Category: Nadia Sawicki

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: 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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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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“Sanitizing” Lethal Injection

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By Nadia N. Sawicki

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.

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Media Matters: Fetal Abnormalities in the Munoz Case

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By Nadia N. Sawicki

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?

Standards of Care and Patient Advocacy in Religiously Affiliated Hospitals

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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. Read More