Author: Lisa Sendrow

Medical Devices Help and Harm Millions: The FDA Needs a Better Regulatory Process

As of the publication of this
article, 2019 has already seen recalls of twelve
medical devices. Most recently, Two Medical Technologies, Inc. recalled
automatic transport ventilators due to a
potential risk of fire
. But these are likely not all of the devices
that should be recalled. The Food and Drug Administration (FDA) hid
about harm caused by medical devices. In its article
discussing these reports, Kaiser, a healthcare delivery system, profiled a
surgeon who was using a surgical stapler to seal tissue around someone’s
appendix, but the stapler locked up. Over two-thirds of surgeons he talked to
about this issue experienced a similar malfunction. The FDA apparently had
granted the makers of these staplers a special exemption “allowing them to file
reports of malfunctions in a database hidden
from doctors and from public view
.” This database, MAUDE, includes
serious injury and malfunction reports for about 100 medical devices. More than
one million reports of malfunctions or harm spanning about fifteen years remain
in the database. The FDA has been notified of 5.4
adverse events between 2008 and 2018. While some
malfunctions are openly reported, thousands more are hidden.

The FDA’s Center for Devices and
Radiological Health is tasked with regulating
medical devices. There are three risk categories that essentially determine the
level of scrutiny they receive during the regulation process. Class I devices
are not at all highly regulated, and do not
actually have to do what they claim to do as long as they are adequately
packaged and properly labeled. Class II devices—which are considered medium
risk and could hurt patients if misused—also do not receive a high level of
oversight, especially if it is a device that is substantially
to a device already allowed on the market. Class III
devices must go through a premarket authorization scientific review process
before approval. However, there are several loopholes
in the regulatory process. First, medical devices often are not tested in
humans before they are released on the market. Second, there is not systemic
way for the government, researchers, or patients to spot problems in the
process. Third, there are not many protections for patients who are harmed by
medical devices.

Class III devices are still not
being regulated enough. The FDA needs to re-evaluate its regulation process,
particularly for Class II and Class III devices. It does not seem that the
“substantially equivalent” test and the premarket authorization process are
working. These sorts of loopholes are creating problems in the medical field.
For instance, if the FDA was actually regulating medical devices, 80,000
due to malfunctions could have been prevented. People would
potentially not be permanently paralyzed, burned, and otherwise permanently
damaged otherwise. Even when devices cause problems, they are rarely
from the market.

The FDA may
always know the extent of risk before the medical device reaches
the market. But there are ways to mitigate these problems before recalling the
devices. One surgeon has called for mandatory
of all implantable devices. The FDA has also called for
and, for at least one type of medical device, has required
companies to submit a report on devices already
on the market
. The FDA recently said that it will start actively
watching how devices perform once on the market, rather than relying only on
patients to report problems. Hopefully in the coming years, the FDA will no
longer see huge medical device recalls.

An Attorney’s Duty to Concussed Athletes

In November 2018, the National Hockey League (NHL) joined the National Football League (NFL) to attempt to resolve their concussion litigation. The NHL agreed to a settlement with approximately 300 former hockey players, who had unsuccessfully attempted to certify their lawsuit as a class action. NHL Players alleged negligence for how the NHL dealt with head injuries, and claimed that the league concealed the long-term risks of head injuries and concussions. In the NFL, reports have shown an increasing number of retired NFL players who have suffered concussions and developed memory and cognitive issues, including chronic traumatic encephalopathy (CTE). To date, researchers have diagnosed CTE in 110 of 111 former NFL players. At the college level, there is a growing list of legal claims against the National Collegiate Athletic Association for failing to protect athletes from the risks associated with head injuries. For sports law and health law attorneys, concussion litigation is an important issue, particularly as it relates to CTE and second-impact syndrome (SIS).   

Contact sport athletes and military veterans, populations that have a history of repetitive hits to the head have the highest risk of CTE. CTE can only be identified during a postmortem autopsy, but symptoms can be present years before death. SIS occurs when an individual receives a second head injury before recovering from the first, and often leads to permanent disability or sometimes death. Attorneys can play a large role in preventing or helping athletes decrease their risk of concussions. There are several significant federal lawsuits, including at American University, and many state lawsuits that are deciding landmark legal issues. One such case is Schmitz v. NCAA, where the Ohio Supreme Court held that the “discovery rule” allows former athletes to file suit based on traumatic brain injury symptoms that do not manifest until decades after the alleged head trauma occurred. The increase in lawsuits, even when they end in settlement, may lead more athletes to seek compensation and hopefully to minimize the risk of brain injury in sports.

Concussions will continue to be
a litigated issue, both at the collegiate and the professional levels. As
lawyers, what
is our duty
to these concussed athletes? And what is the standard of
care due to athletes who suffer concussions? Most importantly, litigators need
to become familiar with the symptoms of concussions, which can include physical,
cognitive, and behavioral
changes. Litigators also need to
understand the athlete’s pre- and post-concussion cognitive abilities, along
with understanding the severity and short- and long-term effects of a
concussion. Pre-season
neurological testing and prior medical history
are probably the best
tools to determine an athlete’s pre-concussion cognitive abilities. Baseline
testing is useful to compare abilities, since it is not meant to be a
comprehensive assessment, which can provide an objective baseline measure of
the effects of a concussion. Prior medical records also reveal past concussions
and anything that may affect an athlete’s abilities, including mental health. During
the concussion, litigators can interview
witnesses to the concussion and obtain medical records
regarding the
diagnosis after the concussion. Then, litigators can begin to investigate the
diagnosis, and determine whether the athlete meets any of the symptoms of a

Litigating claims on behalf of
concussed athletes is difficult, but the advances of medicine and awareness of
symptoms may lead to changes in the law. Going forward, one of the benefits of
concussion litigation is that it will likely change how contact sports are played,
from youth to professional sports. Litigators who want to protect athletes,
along with coaches, should begin to discuss protecting athletes at a young age,
if it removes some of the drama of athletics
. Many athletes have
lost their lives and lifestyles from CTE and SIS, and we can ensure better
protections for budding athletes. 

The Prison System and Mental Health

In the United States, people with severe mental illness are three times more likely to be in a prison instead of a mental health institution. Forty percent of people with severe mental illness will also spend time in a jail, prison, or correctional facility. There are many people with mental health issues who are being punished, including being executed and kept in solitary confinement.


Even though people with intellectual disabilities may not be executed under the Eighth Amendment, the Supreme Court has held that people who are mentally ill may still be executed, including people will severe mental illnesses, and only that the insane may not be executed. The “insane” is defined as “those who are unaware of the punishment they are about to suffer and why they are to suffer it.” But the Court has also said that the Eighth Amendment requires prison officials to provide a system of ready access to adequate medical care, including mental health care. However, states have not always followed the Court’s guidance, particularly when it comes to solitary confinement and the death penalty. Between 2010 and 2017, twenty-six percent of prisoners who were executed had a history of mental illness or were treated with psychotropic medication. Currently, between five and ten percent of death row prisoners are estimated to be suffering from a mental illness.


In October 2018, Yale Law School issued a report that over 4,000 prisoners in solitary confinement have a mental illness. Solitary confinement can often exacerbate or even trigger a prisoner’s mental health issues. Prisoners are kept in total isolation for twenty-two hours per day for at least fifteen consecutive days. In New Mexico, for example, sixty-four percent of prisoners with mental health issues were kept in solitary confinement. Unfortunately, prisoners who are kept in solitary confinement often leave more mentally damaged than when they entered, and are less likely to successfully reenter society.


The prison system must change to help prisoners who have a history of mental illness, and not further criminalize them. Many states are considering legislation to end the practice of executing prisoners with a mental illness and there are other states that are ending or restricting solitary confinement. For instance, in the fall of 2017, Colorado established a procedure to immediately provide prisoners with treatment rather than place them in segregated lock-up.


Prisoners can also have difficulty obtaining treatment because their insurance may no longer cover their medications and they also do not have reliable access to therapy while in prison. Mental Health America made suggestions to improve mental health access for the incarcerated, including investing in mental health courts and creating systems of support for people who are incarcerated or recently released and who need access to a community-based service. States can also reevaluate Medicaid exclusions on prisoners, so prisoners can still obtain their medications and their mental health issues will not be exacerbated while incarcerated. Authors of an article in the American Journal of Public Health have additionally suggested providing telemedicine, integrated family counseling, and cognitive-behavioral therapies to complement medication and also reduce levels of reoffending. There also need to be better transitional plans for prisoners to reintegrate into the community and still obtain mental health treatment. Prisoners who received a professional diagnosis of a mental health disorder were seventy percent more likely to return to prison when they did not have any correctional intervention and treatment.


It may also be prudent to determine whether a new mental health standard should be established for prisoners who develop mental health issues while in prison. The Supreme Court will soon decide a case about the execution of a man who developed severe mental health issues will in prison, in which case there may be an answer soon.

Telemedicine: Making Health Care a Reality for All

The American Telemedical Association, a leading telehealth association, describes telemedicine as the remote delivery of health care services and clinical information using telecommunications technology including through the internet and cellphones. Telemedicine has seen an exponential increase in the last few years with about 200 telemedicine networks and 3,500 service sites in the United States. Litigation regarding telemedicine issues was somewhat prevalent in the early 2000s, but has not been highly litigated in the last few years. Now the creation of telemedicine networks is keeping people healthy and out of hospitals as physicians and patients are downloading telemedicine apps, making healthcare available with the push of a button. Because of these advances and the lack of litigation and legislation, there may be changes to telemedicine in the near future.


Overall telemedicine has benefited people. The increase of health care costs has made it difficult for patients to have the means to see their doctors. Additionally, living in a rural area or not having easy access to transportation can make it hard for patients to access specialized programs. Doctors are trying to find ways to see more patients at lower costs and telemedicine is making this a reality. About two months ago, CVS Health announced that it would offer a telemedicine service through its smartphone app to treat easy-to-diagnose issues like colds, skin issues, and general wellness matters. At first, the service will cost $59 and then insurance coverage will be available in the coming months.


Medicaid is also accepting telemedicine to cover medical diagnosis, although the administration of the program is left to the states’ discretion. In July 2018, the Centers for Medicare and Medicaid Services (CMS) published a 1,400 page document with new proposed rules indicating that there would likely be changes to the telemedicine system. Comments to the document were due in early September 2018, so we may be breaking new barriers into health care soon. Pursuant to CMS’s proposed rules, patients would need to have a preexisting relationship with the doctor. If CMS expands this program to allow telemedicine between physicians and patients without preexisting relationships, this may open the door for legal issues. However, these new rules should simplify the process even further. They will remove barriers for those who need care so that providers can virtually check on patients and at the same time, spend time with patients who need in-person care. And telemedicine will also help the disabled and elderly who may rely on having someone who can take them to their appointment.


The federal government has not made many decisions about telemedicine, even though CMS is starting to make new ground and Congress is starting to look into legislature concerning telemedicine. Therefore, states are starting to pass bills to make telemedicine more prevalent in their states. The Texas legislature overruled its state medical board to enable telemedicine physician-patient relationships to proceed without an initial in-person visit; the Michigan and Indiana legislatures reversed restrictions on telemedicine regarding in-person visits; and telemedicine is seeing support in Pennsylvania and Louisiana.


However, there are still some issues that need to be explored before telemedicine can become a truly effective national resource. Since physicians and patients may not be in the same jurisdiction, and jurisdictions tackle certain health care issues differently, there may be an issue in crossing jurisdiction for treatment. Insurance companies will also have to determine how private insurers will cover telemedicine services. Overall, Congress should look into regulating telemedicine so that insurance providers and legislation help achieve the goal of providing healthcare to those who may not have easy access.