Bird's eye view of a town with identical looking-houses lined up close together

Housing Law and Health Equity: No Bliss in Ignorance

By Katie Moran-McCabe and Scott Burris

Florence Nightingale once said, “The connection between health and the dwellings of the population is one of the most important that exists” — a statement that is as true today as it was at the turn of the 20th century. A decent dwelling and diverse communities, where there is access to transportation, good schools, shops, parks, socioeconomic mixture, social capital and collective efficacy, and economic opportunity are all features necessary for both a high-level and equitable distribution of well-being.

The promise of healthy housing and communities, however, falls short in the United States. Much of the housing in the U.S. is expensive, unsafe, and inadequate in supply. Read More

Medical Publications as Evidence

By Alex Stein

Whether a medical publication – a book or an article – can be used in court as evidence for its truth is determined by the “learned treatise” exception to the hearsay rule. This exception provides that a court can admit into evidence an excerpt from a treatise or periodical when it “is called to the attention of an expert witness on cross-examination or relied on by the expert on direct examination” and when “the publication is established as a reliable authority by the expert’s admission or testimony, by another expert’s testimony, or by judicial notice.”  Federal Rule of Evidence 803(18) and its state equivalents.

The Supreme Judicial Court of Massachusetts has recently narrowed this exception.  Read More

Two new publications on “European patent strategies under the UPCA” and on “Synthetic Biology & Intellectual Property Rights”

By Timo Minssen

I am pleased to announce two new publications on (1) “European patent strategies under the UPCA” and (2)  “Synthetic Biology & Intellectual Property Rights”:

1) Minssen, T & Lundqvist, B 2014, ‘The ”opt out” and “opt-in” provisions in the Unified Patent Court Agreement – Impact and strategies for European patent portfolios‘ , published  in N I R (Nordic IP Review), vol 2014, nr. 4, s. 340-357.

Abstract: Many questions concerning the UPC’s jurisdiction during the transitional period for European Patents under Article 83 UPCA remain unsolved. Focusing on the “opt in” and “opt out” choices under Article 83 (3) & (4), this paper discusses the legal nature and prerequisites of these provisions, as well as the options and strategic choices that patent proprietors and applicants are facing. Considering the pros and cons of the emerging unitary system in light of a persisting uncertainty of how to interpret relevant stipulations, it is emphasized that there will be no clear-cut solutions. Rather the suitability of each approach will have to be evaluated on a case-by-case basis, taking into account all circumstances surrounding an invention, its patent-claims and the underlying business strategy. Recognizing that the worst thing to do is to do nothing at all, we conclude with a summary and some general remarks.

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Lost Chances to Recover: An Elaboration

By Alex Stein

An important development of the lost-chance doctrine recently took place in Rash v. Providence Health & Services, — P.3d —- (Wash.App.Div.3 2014).

An 82-year old patient with a critical heart condition was hospitalized to undergo surgery. The patient’s heart condition made her death inevitable, but she managed to prolong her life with the help of medications. The hospital negligently failed to give the patient blood pressure medications. As a result, the patient suffered a series of strokes from which she died. The hospital’s negligence thus accelerated the patient’s demise.

The patient’s heirs sued the hospital for medical malpractice. The patient’s preexisting condition doomed the plaintiffs’ claim that the hospital’s negligence was the but-for cause of her death. The plaintiffs consequently demanded compensation for the lost chance of  better outcome, pursuant to Herskovits v. Grp. Health Coop. of Puget Sound, 664 P.2d 474 (Wash. 1983); and Mohr, 262 P.3d 490 (Wash. 2011). Read More

Saturday, April 5th: Aid Grade! (from Harvard Effective Altruism)

A communication from Harvard Effective Altruism:

 

Hi altruists,

Saturday, April 5th is a big day for EA at Harvard: we have three different awesome events for you! Our guest for the day, flying up from DC for the occasion, will be Dr. Eva Vivalt, the founder of AidGrade. AidGrade helps figure out what works in international development by doing rigorous and engaging analyses of different interventions to find out their effects. They’re also looking for interns and full-time hires for this work, so please visit if you’re interested!

We’ll be having a talk on AidGrade’s research from 1-2pm, followed by a research-a-thon from 2-6 where we help AidGrade do some meta-analysis. The day will be topped off by a Boston-area effective altruism meetup at Clover–with another special guest, Jacob Trefethen of 80,000 Hours Cambridge UK, and many awesome local effective altruists.

Read More

New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

By Timo Minssen

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

Read More

Harvard Effective Altruism: Josh Greene this Tuesday

Emotion, Reason and Altruism
with Professor Joshua Greene

Tuesday, March 11th, 7 PM,
Fong Auditorium, Boylston Hall
Why do people have radically different opinions as to who to help and how? How can we get along with people who seem to fundamentally disagree with us about what to want? Professor Josh Greene addresses this and more in Emotion, Reason, and Altruism.
Joshua Greene direct Harvard’s Moral Cognition Lab, which uses cutting edge cognitive neuroscience techniques to study how people actually make moral decisions, integrating thinking from philosophy, social science, and social psychology to address questions of why people disagree as much as they do, and what we can do about it.

The Apology Rule

By Alex Stein

In a recent case, Lawrence v. Mountainstar Healthcare, — P.3d —-, 2014 WL 685594 (Utah App. 2014), Utah’s Court of Appeals sharpened the distinction between two categories of doctors’ statements: (1) “we messed up” statements that acknowledge a complication or fault;  and (2) statements expressing the doctor’s benevolence and apology for what happened to the patient. The Court held that fault statements are admissible as a party admission, whereas apology statements are privileged under Utah’s “apology rule”: Utah Code Ann. § 78B–3–422, Utah R. Evid. 409. The “apology rule” renders privileged care-providers’ statements that express “apology, sympathy, commiseration, condolence, or compassion; … and a general sense of benevolence”; or describe “the sequence of events relating to the unanticipated outcome of medical care.”

The Court carried out this analysis in connection with a patient’s malpractice suit against a hospital. The Court ruled that the patient was entitled to adduce the hospital’s “we messed up” statements that acknowledged its nurse’s negligence (but nevertheless dismissed the patient’s appeal).

This decision presents an interesting puzzle. Under Utah law, when a doctor approaches his patient’s spouse and says “I am sorry we messed up,” this sentence will be redacted into the privileged “I am sorry” and the unprivileged “We messed up.” This approach motivates doctors to formulate their apologies narrowly and never apologize spontaneously. But calculated apologies are not what the “apology rule” wanted to incentivize. Calculated apologies are lacking the genuine apologies’ virtue and benefit the patient and her family only when the doctor is insincere. This undesirable consequence is an example of what T.M. Scanlon calls “the teleological paradox” in his book What We Owe to Each Other (1998).

Capsule Endoscopy Instead of Colonoscopy? The FDA Approves the PillCam COLON

By Jonathan J. Darrow

In January, the Food and Drug Administration (FDA) approved the use of the PillCam COLON 2 as a minimally-invasive means of viewing the colon, a development that is sure to be welcomed by U.S. patients who currently undergo an estimated 14 million colonoscopies each year.  While the approval represents a major step forward, the PillCam is unlikely to supplant current procedures just yet.

The colon has traditionally been examined via optical colonoscopy, a procedure perceived by many to be uncomfortable and embarrassing that involves insertion through the rectum of a 5-6 foot long flexible tube as part of an examination that can take 30 to 60 minutes. Air must be pumped in through the rectum in a process called “insufflation.” Sedatives and pain medication are generally used to help relieve discomfort. In contrast, the PillCam COLON contains a power source, light source, and two tiny cameras encapsulated in an easy-to-swallow pill that produces no pain or even sensation as it moves through the colon. Reflecting the absence of discomfort, one report from a clinical researcher noted that a few patients have insisted on X-rays to confirm that the device had passed in their stool (FDA Consumer). The pill takes about 30,000 pictures before passing naturally from the body, which usually occurs before the end of its 10-hour battery life.

The safety record of capsule endoscopy, the category to which the PillCam COLON belongs, so far appears to compare favorably with the alternatives. Capsule endoscopy may be less likely to produce accidental colonic perforations or other serious complications, which occur in less than 1% of traditional colonoscopies despite the best efforts of the treating physician. Tears of the colon wall can in turn “rapidly progress to peritonitis and sepsis, carrying significant morbidity and mortality.” (Adam J. Hanson et al., Laparoscopic Repair of Colonoscopic Perforations: Indications and Guidelines, 11 J. Gastrointest. Surg. 655, 655 (2007)). Splenic injury or other serious complications also occur rarely with optical colonoscopies. Unlike “virtual colonoscopy,” which uses computed tomography (CT) to peer into the body, capsule endoscopy does not involve bombarding the body with radiation. A leading study published in the New England Journal of Medicine reported no serious adverse events among 320 subjects given the PillCam COLON, and concluded that use of the device was “a safe method of visualizing the colonic mucosa through colon fluids without the need for sedation or insufflation.” Read More