Redealing the Unfortunate Hand: Biosimilar Tort Preemption

Ryan Dowell, MJLST Staffer

Most people have had to take prescription medication at some point. Acquiring these medications is an experience often characterized by another stuffy waiting room and forking over a fair amount of money (enough that 8% of adults forgo or delay filling prescriptions). Finally the pharmacist hands over the goods and it’s time to get out ASAP. Who takes the time to stop and look if it’s name-brand or generic?

Generics, which are required by the FDA to have the same active ingredient and performance as the brand-name drug, account for almost 80% of prescriptions filled in the US. For most customers, the only impact of generic medications is a smaller dent in the wallet (to the tune of $1.68 trillion from 2005-2014). Anecdotally, the tug-of-war between name and generic medications has driven down my out-of-pocket expenses … somewhat surprisingly for the name-brand drug, which is currently cheaper than its new-to-market generic competitor.

Last year, in Generic Pharmaceuticals and the “Unfortunate Hand” Dealt to Harmed Consumers: The Emerging State Court Resistance, Arlen W. Langvardt discussed the impact of a trilogy of SCOTUS rulings that preempt tort claims by people harmed by generic drugs First, Wyeth v. Levine determined that Congress has not given express preemption to FDA approval of prescription drugs and FDA may regard common-law tort actions as a piece of drug regulation. In other words, FDA approval does not preempt tort actions by harmed customers against drug manufacturers.

After Wyeth, SCOTUS found that such tort claims were preempted in PLIVA, Inc. v. Mesning. This difference hinged on the fact that the subject drug was generic. Generics must essentially mirror the brand-name drug, limited for the most part to the characteristics previously approved by the FDA. Conflicting state & federal requirements resulted in preemption via impossibility; that is the FDA requirements prevented compliance with state requirements. The phrase “unfortunate hand” was coined here to refer to customers’ inability to seek redress when the harm came from generics, yet those who received brand-name medications were not barred by preemption. Mutual Pharmaceutical Co. v. Bartlett followed Mensing, again preempting tort claims stemming from generics; this time preempting both failure-to-warn (as in Mensing) and design-defect claims due to impossibility. The sum of these cases is that generic manufacturers are functionally unable to alter the product under FDA regulation, thus cannot adapt it to meet other standards, which result in impossibility preemption.

Langvardt’s article discusses this as part of the “war over whether tort claims against drug makers should be permitted at all.”  With most prescriptions filled with generics, consumers have little viable recourse through tort claims. Langvardt examines potential means of opening claims for those who suffer such harms from generic drugs; including [unlikely] Congressional action, changes in FDA regulations, and certain actions in state courts.

The issue of generic drug tort liability will likely see new developments with the rise of biologics, where the ‘tied-hands’ reasoning may be less persuasive. Since biologics are complex and often not 1:1 replicable, generic biologics take the form of FDA-approved biosimilars and “interchangeable biological products”.Biosimilars are “highly similar to an already FDA-approved biological product … and have been shown to have no clinically meaningful differences.” “Interchangeable biological products” are biosimilars that are additionally expected to produce the same clinical result. Approval for these products is similar to that for generics, relying heavily on the reference product.

Many harms from prescription drugs are not realized until many years down the road. Here the products are merely similar, not identical–what may seem benign could have a later impact. Generic manufacturers might not be as insulated by an impossibility defense. Perhaps more clearly, the FDA has stated that biosimilars are not generics. For these medications, this might be a key opportunity to distinguish from the trilogy described by Langvardt and allow consumers to recover when harmed.


Bet on Science: Transplantation Without Human Donation

Rhett Schwichtenberg, MJLST Staffer

There is no question that the American organ donor process is flawed. An individual makes the selfless decision to become an organ donor, but upon death their organs remain in their body.  Although the law states that the donor is the only person that can revoke an anatomical gift, hospital practice will almost never harvest an organ without the family’s consent. A recent article published in the Minnesota Journal of Law, Science & Technology has proposed a solution to the 120,000 Americans waiting for organs: paying the donor $5,000 per organ. This solution could have many positive impacts, but many negative ones as well.

First, this solution will have a strong influence on the socio-economically poor, as an individual could make up to $40,000 for their family by donating the eight organs currently eligible for donation (not including hands and face, added in 2014). This amount of money would put low-income families in a horrible position where they might choose to forego medical treatment in order to provide for their family. This reward manages to take the decision away from the socio-economically poor by incentivizing death. Though middle-class individuals might also elect to choose money over treatment, the decision is based more on want than on need.

Second, with advancing technologies, organs harvested from fatalities will become less frequent. Take, for instance, the new technology of self-driving cars. In the near future, self-driving cars will dominate the automotive industry. Given that in 2016, 13.6 percent of organ donors died in a road accident, the number of available organs will only decrease in years to come. In a very recent article, Elon Musk stated that nearly all new cars will be self-driving within ten years.

Although self-driving cars might be farther down the road than Musk declared, scientists have made a major breakthrough in the biological field. Researchers have successfully used an enzyme to integrate human stem cells into developing pig embryos. This technology makes it possible to edit a pig’s DNA sequence coding for a certain organ, and insert code that would “theoretically grow a human organ for patient transplantation.” Artificially creating human organs would single-handedly eliminate the need for organ donation.

In addition to biological advancements, the tech industry has been a major player in organ creation. The use of 3D printing in the medical industry was instantly commercialized for its ability to create prosthetics and fake organs to practice surgical procedures. Today, Wake Forest Institute for Regenerative Medicine has developed a 3D printer capable of “print[ing] tissues and organs by utilizing cells as the main filament or component of the 3D printer.” Using an individual’s own cells to 3D print new organs for them would also eliminate the need for organ donation.

With such large advancements in science and technology, I do not believe there is a need to incentivize organ donation. This would result in a disparity between rich and poor and create situations where an individual has to choose between life or death for all the wrong reasons. Until science reaches the point where human organs can be created, individuals who wish to donate their organs upon death need to take steps to ensure their wish is fulfilled. Such steps include preparing an advance directive or a living will, signing a donor card, obtaining a health care power of attorney, and informing family members of their decision. Paying someone for their organs is simply not the solution.


Exploring the Final Frontier—The Relevance of Brain Imaging in Litigation

Mary Riverso, MJLST Staffer

Human curiosity and technological advancements have led to the exploration of the ends of the earth, the deep seas, even outer space. We have learned so much about the animals we live amongst, the nooks and crannies of planet Earth, and our role in the universe. But as we continue to explore farther and farther outward, we often overlook how little we actually know about ourselves.

The human brain remains predominantly mysterious and unknown. Neuroscientists continue to attempt to map the brain, to assign different functions and behaviors to the different regions of the brain supposedly responsible for them. However, a thorough understanding remains nearly impossible given the intricate circuitry of brain functioning. While certain areas of the brain are sometimes responsible for discrete tasks, complex functions are not exclusively localized. It is more accurate to think of the brain as composed of neuron circuits – the different regions constantly connecting with one another via neuron circuits to work together to process information and complete tasks. Technological advancements now allow for many groundbreaking and non-invasive means of observing the functioning brain. For example, devices administering scans for functional magnetic resonance imaging, or fMRI, monitor blood flow to detect areas of activity. Whereas an electroencephalogram, or EEG, is a test that measures and records the electrical activity of your brain. Finally, magnetoencephalography, or MEG, captures the magnetic fields generated by neural activity. As the capacity and means to monitor brain functioning expand, the potential for successful brain mapping increases. As a result, using brain images resulting from these scans as evidence in litigation becomes more tempting.

The potential for brain imaging to be used as expert evidence in litigation is already being explored. Criminal defendants, such as Herbert Weinstein, want to use the results from brain scans and tests to show that they are not responsible for their criminal actions due to a physical mental disease or defect. Other defense teams see the potential of brain imaging to aid in assessments of truth-telling. Physicians who administer the tests must be willing to testify as expert witnesses to the results and their medical conclusions. Often times, the physicians probe brain function and analyze energy utilization of the brain and then administer tests of human behavior and mental representations to provide a basis for their medical conclusions. However, a major hurdle for potential neuroscientific evidence is its relevance under Federal Rule of Evidence 401 (“FRE 401”). FRE 401 demands that before such evidence be admitted, it must have a tendency to make a fact of consequence more of less probable. But because the brain remains so misunderstand, it is difficult, or arguably impossible, to draw any exact conclusions that a physical disease or defect in fact caused a behavioral or mental defect.  As a result, courts have come out on either side of the threshold issue in FRE 401 – some have found that the neuroscientific evidence is appropriate for consideration by a jury who can decide what inferences to draw from it, while others find that this kind of evidence is too prejudicial while being only minimally probative and exclude the evidence under FRE 403, and still others allow the evidence but only for limited purposes, such as the sentencing phase of proceedings instead of the guilt phase. As technology continues to advance and neuroscientists continue to learn more about brain functioning, this kind of evidence may become commonplace in litigation. But for now, the admissibility decision seems to be fact-and-circumstance dependent, based on the case, the expert, the evidence, and the judge.


Genetically Modified Foods And The Consumer Quest For Disclosure

Nicholas Ratkowski, MJLST Staffer

In 2000, the Minnesota Journal of Law, Science, and Technology (MJLST) proudly published its first issue, spanning a variety of issues between Patent Protection of Computer Programs to an analysis of the First Amendment through the lens of Jesse Ventura. One Note addressed how genetically modified foods (GMOs) should be labeled, if at all. In the seventeen years since MJLST’s inception, much has changed – how has the landscape of GMO labeling progressed?

In 2000, the principal argument was whether or not GMOs should be specially labeled as such; the author references unexpected concomitant protein allergies and environmental effects as prime concerns. As of 2000, scientists had not identified any negative effects from consuming GMOs. The Note notes different approaches between Europe and the United States, with the former relying on strict disclosure requirements, and the latter ignoring the issue (for the most part). At the time of authorship, “[m]ore than 4,500 GM plants ha[d] been tested, and at least 40 ha[d] passed government reviews” and “as much as 70% of processed foods contain[ed] GM components. The Note “propose[d] that the most appropriate method of resolving the labeling issue involves developing a new, international, voluntary labeling standard for products that have not been developed through genetic engineering techniques or do not contain genetically engineered ingredients.”

Now to the fun part – has anything changed? The short answer is not really. In 2013, Connecticut became the first state to “successfully enact a law requiring food containing genetically modified ingredients to be labeled as such, though it comes with the unusual requirement that four other states must pass similar legislation.” As of 2017, more than 70 bills across 30 states have been proposed in an effort to require labeling of GMOs. Only two states (Vermont and Maine) have joined Connecticut’s lead in forcing disclosure of genetically modified foods. Maine’s disclosure law requires disclosure, but is subject to a litany of exceptions. Vermont’s seems a bit more stringent, but is also easily circumvented. See §3043(d) and §3044 (for example, “Any processed food that would be subject to subsection 3043(a) of this title solely because it includes one or more materials that have been produced with genetic engineering, provided that the genetically engineered materials in the aggregate do not account for more than 0.9 percent of the total weight of the processed food”).

It is perhaps surprising then that GMOs remain mostly invisible to the average consumer in the United States, considering “[m]ore than 70 percent of Americans say they don’t want genetically modified organisms in their food” and “92 percent of Americans want genetically modified foods to be labeled,” according to a 2014 Consumer Reports survey. I’m not smart enough to tell you whether or not eating GMOs has any effect on health, much less whether that effect would be positive or negative. I can, however, posit a theory to explain this paradox, albeit not a novel one – the Pro-GMO lobby is simply too powerful for states to butt heads with in the courts on the taxpayers’ dime. With Monsanto leading the charge, the pro-GMO lobby has spent tens of millions of dollars to fight state-level labeling initiatives. In 2013, lobbyists spent $9,300,000 to prevent GMO disclosure requirements. In just the first quarter of 2014, lobbyist spent another $9,000,000. How can states compete?

If the U.S. ever makes the policy decision to implement widespread labeling requirements for GMOs, doing so will require federal legislation; states have been shown to lack the resources necessary to fight the purveyors of incomplete information that are GMO lobbyists. On the other hand, would labeling have any discernable effect on consumers? Maybe not, but I believe consumers should have the choice to pick what they eat, and how their food is sourced.


En-Chantix: Smoking Cessation & Involuntary Intoxication

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?

[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

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

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

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?

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.