FitBits Be Free: General Wellness Products Are Not (Generally) Medical Devices

By Nicolas Terry

The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).

The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions. Continue reading

Introducing a new global antibiotic R&D partnership

Yesterday US HHS announced a new global partnership to fund pre-clinical antibiotic R&D, coordinated by the Boston University School of Law. The partnership is known as CARB-X, which is the abbreviation for the Combating Antibiotic-Resistant Bacteria (CARB) Biopharmaceutical Accelerator.  CARB-X is the culmination of one key part of the US National Action Plan on antibiotic resistance.  Background paper in Nature Reviews Drug Discovery.

Under the grant, BU Law will coordinate more than $350 million in new funds for R&D over the next five years, in partnership with BARDA, NIAID, the Wellcome Trust, the AMR Centre, MassBio, the California Life Sciences Institute and the Broad Institute at Harvard and MIT.  Kevin Outterson is the PI and Executive Director of CARB-X.

While the bulk of the project funds pre-clinical R&D, we are also interested in the role of law, IP and other innovation incentives, using the unique dataset that CARB-X will generate.

Is Gaming the Transplant List an Ethical Dilemma?

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending. Continue reading

Fighting the Next Pandemic: Airline Vaccine Screens

Whether it is Ebola, H1N1, the season flu, or the next nasty bug that we cannot yet even imagine, if we wanted to efficiently spread the disease, one could not do much better than packing several Flight routeshundred people into a cylinder for a few hours, while they eat, drink, defecate, and urinate.  Even more, to make sure that the disease cannot be contained in a particular locality, we could build thousands of those cylinders and move them rapidly from one place to another worldwide, remix the people, and put them back in the cylinders for return trips back to their homes, schools, and jobs.

We are (hopefully) not going to stop airline travel.  But we can make it a lot safer, by ensuring that almost everyone who boards these flights is vaccinated.  That’s the thesis of a new paper out this week.

Airlines carry two million people every day.  And, prior research has shown that airline travel is a vector of disease.  In fact, when the September 11 attacks caused airline travel to fall, seasonal flu diagnoses fell too.

The threat of pandemics is quite real, and more generally, the mortality and morbidity associated with infectious disease is a severe public health burden.  About 42,000 adults and 300 children die every year from vaccine-preventable disease.  New vaccines are on the horizon.

Arguably, airlines have market-based and liability-based reasons to begin screening passengers, whether for vaccinations generally or for particular ones during an outbreak.  Although the states have traditionally exercised the plenary power to mandate vaccinations, and have primarily focused on children in schools, the U.S. federal government also has substantial untapped power to regulate in this domain as well.

Learning from mistakes in the NHS: a special report by the Parliamentary and Health Service Ombudsman (PHSO) into how the NHS failed to investigate properly the death of a three-year-old child.

By John Tingle

In the UK where health is concerned money is a particularly poor compensator for the loss of a limb, faculty or even a family member. In my experience patients who have suffered adverse health incidents, negligence, more often than not, are not primarily motivated by obtaining monetary compensation. They seek in the main an explanation of what occurred and why, an apology and an assurance that what happened will not happen to anybody else; that lessons have been learned.

The NHS (National Health Service) for decades has been unable to provide a satisfactory complaints and patient adverse incident investigation service which provides these outcomes generally. More often than not patients have to resort to complaining or beginning litigation in order to find out what happened and why and the process that they have to embark on can alienate them even more as they soon hit major and seemingly unsurmountable obstacles. The NHS maintains a defensive and blame ridden culture when errors happen as the terrible events of Mid Staffordshire revealed.

The report Continue reading

DUE AUGUST 5: Call for Apps – Petrie-Flom Center Harvard Grad Student Fellowship

THE PETRIE-FLOM CENTER

STUDENT FELLOWSHIP PROGRAM, 2016-2017

CALL FOR APPLICATIONS 

The Center and Student Fellowship. The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is an interdisciplinary research program at Harvard Law School dedicated to the scholarly research of important issues at the intersection of law and health policy, including issues of health care financing and market regulation, biotechnology and intellectual property, biomedical research, and bioethics. The Student Fellowship Program is designed to support closely-mentored student research in these areas. For more information on our recent fellows and their work, see our website.

Eligibility. The student fellowship program is open to all Harvard graduate students who will be enrolled at the University during the fellowship year and who are committed to undertaking a significant research project and fulfilling other program requirements. Although the fellowship is open to all graduate students, including those in one-year programs, we encourage those who are in multi-year programs at Harvard to wait until after their first year to apply.

Requirements. All student fellows will have the following responsibilities: Continue reading

Marking the 40th Anniversary of In re Quinlan’s Landmark Contribution to Death & Dying Jurisprudence

by Norman L. Cantor

In 1976, the N.J. Supreme Court issued a remarkably insightful ruling regarding the legal status of a permanently unconscious patient.  In re Quinlan served as a judicial beacon guiding development of death & dying jurisprudence.  Its impact is reminiscent of the judicial role played by Brown v. Board of Education in public education.

To appreciate the wondrous nature of Quinlan, recall the setting and background of the case.  In 1975, a 22 year-old woman, Karen Ann Quinlan, was lying unconscious in a N.J. hospital following 2 anoxic episodes caused by toxic ingestions.  She was sustained by a mechanical respirator and a naso-gastric tube.  The diagnosis was PVS (permanent vegetative state) and the prognosis was that the patient would inevitably die within a year without regaining consciousness.  Ms. Quinlan’s devoted parents reluctantly concluded that their daughter would not want to be maintained in her dismal, hopeless condition.  Their priest and spiritual advisor told them that Catholic doctrine would permit withdrawal of “extraordinary” medical intervention such as the respirator.   But when the parents asked the attending neurologist, Dr. Morse, to withdraw Karen’s respirator, he refused.  He contended that professional medical standards precluded that course.  The hospital concurred.  Facing this resistance, Ms. Quinlan’s father turned to the N.J. chancery court seeking formal appointment as his daughter’s guardian with explicit authorization to direct withdrawal of the respirator.

A variety of interested parties responded to Mr. Quinlan’s chancery petition and they all opposed it.  The county prosecutor asserted that pulling the respirator plug would constitute homicide and the state attorney general concurred.  The attending physicians and the hospital contended that pulling the plug would violate their professional responsibilities to the patient.  And a special guardian ad litem appointed to represent Karen Ann Quinlan insisted that it was in the helpless patient’s best interests to have her life prolonged.  The lower court denied the father’s petition and Mr. Quinlan appealed.

On appeal, the N.J. Supreme Court in 1976 faced the unenviable task of shaping legal policy toward medical conduct likely to precipitate the death of a helpless patient.  This was largely uncharted legal territory with no definitive precedents in state or federal courts.  Common sense said that it can’t be a legal mandate to keep pumping fluids and gases into moribund patients until the last possible breath.  Yet a chorus of naysayers proclaimed that pulling the respirator plug on Ms. Quinlan would be unlawful homicide, or a breach of professional medical responsibility to preserve patients’ lives, or a violation of a guardian’s fiduciary obligation to act in a ward’s best interests.  And even if some circumstances might warrant removal of life-preserving medical interventions, hard questions existed about who is entitled to be the decision maker and what test or criteria govern such surrogate decision making.

Continue reading

Recent Developments in Off-Label Promotion

By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Continue reading

Jon Mark Hirshon on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

twihl 5x5
Listen here! Our guest this week is Jon Mark Hirshon, M.D., M.P.H., Ph.D., an Associate Professor in the Department of Emergency Medicine and in the Department of Epidemiology and Public Health at the University of Maryland School of Medicine. Jon Mark is also on the board of the American College of Emergency Physicians, and is an internationally recognized expert on acute care. His teams have trained approximately 900 physicians from countries in the Middle East in topics ranging from clinical care of trauma patients to disaster preparedness to research methods.Our lightning round featured discussions of an issue brief, “How Has the Affordable Care Act Affected Health Insurers’ Financial Performance?,” as well as a news story on some insurers’ dissatisfaction with the ACA. While health costs may increase GDP, they are hurting some insurers’ bottom lines. On the health IT front, we focused on ransomware and non-covered entities’ data. And continuing our wellness coverage, we mentioned employers’ new enthusiasm for mobile monitoring of employees’ mental health–what Rachel Emma Silverman’s twitter feed has jokingly called “#textualhealing.”

During his interview, Jon Mark focused on policy issues in acute care. He discussed a lawsuit filed by the American College of Emergency Physicians against the federal government reflecting ACEP’s concerns about reimbursement. Jon Mark also described the many challenges now facing emergency departments, ranging from narrow networks that fail to fairly compensate care, to user-unfriendly IT systems. Jon Mark also offered practical solutions for increasing access to acute care–an urgent policy concern given America’s dismal overall grades for access to emergency care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Call for Proposals: BioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the second annual bioIP Faculty Workshop on May 5, 2017 at Loyola University of Chicago School of Law in Chicago, IL.

The Workshop offers a unique opportunity for three scholars in their first decade of teaching to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology, life sciences, food and drug law, and intellectual property (hence, bioip), broadly defined. A Review Committee comprised of faculty from the Boston University School of Law, Georgia State University College of Law, and the Loyola University Chicago School of Law will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience, including VAPS and Fellows, are eligible for participation in the Workshop. Those interested in participating should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at thutchinson@aslme.org by Oct 14, 2016.

Selected abstracts will be announced later in Fall 2016 with the full draft papers due by April 1, 2017. The organizers will cover reasonable travel and lodging expenses for selected scholars.

For questions, please email Cynthia Ho at cho@luc.edu.

The vexed problem of properly discharging elderly patients from hospital back into the community

By John Tingle

The National Health Service (NHS) just does not seem to be able to deal properly with discharging elderly patients from hospital back into the community. There have been major issues in this area going back decades. Stories in the media and official reports regularly appear about ‘bed blocking’ by elderly patients or hospitals discharging them back into the community without proper care arrangements being made.

There is a real fear that the NHS will never be able to turn things around here and that the lessons of the past are not being learnt .There are seemingly intractable problems being faced by trusts, social services and others in doing a proper job with elderly patient discharge.The high financial cost to the NHS of keeping well elderly patients in hospital has also been widely discussed.

Hospitals and social services have faced a barrage of criticism of failing to have coordinated care policies and arrangements leading in some cases to deaths of patients.
Two reports have been published recently which show that patient safety is being seriously compromised in this area. Continue reading

Updated Nurse Practitioner Scope of Practice Map

The Policy Surveillance Program staff has recently updated the Nurse Practitioner Scope of Practice Dataset on LawAtlas.org to include laws through May 2016.

Fifty jurisdictions and the District of Columbia have laws pertaining to nurse practitioners’ scope of practice. In general, scope of practice laws regulate the autonomy nurse practitioners are given within their practice to treat patients. State laws fall into two main categories: limited practice and full practice. In limited practice states, the law limits autonomy for nurse practitioners by requiring them to collaborate with, or work under, the supervision of another health care provider. By contrast, full practice states allow nurse practitioners to practice independently.

In total, there are 29 limited practice states. In those states, collaboration, supervision, or a combination of the two are required in performing activities such as prescribing medication, ordering tests, performing examinations, and counseling or educating patients, among other activities.

1map

– States with limited practice authority

Continue reading

Medical Malpractice vs. General Negligence under California Law

By Alex Stein

In its recent decision, Flores v. Presbyterian Intercommunity Hosp., 369 P.3d 229 (Ca. 2016), the California Supreme Court has sharpened the critical distinction between “medical malpractice” and general negligence.

Under California statute, a plaintiff’s ability to file a medical malpractice suit expires in one year after the accrual of the cause of action. The statute tolls this period for two additional years, provided that the plaintiff files the suit within one year after he discovers the injury or could reasonably have discovered it. Cal. Code Civ. Proc. § 340.5 (providing that suits for medical malpractice must be filed “three years after the date of injury or one year after the plaintiff discovers, or through the use of reasonable diligence should have discovered, the injury, whichever occurs first.”). For other personal injury suits, the limitations period is “two years of the date on which the challenged act or omission occurred.” Cal. Code Civ. Proc. § 335.1.

In the case at bar, the plaintiff was injured when one of the rails on her hospital bed collapsed. Continue reading

NOW AVAILABLE FOR PRE-ORDER! Nudging Health: Health Law and Behavioral Economics

This volume, edited by I. Glenn Cohen, Holly Fernandez Lynch, and Christopher T. Robertson, stems from the Petrie-Flom Center’s 2014 Annual Conference “Behavioral Economics, Law, and Health Policy.” Pre-order your copy today!

Nudging HealthBehavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver’s seatbelt isn’t fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes.

Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics—but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform.

Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues—from the Affordable Care Act to prescription drugs.

Read the introduction on SSRN and pre-order your book now!

NOW ONLINE! Oxford Union Debating Society DNA Manipulation Debate

DNA fingerprints.The Oxford Union Debating Society at Oxford University has published full video of its DNA Manipulation Debate, filmed on May 26. The Motion under debate was, “This House Believes the Manipulation of Human DNA is an Ethical Necessity.” Oxford billed its DNA Manipulation Debate as “historic” in a year when rapid advances in gene editing and genome synthesis suddenly confront humans with the possibility of being able to write, edit, re-write, and ultimately control their own genetic destinies.

The team supporting the Motion was led by Sir Ian Wilmut, famous for cloning Dolly the Sheep and now Chair of the Scottish Centre for Regenerative Medicine at the University of Edinburgh, and included Oxford’s noted moral philosopher Julian Savulescu and Oxford student debater Lynda Troung, a fast-rising star in RNA research.

The team opposing the Motion included Dr. Norman Fost, professor emeritus of pediatrics and director of the medical ethics program at the University of Wisconsin; Professor Barbara Evans, Director of the Center for Biotechnology & Law at the University of Houston Law Center and a frequent participant in Petrie-Flom conferences; and Oxford student debater Dr. Rahul Gandhi, a young medical doctor and monk focusing on rural healthcare, who is pursuing an MBA at Oxford this year as a prelude to seeking an MPH at Harvard next year.

Continue reading

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of June. The selections feature topics ranging from lessons from the history of randomized controlled trials, to the prevalence and predictors of generic drug skepticism among physicians, to the availability and dissemination of results from FDA-mandated post-approval studies of medical devices. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Bothwell LE, Greene JA, Podolsky SH, Jones DS. Assessing the Gold Standard–Lessons from the History of RCTs. N Engl J Med. 2016;374(22):2175-81.
  2. Gellad WF, Good CB. Prescription of Brand-Name Medications When Generic Alternatives Are Available-Patently Unfair. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  3. Hwang TJ, Sokolov E, Franklin JM,  Kesselheim AS. Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016;353:i3323.
  4. Ioannidis JP. Why Most Clinical Research Is Not Useful. PLoS Med. 2016;13(6):e1002049.
  5. Kesselheim AS, Gagne JJ, Eddings W, Franklin JM, Ross KM, Fulchino LA, Campbell EG. Prevalence and Predictors of Generic Drug Skepticism Among Physicians: Results of a National Survey. JAMA Intern Med. 2016;176(6):845-7.
  6. Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG. Variations in Patients’ Perceptions and Use of Generic Drugs: Results of a National Survey. J Gen Intern Med. 2016;31(6):609-14.
  7. Luo J, Seeger JD, Donneyong M, Gagne JJ, Avorn J, Kesselheim AS. Effect of Generic Competition on Atorvastatin Prescribing and Patients’ Out-of-Pocket Spending. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  8. Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):713-8.
  9. Quesada O, Yang E, Redberg RF. Availability and Dissemination of Results From US Food and Drug Administration-Mandated Postapproval Studies for Medical Devices. JAMA Intern Med. 2016 Jun 27. [Epub ahead of print]
  10. Sarpatwari A, Kesselheim AS. Navigating the Dermatological Drug Cost Curve. JAMA. 2016;315(24):2724-5.
  11. Sarpatwari A, Avorn J, Kesselheim AS. State Initiatives to Control Medication Costs–Can Transparency Legislation Help? N Engl J Med. 2016;374(24):2301-4.
  12. Schwartz LM, Woloshin S, Zheng E, Tse T, Zarin DA. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials. Ann Intern Med. 2016 Jun 14. [Epub ahead of print]

UPDATED – Dental Hygiene Practitioners: Why they’re needed in Massachusetts, and why the amendment failed

Special guest post from Kelly Vitzthumoral health policy analyst at Health Care For All, a Massachusetts health policy and consumer advocacy organization. This post has been updated to reflect the non-inclusion of the Dental Hygiene Practitioner amendment in the final version of Massachusetts’ FY 2017 budget.

Former U.S. Surgeon General David Satcher described poor oral health as “a Silent Epidemic.” Oral health diseases are by and large preventable, and yet they are incredibly widespread. Disadvantaged and marginalized populations suffer disproportionately from poor oral health, and children are especially vulnerable. Many low-income individuals and families are priced out of needed care and struggle to find providers who accept Medicaid.

Though Massachusetts is a leader in health care and health reform, oral health is still often overlooked in state health policy discussions. Though MassHealth – Massachusetts’ Medicaid program – covers 40% of the state’s children, most dentists do not accept it. A shocking proportion of children have untreated oral decay, which affects their ability to eat, learn, and play. A full tenth of the population currently lives in a federally-designated Dental Health Professional Shortage Area (DHPSA), and emergency department visits for preventable dental conditions cost the state millions annually. Continue reading

Whole Woman’s Health and the Future of Abortion Regulation

By John A. Robertson

Whole Woman’s Health v. Hellerstedt (WWH) is the most important abortion case since Casey in 1992, and a major setback for the anti-choice movement.  By allowing courts to weigh the importance of the health benefits of a regulation, it will most likely invalidate most TRAP laws, which usually only marginally advance health while making it more difficult for women to access abortion.  WWH, however, will not stop the anti-choice movement from pressing its fight against abortion in other ways.  It now controls many state legislatures, and more legislation in areas left open by WWH may be expected.

Future health-related regulation will have to hew to the WWH line of providing real benefit, at least if substantially limits access to abortion.  But close questions may still arise.  What if a state has a valid health justification for a regulation that does limit access to abortion, as Jonathan Will notes would occur if a state law that directly promotes women’s health leads to that one clinic closing, as might occur in a state like Mississippi?  Here there would be a substantial burden on access, but given the health benefit of the law, which interest should take priority?  Neither Casey nor WWH are clear on this point.  In my view the question will turn on how great is the health benefit from the requirement.  A state, for example, should be able to close the only clinic in the state if it was as derelict as the Gosnell clinic.  In that case, however, one could show serious danger to women’s health and life that would be comparable or even greater than the risk of childbirth.  If the health benefit is less but still substantial, the question is harder.  Such a situation would call into question whether the state itself must allow even a sub-standard abortion facility even when acceptable facilities exist across a state line. (See Jackson Women’s Health v. Currier.) Continue reading

Data at Work

By Scott Burris, JD

The past few weeks saw two important studies published using legal mapping data to understand the role law plays in addressing health inequity and disparities. Both provide immediately actionable insights for health policy.

The first, published in the American Journal of Public Health, evaluates more than 200 changes in state minimum wage laws over 31 years (1980-2011) using LawAtlas data, and the impact of those changes on infant mortality and birth weight. Komro and her colleagues find that a $1 increase in the minimum wage above the federal level was associated with a 1 to 2 percent decrease in the number of low birth weight births and a four percent decrease in infant mortality in the United States. The research was built on data that identified every change in state and federal minimum wages over 31 years. The natural experiment represented by 206 state law changes—which can be compared by month both before and after within state and against states that did not change—can give us great confidence that the effect of the increases is causal. Continue reading

Malpractice, Terminal Patients, and Cause in Fact

By Alex Stein

Any person interested in medical malpractice or torts in general must read the Missouri Supreme Court’s recent decision, Mickels v. Danrad, 486 S.W.3d 327 (Mo. 2016). This decision involved a physician who negligently failed to diagnose the presence of a malignant brain tumor, from which the patient was doomed to die. The patient first saw the physician when he experienced numbness, blurred vision, and headaches. The physician sent the patient to an MRI scan, which he subsequently reviewed but made no diagnosis. Eleven weeks later, the patient arrived at a hospital in an altered mental state and underwent a CT scan of his brain, which showed a malignant and incurable tumor. Four months later, the patient died of that tumor. According to patient’s oncologist – who testified as a witness in a subsequent malpractice trial – the tumor was incurable when the patient first saw the physician. The plaintiffs offered no evidence controverting that testimony. Continue reading