Medical Malpractice Under a National Health System and the ACA

By Matthew H. H. Young

What will happen to the current medical malpractice system under a single-payer system?

To answer this question, I started by looking at the information provided by Physicians for a National Health Program, whose mission is to replace the ACA (Affordable Care Act) with single-payer. On their website under Single-Payer FAQs, it says:

What will happen to malpractice costs under national health insurance?

They will fall dramatically, for several reasons. First, about one-fourth of all malpractice awards go to pay present and future medical costs (e.g. for infants born with serious disabilities). Single payer national health insurance will eliminate the need for these awards. Second, many claims arise from a lack of communication between doctor and patient (e.g. in the Emergency Department). Miscommunication/mistakes are heightened under the present system because physicians don’t have continuity with their patients (to know their prior medical history, establish therapeutic trust, etc) and patients aren’t allowed to choose and keep the doctors and other caregivers they know and trust (due to insurance arrangements). Single payer improves quality in many ways, but in particular by facilitating long-term, continuous relationships with caregivers. For details on how single payer can improve the quality of health care, see “A Better Quality Alternative: Single Payer National Health Insurance.” For these and other reasons, malpractice costs in three nations with single payer are much lower than in the United States, and we would expect them to fall dramatically here. For details, see “Medical Liability in Three Single-Payer Countries” paper by Clara Felice and Litsa Lambkros.

Let me address the most salient part of the above argument, which states that the significant burden of malpractice recoveries composed of future medical costs will be alleviated because all individuals will be insured. Continue reading

CALL FOR ABSTRACTS! 2017 Annual Conference, “Transparency in Health & Health Care: Legal & Ethical Possibilities & Limits”

Medical care prices against a white background

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2017 annual conference, entitled: Transparency in Health and Health Care: Legal and Ethical Possibilities and Limits.

Transparency is a relatively new concept to the world of health and health care, considering that just a few short decades ago we were still in the throes of a “doctor-knows-best” model. Today, however, transparency is found on almost every short list of solutions to a variety of health policy problems, ranging from conflicts of interest to rising drug costs to promoting efficient use of health care resources, and more. Doctors are now expected to be transparent about patient diagnoses and treatment options, hospitals are expected to be transparent about error rates, insurers about policy limitations, companies about prices, researchers about data, and policymakers about priorities and rationales for health policy intervention. But a number of important legal and ethical questions remain. For example, what exactly does transparency mean in the context of health, who has a responsibility to be transparent and to whom, what legal mechanisms are there to promote transparency, and what legal protections are needed for things like privacy, intellectual property, and the like?  More specifically, when can transparency improve health and health care, and when is it likely to be nothing more than platitude?

This conference, and anticipated edited volume, will aim to: (1) identify the various thematic roles transparency has been called on to play in American health policy, and why it has emerged in these spaces; (2) understand when, where, how, and why transparency may be a useful policy tool in relation to health and health care, what it can realistically be expected to achieve, and when it is unlikely to be successful, including limits on how patients and consumers utilize information even when we have transparency; (3) assess the legal and ethical issues raised by transparency in health and health care, including obstacles and opportunities; (4) learn from comparative examples of transparency, both in other sectors and outside the United States.  In sum, we hope to reach better understandings of this health policy buzzword so that transparency can be utilized as a solution to pressing health policy issues where appropriate, while recognizing its true limitations.

Call for Abstracts

We welcome submissions on both the broad conceptual questions described above and more specific policy issues, including: Continue reading

Legal Dimensions of Big Data in the Health and Life Sciences

Please find below my welcome speech at last-weeks mini-symposium on “Legal dimensions of Big Data in the Health and Life Sciences From Intellectual Property Rights and Global Pandemics to Privacy and Ethics at the University of Copenhagen (UCPH).  The event was organized by our Global Genes –Local Concerns project, with support from the UCPH Excellence Programme for Interdisciplinary Research.

The symposium, which was inspired by the wonderful recent  PFC & Berkman Center Big Data conference,  featured enlightening speeches by former PFC fellows Nicholson Price on incentives for the development of black box personalized medicine and Jeff Skopek on privacy issues. In addition we were lucky to have Peter Yu speaking on “Big Data, Intellectual Property and Global Pandemics” and Michael J. Madison on Big Data and Commons Challenges”. The presentations and recordings of the session will soon be made available on our Center’s webpage.

Thanks everybody for your dedication, inspiration, great presentations and an exciting panel discussion.

“Legal Dimensions of Big Data in the Health and Life Sciences – From Intellectual Property Rights and Global Pandemics to Privacy and Ethics”

Continue reading

Healthcare complaints matter: the need to improve the system

Today consumerism is an essential part of the fabric of British society and complaint systems are heralded in many retail and professional environments. The British public have got used to complaining over the years and this attitude has seeped into the provision of health care services.

Records levels of complaints about the National Health Service (NHS) can be seen to be made every year but the NHS just does not seem to be able to get to grips with developing a good patient complaints handling system.

The Health Service Ombudsman (HSO) lies at the top of the NHS complaints structure and makes the final decisions on complaints that have not be resolved by the NHS in England. The HSO has looked into the quality of NHS complaint investigations where serious or avoidable harm has been alleged.Systemic failings in complaint, patient safety investigations were revealed. Failures which unsurprisingly have appeared in numerous complaints reports over the years before.

For the report, the HSO reviewed 150 NHS complaint investigations where avoidable harm or death was alleged. The HSO also spoke to six different trusts and surveyed over 170 NHS complaint managers to gain insights. An advisory group was later convened by the HSO to test findings.

Continue reading

Proposed CMS Sanctions Threaten Theranos’ Future

By Katherine Kwong

The news for blood testing company Theranos has gotten even worse since this blog’s last discussion of the company’s woes. Despite the company’s statements at the end of March that it would correct all of the issues CMS had found, new reports have emerged that Theranos’ California lab may see its federal license revoked. Additionally, Theranos’ founder, Elizabeth Holmes, and Theranos’ president, Sunny Balwani, may be banned from owning or operating any testing laboratories for two years. These potential sanctions have been proposed after regulators concluded Theranos has failed to adequately address concerns raised about its tests by the Centers for Medicare and Medicaid Services (CMS).

How did Theranos get to this point? Continue reading

The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Patient safety perspectives from other countries: introducing the WHO Geneva safe childbirth checklist

By John Tingle

Healthcare providers and policy makers can avoid the expense of reinventing the wheel if they try and look beyond their shores for solutions to patient safety problems. In the UK the work of the patient safety unit of WHO in Geneva helps NHS healthcare providers through the development of patient safety tools and other projects. The  WHO multi-professional patient safety curriculum guide is one example. The learning from error – video and booklet is another. Recently launched by WHO is the Safe Childbirth checklist and guide to implementation.

The Checklist will be a useful patient safety tool in developing, transitioning and developed countries. The scale of the problem is very disturbing. WHO calculate that in 2013, 289,000 women died during and following pregnancy and childbirth, and 2.8 million new-borns died within 28 days of birth. Most of these events could have been prevented and mostly occurred in low resource settings. Women and their babies are being very conspicuously failed by health systems which should be helping them. Continue reading

Minnesota: Leading The Way In Patient Safety

By John Tingle

The UK Government and the Department of Health are taking patient safety very seriously and, since the publication of ‘An organisation with a memory’ in 2000, the UK has like the USA been a world leader in the field of patient safety policies, practices and developments.

In the UK we have a very sophisticated patient NHS (National Health Service) patient safety infrastructure and system along with a NHS Adverse incident reporting system, the NRLS (National Reporting and Learning System). Despite having such a ‘Rolls Royce’, well-established patient safety infrastructure and system, terrible patient safety incidents such as that which happened in Mid Staffordshire a few years ago seem to plague the NHS. Patients died because of poor care and, according to the report, “[t]he Inquiry identifies a story of terrible and unnecessary suffering of hundreds of people who were failed by a system which ignored the warning signs of poor care and put corporate self-interest and cost control ahead of patients and their safety.”Our patient system missed the terrible care failings identified in this inquiry report. We are working hard on improving the system and my posts will provide regular updates on what is happening in the UK, Europe and beyond in patient safety.

Patient Safety: A World Problem Continue reading

Women, Girls, and Mass Incarceration: A Hidden Problem

Goodwin-Headshot11Mass incarceration’s invisible casualties are women and children.  Too often, they are the forgotten in a tragic American tale that distinguishes the United States from all peer nations.  Simply put, the U.S. incarcerates more of its population than anywhere else in the world–and by staggering contrast.  While the U.S. locks away over 700 men and women for every 100,000, here are comparable figures from our peer nations:  England (153 in 100,000), France (96 in 100,000), Germany (85 in 100,000), Italy (111 in 100,000), and Spain (159, in 100,000).  The U.S. accounts for less than 5% of the globes population, yet locks away nearly 25%.  Sadly, this has grave social, medical, psychological, and economic consequences.

Congressional Briefing on Women, Girls, and Mass Incarceration

In a recent essay, published in the Texas Law Review, I explained that, the population of women in prison grew by 832% in the period between 1977-2007—nearly twice the rate as men during that same period. More conservative estimates suggest that the rate of incarceration of women grew by over 750% during the past three decades. This staggering increase now results in more than one million incarcerated in prison, jail, or tethered to the criminal justice system as a parolee or probationer in the U.S. The Bureau of Justice Statistics underscores the problem, explaining in a “Special Report” that “[s]ince 1991, the number of children with a mother in prison has more than doubled, up 131%,” while “[t]he number of children with a father in prison has grown [only] by 77%.” Continue reading

Why Senator Markey’s Message Hurts Children

Last week, Senator Edward Markey (D-MA) placed a hold on the Senate’s nomination of Robert Califf’s as head of the Food and Drug Administration (FDA). The move was less against Califf and more as political leverage against FDA’s approval of OxyContin. In August 2015, FDA approved OxyContin, a prescription painkiller, for pediatric patients ages 11 to 17. OxyContin is the painkiller most associated with United State’s prescription drug abuse epidemic, accounting for an increase in drug overdose and death over the last decade. FDA’s approval of OxyContin for children drew concern from Markey and others that the approval would lead to an increase in drug misuse for children and their family members. Markey, who has prioritized the fight against opioid addiction in his legislative agenda, hopes he can use the hold to convince FDA to reverse its August decision.

Senator Markey’s message is well intentioned, but may ultimately do more harm than good for children.

Before FDA approved OxyContin in August, children who suffered from severe, chronic pain due to cancer, extensive trauma, or serious surgeries had few drugs approved to treat their pain. Many physicians treating severe pain in children prescribed OxyContin off-label, without proof that OxyContin could safely and effectively treat children. These physicians often relied on their experience or intuition to not under or overprescribe the drug. FDA’s approval in August meant the pharmaceutical manufacturer finally provided physicians with instructions, backed by controlled studies, explaining how physicians could safely use OxyContin to treat children with severe pain. Continue reading

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part II My First Take)

By I. Glenn Cohen

My last post was a summary of the NAM’s Recommendations on Mitochondrial Replacement Therapy (MRT). Now here is my take on the report. But keep in mind the report was just released and all I could give it was a quick read, so these are really more like initial impressions: Continue reading

Fixing the Broken Law of Military Medical Malpractice for Birth-Related Injuries

Bill of Health bloggers Alex Stein and Dov Fox have just filed an amicus brief urging the Supreme Court to hear the case of U.S. Air Force Major Heather Ortiz and her baby, who were denied legal remedies for obstetric malpractice by military doctors that left the baby with severe brain damage. The case is No. 15-488 Ortiz v. U.S. ex rel. Evans Army Community Hospital. Professors Fox and Stein urge the Court to overturn the Tenth Circuit’s holding that the federal government’s immunity against liability for intramilitary torts extends to wrongful injuries like those sustained by Major Ortiz’s baby. They argue that this holding misinterprets the immunity, misapplies the Federal Tort Claims Act (FTCA), and constitutes no less than unconstitutional sex discrimination. Fox and Stein explain:

When a civilian spouse of a serviceman receives negligent prenatal care from military doctors and delivers an injured baby as a result of that malpractice, there is no question that Feres immunity does not apply and that the baby can sue the United States under the FTCA. When military medical malpractice injures the baby of a servicewoman, this baby should be equally able to obtain redress under the FTCA.  A system that would single out the civilian children of servicewomen for adverse treatment discriminates against women who serve in the armed forces. . . To interpret the FTCA as the Tenth Circuit did permits discrimination between these two classes of similarly situated victims of military malpractice and violates fundamental principles of equal protection.

To download this brief, click here.

Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

Continue reading

Reproductive Malpractice and the U.S. Military

Check out the new op-ed at HuffPo by Bill of Health bloggers Dov Fox and Alex Stein on the unfair treatment of American servicewomen (and their children) under the Feres doctrine should they fall victim to medical malpractice during their pregnancy or delivery. Fox and Stein call for SCOTUS to fix the loophole it left open in the 1950 case, or for Congress to “set up a fund for compensating children whose disabilities were caused by substandard care at military medical facilities.”  Take a look at the full post here.

New from Bioethicist Art Caplan: How State Right-To-Try Laws Create False Expectations

A new piece by David Farber, Preeya Noronha Pinto, Bill of Health contributor Arthur Caplan, and Alison Bateman-House the Health Affairs blog:

Over the past year, state Right-to-Try (RTT) laws that claim to enable terminally ill patients to access unapproved, experimental drugs, biologics, and devices have swept the nation. As of early May, seventeen states have enacted RTT laws (most recently, Florida and Minnesota), and bills creating such laws are currently pending in over twenty state legislatures.

Although these laws have created an expectation that terminally ill patients will be able to quickly access potentially life-saving treatments by being exempted from the rules of the U.S. Food and Drug Administration (FDA), this expectation is, quite simply, false.

Read the full article here.

Bioethicist Art Caplan: Why a New Alzheimer’s Drug Isn’t A No-Brainer

A new piece by contributor Art Caplan on NBC News:

Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.

In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.

Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]

See the full article here.

The Great Vaccination Debate Rages On: Is There Any Solution?

By: Allison M. Whelan, Senior Fellow, Center for Biotechnology & Global Health Policy, University of California, Irvine School of Law, Guest Blogger

For many years now, there has been ongoing debate about childhood vaccinations and the recent measles outbreak in Disneyland and its subsequent spread to other states has brought vaccinations and questions about communicable diseases back to the headlines.  Politicians, including potential presidential candidates such as Hilary Clinton, Rand Paul, and Chris Christie, are also wading back into the debate.

Most recently, five babies who attend a suburban Chicago daycare center were diagnosed with the measles. As a result, anyone in contact with these infants who has not received the MMR (measles, mumps, rubella) vaccine must remain home, essentially quarantined, for the next twenty-one days—the incubation period for measles. All five of these infants were under the age of one and therefore did not yet have the chance to receive the vaccination, which is not administered until one year of age.

The Chicago outbreak is a prime example of why public health officials emphasize the reliance on herd immunity to protect those who are not yet, or cannot be, vaccinated for legitimate reasons. Unfortunately, the United States has reached a period where it can no longer place much reliance on herd immunity, particularly as more parents decide not to vaccinate their children against very contagious, yet highly preventable diseases. Illness and death are two of life’s certainties, but why should they be given that they are preventable in this situation?  What are the strongest, most rational arguments in this debate? What policy solutions should states consider?  Several options have been proposed over the years, some more feasible and likely than others. Continue reading

A Chief Privacy Officer’s Take on the Chanko Case

Earlier this month, Charles Ornstein explored a New York City family’s charge that their privacy was violated by a local hospital and a reality television show in ProPublica. More specifically, he details how the death of one Mr. Mark Chanko was filmed at NY Presbyterian Hospital without the family’s consent, and then nationally aired on ABC’s NY MED over a year later. Mr. Chanko’s face was blurred for viewers but he remained recognizable to family and friends who watched the show. Since the broadcast, the family has pursued legal action through several New York courts with little success thus far.

The piece has already been commented upon by several smart people, most recently Kay Lazar of the Boston Globe. Just one day after Ornstein’s piece went to press, the Dean of Harvard Medical School Jeffrey Flier (@jflier) tweeted “How could this be allowed to happen?” only to be informed by the Chair of Surgery at Boston Medical Center, Gerard Doherty, (@GerardDoherty4) that three Harvard-affiliated hospitals are in fact currently hosting camera crews for a similar series. The ensuing conversation reminded me just how limited a platform Twitter is for tricky conversations about health care law and ethics. So I did what any self-respecting millennial would do – I went home for the holidays and asked my mom to help me understand what the internet couldn’t.

Continue reading

Ebola and Privacy

By Michele Goodwin

As the nation braces for possibly more Ebola cases, civil liberties should be considered, including patient privacy.  As news media feature headline-grabbing stories about quarantines,  let’s think about the laws governing privacy in healthcare. Despite federal laws enacted to protect patient privacy, the Ebola scare brings the vulnerability of individuals and the regulations intended to help them into sharp relief.

In 1996, Congress enacted the Health Insurance Portability and Accountability Act (HIPAA) to protect patient privacy.  Specifically, HIPAA’s Privacy Rule requires that healthcare providers and their business associates restrict access to patients’ health care information.  For many years, the law has been regarded as the strongest federal statement regarding patient privacy. But it may be tested in the wake of the Ebola scare with patients’ names, photographs, and even family information entering the public sphere.

Ebola hysteria raises questions not only about how to contain the disease, but also to what extent Americans value their healthcare privacy.  What liberties are Americans willing to sacrifice to calm their fears?  How to balance the concern for public welfare with legal and ethical privacy principles?  For example, will Americans tolerate profiling travelers based on their race or national origin as precautionary measures?  What type of reporting norms should govern Ebola cases?  Should reporting the existence of an Ebola case also include disclosing the name of the patient?  I don’t think so, but the jury appears out for many.

Prop. 46: Lawyers v. Doctors

By Emily Largent

California Proposition 46, the Medical Malpractice Lawsuits Cap and Drug Testing Doctors Initiative, is on the November 4, 2014 ballot.  If approved by voters, the initiative would: increase the state’s cap on non-economic damages that can be assessed in medical negligence lawsuits; require hospitals to test certain physicians for drugs and alcohol; and require healthcare providers to check a statewide prescription drug database before prescribing or dispensing certain drugs to a patient for the first time.

The  debate over Proposition 46 has been framed as a battle between doctors and lawyers.  See also here or here.  It’s not hard to see why.  Attorneys have contributed the vast majority of the “yes” campaign‘s $9 million fund.  By contrast, nearly three-fourths of the “no” campaign‘s $57 million has come from six insurance companies; other big backers include the state medical and dental associations.  (It is the most expensive campaign in California this year.)  While the two sides have made a variety of arguments for and against Proposition 46’s various provisions, I want to focus on the putative costs and cost-savings:

First, Proposition 46 would increase California’s current $250,000 limit on non-economic awards (which dates to the Medical Injury Compensation Reform Act of 1975) to $1.1 million, and provide for annual adjustment for inflation going forward. The non-partisan Legislative Analyst’s Office estimates that increased state and local government health care costs from raising the cap likely range from the tens of millions of dollars to several hundred million dollars annually.  On the other hand, a RAND study of EDs in three states with strict malpractice limits found the caps had little effect on the cost of care.  Continue reading