 percent or greater and eight states with enrollment at 25 percent or lower. (Per the Kaiser Family Foundation, the top eight were Vermont, Florida, Maine, DC, Delaware, Pennsylvania, New Hampshire, and North Carolina. The bottom eight were Colorado, Ohio, Alaska, Hawaii, North Dakota, Minnesota, South Dakota, and Iowa).

It would be an interesting and challenging task to explain this variation empirically. Generating reliable statistical inferences from inter-state comparisons is notoriously difficult, and the variables at play here range from the easily measured (percent of population eligible for subsidies, navigator grant amounts, number of participating insurers, premiums) to the not-so-easily measured (enthusiasm for Obamacare, efficacy of state or federal outreach efforts, geography, education, availability and usefulness of charity care and emergency Medicaid, functionality of state exchange website, population health, availability of health services). […]

Read the full post here.

Athlete concussion under-reporting and pressure from stakeholders

By: Christine Baugh

As concussions are increasingly seen as a public health problem, under-reporting and under-diagnosis of concussion is recognized as one barrier to improving the safety of sports participation. A number of studies have previously characterized the extent of under-reporting of concussions among athletes, particularly at the collegiate level. Furthermore, existing research has examined the applicability of theories of behavior change to concussion reporting and created relevant frameworks for examination. Although a growing body of evidence suggests that reporting (or not reporting) a concussion is a decision actively made by the athlete weighing relevant factors, the extent to which interpersonal, intrapersonal, environmental, or policy factors influence athletes’ decisions about whether or not to report a concussion is not fully understood.

A recent study, on which I am a co-author, titled “Concussion under-reporting and pressure from coaches, teammates, fans, and parents,” published in Social Science and Medicine aimed to understand one possible contributory factor to athlete under-report of concussion: pressure on athletes from relevant stakeholders. (Abstract available here.) The survey-based study queried a sample of 328 athletes from 19 contact or collision sports teams (notably excluding football and hockey teams) at 4 colleges in the northeast region of the United States. Among other things, the study asked athletes whether they experienced pressure to return to play after a head impact, specifically asking about pressure from coaches, teammates, parents, and fans. Continue reading

Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?

Given that it was the subject of my first ever blog post on Bill of Health, I am very pleased to share my new paper: “Are All Abortions Equal? Should There Be Exceptions to the Criminalization of Abortion for Rape and Incest?” which has just been published in the Journal of Law, Medicine, and Ethics (it is behind a paywall, but there is a version they have allowed me to post on SSRN that has all the text but not the formatting that can be freely downloaded).

This paper is likely to piss off people both on the Left and the Right of the abortion issue, which I think of as a feature not a bug ;), but in any event I hope will prompt a good conversation. Here is the abstract:

There was a moment in the 2012 campaign, when Mitt Romney attempted to “pivot” to the center and get away from the statements of those like Todd Akin who made comments about how in cases of “legitimate rape,” the victims’ bodies “have ways to try and shut that whole thing down.” The way Romney did his pivot was to make clear that while he was against abortion, he would, of course, make an exception for women who had been raped or whose pregnancy was the result of incest. This has become something of a moderate orthodoxy among those who oppose abortion. Continue reading

Bioethicist Art Caplan: Chinese Scientists Try To Alter Genomes In Human Embryos

A new piece by contributor Art Caplan in Forbes:

Bet you did not know that today is National DNA Day. It is. But before we all begin to party over our biological programming, remember this is also the day when the world is trying to figure out how to respond to a paper from a team of scientists in China stating that they tried to alter the genomes of human embryos using a new technique known as CRISPR.

Without getting bogged down in the details, CRISPR it is a new powerful tool that permits editing or clipping out segments of DNA and inserting novel genetic material. The Chinese group used it for the first time in human embryos, thereby taking a baby step across the line to trying out a technology that someday could be used to change the DNA of our descendants to repair genetic diseases, get rid of traits we don’t like or to try and build better, improved babies. Yes, that is the low moan of eugenics you hear in the background of this CRISPR experiment. Happy National DNA Day to you, too. […]

Read the full article here.