Loyola University Chicago School of Law is currently accepting applications to fill its chair in health law and policy, named in honor of law school alumnus and donor Bernard J. Beazley. Details regarding qualifications and application requirements can be found on Loyola’s Careers site.
Much has been written about the Supreme Court of Pennsylvania’s recent decision in Shinal v. Toms, in which the court held that a physician’s duty to obtain informed consent, as codified in Pennsylvania’s MCARE Act, is non-delegable. According to the court, a physician faced with an informed consent suit cannot defend himself on the grounds that the patient was adequately informed of the risks and benefits of treatment by a physician assistant, nurse, or other intermediary acting under the physician’s direction. Pennsylvania is not the first state to adopt this view – courts in other jurisdictions (Connecticut, Louisiana, South Dakota, Texas, New Mexico) have similarly held that the duty to secure informed consent rests with the treating physician alone.
The MCARE (Medical Care Availability and Reduction of Error) Act was passed in 2002 to reform Pennsylvania’s medical malpractice laws, and refers to the duties and rights of “physicians” and “patients.” Shinal, likewise, addressed the issue of informed consent in the context of medical treatment. Thus, I was very surprised to learn that some commercial institutional review boards (IRBs), in reliance on the Pennsylvania Supreme Court’s decision, have been advising clinical trial investigators to revise their consent forms and processes to ensure that physician-investigators – and not recruitment coordinators, nurses, or other study staff – secure the consent of research participants.
Schulman, one of the most well-known commercial IRBs, recently posted about the Shinal case on its website; while noting that the case focused on medical malpractice “and does not address consent in the research context,” it advised investigators to “discuss with their legal counsel the impact of this decision on their consent process.” Sterling IRB had a similar post, advising investigators to “consider drafting consent form updates to clearly require that only physician members of the research team may obtain informed consent from a research subject.” In an e-mail that went directly to investigators and study staff, Sterling also suggested that they submit updated consent forms that “make clear that the only person who can obtain consent is the PI/physician.” A recent article in the Journal of Clinical Research Best Practice, titled “What Impact will the Shinal Case have on Informed Consent in Clinical Research?,” offered a more detailed analysis of the case, and concluded that “there is little to suggest that courts would not uniformly apply the same informed consent standards used in the medical practice to clinical research.” Continue reading
It is well known that maternal mortality rates in the United States are higher than in other countries in the developed world, and that many of these deaths are preventable. But a report published by NPR last week, just a few days before Mother’s Day, drew a direct link between these poor maternal outcomes and health care providers’ focus on fetal health. The report quotes Barbara Levy, vice president for health policy and advocacy at the American Congress of Obstetricians and Gynecologists, who said, “We worry a lot about vulnerable little babies, [but] we don’t pay enough attention to those things that can be catastrophic for women.” According to the authors of the NPR report, “newborns in the slightest danger are whisked off to neonatal intensive care units … staffed by highly trained specialists prepared for the worst,” while new mothers are instead monitored by nurses and physicians “who expect things to be fine and are often unprepared when they aren’t.”
These patterns are consistent with what Prof. Jamie Abrams calls “fetal consequentialism” – the premise that the birth of a healthy child outweighs any harm to the birthing mother. The increase in U.S. maternal mortality rates highlighted in the NPR report is certainly a product of such fetal consequentialism. So is the practice of obstetric violence, described in my previous posts, where health care providers dismiss birthing mothers’ informed requests for minimal intervention during labor and delivery in an effort to reduce the risk of fetal harm, even when that risk is minimal. Fetal consequentialism is likely driven not only by providers’ judgments of the relative liability risks for harms to fetuses versus harms to mothers, but also by conservative societal trends (evidenced by increasing anti-abortion legislation) that preference fetal interests over maternal interests. Continue reading
Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for its inaugural Wiet Life Science Law Scholars Conference on Friday, October 13, 2017.
The conference is designed to provide a new intellectual venue for life science professors, scholars, and practitioners to convene and discuss current research and scholarship. The phrase “life science law” aims to capture research and disciplines spanning food and drug law, health law, intellectual property (IP), biotechnology, environmental, administrative, antitrust, and other realms that involve the life sciences in some meaningful respect. Our goal is to foster recognition of life science law as a cohesive, dynamic, area of legal study and strengthen connections among national life science law scholars.
Loyola is currently soliciting 750-1,000 word abstracts reflecting early or mid-stage ideas for the purpose of workshopping with other conference scholars. Modeled after successful events for law professors and scholars in other areas, participants will be organized in topical panels of three to five authors with approximately 15-20 minutes allotted to each abstract presentation, followed by discussions with scholar attendees. Abstracts from the authors will be distributed one week prior to the conference; authors may also submit draft articles for distribution to conference attendees.
SUBMISSION AND REVIEW TIMELINE: The deadline for 750-1,000 word abstracts, including author contact information is June 15. Submit via email to email@example.com with subject line Wiet Life Science Law.
Authors will be notified of speaker selections by email on or before July 15.
There is growing public recognition that women’s autonomy rights during labor and delivery are being routinely violated. Though such violations rarely rise to the level of egregious obstetric violence I described in an earlier blog post, women recognize that hospital births, even for the most low-risk pregnancies, often involve cascades of medical interventions that lack evidence-based support and can have negative health consequences for both mother and child. Indeed, evidence suggests that an increasing number of women are pursuing options like midwife-assisted birth, delivery in free-standing birthing centers, and even home birth in an effort to avoid interventionist hospital practices. According to the 2013 Listening to Mothers Survey, nearly six in ten women agree that birth is a process that “should not be interfered with unless medically necessary.”
One tool that women frequently use to increase the likelihood that their autonomous choices will be respected during labor and delivery is the birth plan, a document that outlines a woman’s values and preferences with respect to the birthing process, and serves as a tool for facilitating communication with care providers. However, while most women view the creation of a birth plan as empowering, there is little evidence to suggest that the use of birth plans actually improves communication, increases women’s feelings of control, or affects the process or outcome of childbirth. In fact, there appears to be some resistance within the medical community to women’s reliance on birth plans, with one article describing “the two words ‘birth plan’ strik[ing] terror in the hearts of many perinatal nurses.” Continue reading
In 2013, Kimberly Turbin came to Providence Tarzana Medical Center for a momentous occasion – the birth of her first child. In the delivery room, she was surrounded by supportive family members. Her mother stood by her side with a video recorder, hoping to capture the once-in-a-lifetime event for posterity.
And this is where Kimberly’s birth story veers off course. According to the complaint filed in Los Angeles County Superior Court against her OB/GYN, Dr. Alex Abbassi, Kimberly is a survivor of sexual assault who had confided in the medical staff that she had previously been raped. She requested that the staff ask permission before touching her, and asked them to “be gentle.” And when Dr. Abbassi told Kimberly during delivery that he would be performing an episiotomy – a surgical procedure in which the perineum and vaginal wall are cut to provide more room for the baby to pass through the vaginal canal – Kimberly objected. When she asked why the episiotomy was necessary, Dr. Abbassi provided no medical justification. He responded, “What do you mean, Why? I am the expert here! … You can go home and do it! You go to Kentucky!” Kimberly continued to object, loudly saying “No!” and “No, don’t cut me!” numerous times. Dr. Abbassi proceeded nevertheless, cutting her perineum twelve times. A video of this entire encounter, which is extremely graphic and difficult to watch, is viewable on YouTube.
These allegations, if true, present a textbook case of battery – the defendant intended to cause contact with the patient, the contact was harmful and offensive, and the contact was neither consented to nor justified by any emergency. And yet, when Kimberly filed suit for battery and intentional infliction of emotional distress, Dr. Abbassi moved to dismiss her suit – he argued that because Kimberly’s claim was grounded in the failure to obtain informed consent, it constituted negligence under California’s medical malpractice laws and therefore was barred by a shorter statute of limitations. In June of 2016, however, Judge Benny Osorio denied Dr. Abbassi’s motion to dismiss the battery claim, holding that the “alleged act of proceeding against the express wishes of Plaintiff … is premised on intentional misconduct and not professional negligence.”
The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.
The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.
Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.
Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at firstname.lastname@example.org by Oct 14, 2016.
Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.
For questions, please email Cynthia Ho at email@example.com.
The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions on innovations in life sciences and stakeholder and agency responses for presentation at our Tenth Annual Health Law Symposium. The Symposium will take place at Loyola University Chicago School of Law on Friday, October 28, 2016 at 9:30am.
The Symposium will explore recent innovations in life sciences and responses by regulatory agencies including FDA, FTC, and DOJ as well as stakeholder responses and recommended next steps for policy and regulatory reforms.
A range of topics will be considered, including but not limited to gene editing, mobile health,
cybersecurity, personalized/precision medicine, 3-D printing technologies, Cancer Moonshot 2020, biosimilars and interchangeable biologics, and vaccine development and incentives (e.g., Zika).
Submission Information: Those interested in participating, please send a 1000-word abstract to health-law at luc.edu by May 31, 2016. Authors will be notified of decisions no later than June 15, 2016. If your abstract is selected, a full paper will be due by January 6, 2017.
Covered expenses: Hotel, travel, ground transportation, three provided meals.
Loyola University Chicago School of Law is pleased to invite applications for a full-time tenure-track position, at the rank of Assistant/Associate Professor with expertise in health law, beginning in fall 2016. We seek a scholar-teacher whose substantive interests are in the areas of administrative law, healthcare regulation, corporate health law and/or food and drug/pharmaceutical law. The full job announcement can be found at www.careers.luc.edu.
By Alexandra Gross
What does “access” really mean for the purposes of PPACA’s contraceptive coverage mandate?
For two years, I’ve been enrolled in Loyola University of Chicago’s Student Health Insurance Plan, provided through a Blue Cross Blue Shield Illinois (BCBSIL) PPO plan. During this time, I have had to pay out-of-pocket for my contraceptive method every month. As a student studying health law, I was aware of the ACA’s contraceptive coverage mandate, § 2713 of the Public Health Services Act, which requires non-grandfathered health insurance plans to provide access to a full range of Food and Drug Administration approved contraceptive methods without cost sharing. The contraceptive coverage mandate reflects Congress’ determination that “access to preventive services without cost sharing is necessary to achieve access to basic health care,” particularly for women, as they have unique health care needs. The contraceptive coverage mandate also states that plans and insurers may impose “reasonable medical management techniques” to control costs and promote efficient delivery of care. For example, plans may cover a generic drug without cost sharing, but impose cost sharing for the equivalent brand name drug. Even with the imposition of medical management techniques, I still could not figure out why every single woman I talked to who was on my plan had a copayment of twenty dollars or more a month.
My colleagues and I assumed our issues with contraceptives were a result of attending a religiously affiliated institution. We were wrong. Loyola has properly sought a religious exemption from providing contraceptive coverage and communicated to the students and employees that BCBSIL should be accommodating us directly, without Loyola’s involvement. However, in practice, the accommodation is failing the students and employees at Loyola University of Chicago. Continue reading
Did HHS shoot itself in the foot by providing an accommodation to religious non-profits?
In holding that the contraceptive mandate imposed by HHS on Hobby Lobby and Conestoga Wood was not the “least restrictive alternative” for providing no-cost contraceptive coverage to women, the Supreme Court pointed to the accommodation HHS recently provided to religiously-affiliated non-profit corporations. Under the accommodation, “eligible organizations” such as religiously-affiliated hospitals and universities can avoid funding insurance coverage for contraceptives if they certify that they have a religious objection to providing such coverage. In such cases, the eligible organization’s insurance issuer must exclude contraception from the organization’s group health insurance plan, and instead provide a separate issuer-funded contraceptive plan directly to employees. Given that such an accommodation is already in place for some employers, the Supreme Court noted, “HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.”
One obvious problem with the Court’s assertion, noted in Justice Ginsburg’s dissent, is that the Court expressly declined to determine whether such an accommodation would in fact be permissible under RFRA. Given the challenges to the accommodation-by-certification requirement already brought by organizations like Little Sisters of the Poor, it is far from clear that the current composition of the Supreme Court would uphold this requirement if faced with a direct challenge.
A second, perhaps less obvious, concern about the Court’s proposal that the eligible employer accommodation be extended to for-profit corporations is that HHS may now regret providing it – and as a result, HHS may refrain from making similar accommodations in the future, which would be a significant loss to defenders of religious freedom.
Courts evaluating First Amendment and RFRA claims have long held that they are in no position to evaluate the validity, centrality, or reasonableness of a claimant’s sincere religious beliefs. And while there is room for courts to evaluate whether a claimant’s beliefs are indeed “sincere,” many courts shy away from doing so because of a perceived overlap between judgments about centrality and about sincerity.
In Hobby Lobby, the sincerity of the corporation’s beliefs was not in dispute. Hobby Lobby asserted (and HHS accepted the claim) that it had a sincere religious belief that life begins at conception, and that this belief prohibited it from facilitating access to contraceptives that operate after that point.
But recent news reports have shown that Hobby Lobby has, in fact, been involved in activities that seemingly run afoul of this belief – including investing in pharmaceutical companies that manufacture the contraceptives they raise objections to in their lawsuit, as well as drugs commonly used for abortion; investing in insurance companies that cover abortion and emergency contraceptives; and actually providing coverage for emergency contraception in their own health plan until 2012.
While these facts were not raised before the courts hearing Hobby Lobby’s RFRA claims, First Amendment precedent suggests that they would be relevant to a judgment about the sincerity of Hobby Lobby’s religious beliefs. Surely a company that believes life begins at conception would have more difficulty demonstrating the sincerity of its beliefs when some of its conduct supports activities that are in direct opposition to this stated belief. This is not to say that a court would ultimately conclude that Hobby Lobby’s religious beliefs were insincere – but rather, that a court could legitimately consider these facts without treading into the dangerous territory of judging the merits and centrality of Hobby Lobby’s beliefs to the exercise of its faith.
Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research. Continue reading
Many medical providers learn about the law the way kids learn about sex – whispers with friends, internet message boards, and media depictions of the most dramatic and unrealistic kind. And while both medical schools and junior high schools offer some type of formal education, it is quite limited, especially as compared to the information these students collect through other, less reputable, sources. As a result, many medical providers go into practice with a dark cloud over their heads – the “scared straight” model of legal education, if you will.
We’ve heard a lot about the practice of defensive medicine – ordering more tests and procedures than are medically necessary in an effort to protect oneself from potential liability. But fear of liability manifests itself in other, less dramatic, ways as well – for example, in overly-restrictive interpretations of HIPAA requirements that make it difficult for patients and their care providers to access needed medical information. In reality, however, much of the fear of liability experienced by medical professionals is unfounded.
Oklahoma’s botched execution of Clayton Lockett has brought increased attention to an issue that I have been concerned with for years – the increased “medicalization” of legally sanctioned executions, and, in particular, the role that medical professionals and the scientific community play in this process.
Until the 20th century, most executions were conducted publicly – execution was a communal ritual that served as a means of catharsis. But the American execution process has, over time, become less visible, and, as a consequence, subject to less public oversight. I believe that the movement of the capital punishment process “behind the curtain,” both literally and figuratively, should trouble death penalty opponents and supporters alike.
The standard lethal injection protocol used throughout the United States was developed in 1976 by Dr. Jay Chapman, Oklahoma’s state medical examiner, and Dr. Stanley Deutsch, chair of the Oklahoma Medical School anesthesiology department. Without testing or research, they settled on a three-drug protocol for executing prisoners – sodium thiopental, a short-acting barbiturate; pancuronium bromide, a paralytic; and potassium chloride, which stops the heart. Until recently, this was the combination used in every state.
Things began to change when Hospira, the U.S. pharmaceutical company that manufactured sodium thiopental, stopped making the drug in 2011. Since then, European manufacturers of sodium thiopental and pentobarbital have limited the production of these drugs, and the European Commission has restricted their export to the U.S. for execution purposes. And just last year, the U.S. Court of Appeals for the District of Columbia ruled in Cook v. FDA that the FDA lacks authority to permit importation of these drugs, which, when used for lethal injection, are considered “misbranded” under the FDCA. As a result, many states, including Oklahoma, have had to resort to other alternatives.
The tragic case of Marlise Munoz is finally at an end, now that John Peter Smith Hospital has, pursuant to an order by Judge R. H. Wallace, Jr., taken Ms. Munoz off life support and released her body to her family. A few questions about the media’s role in this case linger in my mind, however; I will be addressing them in a series of posts.
In the days immediately preceding the court’s ruling, media reports frequently mentioned that the fetus Ms. Munoz was carrying was “distinctly abnormal.” My impression is that these reports were intended to strengthen the case, at least in the public’s eyes, for withdrawal of life support. Maintaining a dead body on life support against the family’s wishes in order to preserve the life of an able fetus is one thing, commentators seemed to suggest, but the case for doing so when the fetus suffers from hydrocephalus, heart problems, and deformation of the lower extremities is less compelling.
In the eyes of pro-life advocates committed to preserving the potentiality of life at all costs, however, the fetus’ medical condition seems irrelevant. Unless a fetus is definitively not viable (which in this case the hospital finally conceded it was), a true commitment to the preservation of fetal life would not waver in the face of likely disability upon the child’s birth.
The fervent media reporting about the abnormality of the Munoz fetus seems, at least to me, to reflect a disconnect between the public’s perception of the significance of fetal disability in such cases, and its significance to disability advocates and advocates of pro-life policy. What lessons, if any, can we learn from this disconnect?
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
Loyola University Chicago’s Stritch School of Medicine recently announced that it is accepting applications from DREAMers – undocumented immigrants who are eligible for the Deferred Action for Childhood Arrivals (DACA) program, which grants qualified applicants a two-year, renewable authorization to remain and work within the United States. This news was met with predictable responses on both sides of the immigration debate – DREAMers applauded the decision, while critics of immigration reform derided the program as a “campaign by that elites who run higher education” who are insensitive to the program’s effects on American citizens.
Media reporting on Loyola’s new policy, however, has been unclear with respect to one issue – whether DREAMer graduates will ultimately be able to obtain medical licenses in the states in which they intend to practice. According to Geoffrey Young, senior director of student affairs and programs at the Association of American Medical Colleges in Washington, who was quoted in an article in Crain’s Chicago Business, “They’ll all be M.D.s, but whether or not they can practice legally in states is to be determined.”
Under the best interpretation of current law, however, DREAMers who successfully graduate medical school cannot be barred from obtaining a medical license on account of their citizenship status. While some states’ licensing requirements still include a citizenship requirement (New Jersey, for example, requires that applicants for a medical license be U.S. citizens or declare their intention to be a citizen; those who fail to gain citizenship within a set period of time will have their temporary licenses revoked), Supreme Court precedent indicates that withholding medical licensure based on citizenship status would likely violate the Equal Protection clause of the Fourteenth Amendment.
I’m pleased to announce that Loyola University Chicago School of Law is seeking to fill the recently created Bernard J. Beazley Chair in Health Law and Policy. My colleagues and I at the the Beazley Institute for Health Law and Policy are excited for the opportunity to welcome a distinguished scholar of health law into the Loyola community.
Additional details about the position are below the fold. Continue reading
A recent article in the New York Times (“Death Row Improvises, Lacking Lethal Mix”) described the challenges that correctional departments in death penalty states face in obtaining the drugs needed for lethal injection. The manufacturers of pancuronium bromide and pentobarbital, for example, have refused to supply drugs for execution purposes, and the U.S. Court of Appeals for the District of the District of Columbia recently ruled that the FDA cannot approve importation of sodium thiopental. States such as Missouri, Arkansas, and California are now struggling to decide how to approach the issue.
The article quotes death penalty supporter Kent Scheidegger, of the Criminal Justice Legal Foundation, who describes the legal challenges to lethal injection drugs as a “conspiracy to choke off capital punishment by limiting the availability of drugs.” Also quoted is Robert Blecker, a professor of criminal law at New York Law School, who refers to the drug challenges as “an abolitionist tactic to gum up the works … It’s just another tactic.” Such comments do a disservice to those on both sides of the political spectrum who have legitimate concerns about the methods by which states execute death row prisoners. Not every challenge to lethal injection techniques is a subversive tactic to overturn the death penalty. In engaging in debate on this issue, commentators ought to look beyond their own political perspectives and consider that the arguments made by opponents are made in good faith and do not always reflect a predetermined political view.
While many opponents of lethal injection techniques are driven by a moral opposition to the death penalty, the arguments about the problems with these techniques are valid regardless of one’s political position. Surely, even a supporter of the death penalty can believe that the methods used to execute prisoners matter – that lethal injection techniques ought to be effective and efficient, and ought to be designed to avoid the types of errors that have caused complications in the past. One’s support for the death penalty as a penal tool should not negate human compassion for even the most hardened criminal’s last moments on earth. While death penalty states may be eager to move forward with executions as quickly as possible, it is foolish for this motivation to drive the adoption of untested and unproven drugs.
While there are very real logistical challenges to testing new execution techniques, death penalty supporters are wrong to describe the arguments presented by opponents of the current system of lethal injection as merely conspiratorial tactics to “gum up the works.” Rather, these arguments reflect legitimate concerns about the end-of-life experiences faced by the 40 to 60 prisoners who are executed every year. Commentators such as Scheidegger and Blecker, if truly committed to the death penalty, ought to find ways to satisfy critics’ concerns about humane execution methods, rather than dismiss critics as politically-motivated obstructionists.