Month: December 2014

The Constitutionality of Damage Caps in Pennsylvania

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By Alex Stein

In its recent decision, Zauflik v. Pennsbury School Dist., — A.3d —- (Pa. 2014), the Supreme Court of Pennsylvania upheld the constitutionality of the statutory $500,000 cap on tort compensation payable by the local government. This decision was delivered in a case involving a student who lost her leg in an accident in which a school bus accelerated out of control onto a sidewalk and struck her (along with other nineteen students). The jury awarded the student $14,036,263.39 ($338,580 for past medical expenses, $2,597,682 for future medical expenses, and $11.1 million for past and future pain and suffering), but the court reduced the award to $500,000.

In affirming that ruling, the Pennsylvania Supreme Court rejected a number of constitutional challenges against the statutory cap. Read More

Art Caplan: Support Nurse Who Resisted Force-Feeding at Guantanamo

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Art Caplan has a new piece supporting the nurse who resisted force-feeding at Guantanamo, on NBC News:

Lost in all the talk about the CIA’s history of brutal interrogation tactics after Sept. 11 is this: A real live case involving a U.S. Navy nurse on trial for what he did not do at the notorious Guantanamo prison.

The nurse, in his 18th year in the Navy, volunteered to serve at Guantanamo, where some of those being held prisoner went on hunger strikes. They were following a long tradition going back to the H-Block Irish hunger strikers in Britain who found no other way to protest their internment and prison conditions but to refuse food.

The Navy brass at Gitmo decided that these prisoners were going to eat. They dragged them out of their cells, put them in full body restraints, shoved a tube through their nose and down into their stomachs and force-fed them with artificial food.

Read the full article here.

How Should the FDA Regulate Fecal Transplantation Safely and Effectively?

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By Rachel Sachs

Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT.  Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country.  For those who are unfamiliar with FMT, it is a startlingly effective treatment for recurrent C. difficile infection.  C. diff infections have become among the most common hospital-acquired infections in the United States, causing more than 300,000 hospitalizations and 14,000 deaths annually.  And unfortunately, many of these infections are resistant to antibiotics, with resistance rates rising rapidly.  But FMT may provide a way forward: a recent randomized trial (antibiotics versus antibiotics plus FMT) was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those in the antibiotics groups.

Coincidentally, I’ve been working with OpenBiome over the past few months on an interesting question that the New Yorker article touched on only briefly: how should the FDA regulate FMT to best ensure its safety and efficacy?  At present, the FDA is proposing to regulate FMT as a biologic drug.  However, many (including OpenBiome’s co-founder, Mark Smith) have argued that it ought to be regulated like human tissue, which from a scientific standpoint it resembles more closely than it does a small molecule drug, given the challenge of characterizing stool’s active ingredients and providing consistency across batches.  OpenBiome’s Policy Director, Carolyn Edelstein, and I are currently working on a paper examining the pluses and minuses of the FDA’s current approach.  I want to briefly summarize a few key points of our paper here, but essentially we argue that classifying FMT as a drug is simultaneously underregulatory and overregulatory.  Our primary goal is to ensure that patients have access to safe, effective treatments – and that means the FDA should be more involved in regulating some aspects of FMT, and less involved in others.

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The ACA’s Cerberus

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By Kelsey Berry

Following the Midterm Elections, the fate of the Affordable Care Act in a Republican-controlled Congress has been much speculated about. Jonathan Oberlander just published a piece in the New England Journal of Medicine arguing that we should be less concerned about Congress, and more concerned about the Supreme Court’s potential to shake the foundations of the law.

Congress, he claims, may be wary to threaten popular provisions of the health care law now that many constituents have benefited from them. Even if ACA beneficiaries may not recognize that they are benefiting from the contentious law, the very methods available to Congress to dismantle the law — i.e., chipping away at specific provisions — may produce greater awareness of the law’s contents and even provoke opposition toward efforts to undermine it. Moreover, Obama’s veto power may keep the law stable enough through 2 more years of implementation that by the time we risk having a Chief Executive who opposes the law, the law’s benefits will be more entrenched and successes more obvious, further straining repeal or dismantle efforts. In short, it looks to Oberlander as if the core of the law (if not some of the peripheral provisions) is safe from Congressional action, and potentially even getting safer.

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Worth Reading This Week

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By Nicolas Terry

The Right to Try Meets the Reality of Drug Approval

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By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Read More

2015 Edition of the International Compilation of Human Research Standards Released

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The 2015 edition of the International Compilation of Human Research Standards has just been released and is available online.

The Compilation features listings of over 1,000 laws, regulations, and guidelines on human subject protections in 113 countries, as well as standards issued by a number of international and regional organizations. Six new countries are included in the 2015 edition: Ghana, Guinea, Liberia, Malaysia, Saudi Arabia, and Sierra Leone.  The 2015 edition also includes hundreds of updates from the previous edition.

The listings are organized into seven categories: Read More

Arthur Caplan on Hyperbaric Oxygen Therapy

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Art Caplan has a new piece on hyperbaric oxygen therapy over at NBC News:

Hyperbaric oxygen therapy. Have you ever heard of it? The Internet sure has.

Centers and clinics tout the benefits of sitting in a tank breathing 100 percent oxygen at higher than atmospheric pressure for treating autism, infant brain trauma, multiple sclerosis, chronic fatigue, cerebral palsy and many other conditions.

There’s just one problem: There is no solid evidence that hyperbaric oxygen therapy does anything for any of these disorders.

Read the full article here.