My last post presented the debate over force feeding hunger striking prisoners in Israel. This post will discuss another group subjected to the dramatic means of force feeding in extreme circumstances, Anorexia Nervosa patients (AN).
Although ethical justifications for force-feeding are similar for both Anorexics and Hunger strikers (save life), the legal framework is completely different in each context. Whereas hunger striking prisoners were dealt with via ad-hoc legislation meant to answer national security threats, AN patients are handled within the framework of mental health law. In the U.S., compulsory hospitalization of mental patients occurs through the state’s Civil Commitment Laws, which require dangerousness resulting from a mental illness to be evaluated by a psychiatrist.
Is the different legal attitude justified? How is it that the same act performed by prisoners is viewed as a political assertion but when done predominantly by adolescent middle-upper class girls, it is considered mental illness?
Here is HHS’s own summary of what has changed and what it thinks is most important:
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991. A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register. The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015. There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting is planned to be held in Washington, D.C. in October.Continue reading →
Yale Law School and so many others in the medical-legal community mourn the sudden passing of our colleague and friend, Robert (“Bo”) Burt. As many readers of this blog know, Bo was an early pioneer in thinking about doctor-patient relationships and the hardest questions about the end of life. He worked for years on the Soros Project, Death in America, and authored numerous books, including In the Whirlwind: God and Humanity in Conflict (Harvard Univ. Press, 2012); Death is That Man Taking Names: Intersections of American Medicine, Law and Culture (Univ. of California Press and the Milbank Memorial Fund, 2002); and Taking Care of Strangers: The Rule of Law in Doctor-Patient Relations (Free Press, 1979). His YLS obituary is here. He will be sorely missed and always remembered.
In “D.M.A. s/ declaración de incapacidad” decided early this month, the Supreme Court of Argentina upheld the right to decide about one´s own death (“muerte digna”). As I had explained in a previous comment written when the ruling of the case was pending, the case involved a patient, M.A.D., that had been in a permanent, irreversible, vegetative state for 20 years due to a car accident. His sisters requested the discontinuation of the vital supportive measures which maintained M.A.D alive in an artificial way. Although this was not the first time that the Court discussed the right to die, it was a different case in that there was not a patient’s written statement on whether it was appropriate for him to continue or not certain medical treatment to keep him alive.
The Argentine National Congress had already passed legislation stating that, whenever a patient is unable to give informed consent, her relatives can do so in her name. On that basis, following the opinion of the sisters of M.A.D., the Supreme Court ordered the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way. Continue reading →
France recently confronted its version of America’s 2005 Schiavo case (in which the Florida Supreme Court upheld a spouse’s determination to end life support to a permanently unconscious patient despite the patient’s parents’ objections). In 2014, France’s Conseil d’Etat ruled that artificial nutrition and hydration (ANH) could be withdrawn from a permanently vegetative patient based on oral statements that the patient had made, while competent, indicating unwillingness to be medically sustained in such a condition. The patient’s objecting parents then sought a declaration from the European Court of Human Rights (ECHR) that such termination of life support would violate the European Convention on Human Rights. On June 5, 2015, the ECHR rejected the objecting parents’ contention, finding that France’s approach met human rights standards both in the process and the criteria followed by medical personnel in deciding to end life support. Lambert v. France, #46043/14 (ECHR 2015).
Vincent Lambert, then 32 years old, was grievously injured in a 2008 traffic accident. He suffered massive brain trauma and was hospitalized for the next 7 years at Reims University Hospital. His precise medical status was initially uncertain. In July 2011, a medical evaluation found him to be “minimally conscious plus.” Over the next year and a half, he underwent 87 speech therapy sessions which failed to establish any code of communication between Mr. Lambert and his surroundings. In early 2013, the attending physician, Dr. Kariger, initiated a process to review Mr. Lambert’s condition and to determine whether the ANH sustaining Mr. Lambert should be withdrawn.
The process that followed was extensive. During 2013, Dr. Kariger consulted with 6 physicians concerning the patient’s mental status and held 2 family meetings at which Mr. Lambert’s wife, Rachel, his parents, and 8 siblings were present. In January 2014, Dr. Kariger announced his determination to end artificial nutrition and reduce hydration. Dr. Kariger’s written report explained that Mr. Lambert had become permanently unaware of his environment and, according to accounts of Mr. Lambert’s prior oral expressions, he would not wish to be medically sustained in such a debilitated condition. Five of the six medical consultants agreed, as did the patient’s wife and 6 of his 8 siblings.
The Fifth Circuit decision in Whole Women’s Health v. Cole upholding Texas’ law requiring all abortions, including medication abortions, to be performed in a licensed ambulatory surgical center (ASC) by doctors with admitting privileges at nearby hospitals seems outrageous on several counts. It defies a medical consensus that abortions performed in physician’s offices or licensed outpatient clinics are exceptionally safe. With the risk of death less than 1% nationally and even lower in Texas, first trimester and many early second trimester abortions simply do not need the extensive sterility precautions and other operating room requirements needed for more invasive procedures. Indeed, colonoscopies, which have a higher morbidity and mortality rate, are permitted in non-ASC settings.
Nor does the admitting privilege requirement appreciably add to safety. With hospitalists currently taking over care of most patients admitted to hospitals, the same doctor often does not provide both outpatient and hospital-based care, and emergency room doctors are trained to respond to any emergency. Nor are admitting privileges necessarily an indication of a doctor’s clinical competence. They are denied or awarded on many grounds unrelated to competency, i.e., likely frequency of future admissions, and thus do not usually impact the quality of outpatient care. Continue reading →
By now, we’ve all heard the commotion around Indiana’s new Religious Freedom Restoration Act (RFRA), although it appears that the public’s fickle attention has already moved on to other matters. Despite some headlines to the contrary, the law originally said nothing explicitly about discrimination on the basis of sexual orientation. It focused exclusively on religious freedom, allowing the government to impose a substantial burden on “any exercise of religion” only if it is able to demonstrate that burdening the person in question is the least restrictive means of furthering a compelling governmental interest.
In line with the Supreme Court’s opinion in Hobby Lobby, which held that corporations are persons capable of exercising religion, the Indiana law defines “person” to include individuals, organizations organized for religious purposes, and business entities that “may sue and be sued” and exercise “practices that are compelled or limited by a system of religious belief held by: (i) an individual; or (ii) the individuals; who have control and substantial ownership of the entity, regardless of whether the entity is organized or operated for profit or nonprofit purposes.” […]
Efforts to improve health care quality under the ACA have been directed towards expanding EHR use and health IT, improving care delivery by promoting care coordination and population health, and laying incentives for providers to meet quality measures. The 33 ACO quality measures include 8 measures to evaluate preventive care, 12 measures to address goals of managing 4 common diseases, and 7 to assess patient satisfaction. Though quality improvements have not been consistently shown, studies have found modest Medicare spending reductions. In fiscal year 2013, CMS began reducing health care reimbursement rates to hospitals with excessive 30-day readmission rates, as generalized by their readmission rates for heart attacks, heart failure, and pneumonias. These were extended to include readmission rates for hip and knee surgeries in fiscal year 2015. And, as readmissions were estimated to account for $17.5 billion of Medicare costs in 2012 (in part attributable to insufficient discharge services, access to outpatient care, and follow-up), efforts to curb them are expected to continue.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
On Wednesday, March 25, Arizona legislators passed a bill prohibiting women from buying insurance plans that cover abortions on the federal health exchange. Senate Bill 1318 also includes a provision on medical abortions, which are typically used during the first nine weeks of gestation. Medical abortions involve taking two pills within a few days of each other. The law requires doctors performing such abortions to tell their patients that if they reconsider their abortion after taking their first pill, they should return to the doctor for a procedure that can allegedly “reverse” the abortion. The law amends Arizona Statute § 36-2153 to add that at least twenty-four hours before an abortion is performed, the physician must orally and in person inform the woman that “it may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” The law also requires the Department of Health Services to update its website to include information about the potential ability to reverse a medical abortion. Republican Governor Doug Ducey, who opposes abortion rights, signed the law on March 30, 2015.
Like any law addressing abortion, the law is controversial. Abortion opponents lauded the bill, stating that Wednesday, March 25th was a “great day for women in Arizona who are considering getting an abortion to get all the facts they need.” On the other hand, women’s rights and health care providers’ groups oppose the coverage exclusion and vehemently oppose the abortion “reversal” provisions. Senate Minority Leader Katie Hobbs called it “junk science” and “quack medicine.” Arizona-based gynecologist Ilana Addis stated that there is no evidence to support this provision and women would essentially be “unknowing and unwilling guinea pigs.” Continue reading →
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law
On March 12, 2015, Texas Representative Elliot Naishtat (Austin) filed HB 3183, which would repeal the Texas law that currently prohibits pregnant women from exercising their advance directives. The existing statute includes the following language: “I understand that under Texas law this directive has no effect if I have been diagnosed as pregnant.” The bill strikes this sentence and would allow health care providers and medical institutions to honor a woman’s wishes about end-of-life care.
The bill is known as “Marlise’s Law,” named for Marlise Muñoz of Fort Worth, Texas, who was kept on mechanical support for two months after she was declared brain dead in 2013. Muñoz collapsed in her home in November 2013 when she was 14 weeks pregnant. She was declared brain dead two days later but John Peter Smith Hospital said it was legally prevented from removing life support because she was pregnant. Continue reading →
A.F. was an elderly patient admitted to our service for a diagnostic work-up and management of a large pocket of pus surrounding her lungs. Until recently, she was very independent and in good health; this was her third hospitalization for the same reason in one month. Radiographic imaging was consistent with pneumonia but other causes could not be ruled out. She had not responded to antibiotics, she had no other signs of infection, and numerous cultures from her blood, pus, and sputum failed to grow microbes. Extensive testing for other possible causes was also negative. At that point, we all had the same suspicion—cancer. Some tumors in the chest can cause inflammation that may look like a pneumonia and result in a collection of pus. That inflammation can also hide the tumor on imaging. In fact, it would be a few weeks, after we drained all of the pus and the inflammation subsided, until we would have a clearer image of the lungs. Though cancer was a plausible explanation, we had no evidence at that time. Should we have discussed our concerns with A.F.? The diagnosis was not certain, so we didn’t…
In daily clinical practice, uncertainties come in many forms. Outcomes for most medical interventions are probabilistic (they are not 100% predictable). And those probabilities are often ambiguous (they are more often ranges than specific percentages) or simply unknown. At a broader level, science is underdetermined, medicine is inductive, and innumerable non-medical forces influence the medical landscape (biases, conflicts of interest, values, etc.).
Time is running out on fixing the way we die. As readers of this blog know, the courts first declared a right to refuse unwanted life-sustaining treatment in the 1976 Quinlan case. Nearly 4 decades later, too many people are still burdened with treatments they don’t want, can’t get support for care at home, and are dying without good relief of pain and suffering. So it was no surprise that the highest court in Canada finally threw in the towel. In its Feb. 6 opinion in Carter v. Canada, the court found people still “suffering intolerably as a result of a grievous and irremediable medical condition.” The court thus recognized a right to physician aid in dying. Canada now has a year to set up a system that will permit the practice while protecting the vulnerable from abuse.
Allison M. Whelan, J.D.
Senior Fellow, Center for Biotechnology &Global Health Policy, University of California, Irvine School of Law
A legislative advisory committee is set to present an amended bill to the Minnesota State Legislature this session that raises the standard of care provided to incarcerated pregnant women in Minnesota prisons.
The amendment seeks to clarify language of a law passed on May 8, 2014 seeking to ensure incarcerated pregnant women receive the same standard of care they would receive outside a correctional facility. The Minnesota Senate and House unanimously passed the bill, which was described as “a first step toward providing a healthy start in life for the babies born to the estimate 4,200 women per year in [Minnesota] who are pregnant at the time of their arrest.” It was the first law to consider the unique needs of pregnant inmates. Continue reading →
As an update to my previous post here on medical students and professionalism, Judge Sutton writing for the Sixth Circuit found that a medical school could deny a degree to a medical student for failing to meet “professionalism” requirements. According to the opinion, the medical student had come late to classroom sessions, allegedly behaved inappropriately at a formal dance, had to repeat his internal medicine rotation due to poor performance, and had been convicted of driving white intoxicated. The Sixth Circuit found that Ohio, where the medical school is located, treats the relationship between a university and a student as contractual in nature, with that contract’s terms supplied by the student handbook. As the handbook in this case included professionalism as part of the academic curriculum, the university’s determination that the student failed to meet professionalism requirements was an academic judgment and thus merited deference by the court.
Last summer, Judge Gwin of the Northern District of Ohio found that the medical school went beyond its scope of duty by extending its determination of professionalism well past academic or patient related matters. The district court found for the student, noting that the “character judgments” found by the university were “only distantly related to medical education.” In my last post, I noted that this separation of personal character from competence to practice medicine seemed troublesome. The Sixth Circuit’s opinion reversing the district court shows similar concerns.
The piece has already been commented upon by several smart people, most recently Kay Lazar of the Boston Globe. Just one day after Ornstein’s piece went to press, the Dean of Harvard Medical School Jeffrey Flier (@jflier) tweeted “How could this be allowed to happen?” only to be informed by the Chair of Surgery at Boston Medical Center, Gerard Doherty, (@GerardDoherty4) that three Harvard-affiliated hospitals are in fact currently hosting camera crews for a similar series. The ensuing conversation reminded me just how limited a platform Twitter is for tricky conversations about health care law and ethics. So I did what any self-respecting millennial would do – I went home for the holidays and asked my mom to help me understand what the internet couldn’t.
In each piece, Keirns outlines the challenges she faced in vaginally delivering her son in a hospital environment that seemed committed to performing a caesarian section. Particularly given Keirns’ expertise in and familiarity with health care, the lack of patient-centered care in the story is striking. Several staff suggested that surgery was a foregone conclusion while others appeared unprepared for her son’s long-awaited arrival.
The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous. The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling. The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential. Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions. The changes go into effect on June 30, 2015. Labeling for over-the-counter medications will not change.
In a prior post, I discussed the Seventh Circuit’s decision in United States v. Nayak, one of the first major “honest services” mail and wire fraud cases to arise since the Supreme Court decidedSkilling v. United States in 2010. In Skilling, the Court found clear Congressional intent to limit honest services prosecutions to “offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407, emphasis added) As I warned in a 2012 article, the Court’s focus on bribery and kickback activity within the context of a fiduciary duty might have wide-ranging consequences in the health care field given the nature of the physician-patient relationship.
The structure of honest services cases differs from that of more traditional forms of mail and wire fraud, which usually involve perpetrators who defraud victims of money or property. In contrast, these “intangible rights” cases eliminate the requirement that the victim suffer a financial loss to the perpetrator. Nonetheless, such fraud is actionable only when the perpetrator in fact owes a heightened duty to provide “honest services” to the victim. While Skilling grounded that duty in a fiduciary relationship, the majority offered little guidance as to which aspects of the relationship were most important. As Justice Scalia noted in his concurrence: “None of the ‘honest services’ cases . . . defined the nature and content of the fiduciary duty central to the ‘fraud’ offense. There was not even universal agreement concerning the source of the fiduciary obligation – whether it must be positive state or federal law . . . or merely general principles, such as the ‘obligations of loyalty and fidelity’ that inhere in the ‘employment relationship.’” (Skillingat 416-17)
The indeterminacy of the fiduciary requirement has particular relevance in the medical context. While the physician-patient relationship is commonly described as a fiduciary one, the characterization is far more complex than may first appear. The disparities in medical knowledge, as well as the inability of patients to access many services (such as prescription drugs) without physician involvement, give physicians a great deal of power over their patients – a characteristic fiduciary responsibility. Yet the relationship lacks other fiduciary hallmarks; the physician, for example, lacks the fiduciary’s traditional control over the beneficiary-patient’s money. Skilling offered little guidance as to which of these characteristics is most relevant to the honest services duty. Continue reading →
Increasing hospitality in medical facilities is not a recent trend. We take for granted that modern hospitals offer clean sheets, towels, a plethora of toiletries, heated blankets, and many other amenities. Conversely, in the hospitals of decades past, many patients relied on family members to bring food and clean sheets. Rows of hospital beds in an open ward precluded privacy. Unhygienic conditions commonly resulted in rodent infestations. And paternalism in medicine was still the norm.
This trend towards hospitality has recently gained new momentum. As featured in a recent article in Kaiser Health News, dozens of hospitals have hired Chief Patient Experience Officers from customer service or hotel industries. Since 2012, when Medicare began penalizing hospitals for poor patient experiences, hospital efforts to improve patient satisfaction have grown. Some hospitals began mandating communication seminars, encouraging nurses to spend more face-to-face time with patients, and calling patients after discharge to follow-up on their recovery. The Affordable Care Act (ACA), further tying hospital reimbursements to patient surveys, has additionally promoted such changes.
A similar trend has arisen with the increased popularity of V.I.P. sections in many hospitals. Though the hospital construction boom is beginning to slow down, the resultant V.I.P. rooms remain. Lenox-Hill Hospital’s maternity suite in New York City, which received a lot of media attention after Beyonce gave birth there in 2012, is one of many luxurious suites across the nation. Some, offering personal shoppers, private chefs, and salon services, are priced upwards of $4,000. While nobody calls for a return to the hospitals of old, many feel suites such as these are excessive. Continue reading →
I previously wrote about California Proposition 46–which proposed to raise the cap on pain and suffering awards in malpractice cases from $250,000 to $1.1 million, require doctors to check a statewide database of drug prescriptions before prescribing some narcotics, and require doctors to undergo random drug and alcohol testing–here.