In response to the religious objections levied against the contraceptives coverage mandate at issue in Hobby Lobby, Zubik, and gobs of other cases, many have argued that this was really a matter of subjugating women – not about religion per se. Well, now we have a test case: Vermont’s governor just signed into law a requirement that public and private health insurance cover vasectomies without copays and deductibles. There won’t be the same arguments about abortifacients here, but many religious employers should object just the same, if they’re being consistent. Now let’s watch and see…
Category: Holly Fernandez Lynch
SCOTUS and More Surprises on Zubik
After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case. The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.
SCOTUS has pulled a few tricks out of its hat to avoid that possibility. First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire). The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept. Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.
So what does that mean? In my view, count it as a win for the government. Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now. Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden. And SCOTUS hasn’t said there is.
What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision. The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president. The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits. Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.
TOMORROW, 3/25 in NYC! Book Talk & Panel: FDA in the 21st Century – The Challenges of Regulating Drugs and New Technologies
FDA in the 21st Century:
The Challenges of Regulating Drugs and New Technologies
March 25, 2016 12:00 PM
92nd Street Y
1395 Lexington Ave. (at 92nd St.), New York, NY
Join co-editors Holly Fernandez Lynch (Petrie-Flom Executive Director) and I. Glenn Cohen (Petrie-Flom Faculty Director) and contributor Lewis Grossman (American University) for a discussion of FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015). This volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.
This is a ticketed event. To learn more, visit the 92nd Street Y’s website!
Sponsored by the 92nd Street Young Men’s and Young Women’s Hebrew Association (New York, New York) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
Some Commentary on How to Think About Secondary Research with Biospecimens
The public comment period on the NPRM to revise the Common Rule has just closed, and now we wait to see what happens (if anything), and when. One of the most controversial proposals in the NPRM would require at least broad consent for secondary research with biospecimens (i.e., research on specimens originally collected for another purpose, either clinical care or a different study), regardless of whether those specimens retain identifiers. This is a substantial change from the status quo, which does not require consent for such research with de-identified specimens. How should we feel about this status quo, and the proposed change? My own view is that it’s really not so bad: the risks to individual research participants are quite low, and the current approach facilitates critically important scientific advancement. There is certainly room for improvement, e.g., to impose punishment on those who would act to re-identify de-identified specimens without permission, to inform the public that such research takes place, and to educate them about its value, perhaps allowing those who still feel very strongly that they prefer not to be included an opportunity to opt-out. But what has been actually proposed has more problems than what it would replace, and in fact, wouldn’t solve some of those it seems to be a response to.
Rebecca Skloot feels otherwise. She is the author of a book called The Immortal Life of Henrietta Lacks, which chronicles the origin of one particularly important cell line – HeLa – derived from cells that had been excised from Ms. Lacks in the course of a 1951 surgery to treat her cancer, and later used for research without her knowledge or permission. Ms. Lacks was poor, uneducated, and black, and her descendants have also faced more than their fair share of adversity. Ms. Skloot paints a compelling story of exploitation, but in my opinion, it is much more effective as a narrative about the horrible and enduring legacy of racism in this country than as proof that researchers who conduct secondary research with biospecimens without consent (as permitted under the current regulations, remember) or even without profit-sharing have behaved badly. After all, if individual risks are low and social benefits high – both true – then what’s the problem? And it is far from clear that specimen sources deserve compensation for no other reason than that their discarded material actually proves valuable to scientists. Nonetheless, the book has been used as a rallying cry by people from all walks of life who believe that they should be allowed to control whether, and potentially how, their specimens are used for research. Indeed, The Immortal Life of Henrietta Lacks is probably the single most important development that pushed the proposed revisions to the Common Rule forward, for the first time since they were released in 1991.
New Developments in the Guatemala STD Experiments Case
In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards. They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.
Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.
As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative. We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential. Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles. The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.
There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed. But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.
More information on the petition is available here.
Book Launch (10/28)! FDA in the 21st Century: The Challenges of Regulating Drugs and New Technologies
Book Launch: FDA in the 21st Century
October 28, 2015 12:00 PM
Wasserstein Hall, Milstein East C, HLS
1585 Massachusetts Ave., Cambridge, MA [Map]
In September 2015, Columbia University Press published FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen. This edited volume stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.
This event will provide a discussion of the book, including questions like: How is the agency faring in the 21st century? What are the greatest challenges to the FDA’s success, and what does success look like? What lessons has it learned and how can it best meet the challenges of today? Should we keep the agency we have, pull it apart, or rebuild from scratch?
Panelists:
- Daniel Carpenter, Freed Professor of Government, Harvard University and Director, Center for American Political Studies at Harvard University
- I. Glenn Cohen, JD, Professor of Law and Faculty Director of the Petrie-Flom Center, Harvard Law School (co-editor)
- Aaron S. Kesselheim, MD, MD, MPH, Associate Professor of Medicine, Harvard Medical School; faculty member, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hosptial
- Holly Fernandez Lynch, JD, MBioethics, Executive Director of the Petrie-Flom Center (co-editor)
- Moderator: Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School, and Associate Epidemiologist, Brigham and Women’s Hospital
This event is free and open to the public.
Order the book now from Columbia University Press using promo code FDA21 and save 30%!
Sponsored by the Harvard Law School Library and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.
NEXT WEEK (10/15): Obamacare, the Contraceptive Mandate, and Religious Freedom Discussion
Obamacare, the Contraceptive Mandate, and Religious Freedom Discussion
Thursday, October 15, 2015 12:00 – 1:00 PM
Wasserstein Hall, Room 2012
Harvard Law School, Cambridge MA [Map]
The Harvard Federalist Society will be hosting Mark Rienzi next Thursday, October 15 to discuss the current contraceptive mandate and accommodation lawsuits. Petrie-Flom Center Executive Director Holly F. Lynch will offer her views in response.
The event will be at 12:00 PM on October 15 in WCC 2012. It will end just before 1:00 so that students can make it to 1:00 classes. The Federalist Society will provide lunch.
A Circuit Split on Contraceptives Coverage
Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate. Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.
First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.
Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met. So far, so good. But that’s the end of my agreement.
I Concur with the Dissent (or, More on Little Sisters)
On September 3, the 10th Circuit declined to rehear en banc several challenges to the contraceptives coverage mandate filed by non-profit organizations, including Little Sisters of the Poor. As SCOTUSBlog explains, these organizations had not themselves asked for en banc review, having already moved on to SCOTUS, but the judges have the option of calling for a vote themselves, which one or more of them must have done. The vote came down 7-5 in favor of refusal, with the dissenting judges (i.e., those who wanted en banc review) issuing an explanation of their position. On this issue, I concur with the dissent. But I still don’t think the objecting non-profits should be off the hook.
When it comes to the contraceptives coverage mandate, non-profits, and now certain for-profits, are accommodated such that they may be relieved of the responsibility to contract, arrange, pay, or refer for contraceptives coverage if they notify the government or their health insurer of their objection to doing so, such that their insurer (or third party administrator of self-insured plans) can provide free contraceptives to their employees, at no cost to and without the involvement of the employer (all further explained here by Greg Lipper). However, many organizations continue to argue that the accommodation fails to relieve them of complicity in providing contraceptives against their religious beliefs. They want flat out exemption from the mandate. Read More
NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!
Just out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.
Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!
And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!
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