United States v. Nayak: The Application of Honest Services Mail and Wire Fraud to the Health Care Industry (Part I)

By Joan H. Krause
[Cross-posted at HealthLawProf Blog]

Since the early 1900’s, the federal mail and wire fraud statutes have been applied to schemes to defraud victims not just of money or property, but also of “intangible rights” such as the right to the “honest services” of an employee or public servant. 18 U.S.C. §§ 1341, 1343, 1346. This expansive theory of honest services fraud has been applied to public officials and private businessmen, although only rarely to physicians or others in the health care system. In 2010, the Supreme Court used the case of former Enron CEO Jeffrey Skilling to impose significant limits on the reach of the honest services fraud theory. Skilling v. United States, 561 U.S. 258 (2010).Skilling itself had nothing to do with health care, arising instead from a prosecution for conspiracy, securities fraud, wire fraud, false representations to auditors, and insider trading in connection with Enron’s massive financial meltdown. Yet in rejecting Skilling’s vagueness challenge to the honest services wire fraud theory underlying his conspiracy conviction, the Court read the statute to limit honest services prosecutions to cases involving bribery and kickbacks – activities with particular salience in the health care context. In a 2012 article, I predicted that while Skilling generally was viewed as narrowing the scope of honest services fraud, the decision might have the paradoxical effect of inviting additional prosecutions in the health care industry.

While intangible rights cases date back to the early 1900’s, modern prosecutions were derailed in 1987 when the Supreme Court ruled that the mail and wire fraud statutes applied only to the deprivation of property rights. McNally v. United States, 483 U.S. 350 (1987). In response, Congress quickly enacted 18 U.S.C. § 1346 to clarify that the statutes did indeed prohibit “a scheme or artifice to deprive another of the intangible right of honest services.” The amendment did not include a definition of honest services, nor offer any other indication as to when the prohibition might apply. In his appeal, Skilling asserted that the provision was unconstitutionally vague because it failed to adequately define the prohibited behavior and granted nearly unfettered prosecutorial and judicial discretion. The Court, however, declined to overturn the statute, finding clear Congressional intent to return to the state of the law prior to McNally: a “solid core . . . involv[ing] offenders who, in violation of a fiduciary duty, participated in bribery or kickback schemes.” (Skilling at 407)

Given the prominence of kickback concerns in health care, I warned that the Court’s focus on kickbacks and bribery might well have the effect of reinvigorating the prosecution of health care intangible rights violations. And indeed on October 20, 2014, the Seventh Circuit decided one of the first major post-Skilling honest services fraud cases involving health care providers, United States v. Nayak. Continue reading

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

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

Hospitable Hospitals and the True Cost of VIP Rooms

By Vadim Shteyler

Increasing hospitality in medical facilities is not a recent trend. We take for granted that modern hospitals offer clean sheets, towels, a plethora of toiletries, heated blankets, and many other amenities. Conversely, in the hospitals of decades past, many patients relied on family members to bring food and clean sheets. Rows of hospital beds in an open ward precluded privacy. Unhygienic conditions commonly resulted in rodent infestations. And paternalism in medicine was still the norm.

This trend towards hospitality has recently gained new momentum. As featured in a recent article in Kaiser Health News, dozens of hospitals have hired Chief Patient Experience Officers from customer service or hotel industries. Since 2012, when Medicare began penalizing hospitals for poor patient experiences, hospital efforts to improve patient satisfaction have grown. Some hospitals began mandating communication seminars, encouraging nurses to spend more face-to-face time with patients, and calling patients after discharge to follow-up on their recovery. The Affordable Care Act (ACA), further tying hospital reimbursements to patient surveys, has additionally promoted such changes.

A similar trend has arisen with the increased popularity of V.I.P. sections in many hospitals. Though the hospital construction boom is beginning to slow down, the resultant V.I.P. rooms remain. Lenox-Hill Hospital’s maternity suite in New York City, which received a lot of media attention after Beyonce gave birth there in 2012, is one of many luxurious suites across the nation. Some, offering personal shoppers, private chefs, and salon services, are priced upwards of $4,000. While nobody calls for a return to the hospitals of old, many feel suites such as these are excessive.  Continue reading

The Learned Intermediary Rule and Direct-to-Consumer Advertising

By Zachary Shapiro

In the field of pharmaceutical product-liability litigation, the Learned Intermediary Rule (LIR) is a defense doctrine for failure to warn claims, which has been adopted in 22 states, and applied in 48. The LIR means that if a pharmaceutical manufacturer that gives an adequate warning to a prescribing physician, the company has no corresponding duty to directly warn the patient.

This rule has been justified by the belief that the prescribing physicians is “in a superior position to impart the warning and can provide an independent medical decision as to whether use of the drug is appropriate for treatment of a particular patient.” Larkin v. Pfizer, Inc. 153 S.W.3d 758, 763-764 (Ky. 2004). Furthermore, historically, pharmaceutical manufacturers lacked effective means to communicate directly to patients. Courts did not want to extend liability when pharmaceutical companies were complying with FDA regulations regarding proper warnings to consumers. Finally, there was a belief that any direct warning would interfere with the doctor-patient relationship.  Continue reading

The Civil Rights Movement and the Blood Supply

By Emily Largent

This year marks the 50th anniversary of the Civil Rights Act of 1964, and this semester, I have been fortunate enough to take a class on the Civil Rights Movement with Professor Randall Kennedy.  This has prompted me to examine the influence of race on healthcare delivery in the 1940s, ’50s, and ’60s.  Racism infected all aspects of the healthcare system, including medical schools and schools of nursing, residencies and post-graduate training, professional societies for doctors and nurses, ambulance services, outpatient clinics, staff privileges at hospitals, hospital admissions, and medical research.  Doubtlessly, the color line in medicine compounded physical ills with emotional and dignitary harms.

I find the stories related to the segregation of the American blood supply during World War II to be particularly interesting because they show that discrimination was a national (i.e., not just a Southern) problem, and there is a small connection to Harvard Law School.  Speak Now Against the Day: The Generation Before the Civil Rights Movement in the South by John Egerton has proven to be an excellent source of information on this topic.

Blacks made contributions to the war effort in many capacities.  William H. Hastie, a graduate of Harvard Law School, took leave from his position as Dean at Howard University School of Law (HUSL) to accept an appointment as civilian aide to Secretary of War Stimson.  Charles R. Drew, a physician who had conducted pioneering research on typing, preserving, and storing blood for later transfusion, helped both Britain and the United States establish blood programs to support military operations. In February 1941, Drew was made medical director of the American Red Cross blood bank program.

Late in 1941, the surgeons general of the United States Army and Navy informed the Red Cross that only blood from white donors would be accepted for military use.  Although it had been conclusively proven that there were no racial differences in blood, the military yielded to prevailing social bias and heavy political pressure.  In January 1942, the War Department revised its position, agreeing to accept blood from black donors, though also insisting on rigid adherence to segregation of the blood supply.  The Red Cross not only accepted that decision but declared that it had no interest in trying to settle racial-social controversies.  Later, Red Cross officials “suggested that those who persisted in criticizing the policy were unpatriotically attempting to cripple the blood donor service and thus harm the war effort itself.”  Continue reading

More Than Just the ACA at Stake in King v. Burwell

Guest post by Erin Fuse Brown
[Cross-posted from Center for Law, Health and Society Blog]

Commentators have been weighing in since the Supreme Court decided it would hear King v. Burwell, the case challenging the ability of millions of Americans to receive subsidies to purchase health insurance on federally operated Exchanges under the ACA.  Debate swirls over whether a decision striking down these subsidies will gut the ACA or not, but at the very least a ruling in favor of the petitioners would have grave consequences for ACA the and the millions that currently receive these subsidies.

There is, however, more at stake in the King case than the ACA.  If the Court takes this opportunity to cut down the ACA, it does so at the cost of the principle of separation of powers and the Supreme Court’s institutional legitimacy and credibility.

Chevron

The question in King will be resolved under the Chevron framework, which provides that if a statutory provision is ambiguous, then the court must defer to the agency’s interpretation, so long as it is permissible.  Reasonable, learned minds have been disagreeing on the meaning of the statutory provision. As Adrian Vermeule has pointed out, of the 9 federal judges that have reviewed this question, 6 have agreed with the government’s interpretation or concluded the statute is ambiguous, and 3 have concluded that the statute unambiguously precludes subsidies. This type of judicial disagreement is evidence itself of statutory ambiguity.  Continue reading

Risk and Reform of Long-Term Care

By Allison Hoffman
[Cross-posted from Health Affairs Blog]

The 50th Anniversary of Medicare and Medicaid offers an opportunity to reflect on how U.S. social policy has conceived of the problem of long-term care.

Social insurance programs aim to create greater security—typically financial security—for American families (See Note 1). Programs for long-term care, however, have had mixed results. The most recent attempt at reform, which Ted Kennedy ushered through as a part of the Patient Protection and Affordable Care Act (ACA), called the CLASS Act, was actuarially unsound and later repealed. Medicare and especially Medicaid, the two primary government programs to address long-term care needs, are criticized for failing to meet the needs of people with a disability or illness, who need long-term services or supports. These critiques are valid.

Even more troublesome, however, long-term care policy, especially in its most recent evolution toward home-based care, has intensified a second type of insecurity for Americans. Continue reading

Tomorrow: “Patients With Passports” Book Launch

Cohen_Medical_TourismBook Launch: Patients with Passports: Medical Tourism, Law, and Ethics

Wednesday, November 19, 2014

Harvard Law School Library
Langdell Hall, Caspersen Room
1557 Massachsetts Ave., Cambridge, MA [Map]

This event is free and open to the public. A light lunch will be served.

I. Glenn Cohen‘s new book Patients with Passports: Medical Tourism, Law, and Ethics  (Oxford University Press, 2014) is the first comprehensive legal and ethical analysis of medical tourism. Examining both the legal and ethical issues raised by medical tourism and how the two interact, it provides the best currently available data and explanations of the industry and tackles the most prevalent legal and ethical issues facing medical tourism today.

Co-sponsored by the Harvard Law School Library.

Article III Standing in Patent Law May Be Before the Supreme Court Soon

Who has standing to challenge a patent’s validity? And under what circumstances can Congress define an injury for the purpose of creating Article III standing? Those questions underlie a new petition for certiorari filed by Consumer Watchdog, who is asking the Supreme Court to reverse a Federal Circuit opinion holding that Consumer Watchdog lacked Article III standing to challenge a patent on embryonic stem cells.

Consumer Watchdog, a non-profit consumer organization, requested an inter partes reexamination of a patent on embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF), alleging that the patent should be invalidated on several grounds. After a lengthy administrative process, the Patent Trial and Appeal Board (PTAB) upheld the patent as valid. Consumer Watchdog subsequently appealed, under sections of the Patent Act that expressly permit third-party requesters (like Consumer Watchdog) in inter partes reexamination proceedings to appeal to the Federal Circuit if they are “dissatisfied” with the PTAB’s decision or if any “final decision [is] favorable to the patentability” of the claims in question. The Federal Circuit held that Article III’s case or controversy requirement imposes a separate, irreducible constitutional minimum requirement on standing — and that Consumer Watchdog hadn’t met that requirement.  Continue reading

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

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

Check out the latest news from the Petrie-Flom Center!

11-14 newsletter screenshot

Check out the November 14th edition of the Petrie-Flom Center’s biweekly e-newsletter for the latest on events, affiliate news and scholarship, and job and fellowship opportunities in health law policy and bioethics.

New BoH Feature: Monthly Round-Up of What to Read on Pharma Law and Policy

Each month, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital/Harvard Medical School reviews the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.  We are thrilled to announce that PORTAL (specifically Aaron Kesselheim and Ameet Sarpatwari) will being posting these curated round-ups at Bill of Health each month, with a full posting including abstracts/summaries at their website.

Below are the abstracts/summaries for papers identified from October.  The selections feature topics ranging from the cost-utility of specialty drugs, to the association between financial conflicts of interest and favorable assessments of newer influenza treatments, to the clinical evidence supporting biomarker testing reported in FDA drug labels.  We thank Lara Maggs and Nazleen Khan for their contributions to this review.

  1. Chambers JD, Thorat T, Pyo J, Chenoweth M, Neumann PJ. Despite high costs, specialty drugs may offer value for money comparable to that of traditional drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1751-60.
  2. Chang CQ, Tingle SR, Filipski KK, Khoury MJ, Lam TK, Schully SD, Ioannidis JP. An overview of recommendations and translational milestones for genomic tests in cancer. Genet Med. 2014 Oct 23. [Epub ahead of print]
  3. Dunn AG, Arachi D, Hudgins J, Tsafnat G, Coiera E, Bourgeois FT. Financial conflicts of interest and conclusions about neuraminidase inhibitors for influenza: an analysis of systematic reviews. Ann Intern Med. 2014 Oct 7;161(7):513-8.
  4. Kesselheim AS, Tan YT, Darrow JJ, Avorn J. Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs. Health Aff (Millwood). 2014 Oct 1;33(10):1770-8.
  5. Miladinovic B, Kumar A, Mhaskar R, Djulbegovic B. Benchmarks for detecting ‘breakthroughs’ in clinical trials: empirical assessment of the probability of large treatment effects using kernel density estimation. BMJ Open. 2014 Oct 21;4(10):e005249.
  6. Naci H, Alexander GC. Regulators should better leverage effectiveness standards to enhance drug value. Pharmacotherapy. 2014 Oct;34(10):1005-11.
  7. Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S. Ensuring patient privacy in data sharing for postapproval research. N Engl J Med. 2014 Oct 23;371(17):1644-9.
  8. Starner CI, Alexander GC, Bowen K, Qiu Y, Wickersham PJ, Gleason PP. Specialty drug coupons lower out-of-pocket costs and may improve adherence at the risk of increasing premiums. Health Aff (Millwood). 2014 Oct 1;33(10):1761-9.
  9. Wang B, Canestaro WJ, Choudhry NK.Clinical Evidence Supporting Pharmacogenomic Biomarker Testing Provided in US Food and Drug Administration Drug Labels.JAMA Intern Med. 2014 Oct 13. [Epub ahead of print]
  10. Woodcock J. Paving the critical path of drug development: the CDER perspective. Nat Rev Drug Discov. 2014 Oct 31;13(11):783-4.
  11. Yeh JS, Austad KE, Franklin JM, Chimonas S, Campbell EG, Avorn J, Kesselheim AS. Association of medical students’ reports of interactions with the pharmaceutical and medical device industries and medical school policies and characteristics: a cross-sectional study. PLoS Med. 2014 Oct 14;11(10):e1001743.

Introducing New Blogger Ameet Sarpatwari

AmeetAmeet Sarpatwari, J.D., Ph.D., is a research fellow at Harvard Medical School and member of the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research] in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. His research draws upon his interdisciplinary training as an epidemiologist and lawyer and focuses on the effects of laws and regulations on therapeutic development, approval, use, and related public health outcomes.

Ameet graduated from the University of Virginia, where he was a Jefferson Scholar. He studied epidemiology at the University of Cambridge, receiving an M.Phil. in 2006 and a Ph.D. in 2010. His doctoral work centered on uncovering disease progression, treatment effectiveness, and co-morbid burden among adults patients with primary immune thrombocytopenia—a rare autoimmune disease—through the establishment of a national disease registry. He subsequently studied law at the University of Maryland, with a focus on health law, as a John L. Thomas Leadership Scholar, graduating in 2013.

Ameet’s work has appeared in such top peer-reviewed medical journals as the New England Journal of Medicine, Clinical Pharmacology and Therapeutics, and Blood.  He is the recipient of Robert Wood Johnson Public Health Law Research grant to examine the public health implications of variation in state drug product selection laws. Among other projects, he is also currently assessing the impact of risk evaluation and mitigation strategies on competition and off-label prescribing, and legal and ethical issues surrounding the use of financial incentives to promote physician use of generic drugs.

Welcome, Ameet!

Introducing New Blogger Aaron S. Kesselheim

ASKAaron S. Kesselheim, M.D., J.D., M.P.H. [Twitter: @akesselheim], is an Associate Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital (BWH). Within the Division, Aaron leads the Program On Regulation, Therapeutics, And Law (PORTAL) [Twitter: @PORTAL_Research], an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law.

Aaron graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. He is also a Patent Attorney and member of the New York State Bar.

Aaron has received wide recognition for his work, which frequently appears in top peer-reviewed medical journals like the New England Journal of Medicine, JAMA, and Annals of Internal Medicine. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. Aaron has testified before Congress on pharmaceutical policymedical device regulation, and modernizing clinical trials, and served as a consultant for the NIHFDAInstitute of MedicineUSPTO, and numerous state government offices.  In 2010, he received AcademyHealth’s Alice S. Hersh New Investigator Award from AcademyHealth, given annually to an outstanding health services researcher under age 40 in the US.

Aaron also serves as a faculty affiliate for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health.  In the 2014-2015 academic year, he will be a Visiting Associate Professor of Law at Yale Law School, where he will teach Food and Drug Administration Law.

Welcome, Aaron!

Protect Those Who Protect Our Food

Check out a new op-ed by our friends, Jacob E. Gersen and Benjamin I. Sachs at Harvard Law School!

CAMBRIDGE, Mass. — EVERY year, 5.5 million people are sickened by norovirus, a highly contagious gastrointestinal bug. According to the Centers for Disease Control and Prevention, norovirus is the leading cause of food-borne illness in the United States and is spread primarily by “infected food workers.” Last year cooks, waiters and other workers were involved in about 70 percent of the outbreaks.

This is just one example of the critical role that food workers play in our nation’s economic and public health systems. And yet, while we often tailor employment rules for work that has a special impact on the public, the law has yet to recognize food workers as a distinct class — an approach that harms consumers, the economy and the workers themselves.

Sick restaurant workers provide a particularly vivid example of the kind of legal reform that’s needed. Until recently, very few restaurant workers had the legal right to paid sick time, which meant that many of them went to work very ill (last week voters in Massachusetts and three cities passed paid-sick-leave laws). Federal law can fix this problem by requiring employers to provide their workers with paid time off. [...]

To read the full op-ed, please click here.

Health and Wealth

By David Orentlicher
[Cross-posted at Health Law Profs blog]

A number of studies have suggested that education, wealth, and other socioeconomic factors are more important than health care in promoting a person’s health. Earlier this week, NPR reported on a study of welfare payments that reinforces the link between income and health. Researchers studied children whose families received benefits through the Mothers Pension Program between 1911 and 1935. Compared to children in families that did not receive program benefits, the children of recipients lived longer, and their longer lives might reflect the fact that they stayed in school longer and earned higher incomes during their working days.

Is Pregnancy a “Disability” in the Ebola Epidemic?

By Kelsey Berry

Much of the recent Ebola coverage has brought to the forefront principles of disaster triage and served as a reminder of the inescapability of rationing health care resources. A piece in The New Yorker recently highlighted the plight of pregnant women and their apparent exclusion from standard Ebola wards in Sierra Leone. Professor and Ethicist Nir Eyal at Harvard Medical School was quoted discussing the role of disaster triage guidelines in allocating resources for Ebola in the case of pregnant women.

Pregnant women have long been identified as more vulnerable to viral infections than other healthy adults, due perhaps to immune system changes occurring naturally during pregnancy. This may have accounted for the increased mortality rate among pregnant women during the 2009 H1N1 influenza pandemic in the US (17% in pregnant women vs. 0.02% in the general population), and it may impact Ebola survival rates as well. A smaller 1995 Ebola outbreak in Kikwit, Zaire had a case fatality rate among pregnant women of 93%, and anecdotal accounts from the current epidemic in Sierra Leone state a 100% case fatality rate. Recent figures from West Africa put the case fatality rate in the general population at 70%. These statistics, among other concerns for resource utilization, lead to an ethical dilemma: whether and how to allocate scarce resources to pregnant women in the present ebola epidemic in West Africa.

If the mortality rates from Kikwit are accurate, Dr. Eyal notes that it means that, “what’s needed to justify giving regular priority to a pregnant woman is a willingness to allow six other people to perish to save her.” But, he notes, the permissibility of excluding pregnant women is sensitive to these rates; if they are wrong, than so too may be triaging pregnant women last.  Continue reading

Upcoming Fairness Hearing in NFL Concussion Litigation

By Christine Baugh

On November 19, Judge Anita Brody will hold a fairness hearing in the class action lawsuit of National Football League (NFL) Players v. NFL re: concussion injury. This is one of the final steps toward final approval (or rejection) of the settlement in the case. Before final approval Judge Brody must determine that the settlement is fair, reasonable, and adequate for the over 20,000 retired NFL players who are included in the class. A variety of concerns have been brought forth publicly regarding the proposed settlement, which received preliminary approval from Brody earlier this year. Around 140 retired NFL players filed objections to the proposed settlement and around 200 have opted out of the class. This blog post provides a brief overview of the settlement and objections to it.

Settlement terms (summarized):

  • Monetary Awards for those with a qualifying diagnosis. Award amount is determined based on a sliding scale that factors in diagnosis, age, and years played in the NFL.
  • Baseline Assessment Program. Class members who are Retired NFL Players have the option to participate in a baseline assessment and medical monitoring program.
  • Education Fund will be established to promote safety and injury prevention in football.

The long-form settlement document can be viewed here.

Concerns (summarized, non-exhaustive): 

A variety of concerns regarding the preliminarily approved settlement have been brought forth through the media and other channels. These are the types of issues that will likely be discussed at the fairness hearing and that Judge Brody will have to weigh in her determination of whether the settlement is fair, adequate, and reasonable for the class as a whole.

Many concerns regard the categories of diagnosis that are eligible for compensation.

Compensable categories are too restrictive: Under the current settlement agreement, former players can be compensated if they have a qualifying diagnosis of Alzheimer’s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease), death with chronic traumatic encephalopathy (between January 1, 2006 and July 7, 2014), and what are called Level 2 and Level 1.5 Impairment (these categories represent a pattern of performance on a battery of neurocognitive tests that is 2 or 1.7-1.8 standard deviations below normal, respectively). Some have argued that, although the categories included are important to compensate, there are other prevalent problems such as pituitary dysfunctiondepression, and mood and behavioral disorders that are associated with repetitive head trauma and should also be covered by the settlement agreement. Others are concerned that there are characteristics about the existing categories that are problematic (see next two points below).  Continue reading

European Responses to the Ebola Crisis, Part I: Initiatives at the European Medicines Agency (EMA)

By Timo Minssen

The current Ebola outbreak already attracted much attention on “Bill of Health” resulting in some excellent blogs on a horrible topic.

While it is evident that the current health crisis requires both immediate responses and more sustainable changes in health care policy, research and regulation, medicines regulators are collaborating internationally to find innovative solutions enhancing evaluation of and access to potential new medicines to fight Ebola outbreaks. In a statement announced by the International Coalition of Medicines Regulatory Authorities (ICMRA) in September 2014, regulators around the world led by the FDA and the EMA have vowed to collaborate in supporting accelerated evaluation of experimental new drugs to treat Ebola virus infections and say they will encourage submission of regulatory dossiers. This clearly backs up the World Health Organization’s (WHO) decision to test experimental Ebola treatments in infected patients in the current outbreak region in West Africa and to speed up the development of vaccines.

In the following I would like to summarize and discuss some of the recent European responses to the current crisis starting with an overview on recent initiatives at the EMA.

Like its US counterpart, the EMA leads a close and consistent dialogue with public and private developers of Ebola products and spends much effort in reviewing available information on the various experimental Ebola treatments currently under development. These experimental drugs range from experimental antivirals or vaccines based on the adenovirus or stomatitis vaccine to experimental therapies based on mono- and polyclonal antibody technologies. One of these unapproved antibody combination drugs – MAPP Biologicals’  ZMapp – has already been used in some care workers affected by Ebola. Other experimental drugs that are currently reviewed by the EMA include Biocryst’s BCX 4430, Fab’entech’s Hyperimmune horse sera, Sarepta’s AVI-7537, Toyama Chemicals and MediVector’s Favipiravir and Tekmira’s TKM-Ebola.

Other companies such as Bavarian Nordic  and the Russian Mikrogen are close to follow.

In addition to monitoring experimental drugs and enhancing global collaboration, the European Medicines Agency has like the FDA initiated several activities in order to support and speed up the development of these drugs towards market approval.  Continue reading