The Federal Circuit Decides Future Lost Earnings Award Not Authorized in Vaccine Case in Which Child Died
Filed under: Bioethics, Children, Drugs & Medical Devices, Liability
The National Childhood Vaccine Act of 1986 requires parties seeking relief for vaccine-related injuries to proceed through a federal vaccination claims system. If a plaintiff prevails in her suit, she (or her estate) will receive damages for pain, suffering, and expenses. Significantly, other awards include death benefits or future earnings. On October 28, 2013, the Federal Circuit answered in the negative the question of “whether the estate of a petitioner who dies prior to judgment is entitled to compensation for lost future earnings.”
Tembenis v. Secretary of Health & Human Services arose out of the epilepsy four-month-old Elias Tembenis developed following vaccination for Diptheria–Tetanus–acellular–Pertussis. His parents filed a Petition for Vaccine Compensation but while the petition was still pending, Elias died of his disorder at age seven. In 2010, a special master determined the vaccine caused Elias’ epilepsy and death.
After the special master’s determination, Elias’ estate and the Secretary of Health and Human Services agreed on damages. The estate received a $250,000 death benefit, $175,000 for actual pain and suffering and past unreimbursable expenses, and $659,955.61 in future lost earnings. The Secretary reserved the right to challenge the future lost earnings award; the special master determined that Federal Circuit precedent suggested that the estate was entitled to lost earnings. The Secretary appealed to the Claims Court which upheld the special master’s ruling.
The Secretary then appealed to the Federal Circuit. The Circuit court analyzed 42 U.S.C. § 300aa–15(a)(3)(B):
In the case of any person who has sustained a vaccine-related injury before attaining the age of 18 and whose earning capacity is or has been impaired by reason of such person’s vaccine-related injury for which compensation is to be awarded and whose vaccine-related injury is of sufficient severity to permit reasonable anticipation that such person is likely to suffer impaired earning capacity at age 18 and beyond, compensation after attaining the age of 18 for loss of earnings determined on the basis of the average gross weekly earnings of workers in the private, non-farm sector, . . .
The Federal Circuit interpreted the language to determine the statute only allows for recovery of future lost earnings. The Court acknowledged the statute does not expressly require a claimant to be alive, but it also does not expressly state an estate can recover future lost earnings of a decedent.
The Court observed that the word “impaired” implies the victim must be living. When the claimant dies before 18, no reasonable expectation exists that she would be working after 18. Thus entitlement to a future lost earnings award is dependent upon the claimant being alive. Further, the Court stated, receiving both a death benefit and a future lost earnings award would be duplicative. The Court took pains to express sympathy to the family, noting that the death benefit of $250,000 was due to be increased as it had not been amended since the statute’s enactment in 1986. However, the amount of payment can only be changed by Congress and even if it does happen, it will be of no consolation or compensation to the Tembenis family.
Filed under: Children, Proposed Legislation, Public Health, State Initiatives
I was stunned to learn recently that female lacrosse players, at least in my town in New Jersey, may not wear hard helmets even though male lacrosse players must wear them. This struck me as ludicrous and unfair. Both sports involve athletes running around with long sticks, hurling dense rubber balls at high speeds. It seemed to me that balls and sticks can strike players in the head and players can collide in either sport. How could we care more about preventing traumatic brain injury (TBI) in boys than in girls? I was outraged. But as it turned out, I also was a bit uninformed. It is not as clear as I thought it would be that we should require girls to wear helmets.
A common objection is that female and male lacrosse are very different sports subject to different rules and requiring different skills. Male lacrosse involves much more brute physical contact, whereas female lacrosse does not permit body checking and demands finesse. As a female senior lacrosse player explains, because girls’ lacrosse sticks have shallower pockets, girls “’have to be more skilled with our cradling, . . . [so our] game is more graceful.’” A male senior midfielder acknowledged that the girls’ “’stick skills are unbelievable’” and that “’the girls’ version is more pure.’” Some believe there is less need for helmets in girls’ lacrosse because of these differences. Moreover, there is concern that requiring girls to wear helmets will encourage girls to play more like boys, which would risk losing the valuable uniqueness of girls’ lacrosse.
As much as I want to honor female players’ pride in their skills and finesse, science should drive the policy decision whether to require girls to wear helmets. Research by Nationwide Children’s Hospital in Columbus, Ohio reveals that girls’ lacrosse has the third-highest rate of concussion among female sports, after soccer and basketball, and “its in-game rate is only about 15 percent less than the rougher male version.” But what do we know about whether helmets can reduce that risk? Not enough. Read more
Filed under: Bioethics, Children, Disparities, Drugs & Medical Devices
Last week, Bloomberg News ran an interesting article by Trista Kelley about the hurdles that the pharmaceutical company Shire has faced rolling out its blockbuster ADHD drug Vyvanse in Europe. The drug was authorized for sale in a number of European countries simultaneously in December 2012, but, as Shire explained in a press release, the company still faced country-by-country negotiations with national pricing and reimbursement authorities. Shire received bad news in early September, when Germany’s Institute for Quality and Efficiency in Health Care announced that the company had failed to show that Vyvanse was better than existing treatments.
As Kelley reports, there is more going on here than just the press of austerity. ADHD is diagnosed much less frequently in Europe than in the United States and, “[w]hile attitudes vary by country, many European parents, teachers and doctors are resistant to using medication to treat what they see as childhood behavior problems.” So Shire has, in the words of its CEO, embarked on a “significant educational effort.”
Presumably as part of this effort, in November 2012 the company hosted a “European Expert Roundtable” on the impact of ADHD on individuals, families and society. In April of 2013, the company released a follow-up “Expert White Paper” that was “initiated, facilitated and funded” by Shire and written by academics from Ireland, the Netherlands, and the United Kingdom, with “medical writing support” provided by two Shire-funded medical communications companies. Perhaps unsurprisingly, the authors of the white paper concluded that the impact of ADHD is substantial and, among other things, they recommended improving access to early diagnosis and treatment. Depending on your priors, Shire’s educational effort could be understood as an important contribution to a broader movement to overcome the ignorance and stigma that stand between children in need and available, effective behavioral health treatments. Or, it could be seen as dangerous disease mongering.
Interestingly, while the United States is more receptive both to the ADHD diagnosis and to treating the condition with medication than is Europe, we are not consistently so. A recently-published study by Douglas McDonald and Sarah Kuck Jalbert found that in 2008 the rate of children being treated with stimulant medication ranged from .4%, in Alaska, to 5.1%, in Delaware, a 14-fold difference. By comparison, nationwide estimates of the prevalence of ADHD range from 5-10% of children. There was even more inconsistency from county to county, with coefficients of variation that, the authors note, were much higher “than reported for most other types of medical practice.”
The question arises, how should we interpret the disparities in diagnosis and treatment, whether between Europe and the United States, or between Alaska and Delaware? Very carefully seems to be the answer. On the one hand, McDonald and Jalbert’s “findings signal wide disparities between established clinical practice guidelines and actual practice.” On the other hand, the authors “caution against drawing the inference that higher treatment rates indicate more accurate identification of ADHD.” It is possible, they write, “that areas characterized by high treatment prevalence are also characterized by high rates of misdiagnosing and overprescribing.” McDonald and Jalbert point a tentative finger at pharmaceutical marketing, both to physicians and directly to consumers, suggesting that it may partially explain the disparities in medication uptake they found.
Characterized as it is by failure to diagnose, inappropriate diagnosis, failure to treat, and inappropriate treatment, ADHD presents a complicated case, even for those who believe that medication is an important treatment option that should be available to children on an equal basis. The involvement of companies like Shire in the conversation about how to respond to the disparities that exist—even when that involvement is clearly disclosed, as it was in the case of the Expert White Paper—has the potential to complicate things further. It could even backfire. A recent study conducted Aaron Kesselheim and colleagues of physicians’ responses to disclosures of pharmaceutical company support found that physicians accorded less “credibility and import” to even the most rigorous industry-funded clinical research.
Filed under: Children, Research, Women's Health Issues
In an article out in the American Journal of Obstetrics and Gynecology, the Global Alliance to Prevent Prematurity and Stillbirth (GAPPS)—a Gates Foundation-funded initiative of Seattle Children’s Hospital and the University of Washington School of Medicine’s Departments of Global Health and of Obstetrics and Gynecology—reports on its efforts to develop “a research agenda related to pregnancy, childbirth, and early life[.]” In addition to interviewing scientific thought leaders and convening a “technical team of 13 prominent researchers from multiple disciplines in the developed and developing world,” the GAPPS spoke to “18 representatives of funding organizations—including government agencies, global foundations, and other financial partners—to gain a deeper understanding of the current perspectives, attitudes, and commitments of funders toward research on pregnancy, childbirth, and early life.”
The GAPPS’ conversations with funders surfaced a number of challenges to increasing funding, including 1) “a range of understanding of the issues[,]” 2) “varying degrees of interest in the topic[,]” and 3) concern about “the challenges of progress with such a long-term and complex problem.” The authors, to their credit, do not deny that the question (questions, really) of what causes prematurity, stillbirth, and other pregnancy and early life problems are among the “most difficult … in biomedical research today.” The authors note that “[d]ifferent biological pathways are involved in the adverse outcomes of pregnancy, and these can be characterized at different biological levels from the genome to the exposome (the combined effects of environmental influences).”
At the level of the exposome, recently-published research by investigators from New Jersey’s own UMDNJ-Robert Wood Johnson Medical School, brings us incrementally closer to understanding the effects of ambient air pollution on stillbirth, while exemplifying the complexity of the science involved. Ambarina Faiz and colleagues compiled data contained in “New Jersey electronic birth certificate records for live births and fetal death certificates for stillbirths linked to their corresponding hospital delivery discharge records from 1998 to 2004[,]” along with data on air pollutants from 25 New Jersey Department of Environmental Protection monitoring stations. Their analysis of the data revealed that “[i]ncreased concentrations of ambient air pollutants during pregnancy were associated with increased relative odds of stillbirth after adjustment for known risk factors for stillbirth, mean temperature, and a neighborhood level measure of socioeconomic status.” Numerous questions remain, though. The authors call for “molecular studies with specific biomarkers … to define more clearly the roles of specific pollutants and to investigate possible biologic mechanisms that lead to stillbirth.”
Drawing on what it learned from funders, as well as from scientific thought leaders and from the technical team it convened, the GAPPS developed eight recommendations aimed at encouraging such research, with the ultimate goal of “making every pregnancy a healthy pregnancy[.]” The GAPPS calls for 1) determining and publicizing the true cost of prematurity, stillbirth, and other pregnancy and early life problems, 2) establishing alliances among funders, researchers, and other stakeholders, 3) agreeing on research priorities, and 4) promoting research opportunities, particularly opportunities for “new investigators from multiple disciplines.” While these are clearly daunting tasks, the authors report that “[s]everal interviewees observed that the Bill and Melinda Gates Foundation has an unparalleled ability to persuade, convene, and organize important players, both nationally and internationally. In particular, they pointed to the potential for the foundation to move the concept of coordinated funding forward.” The prospect of a new clarity about research priorities, combined with a coordinated approach to funding, is a hopeful one for all of us since “healthy outcomes in pregnancy benefit everyone, directly and indirectly.”
*I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue. (My prior posts are here, here, and here). Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.
Filed under: Children, Public Health, Women's Health Issues
As a teenager in the late 1980s, I was a huge fan of the model Christy Turlington Burns. As I’ve blogged about before, in 2011 there’s much more to admire about her than her enduring beauty. Over the weekend, Turlington Burns and others representing her advocacy organization, Every Mother Counts, ran the ING New York City Marathon to, in her words, “make the vital connection for people that so many pregnant women live far from health services around the world and that distance does make a difference [in the prevention of maternal mortality]. Simply put, we want to run so that others don’t have to…”
Just as distance makes a difference in the prevention of maternal mortality, it also makes a difference in the prevention of stillbirth. In the introduction to a special series of articles that ran in The Lancet in April of this year, Zoe Mullan and Richard Horton note that 98% of the estimated 2.64 million stillbirths each year, “occur in low-income and middle-income countries, and in places such as south Asia and sub-Saharan Africa, at least half of them take place during labour or birth.” In addition to reducing maternal and newborn mortality rates, then, closing the literal and figurative distance between pregnant women and childbirth care would prevent many stillbirths from occurring.
In a pair of important articles – Stillbirths: What Difference Can We Make and At What Cost? and Stillbirths: How Can Health Systems Deliver for Mothers and Babies — The Lancet’s Stillbirths Series Steering Committee delves into the prevention question in detail. The Steering Committee systematically assessed 35 potential interventions to determine (1) whether they were effective at reducing the stillbirth rate and (2) “whether they are affordable and implementable in low-income and middle-income countries.” The following ten interventions passed the Committee’s test and were strongly recommended for implementation: “periconceptional folic acid fortification, insecticide-treated bednets or intermittent preventive treatment for malaria prevention, syphilis detection and treatment, detection and management of hypertensive disease of pregnancy, detection and management of diabetes of pregnancy, detection and management of fetal growth restriction, routine induction to prevent post-term pregnancies, skilled care at birth, basic emergency obstetric care, and comprehensive emergency obstetric care.” Of these, the Committee recommended that skilled care at birth and emergency obstetric care take priority, both because they were the most effective at reducing the number of stillbirths and because they additionally benefit women and newborn babies.
The Stillbirths Series Committee estimated that “[i]n 68 countries accounting for 92% of the worldwide burden of stillbirths in 2008, universal coverage of care (99%) with intervention packages in 2015 could save up to 1.1 million (45%) third-trimester stillbirths, 201,000 (54%) maternal deaths, and 1.4 million (43%) neonatal deaths at an additional cost of US $2.32 per person, which is well below the WHO and World Bank criteria for cost-effectiveness.” While it seems only fair to consider this “triple return for every dollar invested” in determining funding priorities, the tragedy of stillbirth does not always “count.”
The World Health Organization’s Global Burden of Disease analysis, for example, which aims to “provide a comprehensive and comparable assessment of mortality and loss of health due to diseases, injuries and risk factors for all regions of the world[,]” does not factor in stillbirths. The WHO explains on its website that “[p]erinatal mortality, defined as number of stillbirths and deaths in the first week of life per 1,000 live births, is a useful additional indicator, and work is ongoing to improve estimates of stillbirth rates, a major component of perinatal mortality.” The United Nations’ Millennium Development Goals similarly fail to include reducing the rate of stillbirths. This should change. In the words of Mullan and Horton in The Lancet, “stillbirths matter to people” and “stillbirth prevention should be placed as highly on global and national health agendas as prevention of maternal and neonatal deaths.”
 I thank Catherine Finizio, the Administrator of Seton Hall Law’s Center for Health & Pharmaceutical Law & Policy, for keeping me focused on this important issue. (My prior posts are here and here.) Cathy’s grandson, Colin Joseph Mahoney, was stillborn at 39 weeks gestation on November 10, 2008.