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: Bioethics, Drugs & Medical Devices, Global Health Care
At last week’s 44th Union World Conference on Lung Health in Paris, one of the main topics of discussion was the World Health Organization’s recently released 2013 Global Tuberculosis Report. On the bright side, the report confirms a steady decline in the prevalence, incidence, and mortality of TB. The world is on track to meet the 2015 target of a 50% reduction in the TB mortality rate by 2015, as compared to 1990.
Yet, despite this good news, many aspects of the report remain disturbing. Of particular concern is the limited progress achieved in diagnosing and treating multi-drug resistant (MDR) TB. WHO estimates that, worldwide, 3.6 percent of newly diagnosed TB cases and 20 percent of previously diagnosed TB cases involved drug-resistant strains. But these averages hide considerable regional variation. In some countries, MDR-TB is estimated to be present in more than 20% of new TB cases and more than half of previously diagnosed cases.
These numbers, however, are just estimates. A pervasive concern is that national detection systems fail to identify about 1 in 3 people who develop TB. The percentage of missed cases is even greater among persons with MDR-TB: WHO estimates that less than a quarter of those with MDR-TB have ever been diagnosed.
WHO has called on the international community to scale up efforts at TB detection, as the first step in a comprehensive process of global TB care. Ideally, detection will be accompanied by access to appropriate treatment, both for the benefit of the individuals who are detected and to reduce the further development of drug-resistant strains. But, unfortunately, this is not always the way things work. In 2012, of the 94,000 TB patients detected with MDR-TB, only 77,000 were started on second-line treatments. In some countries, the treatment gap was even greater; in the African region, only half of those detected with MDR-TB were provided with second-line treatment. According to WHO, ensuring that a diagnosis of MDR-TB is routinely accompanied by access to high-quality treatment “will require high-level political will and leadership and more collaboration among partners, including drug regulatory authorities, donor and technical agencies, civil society and the pharmaceutical industry.”
In the meantime, what are the ethics of diagnosing individuals with MDR-TB if treatment will not be forthcoming? From the perspective of the individual being tested, the diagnosis comes with a host of potential harms, including stigmatization, discrimination, and even detention. If access to treatment – or even humanely administered isolation – cannot be assured, individuals who are given the choice to be tested might reasonably refuse.
At a minimum, persons who are offered MDR-TB testing should be informed of the potential consequences, both positive and negative, as they should be for any other non-trivial medical procedure. If an individual refuses to undergo testing, the burden should be on those seeking to administer the tests to show that overriding the objection is necessary for legitimate public health objectives. In settings where persons who test positive for MDR-TB are not given access to treatment, such a showing could very well be impossible to make.
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: Bioethics, Mental Illness, Neuroscience, Research
In April 2013, President Obama officially announced the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative, with approximately $110 million in funds slated for fiscal year 2014. Identified as an Administration “Grand Challenge,” the long-term aspirations are to:
“accelerate the development and application of innovative new technologies to construct a dynamic picture of brain function that integrates neuronal and circuit activity over time and space. The goal is to build on the growing scientific foundation of neuroscience, genetics, physics, engineering, informatics, nanoscience, chemistry, mathematics and other advances of the past few decades, to catalyze an interdisciplinary effort of unprecedented scope.”
Descriptions of the Initiative emphasize the convergence of numerous technologies as playing a part in the trajectory of the research agenda. The White House Fact Sheet states that “great promise for developing such technologies [to treat neurological and psychiatric disease] lies at the intersection of nanoscience, imaging, engineering, informatics, and other rapidly emerging fields of science.” But to facilitate this, NIH acknowledges “researchers will first need a more complete arsenal of tools and information for understanding how the brain functions both in health and disease.”
The key investments to launch this initiative are to be directed through three core federal agencies: the National Institutes of Health (NIH), with a $40 million allocation for fiscal year 2014; the Defense Advanced Research Projects Agency, with a $50 million allocation; and the National Science Foundation, with a $20 million allocation. Private sector partners are the Allen Institute for Brain Science, the Howard Hughes Medical Institute, the Kavli Foundation, and the Salk Institute for Biological Studies. The White House website lists several components of the initiative, including key investments, strong academic leadership, public-private partnerships, and maintaining the highest ethical standards.
Planning is in early stages, with a BRAIN Working Group of the Advisory Committee to the Director (ACD) of the NIH formed to provide input into the development process. The BRAIN Working Group is charged with reviewing advances in neuroscience, identifying short, mid, and long-term science goals of the Initiative, and developing a scientific plan for achievement of those goals. The ACD has hosted four public hearings in San Francisco, New York, Minneapolis, and Boston to gather perspectives from the scientific community. Last week, the Working Group published an interim report with a list of nine high-priority areas for funding for FY 2014 with an “overarching vision … to combine these approaches into a single, integrated science of cells, circuits, brain and behavior”:
- Generate a census of cell types
- Create structural maps of the brain
- Develop new large-scale network recording capabilities
- Develop a suite of tools for circuit manipulation
- Link neural activity to behavior
- Integrate theory, modeling, statistics, and computation with experimentation
- Delineate mechanisms underlying human imaging technologies
- Create mechanisms to enable collection of human data
- Disseminate knowledge and training
A final report by the BRAIN Working Group is expected in June 2014.
Parallels are already being drawn to the $3.8 billion, 10-year Human Genome Project (HGP) begun in the 1990s, culminating in the publication of the complete sequence of the human genome in 2003. President Obama himself noted in his February 2013 State of the Union address that “every dollar we invested to map the human genome returned $140 to our economy.” While the HGP had many successes, it also fueled many subsequent controversies, many of which took years to play out and some that remain hotly debated today. Two high-profile examples include patent protections for inventions resulting from the HGP (see the Supreme Court’s June 2013 decision in Association for Molecular Pathology v. Myriad Genetics) and adequate privacy and genetic discrimination protections (see the Genetic Information Nondiscrimination Act).
Recognizing the broader ramifications of such a massive federal undertaking, the President has reached out to another expert task force for input. Alongside the BRAIN Working Group, the President has also directed the Presidential Commission for the Study of Bioethical Issues to “explore the ethical, legal, and societal implications raised by this research initiative and other recent advances in neuroscience.” Specifically, the Commission is to “identify proactively a set of core ethical standards – both to guide neuroscience research and to address some of the ethical dilemmas that may be raised by the application of neuroscience research findings.” An August 20, 2013 public meeting of the Commission highlighted several core ethical concerns going forward, including privacy; data protection and management; animal and human subjects research protections; potential use for enhancement purposes; stigma and discrimination; and national security. Extensive blog coverage of the public event is available here, here, and here.
Given the nascent state of the BRAIN Initiative, the overall long-term allotment of funding for research into the ethical, legal and societal implications is unclear. For the HGP, this was between 3-5% of the total budget over the life of the project. Similar research support should be built in to the Brain Initiative as well in an effort to anticipate, and guide, the ethical, legal, and societal aspects that accompany such an endeavor.
The Australian government has announced a new scheme that will compensate living organ donors with cash payments during their recovery period. This is said to be intended not as a payment for the organ, but as a way to minimize the financial burden of donation. The plan should be seen as a step in the right direction for those who favor legalizing payment for organ donation in the United States, and Congress should seriously consider authorizing a similar pilot program.
Australia’s new program has several features, designed to mitigate fears and concerns about paying organ donors. First, the plan reduces the fear that individuals will look to donate their organs out of desperation and economic necessity. This is accomplished by limiting the payments to the currently employed, including self-employed and part-time workers. Additionally the compensation is not extravagant, topping out at $606 a week for up to six weeks. This limited compensation is unlikely to attract financially distressed donors who would otherwise choose not to donate, though it may make it easier for those who are not well-off to commit to a process that will entail significant time off from work. That being the case, most donors would find themselves afterwards in relatively the same financial situation as before they donated.
Second, the money comes from the Australian government, rather than from the recipients themselves. This reduces the appearance of a cash-for-organs system that might be unpopular and ethically problematic. A third party payment system for bone marrow is already developing in the US. The group moremarrowdonors.org has led the effort for such after the 2012 decision of Flynn v. Holder held that payment for donating bone marrow by apheresis is allowed under the current law. If third parties, be they charitable organizations or the US government, make payments to donors a gap is created between the donor and the recipient. This gap will, presumably, allow donors to still feel that they have actually donated and not sold their organ. And, if the altruistic component of donation can be preserved while reducing the financial burden to the donor then it is unlikely that this new scheme will drive away potential donors who do not like the idea of selling their organs.
If this scheme were adopted by the United States it has the potential to drastically increase the supply of kidneys, especially in minority communities. There is currently a huge gap between the supply and demand for kidneys. For racial minorities this gap is even wider. Modest payment for missed work time, coupled with an awareness campaign, would allow low-income individuals to donate their organs without placing themselves in financial jeopardy from missed work. If the amount of money paid to the donor was kept modest, like the Australian scheme, claims of exploitation would be less persuasive.
The US government should closely monitor the Australian pilot program to see if it is effective. If so, it should be rapidly adopted by the US. If not, then consideration should be given to other means of increasing organ donation, including larger cash payments to donors. A US program similar to the new Australian scheme would go a long way to closing the gap between the need for kidneys and the supply of living donors.