Author Archives: Leyla Mansour-Cole

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Belgian Child Euthanasia Bill Sparks Debate

The debate over euthanasia usually revolves around terminally ill adults.  Adults are presumed to be able to make rational, informed decisions about their quality of life and the possibility of ending it.  But in Belgium, this assumption of rationality is being considered in children.

The Belgian Senate approved a bill in December that would allow euthanasia to be administered to a child of any age who repeatedly requests that his or her life be ended.  The bill increases the scope of an existing euthanasia law passed in 2002, which requires that an adult person (1) is competent and conscious, (2) is repeatedly making the request to die, and (3) is suffering unbearably – physically or mentally – as a result of a serious and incurable disorder.  (BBC)  The bill passed in the Belgian Senate would extend the same criteria to children of any age.  There are further restrictions that would apply specifically to children, however:  under the bill, the child must understand what euthanasia is, and their parents and medical teams have to approve the child’s decision to die.  The child must also possess the “capacity of discernment” (a term left undefined in the bill) for his or her request to be considered.  (NYTimes)  The bill next goes to the House of Representatives, where it will likely be enacted.  (USA Today)

In support of the bill, sixteen leading Belgian pediatricians wrote a letter demanding the expansion of euthanasia rights to terminally ill children. They, along with other proponents of the bill, say that giving euthanasia options to terminally ill children is an act of compassion.  Their reasoning is that both children and adults suffer from the same terminal illnesses, so the right to die should equally extend to both groups.  Supporters also claim that terminally ill children are more psychologically mature than their healthy counterparts, which gives them the mental capacity necessary to make such an important decision.  (Deutsche Welle)

Opponents of the bill include religious communities and some bioethics experts.  The Catholic Church has come out in opposition of the bill (USA Today), and an alliance of Catholic, Muslim, Protestant, and Christian Orthodox representatives have published an open letter in opposition.  Carine Brochiner of the European Institute of Bioethics in Brussels equates the right to euthanasia with other rights in Belgium unavailable to children:  “A child cannot buy a house in Belgium.  A child cannot buy alcohol in Belgium.  And this law would allow a child to be killed.  And that is a real problem.”  (Deutsche Welle)  Private citizens are also voicing their opposition. Steve Forbes, the chairman of Forbes Media, published an article calling the practice “HitlerCare.”  (NewsMax)

If the bill passes, Belgium will become the first country to allow euthanasia in children without age restrictions.  Its neighbor to the north, the Netherlands, has long been labeled as the European country most supportive of euthanasia.  The Netherlands became the first country to legalize euthanasia in 2001, and before euthanasia was legalized, the practice was tolerated by government officials.  But even the Netherlands does not allow euthanasia for children under the age of twelve.  (Washington Times)

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Medical Malpractice Law and the Changing Healthcare Landscape

Proponents of tort reform are considering asking Congress to revive the Republican-created Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act, which died in committee in 2011. (GovTrack)  Supporters say that the Affordable Care Act (ACA) did not go far enough to reform the tort system.  (Politico)  The revived HEALTH Act, among other things, would institute a $250,000 federal cap on damages gotten from medical malpractice cases.  A federal cap would please insurance companies and many doctors because it would decrease their liability to pay when patients successfully bring a civil action.  Patient advocacy groups and many lawyers would be unhappy because such a cap would prevent patients from being able to collect high sums of money for emotional claims and would hurt the bottom lines for many medical malpractice lawyers.    Some opponents to caps on damages even suggest that large jury payouts may help make patients safer by holding doctors and healthcare facilities responsible for their care.  (Forbes)

Aside from a $50 million total allowance to experiment with alternatives to the medical liability system on the state level, the ACA does not make any change or reform to the existing tort system. (Politico)  In spite of losing the battle over tort reform in ACA negotiations, proponents of tort reform have once again called for a $250,000 federal cap on noneconomic damages and shorter statutes of limitation.  (AMA)  If supporters of caps can convince the Republican Party to revisit the HEALTH Act, tort reform could become a major political issue in the near future.  Regardless of whether a federal cap is instituted or not, the implementation of the ACA will change the way the healthcare system works as a whole, and therefore will affect the role of litigators within the system.

So what is the future of tort reform in the medical malpractice system?  The short answer is that nobody knows—yet.  The industry is already evolving, as states enact provider liability shields, damages caps, and no-fault funds to pay victims of medical malpractice.  (Harvard)  But predictions about whether claims will increase or decrease under the ACA vary widely.  There are two irreconcilable schools of thought: those who think that the number of claims will increase as the number of people using healthcare services increases, and those who believe that fewer patients will need to bring claims because their insurance will cover their expenses.

If The Number of Claims Decreases Under the ACA: 

Medical malpractice lawyers would face challenges if the number of claims decreases.  Litigators are already forced to use profitability as a major factor when considering whether or not to take on a case.  Often, if the amount of profit predicted at the verdict is less than the amount it would take to try the case, the case is deemed not viable for trial.  The amount of realized profit from a case with a huge award may not be very much if the lawyer had to spend a lot of money to try the case.  The practice of taking the highest-paying cases in favor of lower paying ones is troubling because it leaves clients who have a potentially viable claim without options.  If the number of claims decreases, medical malpractice lawyers will have to choose their cases more carefully than ever, and choose from a potentially less profitable pool.   (CNN)

Compounding this problem is the practice of placing state caps on non-economic damages, which has grown in popularity over the last decade, is hurting the litigators who must pick and choose their cases and the clients with less profitable cases.  Along the same vein as state caps, many support the implementation of a federal damages cap.  There are many potential benefits to a federal damages cap, the most obvious being that doctors would not have to worry about going bankrupt after a medical malpractice case, and could practice medicine without that fear looming over them.  But a federal damages cap could also effectively shut down the medical malpractice tort system if it prevented attorneys from collecting money necessary to pay for the case out of the case’s award.  Unless an alternative system was put in place, this could prevent patients with small claims from securing representation at all.

If the Number of Claims Increases Under the ACA: 

Courts have faced the overcrowding of claims issue for decades, and adding 20-40 million potential new plaintiffs may compound the problem.  As one litigator points out, “The more people you have accessing medical care, the greater the potential incidence of medical mistakes in which injuries or death occur.”  (PR Newswire)

While the fear of further court backlog is valid, there are possible positive aspects of an increase in claims.  For medical malpractice litigators, more complaints mean more choice in which cases to take on.  Currently, many lawyers choose their cases based on how much money they are predicted to bring in.  Having more clients coming to litigators can be a great thing.  Lawyers who currently turn down small-profit cases could take them on if they had other larger cases whose payouts would act as a sort of ‘insurance’ policy for the smaller cases.  Cases with large profit margins could potentially pay for otherwise not-viable cases.  This gives the lawyers trying those cases more freedom to choose the cases that appeal to them both intellectually and financially, rather than relying on only one of those criteria.

Conclusion:

Of course there is the possibility that, as the ACA is implemented, the number of medical malpractice claims stays relatively unchanged.  However, the tumultuous nature of healthcare law makes it unlikely that nearly any aspect of medical care will stay the same.  As one journalist phrased it, when discussing malpractice insurers, “[a] new healthcare world is emerging, and malpractice [lawyers] are going to have to figure out a way to profitably live in it.”  (Property Casualty)

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Drug Shortages and Legislative Solutions

Cancer patients, and patients with a wide range of other ailments, may not be receiving the best possible medicine because the required drugs are in shortage.  The prescription drug market is consistently afflicted with shortages, both minor and major.  Each shortage can affect one particular drug, or a range of drugs within a class.  In 2011, the United States experienced 251 drug shortages. In the same year, 183 (nearly 75%) of these shortages were of sterile injectable drugs, most commonly used for cancer treatments.  (FDA Factsheet)  Doctors do not have the option to prescribe the drugs they believe to work best because they are unavailable.  (The New York Times)

Manufacturing costs are a major contributor to the problem.  Sterile injectable drugs are very costly to make, and thus not many companies are willing to take the risk of setting up facilities to make them.  Further, the facilities that make such medicines are subject to many regulatory rules, including caps on drug prices. This means that, even when there is strong market demand for more product, manufacturers may not be able to afford to produce them, Plainly said, these drugs do not become more expensive when supply is at issue, as they might in an unregulated market, they become scarce. The manufacturing web is so fragile that a certain factory closing can extend a shortage for several months or even years.  (Medscape)

The prescription drug market is “characterized by sporadic shortages of individual drugs and occasional periods during which many drugs in a class are in shortage,” and few legislative or regulatory solutions have made a difference in solving the problem.  (ASPE Brief)  The Food and Drug Administration (FDA) takes measures to prevent and solve these shortages, which include working closely with drug manufacturers to help restore availability and working with other potential manufacturers to encourage them  to increase production to prevent future shortages.  (FDA.gov)  Unfortunately for FDA, its power is limited, and legislative response to this problem has been insufficient.

In 2012, Congress passed the Food and Drug Safety and Innovation Act of 2012 (FDASIA).  Title X of that Act is committed to the issue of drug shortages, and, in part, requires that manufacturers give the FDA prior notification when a shortage is predicted.  Other requirements laid out in Title X include allowances for expedited FDA review of drugs that may help alleviate a shortage, creating an FDA task force dedicated to the issue of shortages, maintaining a drug shortages list, agency analysis of manufacturing quotas (including the ability to change the quotas if a particular drug seems likely to be in shortage), and allowances for hospital repackaging of drugs so that they may be distributed in a more efficient way.  (FDASIA 2012 Summary)

Title X puts forth ideas that could potentially solve part or all of the shortages problem, but some of these measures have flaws that make them potentially useless.  FDASIA undercuts itself often.  For example, section 506D of Title X mandates the creation of a drug shortages taskforce.  The taskforce is to create a strategic plan which should include measures to increase communication between manufacturers and FDA.  The taskforce should also ensure that the Secretary of Health and Human Services considers shortages when executing regulatory actions, considers the implications shortages have on clinical trials, and examines opportunities for more manufacturing partnerships.  Given enough time, these steps could create a useful taskforce, especially if it fosters improved communications between manufacturers and the agency regulating them. But the taskforce is simply not given the time required to become fully ingrained in the market/regulation system.  Section 506(f) is a sunset provision, meaning that the structure and purpose of the taskforce are to end exactly five years after the bill was enacted.  This means that even if it begins to succeed, the taskforce will cease its operations at the end of five years.  It has, essentially, been hobbled with “lame duck” status since the very instant it was created.  Though sunset provisions are not uncommon in legislative acts, one as short as five years does not give the taskforce much time to assert itself before losing its mandate.  Generally, sunset provisions are meant to prevent outdated laws in the far future, but here the sunset provision renders the taskforce useless in a much smaller timeframe.

Despite the other contradictory measures, at least one part of the FDASIA has been proven effective: the early notice requirement.  This requirement forces manufacturers to inform FDA if they anticipate a shortage to be imminent, and has been effective in helping to coordinate efforts to curb existing shortages or even prevent them outright.  The effectiveness of the plan can be seen in the numbers: new shortages are at the lowest they have been since 2006.  (Salon)  It is possible that, given enough time, other sections of the act will prove equally or more effective, and in the future shortages will not be as much of a burden on the medical community as they currently are.  But unless new ideas and initiatives are given more time to become effective and do their jobs, drug shortages will remain a serious problem for the medical community.

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Telemedicine in Rural Communities

Imagine you live in a small rural community in northern Montana with no more than a thousand residents, each of whom lives miles from the next. Your child becomes ill with a sudden high fever and you don’t know what to do.  Just five years ago, this situation would have necessitated an hour drive to the nearest hospital emergency room, or a call to a volunteer-run ambulatory services center.  Now, patients have the option to receive care via telemedicine instead, improving the level of care and making healthcare accessible to more people in rural areas.

Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.  (ATA)    Sometimes referred to as “telehealth,” telemedicine can be accomplished via email, smart phone, two-way video, and many other forms of communication technology.  It can be as simple as two physicians discussing a case via cell phone, or as complex as using video-conferencing to facilitate a real-time consultation between medical providers in two different countries.  (Medical News)  The main benefits of telemedicine derive from its flexibility—any physician can participate in one of its several different user options.  The practice has been lauded by many in the medical community for increasing care options to patients and cost-effectiveness.  Medicaid guidelines recognize the cost difference between face-to-face consultations or examinations and telemedicine, and incentivize the practice through its coverage levels.  (Medicaid)

Telemedicine has had a widespread effect globally, especially in rural communities that lack a brick-and-mortar healthcare presence.   Rural populations consistently face obstacles to healthcare that urban areas do not encounter.   Challenging issues such as a lack of healthcare professionals, physical distance between providers, and a lack of emergency facilities have created a care gap between the people in these two regions.  (Stanford School of Medicine)  The majority of the problems stem a deficiency of healthcare professionals per patient in rural areas.  According to Stanford University’s Rural Health Factsheet, , about 20% of American’s population resides in rural communities, but less than 10% of physicians practice in rural areas.

Telemedicine helps correct that imbalance by ‘bringing’ physicians into the rural communities in which they are needed via electronic media.  Before telemedicine, a patient may have had to wait two or more days for a physician to travel to his town, or had to travel long distances to the doctor.  Now, the same patient can set see his doctor via Skype when it’s most convenient or most needed.   (Healthcare IT News)  Additionally, because web communication software is relatively inexpensive, the cost to the patient is negligible.

Telemedicine has also led to improvement with in-home monitoring.  Clinical observations or costly hospital stays are avoided when a patient is given a device to monitor his status at home which uploads all relevant information to the monitoring physician.  This allows the patient to be at home, even if his home is far away from the nearest medical facility.  At-home monitoring also helps hospitals reduce readmission rates.  (Time)  Fewer readmissions means less billing to Medicare and Medicaid, which reduces the cost of these programs.

Possibly the biggest boon to rural communities is the increased availability of specialists.  In locations where physicians of any type are scarce, finding available specialized care, even types as basic as emergency pediatric care, can be difficult or near impossible.  (University of California)  Telemedicine allows specialized physicians to consult with other physicians on difficult cases—in some situations, they can even virtually examine the patient via video conference and electronic medical records.  In the case of emergency pediatric care, telemedicine consultations have been proven to greatly improve the quality of care for children treated in rural emergency rooms.  (Kaiser Health News, NTCA)

Threre are ways to even further increase the level of health in rural communities via telemedicine.  A 2011 report from the UnitedHealth Center for Health Reform and Modernization gives eight strategies to improve further the reach and abilities of telemedicine in rural communities.  (UnitedHealth Group)  Among the suggestions made were expanding broadband connectivity, offering education to physicians on how to incorporate telemedicine into their practice, and updating regulations to allow the practice across state lines.

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