February 2017

Your Honor, That Guy “Subconsciously” Copied My Music!

Meibo Chen, MJLST Staffer

Under the Copyright Act, 17 USC § 106, a copyright owner of a copyrighted work has exclusive rights to reproduce, create derivative works, distribute, perform, or display that work.  The Copyright Act specifically carves out provisions that make it applicable to the music industry.  Thus, it is no surprise that the music industry frequently utilized the courts to protect its respective works.  While seemingly superfluous and redundant, such legal actions are justified as copyright infringement and piracy cost the US economy nearly $12.5 billion and more than 71,000 jobs yearly.

Copyright infringement, to the traditional public audience, simply would translate to: “that person downloaded my copyrighted music without my permission,” or “that person copied by song without my permission.”  Here is the kicker that the average consumer or musician most likely would not know.  There is such a thing called “subconscious copying” and “subconscious copyright infringement.” The illustrative case is George Harrison vs Bright Tunes Music Corp.  Long story short, the second musician wrote a song that very similar to that of the first musician’s, give or take a few notes and chords.  Even though the judge did not believe the second musician purposefully plagiarized, the second musician was nonetheless liable for a whopping $587,000.00 for subconscious plagiarism.

Flash forward to 2000, the 9th Circuit decided a similar case in Three Boys Music Corp. v. Michael Bolton, and put Learned Hand’s “subconscious copying” concept on the mantle.  More specifically, the 9th Circuit articulated the concept as requiring (1) a chain of events established between plaintiff’s work and defendant’s access to that work or (2) plaintiff’s work has been widely disseminated.

That boils down to an almost ridiculously broken cause of action for copyright infringement.  It is as if more famous musical works get more deference in an infringement case, just because more people heard it.  It also takes the objective standard and throws it out the window, as this “subconscious copying” forces a judge or jury to dive inside the mind of the alleged infringer.  To make it even more ridiculously broken, the fact-finder has to determine the SUBconscious.


Extending the Earth’s Life to Make It Off-World: Will Intellectual Property Law Allow Climate Change to Go Unchecked?

Daniel Green, MJLST Staffer

The National Aeronautics and Space Administration (NASA) recently discovered seven Earth-like planets. Three of these planets are even located the specific distance from the star, Trappist-1, in order to be considered in the proposed “Goldilocks zone” necessary to sustain life, thereby bringing about the conversation of whether a great migration for humanity is in order such as seen in movies of the last ten years such as Passengers, The Martian, Interstellar, even Wall-E. Even Elon Musk and Stephen Hawking have made statements that the human race needs to leave earth before the next extinction level event occurs. The possibility that these planets may be inhabitable presents some hope for a future to inhabit other planets.

Sadly, these planets are forty light years away (or 235 trillion miles). Although relatively near to Earth in astronomical terms, this fact means that there exists no possibility of reaching such a planet in a reasonable time with present technology despite the fact that NASA is increasing funding and creating institutes for such off worldly possibilities. As such, humankind needs to look inward to extend the life of our own planet in order to survive long enough to even consider such an exodus.

Admittedly, humanity faces many obstacles in its quest to survive long enough to reach other planets. One of the largest and direst is that of climate change. Specifically, the rise in the temperature of the Earth needs to be kept in check to keep it within bounds of the two-degree Celsius goal before 2100 C.E. Fortunately, technologies are well on the way of development to combat this threat. One of the most promising of these new technologies is that of solar climate engineering.

Solar climate engineering, also known as solar radiation management, is, essentially, a way to make the planet more reflective in order to block sunlight and thereby deter the increase in temperature caused by greenhouse gases. Though promising, Reynolds, Contreras, & Sarnoff predict that this new technology may be greatly hindered by intellectual property law in Solar Climate Engineering and Intellectual Property: Toward a Research Commons.

Since solar climate engineering is a relatively new scientific advancement, it can be greatly improved by the sharing of ideas. However, the intellectual property laws run directly contrary to this, begging the question as to why would anyone want to hinder technology so vital to the Earth’s survival. Well the answer lies in numerous reasons including the following three:

  • Patent “thickets” and the development of an “anti-commons”: This problem occurs when too many items in the same technological field are patented. This makes patents and innovations extremely difficult to patent around. As such, it causes scientific advancement to halt since patented technologies cannot be built upon or improved.
  • Relationship to trade secrets: Private entities that have financial interests in funding research may refuse to share advancements in order to protect the edge it gives them in the market.
  • Technological lock in: Broad patents at the beginning of research may force others to rely on technologies within the scope of the patent when working on future research and development. Such actions may ingrain a certain technology into society even though a better alternative may be available but not adopted.

There is no need to despair yet though since several steps can be taken to combat barriers to the advancement of solar climate engineering and promote communal technological advancement such as:

  • State interventions: Government can step in so as to ensure that intellectual property law does not hinder needed advancements for the good of humanity. They can do this in numerous action such as legislative and administrative actions, march-in rights, compulsory licensing, and asserting a control over funding.
  • Patent pools and pledges: Patent pools allow others to use one’s patents in development with the creation of an agreement to split the proceeds. Similarly, patent pledges, similarly, limit the enforcement of a patent holder by a promise in the form of a legally binding commitment. Though patent pools have more limitations legally, both of these incentivize the concept of sharing technology and furthering advancement.
  • Data commons: Government procurement and research funding can promote systematic data sharing in order to develop a broadly accessibly repository as a commons. Such methods ideally promote rapid scientific advancement by broadening the use and accessibility of each advancement through the discouragement of patents.

Providing that intellectual property laws do not stand in the way, humanity may very well have taken its first steps in extending its time to develop further technologies to, someday, live under the alien rays of Trappist-1.


Ensuring Quality And Avoiding Bad Eggs: Food Executives, Food Safety And Criminal Sanctions

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is last and #4 in a series on current FDA issues. You can find the previous post herehere and here.]

Food can—and all too often does—make people sick. Anyone who has suffered from food-borne illness would be unlikely to want to repeat the experience. The safety of our food relies in large part on compliance with food safety protocols. From Upton Sinclair’s The Jungle to today, the processing and manufacturing of food is rife with stories of poor practices leading to public health problems.

Maintaining the safety of the nation’s food supply is an ongoing challenge for regulators and businesses. The FDA requires that food be processed or produced using good manufacturing practices, or else risk food being labeled “adulterated” as it was produced under “unfit” conditions. Producing food in such a way as to avoid being “contaminated with filth” seems like a worthwhile goal.

Ensuring food safety sometimes means throwing away product, but it can be a matter of life and death. For example, Listeria concerns prompted Blue Bell Ice Cream to remove all of its product from store shelves in 2015. Three deaths were reported from the ice cream. In the midst of its food safety issues, Chipotle closed all locations across the US on February 8, 2016 to focus improving food safety protocols.

What happens when individuals upend the delicate balance of food safety? In the wake of several high-profile trials, food executives charged with food safety violations may be walking on eggshells. As Food Safety News put it, “Not so long ago, errant food industry managers and executives did not have to worry about going to jail. But they do now.”

What changed? In part, peanut butter, cantaloupe, and eggs. These products might seem like an unlikely combination, but these foods—or rather some of the companies behind them—demonstrate the “New Normal” in food safety enforcement.

Taking peanut butter first, a nationwide Salmonella outbreak sickened hundreds of Americans and killed nine. Stewart Parnell, the executive behind the Peanut Corporation of America, approved shipments of peanut butter that his company had tested positive for Salmonella and those that were known to be “partially covered in dust and rat crap.” Instead of jettisoning product for public safety, he instead demanded, over email, that “[expletive deleted], just ship it. I can’t afford to loose [sic] another customer.” According to the Washington Post, prosecutors sought a life sentence, but he was ultimately sentenced for 28 years. One man, quoted by the Post, whose mother had died due to the peanut butter said, “As far as I’m concerned, he’s a murderer.”

As for cantaloupe, Eric and Ryan Jensen—two Colorado brothers—pled guilty to six counts arising from their role in a 2011 Listeria outbreak. According to the FDA, the Jensen brothers knew they were putting the public at risk by not sufficiently washing their produce and maintaining the fruit in “unsanitary conditions.” As a result, the deadly cantaloupes were linked to 147 hospitalizations and 33 deaths. You read that right; 33 lives were ended due to contaminated cantaloupe.

With regard to eggs, the DeCosters of Quality Egg, LLC may have presented the courts with the most significant responsible corporate officer liability ruling in over forty years, according to the venerable FDA Law Blog. Jack DeCoster and his son Peter, the owner and COO of the company, respectively, were sentenced to three month’s imprisonment for their part in food safety outbreaks that caused an estimated 56,000 Americans to fall ill.

As noted in the Eighth Circuit opinion upholding the prison sentence, the company pled guilty to bribing a food safety inspector and introducing misbranded and adulterated eggs into interstate commerce. The opinion details the conditions at Quality Egg’s Iowa operations in August 2010:

The FDA inspected the Quality Egg operations in Iowa from August 12–30, 2010. Investigators discovered live and dead rodents and frogs in the laying areas, feed areas, conveyer belts, and outside the buildings. They also found holes in the walls and baseboards of the feed and laying buildings. The investigators discovered that some rodent traps were broken, and others had dead rodents in them. In one building near the laying hens, manure was found piled to the rafters; it had pushed a screen out of the door which allowed rodents into the building. Investigators also observed employees not wearing or changing protective clothing and not cleaning or sanitizing equipment.

The FDA concluded that Quality Egg had failed to comply with its written plans for biosecurity and salmonella prevention. One government expert reported that “there were minimal to no records from the poultry [ ] barns to indicate that company personnel [had] implemented the written plans [to eliminate salmonella].” The agency also discovered that the company’s eggs tested positive for salmonella at a rate of contamination approximately 39 times higher than the current national rate, and that the contamination had spread throughout all of the Quality Egg facilities. In October 2010 the FDA instructed Quality Egg to euthanize every hen, remove the manure, repair its facilities, and disinfect its barns to prevent the risk of another outbreak.

As responsible corporate officers, the DeCosters pled guilty to misdemeanor violations of the Food, Drug, and Cosmetic Act (FDCA). In their plea agreements, they stipulated that they “had not known that the eggs were contaminated at the time of shipment, but stipulated that they were in positions of sufficient authority to detect, prevent, and correct the sale of contaminated eggs had they known about the contamination.”

An important question before the Eighth Circuit panel was the requisite knowledge required for imposing criminal penalties, particularly imprisonment, on responsible corporate officials. In the cantaloupe and peanut butter cases reviewed above, each executive knew of food safety violations, but the record in this case did not reveal that the DeCosters had actual knowledge. The three judge DeCoster panel issued a three-opinion ruling, with the majority advancing a concept of responsible corporate officer liability arising from the FDCA and the Supreme Court’s ruling in United States v. Park, 421 U.S. 658 (1975). Under Park, responsible corporate officials were prosecuted under a lower standard than normally used for criminal cases, whether under theories of negligence or strict liability.

The DeCoster majority noted that the FDCA and Park enabled criminal sanctions for responsible corporate officials for their own failure to prevent or remedy the conditions giving rise to the food safety claim. The judges in the majority agreed that vicarious liability was not applicable here, instead it was the executives’ own duty to be aware of, to prevent, and to address potential violations of the FDCA that gave rise to criminal penalties. Writing in concurrence, Judge Gruender reasoned that the DeCosters “are responsible for their own failures to exercise reasonable care to prevent the introduction of adulterated food.” In the absence of actual knowledge, the DeCoster majority ascribed constructive knowledge to the DeCosters in running their operation. They “knew or should have known” of the unsanitary conditions and failed to address or prevent them.

Writing in dissent, Judge Beam reasoned that the DeCoster’s sentence was inappropriate. Judge Beam would reject negligence as an appropriate standard for corporate officer liability under the FDCA, substituting a mens rea requirement similar to that found elsewhere in criminal law. The dissent noted, “there is no precedent that supports imprisonment without establishing some measure of a guilty mind on the part of these two individuals, and none is established in this case” and that “no person associated with Quality Egg had knowledge of salmonella contamination at any relevant time.”

Given the three-opinion decision, the DeCoster case was appealed for an en banc rehearing within the Eighth Circuit, which was denied in September 2016. Petition for certiorari was filed in January 2017, and the case may make it to the Supreme Court.

Public health requires vigilance, especially on the part of those involved with producing and processing the nation’s food supply. The FDA and other food safety regulators work with businesses to maintain public health and safety. Unfortunately, all too often there are bad eggs whose decisions, or lack of awareness, may put the public at risk. Time will tell whether the Supreme Court weighs in on the proper standard for criminal liability for food safety violations in the wake of several recent high-profile cases.


Something to Chew On: The FDA, Food, and a Healthy Dose of Definitions

MJLST Guest Blogger, Tommy Tobin

[Editor’s Note: This post is #3 in a series on current FDA issues. You can find the previous post here and here.]

Is food medicine? The answer to this simple question is surprisingly complicated.

The name of the Food and Drug Administration (FDA) seems to distinguish between foods and drugs. So too does the Federal Food, Drug, and Cosmetics Act, which helpfully defines “food” as “(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.”

While it is not difficult to swallow the concept of chewing gum being food, the broad legal definition of “food” is somewhat circular and does not provide much guidance by itself.  Indeed, the definition of “drug” under the same law notes that drugs are, in relevant part, “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

Setting the table for further discussion, it should be noted that foods and drugs face different regulatory burdens. For example, drugs face pre-market approval. As for foods, the FDA does not have sole regulatory oversight over food products, which it shares with approximately 14 other federal agencies. The Government Accountability Office labeled the patchwork of federal food safety oversight as a “high risk issue” noting that it had caused “inconsistent oversight, ineffective coordination, and inefficient use of resources.”

Knowing whether an item is a drug or a food dictates whether it is regulated appropriately and even which laws apply to the item. From the definitions, it would seem that foods are categorically not drugs. Yet, sometimes foods do function as medicine. For example, the Harvard Food Law & Policy Clinic argues that “for critically and chronically ill people, food is medicine.” Part of the Clinic’s work has advocated for expanded medically-tailored food and nutrition interventions to improve health outcomes and reduce overall health care costs for high-risk, high-need populations. Even outside of high-risk populations, it is likely many of us provide self-care through food, such as sipping chicken soup for colds or the flu.

Adding more food for thought, there are several terms that blur the lines between the categories of “food” and “drug.” The FDA notes that “terms like ‘functional foods’ or ‘nutraceuticals’ are widely used in the marketplace” but are not explicitly defined in the Food, Drug, and Cosmetic Act. While one could devote a book to the regulation of nutraceuticals and functional foods (and some have done so), it is sufficient here to note that nutraceuticals and functional foods have their own definitions in the relevant, non-regulatory literature. According to an article in the aptly-titled scholarly journal Nutrients, a nutraceutical is “food (or part of a food) that provides medical or health benefits, including the prevention and/or treatment of a disease” and functional foods are “food products that have an added positive health benefit” (internal citations omitted). Notably, each definition expressly notes that these items are foods, not drugs. Put another way, an apple a day may keep doctors away, but apples enriched with antioxidants may be a functional food that merits a price premium from consumers.

The terms have largely arisen out of marketing practice, and a combination of the words “nutrition” and “pharmaceutical.” Entire publications have devoted themselves to the news and scholarly analysis of these products, including Nutraceuticals World and the Journal of Functional Foods. One recent article examined whether Jelly Belly, the jelly bean purveyor, could support its claims that its Sports Beans were “clinically-proven” to maximize sports performance.

Further blurring the line between foods and drugs, a “medical food” is defined under a statute that has “drug” in the name, but the product is not actually a “drug.” A “medical food” is defined under the Orphan Drug Act, as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Pursuant to the above definition, the FDA has declared that medical foods must be taken only under the supervision of a physician. According to a recent FDA Guidance Document, medical foods are explicitly not drugs and are not subject to the requirements that apply to drugs. As an example, one medical food, Deplin, is an orange pill that advertises itself as a “prescription medical food” specifically designed to meet the “clinical dietary management of depression and schizophrenia.”

In the supermarket, consumers may stroll from the pharmacy aisles to the food aisles, seeing pharmaceuticals one moment and nutraceuticals the next. With consumers willing to pay a price premium for healthy foods, including functional foods, foods that make claims to reduce disease and promote good health are likely here to stay.


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.