“Error in Judgment” and Informed Consent

By Alex Stein

When conventional standards of practice allow a physician to choose between two or more ways to treat or diagnose a patient, she is free to select any of those ways. The fact that her chosen procedure subsequently proves inferior to the alternatives and works badly for the patient is of no consequence: the physician would not be liable for malpractice because malpractice accusations only attach to actions and not to consequences. Whether a physician did or did not deliver substandard treatment to the patient must be determined prospectively (ex ante) rather than by hindsight (ex post). Because a medically approved procedure that proves inferior to another recommended procedure appears negligent, jurors must receive an effective warning against this misleading appearance. How to best administer this warning is a matter of split among state courts. Read More

Federal Newborn Screening Law Emphasizes Informed Consent

By Allison M. Whelan (Guest Blogger)

On December 18, 2014, President Obama signed into law the Newborn Screening Saves Lives Reauthorization Act of 2014. The Act includes new timeliness and tracking measures to ensure newborn babies with deadly yet treatable disorders are diagnosed quickly. These changes responded to a Milwaukee Journal Sentinel investigation that found thousands of hospitals delayed sending babies’ blood samples to state labs.  A primary purpose of newborn screening is to detect disorders quickly, so any delays increase the risk of illness, disability, and even death.

Although a major reason for the Act’s amendments is to address these problematic delays, another important addition to the Act establishes a parental consent requirement before residual newborn blood spots (NBS) are used in federally-funded research. The Act directs the Department of Health and Human Services (HHS) to update the Federal Policy for the Protection of Human Subjects (the “Common Rule”) to recognize federally-funded research on NBS as “human subjects” research. It also eliminates the ability of an institutional review board to waive informed consent requirements for NBS research.

Read More

A Right to Die? The M.D. Case Before the Argentine Supreme Court

by Martín Hevia

In 2015, the Argentine Supreme Court is to hear a case involving the right to die, death with dignity, and informed consent. Because of a car accident in the Province of Neuquén, M.D., the patient, has been in a permanent, irreversible, vegetative state for 18 years. His sisters and curators have requested the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way.

This will not be the first time that the Supreme Court hears a case of death with dignity. In 2012, the Court heard the case of Albarracini Nieves, who was unconscious when admitted to a hospital in Buenos Aires. The physicians established that a blood transfusion was necessary. But, as Albarracini belonged to the cult “Jehovah’s Witnesses”, he had had made a statement before a public notary in 2008 where he expressed he would not accept any blood transfusions even if his life were in danger. His father requested a cautionary measure that would order the transfusion to be practiced. The first instance court admitted the solicited measure, considering that although Albarracini had expressed that he refused an eventual transfusion, he was not “in a condition to make decisions with full discernment.”The case then reached the Supreme Court, which argued that there were no reasons to doubt over the current validity of Albarracini’s expression of will and that there was no evidence that he would not have considered the significance of his decision.The Court argued that “…this Court has clearly established that Article 19 of the National Constitution grants the sphere of freedom, within which he can freely adopt fundamental decisions about himself without any State or third parties interference, as long as those decisions do not violate third parties’ rights.”The Court stated that“The possibility of accepting or refusing a specific treatment, or selecting an alternative form of treatment, is part of self-determination and personal autonomy; that patients have the right to choose options according to their own values or points of view, even when they may seem irrational or imprudent, and that free choice must be respected.”

The M.D. case is different in that it is difficult to prove the patient’s will – unlike in the Albarracini Nieves case – because there is not a patient’s written statement on whether it is appropriate for him to continue or not certain medical treatment to keep him alive. The Superior Court of Justice of the Province of Neuquén has decided on the case invoking the 2009 Patients´ Rights Act: according to this law, the sisters have standing to grant informed consent in the name of their brother.

The Supreme Court and Argentine lower courts have interpreted the National Constitution and concluded that it grants patients a wide range of autonomous choice as regards their autonomy, reflected in their right to refuse medical treatment.  On that basis, the Supreme Court will probably confirm the decision of the lower court.

February 9-13, 2015: Visit Karolinska Institutet in Stockholm to Learn More About Biobanking

By Timo Minssen

The following information has been extracted from the webpage of the BioBanking and Molecular Resource Infrastructure of Sweden on the course Biobanking as a Resource for Biomedical Research, February 9-13, 2015 at Karolinska Institutet (Stockholm). 

Purpose and Goal

Biobanks constitute a powerful resource in medical research with access to millions of samples and associated data collected within health care and in specific research studies. New “omic-technologies” with high-throughput analytical platforms now permit large scale analyses without the need to wait for years while new samples are being collected.

However, successful research based on human biological samples and associated data requires applied knowledge about how the samples have been collected and processed. Standardized procedures, controlled pre-analytical variables and study documentation are key factors for the reliability and validity of the analytical findings.

This one week course addresses fundamental concepts in biobank infrastructures and biobank research, ethical and legal frameworks, technologies, sample analysis and practical considerations when new samples are to be collected.  Read More

Parental Consent for Youth Contact Sports Participation

As we enter into the fall sports season, it’s unlikely that a week will go by where we don’t hear the current buzzword in sports community: concussion. Whether in reference to an acute player injury, an untimely death, new or ongoing litigation, or rule changes in sport, the athletic community and the public are increasingly aware of the impacts of these brain injuries. Although much of the media attention is directed toward college and professional athletes, youth and high school athletes significantly outnumber their older counterparts and it is thought that they take longer to recover from these injuries.

A recent publication by Mannings and colleagues surveyed 369 parents of 5-15 year old full-contact football players in order to assess the parents’ understanding of concussion (1). Although the study does have limitations, its finding could have important implications. The parents surveyed were often missing critical information about concussions. For example, less than half of parents correctly identified that concussion is a mild traumatic brain injury. Additionally, none of the parents surveyed correctly identified all of the symptoms of concussion queried in the study. Although it is mandated by statute in the majority of states (2) that parents and/or athletes are provided with information about concussions prior to sports participation, the extent to which the information provided (normally in the form of an information sheet) is read, understood, or retained is not well understood.

Sports participation is associated with a myriad of positive physical, psychological, and social outcomes. However, it also comes with the risk of injury, including concussion. For youth and adolescents, parents play a critical role. Most often, children and adolescents rely on parental consent to participate in sports. Given parents’ role as decision-makers, and the finding of Mannings and colleagues, an important ethical issue that needs to be addressed is what level of knowledge should be required for parents to provide informed consent for their child to participate in inherently risky activities such as contact sports?

[This post reflects my own views only.  It does not necessarily represent the views of the Petrie-Flom Center or the Football Players Health Study at Harvard University.]

Art Caplan: WHO Ethics Committee on Ebola Just a Start

Art Caplan has a series of new opinion pieces out on the WHO ethics advisory committee meeting that approved the use of experimental drugs to treat patients ill with Ebola.

He suggests deeper exploration of issues of informed consent, corporate responsibility, and resource allocation in this blog post for The Health Care Blog. As he writes in his piece in NBC News Health:

It is important that the WHO committee affirmed the morality of compassionate use. This addresses the concern that any use of unapproved drugs is inherently exploitative. But there are huge ethical issues that still remain unaddressed and unanswered regarding experimental interventions.

In the wake of the Canadian government’s offering 1,000 doses of an experimental Ebola vaccine to the stricken nations, he also extends the argument from allocation of treatment to allocation of prophylaxis in this opinion piece in NBC News Health:

It is ethically appropriate in the midst of a deadly contagious epidemic to try both untested treatments and experimental preventative vaccines that have shown some promise in animals and no safety issues. But with only 1,000 doses of vaccine available, who should get them? And what do they need to be told?

The most ethical way to distribute limited experimental vaccine, is, as the WHO ethics group noted, with an eye toward collecting information on safety and efficacy. Rather than just handing out vaccine to a small group of people in countries that have seen Ebola outbreaks, it is important to learn as much as possible about whether the vaccine has any efficacy in humans and is safe.

You can read more at the links above.

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.” Read More

Anti-Abortion Practices at Catholic Hospitals as Medical Malpractice

By Alex Stein

The New York Times has recently reported about a suit filed by ACLU against the United States Conference of Catholic Bishops for requiring Catholic hospitals to avoid abortion “even when doing so places a woman’s health or life at risk.” The suit unfolds a disturbing story about an 18-week pregnant woman who rushed to the Mercy Health Partners in Muskegon, Michigan – the only one in her county – after breaking water. According to the suit, the plaintiff’s pregnancy was not viable but posed significant risks to her health. Instead of inducing labor or surgically removing the fetus to reduce the plaintiff’s chances of infection, the doctors at Mercy Health sent her home. The doctors also did not tell the plaintiff that her pregnancy is not viable and that it poses risk to her health. The plaintiff returned to the hospital next morning and was sent home again (!!) despite her bleeding and pain. On her third visit to the hospital – with severe pain and fever – the plaintiff miscarried and her fetus died shortly thereafter.

Described by the NYT as opening “a new front in the clash over religious rights and medical care,” the suit was filed in federal court in Michigan. Read More

Oregon’s Unfulfilled Tort Reform

By Alex Stein

Oregon has a statute capping noneconomic damages recoverable in medical malpractice suits at $500,000.

The Oregon Supreme Court decided that this cap is unconstitutional insofar as it clashes with a person’s right to recover full jury-assessed compensation for injuries recognized as actionable in 1857 when Oregon adopted its constitution. Specifically, it ruled that Article I, sections 10 and 17, of the Oregon Constitution entrench this right and deny the legislature the power to curtail it: see Smothers v. Gresham Transfer, Inc., 23 P.3d 333 (Or. 2001), and Hughes v. PeaceHealth, 178 P.3d 225 (Or. 2008). This ruling separated the constitutionally protected pre-1857 causes of action, which the statutory cap cannot curtail, from the constitutionally unprotected causes of action that came into existence after 1857 and that can consequently be capped.

Consequently, in order to reduce a jury’s award of noneconomic damages to $500,000, the defendant must show that the plaintiff’s complaint was not actionable before 1857. To adjudicate such claims, courts must carry out an historical investigation into Oregon’s medical malpractice law.

The Court’s most recent decision on that issue, Klutschkowski v. Oregon Medical Group, — P.3d —-, 2013 WL 5377913 (Or. 2013), made this task easy to perform. Read More

Daubert as a Problem for Psychiatrists

By Alex Stein

Most psychiatrists don’t know about it, but the switch from Frye to Daubert in the admission of expert testimony matters for them a lot. Psychiatrists treat patients with second-generation antipsychotics: Zyprexa, Risperdal, Clozaril, Seroquel, and similar drugs. A reputable, but still controversial, body of research links those drugs to tardive dyskinesia: a serious neurological disorder involving uncontrollable facial grimacing, repetitive tongue thrusting, and other untoward bodily movements. Under Frye, expert evidence can only be admitted upon showing that it received “standing and scientific recognition” from the relevant community of experts. Absence of a solid consensus disqualifies the evidence. Expert testimony linking tardive dyskinesia to antipsychotic drugs consequently would not be admissible under Frye. Under Daubert, however, it would go into evidence because its underlying research is grounded in scientific method and procedure that can be replicated, examined, and properly explained to the jury.

This is exactly what happened in a recent case decided by the United States District Court for the District of Columbia: Patteson v. Maloney— F.Supp.2d —-, 2013 WL 5133495 (D.D.C. 2013). Read More