Tag: Evidence

Lost Chances to Recover: An Elaboration

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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)

Nir Eyal Leave a comment

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.

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

Timo Minssen Leave a comment

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.

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Harvard Effective Altruism: Josh Greene this Tuesday

Nir Eyal Leave a comment
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

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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

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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

HHIP: Evaluating Effective Charities – GiveWell cofounder Elie Hassenfeld: Tuesday, 8 PM

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Harvard High Impact Philanthropy presents:

Evaluating Effective Charities with Elie Hassenfeld of GiveWell

How can you maximize the impact of your charitable giving?  What distinguishes the most effective causes and organizations? Elie Hassenfeld, co-founder and co-Executive Director of GiveWell, will describe how his organization is revolutionizing charity evaluation with completely transparent, rigorous analysis. Q&A to follow.

8 pm, Tuesday, Nov. 12; Sever 102

RSVP here

Elie Hassenfeld graduated from Columbia in 2004 and co-founded GiveWell in mid-2007 where he currently serves as co-Executive Director. GiveWell finds outstanding charity and publishes the full details of its analysis to help donors decide where to give. The Boston Globe has called GiveWell “The gold standard for giving” and its research has attracted attention from Peter Singer and other media. GiveWell has tracked over $10 million in donations to its recommendations as a direct result of its research.

Medical Malpractice: The “Same Specialty” Requirement in Federal Courts

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By Alex Stein

Medical malpractice suits reach federal courts through two channels: diversity and the Federal Tort Claims Act (FTCA). The FTCA framework was set up (inter alia) for suits against doctors working at veterans hospitals or another facility operated by the federal government. The diversity framework was designed for parties residing in different states. Under both frameworks, duty of care, negligence and all other substantive issues are determined by applicable state law. Federal law, on the other hand, controls every procedural and evidentiary issue. For FTCA, this rule was established in 28 U.S.C. § 2674; see, e.g., Gil v. Reed, 535 F.3d 551, 558 n.2 (7th Cir. 2008) (citing Arpin v. United States, 521 F.3d 769, 776 (7th Cir. 2008)). For diversity litigation, this rule was established by Erie R.R. Co. v. Tompkins, 304 U.S. 64 (1938).

This rule is very clear. Far less clear, however, are the lines separating “substance” from “procedure.”

Many states have established the “same specialty” requirement for expert witnesses testifying about medical malpractice. Under this requirement, an expert witness must practice medicine in the same specialty as the defendant doctor. Failure to satisfy this requirement disqualifies the witness. Her testimony about the duty of care owed by the defendant to his patient becomes inadmissible. This requirement has led to fierce controversies that state courts have resolved in different ways: see here, here, here, here, and here.

How will it play out in a federal court? Read More

Evidence for Policy: Nice If You Can Get It

Temple University Center for Public Health Law Research Leave a comment

By Scott Burris

Sometimes researchers can tell policy makers pretty confidently what public health law interventions really make a difference. The PHLR website has more than 50 Evidence Briefs that summarize the results of systematic reviews of the evidence on interventional public health laws conducted by the Cochrane and Campbell Collaboratives, and the Community Guide to Preventive Services.. We know, for example, that  there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay (Portland, are you listening?). We know that workplace smoking bans prevent heart attacks. For laws like these, we have numerous high quality studies, sometimes even experiments, that show whether or not the law is effective.

Unfortunately, problems don’t wait for evidence, and usually by the time there is a substantial body of evidence in place to review, most states have already made their policy decisions. What do we do when there is a problem that demands action, but there is no clearly effective legal action to take?

One of these days we’ll blog about what we think should happen. But for now, we can look at what often does happen. Usually, it resembles the fads we see in fashion: One state tries something, and other states follow, until a lot of states are doing something that might, or might not be working.

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