Authors

Nadia N. Sawicki is a Georgia Reithal Professor of Law at Loyola University Chicago, and Academic Director of Loyola’s Beazley Institute for Health Law and Policy. Her research focuses on patient decision-making and the informed consent process, particularly in the areas of end-of-life and reproductive care. Her work has been published in a variety of peer-reviewed journals - including the New England Journal of Medicine; Law & Policy; the Journal of Law, Medicine & Ethics; the American Medical Association Journal of Ethics; the Journal of Clinical Ethics; the American Journal of Bioethics; and the Journal of Legal Medicine – as well as in many academic legal journals. She has previously served as a member of the American Bar Association’s Special Committee on Bioethics and the Law, and was the co-chair of the American Society for Bioethics and the Humanities’ Law Affinity Group. Prof. Sawicki received her J.D. from University of Pennsylvania Law School, and her Masters in Bioethics from University of Pennsylvania School of Medicine. She is a graduate of Brown University, with a concentration in biomedical ethics. Prior to joining the Loyola faculty, Prof. Sawicki held the inaugural George Sharswood Fellowship at the University of Pennsylvania Law School, served as a lecturer in History and Sociology of Science at the University of Pennsylvania's School of Arts and Sciences, practiced law with Wolf, Block, Schorr & Solis-Cohen, and clerked for the Honorable J. Curtis Joyner of the U.S. District Court for the Eastern District of Pennsylvania.

Birth Plans as Advance Directives

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By Nadia N. Sawicki

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.”  Read More

Obstetric Battery

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By Nadia N. Sawicki

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.”

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Call for Proposals: BioIP Faculty Workshop

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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 thutchinson@aslme.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 cho@luc.edu.

Call for Proposals: Innovations in Life Sciences and Stakeholder and Agency Responses

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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@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.

Questions: E-mail questions to health-law@luc.edu Read More

Hiring Announcement: Loyola University Chicago Beazley Institute for Health Law

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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.

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Limited Access to Contraceptives in Illinois

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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.  Read More

On Agency Accommodations and Least Restrictive Alternatives

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By Nadia N. Sawicki

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.

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Sincerity and Religious Belief in Hobby Lobby

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By Nadia N. Sawicki

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.

“That’s a Lot of Marijuana”

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By Nadia N. Sawicki

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. Read More

How Medicine Learns About the Law

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By Nadia N. Sawicki

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.

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