Background of Cerebral Palsy

Cerebral palsy is a neurological condition characterized by abnormal movements, muscle tone, or posture.  It is caused by a brain injury or abnormal brain development, most typically during pregnancy, but some cases arise in infancy or very early childhood.  The underlying injury is permanent but doesn’t worsen over time (non-progressive), so the person’s symptoms are relatively the same throughout their life.  Common symptoms include: poor muscle coordination during voluntary movements, such as reaching for things; abnormally stiff or floppy muscle tone; spasticity, which means exaggerated reflexes or too tight muscles; and an abnormal gait, such as dragging one foot, walking on toes, or a “scissored” gait.  Many people with cerebral palsy also suffer from other conditions related to developmental brain abnormalities, such as excessive drooling, difficulty eating and swallowing, seizures, and intellectual disabilities.

There are a variety of treatments for cerebral palsy, but there is no cure. Most treatments are “disability management.” The available treatments typically aim to minimize the symptoms of cerebral palsy and improve the person’s functional abilities. This includes medication, physical and occupational therapy, surgery, and speech therapy.  Assistive devices such as wheelchairs, walkers, and computers with attached voice synthesizers play a critical role in treatment of cerebral palsy.

Robotic Limbs and the Americans with Disabilities Act

Hugh Herr—the same roboticist mentioned above—suggested at a recent conference organized by the Economist that we may soon see people opting to amputate limbs in order to replace them with higher functioning robotic ones. People with cerebral palsy are one population that may be interested in taking such a drastic step.  Some people with cerebral palsy experience symptoms throughout their entire body, while others’ muscular coordination disabilities affect only one side of their body or are isolated in one limb. Those individuals with isolated symptoms could replace the affected limb.  If Mr. Herr’s prediction is taken to the extreme, individuals who experience spastic movements throughout their entire body may be able to replace all of the affected nerves and enjoy smooth coordinated movements.

If people with cerebral palsy opt to replace limbs or more, will their disability be eliminated in the eyes of the law? The answer turns on how disability is defined.  As the law stands now, to qualify for protection under the Americans with Disabilities Act (ADA), a person must meet the statute’s definition of an individual with a disability: “a person who has a physical or mental impairment that substantially limits one or more major life activities, … a history … of such an impairment, or a person who is perceived … as having such an impairment.” The ADA is a civil rights law that aims to protect people with disabilities from discrimination and to ensure that they have access to public services and benefits. Individuals’ status as “disabled” under the ADA is determined on a case-by-case basis.  Being labeled “disabled” comes with complex social and legal consequences and benefits. Accordingly, it is not clear whether those people whose disabilities have been ‘eliminated’ would want to continue to be considered disabled. Further, whether people should be permitted to retain their “disabled” status under the ADA after a functional “elimination” of their disability is a legal, political, and ethical conundrum. Two elements of the ADA’s definition appear to preserve those individuals’ option to retain their “disabled” label under the ADA—the “history” and “percieved … as having” criteria.  Accordingly, the ADA’s current definition decreases the likelihood that Mr. Herr’s prediction is correct. .

The “history” portion of this broad definition seemingly permits a person who has adopted a robotic limb to continue to be considered disabled. Thus, as long as the definition includes “history,” Mr. Herr’s prediction that disabilities will be largely eliminated cannot come true under the ADA.  This suggests that it may be time to rework the ADA’s definition, a difficult task. At what point would it be proper to consider a person no longer disabled, despite their history? One lawyer-bioethicist argues that existing mobility assistive devices, such as wheelchairs, should already be treated as part of the owner’s body under the law in the event that a third party harms it.  But should that argument work in reverse? Once a device that permits its user to function at the same level as people who don’t have histories of disability can be fairly considered part of the body, should that user no longer be considered disabled? How integrated into the body would that device need to be? As assistive technologies become more lifelike and commonplace, it seems that the definition should be changed to make way for a future in which disabilities can be considered largely eliminated.

The “perceived… as having” portion of the definition poses an additional barrier to actualizing Mr. Herr’s prediction. For example, if a person suffers from multiple symptoms or disabilities (like most people with cerebral palsy) how many of their symptoms would need to be ‘cured’ by robotics for that person to no longer be considered disabled? What would happen if a person with cerebral palsy no longer had spastic muscle movements in their arms thanks to robotics, but continued to suffer from the characteristic tongue thrusting or facial symptoms such that others could identify them as someone who suffers from cerebral palsy.  However, given the powerful effect of stigma, whether it would be appropriate to remove that portion of the definition is loaded issue that regulators must approach extremely cautiously.

The definition of “Disability” and Legal Autonomy

A person who is considered disabled from a legal autonomy perspective is someone who lacks legal capacity to perform certain acts.  For example, a person with a communication disability or an intellectual disability as a result of cerebral palsy may not be able to perform the legal acts of communicating consent or making decisions about finances.  Such persons are often appointed guardians or other advocates who assume responsibility for their legal decision-making.  However, as assistive communication devices are improved and become more popular, fewer people with cerebral palsy will require legal proxies or those proxies will play a smaller role.  Helpfully, the Model Rules for Professional Conduct have already established a good precedent for accommodating those changes. The rule for assisting clients with diminished mental capacity requires that a lawyer try to involve the client as much as possible, and to frequently reassess the client’s capacity to make independent decisions.

So, Mr. Herr may be right with respect to disability in the legal autonomy context. For people with cerebral palsy who are disabled because of physical communication impairments, advancements in and increased popularity of devices like the ECO2, a form of “augmentative and alternative communication” (AAC) that creates verbal speech from the user’s head movements, may very well eliminate their disability. Brain-computer interfaces are an even more advanced form of the same idea. Further, people with cerebral palsy who have less legal autonomy because of an intellectual disability (approximately 40% of people with cerebral palsy suffer intellectual disabilities) may enjoy greater independence thanks to technology that promotes early child language development.

Conclusions

New developments in assistive technology will transform the lives of hundreds thousands of people with cerebral palsy. These inventions are changing the way people with disabilities live, as well as how our society thinks about disabilities.  The European Commission (EC) has recognized the need for European law to adapt.  To that end, the EC is funding RoboLaw, a large-scale research project to investigate the interplay between European law and emerging robotic technologies. This was a brief and narrow assessment, but it revealed that whether technology can successfully eliminate disabilities depends in part on the definition of disability in U.S. legal system.  The U.S. should follow Europe’s lead and begin investigating the best way to restructure its laws as well.

There has been significant media attention[1] in recent years to food safety concerns stemming from the conditions at the large farms known as concentrated animal feeding operations (CAFOs), which have supplied the majority of the country’s livestock for consumption since the 1970s. News of outbreaks detrimental to human health such as salmonella and mad cow disease have caused American consumers to start asking more questions about where their food comes from and what regulations are imposed to protect us. The agriculture industry has responded, not with policy changes or greater transparency, but with marketing schemes fronting a concerted effort to shield the operations from public scrutiny. Awareness of health concerns and demand for organic products has made health labels a profitable choice for producers regardless of their actual practices. Eggs provide a good example of the marketing efforts that perpetuate misconceptions about such practices, about whether USDA standards have been imposed, and about the extent of those standards.

Claims stamped on egg cartons are regulated to varying degrees by USDA. The basic egg grades are strictly regulated by USDA, but have little to do with the nutritional or health qualities of the eggs. Almost all eggs sold in grocery stores are labeled “Grade A,” which is actually a signifier for the thickness of the shell and viscosity of the egg whites- Grade B eggs are more commonly used in processed foods.[2] The USDA National Organic Program (NOP) sets standards that farms and handling operations must meet to gain certification and use the USDA Organic seal. These standards are centered on the absence of certain disallowed production methods such as genetic engineering, and use of synthetic chemicals, antibiotics and hormones.  Eggs bearing the USDA seal are audited for compliance once per year by a third-party certifying agent (7 C.F.R. § 205.403). Though NOP regulations prescribe seemingly high standards for livestock living conditions intended to prevent the spread of disease (7 C.F.R. § 205), in practice, the Code leaves large loopholes through which facilities are able to meet the standard for certification without significantly improving conditions under which animals are raised. For example, livestock are required to have “year-round access . . . to the outdoors” (7 C.F.R. § 205.239), but the density of animals indoors, the meaning of “access,” the amount of “access” provided per day, and the quality of the “outdoors” into which the animals are released are all left undefined. As such, there are operations that meet the USDA organic standard that house large numbers of birds in warehouses such that there is little room for movement or ability to actually utilize points of outdoor access, and the outdoor space itself is just a concrete slab.

The labels “free-range” and “cage-free” similarly do not signify actual outdoor access. As opposed to living in battery cages with space the size of a sheet of paper, hens that are raised cage-free have more room for movement and nesting, but still live in large flocks that do not ever see the outdoors. Caging standards, as well as other industry guidelines, are set by the leading trade organization, United Egg Producers, which promotes only self-imposed regulation “based on science,” a reference to the group’s opposition to the use of animal welfare as a justification for standard-setting, and rejection of the branch of science that links inhumane conditions to human health concerns. While “free-range” is a USDA-defined term, neither “free-range” nor “cage-free” claims are subject to third-party audits.

The minimal standards for organic operations and lack of oversight for non-organic operations serve as the backdrop for the intensifying public scrutiny of CAFOs. The farm lobby has responded to animal welfare groups’ attempts to publicize CAFO practices with so-called “ag-gag” legislation, which suppress whistleblower attempts by making it a misdemeanor to enter the premises of or apply for a job at an animal facility with the intention of using a recording device.[3] These laws have been proposed in ten states, and have already passed in Iowa, Missouri, Montana, North Dakota, and most recently Utah.

Though animal welfare groups are leading the battle for public awareness and now making the constitutional challenges to recently passed legislation, they are bolstered by support within the science, public health, and environmental communities. Studies of the increasing prevalence of antibiotic resistance in food borne pathogens like salmonella link the health of livestock to human health. Likewise, environmental studies have shown contamination of drinking water by pathogens carried via animal waste that has leaked into surface water from CAFOs, which generate 575 billion pounds of animal manure annually. As the scientific evidence and environmental impacts of current agricultural practices continue to mount, the jury is still out on where the good eggs are in our agriculture industry, and whether USDA will tighten the yoke on farming practices.

One of the debates in tort reform is whether there should be agency preemption of lawsuits. Proponents argue that government agencies are charged with studying the products, and promulgating rules, regulations and requirements. Therefore, where manufacturers meet those standards, there should be no space for liability to consumers for product failure.  Additional arguments suggest that the money saved from court administration should instead facilitate improving agency research and function. However, dangerous product failures, such as the all-metal hip implant, highlight many counter-arguments. One such counter-argument is that agencies simply are not equipped to handle the knowledge, research, and development required to provide comprehensive standards and monitoring for the variety of products on the market. For example, the F.D.A. oversees food, prescription drugs, medical devices, tobacco, cosmetics, and veterinary medicine. Another argument claims that lawsuits provide valuable knowledge to manufacturers and agencies, through the relevant discovery, facts, and evidence involved in a case. Furthermore, a lawsuit provides a means for recovery to injured consumers. Additional considerations must also include the consequences of lawsuits on the access, price, and availability, of products, as well as the line drawn as to whether a product is risky enough to enough people to warrant these consequences. Certainly, there are advantages and disadvantages to both sides of the preemption argument. Ultimately, at present, tort law has not embraced agency preemption.

Medical devices add another wrinkle to the process. Surgeons and other medical professionals are involved in offering, recommending and installing all-metal hip replacements. The implications on medical malpractice and the learned intermediary doctrine¹, implicate surgeons’ judgment when it comes to products that are available and have passed standards, yet are the subject of complaints. Some surgeons have stopped using all-metal hips altogether, as there are other models available that combine plastic with metal. However, some all-metal models have not been the source of complaints. Ultimately, these questions come down to whose cost-benefit analysis consumers will rely on, and who we will hold accountable if these decisions prove to be unsatisfying.

1The learned intermediary doctrine provides that a manufacturer can be shielded from liability for failure to warn where the manufacturer adequately warned a learned intermediary, such as a prescribing physician, who is responsible for warning the patient.