Category: Contributors

Another Contraceptives Mandate Case

Holly Fernandez Lynch Leave a comment

Following up on Chris Robertson’s and Kevin Outterson’s posts below (here and here), I just wanted to draw your attention to another federal district court opinion on the contraceptives coverage mandate.  This one is from Nov. 19 and involves the owners of Hobby Lobby.  The court denied their motion for a preliminary injunction on the following grounds:

Plaintiffs have not demonstrated a probability of success on their First Amendment claims. Hobby Lobby and Mardel, secular, for-profit corporations, do not have free exercise rights. The Greens [the individual owners] do have such rights, but are unlikely to prevail as to their constitutional claims because the preventive care coverage regulations they challenge are neutral laws of general applicability which are rationally related to a legitimate governmental objective.

Plaintiffs also have failed to demonstrate a probability of success on their Religious Freedom Restoration Act claims. Hobby Lobby and Mardel are not “persons” for purposes of the RFRA and the Greens have not established that compliance with the preventive care coverage regulations would “substantially burden” their religious exercise, as the term “substantially burdened” is used in the statute. Therefore, plaintiffs have not met their prima facie burden under RFRA and have not demonstrated a probability of success as to their RFRA claims.

There are tens of cases challenging the contraceptives mandate pending at the moment, and several have already been dismissed on procedural grounds.  But my current count of the substantive cases is 3 preliminary injunctions granted (Newland, Weingartz Supply, and Tyndale House Publishers), 1 denied (Hobby Lobby), and 1 case holding outright that the mandate violates neither the First Amendment nor RFRA (O’Brien).  Have I missed any?

Upcoming Event – Stem Cell Therapy and Medical Tourism: Of Promise and Peril? 11/28/12

kparas Leave a comment
Wednesday, September 28, 2012
3-4:30 pm (reception to follow)
Austin 111, Harvard Law School

Experimental breakthroughs within the field of regenerative medicine are reported in the media on a daily basis worldwide.  Despite this progress, the overwhelming majority of clinical problems for which stem cell-based intervention offers hope remain therapeutically unproven, and a major gap exists between current public understanding and the availability of innovative therapies.

This event will feature a distinguished panel of speakers addressing various aspects of medical tourism for stem cell therapy.  Presentations will cover the state of stem cell science, historical context and comparisons related to earlier instances of medical utopianism, empirical data on the nature of stem cell tourism, how to address patient hopes in the realm of unproven therapies, and special issues related to stem cell tourism by parents for their children.

The event will be moderated by M. William Lensch, Harvard Stem Cell Institute.  Speakers and topics include:

  • Brock Reeve, Harvard Stem Cell Institute
    Welcome and Introductions 
  • George Q. Daley, Harvard Stem Cell Institute
    Stem Cells: The Gap Between Current Science and Clinical Implementation 
  • Jill Lepore, Harvard University
    Resurrection, Past and Present 
  • Tim Caulfield, University of Alberta
    Stem Cell Tourism: Is the Problem Getting Worse? 
  • Insoo Hyun, Case Western Reserve University School of Medicine
    Therapeutic Hope and Its Challenges for Rational Ethical Discourse 
  • I. Glenn Cohen, Petrie-Flom Center, Harvard Law School
    Stem Cell Tourism, Children, Abuse, and Reporting

There will be substantial time set aside for audience Q&A, and the conversation will continue after the event at an open reception.

This event is free and open to the public.  Co-sponsored by the Harvard Stem Cell Institute and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

More religious objections to contraception coverage

koutterson Leave a comment

I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:

The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.

The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:

This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…

Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.

The court also found “third party standing”

It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.

These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.

Cross-posted from TIE

@koutterson

Are Human Research Participants Deserving of Research Animals’ Rights?

srivera 20 Comments

by Suzanne M. Rivera, Ph.D.

For years, mainstream and extremist organizations have waged campaigns against the use of animals.  While PETA successfully deploys propaganda featuring provocative models in sexually explicit positions to denounce the use of animals for food, clothing and experimentation, other groups, such as the Animal Liberation Brigade, engage in violent (some would say terroristic) actions to disrupt animal research and scare off scientists from lines of inquiry for which the use of animal models is the state of the art.

Part of the philosophy of the anti-animal research groups is a belief in moral equivalency among species.    PETA’s Ingrid Newkirk once famously said, “A rat is a pig is a dog is a boy.”  Does she propose we allow people to suffer with treatable diseases because non-animal models for testing have not yet been developed?  Apparently so.  Newkirk also has gone on the record to say, “Even if animal tests produced a cure for AIDS, we’d be against it.”  This view is out of step with the majority of Americans, who – according to the latest Gallup poll— support animal research.

Among those who regulate and support animal research, there is a very strong commitment to animal welfare.  The “animal welfare” perspective contrasts with the “animal rights” view.  The animal rightists want to end animal use, including research (and also eating meat, hunting, zoos, police dogs and entertainment), because they see it as inherently indefensible.  Animal welfarists, on the other hand, believe animals can be used humanely, under strict rules that seek to prevent unnecessary pain and distress in research animals.  They acknowledging that the animals’ lives are worthy of respect, but do not ascribe the moral status of personhood to them.  The US government requires scientists to assume anything that could cause pain or distress in a human also would be painful for an animal, and they are compelled to provide analgesia and anesthesia accordingly.

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Third World Reproductive Health Outcomes

Michele Goodwin Leave a comment

By Michele Goodwin

The most sophisticated medical technologies are available in the United States.  The luxury afforded elite health care consumers is best captured by “executive health care” and “personalized” medicines.  Given the tailored health care afforded top-tier health care consumers, consciously or unconsciously those at the other end of the spectrum might be overlooked.

For example, the Centers for Disease Control and Prevention issued a report this year that places some US states in the range of Third World countries for health outcomes with mothers and babies.   The report,  Infant Mortality Statistics From the 2008 Period Linked Birth/Infant Death Data Set, exposes a sad reality; race disparities persist in medicine.   The neonatal mortality rate of African Americans is about 2.5 times that of whites.  What’s more—class matters.  But here’s the interesting part.  Class matters at both ends of the scale.

The report exposes how Mississippi, the nation’s poorest state, leads the nation in babies that will die before reaching their first birthday.   According data collected by CNN, “for every 1,000 Mississippi babies born in 2011, 9.4 died before their first birthday.”  One reporter found that such data “makes Mississippi’s infant mortality rate more comparable to countries such as Costa Rica (9.2), Sri Lanka (9.5) and Botswana (10.5) than the United States (6.0).”  The common answer to the challenges of infant mortality looks toward poverty—and in part such analysis is right.  However, wealth matters too and sophisticated reproductive choices can lead to dangerous outcomes.  One of the leading causes of infant mortality is womb-crowding caused by multiple gestations, which has dramatically increased as a byproduct of assisted reproductive technologies.  Those who can afford these sophisticated technologies are usually upper-income individuals, who can afford the multiple rounds of treatments, which are usually required before a pregnancy results.  In fact, ART related births are associated with the 100-fold increase in higher order births in the United States.  Low birth-weight, one of the leading causes of infant distress, is a common feature of multiple births—as are pre-term deliveries.  As we think about solutions to these challenge public health concerns, it will be important to look at both ends of the socio-economic scale.

Twitter Round-Up (11/11-11/17)

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By Casey Thomson

Don’t just read the summaries – check out the tweets themselves! From now on, links to the original tweets will be included in our round-up. Additionally, as a reminder from the last post, retweeting should not be read as an endorsement of or agreement with the content of the original tweet. With that, read on for this week’s round-up…

  • Arthur Caplan (@ArthurCaplan) posted an article about the growing trend of paying for convenience in healthcare with privacy, sometimes without formal consent. The latest example (and the subject of this article) is palm-scanning at New York University Langone Medical Center. (11/11) [Note: Dan Vorhaus also tweeted this the next day.]
  • Frank Pasquale (@FrankPasquale) linked to a post on the potential valuables (medicines, solvents, chemical treatments) hidden amongst newly-discovered marine micro-organisms. With regulations hefty on land but largely non-existent for water, there are concerns that damage from harvesting could result in ecosystem damage or exploitation of water resource-rich developing nations. (11/11)
  • Dan Vorhaus (@genomics lawyer) brought up a link describing the “particularized consent approach” of the website my46, meant to facilitate the process of helping people decide what results of genetic testing to see and when to see such results. Combining this with his post about the direct-to-consumer genomics of 23andMe, it is clear that this is an area to watch. (11/12)
  • Daniel Goldberg (@prof_goldberg) exclaims his love for the term “empathotoxin” in conjunction with the link for this blog post. The post talks about the declining sense of empathy correlated with medical training as according to a research review by American Medicine, with results based on self-reporting. (11/12)
  • Kevin Outterson (@koutterson) tweeted an article about the oncoming scrutiny likely to hit Congress in the throngs of the current meningitis outbreak. While state boards and the F.D.A. are receiving much of the onslaught as a result of their lax oversight, Congress has hindered stronger regulation for drug compounders particularly in regards to defining the F.D.A.’s policing authority – and thus, say some, is partly deserving of blame. (11/14)
  • Daniel Goldberg (@prof_goldberg) also linked to an article that talked of lessening the gaps between the mainstream views concerning disability (the “outside” view) and those within the disability community (the “inside” view) when considering law. By proposing a certain set of “framing rules” facilitated by input from the inside view, nondisabled people can make more informed decisions regarding the relationship to disability. (11/14)
  • Dan Vorhaus (@genomicslawyer) posted an article that followed up on an earlier tweet from our weekly round-ups detailing China’s new draft regulation for human genetic materials, including but not limited to organs. (11/15)
  • Frank Pasquale (@FrankPasquale) included a link to the The New York Times piece on the massive drug shortages plaguing the nation’s healthcare system.  Pasquale noted in his tweet that organizations which purchase on behalf of groups, often for hospitals, may be contributing to this shortage. (11/17)

Overdose Update: Celebrity Edition

Temple University Center for Public Health Law Research 1 Comment

By Scott Burris

You’ve probably heard about the good news/bad news experience of Stephanie Bongiovi, daughter of rocker Jon Bon Jovi. A college student, she ODed on heroin, but help was summoned and she’s going to be fine. The (temporary) bad news for her (and longer term for others in her plight) is that she and a companion were arrested IN SPITE of a recent New York Good Samaritan 911 law passed explicitly to encourage people to call for help.

There are some technicalities and prerequisites, so if you want to see the law it’s available on LawAtlas. But if she or her companion sought help, and absent a hyper-technical reading of the statute (it literally does not protect a victim unable to seek help), the charges should never have been filed and should be dropped. The problem for the rest of us is that these laws only work if people at an OD scene know about them and trust them. High profile arrests like this are — and for once I think there might be some truth to this claim — sending a message not to seek help.

Meanwhile, Leo Beletsky, Jody Rich and Alex Walley have a fine little piece in JAMA that thoroughly catalogues the removable barriers to OD prevention. The table alone is worth thousands of words, which is nice because JAMA’s editors were pretty tight on the word limit despite the importance of the topic.

Opinion granting preliminary injunction on contraceptive coverage mandate

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By Christopher Robertson

Yesterday (Friday Nov 16), U.S. District Judge Reggie Walton granted a preliminary injunction barring enforcement of the contraceptive coverage mandate that was part of the regulations implementing the Affordable Care Act (ACA).  There is lots of news coverage (e.g., HuffPo and WaPo), but as usual, the news organizations do not link to the opinion.  For your convenience, I’ve linked to it in the prior sentence, and provide some very preliminary observations below the fold.

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Petrie-Flom Interns’ Weekly Round-Up: 11/10-11/16

The Petrie-Flom Center Staff Leave a comment

By Hyeongsu Park and Kathy Wang