Month: November 2014

Upcoming Deadline: Submissions for The Journal of Law and Biosciences

The Petrie-Flom Center Staff Leave a comment

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish The Journal of Law and Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal.  JLB includes a New Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools.  The Petrie-Flom Center is responsible for providing the New Developments for one issue per annual volume.  Last year’s contributions may be viewed here.

We are currently seeking Harvard graduate students to contribute New Developments for JLB’s Volume 2, Issue 2 (2015). Interested students from any Harvard school should submit a topic proposal (1 paragraph to 1 page) outlining the new development they wish to cover, along with their current CV, and a short writing sample (5-10 pages), by November 30, 2014. Update: Student contributions may be co-authored, particularly with students from different schools within Harvard. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Four proposals will be selected by December 15, 2014, with one alternate.  Outlines will be due January 19, 2015.  First drafts will be due February 16, 2015, with edits returned by March 2, 2015, and final submissions due to the publisher by April 30, 2015 for publication in July.

New Developments are limited to 4500 words, inclusive of footnotes and references, and formatted according to Blue Book style.  Students will be responsible for reviewing the drafts of other student contributors, and will also receive feedback from the Petrie-Flom Center.  Please keep in mind that New Developments are not full student Notes.  They should focus on describing the policy issue at hand, why it is relevant to scholars and practitioners, and providing analysis/questions for further consideration.

Questions?  Please contact Holly Fernandez Lynch, hlynch@law.harvard.edu. 

Hospitable Hospitals and the True Cost of VIP Rooms

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By Vadim Shteyler

Increasing hospitality in medical facilities is not a recent trend. We take for granted that modern hospitals offer clean sheets, towels, a plethora of toiletries, heated blankets, and many other amenities. Conversely, in the hospitals of decades past, many patients relied on family members to bring food and clean sheets. Rows of hospital beds in an open ward precluded privacy. Unhygienic conditions commonly resulted in rodent infestations. And paternalism in medicine was still the norm.

This trend towards hospitality has recently gained new momentum. As featured in a recent article in Kaiser Health News, dozens of hospitals have hired Chief Patient Experience Officers from customer service or hotel industries. Since 2012, when Medicare began penalizing hospitals for poor patient experiences, hospital efforts to improve patient satisfaction have grown. Some hospitals began mandating communication seminars, encouraging nurses to spend more face-to-face time with patients, and calling patients after discharge to follow-up on their recovery. The Affordable Care Act (ACA), further tying hospital reimbursements to patient surveys, has additionally promoted such changes.

A similar trend has arisen with the increased popularity of V.I.P. sections in many hospitals. Though the hospital construction boom is beginning to slow down, the resultant V.I.P. rooms remain. Lenox-Hill Hospital’s maternity suite in New York City, which received a lot of media attention after Beyonce gave birth there in 2012, is one of many luxurious suites across the nation. Some, offering personal shoppers, private chefs, and salon services, are priced upwards of $4,000. While nobody calls for a return to the hospitals of old, many feel suites such as these are excessive.  Read More

The Learned Intermediary Rule and Direct-to-Consumer Advertising

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By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship.  Read More

The Civil Rights Movement and the Blood Supply

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By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Read More

More Than Just the ACA at Stake in King v. Burwell

The Petrie-Flom Center Staff Leave a comment

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA.  Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA the and the millions that currently receive these subsidies.

There is, however, more at stake in the King case than the ACA.  If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.

Chevron

The question in King will be resolved under the Chevron framework, which provides that if a statutory provision is ambiguous, then the court must defer to the agency’s interpretation, so long as it is permissible.  Reasonable, learned minds have been disagreeing on the meaning of the statutory provision. As Adrian Vermeule has pointed out, of the 9 federal judges that have reviewed this question, 6 have agreed with the government’s interpretation or concluded the statute is ambiguous, and 3 have concluded that the statute unambiguously precludes subsidies. This type of judicial disagreement is evidence itself of statutory ambiguity.  Read More

Risk and Reform of Long-Term Care

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By Allison Hoffman
[Cross-posted from Health Affairs Blog]

The 50th Anniversary of Medicare and Medicaid offers an opportunity to reflect on how U.S. social policy has conceived of the problem of long-term care.

Social insurance programs aim to create greater security—typically financial security—for American families (See Note 1). Programs for long-term care, however, have had mixed results. The most recent attempt at reform, which Ted Kennedy ushered through as a part of the Patient Protection and Affordable Care Act (ACA), called the CLASS Act, was actuarially unsound and later repealed. Medicare and especially Medicaid, the two primary government programs to address long-term care needs, are criticized for failing to meet the needs of people with a disability or illness, who need long-term services or supports. These critiques are valid.

Even more troublesome, however, long-term care policy, especially in its most recent evolution toward home-based care, has intensified a second type of insecurity for Americans. Read More

Tomorrow: “Patients With Passports” Book Launch

The Petrie-Flom Center Staff Leave a comment

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Article III Standing in Patent Law May Be Before the Supreme Court Soon

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By Rachel Sachs

Who has standing to challenge a patent’s validity? And under what circumstances can Congress define an injury for the purpose of creating Article III standing? Those questions underlie a new petition for certiorari filed by Consumer Watchdog, who is asking the Supreme Court to reverse a Federal Circuit opinion holding that Consumer Watchdog lacked Article III standing to challenge a patent on embryonic stem cells.

Consumer Watchdog, a non-profit consumer organization, requested an inter partes reexamination of a patent on embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF), alleging that the patent should be invalidated on several grounds. After a lengthy administrative process, the Patent Trial and Appeal Board (PTAB) upheld the patent as valid. Consumer Watchdog subsequently appealed, under sections of the Patent Act that expressly permit third-party requesters (like Consumer Watchdog) in inter partes reexamination proceedings to appeal to the Federal Circuit if they are “dissatisfied” with the PTAB’s decision or if any “final decision [is] favorable to the patentability” of the claims in question. The Federal Circuit held that Article III’s case or controversy requirement imposes a separate, irreducible constitutional minimum requirement on standing — and that Consumer Watchdog hadn’t met that requirement.  Read More

Upcoming Deadline: Submissions for The Journal of Law and Biosciences

The Petrie-Flom Center Staff Leave a comment

JLB coverThe Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School collaborates with Stanford and Duke Universities to publish The Journal of Law and Biosciences (Oxford University Press), an online, open-access, peer-reviewed journal.  JLB includes a New Developments section, comprised of brief summaries and commentary on recent legislation, regulation, and case law written by graduate students at the collaborating schools.  The Petrie-Flom Center is responsible for providing the New Developments for one issue per annual volume.  Last year’s contributions may be viewed here.

We are currently seeking Harvard graduate students to contribute New Developments for JLB’s Volume 2, Issue 2 (2015). Interested students from any Harvard school should submit a topic proposal (1 paragraph to 1 page) outlining the new development they wish to cover, along with their current CV, and a short writing sample (5-10 pages), by November 30, 2014. Update: Student contributions may be co-authored, particularly with students from different schools within Harvard. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.edu.

Four proposals will be selected by December 15, 2014, with one alternate.  Outlines will be due January 19, 2015.  First drafts will be due February 16, 2015, with edits returned by March 2, 2015, and final submissions due to the publisher by April 30, 2015 for publication in July.

New Developments are limited to 4500 words, inclusive of footnotes and references, and formatted according to Blue Book style.  Students will be responsible for reviewing the drafts of other student contributors, and will also receive feedback from the Petrie-Flom Center.  Please keep in mind that New Developments are not full student Notes.  They should focus on describing the policy issue at hand, why it is relevant to scholars and practitioners, and providing analysis/questions for further consideration.

Questions?  Please contact Holly Fernandez Lynch, hlynch@law.harvard.edu.