March 2017

No Divorce Just Yet, But Clearly This Couple Has Issues: Medicaid and the Future of Federal-State Health Policy

Jordan Rude, MJLST Staffer

With the recent demise of the American Health Care Act (AHCA), the Affordable Care Act (ACA) will remain in effect, at least for now. One of the crucial issues that divided the Republican caucus was Medicaid—specifically, whether the ACA’s expansion of Medicaid should remain in place or be rolled back (or eliminated entirely). Moderate or centrist Republicans, and particularly some Republican governors, wanted to retain the expansion, while the House Freedom Caucus and other conservatives wanted to eliminate it, either immediately or in the near future.

Sara Rosenbaum, in her article Can This Marriage Be Saved? Federalism and the Future of U.S. Health Policy Under the Affordable Care Act examined the changing relationship between federal and state health policy under the ACA. Two areas in which this relationship was most affected were the ACA’s health insurance marketplaces and expansion of Medicaid: In both, the ACA significantly increased the federal government’s role at the expense of state control. The Supreme Court’s ruling in National Federation of Independent Business v. Sebelius held that the federal government could not require states to expand their Medicaid coverage, pushing back against increased federal power in this area. As of today, approximately 20 states have taken advantage of this ruling and chosen not to expand their programs. Rosenbaum argued that the tension between the ACA’s promise of universal coverage and some states’ refusal to expand Medicaid would defeat the purpose of the ACA, and she proposed a federal “Medicaid fallback” to replace lost coverage in those states.

The AHCA proposed a different, and simpler, solution to this problem—phase out the Medicaid expansion over time until it is completely gone. As noted above, this did not have much of a positive reception. Now that the AHCA’s proposal has been shelved, if only momentarily, some states that had not previously expanded Medicaid (such as Kansas) are moving forward with plans to expand it now. Such plans still face stiff opposition from conservatives, but the failure of the AHCA, along with the ACA’s growing popularity, may shift the argument in favor of expansion.

The end result of this recent healthcare debate, however, was retention of the status quo: The ACA is still in effect, and a significant number of states have still not expanded Medicaid coverage. The underlying issue that Rosenbaum discussed in her article has still not been addressed. The clash between federal and state policy continues: The marriage is not over, but it is not clear whether it can be saved.


The Future of Zero-Calorie Soft Drink Trademarks After the TTAB’s Coke Zero™ Ruling and Dr. Pepper Snapple’s Pending Federal Circuit Appeal

Joseph Novak, MJLST Staffer

For the past 13 years, Coca-Cola has been trying to trademark nothing. Well not actually nothing. Zero. As in zero calories. During this time, the Trademark Trial and Appeal Board (TTAB) has denied trademarking Zero for soft drinks, as the term was either generic (Referring to the genus of the good, i.e. Coke Zero as a zero calorie sports drink) or merely descriptive (Describing what the good is, i.e. “Zero” describing “Coke” as a zero-calorie version of the drink); neither of which is distinctive enough upon the Abercrombie spectrum to warrant trademark protection.

Not surprisingly, other large soft drink companies have opposed allowing Coke to register “Zero”, as no other company would be able to use “Zero” on their own mark subsequent to Coke obtaining such a trademark. This past May, the TTAB issued a ruling in favor of Coke (over the opposition of Dr. Pepper Snapple Group) allowing Coke to register numerous trademarks containing “Zero” for their soft drinks. The TTAB held that “Zero” had “acquired distinctiveness through a showing of secondary meaning”, which is a fancy way of saying that Coke had proven that the millions of dollars they had spent on marketing “Zero” meant that consumers of soft drinks were now likely to associate the term “Zero” with the Coca-Cola brand.

The TTAB ruling also contemplates Coke’s trademark infringement claim against Dr. Pepper’s “Diet Rite Pure Zero” mark for likelihood of confusion. For a mark to infringe upon another, the potentially infringing mark must cause confusion to the consuming public as to source, i.e. a showing that consumers of soft drinks would confuse the source of “Diet Rite Pure Zero” with “Coke Zero” given the distinctiveness of the “Coke Zero” mark. The TTAB essentially punts the infringement issue, dismissing Coke’s infringement claim for a failure to prove priority (because Coke could not show that they had acquired distinctiveness through before Dr. Pepper’s use of the term “Zero”, there was no infringement cause of action).

Dr. Pepper Snapple has appealed the issue of distinctiveness to the Federal Circuit, asking the court to find “Zero” as generic for zero-calorie soft drinks. That appeal is still pending. Assuming the TTAB’s finding of acquired distinctiveness for “Coke Zero” holds, the question becomes whether future uses of “[Soft Drink X] Zero” will be barred by the Patent and Trademark Office (PTO) for likelihood of confusion with “Coke Zero”? Or does this TTAB ruling only prevent future use of “Zero” on its own as a mark for soft drinks?

As outlined in this previous MJLST article, both the PTO (in deciding whether or not to register a trademark) and the Federal Circuit (who hears appeals from TTAB decisions) use the Dupont factors to determine whether there is a confusing similarity between a pending mark and an existing mark. These 13 factors, analyzed together as a whole, include:

  1. The similarity or dissimilarity of the marks in their entireties as to appearance, sound, connotation, and commercial impression.
  2. The similarity or dissimilarity and nature of the goods described in an application or registration or in connection with which a prior mark is in use.
  3. The similarity or dissimilarity of established, likely-to-continue trade channels.
  4. The conditions under which and buyers to whom sales are made, i.e. “impulse” vs. careful, sophisticated purchasing.
  5. The fame of the prior mark.
  6. The number and nature of similar marks in use on similar goods.
  7. The nature and extent of any actual confusion.
  8. The length of time during and the conditions under which there has been concurrent use without evidence of actual confusion.
  9. The variety of goods on which a mark is or is not used.
  10. The market interface between the applicant and the owner of a prior mark.
  11. The extent to which applicant has a right to exclude others from use of its mark on its goods.
  12. The extent of potential confusion.
  13. Any other established fact probative of the effect of use.

Like many likelihood of confusion cases, the analysis would likely come down to (1) similarity between the marks in terms of sight, sound, and meaning, and (2) whether or not either side could show actual confusion or a lack of such. For example, Coke would argue that any subsequent use of “Zero” in connection with a soft drink would be likely to confuse consumers that (according to the TTAB ruling) have come to associate “Zero” and soft drinks with Coca-Cola products. On the other hand, any subsequent user of “Zero” for soft drinks would likely have to rely upon a dissimilarity in appearance of the mark (as “Zero” would be the same in terms of sound and meaning), or show a lack of actual confusion between the two marks. Otherwise, the potential subsequent user could attempt to argue that “Coke Zero” is the mark in its entirety, and that “[Soft Drink X] Zero” is inherently dissimilar in its nature and thus, unlikely to cause consumer confusion.

In any regard, evidence of actual consumer confusion often comes down to which side has better survey design and results, which often correlates with which side has more resources to conduct such a survey. Thus, if the Federal Circuit upholds the TTAB decision to allow the “Zero” trademark, you better believe that Coca-Cola will put in a hero-like effort to protect their long sought-after victory over “Zero.”


The Excitement and Danger of Autonomous Vehicles

Tyler Hartney, MJLST Staffer

“Roads? Where we’re going we don’t need roads.”

Ok. Sorry Doc. Brown, but vehicular technology is not quite to where Back to the Future thought it would be in 2017; but, there are a substantial amount of companies making investments into autonomous vehicles. Ford invested $1 billion to acquire an artificial intelligence startup company that had been founded by engineers previously employed by Google and Uber with the intent to develop self-driving vehicles. Tesla already has an autopilot feature in all of its vehicles. Tesla includes a warning on its website that the use of the Self-Driving functionality maybe limited depending on regulations that vary by jurisdiction.

To grasp an understanding of what many of the experts are saying in this field, one must be familiar with the six levels of autonomy:

  1. No autonomy
  2. Driver assistance level – most functions still controlled by human driver
  3. At least one driver assistance system – cruise control or lane monitoring
  4. Critical safety features – shifts emergency safety features such as accident awareness from vehicle to human
  5. Fully autonomous – designed for the vehicle to perform all critical safety features and monitor road and traffic conditions
  6. Human like autonomy – fully capable of autonomy even in extreme environments such as off-road driving

The societal benefits could be vast. With level 4 autonomy on household vehicles, parents and siblings need not worry about driving the kids to soccer practice because the car is fully capable of doing it for them. Additionally, the ridesharing economy, which has grown incredibly fast over the past few years, would likely see a drastic shift away from human drivers. Companies have already begun to make vehicles for the purpose of clean energy ride sharing using autonomous vehicles such as Ollie. Ollie is an electric and 3D printed bus that can be summoned by those in need of a ride in a similar fashion to Uber.

While this self-driving vehicle technology is exciting, are we really there yet? Last June, a fatal car accident occurred involving a Tesla using its autopilot function. The driver in this case had previously touted his car saving him from an accident; he was very confident in the ability of his vehicle. It was later reported by a witness that there was a portable DVD player in the car that was found playing Harry Potter at the time of the accident. If this witness is correct, the driver of the vehicle violated the Tesla disclaimer that reads the autopilot feature “is an assist feature that requires you to keep your hands on the steering wheel at all times.” Some experts argue these manufacturers have to be more upfront about the limitations of their autopilot feature and how drivers should be cautious in the use of this advanced technology. It is no question that the driver of the Tesla (if you can call him that?) was reckless in the use of this technology. But what about the liability of the vehicle manufacturer?

The deceased’s family hired a product defect litigation law firm to conduct an investigation in conjunction with the federal government’s investigation. The goal of these investigations was to determine if Tesla is at fault for the vehicle’s autopilot feature failing to stop. Recently, news broke that the government investigation concluded that no recall must be made for the Tesla vehicles nor did the government levy any fines to the automaker. The government reported that the autopilot feature was not defective at the time of the crash because it was built to protect the driver from rear-end collisions (the man’s car rear-ended a truck) and also gave notice to consumers that the driver must remain fully attentive to the operation of the vehicle.

Legally, it appears that plaintiffs won’t likely have much luck in suits against Tesla in cases like this. The company requires purchasers to sign a contract stating the autopilot function is not to be considered self-driving and that they are aware they will have to remain attentive and keep their hands on the wheel at all times. However, Tesla operates on an interesting structure where purchasers buy directly from the manufacturer which may give them more of the ability to engage in these types of contracts with their consumers. Other automobile manufacturers may have a more difficult time maneuvering around liability for accidents that occur when the vehicle is driving itself. Car companies are going to have to ensure they provide repeated reminders to consumers that, until technology is tested and confidence in the feature is significantly higher, that the autopilot features are in the beta-testing mode and driver attention and intervention is still required.


This Time It’s Personal(ized): Pharmaceutical Companies, Dosing Regimen Patents, and Personalized Medicine

Peter Selness, MJLST Staffer

An area of developing healthcare garnering attention in both the medical community and areas of intellectual property law is that of personalized medicine.   Personalized medicine changes the old one-size-fit-all approach of medication dosing to instead tailor medications to each individual patient based upon their genetic make-up.  This practice promises numerous benefits for patient healthcare, but also has some substantial road blocks to overcome before becoming a reality.  Among the issues facing this field of medicine is the controversy surrounding the patentability of personalized medicine methods.  Several recent cases such as Mayo Collaborative Services v. Prometheus Laboratories and Association for Molecular Pathology v. Myriad Genetics, Inc. have raised serious concerns over whether or not personalized medicine methods are based on patentable subject matter.

This concern was taken one step further in the recent article Decline of Dosage Regimen Patents in Light of Emerging Next-Generation DNA Sequencing Technology and Possible Strategic Responses, which discussed the potential impact this may have on the pharmaceutical industry.  Among the concerns addressed was the impact of not being able to obtain patents on dosing regimens for drugs developed by pharmaceutical companies.  While a pharmaceutical company should have no problem patenting a novel medication it has developed, adding additional patent protection to its patent portfolio surrounding that product, such as patents on dosing regimens, has long been a practice utilized to keep competitors at bay.  Considering the massive investment in research and development required to bring a new drug to market (sometimes billions of dollars), pharmaceutical companies are rightly alarmed by any potential loss of patent protection they may experience on their product.  As the article mentioned, this issue will also surely be compounded by the transition to personalized medicine and integrated healthcare, but it may also be a self-solving problem.

Though the article is concerned with the impact personalized medicine may have on pharmaceutical companies if they no longer can obtain patent protection on dosing regimens, researchers developing personalized medicine methods currently face the same issues.  In order for personalized medicine to have an impact on pharmaceutical companies, it must be a fully developed method that has been integrated into everyday healthcare practices.  For that to happen, researchers must have a fundamental understanding of what specific genes give rise to differences in patients’ responses to medication.  This has proven to be a long and expensive process requiring the systematic sequencing of millions of genes from numerous subpopulations of patients; and all of this work is expensive.  Given that the end result of personalized medicine research is a method of administering medication based on an individual’s genetic make-up, patents on personalized medicine fall victim to the same issue facing pharmaceutical companies’ dosing regimen patents.

Lacking the ability to obtain patent protection on personalized medicine methods, the economic feasibility of research in this area becomes more questionable.  To circumvent this dilemma, those within the field of personalized medicine will most certainly be looking for the same solutions as pharmaceutical companies.  Therefore, one of two results will likely occur, both of which may solve the issues of dosing regimen patentability facing the pharmaceutical companies.  One possibility is that the field of personalized medicine will be unable to economically sustain future research without patent protection and fully integrated healthcare will never become a reality; making this issue disappear for pharmaceutical companies.  The other, more likely, possibility is that in order for research in the field of personalized medicine to continue, those researchers will solve the very dilemma that pharmaceutical companies fear will be brought about by the emergence of integrated healthcare.  Either way, pharmaceutical companies’ dosing regimen patents are so closely tied to the fate of personalized medicine patents that the emergence of integrated healthcare most likely cannot occur in a manner that will be detrimental to pharmaceutical companies’ patent portfolio.


Nebraska: The State of Copyright

Amy Johns, MJLST Staffer

In this day and age, everyone should be aware of the truism that with great power, comes a great lobbying team. Nowhere has this been more evident in recent news than in the case of states that have tried to pass “right to repair” laws. Such a law has most recently been introduced in Nebraska as Legislative Bill 67. The purpose of the law is to require that manufacturers provide their service guides and other materials to the public, making third party repair services viable options for owners of all high-tech devices and allowing self-repair.

The campaign for this bill originated with farmers who wanted greater options to repair their high-tech farm equipment; in rural areas the accessibility of authorized repair shops is extremely limited and makes the cost of repairs much greater than for those in urban areas. Before submitting the bill, state senator Lydia Brasch relied on a December 2016 report from United States Copyright Office, which concluded that contract and consumer protection laws at the state level deal with these issues sufficiently, and that federal copyright issues are not going to preempt state laws in regards to right to repair.

The consequences of this bill extend much farther than just farm equipment, however. Similar bills have been introduced in eight states, and the result would be that manufacturers would lose control of repairing their devices; what independent repair shops see as a “monopoly” over device repair would be ended, as these companies would be required to release spare parts and information. Because of these far-reaching consequences, several companies have lobbied to kill this bill, most prominently Apple. These large companies’ main arguments are that hackers are going to have an easier time using this information to infringe on security and privacy, and also that it will weaken their intellectual property rights. Apple even offered to support the bill if the language excluded phones specifically from the included technology.

For the moment, this issue seems to be moot, as Nebraska’s law has stalled out under industry pressures. However, as these laws continue to arise in other states, this conflict will likely play out again. In particular, it’s worth noting that industries are not arguing that federal copyright law preempts state laws from interfering with copyright agreements on these devices. Rather, they are arguing against the practical implications of greater access to manuals and software information. While bringing up IP rights, these companies don’t use legal justification to argue that states should be prevented from passing these laws. The desirable outcomes of such laws are that consumers will pay less for the products that they need to use in their everyday lives; in response, Apple has claimed that their concern is states like Nebraska becoming a haven for hackers. These alarmist responses seem to be a smokescreen for the very obvious financial interest that Apple and other companies have in being the exclusive provider of repairs to their products. For people in areas where those repair services are hard to access, the consequences are serious, making repairs far more expensive than they would otherwise be. However, for these bills to be seriously considered, there needs to be greater clout on the side of these bills; as is, industry interests are going to outweigh consumer interests and kill these bills before they see the light of day.


The Rise and Fall of A Scholarly Crowdfunding Article

Tim Joyce, Editor-in-Chief, MJLST Vol. 18

Print publication of science and tech articles is a weird thing. On the one hand, a savvy articles selection team will prioritize articles on the most pressing and innovative advancements in the field. On the other, though—and precisely because these articles are so current—a draft piece can be partially outdated even before the publisher’s pressing start rolling. So it is that a little piece on investment crowdfunding, conceived in September 2015, meticulously researched throughout the 2015–16 academic year, and selected in April 2016, for publication in January 2017, can transform from forward-looking thinkpiece to historically-dated comparison piece.

My recent article with MJLST, 1000 Days Late & $1 Million Short: The Rise and Rise of Intrastate Equity Crowdfunding, compares the newly-activated federal Regulation Crowdfunding to Minnesota’s intrastate investment crowdfunding model MNvest. When the piece was originally conceived both of these laws were not yet active; in fact, it was not yet clear that the SEC would ever release final rules for what would become Regulation Crowdfunding. When the issue was ultimately sent to the printers, each of the laws had been active for at least 6 months. Like I said, weird.

This post is intended to update the curious reader on current happenings with investment crowdfunding on both a federal and a state level.

On the federal level, Regulation Crowdfunding rules have been final since October 2015 and active since May 2016. Nearly 200 offerings later, analysts and scholars are already starting to crunch the numbers. [Full disclosure: I am one of those academics. Our paper (co-author Zach Robins of Winthrop & Weinstine) will be presented at the Mitchell-Hamline Law Review Symposium next month, if you’re interested.] Similar to rewards-based crowdfunding models like Indiegogo and Kickstarter, there appear to be some things a crowdfunding issuer can do to increase the likelihood of success of their offering. Here are some examples.

First, a clear business plan is essential to attracting investors. After all, the “crowd” is made of lots of folks without sophisticated investing experience; so you have to find a creative way to hook them without violating securities disclosure restrictions. This isn’t always as easy said than done, and some portal operators have already gotten in serious trouble for violating their obligations to ensure offering accuracy.

Second, and perhaps a bit counterintuitive, the most successful Regulation Crowdfunding issuers actually have slightly higher minimum investments than you would expect. There is no dollar floor to the investment under the rules of Reg CF, but a small minimum opens the door to a potentially unwieldy cap table. In addition, a high minimum investment decreases the number of available spots for investors in the targeted offering amount; there is a very real “exclusivity” effect. To illustrate: it takes 10,000 investors at $10/per to get to $100,000 offering, but you could raise the same $100,000 with only 100 investors at $1,000/per. Issuers get to choose which investors they take on in oversubscription situations, and it can’t hurt to create a little buzz as investors “compete” for limited spots in the offering.

Finally, communicating the business plan using a strong video is a must—industry analysts report that campaigns using any video at raised significantly more money that those without (on the order of 11:1 times more money!). If that video is of good enough quality, according to those same analysts, your offering does even better. Of course, video quality only matters if your network is sufficiently large to reach enough potential investors. For issuers hoping to raise $50,000, that generally means connecting with more than 3,000 people.

There are plenty more nuggets of wisdom to glean from the first 8 months of federal investment crowdfunding offerings, and this post only scratches the surface. For more, see our forthcoming paper in Mitchell-Hamline Law Review’s symposium issue later this year.

As for MNvest, unfortunately, while the law has been technically available for Minnesota crowdfunders since June 2016, it took until the end of the year for the Department of Commerce to approve any portals. So only a handful of issuers and portals are currently active in the space. True to form, for federal crowdfunding offerings at least, craft breweries are making a strong showing (read: in Minnesota, 4 of the first 4 MNvest issuers are breweries!). Hopefully we’ll see more of them as the vehicle becomes more well-known.

One thing that should further aid MNvest issuers is that the SEC recently released final rules that will make it easier and safer for intrastate issuers to use the internet to advertise. Before the rules update, issuers were bound by advertising and solicitation restrictions drafted in the 1970s (that is, before the interwebs). As crowdfunding, almost by definition, requires the use of the internet to reach a crowd, these updates should streamline and loosen up the fundraising process. The new final rules create a new exemption (Rule 147A); state legislatures that based their intrastate laws on old Rule 147 will need to update their laws accordingly first.

Investment crowdfunding laws of the intrastate and federal varieties hold promise for many issuers. And, while there is not yet a perfect model or a one-size-fits-all strategy for fundraising, it is clear that investors and issuers alike are excited by the promise this investment vehicle holds.

Who knows—perhaps in another 18 months the way we crowdfund will have experienced as much change again, to make this piece as quickly “historical” as my earlier article!


Broadening the Ethical Concerns of Unauthorized Copyright and Rights of Publicity Usage: Do We Need More Acronyms?

Travis Waller, MJLST Managing Editor

In 2013, Prof. Micheal Murray of Valparaiso University School of Law published an article with MJLST entitled “DIOS MIO—The KISS Principle of the Ethical Approach to Copyright and Right of Publicity Law”. (For those of you unfamiliar with the acronyms, as I was previous to reviewing this article, DIOS MIO stands for “Don’t Include Other’s Stuff or Modify It Obviously”, just as KISS stands for “Keep it Simple, Stupid”). This article explored an ethical approach to using copyrighted material or celebrity likeness that has developed over the last decade due to several court cases merging certain qualities of the two regimes together.

The general principle embodied here is that current case law tends to allow for transformative uses of either a celebrity’s likeness or a copyrighted work – that is, a use of the image or work in a way that essentially provides a new or “transformative” take on the original. At the other extreme, the law generally allows individuals to use a celebrity’s likeness if the usage is not similar enough to the actual celebrity to be identifiable, or a copyrighted work if the element used is scenes a faire or a de minimis usage. Ergo, prudent advice to a would-be user of said material may, theoretically, be summed up as “seek first to create and not to copy or exploit, and create new expression by obvious modification of the old expression and content”, or DIOS MIO/KISS for the acronym savvy.

The reason I revisit this issue is not to advocate for this framework, but rather to illustrate just how unusual of bedfellows the regimes of copyright and “rights of publicity” are. As a matter of policy, in the United States, copyright is a federal regime dedicated to the utilitarian goals of “[p]romot[ing] the progress of science,” while rights of publicity laws are state level protections with roots going back to the Victorian era Warren & Brandies publication “The Right to Privacy” (and perhaps even further back). That is to say, the “right to publicity” is not typically thought of as a strictly utilitarian regime at all, and rather more as one dedicated to either the protection of an individual’s economic interests in their likeness (a labor argument), or a protection of that individual’s privacy (a privacy tort argument).

My point is, if, in theory, copyright is meant to “promote science”, while the right to publicity is intended to either protect an individual’s right to privacy, or their right to profit from their own image, is it appropriate to consider each regime under the age-old lens of “thou shalt not appropriate?” I tend to disagree.

Perhaps a more nuanced resolution to the ethical quandary would be for a would-be user of the image or work to consider the purpose of each regime, and to ask oneself if the usage of that work or image would offend the policy goals enshrined therein. That is, to endeavor on the enlightened path of determining whether, for copyright, if their usage of a work will add to the collective library of human understanding and progress, or whether the usage of that celebrity’s likeness will infringe upon that individual’s right to privacy, or unjustly deprive the individual of their ability to profit from their own well cultivated image.

Or maybe just ask permission.


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

Angela Fralish, MJLST Invited Blogger

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

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

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

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

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