Articles by mjlst

Farm Drainage Revisited: Will Tile-Drain Effluent Be Considered a Point Source and Fall Under Clean Water Act Regulation?

January 26, 2017
Agriculture, Environmental Law

Theodore Harrington, MJLST Managing Editor

For years, nutrients from farming operations have been leaking into the Raccoon and Des Moines Rivers, and ultimately arriving at the mouth of the Mighty Mississippi. These nutrients, most notably nitrate and phosphorus, are the result of both fertilizers and natural crop growth and have deleterious effects on humans and the environment. As these nutrients mix with groundwater just below the surface, a polluted effluent is created. This effluent is then drained through a grid of plastic piping a few feet below the soil.

Nearly two years ago, Des Moines Water Works (DMWW), a public water utility, sued the Drainage Districts in Sac, Buena Vista, and Calhoun Counties to recover monies spent treating the polluted effluent to make it safe for public consumption. Defendants contend that the polluted effluent does not fall under the jurisdiction of the Clean Water Act, and therefore DMWW is the appropriate entity to bear these costs, which approach $7,000 per day!

Where it stands: Summary Judgment briefs were traded in May and June of last year. Since then, oral arguments have been heard by the Iowa Supreme Court since September 14, 2016. (Click HERE to see John Lande arguing for the Board of Water Works and Michael Reck arguing for the counties.) A federal trial in front of Judge Leonard Strand is set for this coming June in the Northern District of Iowa. The trial will come two and a half years after the original filing, and lengthy appeals, possibly to the Supreme Court, are likely to follow. Though it will be years before we have an answer to the question titling this post, the judgment’s consequences will reach beyond individual farms to the heart of the industry.

Broad Inst. Inc. v. Regents of the Bd. of the Univ. of Cal: PTO to Decide CRISPR Gene Editing Ownership

January 26, 2017
Biotechnology, Patents

Jeffrey Simon, MJLST Staffer

The Broad Institute and the University of California will argue claims related to ownership on Patents relating to CRISPR (clustered regular interspaced short palindromic repeats) gene editing technologies. The arguments will be heard on Dec, 6 by the Patent Trial and Appeals Board.

CRISPR technology utilizes prokaryotic DNA segments to confer immunity to foreign genetic elements. CRISPR editing technology has the potential to alter human DNA sequences by removing existing genes or inserting new ones. Moving forward, CRISPR technology has the potential to develop into a form of gene therapy, whereby the human genome can be edited to fortify one’s immune system against infectious diseases or other hereditary issues. CRISPR technology raises ethical concerns, especially relating to the potential use in altering the genes of human embryos.

Although CRISPR technology has been understood for over a decade, the current case revolves around an improvement using cas9 protein that splices DNA at a specific locus. The Broad Institute asserts that patents filed on behalf of the Massachusetts Institute of Technology and Harvard University Researchers (Broad Institute being the eventual assignee of the patents) maintain priority over those owned by University of California. However, the relevant patents have been asserted pre-AIA. Therefore, priority date will be established by date of the invention rather than under the AIA standard of application date. The Patent Trial and Appeals Board (PTAB) initially maintained that the date of invention was properly asserted prior to the patents upon which the challenge was brought. If the decision of the PTAB is upheld, the University of California patents will invalidate the patents held by MIT and Harvard. It’s important to note that both parties are asserting priority date to a previous University of California patent relating to CRISPR technology. The PTAB may determine that both parties failed to prove priority date ahead of the US Patent Application No. 13/842,859, thus invalidating both parties claims.

The Broad Institute is a research institute associated with MIT and Harvard University. It’s unclear how the decision will affect CRISPR technology moving forward. CRISPR technology has attracted lucrative investments from government agencies and private entities alike. Additionally, since the initial patenting of CRISPR, University of California has licensed out the use of CRISPR technology to numerous firms interested in its applications.

Court’s Remain Unclear About Bitcoin’s Status

January 25, 2017
Economics, Financial Law, New Technology

Paul Gaus, MJLST Staffer

Bitcoin touts itself as an “innovative payment network and a new kind of money.” Also known as “cryptocurrency,” Bitcoin was hatched out of a paper posted online by a mysterious gentleman named Satoshi Nakamoto (he has never been identified). The Bitcoin economy is quite complex, but it is generally based on the principle that Bitcoins are released into networks at a steady pace determined by algorithms.

Although once shrouded in ambiguity, Bitcoins threatened to upend (or “disrupt” in Silicon Valley speak) the payment industry. At their core, Bitcoins are just unique strings of information that users mine and typically store on their desktops. The list of companies that accept Bitcoins is growing and includes cable companies, professional sports teams, and even a fringe American political party. According to its proponents, Bitcoins offer lower transaction costs and increased privacy without inflation that affects fiat currency.

Technologies like Bitcoins do not come without interesting legal implications. One of the oft-cited downsides of Bitcoins is that they can facilitate criminal enterprises. In such cases, courts must address what status Bitcoins have in the current economy. The Southern District of New York recently held that Bitcoins were unequivocally a form of currency for purposes of criminal prosecution. In United States v. Murgio et al., Judge Alison Nathan determined Bitcoins are money because “Bitcoins can be accepted as payment for goods and services or bought directly from an exchange with a bank account . . . and are used as a medium of exchange and a means of payment.” By contrast, the IRS classifies virtual currency as property.
Bitcoins are uncertain, volatile, and complex, but they continue to be accepted as currency and show no signs of fading away. Going forward, the judiciary will need to streamline its treatment of Bitcoins.

Ensuring a Fair Trial in Medical Device Cases

January 21, 2017
FDA, Health, Medical Devices

Frank Griffin, M.D., J.D., Adjunct Professor, University of Arkansas School of Law

Dangerous medical devices have been in the news, and the Institute of Medicine—upon the FDA’s request—made recommendations to make device approval pathways safer, but little has changed.  Orthopaedic device companies use the pathway that the Institute of Medicine called “flawed” to gain approval of 88% of their devices—resulting in an 11.5 times higher recall rate than if a more rigorous pathway to approval were chosen.  Predictably, patients are often harmed by recalled devices (and likely other devices that are not officially recalled), but harmed patients may have no choice but to suffer the “overwhelming misfortune” (envisioned in Escola) of shouldering the burden of the companies’ design choices in the current unnecessarily prejudicial legal environment.

In Daubert v. Merrell Dow Pharmaceuticals, the United States Supreme Court provided a framework for judges’ gatekeeper role in assessing the reliability and relevancy of scientific expert testimony to be heard by the jury.  Unfortunately, judges may be overwhelmed and unintentionally unfair in handling a task that some judges from the beginning considered “daunting” complaining they were “no match” for the experts they face.  Since Daubert, in limine challenges have increased, “primarily driven by a significant increase in the number of in limine challenges raised against plaintiff expert witnesses.”

However, there is hope for the overwhelmed judge sorting through the pretrial in limine motions regarding scientific experts in complex orthopaedic cases.  As explored in depth in my recent article to allow for a fair trial, judges should place defense experts and epidemiology studies under greater scrutiny, while being more willing to admit the few experts available to plaintiffs in these often-novel cases.  In addition, courts should require all experts to file conflict of interest disclosure forms under penalty of perjury similar to those used in the orthopaedic journals to assist with assessment of reliability—given that an overwhelming (>97%) majority of experts with stock options, consulting contracts, employment contracts or royalties report positive outcomes in their studies, and also considering that studies are generally reproducible only when <25% of the data comes from developers.  On the plaintiffs’ side, judges should be more open to allowing experience experts and experts who do their research in preparation for trial—because in these novel cases, no other non-industry experts may exist to expose problems.

My article—“Prejudicial Interpretation of Expert Reliability on the ‘Cutting Edge’ Enables the Orthopaedic Implant Industry’s Bodily Eminent Domain Claim”—highlights information of which courts, attorneys, doctors, and patients should be aware.  The article provides ways that the court may stand on equal ground with experts in these complex cases to fairly assess reliability and to do its part to create a safer and more effective medical device market that does not unnecessarily “take” Americans’ health.

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

January 2, 2017
Bioethics, FDA, Health, 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.

Did the Warriors Commit a Flagrant Privacy Foul?

December 21, 2016
Constitutional Law, First Amendment, Litigation, Privacy

Paul Gaus, MJLST Staffer

Fans of the National Basketball Association (NBA) know the Golden State Warriors for the team’s offensive exploits on the hardwood. The Warriors boast the NBA’s top offense at nearly 120 points per game. However, earlier this year, events in a different type of court prompted the Warriors to play some defense. On August 29, 2016, a class action suit filed in the Northern District of California alleged the Warriors, along with co-defendants Sonic Notify Inc. and Yinzcam, Inc., violated the Electronic Communications Privacy Act (18 U.S.C. §§ 2510, et. seq.).

Satchell v. Sonic Notify, Inc. et al, focuses on the team’s mobile app. The Warriors partnered with the two other co-defendants to create an app based on beacon technology. The problem, as put forth in the complaint, is that the beacon technology the co-defendants employed mined the plaintiff’s microphone embedded in the smartphone to listen for nearby beacons. The complaint alleges this enabled the Warriors to access the plaintiff’s conversation without her consent.

The use of beacon technology is heralded in the business world as a revolutionary mechanism to connect consumers to the products they seek. Retailers, major sports organizations, and airlines regularly use beacons to connect with consumers. However, traditional beacon technology is based on Bluetooth. According to the InfoSec Institute, mobile apps send out signals and gather data on the basis of Bluetooth signals received. This enables targeted advertising on smartphones.

However, the complaint in Satchell maintains the defendants relied on a different kind of beacon technology: audio beacon technology. In contrast to Bluetooth beacon technology, audio beacon technology relies on sounds. For functionality, audio beacons must continuously listen for audio signals through the smartphone user’s microphone. Therefore, the Warriors app permitted the co-defendants to listen to the plaintiff’s private conversations on her smartphone – violating the plaintiff’s reasonable expectation of privacy.

While the Warriors continue to rack up wins on the court, Satchell has yet to tip off. As of December 5, 2016, the matter remains in the summary judgment phase.

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.

Digital Tracking: Same Concept, Different Era

December 9, 2016
Internet, Privacy

Meibo Chen, MJLST Staffer

The term “paper trail” continues to become more anachronistic in today’s world as time goes on.  While there are some people who still prefer the traditional old-fashioned pen and paper, our modern world has endowed us with technologies like computers and smartphones.  Whether we like it or not, this digital explosion is slowly consuming and taking over the lives of the average American (73% of US adults own a desktop or laptop computer, and 68% own a smartphone).

These new technologies have forced us to re-consider many novel legal issues that arose from their integration into our daily lives.  Recent Supreme Court decisions such as Riley v. California in 2014 pointed out the immense data storage capacity of a modern cell phone, and requires a warrant for its search in the context of a criminal prosecution.  In the civil context, many consumers are concerned with internet tracking.  Indeed, the MJLST published an article in 2012 addressing this issue.

We have grown so accustomed to seeing “suggestions” that eerily match our respective interests.  In fact, internet tracking technology has become far more sophisticated than the traditional cookies, and can now utilizes “fingerprinting” technology to look at battery status or window size to identify a user’s presence or interest. This leads many to fear for their data privacy in similar digital settings.  However, isn’t this digital tracking just the modern adaptation to “physical” tracking that we have grown so accustomed to?

When we physically go to a grocery store, don’t we subject ourselves to the prying eyes of those around us?  Why should it be any different in a cyberspace context?  While seemingly scary accurate at times, “suggestions” or “recommended pages” based on one’s browsing history can actually be beneficial to both the tracked and the tracker.  The tracked gets more personalized search results while the tracker uses that information for better business results between him and the consumer.  Many browsers already sport the “incognito” function to disable the tracks, bring a balance to when consumers want their privacy.  Of course, this tracking technology can be misused, but malicious use of a beneficial technology has always been there in our world.

Recent Ninth Circuit Ruling an Important One for State and Local Governments Seeking to Regulate Genetically Modified Plants

December 4, 2016
Biotechnology, Food and Agriculture, New Technology, Public Health

Jody Ferris, Note & Comment Editor

Genetically modified plants (GMOs) are and have always been a hot topic in agriculture and food policy.  Since they were first developed, groups have been lobbying at various levels of government to impose regulations on how they are grown or to have them banned outright. A noteworthy decision has come down for those following legal challenges to GMO regulation. In Alika Atay et al. v. County of Maui et al., the Ninth Circuit court in Hawaii has ruled that state and local governments may regulate the production of GMOs in their jurisdictions.

The original suit was filed by GMO proponents after the County of Maui enacted a ban on genetically modified crops.  The court held that federal regulation of GMOs does not preempt state and local regulation after the variety is commercialized. This means that the United States Department of Agriculture holds jurisdiction over all GMO varieties prior to commercialization, which is the period during development and testing before the variety is sold on the market. According to the Ninth Circuit, after the variety is commercialized, however, state and local governments are free to enact regulations, including outright bans of GMO production, without the need to worry about federal preemption.

Interestingly, the county regulations in Hawaii that were at issue in the suit were nonetheless stricken down by the court because the State of Hawaii already has a comprehensive regulatory scheme which the court held to preempt county GMO regulations.  This outcome disappointed local environmental and anti-GMO groups due to their support of the new county level GMO restrictions.  However, the decision will help clarify the respective regulatory responsibilities between individual counties and the State of Hawaii. Despite the disappointment of these groups, the decision that there is no federal preemption on regulation of commercialized GMO varieties is an important one for many of the states in the Ninth Circuit, as there are counties in Washington and California, for example, which have also enacted bans on GMO production.

This decision will likely be an encouraging one for states wishing to enact their own regulations for how GMO varieties are grown and handled.  It is also encouraging for individual counties who wish to enact GMO bans or county level regulations, should state level regulations not be preemptive.  It will certainly be interesting to follow how state and local governments structure any future regulatory activities in light of this ruling.

Faux News vs. Freedom of Speech?

December 2, 2016
Constitutional Law, Internet, Social Media

Tyler Hartney, MJLST Staffer

This election season has produced a lot of jokes on social media. Some of the jokes are funny and other jokes lack an obvious punch line. Multiple outlets are now reporting that this fake news may’ve influenced voters in the 2016 presidential election. Both Facebook and Google have made conscious efforts to reduce the appearance of these fake news stories on their sites in attempt to reduce the click bait, and thus the revenue streams, of these faux news outlets. With the expansion of the use of technology and social media, these types of stories become of a relevant circulation to possibly warrant misinformation being spread on a massive level. Is this like screaming “fire” in a crowded theatre? How biased would filtering this speech become? Facebook was blown to shreds by the media when it was found to have suppressed conservative news outlets, but as a private business it had every right to do so. Experts are now saying that the Russian government made efforts to help spread this fake news to help Donald Trump win the presidency.

First, the only entity that cannot place limits on speech is the state. If Facebook or Google chose to filter the news broadcasted on each site, users still do not have a claim against the entity; this would be a considered a private business choice. These faux news outlets circulate stories that have appeared to be, at times, intentionally and willfully misleading. Is this similar to a man shouting “fire” in a crowded theatre? In essence, the man in the aforementioned commonly used hypothetical knows that his statement is false and that it has a high probability of inciting panic, but the general public will not be aware of the validity of his statement and will have no time to check. The second part of that statement is key. The general public would not hypothetically have time to check the validity of the statement. If government were to begin passing regulations and cracking down on the circulation and creation of these hoax news stories, it would have to prove that these stories create a “clear and present danger” that will bring significant troubles that Congress has the right to protect the public from. This standard was created in the Supreme Court’s decision in Schenck v. United States. The government will not likely be capable of banning these types of faux news stories because, while some may consider these stories dangerous, the audience has the capability of validating the content from these untrusted sources.

Even contemplating government action under this circumstance would require the state to walk a fine line with freedom of political expression. What is humorous and what is dangerously misleading? For example, The Onion posted an article entitled “Biden Forges Presidents Signature Executive Order 54723,” clearly this is a joke; however, it holds the potential ability to insight fury from those who might believe it and create a misinformed public that might use this as material information when casting a ballot. This Onion article is not notably different from another post entitled “FBI AGENT SUSPECTED IN HILLARY EMAIL LEAKS FOUND DEAD IN APPARENT MURDER-SUICIDE” published by the Denver Guardian. With the same potential to mislead the public, there wouldn’t really be any identifiable differences between the two stories. This area of gray would make it extremely difficult to methodically stop the production of fake news while ensuring the protection of the comedic parody news. The only way to protect the public from the dangers of these stories that are apparently being pushed on to the American voting public by the Russian government in an attempt to influence election outcomes is to educate the public on how to verify online accounts.

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