Ethics

Fi-ARRR-E & Fury: Why Even Reading the Pirated Copy of Michael Wolff’s New Book Is Probably Copyright Infringement

January 8, 2018
Copyrights, Ethics, Intellectual Property, Internet, Social Media

By Tim Joyce, MJLST EIC-Emeritus

THE SITUATION

Lately I’ve seen several Facebook links to a pirated copy of Fire & Fury: Inside the Trump White House, the juicy Michael Wolff expose documenting the first nine months of the President’s tenure. The book reportedly gives deep, behind-the-scenes perspectives on many of Mr. Trump’s most controversial actions, including firing James Comey and accusing President Obama of wiretapping Trump Tower.

It was therefore not surprising when Trump lawyers slapped a cease & desist letter on Wolff and his publisher. While there are probably volumes yet to be written about the merits of those claims (in my humble opinion: “sorry, bros, that’s not how defamation of a public figure works”), this blog post deals with the copyright implications of sharing and reading the pirated copy of the book, and the ethical quandaries it creates. I’ll start with the straightforward part.

THE APPLICABLE LAW

First, it should almost go without saying that the person who initially created the PDF copy of the 300+ page book broke the law. (Full disclosure: I did click on the Google link, but only to verify that it was indeed the book and not just a cover page. It was. Even including the page with copyright information!) I’ll briefly connect the dots for any copyright-novices reading along:

- Wolff is the “author” of the book, a “literary work” that constitutes an “original works of authorship fixed in any tangible medium of expression” [see 17 USC 102’].
- As the author, one of his copyrights is to control … well … copying. The US Code calls that “reproduction” [see 17 USC 106].
- He also gets exclusive right to “display” the literary work “by means of a film, slide, television image, or any other device or process” [see 17 USC 101]. Basically, he controls display in any medium like, say, via a Google Drive folder.
- Unauthorized reproduction, display, and/or distribution is called “infringement” [see 17 USC 501]. There are several specific exceptions carved into the copyright code for different types of creative works, uses, audiences, and other situations. But this doesn’t fall into one of those exceptions.

So, the anonymous infringer has broken the law.

[It’s not clear, yet, whether this person is also a criminal under 17 USC 506, because I haven’t seen any evidence of fraudulent intent or acting “for purposes of commercial advantage or private financial gain.”]

Next, anyone who downloads a copy of the book onto their smartphone or laptop is also an infringer. The same analysis applies as above, only with a different starting point. The underlying material’s copyright is still held by Wolff as the author. Downloading creates a “reproduction,” which is still unauthorized by the copyright owner. Unauthorized exercise of rights held exclusively by the author + no applicable exceptions = infringement.

Third, I found myself stuck as to whether I, as a person who had intentionally clicked through into the Google Drive hosting the PDF file, had also technically violated copyright law. Here, I hadn’t downloaded, but merely clicked the link which launched the PDF in a new Chrome tab. The issue I got hung up on was whether that had created a “copy,” that is a “material objects … in which a work is fixed by any method now known or later developed, and from which the work can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device.” [17 USC 101]

Computer reproductions are tricky, in part because US courts lately haven’t exactly given clear guidance on the matter. (Because I was curious — In Europe and the UK, it seems like there’s an exception for temporary virtual copies, but only when incidental to lawful uses.) There’s some debate as to whether it’s infringement if only the computer is reading the file, and for a purpose different than perceiving the artistic expression. (You may remember the Google Books cases…) However, when it’s humans doing the reading, that “purpose of the copying” argument seems to fall by the wayside.

Cases like Cartoon Network v. CSC Holdings have attempted to solve the problem of temporary copies (as when a new browser window opens), but the outcome there (i.e., temporary copies = ok) was based in part on the fact that the streaming service being sued had the right to air the media in question. Their copy-making was merely for the purposes of increasing speed and reducing buffering for their paid subscribers. Here, where the right to distribute the work is decidedly absent, the outcome seems like it should be the opposite. There may be a case out there that deals squarely with this situation, but it’s been awhile since copyright class (yay, graduation!) and I don’t have free access to Westlaw anymore. It’s the best I could do in an afternoon.

Of course, an efficient solution here would be to first crack down on the entities and individuals that first make the infringement possible – ISPs and content distributors. The Digital Millennium Copyright Act already gives copyright owners a process to make Facebook take bootleg copies of their stuff down. But that only solves half the problem, in my opinion. We have to reconcile our individual ethics of infringement too.

ETHICAL ISSUES, FOR ARTISTS IN PARTICULAR

One of the more troubling aspects of this pirateering that I saw was that the link-shares came from people who make their living in the arts. These are the folks who–rightly, in my opinion–rail against potential “employers” offering “exposure” instead of cold hard cash when they agree to perform. To expect to be paid for your art, while at the same time sharing an illegal copy of someone else’s, is logically inconsistent to me.

As a former theater actor and director (read: professional almost-broke person) myself, I can understand the desire to save a few dollars by reading the pirated copy. The economics of making a living performing are tough – often you agree to take certain very-low-paying artistic jobs as loss-leaders toward future jobs. But I have only met a very few of us willing to perform for free, and even fewer who would tolerate rehearsing with the promise of pay only to be stiffed after the performance is done. That’s essentially what’s happening when folks share this bootleg copy of Michael Wolff’s book.

I’ve heard some relativistic views on the matter, saying that THIS book containing THIS information is so important NOW, that a little infringement shouldn’t matter. But you could argue that Hamilton, the hit musical about the founding of our nation and government, has equally urgent messages regarding democracy, totalitarianism, individual rights, etc. Should anyone, therefore, be allowed to just walk into the theater and see the show without paying? Should the cast be forced to continue performing even when there is no longer ticket revenue flowing to pay for their efforts? I say that in order to protect justice at all times, we have to protect justice this time.

tl;dr

Creating, downloading, and possibly even just viewing the bootleg copy of Michael Wolff’s book linking around Facebook is copyright infringement. We cannot violate this author’s rights now if we expect to have our artistic rights protected tomorrow.

Contact Me!

These were just some quick thoughts, and I’m sure there’s more to say on the matter. If you’d like to discuss any copyright issues further, I’m all ears.

Fi-ARRR-E & Fury: Why Even Reading the Pirated Copy of Michael Wolff’s New Book Is Probably Copyright Infringement

January 8, 2018
Copyrights, Ethics, Intellectual Property, Internet, Social Media

By Tim Joyce, MJLST EIC-Emeritus

THE SITUATION

Lately I’ve seen several Facebook links to a pirated copy of Fire & Fury: Inside the Trump White House, the juicy Michael Wolff expose documenting the first nine months of the President’s tenure. The book reportedly gives deep, behind-the-scenes perspectives on many of Mr. Trump’s most controversial actions, including firing James Comey and accusing President Obama of wiretapping Trump Tower.

It was therefore not surprising when Trump lawyers slapped a cease & desist letter on Wolff and his publisher. While there are probably volumes yet to be written about the merits of those claims (in my humble opinion: “sorry, bros, that’s not how defamation of a public figure works”), this blog post deals with the copyright implications of sharing and reading the pirated copy of the book, and the ethical quandaries it creates. I’ll start with the straightforward part.

THE APPLICABLE LAW

First, it should almost go without saying that the person who initially created the PDF copy of the 300+ page book broke the law. (Full disclosure: I did click on the Google link, but only to verify that it was indeed the book and not just a cover page. It was. Even including the page with copyright information!) I’ll briefly connect the dots for any copyright-novices reading along:

- Wolff is the “author” of the book, a “literary work” that constitutes an “original works of authorship fixed in any tangible medium of expression” [see 17 USC 102’].
- As the author, one of his copyrights is to control … well … copying. The US Code calls that “reproduction” [see 17 USC 106].
- He also gets exclusive right to “display” the literary work “by means of a film, slide, television image, or any other device or process” [see 17 USC 101]. Basically, he controls display in any medium like, say, via a Google Drive folder.
- Unauthorized reproduction, display, and/or distribution is called “infringement” [see 17 USC 501]. There are several specific exceptions carved into the copyright code for different types of creative works, uses, audiences, and other situations. But this doesn’t fall into one of those exceptions.

So, the anonymous infringer has broken the law.

[It’s not clear, yet, whether this person is also a criminal under 17 USC 506, because I haven’t seen any evidence of fraudulent intent or acting “for purposes of commercial advantage or private financial gain.”]

Next, anyone who downloads a copy of the book onto their smartphone or laptop is also an infringer. The same analysis applies as above, only with a different starting point. The underlying material’s copyright is still held by Wolff as the author. Downloading creates a “reproduction,” which is still unauthorized by the copyright owner. Unauthorized exercise of rights held exclusively by the author + no applicable exceptions = infringement.

Third, I found myself stuck as to whether I, as a person who had intentionally clicked through into the Google Drive hosting the PDF file, had also technically violated copyright law. Here, I hadn’t downloaded, but merely clicked the link which launched the PDF in a new Chrome tab. The issue I got hung up on was whether that had created a “copy,” that is a “material objects … in which a work is fixed by any method now known or later developed, and from which the work can be perceived, reproduced, or otherwise communicated, either directly or with the aid of a machine or device.” [17 USC 101]

Computer reproductions are tricky, in part because US courts lately haven’t exactly given clear guidance on the matter. (Because I was curious — In Europe and the UK, it seems like there’s an exception for temporary virtual copies, but only when incidental to lawful uses.) There’s some debate as to whether it’s infringement if only the computer is reading the file, and for a purpose different than perceiving the artistic expression. (You may remember the Google Books cases…) However, when it’s humans doing the reading, that “purpose of the copying” argument seems to fall by the wayside.

Cases like Cartoon Network v. CSC Holdings have attempted to solve the problem of temporary copies (as when a new browser window opens), but the outcome there (i.e., temporary copies = ok) was based in part on the fact that the streaming service being sued had the right to air the media in question. Their copy-making was merely for the purposes of increasing speed and reducing buffering for their paid subscribers. Here, where the right to distribute the work is decidedly absent, the outcome seems like it should be the opposite. There may be a case out there that deals squarely with this situation, but it’s been awhile since copyright class (yay, graduation!) and I don’t have free access to Westlaw anymore. It’s the best I could do in an afternoon.

Of course, an efficient solution here would be to first crack down on the entities and individuals that first make the infringement possible – ISPs and content distributors. The Digital Millennium Copyright Act already gives copyright owners a process to make Facebook take bootleg copies of their stuff down. But that only solves half the problem, in my opinion. We have to reconcile our individual ethics of infringement too.

ETHICAL ISSUES, FOR ARTISTS IN PARTICULAR

One of the more troubling aspects of this pirateering that I saw was that the link-shares came from people who make their living in the arts. These are the folks who–rightly, in my opinion–rail against potential “employers” offering “exposure” instead of cold hard cash when they agree to perform. To expect to be paid for your art, while at the same time sharing an illegal copy of someone else’s, is logically inconsistent to me.

As a former theater actor and director (read: professional almost-broke person) myself, I can understand the desire to save a few dollars by reading the pirated copy. The economics of making a living performing are tough – often you agree to take certain very-low-paying artistic jobs as loss-leaders toward future jobs. But I have only met a very few of us willing to perform for free, and even fewer who would tolerate rehearsing with the promise of pay only to be stiffed after the performance is done. That’s essentially what’s happening when folks share this bootleg copy of Michael Wolff’s book.

I’ve heard some relativistic views on the matter, saying that THIS book containing THIS information is so important NOW, that a little infringement shouldn’t matter. But you could argue that Hamilton, the hit musical about the founding of our nation and government, has equally urgent messages regarding democracy, totalitarianism, individual rights, etc. Should anyone, therefore, be allowed to just walk into the theater and see the show without paying? Should the cast be forced to continue performing even when there is no longer ticket revenue flowing to pay for their efforts? I say that in order to protect justice at all times, we have to protect justice this time.

tl;dr

Creating, downloading, and possibly even just viewing the bootleg copy of Michael Wolff’s book linking around Facebook is copyright infringement. We cannot violate this author’s rights now if we expect to have our artistic rights protected tomorrow.

Contact Me!

These were just some quick thoughts, and I’m sure there’s more to say on the matter. If you’d like to discuss any copyright issues further, I’m all ears.

Act Fast! Get Access to Your Genetic Past, Present, and Future for One Low, Low Price

October 23, 2017
Biotechnology, Ethics, Health Law

Hannah Mosby, MJLST Staffer

It’s Saturday morning, and you’re flipping through channels on your TV when you hear the familiar vocal inflections of an infomercial. For three monthly installments of $19.99, you can get access to your complete genetic ancestry, and any genetic predispositions that might impact your health—both now and in the future. From the comfort of your couch, you can order a kit, provide a DNA sample, and poof. . . a month or two later, you know everything you could ever want to know about your own genetic makeup. Sounds a little far-fetched, right?

Wrong. It’s 2017, and genetic testing kits are not only readily accessible to the public—they’re relatively inexpensive. Curious about whether you’re really German and Irish? Wondering if you—like your mother and her grandmother—might develop Alzheimer’s disease? Companies like 23andMe have you covered. The company advertises kits that cover both ancestry and certain health risks, and has recorded the sale of over 2 million testing kits. Maybe you’ve heard your friend, your coworker, or your sister talking about these genetic tests—or maybe they’ve already ordered their own kit.

What they’re probably not talking about, however, is the host of bioethical implications this sort of at-home genetic testing has. To some, ancestry may be cocktail party conversation, but to others, heritage is an enormous component of their personal identity. Purchasing a genetic testing kit may mean suddenly finding out that your ancestry isn’t what you thought it was, and consumers may or may not understand the emotional and psychological implications of these kinds of results. Genetic health risks present an even bigger ethical challenge—it’s all too easy to mistake the word “predisposition” for a diagnosis. Unless consumers are thoroughly educated about the implications of specific gene variants, companies like 23andMe aren’t providing useful health data—they’re providing enormously impactful information that the average consumer may not be equipped to understand or cope with.

It’s also easy to forget about the data privacy concerns. According to 23andMe’s commercial website, “23andMe gives you control over your genetic information. We want you to decide how your information is used and with whom it is shared.” That sounds nice—but is that “meaningful choice” masked in legal-ese? Existing federal regulation bars discriminatory use of genetic information by insurance companies and employers, but how does that affect other entities, if it does at all? Third-party access to this highly personal information is under-regulated, and it can’t be adequately safeguarded by “consent” without thoroughly explaining to consumers the potential implications of third-party disclosure.

It’s easy to get wrapped up in new and exciting biotechnology—especially when it’s publicly accessible. And we should be excited. . . accessibility and transparency in a field as intimidating as genetics can be is worth celebrating. Further, genetic testing brings with it a host of preventative health and personal benefits. However, it also raises some ethical and regulatory concerns, and it’s important to make sure our enthusiasm—as consumers, but also as entrepreneurs—for genetic technology doesn’t outpace the regulatory systems available to govern it.

Happy Mother’s Day to All the Moms!: Law, Science, Technology and Beagles

May 7, 2017
Biotechnology, Ethics, Food and Drug Law

Angela Fralish, MJLST Guest Blogger

Beagles are well-known as a quintessential family dog because they love humans and listen to their owners (most of the time). What is less known, is that those same traits are the primary reasons they are used in 95% of canine medical experimentation. Although, beagles are not biologically comparable to humans, they are compliant people-pleasers, making them ideal subjects for scientific experiments.

This reality is a hard pill to swallow for animal lovers and scientists alike. To scientists, research beagles are a necessary evil decreasing the pain and suffering of humans. To advocates, beagles are victims of unspeakable cruelty.

One law bridges the divide between these opposing views to help the beagles. The Beagle Freedom Bill, created by the Beagle Freedom Project (BFP), forges a compromise between animal rights lawyers, scientists and medical technologists. The Bill asks that ”tax-payer funded laboratories offer up the “experimentally-spent” dogs and cats for public adoption through rescue organizations.” In other words, once the beagle is no longer used for research, the dog is given a home instead of euthanasia. Minnesota was the first state to sign the Bill into law in 2014, and since then, 5 more states have joined. Currently, 5 additional states are considering adopting this law as well.

In addition to legislative measures, the BFP has found other ways to help research beagles. They have created new technology such as the Cruelty-Cutter app which helps shoppers easily scan products for humane animal testing, and sued the USDA demanding restoration of scrubbed animal records. The Beagle Freedom Project is a leader in animal science law and a great example of how lawyers, scientists and technologists can work together for the greater good of both humans and animals.

Scientists are working to replace this “necessary evil” as well. According to Dr. Teresa Arora’s article Substitute of Animals in Drug Research: An Approach Towards Fulfillment of 4Rs, research methods are being developed that are “superior to using animals to learn about human disease or predict the safety of new drugs [and include] stem cells, microdosing, DNA chips, microfluidics chips, human tissue, new imaging technologies, and post-marketing drug surveillance.” There is even a Center for Alternatives to Animal Testing at John Hopkins University and the NC3R in the UK.

For an employee of medical research looking to carve out meaning in their every day workweek, helping research animals through new collaborative measures is one way to answer the call. As a lawyer, scientists or technologist, you can help develop policy, arbitrate between groups, hold violators accountable, assist in medical technology development, vote for the Beagle Freedom Bill or adopt a research beagle. According to Congressman Earl Blumenauer, “members of Congress are realizing that protecting animals is not just the right thing to do, it’s also developing to become potent politically.” Congress will need help understanding the relationship between animal models and science in order to make improvements. That help will come from people who work in these fields on a daily basis.

The Beagle Freedom Bill highlights the plight of animals languishing in labs and promotes cruelty-free lifestyle choices everyone can make. Now that BFP has opened the door, it is time for all of us to show a little gratitude to the beagles for their sacrifice in advancing medical science such as chemotherapy and insulin. We can do this in our own unique ways, and although we can’t change the world for all beagles, for some beagles, we can change the world.

As Mahatma Ghandi stated, “The greatness of a nation and its moral progress can be judged by the way its animals are treated.” I hope ours is one of progress.

A Different Kind of Egg for Easter: Scientific Proof of Fetal Pain and the Legal Right to Choose Abortion

April 7, 2017
Ethics, Health Law, Reproductive Health

Angela Fralish, MJLST Invited Blogger

On January 3, 2017 Congressman Trent Franks from Arizona suggested a major change in the law which could overturn precedent of more than 30 years. He introduced the “Pain-Capable Unborn Child Protection Act” which generally prohibits abortions after 20 weeks. Fueling this highly controversial legislation is a complex scientific and legal debate as to whether or not the fetus can feel pain at 20 weeks, and if that proof should result in a change in the law.

Advocates on both sides of the Act include physicians, legislators, constitutional law experts, policy interest groups, philosophers and neuroscientists. Supporters of non-interference prior to viability advocate that proof of fetal pain is not substantiated. One the other side, fetal pain protestors argue that a fetus can in fact feel pain at 20 weeks, and abortions should be proscribed between after that time.

The Supreme Court ruled in watershed cases Roe v. Wade (1973), and Planned Parenthood v. Casey (1992), that a woman’s right to elect an abortion prior to viability, which is usually 23 to 24 weeks, is a constitutionally protected “fundamental right.” Time and time again, the Supreme Court has upheld that precedent, and prevented the right to interfere with a woman’s choice prior to viability. However, new medical technology advances call the old law into question. As Supreme Court Justice Sandra Day O’Connor noted in Roe, medical science will reduce the point of viability and “Roe is clearly on a collision course with itself.”

Scientifically speaking, both parties have referenced the anatomical makeup for fetal pain to support their arguments. Studies show that the thalamus and pain sensor receptors, usually developed by 20 weeks, are used to process pain. The counter argument is that the anatomical capability to feel pain does not equate to actually feeling pain: fetuses at 20 weeks lack the necessary pain pathways, or physiological ability to communicate pain, even if the thalamus and receptors are available. Legislative findings of the Pain-Capable Unborn Child Protection Act argue that fetuses at 20 weeks not only respond to touch, but also emit stress hormones and recoil at painful stimuli. Thus, some have concluded that fetuses are indeed “capable” of feeling pain and abortion should be proscribed at that time.

So where should the court draw the line? One past example of legislation related to medical uncertainty related to fetal pain was the Partial Birth Abortion Act of 2003. After much controversy, this act was upheld by Gonzalez v. Carhart (2007) noting that “medical uncertainty does not foreclose the exercise of legislative power in the abortion context any more than it does in other contexts.” In this sense, Congressman Trent Franks’ bill could potentially pass, despite long held precedent, because the courts retain legislative power within the abortion context when there is medical uncertainty. However, much like the Partial Birth Abortion Act, if Congress passes this legislation, it will be up to the state courts and modern day legal advocates to reinforce or discredit it on a case-by-case basis.

Only time will tell how this intricately webbed science-law issue will play out. Judith Munson quoted as early as 1975 in her article Fetal Research: A View from Right to Life to Wrongful Birth, “The controversy has become a contest between the state of the art and the state of the law.” Constitutional lawyers, physicians and the general public certainly have their work cut out for them in understanding how medical science impacts the law. As O.D. Jones remarks, “Law and neuroscience seem strange bedfellows. But the engagement of law with neuroscientific evidence was inevitable.” This holds especially true in relation to mother chicks and decisions regarding their “eggs.”

Is There a Reasonable Pot of Gold at the End of the Rainbow?: Legal Ethics, Brain Stimulation and Neuroprosthetics

March 3, 2017
Biotechnology, Ethics, Neuroscience

Angela Fralish, MJLST Invited Blogger

As expert bioethicist Dr. Walter Glannon remarks, “Interventions in the brain raise general ethical questions about weighing the potential benefit of altering neural circuits against the potential harm from neurophysiological and psychological sequelae.” Laws governing human subject research for these interventions mandate that “risks to subjects are reasonable in relation to anticipated benefits.” Modern brain technologies in neuroprosthetics make the harm/benefit analysis challenging because there are many unanswered questions surrounding neuroprosthetic implementation.

So what is a neuroprosthetic? Neuroprosthetic devices use electrode muscle and nerve stimulation to produce muscle contraction and restore motor function. Basically, since the brain controls the body, a device is put on the brain telling it to make the body work. Through neuroprosthetics devices, a person may restore movement by bypassing nervous system damage which allows greater independence in daily living. To someone whose dependence is caused by non-working body parts such as blindness, Parkinson’s or spinal cord paralysis, this technology holds great potential for a higher quality of life.

However, the use of a neuroprosthetic may involve negative side effects. Some are more behavioral such as gambling and addiction while others are biological like pain from overstimulation. For instance, Steffen K. Rosahl discusses how “relatives and friends sometimes complain of personality changes in the patient, ranging from transient confusion and bradyphrenia to euphoria or depression.” Further, implanting the device is not an exact science and if done incorrectly, a completely different result may occur such as loss of speech or other unknown changes. Research also indicates that an autonomy-capable neuroprosthetic can influence the brain if its actions go unchecked, making it a threat to the user and his or her surroundings. There are serious risks and concerns associated with the use of neurprosthetic technology.

The juncture of law, science and research is especially prevalent in modern neurological research. The cochlear implant is one such example. While the implant has allowed many children all over the world to hear for the first time, it has also led to shock and convulsions. In Sadler v. Advanced Bionics, Inc., the plaintiffs won a $7.25 million verdict in a negligence action when the manufacturer failed to adequately test or obtain approval for a new material in one of their implant designs. The unanswered legal questions in this case evolved around product recalls for implants, overcoming federal preemption, regulatory laws governing research submissions and product liability. Exactly how does a business recall an implant in someone’s brain!?

Clearly, legal-science partnerships are in high demand in advancing neurological research. Scientists need to understand the law and lawyers need to understand science. This principle is critically important when research institutions weigh the risks and benefits to subjects before that device ever hits the market. As Stephen Breyer, associate justice of the U.S. Supreme Court, stated, “In this age of science, we must build legal foundations that are sound in science as well as in law. Scientists have offered their help. We in the legal community should accept that offer.”

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

January 31, 2017
Ethics, Health Law, 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.

A New Year! a New You!: Update Your Look on Regenerative Healing Law

January 2, 2017
Administrative Law, Biotechnology, Ethics, Food and Drug Law, Health Law, Patents

Angela Fralish, MJLST Invited Blogger

Stephen Breyer, Associate Justice for the Supreme Court remarked that in this age of science, we must build legal foundations that are sound in science as well as in law, because a judge is not a scientist and a courtroom is not a scientific laboratory. Further, our decisions should reflect a proper scientific and technical understanding so that the law can respond to the needs of the public.

Human regenerative healing from embryonic stem cell research has sparked many debates on the public’s needs. On one hand, this research has the ability to relieve great suffering and even death, but on the other hand, it is accompanied by the using and destroying of human life. Moral controversy is a dark cloud looming over any courthouse looking to rule on the science of regenerative healing.

Legislative measures have ebbed and flowed with presidencies. Presidents Clinton, Bush and Obama have used executive orders to either expand or reduce federal funding of regenerative healing. President-Elect Trump’s policy is unknown. According to an NPR article issued in November 2016, “his campaign said little about research and development in general, or health research in particular.” This will be an important point in the near future as a Swedish scientist broke taboo in September of this year by altering healthy human embryos. Further, the NIH plans to lift the ban on regeneration in chimeras in early 2017. As it stands, the federal perspective towards future regenerative healing technology remains unclear.

The most recent executive response has been the Cures Act signed on December 13th of last year by President Obama. Sections 3033-3036 support an expedited FDA review of regenerative therapies and demand an update to regulatory law. Practically speaking, this means that clinical trials will be shortened to get the product on the market faster. While some worry this change will compromise ethics, others worry about the United States ability to keep up with a global market. Dr. Brenda Canine quotes, “If concerted long-term investments in research are not made, America will lose an entire generation of young scientists.”

One established principle in regenerative healing is ownership rights under intellectual property law. Challenges have been made on the grounds that researchers are attempting to patent “life,” but courts have allowed ownership rights to certain cell lines. Dr. Nicholas Zachariades wrote in his article titled Stem Cells: Intellectual Property Issues in Regenerative Medicine that “with respect to the stem cells and their use in the field of regenerative medicine, the U.S. Patent and Trademark Office has recognized inventions involving stem cells as patent-eligible subject matter.” He cites to Consumer Watchdog v. Wisconsin Alumni Research Foundation (WARF) where the plaintiff sued WARF for the patent being too broad, but lost because they lacked standing. WARF maintains a valid patent for “in vitro cell culture.”

Keeping up with science will continue to be a challenge. While it is against norms to destroy healthy embryos, there is a pressing need for the U.S. to compete in a global market. Hopefully, researchers, lawyers and politicians will eventually find a way to merge ethical, legal and federal funding policies related to stem cell research and regenerative healing into a solid legal foundation.

The GIF That Keeps on Giving: The Problem of Dealing With Incidental Findings in Genetic Research.

December 10, 2016
Biotechnology, Ethics, Healthcare, Privacy

Angela Fralish, MJLST Invited Blogger

The ability to sequence a whole genome invites a tremendous opportunity to improve medical care in modern society. We are now able to prepare for, and may soon circumvent, genes carrying traits such as Alzheimer’s, breast cancer and embryonic abnormalities. These advancements hold great promise as well as suggest many new ways of looking at relationships in human subject research.

A 2008 National Institute of Health article, The Law of Incidental Findings in Human Subjects Research, discussed how modern technology has outpaced the capacity of human subject researchers to receive and interpret data responsibly. Disclosure of incidental findings, “data [results] gleaned from medical procedures or laboratory tests that were beyond the aims or goals of the particular laboratory test or medical procedure” is particularly challenging with new genetic testing. Non-paternity for example, which has been found in up to 30% of participants in some studies, result in researchers deciding how to tell participants that they are not biologically related to their parent or child. This finding could not only impact inheritance, custody and adoptions rights, but can also cause lifelong emotional harm. Modern researchers must be equipped to handle many new psychosocial and emotional variables. So where should a researcher look to determine the proper way to manage these “incidentalomas”?

Perspectives, expectations, and interests dictating policies governing incidental finding management are diverse and inconsistent. Some researchers advocate for an absolute ban on all findings of non-paternity because of the potential harm. Others argue that not revealing misattributed paternity result in a lifetime of living with inaccurate family health history. These scenarios can be difficult for all involved parties.

Legal responsibility of disclosure was indirectly addressed in Ande v.Rock in 2001 when the court held that parents did not have property rights to research results which identified spina bifida in their child. In 2016, an incidental finding of genetic mutation led a family to Mayo Clinic for a second opinion on a genetic incidental finding. The family was initially told that a gene mutation related to sudden cardiac death caused their 13-year-old son to die in his sleep, and the gene mutation was also identified in 20 family members. Mayo Clinic revealed the gene was misdiagnosed, but the decedent’s brother already had a defibrillator implanted and received two inappropriate shocks to his otherwise normal and healthy heart. Establishing guidance for the scope and limits of disclosure of incidental findings is a complex process.

Under 45 C.F.R. §§ 46.111 and 46.116, also known as the Common Rule, researchers in all human subject research must discuss any risks or benefits to participants during informed consent. However, there is debate over classification of incidental findings as a risk or benefit because liability can attach. Certainly the parents in Ande v. Rock would have viewed the researchers’ decision not to disclose positive test results for spina bifida as a risk or benefit that should have been discussed at the onset of their four-year involvement. On the other hand, as in the Mayo Clinic example above, is a misdiagnosed cardiac gene mutation a benefit or risk? The answers to these question is very subjective.

The Presidential Commission for the Study of Bioethical Issues has suggested 17 ethical guidelines which include discussing risks and benefits of incidental finding disclosures with research participants. The Commission’s principles are the only guidelines currently addressing incidental findings. There is a desperate need for solid legal guidance when disclosing incidental findings. It is not an easy task, but the law needs to quickly firm-up a foundation for appropriate disclosure in incidental findings.

Copycats to Copycows: The Cloned Livestock Industry Emergence

October 17, 2016
Biotechnology, Ethics, New Technology

Ryan Dowell, MJLST Staffer

In the two decades since Dolly, a comically named sheep, animal cloning has remained little more than fiction to the average person. Behind the scenes, however, the field has progressed tremendously. Success rates today are estimated to be 70% or higher, compared to less than half a percent when cloning Dolly and her siblings. As the technique has been perfected, the obvious result has occurred: animal cloning has become a nascent industry.

Cloning has long been present in human society, in a form that many people may not recognize: plants. From simple home-garden cutting & replanting to industrial-scale cultivation from tissue samples; these techniques produce genetically identical individuals (i.e. clones) used as floral cultivars, tree planting, and especially foods. A large number of plants grown for human consumption are clones—which means that you, dear reader, have probably eaten a clone. Plant cloning has not encountered the same scrutiny as that with animals, perhaps due to its natural occurrence or millennia-long history of human use.

Dolly was merely the proverbial ‘dipping our toe into’ animal cloning. True to the writings of Michael Crichton (or the movies, if one so prefers), it didn’t take long for Jurassic Park-esque attempts to clone endangered and extinct animals. Cloning was not limited to such an idealistic use—a market emerged. Grieving pet owners could, at significant cost, get clones of their beloved pets. Despite the cost (still a five-digit price tag), a market for such services has continued to develop. Further demonstrating the human capacity for expensive animal-keeping hobbies, equine cloning has emerged as a means to “insure that prized horse and its unique qualities.” If one were to stop here, cloning seems to be a niche market for the wealthy.

The emerging cloning industry has not stopped at pets and exotic creatures. With the science complete and industrial production moving forward, livestock cloning is set to erupt in the coming years. A ‘cloning factory’ is opening in China. This factory is intended to produce not only pets and horses, but also prime beef cattle and drug-sniffing dogs. Following the same reasoning underlying farming’s predilection for plant clones, elimination of genetic variations could significantly improve farming techniques—maximizing yield, minimizing labor and resource inputs, matching strains to specific regions, and so on. In a world with mounting concern over the meat sustainability, improvements to production are key and cloning provides the means to significantly advance the field.

In many emerging fields, law and regulation react to the development and often impede progress. Fortunately, the issue of animal cloning has already been addressed—the FDA regulates the field & was essentially prescient. In 2008, the FDA released a guidance stating “meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food we eat every day.” The FDA examined cloning (also known as somatic cell nuclear transfer or SCNT), under the umbrella of assisted reproductive technologies (ART), which have long been utilized by farmers. The analysis noted that these animals would have essentially identical genetics to the source, unless reprogramming occurred (which can be done with other ARTs); that risk associated with the cloned animals is no different than the source organism. It was noted that cloned offspring have higher risk of adverse health issues early in life compared to offspring from other ARTs. However, none of these issues are unique to clones and other than early-life issues, clones are as healthy as non-clones. Livestock cloning has passed FDA scrutiny and manufacturing infrastructure is in place; it is poised to develop rapidly.

Public opinions may prove to be the final hurdle for livestock cloning. If one tells a fruit-eater that he or she is eating a clone (or as a botanist might put it the ovary of a clone), the fruit-eater will likely be unaware of this fact and less than pleased that his or her enjoyment of that fruit has been disrupted by the interjection. Alternatively, a substantial portion of the population believes GMOs are not safe for them to consume, which is untrue (see here, here, here, here, and here). A similar scenario to either of these might present itself here: (1) everyone blissfully consumes food without the need for nitty-gritty detail of its origin (since there is no discernable or material difference), or (2) misinformation is allowed to spread and ‘poison the well.’ The deciding factor will likely be education; the current state of affairs presents the opportunity to preemptively educate the public on the FDA’s findings and regulations.

Livestock cloning is poised to expand rapidly in the future and now we face a crucial time in its acceptance: a public educated on the issue will be equipped to fairly determine whether such livestock should be consumed, without a torrent of pseudo-science obscuring the decision. The FDA has examined clones and found them to be nearly identical to non-clones (pun very much intended) in regards to human consumption.

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