Genetic Testing: Thorny Ethical Puzzles in Returning Results From Researchers

March 1, 2014
Bioethics

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.

The High Cost of Medical Errors

March 1, 2014
Healthcare, Public Health

Mayura Iyer, MJLST Staff

When we feel unwell, or have an injury, or are battling a serious condition, we turn to doctors and hospitals to take care of us and return us to health. But what if these professionals are actually adding to the harm? A recent study in the Journal of Patient Safety stated that between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These numbers are staggering and make medical errors the third leading cause of death in America. With statistics like that, you would expect the problem to be the topic of every major headline, however, these facts are not well documented or disseminated.

John Grout, John Hill, and Arlen Langvardt discussed the prevalence and causes of medical errors and how to mistake-proof the healthcare industry in their article in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology. Their article stated that medical errors stem from the multi-factorial, complex nature of medical procedures and from the subjective component of providing medical care. However, the article goes on to suggest several ways in which medical errors can be minimized through “mistake-proofing” measures that have had great success in other industries. The article gives examples of a variety of mistake-proofing methods, from using devices to monitor staff hygiene to using computers to aid the process of prescribing medication.

So why, when there are ways to tackle the issue, are the rates of medical errors not improving? Part of the problem is the institutionalized culture of healthcare. There has historically been a pass of sorts for the errors of doctors, granting them a pardon for reasonable human error. Furthermore, there is a culture of overlooking the mistakes of colleagues – partly because of a fear of retaliation and partly because there is an unspoken rule of maintaining and protecting professional reputations. However, when the cost of error is equal to the value of human life, it is necessary to break down harmful practices and implement policies that will adequately address the problem of fatal medical errors.

Academics, administrators, and doctors themselves have recognized this issue and even suggested easily to implement methods of error reduction. Dr. Marty Makary, a surgeon at Johns Hopkins Hospital, has suggested simple ideas like using cameras to record medical procedures and electronically-published reviews and ratings to make healthcare providers more accountable and thus minimize errors. With the problem only increasing, it will soon be impossible for healthcare providers to ignore. But recognizing the problem is only the first step; the more complicated task will be implementing policies that address the issue and ensuring adequate compliance. However, with the insight offered by practitioners and academics alike, the solution to this problem seems within reach.

Everything That Can Be Digital Will Be

February 22, 2014
Intellectual Property

Dylan J. Quinn, MJLST Staff

This past spring, the Supreme Court delivered a landmark decision in regard to the first sale doctrine by reversing the Second Circuit in John Wiley & Sons, Inc. v Kirtsaeng. The First Sale Doctrine allows a buyer or recipient of a copyrighted work to dispose of, lend, or distribute that copy as they see fit. In Wiley, the Court ruled in favor of the Defendant – who bought books in another country at a lower cost, imported them to the U.S., and then re-sold them at a higher market rate – thereby solidifying that the doctrine applies to copies of a copyrighted work lawfully obtained abroad.

A year prior to the ruling, in Volume 13, Issue 2, of the Minnesota Journal of Law Science & Technology, Benjamin Hamborg critiqued the Second Circuit for ruling against the Defendant, arguing that the Supreme Court needed to overturn the decision because the Circuit Court failed to give proper weight to the legislative history of the first sale doctrine and the negative public policy implications that would arise from affirming the ruling. The Supreme Court was in agreement with Hamborg, and seemingly eliminated those public policy concerns and the uncertainty surrounding the doctrine.

Hamborg discussed the potential dangers posed to libraries if they were not allowed to distribute works that were manufactured abroad, and while Wiley seemed to put an end to those issues, the movement of libraries into a more digital age has raised recent concerns about libraries’ ability to lend or distribute e-books and other digital works. Currently, redistribution of a digital work is not given the same “first sale” protection from copyright infringement claims because digital works do not decay over time and copies are just as valuable as the original – thereby having unknown consequences on the market for the copyrighted works. As libraries convert more and more of their collections into digital formats, we could be moving into an era where a dispute over a licensing agreement removes a large portion of a library’s collection instantly.

The recent concerns over libraries by no means represent the first discussion about a potential “digital” first sale doctrine, however it is just another example of the pressure pushing down on Congress to address the proper application of the first sale doctrine in a digital age. Back in 2001, the Copyright office addressed proposals for a digital first sale doctrine, and responded that “there was no convincing evidence of present-day problems” and that no expansion of first sale would be recommended. In the years since, there have been few developments that suggest Congress is ready to address the issue, until recently.

In the last two years, the Department of Commerce solicited comments on a possible digital first sale doctrine, the Director of the Copyright Office discussed possible options Congress could weigh if addressing the issue, and a court ruled against expanding the first sale doctrine into the digital sphere – stating that it is an issue for Congress. The recent resurgence of concerns over libraries is just another indication of the pressure facing Congress to address the application of the first sale doctrine on the internet.

While the issue clearly impacts libraries, the issue has massive implications on the entire online market place. It is a tall order to address such a large issue, but eventually something has got to give. At some point there needs to be alternative legislation or expansion of the first sale doctrine on the internet. The slogan surrounding the early days of internet sums it up best: everything that can be digital will be.

A Farm Bill for Hansel and Gretel

February 18, 2014
Food and Agriculture, Healthcare, Public Health

Ke M. Huang, MJLST Staff

Once upon a time, a farmer and his new wife, who had no means to support the farmer’s first wife’s children, decided to abandon the children in the woods. These children–Hansel and Gretel–found in the woods a charming little house made of sweets. A wicked witch lived in that house.

Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a “jobs bill,” and “innovation bill,” a “research bill,” and a “conservation bill.” Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.

Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill’s purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.

A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.

In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.

In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children’s family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.

Forensic Science Reform: A 2014 Update

February 16, 2014
Forensics

Eric Maloney, MJLST Lead Managing Editor

My article in Volume 14, Issue 2, Two More Problems and Too Little Money: Can Congress Truly Reform Forensic Science?, detailed a number of problems and key players in the field of forensic science reform. Given that this is an ever-changing issue and the problems I examined were, at the time, still largely unresolved, I present this as a quick update on what has happened since the article was published.

Annie Dookhan

Annie Dookhan was the Jamaica Plains, MA forensic drug analyst who resigned from her position and faced various criminal charges stemming from misconduct that included false test results and contamination of drug samples.

In November 2013, Ms. Dookhan eventually plead guilty to a grand total of twenty-seven (!) crimes, including misleading investigators, filing false reports, and evidence tampering. She was sentenced to 3-5 years in state prison, two years of probation, and possible mental health counseling. The sentencing judge described Ms. Dookhan as a “broken person undone by her own ambition.”

However, the consequences of Ms. Dookhan’s conduct have ranged far beyond a sole criminal proceeding. According to the Boston Globe, the state of Massachussetts has spent $8.5m reviewing past drug cases and holding hearings, with the final amount budgeted to be twice that number. State courts have held nearly 3,000 hearings for affected defendants or convicts, not to mention the 600-plus defendants the Globe had found that had had convictions erased or set aside, pending new trials, resulting from Ms. Dookhan’s lab misconduct.

The lab in Jamaica Plains has remained closed since the scandal began, and at least one other analyst who worked with Ms. Dookhan has also been fired, for allegedly claiming to have a college degree she did not have.

St. Paul Crime Lab

The St. Paul Police Department’s crime lab in St. Paul, MN came under scrutiny due to lack of training, documentation, and proper operating procedures, and closed in 2012. At the time of the article, it was largely unknown what potential effect this could have on defendants facing charges or those already convicted.

In contrast with the Dookhan situation, the fallout from the St. Paul lab has been much more minimal. The lab re-opened in August 2013, thanks to a $1m refurbish that included new equipment, new personnel, and a narrower focus on fingerprint analysis, as the lab would no longer perform drug testing. The lab also plans to seek accreditation within the next two years.

The effect on criminal proceedings has also been minimal. Defendants haven’t had much success in challenging their convictions based on evidence tested in the St. Paul lab. While 1,700 drug cases had been cited as possibly qualifying for relief based on their use of St. Paul crime lab evidence, the Star Tribune only identified seventeen cases where public defenders have challenged past convictions. A Minnesota state crime lab re-tested 197 samples from the St. Paul lab and found an innocent substance wrongly identified to be illicit only once; the state lab actually found suspected drugs in two samples that had been cleared by the St. Paul lab.

National Commission on Forensic Science

While Senator Leahy’s legislation did not survive the 112th Congress, there is progress happening at the federal level to study forensic science issues. The Department of Justice and the National Institute of Standards and Technology have come together to form the National Commission on Forensic Science, which recently appointed a number of forensic science experts to the commission. The commission is aiming to develop formal training and certification requirements, as well as policy recommendations and guidelines for professional responsibility. While it’s far too early in this process to judge the efficacy of the commission, its existence will hopefully constitute a step in the right direction for forensic science nationwide.

Athletic Performance Heavyweights on Verge of Patent Battle

February 16, 2014
Patents

Comi Sharif, MJLST Staff

Last week, athletic apparel giant Adidas filed a complaint accusing Under Armour of patent infringement. The complaint identifies ten Adidas-held patents that are used in mobile applications to collect and share workout-related data. The patents currently implemented in Adidas’s “miCoach” product line are allegedly being put to similar use in Under Armour’s “Armour39” products. The technology allows users to monitor their workout progress, and record and share statistics such as calories burned, heart rate intervals and distances traveled.

Both companies are major players in the fast-growing wearable technology fitness market. Adding fuel to the rivalry is the fact that Under Armour’s director of product and innovation previously worked as a senior innovation engineer at Adidas for over a decade. In addition, Under Armour recently announced a sponsorship deal with the University of Notre Dame, which ended a run for the school as one of Adidas’s biggest partners.

Though this dispute is only just getting underway, the results will be an important indicator for future events. If Adidas can succeed in preventing Under Armour and others from using the identified patents in its products, Adidas could put itself in a strong market position moving forward, while Under Armour would be relegated back to the drawing board. As fitness and mobile interconnectivity continue to trend worldwide, the intensity of the competition to gain market share is sure to increase as well. Holding and protecting patents could be the key that separates the winners and the losers in this race to the top. Stay tuned.

Oops! They Did It Again . . .

February 4, 2014
First Amendment, Healthcare, Healthcare Reform

Roma Patel, MJLST Staff
The Affordable Care Act is making its way back to the Supreme Court, this time with a different mandate under judicial scrutiny. In November the Court announced it would hear Sebelius v. Hobby Lobby Stores, Inc., regarding the comprehensive, yet controversial, health care law. Unlike National Federation of Independent Business v. Sebelius, where the Court upheld the ACA’s individual mandate to buy health insurance as a constitutional exercise of Congress’s taxing power, the Hobby Lobby case involves a religious liberty challenge against the ACA’s requirement that employers provide insurance coverage for contraception and some drugs that some believe cause abortions.

Hobby Lobby is a private corporation that owns arts-and-crafts stores throughout the country. The company is owned by the Green family, Evangelical Christians who believe that life begins at fertilization. Because Hobby Lobby is a for-profit employer of more than 50 people, the ACA will require it to provide insurance coverage of a full range contraception.

In June 2013 the U.S. Court of Appeals for the 10th Circuit ruled in favor of Hobby Lobby, stating that corporate entities are entitled to religious freedom. The 3rd and 6th Circuits split from the 10th Circuit and held that for-profit corporations do not have religious rights on two other cases challenging the ACA. On September 19, both Hobby Lobby and the 3rd Circuit case, Conestoga Wood Specialties Corp. v. Sebelius, were appealed to the Supreme Court.

Commentary on the Hobby Lobby case can best be described as dicey. Conservative and religious bloggers have hurled phrases such as, “atheist bullies” and “an attack on First Amendment rights” while the left cry, “war on women” and “crazed bible thumpers.” The broader issues at stake here are understandably divisive and extremely personal.

Amidst the often-exacerbated discussion of the case and the issues surrounding it is a desperate need to set the record straight: this is not a First Amendment issue, per se. What the Supreme Court will decide is Whether the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. §§ 2000bb et seq., which provides that the government “shall not substantially burden a person’s exercise of religion” unless that burden is the least restrictive means to further a compelling governmental interest, allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objections of the corporation’s owners.

Hobby Lobby argues the provision forces it to pay for methods of contraception which the owners find religiously immoral; namely the Plan B morning-after pill, an emergency contraceptive called Ella, and two different kinds of intrauterine devices (IUDs) that may sometimes work by preventing a fertilized egg from implanting into the uterus.

Counsel for the government argues that rights to religious freedoms do not apply to for-profit corporations and that health decisions should be between a woman and her physician, there is no place to an employer to impose his or her personal beliefs on someone else’s.

Amicus briefs have been flooding the Supreme Court’s doors defending both sides of the issue. Questions of corporate personhood and whether the Court’s decision could open a huge hole in the longstanding history of religion and the practice of medicine remain relevant. For example, some religions don’t believe in blood transfusions, so does that mean business owners with such beliefs can refuse to provide insurance coverage for an employee’s transfusion? Religious beliefs are personal and deeply subjective, how can health policy makers expand on patient coverage without being at odds with subjective beliefs?

The ultimate question is whether the ACA unduly infringes on the right to religious expression or if it pursues the least restrictive means of enforcing its provision on contraception with regard to the First Amendment. The result of Hobby Lobby will be close and the case will be one to watch.

Akamai Provides a New Induced Infringement Standard, but How Do We Use It?

February 3, 2014
Intellectual Property, Patents

Ryan J. Connell, MJLST Lead Articles Editor

In the spring 2013 issue of the Minnesota Journal of Law, Science & Technology Mr. Roy D. Gross examined the use of circumstantial evidence to prove inducement of infringement. Mr. Gross’s article is titled Can an Inference of Intent to Induce Infringement of a Patent Be Drawn Where Other Reasonable Inferences Exist? An Examination of the Use of Circumstantial Evidence to Prove Inducement of Infringement. Mr. Gross ultimately argues that that the doctrine of specific intent to infringe in patent cases should be harmonized with the standard used for inequitable conduct.

It is important to discern the boundaries of specific intent to infringe in light of the recent Akamai case. Akamai Techs. Inc. v. Limelight Networks Inc., 692 F.3d 1301 (Fed. Cir. 2012). In Akamai the Federal Circuit arguably made it easier for a patent owner to hold a person liable for induced infringement of a method claim when no single person performed all the steps of the method. The Akamai decision still requires the alleged inducer to have the specific intent to induce infringement. Akamai, 692 F.3d at 1308. The results of Akamai are mixed then, on one hand patent owners can now go after those who induced infringement but never induced a single party to infringe the patent. On the other hand the patent owner must still provide evidence of a specific intent to induce infringement.

Proving induced infringement is a difficult task. Direct evidence of inducement is often hard to come by and the patent owner must often resort to using circumstantial evidence to prove specific intent. Mr. Gross suggests courts to weigh the following three factors, in light of circumstantial evidence, when determining if the requisite intent is present: (1) nexus; (2) control; and (3) mitigating evidence of intent not to infringe.

Akamai has closed an undesirable loophole in patent law. For Akamai to reach its full potential however, courts and litigators need to understand how to weigh circumstantial evidence that may be more strained in cases where a patent is collectively infringed as opposed to directly infringed by one actor. Articles such as this can help the legal community understand how to use circumstantial evidence in light of the new induced infringement standard.

Akamai Provides a New Induced Infringement Standard, but How Do We Use It?

February 3, 2014
Intellectual Property, Patents

Ryan J. Connell, MJLST Lead Articles Editor

In the spring 2013 issue of the Minnesota Journal of Law, Science & Technology Mr. Roy D. Gross examined the use of circumstantial evidence to prove inducement of infringement. Mr. Gross’s article is titled Can an Inference of Intent to Induce Infringement of a Patent Be Drawn Where Other Reasonable Inferences Exist? An Examination of the Use of Circumstantial Evidence to Prove Inducement of Infringement. Mr. Gross ultimately argues that that the doctrine of specific intent to infringe in patent cases should be harmonized with the standard used for inequitable conduct.

It is important to discern the boundaries of specific intent to infringe in light of the recent Akamai case. Akamai Techs. Inc. v. Limelight Networks Inc., 692 F.3d 1301 (Fed. Cir. 2012). In Akamai the Federal Circuit arguably made it easier for a patent owner to hold a person liable for induced infringement of a method claim when no single person performed all the steps of the method. The Akamai decision still requires the alleged inducer to have the specific intent to induce infringement. Akamai, 692 F.3d at 1308. The results of Akamai are mixed then, on one hand patent owners can now go after those who induced infringement but never induced a single party to infringe the patent. On the other hand the patent owner must still provide evidence of a specific intent to induce infringement.

Proving induced infringement is a difficult task. Direct evidence of inducement is often hard to come by and the patent owner must often resort to using circumstantial evidence to prove specific intent. Mr. Gross suggests courts to weigh the following three factors, in light of circumstantial evidence, when determining if the requisite intent is present: (1) nexus; (2) control; and (3) mitigating evidence of intent not to infringe.

Akamai has closed an undesirable loophole in patent law. For Akamai to reach its full potential however, courts and litigators need to understand how to weigh circumstantial evidence that may be more strained in cases where a patent is collectively infringed as opposed to directly infringed by one actor. Articles such as this can help the legal community understand how to use circumstantial evidence in light of the new induced infringement standard.

Crime and Treatment: A Creative Drug Policy

February 3, 2014
Criminal Law, Drug Policy

by Shirshira Kother, MJLST Staff

In our society, it seems as though drug addiction is a commonality for prison inmates. It tends to play some role in every crime scene and horrific headline that we hear about. Drugs have been a driving force for many criminals because it significantly alters their decision-making and ultimately affects their actions. While there is no mistake that those who act under the influence of drugs will be subject to justice system, there perhaps a better way to discourage this behavior by redefining addiction.

An article titled Why Neuroscience Matters for Rational Drug Policy in volume 11 of the Minnesota Journal of Law, Science and Technology, explores the possibility of addiction as a neurological problem that may be solved by specific treatment to rewire an individual’s brain. David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions.

David M. Eagleman, Mark A. Correro & Jyotpal Singh analyze how consistent use of chemical substances destruct areas of the brain that control voluntary actions. The article continues to explain how policy regarding drug use and addiction should be more geared toward treating those affected by the condition versus punishing them for becoming addicted. They suggest that chronic users may not actually continue their use on their own accord but are driven their brains. Chemical abuse can restructure the functions within the brain and lead many criminals to act out of deprivation of the drug. This concept has come across several arguments, most of which revolve around the policy effect of allowing criminals to “blame their brains” for their actions. The authors however suggest that the mere explanation of chemical abuse and how its effects have led to a crime does not, relieve the individual of their responsibility. It allows the system to better rehabilitate the individual.

The process suggested would mirror the procedure used to treat an aliment in order to restore one’s health. The use of drugs is associated with positive stimulus and once the brain has been repeated exposed to a chemical, it becomes dependent on that stimulus to function and destroys behavior inhibition, which often leads to impulsivity. Depriving it of the substance can cause severe side affects to the individual and drive them to act without thought or reason. The article introduces two new radical methods in rehabilitating these individuals. Most medications used to treat addicts either reduce the positive response the drug elicits or counter acts the reaction by producing a negative one. By using real time neuroimaging, doctors can better understand cues associated with craving and try to override the responses to those cues. A second suggested method is a vaccine to block the receptors related to the positive response addicts experience when using drugs. This vaccine would not allow the addict to get high thus reducing their use.

While still fairly new, these two innovations can change rehabilitation of those incarcerated from chemical use and abuse related crimes. Perhaps, the biggest concern is whether these options will have long-term positive effects and keep the individuals off of drugs. If successful, this method would not only remove potentially dangerous individuals from society but also groom them to rejoin the world: chemical free.

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