Bioethics

Lies, Damn Lies, and Facts

David B. Tibbals, MJLST Staff

Apparently Daniel Patrick Moynihan wasn’t referring to the legal profession when he argued that “everyone is entitled to his own opinions, but not his own facts.”

This past week, the U.S. Court of Appeals for the Fifth Circuit issued its ruling in Planned Parenthood v. Abbott, taking exception to the district court’s version of the facts. The court’s ruling upheld some provisions of House Bill 2, the Texas law that inspired the hours-long filibuster by Texas state senator Wendy Davis.

In an opinion authored by Judge Edith Jones, the court ruled as constitutional the law’s requirement of doctors to have admitting privileges at a hospital within thirty miles of wherever they perform an abortion procedure. With a critical view of the district court’s factual assessment, the court held that the thirty-mile admitting-privileges requirement does not “affect a significant (much less “large”) fraction of . . . women, and it imposes on other women in Texas less of a burden than the waiting-period provision upheld in Casey.”

Likewise, the court upheld the law’s proscription of off-label usage of abortion-inducing prescription drugs. Despite a claim that this represented the complete embargo of what may be the only safe abortion procedure for some women, the court characterized this as speculation, cautioning that courts “must base decisions on facts, not hypothesis and speculation.” And, as has been noted in this journal, “while FDA-approved indications cannot be construed to limit medical judgment, states . . . may enact legislation forcing compliance with such indications.”

Given the general awareness of the case, an arguable circuit split, and the torrent of recent state abortion legislation, surely this case seems destined for the Supreme Court. But how can the nine justices possibly reach a conclusion if the two lower courts couldn’t even agree on the facts? Didn’t the Roe Court argue that abortion law must be “free of emotion and of predilection,” premised on factual objectivity? Shouldn’t these questions be easy to answer?

The disagreement within this particular case reflects a greater problem within the nation’s abortion law canon. In the forty years since Roe, courts have struggled to consistently define just what virtues ought to guide abortion law.

Although the Court placed great emphasis on “now-established medical fact” from the outset, a closer look suggests that medical facts haven’t been treated nearly as sacred as one might believe. Indeed, as Forsythe and Kehr note, the factual record in Roe was very much abbreviated and curated: The Court’s ruling “was based on no factual record and no reliable medical data. The Justices did not analyze, let alone regulate, the contrary data; they simply ignored them.”

Over the last forty years, the Court has bandied about terms such as “advanced knowledge” and “substantial medical authority,” suggesting the primacy of medical facts. But regardless of how it has treated the particular facts it has examined, the Court has also failed to consistently adhere to the fundamental objectivity professed in Roe. Although the Court felt its ruling in Casey reaffirmed Roe’s objectivity, its “undue burden” standard introduced a great deal of subjectivity into abortion law. As Justice Scalia articulated in Stenberg, what qualifies as an “undue burden” “cannot be demonstrated true or false by factual inquiry or legal reasoning.”

It is yet unclear whether Abbott will indeed make it to the Supreme Court. No matter your view on the legal status of abortion, this fundamental inconsistency in the application of factual standards ought to be distressing. It is vital that the Supreme Court clarify a jurisprudence once labeled by former Chief Justice Rehnquist as “a virtual Procrustean bed.”


Revisiting the Legality of Physician-Assisted Suicide

Alison Key, MJLST Staff

Already this year, two states have expanded options for physician-assisted suicide (PAS) by striking all or part of statutes designed to criminalize the end of life treatment.

In January, a state trial court in New Mexico reviewed NMSA § 30-2-4, which prohibits physician-assisted suicide. The New Mexico trial court ruled that patients have a right under the State’s due process clause to choose to pursue a physician’s aid in dying, therefore the state law violated the state’s constitution. Commentators expect this ruling to be reviewed by the New Mexico Supreme Court, or possibly expanded to other districts through similar trial court decisions.

In Minnesota, the victory was smaller, but application more widespread. Last week, the Minnesota Supreme Court struck portions of the Minnesota law prohibiting assisted suicide as unconstitutional. The Minnesota Supreme Court held that the Minn. Stat. § 609.215, which prohibits “intentionally advis[ing], encourag[ing], or assit[ing] another in taking the other’s own life” was in conflict with First Amendment rights to free speech. Of the three actions prohibited in the statute, “advising” and “encouraging” suicide, the Minnesota Supreme Court ruled, are protected under the First Amendment.

While the Minnesota case was determined on constitutional grounds largely irrelevant to the ethics of PAS, both the Minnesota and New Mexico decisions have contributed to the larger, national trend of eliminating the legal barriers to PAS as a medical treatment. These two recent cases are significant in the larger debate on physician- and health care provider-assisted suicide, which has been gaining increased attention in recent years.

Minnesota and New Mexico, before this year, belonged to a majority of states that banned assisted suicide. (A few states, like Minnesota, also banned “encouraging” or “advising” suicide; these laws are rare because of First Amendment complications.) While there is no federal legislation on the subject (the Supreme Court in Washington v. Glucksberg held only that there is no right to PAS under the federal due process clause), four states have legalized PAS: Montana, Oregon, Vermont, and Washington. The ongoing litigation in New Mexico may soon bring that number to five. Three of these four states (Oregon, Vermont and Washington) legalized PAS through legislation or referendum, while Montana and parts of New Mexico have legalized PAS through state judicial precedent (in 2008 and 2014, respectively; the New Mexico decision from last January is currently only applicable in one district). Because all legalization efforts have occurred in the last three decades, the trend to eliminate legal barriers to PAS appears to be a recent one. Oregon has the oldest PAS law on the books, from 1994, while the remaining states have all legalized PAS since 2008.

In addition to the recent trend to legalize PAS, another interesting trend is the division in support for PAS between the public and experts. Among those presumed to be experts (based on subscription to the New England Journal of Medicine), about 67 percent of those polled in the United States indicated opposition to PAS. One of the more vocal opponents of PAS is a physicians’ professional organization: the American Medical Association. The AMA takes the position that PAS is “fundamentally inconsistent with the physician’s role” and is an improper extension of the right to refuse treatment. The AMA’s published opinion has remained unchanged since 1996, suggesting it is not reflective of the current trends toward more liberal PAS laws.

Conversely, the public tends to support PAS, if termed correctly. A Gallup poll last May indicated that 70 percent of the public agreed that “when patients and their families wanted it, doctors should be allowed to ‘end the patient’s life by some painless means.'” The favorable percentage dropped to 51 percent when the question was changed to include the word “suicide,” suggesting a social connotation of the word suicide, rather than disapproval of the act itself. The public’s pro-PAS view seems to be driving the current trend to remove legal barriers to PAS.

It is clear that the hard stance against PAS has eroded in recent decades. The New Mexico state trial court decision in January announced, “[c]ertainly the medical and legal ethical considerations regarding end of life care have changed over the past fifty years. ” Last year alone, six states introduced bills to directly legalize PAS, including Connecticut, Vermont (passed), New Jersey, Kansas, Hawaii, and Massachusetts. In four other states, bills related to the issue of PAS, short of full legalization were introduced.

After the Minnesota Supreme Court ruling last week, another case on assisted suicide pending before the Minnesota Supreme Court has the public’s attention. With yet another PAS case coming before the Minnesota Supreme Court, New Mexico courts contemplating the expansion of the trial court ruling across the state, and bills becoming a frequent occurrence in other states, PAS legalization is becoming a trend to watch–in Minnesota, New Mexico, and nationally. With baby boomers nearing the age where end of life decisions become more pressing, discussions about legalizing PAS to expand end of life options will become more prevalent and more urgent.


Genetic Testing: Thorny Ethical Puzzles in Returning Results from Researchers

Savir Punia, MJLST Lead Notes and Comments Editor

The Minnesota Journal of Law, Science and Technology Symposium article, The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science, by Professor Susan Wolf, discusses the current issues researchers are facing with genetic testing. At present, there is a dramatic rise in genetic-based research and tissue banks seeking to discover the genetic mutations and disorders responsible for some of the worst ailments plaguing humans today. As researchers are able to gather data using increasingly sophisticated tools, researchers are finding things they are not looking for, including information that could make a big difference for a donor. According to the 2012 New York Times Article, Genes Now Tell Doctors Secrets They Can’t Utter, we are at an awkward interval where our ability to capture information is exceeding our ability to know what to do with it.

Currently, the federal government’s National Institute for Health (NIH) is funding projects, including Professor Wolf’s research project on return of results, in order to develop guidelines in this thorny subject area. Until then, researchers are operating with a heightened nervousness about when and how to disclose research results to study participants or their families. According to Professor Wolf’s symposium article, researchers are already expressing anxiety “that they must navigate between legal threat on both sides – liability for failure to return findings on one side, and liability for wrongly returning on the other.”

Given the current state, researchers are tasked with dealing with challenging situations on their own. For example, researchers studying genes unrelated to breast cancer notice members of one family have a breast cancer gene, does this obligate researchers to disclose this finding or not. Currently, a lot of this depends on the types of consent forms used in the research projects. For example, the New York Times article discusses to similar situations with very different results. In the first research project investigators discover that a family does have a breast cancer gene, but does not disclose it because the consent form stated no results would be returned, essentially tying the hands of the researchers. In another study, researchers discovered a woman who had a strong family history of breast and ovarian cancer did not carry her family’s breast cancer gene, and they decided on ethical grounds to breach their consent forms stipulations in order to inform the woman and her family. These types of situations are becoming an ever increasing problem, and with no guidance or base line rule issued by any public health organization, researchers will continue to get caught up in return of research results.

Genetic research has brought about rapid advancement and change in how we approach human health, but it also has brought about some great challenges. As important as genetic research is, the individual submitting to it must not be forgotten. As genetic researchers sequence whole genomes and discover mutations in research participants’ sequences, there will be more of an imperative to communicate those results back in order to help that participant seek preventative care. Moreover, genetics are unique in that mutations in one individual may affect that individual’s entire family. Research participants’ families have a stake in their family members’ genetic sequences, because what is discovered there could also affect their own lives. Whether to return results to family members is a much more controversial issue and includes certain traditional healthcare privacy rules. As genetics continue to grow and play an important part in our healthcare, issues such as the ones above will need to be clarified and outlined. Research in this area is occurring at a fast pace, and Professor Wolf and her colleagues will be watched closely as they work toward establishing guidelines to power genetic research into the future.


What does it Mean to be Human?

by Mike Walls, UMN Law Student, MJLST Staff

What does it mean to be human? Where does our conception of life and death come from? Scholars and writers alike have been toiling with these questions for centuries. Our understanding of the term “human” is often embedded in the culture we grew up in. For some, human may simply mean the physical embodiment of our soul. To them, the human form is no more than just a transitory stage in our soul’s celestial journey. For others, the term is specifically defined by our genetic makeup, chromosome for chromosome, allele for allele, etc. However, our legal understanding of “human” has been especially difficult to discern. States have taken many different approaches.

In his article, “Defining the Essence of Being Human,” Professor Efthimios Parasidis discusses various states’ interpretations of human. Parasidis discusses Ohio’s interpretation of human life as beginning when one can detect the fetal heartbeat. For Ohio citizens, life begins with the beating heart, but it is unclear what this definition means for heart-related anomalies in adult-life, such as a person whose heart ceases to pump blood temporarily. Nebraska focuses on whether pain can be detected in the fetus, although the Act glosses over individuals who are incapable of experiencing pain, or fetus’s with delayed sensory development. Mississippi’s unsuccessful amendment attempted to define “person” as “every human being from the moment of fertilization, cloning, or the equivalent thereof,” which left the door open to further criticism. Should splicing human genes with animal genes necessarily discount human-like organisms from our understanding of human? Would a “manimal” have been covered under the Mississippi law? It appears that elsewhere around the world introducing animal genes into the human form is forbidden, whereas human genes introduced into animals is sometimes permitted.

Parasidis’ discussion of various states’ conceptions of human life involving pain, heartbeats, and fertilization, led him to attempt to answer the question: “What distinguishes humans from other species?” His answer fell into two categories, the anthropological record (Homo sapiens, Homo neanderthalensis, etc.) and genetics. He concluded that both explanations are vague (or at least their boundary lines do more to raise serious questions than to console skeptics).

As I ponder Parasidis’ article as a grown-up, the kid in me has found it difficult to set aside my childhood curiosity for science-fiction. What wisdom could I take from science-fiction without getting sidetracked? I turned to Dr. Moreau for answers. In 1896, H.G. Wells published The Island of Dr. Moreau, based on a mad-scientist destined to create half-men, half-animals, through vivisection. Wells wrote this piece without knowledge of genes or modern discoveries in anthropology and human origins. Wells’ interpretation of human and animal is both poetic and informative, and his philosophy on scientific inquiry plagued by moral dilemmas speaks through Dr. Moreau.

Astonished by the bestial creatures he saw on Dr. Moreau’s island, the weary naturalist Prendrick viewed Moreau as a heartless scientist, detached from the ethical world we live in. In my favorite chapter, Dr. Moreau Explains, Moreau lays out his unadorned view on the commonalities between man and animal. After Dr. Moreau inserts a blade into his own thigh, he states the following:

“Then I am a religious man, Prendrick, as every sane man must be. It may be I fancy I have seen more of the ways of this world’s Maker than you–for I have sought his laws, in my way, all my life, while you, I understand, have been collecting butterflies. And I tell you, pleasure and pain have nothing to do with heaven and hell. Pleasure and pain–Bah! . . . men and women set on pleasure and pain, Prendrick, is the mark of the beast upon them, the mark of the beast from which they came. Pain! Pain and pleasure–they are for us, only so long as we wriggle in the dust . . . .”

On the one extreme, Dr. Moreau believed that anything fathomed under the laws of science (and thus, to him, created by God), was permissible scientific inquiry. To him, pain is unmistakably detached from religion–rather it is incidental to experimentation. Moreover, Dr. Moreau believed pain is simply whatever we make of the sensation (“The capacity for pain is not needed in the muscle, and only here and there over the thigh is a spot capable of feeling pain. Pain is simply our intrinsic medical adviser to warn us and stimulate us.”). Moreau’s religion is his scientific inquiry, completely unfettered from ethical obligations. On the other hand, Nebraska takes the opposite view. Pain is the factor between life and death. But for Nebraskan legislators, is the criterion of inflicting “pain” on a fetus any more of a medical description than it is a moral obligation? Dr. Moreau and Professor Parasidis would probably argue that simply detecting pain is a smokescreen for anti-abortionists. The Nebraskan viewpoint that pain is a medical factor that necessarily dictates abortion rights might be fogging the issue. I struggle to understand some of our states’ preemptive abortion policies, as does Professor Parasidis, in their inability to separate conceptions of human life (when pain is felt) from their legal obligations owed to the individual (informed by science).

The point of all this is rather simple. No matter how we decide to determine what is human, or when life begins, public policy should influence how exacting our legal definition of human is. Dr. Moreau wouldn’t sacrifice scientific inquiry for the ethical norms of others. To him, everyone else must reconcile their moral differences with science. Professor Parasidis argues that when legislators use descriptive characteristics (like pain) in their legal definitions, they should also consider other policy implications. Besides the fetus, who else is affected? By redirecting our focus to science, we may free ourselves from biases currently clouding our reproductive rights jurisprudence, and potentially answer the question, what is the essence of being human?


Subpeona of Data Provided by Research Participants under Confidentiality Agreement Raises Concerns

by Sabrina Ly

Thumbnail-Sabrina-Ly.jpg On February 25, 2013, an article was published in The Dartmouth describing the implementation of its Committee for the Protection of Human Subjects. The purpose of the committee is to answer ethical questions and review proposals regarding human subjects participating in research at Dartmouth College. The committee is comprised of experts and community members “who analyze the risk posed to participants by Dartmouth-affiliated researchers’ studies.” The timing of its creation could be coincidental, but may have been in response to legal action taken against Boston College subpoening confidential data provided by research participants in the “Belfast Project” in 2012.

Prior to interviews taking place as part of the Belfast Project, researchers promised interviewees that their identities and information contained in the transcripts would not be released until after their deaths. However, upon discovering the existence of the transcripts, British law enforcement worked with the U.S. Department of Justice to subpoena the transcripts to use in its criminal proceedings. This raised significant ethical issues pitting the needs of law enforcement against the need for participant confidentiality in certain research that benefits the public.

The problem of subpoenaing confidential human research information is further elaborated in an article recently published in Issue 14.1 of the Minnesota Journal of Law, Science and Technology. In Certificates of Confidentiality: Protecting Human Subject Research Data in Law and Practice, Wolf, et al., discuss the importance of enforcing a certificate of confidentiality in human research studies. Confidentiality in order to obtain information from human subjects during research is vital to progression and understanding in health, science and many other fields. Often research requiring a promise of confidentiality involves difficult and controversial subjects that would be nearly impossible to study without an assurance of confidentiality.

A certificate of confidentiality encourages individuals to volunteer information they might not otherwise be willing to disclose by protecting their identity and privacy. By breaking the promise of confidentiality, the subpoenaing of the “Belfast Project” threatens academic freedom, and may deter future research participants from providing accurate personal information. Such reluctance to provide information could harm the work of researchers who might otherwise advance understanding and provide valuable insights on difficult issues. One example in which research is difficult without confidentiality is the willingness of individuals to share information about their sexuality, sexual behaviors, or drug-using behaviors. In past studies, researchers have been able to use this information to derive how HIV spread and implement methods to prevent the spread.

The broad benefits to society of upholding academic freedom, the right to privacy, and freedom of information, far outweigh any claim law-enforcement may have to subpoena confidential research data. While an individual prosecution may be important, the damage caused by allowing such a breach of confidentiality could greatly hinder society-benefiting research. The importance of enforcing certificates of confidentiality to prevent the criminalization of human research subjects is significant.

Boston College has filed a petition for a writ of certiorari in the Supreme Court to appeal the First Circuit’s ruling upholding the subpoenas.


Biobanks Revisted

by Jeremy So, UMN Law Student, MJLSTManaging Editor

Thumbnail-Jeremy-So.jpgOn October 28, Australian researchers published new information about the genetic basis for endometriosis, a condition where the cells lining the uterus flourish in other areas of the body. The researchers, instead of recruiting their own research subjects, analyzed samples stored in biobanks in Australia, Japan, and Europe. Because of their approach, the researchers were able to identify common markers that appeared across the ethnically-diverse study population. The Australian team’s findings highlight the increasing importance of biobanks–repositories for biological research samples–which have become a valuable resource in the fields of genomics and personalized medicine

The increasing importance of biobanks was recently highlighted in a symposia sponsored by MJLST. In the accompanying Spring 2012 issue, researchers and lawyers discussed the one of the primary problem facing researchers who use biobanks: whether to return research results and incidental findings to research participants.

While the Australian researchers have decided to track down the original participants in order to share their findings, other researchers have hesitated to use the same approach. Karen J. Maschke highlighted several such reasons in her recent article “Returning Genetic Research Results: Considerations for Existing No-Return and Future Biobanks.” In the article, Maschke focuses on the approaches of American biobanks researchers, who generally do not share their results with individuals whose DNA was analyzed.

For American researchers, Maschke notes that samples stored for biobank research are regularly deidentified, making it difficult to impossible to contact the original donor. Such a system exists in part because of concerns over whether consent would be granted for samples to be used in certain types of research. Combined with conflicting interpretations of government regulations and other difficulties in actually returning sample results, researchers have hesitated to adopt a disclosure-based system for research results.

Although some may remain hesitant, cooperation between researchers and biobank participants has not necessarily led to negative outcomes.

The importance of resolving this conflict is highlighted by the increasing prevalence and importance of biobanks to scientific research. Several countries are working on expanding their biobank networks. Now, before competing standards come to dominate the field, a uniform system for the return of results should be determined and implemented.


Incidental Findings: It’s My DNA, and I Want to Know if Something is Wrong With it.

by Ryan J. Connell, UMN Law Student, Joint Degree Program Fellow, MJLST Staff

Thumbnail-Ryan-Connell.jpgAs genetic research continues to develop, researchers are more apt to make incidental discoveries in the course of the research on a subjects DNA. Susan Wolf, Founding Chair of the University of Minnesota’s s Consortium on Law and Values in Health, Environment & the Life Sciences, points out in her article “The Role of Law in the Debate over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science,” that, with this development, there is a serious question that must be asked, but that the law does not really answer: do researchers have to report these incidental findings to the subject?

Is this something that necessarily must be addressed by the law? I think so. Researchers need guidance on this front. Right now if a researcher finds something that may or may not have adverse health consequences for a subject the researcher must balance competing interests. What if they do disclose the risk? Is a pure researcher qualified to evaluate medical risks? The researcher could be very wrong in their analysis; could a subject who was told that they might be at risk for a serious health problem, but was not, hold a researcher liable for emotional stress? On the other hand, if a researcher comes across some potential risks and does not tell the subject, and the subject suffers as a result, should the researcher be liable?

I think the answer to this problem lies in waivers. Before people make themselves subject to research they should sign a waiver to either not hold a researcher liable for any incidental findings reported, or agree to not receive any information about any incidental findings.

This really should be the patient’s decision. Some geneticists think that it is better not to let people know if they have a risk for Huntington’s disease, or Alzheimer’s disease because there are no interventions. Likewise some geneticists feel that they would only report a risk of cancer if it is specifically requested.

From my point of view, if my genes are used for research and the researchers find that I am at risk for something, I want to know. I don’t care if there is nothing that I can do about it; I should know about it. My personal view is not shared however, some feel like they want to contribute to research, and then they don’t want to be bothered again.

This is a complicated issue with no clear solution. How do you feel? Do you want a researcher to tell you if they think you are at risk? Would you hold a researcher liable if they mistakenly told you that you were at risk for a horrible disease? Or would you be more likely to hold a researcher liable for not telling you that you were at risk for a disease? Do you think a waiver, or some other agreement is necessary between a researcher and a subject before any research is conducted?


Unlocking the Abortion & Evolution Debates:Defining the Essence of Being Human

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Emily-Puchalski.jpgAs scientific research and technological advancement abound in our modern world, often times the law struggles to keep up. The law’s struggle to keep up is evident in debates centering on defining personhood. The question of what it means to be a person/human involves the controversial issues of abortion and evolution, which have divided our nation for decades. Although scientists are helping our understanding of what being human means by studying life at its most basic, controversy abounds regarding not only the results of the studies but also the theoretical underpinnings of even allowing the studies. As our nation becomes more polarized between conservative and liberal thinkers the struggle of defining personhood has come to the forefront in politics.

In his recent article in the Minnesota Journal of Law, Science & Technology, Defining the Essence of Being Human, Efthimio Parasidis contemplates how science could aid the law in attempting to define a person and looks at modern examples of the personhood debate. One of the examples Parasidis describes are personhood amendments that are often backed by anti-abortion groups seeking to have life defined as beginning at conception. These so called personhood amendments have begun to spring up in various states and in many instances the groups attempt to get them on ballots for the public’s vote. Interestingly, after Parasidis’s publication an attempt in Ohio to define life as starting with fertilization failed to get the requisite number of signatures to get on the ballot.

The failure of Personhood Ohio to get the requisite number of votes could foreshadow a big issue in the upcoming presidential election, because Ohio is a battleground state for the by all accounts close presidential race between Obama and Romney. Whether the failure of the amendment signals trouble for the Romney-Ryan ticket is unknown. Interestingly, Romney’s position on abortion has been he opposes abortion except in cases where it may be required for the mother’s health or the pregnancy was the result of rape or incest. While Ryan seems to have tempered his pro-life views during the election.The Romney-Ryan ticket is in a difficult place trying to win the conservative vote while still trying to win Ohio where enough signatures were not garnered.


Unlocking the Abortion & Evolution Debates:Defining the Essence of Being Human

by Emily Puchalski, UMN Law Student, MJLST Notes & Comments Editor

Thumbnail-Emily-Puchalski.jpgAs scientific research and technological advancement abound in our modern world, often times the law struggles to keep up. The law’s struggle to keep up is evident in debates centering on defining personhood. The question of what it means to be a person/human involves the controversial issues of abortion and evolution, which have divided our nation for decades. Although scientists are helping our understanding of what being human means by studying life at its most basic, controversy abounds regarding not only the results of the studies but also the theoretical underpinnings of even allowing the studies. As our nation becomes more polarized between conservative and liberal thinkers the struggle of defining personhood has come to the forefront in politics.

In his recent article in the Minnesota Journal of Law, Science & Technology, Defining the Essence of Being Human, Efthimio Parasidis contemplates how science could aid the law in attempting to define a person and looks at modern examples of the personhood debate. One of the examples Parasidis describes are personhood amendments that are often backed by anti-abortion groups seeking to have life defined as beginning at conception. These so called personhood amendments have begun to spring up in various states and in many instances the groups attempt to get them on ballots for the public’s vote. Interestingly, after Parasidis’s publication an attempt in Ohio to define life as starting with fertilization failed to get the requisite number of signatures to get on the ballot.

The failure of Personhood Ohio to get the requisite number of votes could foreshadow a big issue in the upcoming presidential election, because Ohio is a battleground state for the by all accounts close presidential race between Obama and Romney. Whether the failure of the amendment signals trouble for the Romney-Ryan ticket is unknown. Interestingly, Romney’s position on abortion has been he opposes abortion except in cases where it may be required for the mother’s health or the pregnancy was the result of rape or incest. While Ryan seems to have tempered his pro-life views during the election.The Romney-Ryan ticket is in a difficult place trying to win the conservative vote while still trying to win Ohio where enough signatures were not garnered.


Got GMOs?

by Ude Lu, UMN Law Student, MJLST Staff.

Ude-Lue.jpgGMOs, genetically modified organisms, have long been a part of our daily diet. For example, most of the soybeans and corn on the supermarket shelves are GMOs. Currently, the issue of whether these GMOs should be labeled so that customers can make informed purchases is in a heated debate in California. California Proposition 37, which would require labeling of GMOs, will soon be voted in November this year. Proponents from both sides have poured millions of dollars into the campaign.

GMOs are plants that have been genetically engineered to be enhanced with characteristics that do not occur naturally, so that the harvest can be increased and the cost can be lowered. One example of a prominent GMO is soybean. Monsanto–a Missouri based chemical and agriculture company–introduced its genetically modified soybean, Roundup Ready, in 1996. Roundup Ready is infused with genes that resist weed-killers. In 2010, 93% of soybeans planted in the United States were Roundup Ready soybeans.

Although GMOs are one of the most promising solutions to address the sustainability of food supply in view of the growing global population, there are concerns in the public regarding their safety, and confusion as to which federal agency has responsibility for regulating them.

Amanda Welters in her article “Striking a balance: revising USDA regulations to promote competition without stifling innovation” published in the Minnesota Journal of Law, Science, and Technology explains the current regulatory scheme of GMOs. Three primary agencies regulate GMOs: the Food & Drug Administration (FDA), the Environmental Protection Agency (EPA), and the United States Department of Agriculture (USDA). The FDA regulates GMOs in interstate commerce that are intended to be consumed by animals or humans as foods, the EPA monitors how growing of GMOs impacts the environment, and the USDA assesses the safety of growing GMO plants themselves.

Specifically, the Animal and Plant Health Inspection Service (APHIS) in the USDA is responsible for ensuring crops are free of pests and diseases. APHIS is currently in the process of revising its regulations for GMOs in an attempt to improve transparency, eliminate unnecessary regulations and enhance clarity of regulations. Under the proposed regulations there will be three types of permits for GMOs: interstate movement, importation, and environmental release.

Taking the position that GMOs are generally beneficial and unavoidable, Welters suggests that the USDA should frame a regulatory structure similar to the Hatch-Waxman Act and the Biosimilar Act to promote both innovation and competition. Readers interested in the regulatory issues of GMOs and the balance between the interests of patent innovators and generic follow-ons would find Welters’ article informative and insightful.