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You Can Design Your Clothes, but Can You “Design” a Baby? Ethical Objections to Genetic Modification of Embryos and the Prevention of Diseases in the Unborn

Zanna Tennant, MJLST Staffer

The term “designer babies” has been thrown around quite a bit by those who find the genetic modification of babies to be morally repugnant. However, these fears are often blown out of proportion considering the benefits that such genetic testing and modification can give to babies in utero. The age-old debate of science versus religion is evident here, as scientists argue that genetic alteration can save lives while many with religious or spiritual backgrounds fear the ethical implications. How the world and the law should react to this newer science is still very much a controversial topic. Many countries have banned genetic modification of embryos altogether, while some are still unsure how to proceed. Despite these fears, genetic alteration should not be completely abandoned. It has the potential to prevent genes for diseases from passing from parent to child and save lives. It should not, however, be completely unregulated. While it is difficult to say precisely how to regulate and who should be in charge of such regulations, this is something that governments and the world as a whole must decide. This is exactly the challenge genetic testing faces today, especially from those who oppose it on religious or ethical grounds.

Women or others who may be having trouble conceiving or are concerned about possible hereditary diseases are among those likely to pursue in-vitro fertilization, a process by which a sperm and an egg are combined in a lab. This process results in an embryo. “Designer babies” are babies that come from embryos created by in-vitro fertilization (IVF) and are specifically selected because of the presence of “good” genes like intelligence, or the absence of “bad” genes, such as BRCA 1.  The genes of the embryos are then altered through the process of heritable genome altering, whereby scientists alter the DNA of the egg, sperm or any other cells involved in the process in order to achieve a desired result.For example, suppose an embryo has the gene for sickle cell anemia. Diseases often show up in DNA in the form of a genetic alteration, such as the presence of an extra chromosome or the absence of one. The embryo in this example would be taken to a lab where a scientist could alter it to get rid of the gene for sickle cell anemia. Heritable genome altering could prevent life-altering disabilities and diseases in children who otherwise may not survive.

Despite the enormous lifesaving potential, there is a large movement against genetic alteration of embryos. One of the biggest challenges genetic alteration faces is whether it is ethical to alter the genes of an unborn child. Many fear that this genetic alteration would be used to change what they consider to be superficial genes, such as hair or eye color. They think this is man’s way of “playing God” and is unnatural. Factors such as religion and spirituality heavily influence what people think about gene altering of babies. Some see the altering of embryos as going against God’s wishes.  Along with this issue, people who believe that life begins at conception are concerned with the rights of the embryos. Similar to the controversial topics of reproductive rights and abortion, there are those who think that altering the genes of an embryo violates the human rights of what they perceive to be a living child. They see the embryo as already being alive and having the same rights as any post-birth child. On the other side, there are those, including many scientists, who do not conflate the embryo with a human child and find their beliefs in line with those who support the right to choose. People are also concerned about the unknown effects of gene alteration since it is a more recent development and scientists believe that the genetic alerting of DNA might affect future generations in unknown ways. There is also concern about increasing socio-economic inequality due to the high price tag that comes with genetic alteration. In vitro fertilization on its own is expensive, but genetic alteration is upwards of $500,000. Should this technology become available to the public, only the very wealthy would be able to afford it, thereby increasing the divide between the rich and the poor.  Because of the controversy surrounding heritable genome altering, legal systems in different countries are often unsure what to do.

Some forty countries, such as China and Japan , have completely banned heritable genetic altering. In 2019, a biophysicist in China was criminally charged with illegal medical practice and sentenced to three years in prison after he edited genes of two embryos which later became baby girls. He used a new tool, CRISPR, which allows scientists to more easily edit genes and DNA. He was universally condemned, save for the scientific community. There are other countries, however, that have not banned heritable genome altering. Rather, they have placed strict regulations on how it is to be used. In the United Kingdom, they have banned all forms of genetic alteration except for the modifications of nuclear mitochondrial DNA, which are heavily regulated. Mitochondrial DNA testing focuses on diseases in the mitochondria of a cell that can be passed down from mother to child. This testing allows potential families to determine if the mitochondria in the embryo has a disease and allows them to replace the defective part of the mitochondria with a healthy part. Clinical trials for mitochondrial replacement therapy are allowed in the UK, but they are only allowed for medical purposes. Similarly, mitochondrial replacement therapy is offered on a case by case basis only to those who meet the necessary medical criteria. Even in the few countries which have not outright banned genetic alteration, there is still strict regulation and strong public criticism.

As in the rest of the world, genome editing is controversial in the United States. Although it is not technically illegal, it is regulated under the FDA and the National Health Institute. Any genetic testing must be approved by the FDA, which is no easy task. Generally, the editing of somatic cells is allowed, while the editing of germline cells is still very much up for debate. Somatic cells are those cells which have already been differentiated as blood cells or liver cells, while germline cells are those in the egg, sperm, or embryo. Alerting somatic cells is akin to altering the function of cells. Germline editing, on the other hand, is the controversial case of actually altering the genes that determine who a person is. There are clinical trials that have been approved for the use of CRISPR in somatic cell editing.  Recently, the FDA stated that the use of federal money cannot be used to research germline editing, but it can go towards funding for somatic cell editing. While the US has yet to actually ban germline editing, there is essentially a moratorium on its use as it is disfavored by many government officials. However, the US does permit the use of preimplantation genetic screening (or diagnosis), which is either heavily regulated or banned in other countries. Preimplantation genetic screening is a process used to test embryos for genetic abnormalities that could indicate a disease and help parents to find a healthy embryo to use. It is used in the course of IVF and can help parents to increase the likelihood that their child will make it to term and be healthy. PGS raises similar ethical concerns to genetic alteration due to its focus on finding the best embryo and using science to change DNA, which is why it is banned in some countries.

Despite the numerous, and admittedly (mostly) valid concerns, it would be contrary to human progress to completely rule out heritable genome testing. This process can save the lives of thousands of children yet to be born and could even erase a disease from a family’s hereditary line. Although there are certain inherent risks, the only way for the world to move forward with this achievement is to allow, within reason, clinical trials to take place so that scientists can better understand how best to alter genes. The federal government should, with regulations enacted, encourage the use of gene altering. Although states have admittedly said very little about gene editing, they, too, should support its use. Only through controlled, regulated tests can the best practices and the unknown consequences of gene editing be discovered. The focus of gene editing should be on how it can progress the medical field. People’s fear that gene editing will be used for superficial purposes is unfounded, scientists claim, as there is not a one for one ratio between a gene and, say, the trait for blue eyes. Scientists can better predict hair or eye color, but they cannot determine these traits with one hundred percent certainty, nor can they easily find and gene and determine that it is the gene for intelligence.The government could also easily limit gene editing for health reasons and medical research, thereby making this fear irrelevant. The US government, unlike other countries, has yet to really take a stand one way or the other when it comes to gene editing. It is time that the federal government get behind this scientific wave that could potentially erase diseases altogether from the human population.



Death of a Gravesite: Alternatives to the Traditional Burial Practice

Jennifer Novo, MJLST Staffer

Halloween is often a time for ghosts, the dead, and for some, is the perfect time to make a trip to a local graveyard or cemetery. The obvious association with death as the final resting place for many makes graveyards an inherently spooky destination. Burial is just one of the many methods used for the final disposition of human remains around the world and is a common practice in the United States. However, considering environmental and economic factors, it may be time to consider alternative forms of final disposition.

In the United States, there is a presumed right to a decent burial under common law. Beyond that, different jurisdictions within the United States have their own regulations for the disposal of dead bodies and the reporting of deaths and final dispositions of the remains. For example, Minnesota Statute § 149A outlines regulations with the purpose of “regulat[ing] the removal, preparation, transportation, arrangements for disposition, and final disposition of dead human bodies for purposes of public health and protection of the public.” This chapter outlines license requirements, safety standards, and guidelines for a number of disposition practices, not just burial.

There are a number of negatives, from environmental to economic, to the modern burial. Modern burials consist of burying a casket containing embalmed remains. This practice has serious environmental effects. Embalming is used to delay the decay of a body, and the chemicals used for embalming include formaldehyde, phenol, methanol, and glycerin, all of which are irritants and some of which are carcinogenic or toxic. Over time, once the body and the casket have decomposed, these chemicals will seep into the soil and water table of the surrounding area and pose a health risk to the living. Burials also negatively affect the environment by using a large amount of resources to create caskets (hundreds of thousands of tons of various metals and concrete as well as millions of board feet of wood). Another primary negative environmental impact that burial has is that graveyards use up a lot of space (as of late 2018, there are a little under 145,000 graveyards across the United States totaling to approximately 1 million acres of land). This land requires a lot of maintenance, water, and fertilizer to keep green. In addition to the environmental effects, burials are expensive. By 2017, funeral expenses increased 227.1% and the cost of burial caskets rose by 230% since 1986. The current cost of a traditional full-service burial in North America is between $7,000 and $10,000.

In 2017, a report by the National Funeral Directors Association (NFDA) found that for the first time, more Americans were cremated than buried. Researchers ascribed this change to shifting religious beliefs and generational differences. Economically, cremations are less expensive than traditional burials. Additionally, cremation removes the need for large swaths of land required by burials. However, like burials, cremation has negative environmental impacts. For example, studies have suggested that the high level of energy required to cremate a body damages the environment. Additionally, the cremation process releases various chemicals (such as carbon monoxide, sulfur dioxide, and mercury) and soot into the atmosphere, and the resulting sterile ashes lack nutrients that could contribute to ecological cycles.

As people are becoming more aware of the downsides to traditional burial and cremation, other methods of final disposition have been created and adopted that address some of these concerns.

One alternative comparable to a traditional burial is a natural or green burial, in which a body is buried either in a shroud or a biodegradable container without going through the embalming process. Some types of natural burial (conservation burial) take this a step further in that some of the fees associated with the burial go towards protecting the land through a conservation easement.

One alternative comparable to traditional cremation is a flameless cremation process known as alkaline hydrolysis, in which the body is dissolved, leaving bone powder and a liquid that can then be “recycled” in a local wastewater treatment plant. Only a handful of states, including Minnesota, have formally adopted regulations for this final disposition process.

A number of states, including Minnesota, do not have many (or any) restrictions on remains post-cremation, so a number of alternatives focus on ways cremated remains can be used to negate the negative environmental effects of the traditional cremation process. Some examples include sending ashes in a concrete ball to the ocean floor to promote the growth of coral reefs, placing ashes in a pod that will eventually grow into a tree, and mixing ashes with fertilizer to feed a particular tree in lieu of having a gravestone.

Death is frightening and uncomfortable to think about, and contemplating the treatment of a loved one’s (or one’s own) remains is depressing. However, decisions on these matters have lasting effects for friends, family, and even the general population. There is a lot of legal leeway surrounding final disposition, so it never hurts to consider the options before it’s too late.


Should the FDA Strengthen Pet Food Regulation?

Jennifer Satterfield, MJLST Staffer

Recently, the Food and Drug Administration (FDA) began an investigation following numerous reports of dilated cardiomyopathy (DCM), a type of heart disease, in dogs. The FDA is exploring a potential connection between DCM and certain diets containing legumes (e.g., peas or lentils), legume seeds (pulses), or potatoes as main ingredients. These ingredients are commonly associated with “BEG” diets (boutique companies, exotic ingredients, or grain-free diets). The FDA has compiled a spreadsheet of all the DCM reports prior to April 30, 2019. The most frequently identified brands include: “Acana (67), Zignature (64), Taste of the Wild (53), 4Health (32), Earthborn Holistic (32), Blue Buffalo (31), Nature’s Domain (29), Fromm (24), Merrick (16), California Natural (15), Natural Balance (15), Orijen (12), Nature’s Variety (11), NutriSource (10), Nutro (10), and Rachael Ray Nutrish (10).”

The DCM scare has led pet owners to question the safety of pet food products and turn to online forums for help, including a popular Facebook group called Taurine-Deficient (Nutritional) Dilated Cardiomyopathy. This group’s purpose is to “share information concerning Nutritionally-Mediated DCM among veterinarians, breeders, members of the Ph.D. & DVM research community, nutritionists, food brand representatives, nutrient suppliers, and concerned dog owners.” Some of the most common concerns among dog owners in this group are “what should I be feeding my dog?” and “what food is safe for the long term?”

Unfortunately, the FDA only requires that pet food be “[s]afe to eat; [p]roduced under sanitary conditions; [f]ree of harmful substances; and [t]ruthfully labeled.” However, the Federal Food, Drug, and Cosmetic Act (FFDCA), the statute that gives the FDA the authority to regulate pet food, does not require any pre-market review. Hence, pet foods do not need to be formally approved or undergo testing before hitting the shelves. Consequently, the federal government may have inadvertently allowed pet foods to reach the market that may not be safe for animals in the long term. For example, french fries are “safe to eat.” But, eating just french fries every day for a person’s entire life is not healthy, and will probably lead to medical complications. Since dogs generally eat the same dog food over the course of their entire lives, the food may be “safe to eat,” but may not be healthy as the dog’s sole source of nutrition.

Although the FDA has partnered with the Association of American Feed Control Officials (AAFCO), AAFCO does not have regulatory authority. For a dog or cat food to have a “complete and balanced” label, it must meet either one of the nutrient profiles established by AAFCO or pass a feeding trial using AAFCO standards. But AAFCO cannot enforce its standards, and, what is more, its recommendations may not even be good enough to ensure pet food safety in the long term. For example, both the nutrient profile and feeding trial methods leave uncertainty regarding nutrient bioavailability (the nutrients the animal’s body actually absorbs and uses).

Moreover, the AAFCO feeding trial protocol only requires eight animals to participate and only six out of the eight need to complete the entire trial over a period of twenty-six weeks. This extremely small number of test subjects over a relatively short period of time is not enough to make a determination on the safety or nutritional longevity of a specific pet food. As a comparison, a human-controlled feeding clinical trial used a “relatively small” sample size of twenty two people per group. Logically, pet food companies should be conducting feeding trials with a substantially larger number of test subjects over a much longer time period.

To prevent another scare, like the surprising potential link between DCM and certain dog foods, and to ensure the safety of pet food, the FDA should require stringent pre-market testing using sound scientific methods. But, since it is likely that the FDA does not have the statutory authority to increase its regulatory oversight of the pet food industry based on the FFDCA, Congress should step in and require it. It is also important to note that, while pet food is also regulated by states, these regulations typically deal with labeling and nutrient profiles. Considering the federal government’s failure to ensure pet food safety, states may also be able to step up and require pre-market testing. For many people pets are like family and, surely, pet owners want the safest, healthiest options for their beloved family members.

 


Putting Patient Values in Value-Based Medicare

Peter J. Teravskis, MJLST Staffer

The vast majority of payments to medical providers are based on a fee-for-service reimbursement model. The fee-for-service model reimburses providers for every test, exam, intervention, and procedure they perform, potentially contributing to over-billing, increased health care costs, and waste. On the other hand, value-based care models tie provider reimbursement to efficiency of care and measures of patient wellness and satisfaction. For this reason, in recent years, there has been a nationwide effort to transition provider reimbursement away from fee-for-service towards value-based care.

In line with this effort, the Affordable Care Act contains many provisions designed to encourage the transition to value-based care. In 2015, then-Secretary of Health and Human Services Sylvia M. Burwell tasked the Centers for Medicare and Medicaid Services (CMS) with two goals for 2018: increasing (1) value-based purchasing practices, and (2) use of value-based reimbursement models (called alternative payment models or “APMs”) by Medicare providers. The hospital value-based purchasing program rewards acute-care providers for making purchasing decisions based on quality metrics rather than the volume of services provided while still operating in a fee-for-service framework. On the other hand, the APM adoption plan seeks to discard fee-for-service reimbursement entirely by encouraging the adoption of payment models that reimburse providers based on patient outcomes and efficiency of care rather than volume.

While CMS efforts have resulted in increased adoption of value-based care models, early data suggests that these models may not deliver the health and financial benefits initially promised. For example, recent studies indicate that multiple value-based Medicare reimbursement models in several clinical contexts fail to demonstrate meaningful improvements in hospital readmission rates, health outcomes, quality of care, and patient satisfaction. Nevertheless, some marginal cost savings have been reported. However, cost savings may be even more limited than the studies suggest. Government metrics may overestimate the actual adoption of value-based practices given the loose definition of “value-based care.” Further, the New York Times Upshot reports that CMS may overestimate the adoption of value-based purchasing metrics by miscounting many volume-based purchases as value-based purchases.

CMS’s attempt to implement value-based care through this top-down incentive structure is also ethically fraught. Current value-based care models have been criticized for making assumptions about what patients actually value, rather than adopting a pluralistic understanding of patient values. This “monistic” value system decreases patient autonomy in their health care decisions. Indeed, ethicists contend that it is only ethical to impose value-based decisions on patients if there is “strong and sound evidence” that they deliver “equivalent or greater clinical benefit at lower cost.” This ethical principle greatly limits the number of value-based reforms that can be instituted at the national- or hospital-level. Indeed, all other value-based decisions should be made in consultation with individual patients, taking into account their unique value systems. Furthermore, it is “ethically suspect” to withhold otherwise beneficial treatments based on cost savings alone. Unfortunately, value-based care models favor health care market efficiency and could penalize providers who tailor care to patient values rather than the monistic value structure described above.

Given the ethical limitations of value-based decisions that can be made without patient input, the early empirical shortcomings of Medicare’s value-based care initiatives may be partially explained by the slow process of aligning care to patient values. Specifically, the value-based decisions most likely to improve care and costs require physicians to (1) understand individual patients’ values, and (2) tailor efficient and effective care to align with those values. Unlike the APM adoption initiative which takes a holistic approach to incentivize value-based care, the hospital value-based purchasing plan does not allow for significant patient-provider collaboration, especially in the acute care setting where patient interactions are brief.

Recently, the Trump administration has reoriented value-based purchasing agreements to focus on drug price reduction and signaled it will slow the pace of APM adoption (a move that was criticized for creating uncertainty among health care market stakeholders). This deceleration likely stems, in part, from concerns over mandating the adoption of certain APMs in rural communities. Regardless of the motive, decelerating APM adoption will likely prove beneficial. The process of aligning care with patient values is largely intangible in the short-term; therefore providers and patients alike will benefit from the additional flexibility of a slower, voluntary transition away from fee-for-service reimbursement. Nevertheless, CMS must not lose sight of the goal of providing Medicare beneficiaries high-value-care while still affording providers the time and financial latitude to ensure that long-term benefits are genuinely patient-value-centric.


Update: Tribal Sovereign Immunity Can’t Protect Allergan From the PTAB

Brenden Hoffman, MJLST Staffer

 

Last September, the pharmaceutical company Allergan entered an agreement with the Saint Regis Mohawk Tribe where the pharmaceutical company sold its patents for the wildly successful drug Restasis to the tribe. The six patents were then licensed back to Allergan.  These moves have been widely criticized as a sham transaction. For more information about this controversy and its role in the ongoing debate over inter partes reviews (IPR’s), see my October 15, 2017 post here.

On February 23, 2018, the PTAB ruled that tribal sovereign immunity does not apply to IPR’s and denied the Saint Regis Mohawk Tribe’s Motion to Terminate the challenges to the Restasis patents made by Mylan Pharmaceuticals Inc., Teva Pharmaceuticals USA Inc. and Akorn Inc.   In this decision, the PTAB dealt a serious blow to the Allergan/Saint Regis Mohawk Tribe deal, finding that tribal sovereign immunity does not apply to IPR proceedings generally and that in this specific instance, that there was no real tra


Could EU General Data Protection Regulation (GDPR) Strengthen the United States Consumer Privacy Protection Laws?

Young Choo, MJLST Staffer

 

The EU General Data Protection Regulation (GDPR) will replace the Data Protection Directive 95/46/EC in May of 2018. Unlike the Directive, GDPR does not require each European state to enact a national statute. The GDPR would uniformly apply to countries in the European Union. European Commission proposed the GDPR to “strength and unify data protections for people in the European Union.” The regulation also addresses the export of personal data outside of the European Union. More specifically, Article 3 of GDPR says that “if you collect personal data or behavioral information from someone in an EU country, your company is subject to the requirements of the GDPR.”  Consequently, companies in United States dealing with European Union consumer information are expected to be in compliance with GDPR.

 

In light of the new regulation, the U.S. companies, either have facilities in the EU or having personal data of European, are busy to be in compliance with the GDPR. What would be generally required under the GDPR for the U.S. companies? The first step would be deciding whether GDPR applies to the company. The second step would be having a Data Protection Officer (DPO). A Data Protection Officer (DPO) is “a position within a corporation that acts as an independent advocate for the proper care and use of customer’s information.” The third step would be creating a strategy to be in compliance with the GDPR. To do so, drafting a Privacy Policy agreement in line with the GDPR is necessary. Key requirements should be provided in the privacy policy under the GDPR would be (1) “Privacy Notices”; (2) “Consent”; (3) “Data Subjects’ Rights”; (4) “Security”; (5) “Data Protection Assessment”; (6) “Breach Notification”; (7) “Service Providers”.

 

Could these U.S. companies’ movement to be in compliance with GDPR also influence the United States’ Data Protection law as well? The answer is “possibly”. California recently initiated the move toward more stringent data privacy laws. “The California Consumer Personal Information Disclosure and Sale Initiative (#17-0039) may appear on the ballot in California.” The Initiative includes the following rights for consumers:

 

Gives consumers right to learn categories of personal information that

businesses collect, sell, or disclose about them, and to whom information

is sold or disclosed. Gives consumers right to prevent businesses from

selling or disclosing their personal information. Prohibits businesses from

discriminating against consumers who exercise these rights.

Allows consumers to sue businesses for security breaches of consumers’ data, even if consumers cannot prove injury. Allows for enforcement by consumers, whistleblowers, or public agencies.

 

Another impact the movement toward stringent data protection compliance could bring is the changes of perception of “harms” in the data breach setting. United States courts have not considered “data breach” itself as a harm. They always required an additional showing of consequential harm arising out from the data breach, such as money spent on monitoring the data breach or any credit card misuses arising from the breach. On the other hand, the E.U. data protection law is strongly based on the idea that data breach itself is a harm because privacy is a fundamental human right. It is important to note how circuit courts would decide Article III on a standing issue, one of the requirements for the plaintiffs to prove is a “concrete and particularized harm”, in the data breach setting.

 


Say It to My Face: Why You Don’t Get to Use My Old LinkedIn Headshot to Promote Your Business, Even if You Took My New One

Tim Joyce, Former MJLST Editor-in-Chief

 

[This article unintentionally picks back up on a more theoretical LawSci Forum post from spring 2017 by Travis Waller.]

 

The Situation

A few weeks ago I got all “fired up” about copyright. [To figure out why that’s a terrible #dadjoke, you’ll have to read that post here.] I honestly thought I’d have time to cool down again (fire pun #2!), and let the smoke clear (TRIFECTA?!!) before getting so incensed again (ok, I’ll stop now).

Then, I opened my LinkedIn feed early last week.

Staring back was a side by side comparison of my current profile pic–a quirky, raised-eyebrow homage to the Uncle-Sam-finger-pointing “I Want You” posters of yesteryear–and the new website head-shot we had just chosen for my law firm’s website refresh–a still-relaxed but decidedly more traditional affair. [Click my name above to see my current LinkedIn pic.]

In and of itself, the juxtaposition was not terribly unpleasant. After all, these were both pictures that I had personally selected from dozens in each photo-shoot, and I was the one who chose to make the older photo my profile pic. It was the text accompanying the pictures that really got me lit up. Taking the high road here, I won’t identify the author (the photographer) or reprint the text verbatim. But the went something like,

“This* guy [*me, here] made a terrible mistake ever using the older pic. It might be appropriate for actors and comedians, but not serious lawyers. If you need help figuring out how to look like a competent professional on LinkedIn call me [the photographer] for an appointment.”

Needless to say, insulting. After all, I did enjoy a career as a professional actor pre-law school, and the picture was entirely appropriate for my purposes there.

But even more than insulting, the photographer’s LinkedIn post almost certainly illegal, for 2 reasons.

 

#1 – Copyright law says you don’t get to use other people’s pictures without their permission.

Copyright scholars of any sophistication know that the law gives the creator of an original work of authorship, among others, the right to, well, make copies. Simple, but powerful nonetheless.

An author like, say, a budding amateur photographer capturing a snarky Uncle Sam poster-inspired head-shot has as much right to control the duplication of his own images as an arguably-overpriced full time corporate head-shot “artist.” Without the original author’s permission, a copy like the one in the side-by-side comparison post violates the exclusive right to “reproduce” the work.

Now, because apparently it’s Fair Use week this week, I’ll address that elephant in the room. Our friends at the US Copyright Office note that the analysis of whether a use counts as “fair” is not generally a straightforward process. Whether a secondary user of copyrighted content falls into the fair use exception turns on a combination of four factors. But, they did describe a case where “the use of [copyrighted] celebrity images by a gossip website was not fair.”

While I’m not a celebrity by many definitions, the reasoning should hold even more for less-famous folks. You need permission to use an image that you don’t own, especially for business purposes. Which brings me to my next legal gripe…

 

#2 – Misappropriation is Not a Joke, Jim!

(Admittedly, that header link is mainly to sneak in a YouTube clip from one of my favorite shows. But still relevant!)

The second reason why this corporate photographer’s post is almost certainly illegal is that she was using my likeness for her financial gain, again without my permission.

Here in Minnesota, our common law recognizes a right to publicity. Way back in ‘95, shortly before we called him Governor The Body, pro-wrestler Jesse Ventura went to federal court because, he alleged, WWF president Vince McMahon owed him money. Turns out Ventura was giving color commentary on some wrestling matches that McMahon then sold on videotape (remember those?); Ventura argued that hadn’t been part of the negotiated arrangement, so he wanted backpay of a sort. [This is all super true, and a super surreal case to read. Ventura v. Titan Sports, Inc., 65 F.3d 725, 730 (8th Cir. 1995).]

The estate representative for another Minnesota celebrity, the late Purple One themself (i.e., Prince), played a role in getting this “right to publicity” extended posthumously. So, now you can’t misappropriate someone’s likeness for financial gain after their death, either. [This is really fun research tonight. Paisley Park Enterprises, Inc. v. Boxill, No. 17-CV-1212 (WMW/TNL), 2017 WL 4857945, at *6 (D. Minn. Oct. 26, 2017).]

The upshot is that I have a common law right to tell the new headshot photographer to knock it off, right away. And that’s just what we did, in a strongly-worded email. Not quite as imaginative as some recent cease & desist messages we’ve heard about, but it did the trick.

 

Takeaways

Pro-tip #1: If you’re going to defame a new lawyer by stealing his old headshot and misappropriating his identity to promote your photography business, probably best not to have connected with him recently so he sees the post in his LinkedIn feed.

Pro-tip #2: SO many potential copyright and individual rights issues can be cleared up with a simple phone call or email asking permission. I would gladly have discussed ahead of time the use of the old picture. I would even have suggested appropriate wording for the post that didn’t disparage my previous photographer or conspicuously omit that the old photo was for a different career. Now, though, I’m not inclined to help out at all, and will be diligently checking back to police her use of my new photos.

Pro-tip #3: If you encounter a situation like this, and can’t make lemons out of lemonade by blogging, call a knowledgeable attorney (like me!) to draft a killer C&D.

 

tl;dr

I got really heated when some lady violated copyright and right to publicity laws by taking my picture and writing less-than-flattering things about it on LinkedIn. You can’t reproduce other people’s copyrighted works without permission or fair use exception. And you can’t use other people’s likeness for your own financial gain without permission. Don’t defame a lawyer with lots of time on his hands – it’ll end badly for you.

 

Contact Me

I wrote this to blow off steam and make some terrible puns along the way, but I also really enjoy talking copyright with people. Do you have a question or comment? Contact me here.


Health in the Fast Lane: FDA’s Effort to Streamline Digital Health Technology Approval

Alex Eschenroeder, MJLST Staffer

 

The U.S. Food and Drug Administration (FDA) is testing out a fast-track approval program to see if it can accommodate the pace of innovation in the technology industry and encourage more ventures into the digital health technology space. Dr. Scott Gottlieb M.D., Commissioner of the FDA, announced the fast-track pilot program—officially named the “Pre-Cert for Software Pilot Program” (Program)—on July 27, 2017. Last week, the FDA announced the names of the nine companies it selected out of more than 100 applicants to participate in the Program. Companies that made it onto the participant list include tech giants such as Apple and Samsung, as well as Verily Life Sciences—a subsidiary of Alphabet, Inc. The FDA also listed smaller startups, indicating that it intends to learn from entities at various stages of development.

The FDA idea that attracted applicants from across the technology industry to the Program is roughly analogous to the TSA Pre-Check Program. With TSA Pre-Check certification, travelers at airports get exclusive access to less intensive pre-boarding security procedures because they submitted to an official background check (among other requirements) well before their trip. Here, the FDA Program completes extensive vetting of participating technology companies well before they bring a specific digital health technology product to market. As Dr. Gottlieb explained in the July Program announcement, “Our new, voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the . . . developer, rather than primarily at the product (as we currently do for traditional medical products).” If the FDA determines through its review that a company meets necessary quality standards, it can pre-certify the company. A pre-certified company would then need to submit less information to the FDA “than is currently required before marketing a new digital health tool.” The FDA even proposed the possibility of a pre-certified company skipping pre-market review for certain products, as long as the company immediately started collecting post-market data for FDA to confirm safety and effectiveness.

While “digital health technology” does not have a simple definition, a recently announced Apple initiative illustrates what the term can mean and how the FDA Program could encourage its innovation. Specifically, Apple recently announced plans to undertake a Heart Study in collaboration with Stanford Medicine. Through this study, researchers will use “data from Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions like atrial fibrillation.” Positive research results could encourage Apple, which “wants the Watch to be able to detect common heart conditions such as atrial fibrillation”, to move further into FDA regulated territory. Indeed, Apple has been working with the FDA, aside from the Program, to organize the Heart Study. This is a critical development, as Apple has intentionally limited Watch sensors to “fitness trackers and heart rate monitors” to avoid FDA regulation to date. If Apple receives pre-certification through the Program, it could issue updates to a sophisticated heart monitoring app or issue an entirely different diagnostic app with little or no FDA pre-market review. This dynamic would encourage Apple, and companies like it, to innovate in digital health technology and create increasingly sophisticated tools to protect consumer health.


Scents: The Unconventional Potential for Trademarks

Amber Peterson, MJLST Staffer

Trademarks are intended to create an immediate brand recognition in the consumer’s mind. Consumers who are satisfied with a product must have a way to easily distinguish it from nearly identical or similar products from competitors. Thus, trademarks play a powerful role in branding and marketing as seen in the Nike “swoosh” and the Target bullseye. These traditional marks or logos are what are typically thought of when thinking about trademarks. However, unconventional trademarks such as the catch phrase “Hasta la Vista Baby” from the film, “The Terminator” and the red color of Christian Louboutin soles can be just as effective to identify a product or service.

The key requirement is distinctiveness. If a product can be thought of as inherently distinctive, it can be trademarked. Thus, the United States Patent and Trademark Office allows the trademarking of a scent since scent is distinctive in that it is deeply tied to memory recognition. Although this option is available, few have accomplished the task since the Patent and Trademark Office has put strict boundaries around what smells qualify.

First, the scent must serve no important practical function other than to help identify and distinguish the brand. This means that those smells whose only purpose is smell-related, such as perfumes and air fresheners, cannot receive scent trademark protection. Second, a detailed written description of the non-visual mark is required to complete the registration process. The problem with scents is the subjective nature of them. The perception of smell can be very different among a number of noses and is thus open to interpretation. This creates difficulty in successfully representing the scent graphically which is required to determine whether something is or is not appropriate for a trademark.

To date, there are only about 12 scent trademarks in the United States (e.g., the flowery musk smell in Verizon Wireless stores and the pina colada scent that a ukulele company scents its ukuleles with). As evidenced, the process of registering a scent can be challenging. However, there are marketing advantages that may make it worthwhile if the product or service resonates more deeply with a consumer compared to a typical visual mark or logo trademark.