5/2-3: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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CONFERENCE – CLASHING RIGHTS & REPRODUCTIVE AUTONOMY

Join us at Northeastern University School of Law at 1 p.m. on April 25, 2014 as leading academics and practitioners discuss the tensions between free speech and reproductive rights.

For more information, see http://www.northeastern.edu/law/academics/institutes/health-law/events/clashing-rights/

A Case Against the “Noncompliant” Patient

By Deborah Cho

In recent years, providers have attempted to shift how health care is delivered so as to include the patient in the decision-making process.  This concept of shared decision-making was most memorably relayed to me in medical school through a critical lesson during which we were instructed to replace the word “noncompliant” with “non-adherent” when describing patients who were unwilling or unable to stick with treatment regimens.    Noncompliance painted a picture of a paternalistic provider mandating the rules of play, while the patient cowered below as a disobedient subordinate.  It also implied that the patient did something wrong by breaking the rules and that the actions of the patient ought to be modified to fit the rules, rather than the other way around.  On the other hand, non-adherence signified that the patient was a contributing partner in the development of the treatment plan and, further, that he may be justified for not abiding by the terms of his plan.

There were two overarching reasons for the shift to the shared decision-making model: first, that this would produce better overall clinical results and second, that this view shows more respect for patient autonomy.  Providers were learning and accepting that treatment plans prescribed within their vacuums could fail to be affordable, intelligible, or even realistic given a patient’s life circumstances.

So how does this relate to law students and lawyers?

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It’s Doctors’ Duty to Promote Gun Safety With Patients

Art Caplan has a new opinion piece up at Medscape: “It’s Doctors’ Duty to Promote Gun Safety With Patients.” From the article:

There is a huge problem with guns in the United States, and there are many things that public health can do, and many things that doctors should do to try to minimize the threats that guns pose to children, families, and all of us. One of the leading problems with guns is that we don’t educate children to know what to do when they find a gun or see a gun. So, if a 5- or 6-year-old sees a gun, we need a program that teaches that child that if you see a gun, walk away, get out of the area, and then tell an adult. That is a public health program. It’s something that school nurses could do. It’s something that pediatricians should talk about with their child patients. It’s something that families should hear about. We need a campaign. Vivek Murthy, the Surgeon General candidate, thinks that it is an appropriate thing to do. Apparently, the NRA doesn’t.

You can watch or read the full piece on the Medscape website (access requires a login and password, but registration is free).

Video Debate: Richard Epstein and Ryan Abbott on FDA Involvement in Off-Label Drug Use

Video: Here.

On January 13, 2014 the Southwestern Law School Federalist Society student chapter hosted a debate about the FDA’s role in regulating off-label drug use featuring Professor Richard Epstein, the Laurence A. Tisch Professor of Law at NYU and the Kirsten Bedford Senior Fellow at the Hoover Institution, and Ryan Abbott, Associate Professor of Law at Southwestern Law School and Visiting Assistant Professor of Medicine at the David Geffen School of Medicine at UCLA.

Before a drug can be sold legally in the United States, the Food and Drug Administration (FDA) must approve it as safe and effective for a particular indication or use — the use then appears on the drug’s label. Federal law, however, allows doctors to prescribe drugs that the FDA has approved for one indication for any other indication, even though the FDA never evaluated the safety or efficacy of the drug for that use.

Off-label prescribing is an integral part of modern-day medicine. Patients may benefit when they receive drugs or devices in contexts not approved by the FDA. In fact, in some instances an off-label use may be the standard of care for a particular health problem. However, off-label prescribing can also harm patients, especially when an off-label use lacks a solid evidentiary basis.

For this reason, the FDA forbids drug companies from promoting their own products for off-label use, except for certain activities such as disseminating research literature and sponsoring educational programs. In recent years, civil and criminal actions against drug companies for illegal promotion for off-label use have proliferated, leading to many large settlements. For example, in July 2012, GlaxoSmithKline pled guilty and paid $3 billion to resolve criminal and civil liability arising from the company’s unlawful prescription drug promotion, failure to report safety data, and false price reporting practices.

As a result of this recent litigation, many have questioned the FDA’s current role in regulation of off-label use and whether more or less intervention is needed. This debate sought to address these very issues.

Both Professors have written about FDA regulations. For example, Professor Epstein in his book, Overdose: How Excessive Government Regulation Stifles Pharmaceutical Innovation, and in an article in the Minnesota Law Review, “Against Permititis: Why Voluntary Organizations Should Regulate the Use of Cancer Drugs.” Professor Abbott has written about FDA regulations in the Iowa Law Review, Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety, and he has an article forthcoming with Ian Ayres at Yale Law School on Mechanisms for Regulating Off-Label Drug Use.

3/20-21: Risk, Perception, and Response Conference at Harvard School of Public Health

Risk, Perception, and Response Conference

March 20-21, 2014

Harvard School of Public Health
677 Huntington Avenue
Boston, MA 02115

This event will be webcast. Link will be posted here on March 20 and 21.

View draft agenda and papers.

To register, click here. There is no charge for registration.

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Sunstein to be Keynote Speaker

We are pleased to announce that Cass R. Sunstein will be the keynote speaker for HCRA’s Risk, Perception, and Response conference. Mr. Sunstein is the Robert Walmsley University Professor at Harvard and founded the Program on Behavioral Economics and Public Policy at Harvard Law School. He is the author of numerous articles and books, includingNudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008) and most recently Simpler: The Future of Government (2013). From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs.

Conference Overview 

How people react to scientific evidence of risk is mediated by many factors, including how risk information is perceived and communicated, how we react to social and cultural influences, and how choices are structured. Examples abound of situations where individuals’ risk perceptions lead them to act in ways that appear contrary to their own interests, overreacting to or neglecting risks. How can situations in which individuals are likely to respond poorly be identified, and what can be done to improve their responses? To increase our understanding of the factors that contribute to these behaviors and to develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.develop better options for fostering sound decisions, the Harvard Center for Risk Analysis commissioned a series of papers that will be presented at this March 20-21, 2014 conference.

Click here to view the detailed agenda.

Tips from a former medical student – Part II

By Deborah Cho

[See Part I here]

Last week, I wrote the first of a two-part series on tips that may be helpful for law students and lawyers interested in or working in health/medical law.  I continue with Tip #4 here.

4. If you need to learn about a disease, procedure, or drug that you know nothing about, your best starting point is probably Wikipedia.  Google will lead you to some incorrect answers, and diagnose-yourself websites will give you answers that are much too broad to use practically in legal practice.  Once you have familiarized yourself with the general topic on Wikipedia, you can then go back to your search engine of choice for more specific terms and weed out the wrong information.  Starting on PubMed or GoogleScholar probably isn’t the best idea either because most of what you’re reading will be highly technical and the articles you find will likely be about novel uses or instances of whatever you’re searching.  Another fantastic source is UpToDate, an evidence-based Wikipedia-like source for healthcare providers, but many people may not have access to all the information on this site.

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Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Continue reading

Tips from a former medical student – Part I

By Deborah Cho

As a student in the Disability Litigation Clinic, one of the many fantastic clinics here at Harvard Law school, I’ve come to appreciate the value of hands-on experience as an essential component of legal education.  One issue that we as students are often faced with, however, is a lack of familiarity with the particular subject matter we are assigned to work with.  Now, I know that topic-specific knowledge typically comes on the job, but I’m starting to see that many of us trying to practice law touching the medical field never really have a chance to learn the basics of the medical world and just how essential that basic knowledge really is.

As a short introduction to this post, I will say that I spent several of my college years volunteering and doing research at various hospitals and clinics, went to medical school for two years, have an M.A. in Bioethics (noting this to add to my hours spent in a hospital), have interned in the health care division in state government, have interned in a health law nonprofit firm, and, as noted above, am enrolled in the Disability Litigation Clinic right now.  All that to say, please take everything I write here with a grain of salt.  I am by no means an expert on this, but have found that this information has helped me throughout my healthcare-related legal experience so far and I hope that this will spark dialogue and interest on this subject.

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This Oscar Is No Grouch: Can Oscar Health Succeed in Making Health Insurance Fun?

By Kate Greenwood

Cross-Posted at Health Reform Watch

On Wednesday night, I went to a panel presentation sponsored by the group NYC Health Business Leaders on the roll out of New York State’s health insurance exchange.  Among the speakers was Mario Schlosser, the co-founder and co-CEO of the venture-capital-backed start-up health insurance company Oscar Health, which offers a full range of plans through New York’s exchange.  As NPR reportedlast month in a story about Oscar, “it’s been years since a new, for-profit health insurance company launched in the U.S.”, but the Affordable Care Act created a window of opportunity for new entrants.

Schlosser began his talk by giving us a tour of his personal account on Oscar’s website, www.hioscar.com.  Among other things, he showed us the Facebook-like timeline, updated in real time, which tracks his two young children’s many visits to the pediatrician.  He typed “my tummy hurts” into the site’s search engine and the site provided information on what might be wrong and on where he might turn for help, ranging from a pharmacist to a gastroenterologist, with cost estimates for each option.  Additional searches yielded information on covered podiatrists accepting new patients with offices near his apartment and on the out-of-pocket cost of a prescription for diazepam (which was zero, since there is no co-payment for generic drugs for Oscar enrollees).

As an audience member noted, none of this is new exactly.  What is new is to have this kind of data-driven, state-of-the-art user experience being offered by a health insurer.  Schlosser told the audience that Oscar’s pharmacy benefit manager and other vendors are providing the company with real-time data that other insurers have not demanded.  And, according to Schlosser, Oscar’s customers are responding.  Nearly all of them have used the company’s website.  A surprising five percent of them use the company’s website every day. Continue reading

Disclosing Genetic Risks: Lessons from the Philosophy of Language

By Michael J. Young

Earlier this month, landmark findings were published in the American Journal of Psychiatry illuminating the effect of disclosing genetic risk for Alzheimer’s disease on older adults’ cognition and memory.  In a case-control study, researchers administered memory function tests to a group of known carriers of the apolipoprotein E4 allele (one of the best studied genetic risk factors for developing Alzheimer’s disease), half of whom were informed of their carrier status, and half of whom were not informed of their carrier status.  They reported “[s]ignificant genotype-by-disclosure interaction effects were observed on several memory rating scales and tests of immediate and delayed verbal recall. Older adults who knew their ε4+ genotype judged their memory more harshly and performed worse on an objective verbal memory test than did ε4+ adults who did not know. In contrast, older adults who knew their ε4− genotype judged their memory more positively than did ε4− adults who did not know…informing older adults that they have an APOE genotype associated with an increased risk of Alzheimer’s disease can have adverse consequences on their perception of their memory abilities and on their performance on objective memory tests. Similar consequences might be expected if other indices of an increased risk of Alzheimer’s disease are disclosed (e.g., neuroimaging or CSF biomarkers of preclinical Alzheimer’s disease.)”

These findings raise profound questions for practitioners who must make regular decisions concerning how to communicate health risk information to patients, and more fundamentally, about what principles and policies ought to govern which findings should be disclosed or disguised.

The study and its implications bear striking correlates to a set of key issues in philosophy of language relating to the meta-descriptive aspects of speech and discourse.  In a series of lectures later published as How We Do Things with Words, philosopher J.L. Austin persuasively argued against a longstanding philosophical tradition that had conceptualized language as a construct that exists solely to describe reality as it is or is imagined to be; Austin reasoned that language can serve not only to describe facts but can also serve to establish new facts by representing them as such.

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Are We Misusing the “Brain Death” Diagnosis to Hurry Along Families?

Cross-posted from HealthLawProf Blog. Originally posted January 20, 2014.

What are We Learning About Brain Death from the McMath and Munoz cases?

By Jennifer S. Bard, J.D., M.P.H., Ph.D.

With the understanding that this is one of those topics that health law professors are supposed to know something about, here is a quick update of what’s going on.  Along with my own views about the possible misuse by hospitals of declaring brain death in what are really medical futility cases.

Jahi McMath, age 12, in California who lost consciousness after a routine tonsillectomy and Marlize Munoz, age 32  in Texas who collapsed on her kitchen floor have both become involuntary public figures as their families struggle to make sense of both their medical conditions, which are complex, and of the laws which have declared them both legally dead based on a lack of brain activity.  In legal terms, a person declared “brain dead” has the same status as any other dead person.  Each state is entitled to make its own decision of whether or not to adopt a brain death statute.  California’s and Texas’ are similar in that they require the “complete cessation” of all brain activity.  The declaration of death is, in all states, a legal act.  Most hospitals have a policy similar to this one which set criteria and require the participation of at least two doctors.  A declaration of death cuts off any rights of the individual.  The family of someone declared dead is no longer a surrogate decision maker.  Rather, they have something like property rights to the disposal of the remains.    More pointedly, a declaration of death ends all eligibility for medical insurance, including Medicaid and Medicare.  If a family decides to release the organs for donation, their host becomes not a patient but rather a “heart beating organ donor.” 

When a family wants to donate their loved one’s organs, a declaration of brain death is helpful mechanism for doing so.  Indeed, a series of high profile cases involving anencephalic infants in the 1990s pointed out the frustrations of parents who wanted to donate their children’s organs but could not because they retained minimal brain function.  However, there is never any legal need  for a declaration of brain death in order for a family to withdraw life sustaining treatment.  In 1993 bioethicist Robert Veatch wrote an important article in the Hastings Center Report in which he pointed out that “no one really believes that literally all functions of the entire brain must be lost for an individual to be dead.”  And indeed, no one really believes that a piece of paper converts a warm, breathing body from alive to dead.

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DC Circuit Upholds FDA Authority Over Stem Cells

Earlier this week, the D.C. Circuit upheld the FDA’s authority to regulate stem cells (for a good news report see here). The company in question, Regenerative Sciences, had received a warning letter from FDA, which the company challenged claiming that its use of stem cells as therapy was not prohibited by existing federal law and that the FDA lacked authority to regulate it. They lost before the district court and appealed to the D.C. Circuit.

In a unanimous decision (by judge Griffith for himself, Judge Srinivasan and Edwards) the D.C. Circuit affirmed this decision. Here are some key passages: Continue reading

Sexual Abuse by a Gynecologist Meets Tort Reform

By Alex Stein

A gynecologist’s patient filed a suit alleging that he touched her inappropriately and made sexually charged comments during her office visits. The suit was filed against the gynecologist and his employer. The plaintiff’s allegations against the gynecologist included medical negligence and intentional infliction of emotional distress. Her cause of action against the employer consisted of negligent supervision and negligent infliction of emotional distress. After settling her suit against the gynecologist for an undisclosed amount, the plaintiff attempted to proceed with her action against the employer. The employer moved for summary judgment, which was granted by the trial judge and affirmed by the court of appeals. The plaintiff’s appeal to the Supreme Court of Kansas was equally unsuccessful: Cady v. Schroll, — P.3d —-, 2014 WL 265551 (Kan. 2014).

Here is why: Continue reading

The Battle of Privileges

By Alex Stein

When a patient files a malpractice suit against a doctor, she waives the evidentiary privilege that protects the information pertaining to her treatment by the doctor. This information extends to all communications between the patient and the doctor, the patient’s medical history, diagnosis, treatment, and medical records. The patient’s waiver of the privilege is not absolute. Rather, it relates only to information and documents needed for the doctor’s defense. The same principle applies to the patient’s treating physician whom she did not sue. The defendant is entitled to subpoena this nonparty physician and obtain from her information and documents relevant to his defense.

To realize this entitlement, the defendant’s attorney needs to interview the nonparty physician before trial. The patient’s attorney demands to be present at that interview to protect her client’s privilege by appropriately limiting the physician’s questioning by the defendant’s attorney. The defendant’s attorney counters this demand by invoking the attorney-client privilege and its “work product” extension.

This battle of privileges has no easy solution. Continue reading

Unconstitutional Time Bars in Washington

By Alex Stein

Schroeder v. Weighall — P.3d —-, 2014 WL 172665 (Wash. 2014), is the second Washington Supreme Court’s decision that voids the Legislature’s time bar for medical malpractice suits.  The first decision, DeYoung v. Providence Medical Center, 960 P.2d 919 (Wash. 1998), voided an eight-year repose provision for violating the constitutional prohibition on special privileges (Article I, section 12). This statutory provision benefited healthcare providers and their insurers at the expense of injured patients whose cause of action accrued over a long period of time and consequently tolled the statute of limitations.  The Court held that the Legislature had no rational basis for blocking suits filed in connection with more-than-eight-years-old incidents of medical malpractice. The Court based that decision on the finding by the National Association of Insurance Commissioners that old medical malpractice incidents account for “less than one percent of all insurance claims nation-wide.” This finding convinced the Court that the “relationship between the goal of alleviating any medical insurance crisis and the class of persons affected by the eight-year statute of repose is too attenuated to survive rational basis scrutiny.”

In Schroeder, the Court used the same constitutional prohibition to void a new statutory provision that eliminated tolling of the statute of limitations for minors in medical malpractice actions. Continue reading

Progress is Possible in the Institutional Corruption of Healthcare

Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests).  For those who have been working long and hard on these issues, they are cause for hope.  The needle does move.

First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs.   My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money.  In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions.  (See their newfound commitment to opening up their clinical trial data too.)

The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions.  My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies.  Yet, something has caused Glaxo to change course.

Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries.  The counterfactual is that the NFL could have kept the money, of course.  But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf.  The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.

This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid.  Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies.  Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk?  If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.

 EDIT:  Corrected link to NFL story on NYT, and corrected amount from $100M to $30M.  Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.

Sleep versus Training: The NY Times on Surgical Work Hours

Pauline Chen at the NY Times Blog has an article on cut backs on the number of hours of training for young surgeons.

According to her story:

“For the past decade, in response to increasing pressure from politicians, unions and sleep experts, the Accreditation Council for Graduate Medical Education, the organization responsible for accrediting American medical and surgical training programs, has been working to cap the hours that residents work. In 2011 the council passed the strictest limits yet. To maintain their accreditation, residency training programs had to abide by a 22-page set of scheduling rules that limited all in-hospital work including any elective “moonlighting” jobs to 80 hours per week, mandated the number of hours “free of duty” after different “duty periods” (eight hours off after 16-hour duty periods and 14 hours off after 24-hour duty periods) and even specified the timing of “strategic napping” in no uncertain terms (after 16 hours of continuous duty and between the hours of 10 p.m. and 8 a.m.).

While most residency programs chafed under the exhaustively detailed regulations, surgical training programs had particular difficulty adopting the new mandates. For nearly a century, surgical residency had been a period of both intensive experience and increasing responsibility under the guidance of more experienced surgeons. More recent research has affirmed that approach, demonstrating the strong link between a surgeon’s operative skill, the number of operations performed and patient outcomes. With limits set on their time at the hospital, young surgeons-in-training had fewer opportunities to care for patients or scrub in on operations. While previous generations of trainees had the luxury of participating in at least one operation a day, new trainees had only enough time to be involved in two or maybe three operations each week.

Calculating the number of hours “lost” by cutting back on in-hospital time, surgical leaders estimated that young surgeons-to-be were now missing out on as much as a year’s worth of experience”

She relies heavily on an new Annals of Surgery Article, wherein, as Chen reports,

“Researchers sent questionnaires to the directors of subspecialty fellowship training programs and asked them to comment on the bedside and operating skills of the young surgeons enrolling in their programs. These fellowships are a kind of high-level and often prestigious surgical “gap year” where young surgeons who have completed the basic five-year surgery residency can delay independent practice to pursue an additional year or two of training.

The results were abysmal. Fewer than half of the young surgeons could operate or make clinical decisions on their own. Nearly a third of them were incapable of performing even the most basic operations like a gallbladder removal on their own. And a quarter were unable to recognize the early signs of complications.

Even in areas of surgery where the young surgeons had had supplementary online learning modules during their residency, they performed poorly, with more than half unable to perform basic maneuvers.”

While acknowledging that “some observers have criticized the study for being self-serving – most respondents also noted that the young surgeons’ deficiencies resolved after additional training under their auspices —” Chen’s article reads largely as an attack on these new residency work hour rules.

Since I have written on the subject of these residency work hour rules with sleep specialists earlier this year in the Journal of Law, Medicine, and Ethics, it may be unsurprising that I take a somewhat different view.

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Standards of Care and Patient Advocacy in Religiously Affiliated Hospitals

By Nadia N. Sawicki

The New York Times reported today that the ACLU has filed a lawsuit against the United States Conference of Catholic Bishops on behalf of Tamesha Means, a patient at Mercy Health Partners in Michigan.  The suit alleges that Means suffered physical and emotional harm as a result of the Conference of Bishops’ ethical directives relating to pregnancy termination, which Mercy, as a Catholic health institution, is required to follow.

According to the ACLU press release and the Times article, when Means’ water broke 18 weeks into her pregnancy, she rushed to Mercy Health, the only hospital in her county.  According to medical experts, the fetus had “virtually no chance of surviving” and posed a significant risk to Means’ health.  Mercy physicians did not share this information with Means, and discharged her without informing her that terminating the pregnancy and extracting the fetus was the safest course of action from a medical perspective. Means returned to the hospital twice in the next two days, suffering from infection and extreme pain, but it wasn’t until she miscarried that the staff at Mercy attended to her medical needs.   An obstetrician at the University of Wisconsin Medical School quoted in the Times described Mercy’s treatment of Means’ condition as “basic neglect.”

Rather than suing Mercy Health Partners, Means and the ACLU are suing the Conference of Bishops.  They argue that by directing Catholic hospitals to avoid terminating pregnancies or providing referrals (even when a woman’s health is at risk), the Conference of Bishops is ultimately responsible for the harms suffered by Means and other women in her position.  According to Louise Melling, deputy director of the ACLU, “This isn’t about religious freedom, it’s about medical care.”

There are a host of legal, ethical, and religious issues associated with the Tamesha Means case.  But in this post, I’d like to focus on only one - the division of legal responsibility between health care providers and third parties when it comes to patient advocacy and quality of care. Continue reading