The Globalization of Infectious Diseases

By Rachel Sachs

The recent arrival of Ebola in the United States has captured the attention of both the public and the media for many reasons.  One key reason is that Ebola is making many people realize for the first time that serious diseases which were formerly confined largely to developing countries have the potential to spread more widely across the globe.  But Ebola is not the first infectious disease to spread in this way, and it’s valuable for Americans to realize that many diseases which are often viewed as existing only in developing countries are already present in the developed world, due to a complex set of factors including migration and climate change.

Specifically, serious diseases transmitted by insects like chikungunya, dengue fever, and Chagas disease are already here in the United States.  I blogged here in August about DARPA’s prize to predict the spread of chikungunya, and the CDC’s estimates suggest that the disease may be finding a foothold in this country, with 11 locally-transmitted cases in addition to the more than 1500 travel-associated cases confirmed so far in 2014.  Compared to an average of just 28 cases per year since 2006, the spread is concerning.  Scientists also contend that dengue fever, a disease with similarly debilitating symptoms, is now endemic to Florida.

The case of Chagas is even more dramatic.  Categorized by the CDC as a “neglected parasitic infection,” it is estimated that 300,000 infected people live in the United States.  That’s ten times as many people as are diagnosed with ALS, a disease which has made much more of a mark on the public consciousness.  Chagas’ impact (both human and economic) on the United States’ health system is and will continue to be extremely costly, with one study estimating the economic cost to the United States at roughly $900 million annually.  Some of these costs are indirect — for instance, donated blood must now be screened for the presence of the parasite, to prevent its transmission.  But most are direct.  Over the long term, Chagas can cause severe, even fatal damage to the heart and gastrointestinal tract.  Read More

More on the Maine Ebola Order

By Nicolas Terry

Today’s order from Chief Judge LaVerdiere is available here. It removes restrictions on Kaci Hickox’s movements and essentially orders her to comply with the latest CDC guidelines that she was already following on a voluntary basis. According to this report the state troopers that had been posted outside her house have left. Two paragraphs at the end of the order are worth quoting in full.

First, we would not be here today unless Respondent generously, kindly and with compassion lent her skills to aid, comfort, and care for individuals stricken with a terrible disease. We need to remember as we go through this matter that we owe her and all professionals who give of themselves in this way a debt of gratitude.

Having said that, Respondent should understand that the court is fully aware of the misconceptions, misinformation, bad science and bad information being spread from shore to shore in our country with respect to Ebola. The court is fully aware that people are acting out of fear and that this fear is not entirely rational. However, whether that fear is rational or not, it is present and it is real. Respondent’s actions at this point, as a healthcare professional, need to demonstrate her full understanding of human nature and the real fear that exists.…

An interview with Ms Hickox suggested she was taking the judge’s advice, “I am sensitive… I don’t want to make anyone uncomfortable.” However, according to this recent report Governor LePage believes, “we don’t know what we don’t know about Ebola” and does not trust Ms. Hickox.

The Medical Liability Climate: The Calm Between Storms Is the Time For Reforms

By: Michelle Mello, JD, PhD
Stanford Law School and Stanford University School of Medicine

On November 4, Californians will vote on Proposition 46, a ballot initiative to adjust the $250,000 state’s noneconomic damages cap in medical malpractice cases for inflation, raising it to $1.1 million virtually overnight.  It’s a long overdue move – California has one of the most stringent damages caps in the country, and the cap really affects access to the legal system.  Now is the perfect time to do it, because after years of turbulence, the medical liability environment has calmed.

In an analysis published October 30 in the Journal of the American Medical Association (JAMA), David Studdert, Allen Kachalia and I report that data from the National Practitioner Data Bank show that the frequency and average cost of paid malpractice claims have been declining.  The rate of paid claims against physicians decreased from 18.6 to 9.9 paid claims per 1,000 physicians between 2002 and 2013, with an estimated annual average decrease of 6.3% for MDs and a 5.3% decrease for DOs. Among claims that resulted in some payment, the median amount paid increased from $133,799 in 1994 to $218,400 in 2007, an average annual increase of 5%. Since 2007 the median payment has declined, reaching $195,000 in 2013, an average annual decrease of 1.1%.

Trends in insurance premiums vary more according to which market you’re looking at, according to data from the Medical Liability Monitor’s Annual Rate Survey, but also look pretty favorable overall. None of the locations we examined showed large increases over the last 10 years, and most showed flat or declining premiums.  Read More

Courts as Ebola Educators

By Scott Burris

News in this afternoon is that a Maine state judge has lifted the quarantine order on nurse Kaci Hickox, saying that she “currently does not show symptoms of Ebola and is therefore not infectious.”

The ruling conforms to the best available scientific evidence and CDC recommendations.  It also shows the importance of judicial review as a check on the exercise of emergency powers. Hearkening back to the many school exclusion cases during the HIV epidemic, I hope it will help reassure a public confused by the gap between what CDC and other experts say is necessary and what some political leaders are doing.  The best way for government to keep our trust in this outbreak is to offer accurate information — and then behave accordingly.

Upcoming Event: International Sexual and Reproductive Rights Lawfare Conference

gavel_scales_slideInternational Sexual and Reproductive Rights Lawfare Conference

November 6, 2014 8:30 AM –  5 PM
November 7, 2014 9 AM – 1:30 PM

Harvard Law School Milstein West A
1585 Massachusetts Ave.
Cambridge, MA 02138

RSVP to rcantor@hsph.harvard.edu.

Please join us as we examine litigation on sexual and reproductive rights before international courts and tribunals by both progressive and conservative movements. The conference will explore the forces and dynamics at play resulting in these cases, the functioning of international adjudication, as well as diverse effects of litigation, for the litigants, social policy, politics and public opinion; and the consequences for the adjudicating bodies themselves and their legitimacy.

See the full agenda [PDF]. 

The conference is organized with Harvard University’s FXB Center on Health and Human Rights, the Harvard Law School Human Rights Program, the University of Oslo, and the Comparative Sexual and Reproductive Rights Lawfare project at the Centre of Law and Social Transformation, University of Bergen and Chr. Michelsen Institute.

Doctors’ Decision-Making: Regression Proof?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

As I have blogged about before, last year, in Kaiser v. Pfizer, the First Circuit joined the handful of courts to have approved a causal chain of injury running from a pharmaceutical company’s fraudulent promotion, through the prescribing decisions of thousands of individual physicians, to the prescriptions for which a third-party payer paid.  To establish but-for causation in the case, Kaiser submitted an expert report and testimony from Dr. Meredith Rosenthal, a health economist at the Harvard School of Public Health. Dr. Rosenthal conducted a regression analysis to determine the portion of physicians’ prescribing of the drug Neurontin that was caused by the defendant’s fraudulent promotion, arriving at percentages ranged from 99.4% of prescriptions for bipolar disorder to 27.9% of prescriptions for migraine.

Pfizer argued that Dr. Rosenthal’s regression analysis should not have been admitted (and at least suggested that such an analysis should never be admitted in a third-party payer case) because regression analysis could not “take into account the patient-specific, idiosyncratic decisions of individual prescribing physicians.” Dr. Rosenthal’s report, the company argued, “merely demonstrated ‘correlation’ and not ‘causation.’”  The First Circuit disagreed, upholding the lower court’s determination that the challenged evidence was admissible under Federal Rule of Evidence 702, because “regression analysis is a well-recognized and scientifically valid approach to understanding statistical data” and because it “fit” the facts of the case.

Eric Alexander, a partner at Reed Smith, made a similar argument to Pfizer’s when he critiqued a decision issued in July in a third-party payer case in the Eastern District of Pennsylvania. Writing at the Drug and Device Law blog, Alexander criticized the court for failing to address “the fundamental—to us—issue of whether an economist [Dr. Rosenthal was the plaintiff’s expert in that case, too] can ever determine why prescriptions were written.”  Alexander points out that “[t]o get to millions of dollars of revenue from prescriptions, many physicians have to prescribe the drug to many patients[,]” and those physicians can “pretty much do what they want[.]” Economists, Alexander argues, should not be allowed to by-pass this complexity and simply “assume” causation.

I would argue that, as idiosyncratic as physician decision-making may be, it is not uniquely so.  Read More

Call for Submissions: The Journal of Law and Biosciences

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. Proposals should be sent to Holly Fernandez Lynch, hlynch@law.harvard.eduUpdate: Student contributions may be co-authored, particularly with students from different schools within Harvard.

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