Articles by mjlst

En-Chantix: Smoking Cessation & Involuntary Intoxication

February 13, 2017
Criminal Law, FDA, Health

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.

En-Chantix: Smoking Cessation & Involuntary Intoxication

February 13, 2017
Criminal Law, FDA, Health

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #2 in a series on current FDA issues. You can find the previous post here.]

Smoking cessation is a difficult process. To assist patients in the process, many physicians are turning to Chantix (Varenicline), which is advertised as the nation’s #1 prescribed prescription anti-smoking medication. Health professionals have lauded the product as a useful adjunct to other methods of smoking cessation treatment and over 10 million Americans have received prescriptions for the drug.

After the introduction of Chantix into the market, reports of adverse events, including potentially serious neuropsychiatric effects, prompted the FDA to issue a black box warning in 2009 for the drug. In 2014, McClatchy reported that Pfizer, Chantix’s manufacturer, had paid at least $299 million to settle civil claims regarding the drug and its alleged neuropsychiatric effects. In December 2016, the FDA approved the removal of this black box warning. While these events certainly are of interest to drug manufacturers and regulators, they also have surprising implications for criminal law.

What if your anti-smoking drug led you to commit a violent crime? Could you convince a jury that the anti-smoking pill made you do it? That is precisely the question posed by some criminal defendants across the country.

Involuntary intoxication can be an affirmative defense for criminal offenses, and this defense is recognized as a complete defense. As a complete defense, the court recognizes that the defendant committed the action alleged but absolves the accused of criminal responsibility due to the circumstances surrounding the commission of the crime.  While standards for this defense vary, criminal defendants alleging such a defense generally claim that they were intoxicated and that this intoxication was not the result of their voluntary action. Many courts apply the same standard as in an insanity defense, which asks whether the intoxicated defendant became unable to distinguish right from wrong.

In one high-profile case, an American soldier repeatedly stabbed and brutally murdered another soldier at Fort Benning, Georgia. The defendant in this case, United States v. MacDonald, was taking Chantix and claimed that he should have been afforded an involuntary intoxication instruction at trial. The US Court of Appeals for the Armed Forces ruled that the lower court had a sua sponte duty to instruct on the defense of involuntary intoxication, finding that it was error to fail to provide a separate and distinct involuntary intoxication instruction in such a case. The MacDonald defendant was granted a rehearing, whereupon his sentence was decreased from life without parole to 45 years with credit for time served pursuant to a plea deal. The case went up on appeal on January 27, 2017 and was affirmed.

In another case, a Maryland man invoked Chantix when he was accused of attempting to kill his wife. As reported in the Washington Post, the man shot his wife and tried to get a second shot off but the gun malfunctioned. At trial, he claimed that Chantix caused an internal imbalance of chemicals, resulting in involuntary intoxication. The judge agreed and ordered that he be released. The local paper reported that a small protest followed the Maryland order, with protestors carrying signs that read “Abusers blame victims, Judges blame Chantix.”

When defendants allege a so-called “Chantix defense,” it is far from a sure thing. Providing a court with evidence in addition to conclusory allegations may improve the chances of a favorable finding.  For example, a Florida man argued with his father and shortly thereafter killed him. Subsequent to the murder, the man called 911 attempting to blame a non-existent intruder. According to the court, the “Chantix defense” was considered but ultimately rejected by the defense counsel. After trial, the man brought a prisoner litigation action. In rejecting the suit, the court concluded, inter alia, that “even if a reasonable juror could find that Chantix rage exists,” the prisoner had presented no evidence that he was so affected.

As noted in the Washington Post, involuntary intoxication is not a new defense but it is being invoked with increasing success nationwide. While the FDA recently removed Chantix’s black box warning, the “Chantix defense” demonstrates the fascinating interplay between FDA law and criminal law. It remains to be seen just how much the defense bar will incorporate this defense into clients’ strategies.

3D Printing: What Could Happen to Products Liability When Users (And Everyone Else in Between) Become Manufacturers?

February 12, 2017
3-D Printing, FDA, Product Liability

[Editor’s Note: Invited Bloggers James Beck & Matthew Jacobson co-authored the article on 3D printing in MJLST’s recent issue. This post summarizes the main arguments of their analysis.]

3D printing has the potential to disrupt and transform not only how and where objects are made, but all aspects of the law, including products liability.  In their recent article, 3D Printing: What Could Happen to Products Liability When Users (And Everyone Else in Between) Become Manufacturers (18 Minn. J.L. Sci. & Tech. 145), James Beck and Matthew Jacobson explore the legal implications 3D printing may have on product liability common-law and how courts, legislatures, and regulatory agencies may act in the wake of this novel technology.  The first part of this comprehensive guide covers what is 3D printing and how this new technology works, an overview of traditional tort liability concepts, and the gray area that forms when the two meet.  The second part of the article focuses on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.

Given that 3D printing appears to be the next greatest chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues affecting this body of law arising from the 3D printing of products.

As the article explains, 3D printing is already starting to revolutionize different industries, including automotive, aerospace, and healthcare.   Individuals can already “print” products from a store (online or brick-and mortar) and their own homes (assuming they have a 3D printer and the necessary software and supplies).  In the future, airplane parts may be able to be printed from airports, car parts at a mechanic’s shop, and medical devices at a hospital or doctor’s office.  As the technology develops, the question becomes will the law also develop, especially as people get injured by these 3D printed products and the processes in by which they are printed.

Products liability is a relatively new area of the common law—although not as new as 3D printing—beginning its development in the 1960s, when manufacturing transitioned from local artisans and workshops to assembly-line processes.  Now that 3D printing may once again change the traditional way in which we view manufacturing, the law may also have to change once again.  Because strict products liability focuses on where products are manufactured and who designs and manufacturers those products, it may not be suited to address how and where 3D printed products are made.  These issues include what is a “product,” who is a “manufacturer,” what is the “marketplace,” and who has a duty to warn.  Each of these questions raises numerous issues, which will need to be addressed as courts are faced with the potential inadequacies in the common-law.  3D printing manufacturing techniques may also increase the number of possible products and manufacturers (once those terms are defined), so there are more scenarios of who may be liable then with traditional manufacturing techniques, which will result in courts and juries being left to sort it all out.

Beck and Jacobson discuss these issues and the current state of the common-law in depth, which includes analysis of product liability court opinions with respect to 3D printing (so far minimal) and comparable (to the extent possible) products and technologies.  While it is still uncertain how products liability law will develop or change, what is certain is that the law will change, and the authors offer their take on the changes that may come.

The potential issues 3D printing may have on products liability law only becomes more multifaceted, as the 3D printed products become more complex and technical, such as medical devices and pharmaceutical drugs and production shifts from central facilities to hospitals/doctors’ offices.  As the article explains, 3D printing has perhaps the greatest potential to benefit human lives and health care, even if the exact nature of those developments are hard to predict.  But with that great potential comes legal uncertainty, especially since medical devices and drugs are regulated in the United States by the Food and Drug Administration (“FDA”).

One of the legal challenges explored in article is the FDA regulatory framework for 3D printed medical devices.  The FDA currently views 3D printing as another form of advanced manufacturing, and thereby fits this technology in its already existing framework.  The FDA has already cleared (through its “510(k)” process) approximately 85 medical devices and approved one drug manufactured through 3D printing technology.  However, manufacturing truly innovative medical devices—such as bio-printed devices, medical devices made using a patient’s own stem cells—through 3D printing will require more FDA guidance.  As the article discusses, 3D printing is on the FDA’s agenda and the agency is continuing to better understand this technology and its place in improving healthcare.

The article not only points out the unknown product liability issues that may result from 3D printing, but also offers strategic insights, which may be useful to mitigate risk or to develop the common-law.  The article is a necessary guide for anyone involved in the 3D printing process, including manufactures of 3D printed products, manufactures of the printers, the computer software designers, the manufactures of 3D printing scanners, sellers of 3D printed products (all possible product liability defendants in the future), and even consumers or users of these products.

While the article focuses primarily on tort liability, the authors and their colleagues have published two white papers on similar issues, as well as other key legal issues including intellectual property, constitutional law, commercial litigation, data privacy, environmental effects, health risks in the workplace, and insurance risks and recovery:  3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles and 3D Printing of Manufactured Goods: An Updated Analysis.  The article, along with the two white papers, provide a wide-ranging guide on the legal implications of this novel technology across different practice areas.

Evaluating an FDA Ban on Use of Human-Used Antibiotics in Animals

February 9, 2017
Drug Policy, FDA, Health, Regulatory

Nathan Vanderlaan, MJLST Staffer

Over the past several years, antibiotic resistance in humans has become one of the leading health concerns in the United States. Many heads are turning towards the U.S. farming industry, and the antibiotic consumption by animals as a leading culprit. Today, about 80% of all antibiotic consumption in the United States is attributable to animal consumption. Many argue that unless the government takes stronger regulatory stances on the animal consumption of antibiotics, an inability to effectively fight a number of illnesses due to antibiotic resistance will be on the horizon.

In her article “Slowing Antibiotic Resistance by Decreasing Antibiotic Use in Animals,” Jennifer Nomura argues that the FDA should implement a total ban on the use of antibiotics in animals that are also used therapeutically in humans. Currently, the FDA has taken the position that there is no definitive proof that antibiotic use in animals leads to greater resistance in humans. As such, they intend to allow producers to continue to use antibiotics used to treat humans in farming practices until a scientific correlation between resistance and farm use is established. Nomura advocates that the FDA transition from this “wait-and-see” policy and enter the realm of stiff antibiotic regulation. She argues that the FDA is under such an obligation based on their duty to minimize risks to human health. However, this duty may suggest that the FDA should not rush into a total ban on antibiotics also used in human health.

An all-out ban on such antibiotics may in fact have a more detrimental impact on human health. The potential that a ban would lead to increased incidence of disease cannot be underscored. While Nomura suggest that disease may be kept down due to improved farming practices, the reality of creating the infrastructure to promote such practices may not be feasible for a country with such high meat production. And although several countries have been successful in making the transition from these kinds of antibiotics, their success may not be entirely indicative of the success a large country like the U.S. will have. If the incidence of disease goes up after a ban, consumers will likely suffer medically and financially, and these risks cannot impulsively be set aside.

Nonetheless, the FDA must take notice of the growing problem of antibiotic resistance. Resistance is giving rise to “super-bugs” and leading to more unpreventable deaths every year. While steps must be taken to address these growing concerns, any action taken by the FDA should not be hasty. Instead of an outright ban on all antibiotics used for humans as well, the FDA should do a full risk analysis regarding the impact giving these drugs to animals poses to humans. Then the FDA should conduct an individual analysis of the highest risk antibiotics being used, tackle these antibiotics first, and then slowly transition away from the use of certain antibiotics once it is determined such a transition will not threaten the health of humans or the nations live stock.

Dinner for Two? Federal Regulations Indicate a Newfound Love for the Pediatric Medical Device Market

February 8, 2017
FDA, Healthcare, Medical Devices, Regulatory

Angela Fralish, MJLST Invited Blogger

In December 2016, President Obama signed the 21st Century Cures Act which includes Subtitle L “Priority Review for Breakthrough Devices” and Subtitle M “Medical Device Regulatory Process Improvement.” Subtitle L addresses efficiency in medical device development by allowing inventors to request an expedited review for inventions that target disease, and for which there is no alternative device is currently on the market. Subtitle M requires FDA staff to be trained in least burdensome concept reviews and allocates $500 million to speed up commercialization.

This Act presents growth opportunities for the pediatric medical device market which often lacks device development due to time and expense. Under the Cures Act, if the device targets a childhood disease and there is no alternative, this new regulation requires a priority review determination within 60 days from the FDA Secretary. Additionally, there are now $500 million supporting implementation of the priority review.

Currently, pediatric devices can take up to 10 years and $94 million to develop. Market incentives often drive device innovation and the market for children is small. Consequently, most developments are not initiated for profit, but for personal interest in children’s health.

For example, despite using an expedited review process under a humanitarian device exemption, an implantable rib to prevent thoracic collapse took 13 years just to get FDA approval to begin the commercialization process. The pediatric medical device market is viewed by some as a crisis and the 21st Century Cures Act has the potential to improve kids’ health.

For lawyers, scientists and engineers, an increase in device development leads to an increase in demand for regulatory, design, reimbursement and scientific technology experts. Lawyers can make a major difference in getting devices from bench-to-bedside. On the other side of the fence is demand for the same to protect consumers from manufacturers taking advantage of the Cures Act. In fact, some tort lawyers directly oppose the Cures Act for fear of watered-down processes for safety in devices.

However, regardless of one’s stance on the issue, it’s a good time to show some legal love to the kiddos in need of growth in the pediatric medical device market.

Split Ends: WEN Hair Care & the FDA’s Regulation of Cosmetics

February 7, 2017
Class Action, FDA, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.

Split Ends: WEN Hair Care & the FDA’s Regulation of Cosmetics

February 7, 2017
Class Action, FDA, Regulatory

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: The LawSci Forum is pleased to announce a new series on current issues in FDA law. This post is #1 in the series, with more in the coming weeks.]

We have all been tempted by late-night television infomercials and their promises. If the product works, our lives become more convenient; if it doesn’t, we’re only out a few dollars and the product will gather dust. For thousands across America, one product that promised a hair-care revolution left them scratching, itching, and balding.

The Food & Drug Administration (FDA) is investigating over 20,000 incidents of adverse events resulting from WEN by Chaz Dean. Los Angeles-based stylist Chaz Dean is the face of the WEN brand, endorsed by Brooke Shields, Alyssa Milano, and other celebrities. Sold on QVC, infomercials, and elsewhere, WEN is unlike most shampoos. It is marketed as a “revolutionary way to cleanse and hydrate the hair” without water.

There’s another way that WEN is unlike most shampoos: using WEN all too often results in large clumps of hair falling off one’s head. The FDA has received complaints of baldness in addition to hair loss, itching, and rashes after consumers tried WEN products. In July 2016, the FDA issued a Safety Alert to warn the public about potential results of using this hair care product. In that warning, the FDA noted that this was the largest number of reports ever received for a hair cleansing product.

Unsurprisingly, litigation has ensued. One California case has resulted in a preliminary class action settlement of over $26 million. Filed in the Central District of California, the suit alleges that the plaintiffs, and their similarly-situated class members, suffered hair loss and scalp irritation, among other injuries. One class representative allegedly lost one-third of her hair after she used WEN’s Sweet Almond Milk kit. In addition, plaintiffs claimed that the WEN was falsely advertised as safe and failed to warn users of potential harm.

Under the terms of the preliminary settlement, notice will be given to 6 million class members, defined as any American purchaser of WEN hair care products between November 2007 and August 1, 2016. A warning will be added to the product’s packaging telling users to seek immediate medical attention for adverse reactions. While many claimants in the class can submit claims for a $25 payment, those with more extensive damages can submit claims for additional recovery. For example, those that have lost more than 50% of their hair with minimal “hair regrowth” could recover as much as $20,000.

But, wait there’s more! The nature of the allegations against WEN have led many consumers, lawmakers, and even the New York Times to ask whether the FDA should have the authority to recall dangerous cosmetics from the market. Currently, the FDA is not authorized to order recalls of cosmetic products. Instead, such recalls are voluntary efforts by manufacturers or distributors.

A cursory inspection of the FDA’s name reveals that “cosmetics” is nowhere to be found in the title of the Food & Drug Administration. While the FDA notes that cosmetic companies and marketers “have the legal responsibility to ensure the safety of their products,” the WEN case provides an opportunity to reflect on the FDA’s regulatory authority over cosmetic products.  For example, the FDA may order warning statements on cosmetics that present health hazards and work with manufacturers on voluntary recalls. Time will tell whether WEN prompts further action to regulate cosmetic products.

Would Monetary Compensation Incentivize You to Register as an Organ Donor?

January 31, 2017
Ethics, Health, Public Health

Na An, MJLST Article Editor

In the United States, the number of patients on the waitlist for receiving organ donations is much greater than the limited number of supplies.  One person is added to the list every 10 minutes, while only 3 in 1,000 people die in a way that allows for organ donation.  As deceased individuals constitute about two thirds of organ donors, 22 patients die waiting for a transplant every day.  The organ shortage also devastates the qualify of life for more than 100,000 people, and costs national economy tens of billions of dollars every year.  It incentivizes international organized black markets and human trafficking.  The organ shortage has multiple reasons, chief among which is people’s unwillingness to register as donors.  Study has shown that 95% of U.S. adults support organ donation; yet, only 48% of them actually signed up as donors.  Additionally, hospital procedures and customs often allow a family’s objection to undermine the wish of an intended donor.

Currently, the organ donation system is regulated by state law, federal law, government agencies, and hospital procedures.  Each state maintains its own donor registry, mostly linked to the driver’s licensing process, and state laws vary in their donation education program.  The National Organ Transplant Act (Act) instituted the Organ Procurement and Transplantation Network (OPTN) to match donated organs with recipients on the waitlist.  The Act also prohibits the sale of organs.  While the legislatures and courts remain silent, hospital procedures dictate.  For example, hospitals will almost never retrieve organs without the family consent even when doing so would be against the wish of the deceased.  Complicating the issue further is the inherent human rights of the donor, his/her family, and the recipient.

Confronting these issues, Stephanie Zwerner, in her article “A Small Price to Pay: Incentivizing Cadaveric Organ Donation with Posthumous Payments,” proposed a national donor registry and incentivization system.  First, a national donor registry will replace state registries, and eliminate the interstate discrepancies and inefficiencies.  The national registry can be consolidated with OPTN for effective administration.  To improve the validity of donor intent documentation, the article proposed donor registration through health insurance application, registration to vote, or income tax reporting.  Unlike “check-the-box” in driver licensing, everyone will be given a chance to fully consider their decisions.  Families and hospitals would be more willing to respect the wishes of intended donors.

To further incentivize registration, the article proposed a single lump sum payment to the donor’s estate financed by the recipient’s health insurance provider upon the event of an executed cadaveric organ donation.  Monetary compensation for organ donation has been a controversial topic.  Not only it is illegal under federal statute, it has also been considered as the “commodification of human body parts” and an intrinsic evil.  It decreases respect for life and human body, and can lead to exploitation of people in dire economic circumstances.  Acknowledging these negative consequences, the author presented several benefits: increasing donations while decreasing familial objections, saving lives, relieving people on the waitlist for many years of suffering, reducing black markets and the economic burden on national economy.  Considering that one donor could potential save eight lives, the article argues that the benefits outweigh the negative implications.

Social and Legal Concerns as America Expands Into the Brain-Computer Interface

January 31, 2017
Criminal Law, Health, New Technology

Daniel Baum, MJLST Staffer

A great deal of science and technology has been emerging in the field of the brain-computer interface, the connection between the human brain and machines. In addition to forming effective prosthetics and helping doctors repair brain damages, technology in the brain-computer interface has recently allowed a man to operate a prosthetic hand and an electric wheelchair with his mind using only a microelectrode array surgically implanted into his arm’s nerve fibers. The professor who developed the implant also experimented on himself, and made himself able to see in the dark: with an implant into the median nerve of his wrist, he could use the electric feedback from an ultrasonic range-finding sensor mounted on his hat to guide himself around a room blindfolded. Since this technology is still in its experimental stages, American law does not have much to say about human enhancements. Already, dangerous medical devices can lead to confusing and unfair trials, and it’s easy to imagine courtrooms getting even more confusing and unfair as medical devices progress into the brain-computer interface. This technology is close enough that the implementation of legal changes now could help this emerging technology develop in ways that will balance minimizing harm with utilizing its enormous potential to make people better.

Current laws impose no affirmative duty on manufacturers to allow pacemaker users access to their own data, and the top five manufacturers do not allow patients to access the data produced by their own pacemakers at all. As we begin to view machines as extensions of ourselves, in order to maintain our personal autonomy, we will need to be able to control who accesses the data we produce. This calls for an already necessary legal change: a right to access and control access to the data generated by objects that are effectively extensions of ourselves.

As this technology moves from healing disabled humans to giving normal people supernormal powers, its use will become much more widely pursued—“the disabled may prove more abled; we may all want their prostheses.” If other job applicants are capable of so much more because of their built-in brain-computer interface technology, employers may discriminate against natural, unenhanced humans. To protect people who cannot or who choose not to install machinery in the brain-computer interface, for financial, medical, ethical, religious, or any reasons, an independent statutory scheme with the purpose of eliminating discrimination both for and against individuals with brain-computer interface devices would not disturb the currently established disability protocols in the Americans with Disabilities Act and could be amended to account for each new form of machinery.

Another frightening concern arises once these enhancements become capable of connecting to the internet: if someone hacks into somebody else’s machinery and makes that person damage something or someone, who will be criminally and civilly liable for the damage? Since American law does not have much to say about human enhancements, no defense has been defined for the person who was hacked into and forced to cause harm. The person whose body actually committed the act could try pleading the affirmative defense of duress—that is, the defendant was compelled to commit the crime against his or her will or judgment—but the U.S. Supreme Court held in 2014 in Rosemond v. United States that “circumstances that traditionally would support a necessity or duress defense” require proof that the defendant “could have walked away.” The hacker took away the defendant’s control of his or her own body, making it impossible for the defendant to have walked away. To solve this problem, states that recognize the defense of insanity could amend their statutes to allow defendants who were mentally unable to control their own bodies due to hacking to plead the affirmative defense of insanity. States that conform to the Federal Rules of Criminal Procedure would then order the defendant to be mentally examined by an expert who could determine and tell the court to what extent the defendant was in control of his or her own mind and body at the time of the crime. The defendant could them implead the hacker to shift the liability for committing the crime. However, since the insanity defense is a mental health defense and brain-computer interface devices aren’t necessarily related to mental health, states may want to define a new affirmative defense for being hacked into that follows a similar procedure but that better fits the situation and that doesn’t carry the stigma of mental disorder.

New machinery in the brain-computer interface is exciting and will allow us both to heal physical and mental damages and to develop supernormal powers. Legal changes now could help this emerging technology develop in ways that will balance minimizing harms like invasions of privacy, discrimination, and hacking with utilizing its enormous potential to make people better.

Confusion Continues After Spokeo

January 27, 2017
Internet, Privacy

Paul Gaus, MJLST Staffer

Many observers hoped the Supreme Court’s decision in Spokeo v. Robins would bring clarity to whether plaintiffs could establish Article III standing for claims based on future harm from date breaches. John Biglow explored the issue prior to the Supreme Court’s decision in his note It Stands to Reason: An Argument for Article III Standing Based on the Threat of Future Harm in Date Breach Litigation. For those optimistic the Supreme Court would expand access to individuals seeking to litigate their privacy interests, they were disappointed.

Spokeo is a people search engine that generates publicly accessible online profiles on individuals (they had also been the subject of previous FTC data privacy enforcement actions). The plaintiff claimed Spokeo disseminated a false report on him, hampering his ability to find employment. Although the Ninth Circuit held the plaintiff suffered “concrete” and “particularized” harm, the Supreme Court disagreed, claiming the Ninth Circuit analysis applied only to the particularization requirement. The Supreme Court remanded the matter back to the Ninth Circuit, casting doubt on whether the plaintiff suffered concrete harm. Spokeo violated the Fair Credit Reporting Act, but the Supreme Court characterized the false report as a bare procedural harm, insufficient for Article III standing.

Already, the Circuits are split on how Spokeo impacted consumer data protection lawsuits. The Eighth Circuit held that a cable company’s failure to destroy personally identifiable information of a former customer was a bare procedural harm akin to Spokeo in Braitberg v. Charter Communications. The Eighth Circuit reached this conclusion despite the defendant’s clear violation of the Cable Act. By contrast, the Eleventh Circuit held a plaintiff did have standing when she failed to receive disclosures of her default debt from her creditor under the Fair Debt Collections Practices Act in Church v. Accretive Health.

Many observers consider Spokeo an adverse result for consumers seeking to litigate their privacy interests. The Supreme Court punting on the issue continued the divergent application of Article III standing and class action privacy suits among the Circuits.

Home | Contact Publishing Services | My Account