Author: TSA Press

WASHINGTON: What looks like progress for the Pentagon in its five-month legal battle with Amazon Web Services is just a new variety of stalemate, a leading acquisition expert said.

“The machinations of the legal system will continue to provide pyrrhic victories to DoD or some contractors,” former Hill and Pentagon staffer Bill Greenwalt told me, “but in the end, no matter what happens, DoD – after almost three years struggling to make JEDI work – will end up trailing the commercial IT market, as it has done now for decades.”

The Department of Defense was already behind the curve when it comes to adopting cloud computing, Greenwalt said. Even government intelligence agencies have moved faster, let alone the private sector.

“Look at the timelines,” he told me. “The cloud first appears at the CIA in 2013 and in the commercial marketplace in the 2000s. DOD was way behind the curve in 2017 when it started this acquisition.”

Today, Greenwalt argued, because the Joint Enterprise Defense Infrastructure (JEDI) program is suffering so many delays while technology forges ahead, it is being litigated into irrelevance. By effectively dragging out the trial, the latest legal developments only make that worse.

What Went Wrong

On Friday, over Amazon’s bitter opposition, the chief judge of the Court of Federal Claims approved a Pentagon motion in the lawsuit over the Joint Enterprise Defense Infrastructure. JEDI is a cloud computing contract worth up to $10 billion that the Defense Department awarded to rival Microsoft – unfairly and in large part due to President Trump’s meddling, Amazon says.

The judge had already ordered Microsoft and the Defense Department to stop work on the project because Amazon had a reasonable chance to prove at least part of its case. While the Pentagon denies undue White House influence, it has admitted that it might have mishandled certain technical aspects of the competition, so it filed a motion to pause the cause and “remand” it back to DoD officials to try again.

Amazon argued the conditions of the Pentagon’s proposed do-over were so hopelessly narrow it wouldn’t make a difference. The Pentagon and Microsoft countered that Amazon wanted terms so broad they’d effectively give it a second chance to bid – with the unfair advantage that Amazon now knows exactly what price to put on its proposal to underbid Microsoft. Friday’s ruling, while still under seal, effectively sided with the Pentagon.

“We are pleased with the court’s decision to grant our motion,” said Pentagon spokesman Lt. Col. Robert Carver. “We will immediately execute the procedures outlined in the motion [and] we remain focused on delivering this critical capability to warfighters as quickly and efficiently as possible.”

If your head is spinning from this simplified summary of a mind-bending legal matter – and trust us, the technology is just as complex – then Greenwalt has some good news for you. Ultimately, none of it matters.

“It is just another example of how flawed this acquisition process has been from the start,” he told me, “and how the bid protest process has continued to torture DoD and blind it from pursuing alternative paths.

It’s not just the trial that’s a dead end for both sides. “I think they have been wasting their time since the first Request For Proposals,” Greenwalt said.

In fact, he suggested, the Department of Defense should have known this was going to be a mess from the start, based on recent history. “The REAN protest” – in which an Amazon partner beat Oracle for an earlier Pentagon cloud contract in 2018, only for the GAO to overturn it –  “should have given DoD an early indication that this was going to be a nasty process, with everyone eventually tainted by a brutal fight to the death over a winner-take-all procurement,” Greenwalt told me.

The REAN award used an increasingly popular contracting mechanism called Other Transaction Authority (OTA), a law which Greenwalt helped draft. JEDI, likewise, tried to bypass the usual acquisition bureaucracy to get new technology in at the speed of Silicon Valley. But trying to run government procurement more like a business runs afoul of a fundamental problem. No private company lets losing bidders force it to do business with them; the government sometimes does.

Time To Reboot

So what should the Defense Department have done differently from the start? What can it do differently now?

“There were other options then —and now DOD has even more options,” Greenwalt said. “It may be time to just pull the plug and start over, but there may be too much pride invested to do otherwise.”

“From the start, instead of focusing on one cloud to rule them all, DoD should have put all of the cloud providers on a IDIQ [Indefinite Delivery, Indefinite Quantity] contract and then issue task orders to those companies that met their security and operational standards for individual tasks,” he said. In other words, rather than try to award the whole program to a single company, break it up into chunks and dole them out over time to different companies, based on whoever offered the best price and performance for that particular piece.

Now, the Pentagon insists it won’t split the JEDI contract because it already has too many clouds. The different armed services, defense agencies, and their subunits are all signing different contracts on different terms – over 500 of them. But, if you set clear standards and make your vendors stick to them, it is possible to have a single cloud computing system that works as a seamless whole, even if different companies provide different parts of it. In fact, that kind of “multi-cloud” approach is increasingly common in the commercial world.

If the Pentagon had gone multi-cloud from the start, “it would have then been, for a change, ahead of the commercial market,” Greenwalt said. “It could have been experimenting with cloud providers and other solutions that manage multiple clouds for the last two years.”

Even now, it’s not too late to try a different approach, he said. “There are other clouds already being used at the services and defense agencies,” Greenwalt told me. “DoD’s focus now should be to look at these experiments and where the commercial market is going. They may decide that, except for JEDI’s cool name, it may already be obsolete, and a new strategy for secure cloud applications is needed.”

The Above the Law staff continues to track daily changes to the legal industry landscape from law firm layoffs to law school grading changes. Now that we’re roughly a month into the lockdown era, Joe and Kathryn discuss the state of play. The merits of law firm layoffs, furloughs, and salary cuts, law school grading changes, and whether there’s a future for the bar exam.

From time to time, I take a look at software and technology products and try to alert the legal community, particularly readers in legal operations, to solutions that really seem to solve a problem. Recently, I’ve been looking at corporate compliance tools, and I had an opportunity to speak with Jordan Domash, GM of Relativity Trace, who heads up the development and deployment of this corporate compliance application. Below is an edited distillation of our conversation.

What is Relativity Trace and what problem does it solve?

It’s a proactive communication surveillance application designed to help corporations comply with regulatory requirements, particularly in heavily regulated market segments like banking and finance. With Relativity Trace, companies can define their risks across enterprise communication channels and generate alerts that inform compliance officers and leadership that certain noncompliant communications are taking place.

What led to the development of Relativity Trace?

So, a lot of companies had been thinking about compliance in the same reactive sort of way that people think about e-discovery — an event occurs, they collect the data, and then they analyze that data in connection with a litigation or investigation. Relativity customers began to ask if they could leverage the features of the e-discovery platform to analyze data in real time. Since Relativity was already handling some of the downstream e-discovery processes and had developed capabilities to sift through large volumes of unstructured data, it made logical sense to listen to the customer and begin developing more left-side-of-the-EDRM tools like Relativity Trace.

Describe a typical use case for Relativity Trace.

If two traders at investment banks are colluding in communications between themselves on how they might profit on market-moving information — let’s say, there’s a huge order about to be placed that could actually impact a company’s stock price. That’s illegal if it’s done ahead of the order. What Relativity Trace can do is ingest the communication data, whether it’s from an email, audio, Slack, or text messages, or any other form of communication the system is configured to capture, and Relativity Trace will use predefined rules to identify communications between the traders who are colluding. That’s a classic use case.

What is Relativity Trace doing behind the scenes? What tech is it leveraging?

Relativity Trace leverages the speed of search and machine learning to identify text and metadata that may be of interest to a compliance officer. Relativity Trace connects to about 50 data sources — almost any form of communication in use on the market. An agent server leverages the power of the Relativity platform to automatically ingest and index the text and metadata of communications. Relativity Trace customers are governed by regulations, and they are essentially looking for very similar things — instances of fraud, trading improprieties, collusion. So, it’s easier to identify the risk and exposure points and match that risk to the regulatory framework to analyze a population of data — communications data.

Relativity Trace has 18 out-of-the-box rules-based policies that are purpose-built for financial institutions and other regulated organizations. These policies are based on the lexicon (words) used in the industry and other predefined rules that are configured for compliance professionals. And, of course, users can create customized rules.

The solution also leverages machine learning to weed out spam messages and to identify false or innocuous alerts and legitimate alerts. In the same way that technology-assisted review helps to distinguish between relevant and nonrelevant documents, over time Relativity Trace teaches itself which alerts require further action, and which may be ignored.

Does Relativity Trace cause organizations to use a lot of storage space?

Data management is baked into Relativity Trace. It is true, large organizations have massive amounts of data, and if Relativity Trace were ingesting, indexing and storing all that data, it would be a gargantuan task and quite costly to store it all. Fortunately, with Relativity Trace, if a file ingested into the system does not trigger an alert, that file is automatically purged, thus keeping storage to a minimum. Only the potentially relevant files are stored for any period of time.

What does the output look like?

Relativity Trace is made available as one of the many tabs across the top of the Relativity platform. An initial dashboard displays critical high-level information for compliance professionals, but the actual documents that cause an alert are viewable in a simple document list alongside the Relativity viewer. From there, users can dig into the documents to more closely analyze the communications.

Many might ask why Relativity is developing software that is directed at other than e-discovery processes?

It is true that Relativity Trace is largely directed at the corporate compliance user rather than the traditional e-discovery market. But if you think about it, Relativity’s mission is to “organize data, discover the truth, and act on it.” So, while Relativity built a platform to solve e-discovery problems, Relativity Trace is entirely consistent with the Relativity mission.

Domash told me, also, that since the launch of the solution in 2018, instances of Relativity Trace are currently in frequent use on both the partner and customer side in the United States and EMEA. Interesting, too, is that Relativity Trace is available as a standalone product with only the features you need to run it, or as part of an existing Relativity instance. Channel partners are offering it as well to their corporate clients.

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Mike Quartararo is the President of the Association of Certified E-Discovery Specialists (ACEDS), a professional member association providing training and certification in e-discovery. He is also the author of the 2016 book Project Management in Electronic Discovery and a consultant providing e-discovery, project management and legal technology advisory and training services to law firms and Fortune 500 corporations across the globe. You can reach him via email at mquartararo@aceds.org. Follow him on Twitter @mikequartararo.

If you’re a legal professional looking for predictions about when courts will ramp back up and legal work return to normal, you’ve still not come to grips with reality.

Courts have largely closed to the public, literally slamming the door on access to justice to millions of citizens.

This is institutional failure. As Jordan Furlong argues in his pandemic and the law series, “Institutions need resilience in a crisis, just like people do. If your institution was forced to shut down because of the pandemic, then it failed its resilience test. It wasn’t there for us when we needed it.”

The hand-wringing and denial in pre-COVID-19’s overburdened, underfunded justice system, has shifted to crisis and triage. Or worse, total standstill.

But is there a silver lining?

“This crisis might not have been the disruption we wanted, but it’s the disruption we needed,” Michigan Supreme Court Chief Justice Bridget McCormack said to more than 450 lawyers, judges, advocates, and others gathered Monday for a Legal Services Corporation briefing on the state of access to justice.

McCormack voiced plainly what many others on the call said was happening in California, Tennessee, Washington, and areas with large legal aid service agencies such as Detroit, New York City, New Orleans, and Miami. Courts are scrambling to adopt technology solutions to get operations back online and to increase services during the pandemic.

McCormack’s comment also signals that there is no going back. Now that courts are seeing how new processes that don’t require a physical court presence can provide access to more people, it’s going to be impossible to justify returning to the status quo ante.

Legal futurist Richard Susskind has long advocated for a shift in thinking with the courts, one he and Furlong predict most certainly is changing during this global crisis: Courts aren’t a place, but a service.

When we think about courts as a service rather than a place, it’s much easier to conceptualize technology-driven or facilitated dispute resolution.

In fact, it’s hard to think about returning to the status quo, with a rigid expectation for physical presence and an overly complex process built serving a place rather than serving justice.

But even Susskind, whose book “Online Courts and the Future of Justice” was presciently released in December, couldn’t have predicted such a rapid shift to technology-facilitated court access.

“Rather than perhaps the decade I was anticipating, in a fortnight we have seen huge numbers of courts around the world shutting, and we have seen correspondingly large numbers of cases being held by video conference and telephone conference too,” Susskind told legal technology expert Bob Ambrogi during a recent interview.

These aren’t seamless proceedings. Nor should they be expected to be. Instead, this is a massive experiment that we can expect will yield enormous data points and anecdotes about what works and what needs adjusting to adequately conduct legal business and uphold the rule of law in a digital environment.

Still, it would be shortsighted and a mistake to think that things will return to “normal.” Things shouldn’t return to normal for the justice system.

Well before the pandemic triggered court closings and the ceasing of jury trials for some indeterminate period, courts were grappling with an access to justice crisis. Courts have long been underfunded and equal access out of reach for the majority of Americans.

What we should expect from our institutions at this point is continued testing while they scramble to bring operations back online.

On Monday’s call, the number one fear for heads of legal aid agencies around the country: funding.

The economic impact will most certainly hit already stretched court systems hard. Agency heads and chief justices indicated they are bracing for what could be an overwhelming number of cases from the neediest populations, especially in areas of housing, employment, medical debt collection, and domestic violence.

“We know that a tidal wave of legal needs is headed our way, and we have to be ready to respond,” said ABA President Judy Perry Martinez, who appointed a national task force to assess and respond to COVID-19-related legal needs.

Callers were assured by Rep. Joe Kennedy III, D-MA, and Rep. Fred Upton, R-MI, that there is an awareness of and bipartisan support for front line legal services for those particularly hit hard by the pandemic.

The only way forward is to find new ways of doing business for the courts.

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Molly McDonough is a longtime legal affairs writer and editor. Before launching McDonough Media, she was editor and publisher of the ABA’s flagship magazine, the ABA Journal. She writes about access to justice at A Just Society.

Coming soon to a computer screen near you… it’s The Changing Lawyer LIVE!, a one-day virtual conference on April 23, 2020. Whether you’re missing the fellowship of your office, searching for actionable advice about how to deal with the ever-changing demands of a global pandemic, or looking for inspiration to keep plugging, The Changing Lawyer LIVE! offers something for everyone. 

Each year, Litera’s flagship publication, The Changing Lawyer, highlights new and noteworthy changes in the legal industry and discusses the ways that law firms, legal service providers, and individual lawyers rise to overcome challenges and adapt to the changing landscape. It celebrates Litera’s strengths as an industry and shares the company’s learnings so that everyone can be inspired to create new solutions in a world of constant change.

This year, the coronavirus pandemic has fast-tracked change for everyone. Unfortunately, it’s also stripped professionals of the opportunity to meet in person at clients’ offices, regional networking events, and annual conferences. And while Litera’s created a blog series on business continuity to help clients navigate the new realities of working remotely, eliminating face-to-face meetings, and updating paper-based processes, the company thought we could do more for our community.

That’s why Litera has assembled an exceptional range of keynote speakers who hail from all walks of life and who have faced down seemingly insurmountable challenges before this. They offer compelling stories that can serve to inspire and motivate all, including:

• Molly Bloom, entrepreneur and author of the memoir Molly’s Game, about overcoming setbacks;
• Scott Dorsey, co-founder and former CEO of ExactTarget, about how to grow in an ever-shifting market; and
• Gretchen Rubin, author of the national best-seller The Happiness Project, about how to weather the storm.

But while it’s great to get fired up by stories of success against all odds, sometimes you need concrete, actionable advice on how to get through the next week, or day, of working under unprecedented conditions. That’s why Litera has also set up panel discussions offering insights about how the legal sector is responding to recent events and what you should prepare for in the future. They include discussions about working from home, setting priorities during today’s circumstances, and managing knowledge remotely. The panels feature a veritable who’s who of industry experts, such as:

• Judi Flournoy, CIO at Kelley Drye & Warren;
• Joy Heath Rush, CEO of ILTA, the International Legal Technology Association;
• Nikki Shaver, Managing Director, Innovation and Knowledge at Paul Hastings;
• Greg Lambert, Chief Knowledge Services Officer at Jackson Walker; and
• Noah Waisberg, founder and CEO of Kira Systems.

The event wraps up the day with virtual networking where you can mingle with colleagues you haven’t seen lately and enjoy happy hour from the comfort of your own home.

Litera was inspired to create this virtual conference not only because it’s missing the camaraderie of the usual face-to-face meetings but also because the company wanted to give back to the workers who are on the front lines. That’s why all proceeds will go to the CDC Foundation’s Emergency Response Fund to help it fight the battle against COVID-19.

This is an event you won’t want to miss. Registration is open for $25 per person until the day of the event. Can’t wait to (virtually) see you there!

The thing about pandemics is, well, that they’re everywhere. That’s the whole “pan” part. Global law firms have unique challenges that impact the way they’re dealing with COVID-19 and the economic upheaval surrounding it.

Magic Circle firm Clifford Chance, which is the 7th largest in the world under the Global 200 index, is joining the COVID-19 austerity measures. So what is Clifford Chance doing? They’re deferring global partner distributions, salary reviews and raises are frozen, and while bonuses will be paid, the timing of said payments may be delayed. The good news is that the firm is not currently planning on any layoffs or furloughs.

The firm made the following statement about their cost-cutting measures:

“We are a strong and resilient organisation, with over five years of robust global growth behind us. Our teams are always a source of huge pride, they are fantastically talented, motivated and collaborative, and never more so since the virus has begun to spread.

Over the coming months our aim is to keep these teams together and to work shoulder to shoulder with our clients who need our support now more than ever.”

If your firm or organization is slashing salaries, closing its doors, or reducing the ranks of its lawyers or staff, whether through open layoffs, stealth layoffs, or voluntary buyouts, please don’t hesitate to let us know. Our vast network of tipsters is part of what makes Above the Law thrive. You can email us or text us (646-820-8477).

If you’d like to sign up for ATL’s Layoff Alerts, please scroll down and enter your email address in the box below this post. If you previously signed up for the layoff alerts, you don’t need to do anything. You’ll receive an email notification within minutes of each layoff, salary cut, or furlough announcement that we publish.

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Kathryn Rubino is a Senior Editor at Above the Law, and host of The Jabot podcast. AtL tipsters are the best, so please connect with her. Feel free to email her with any tips, questions, or comments and follow her on Twitter (@Kathryn1).

Good news, Georgians! As of Friday, you’ll be able to hit the gym to work up a sweat, shower up, and then relax with a socially distant massage. On the way home you can hit the salon for a mani-pedi, get your teeth cleaned at the dentist, and then celebrate with a brand new “post”-pandemic tattoo. You’ll have to wait until Monday to grab dinner and movie with a date, though, because restaurants and theaters can’t open until the 27th. But reserve your seats now, because The Peach State is back in business, baby!

Yesterday Georgia Governor Brian Kemp announced an Executive Order to reopen the economy in accordance with White House guidance. Well, more or less in accordance, since the president’s plan calls for a “downward trajectory of documented cases within a 14-day period,” and Georgia, with almost 20,000 confirmed cases, is … not that.

Nevertheless, Kemp announced yesterday that, “Given the favorable data, enhanced testing, and approval of our healthcare professionals, we will allow gyms, fitness centers, bowling alleys, body art studios, barbers, cosmetologists, hair designers, nail care artists, estheticians, their respective schools, and massage therapists to reopen their doors this Friday, April 24, 2020.”

He failed to coordinate with local leaders, blindsiding the mayors of Atlanta and other cities, but Kemp insists that “This measure will apply statewide and will be the operational standard in all jurisdictions. This means local action cannot be taken that is more or less restrictive.” Because if it’s good enough for Taliaferro County, with 8 people per square kilometer, obviously it’s good enough for Gwinnett County, with 2,287 people in the same area.

Lest one be tempted to criticize the governor for taking a cavalier approach to his constituents’ health, please note that he encourages employers to send home workers whose fevers exceed 100.4, “enhanc[e] sanitation of the workplace as appropriate,” provide PPE “as available,” cancel in-person meetings, close the staff break room, and generally maintain six feet of distance between people on the premises. The governor did not specify exactly how he envisioned a socially distant bikini wax might work, but Georgia’s beaches are now open, so take up your ibuprofen and climb up on that table, ya big ape!

Nor did Mr. Kemp specify how he intends to open up non-essential businesses while Georgians have been ordered to shelter in place.

“The shelter in place order is still active and will expire at 11:59 PM on April 30 for most Georgians. We urge everyone to continue to follow CDC and DPH guidance by sheltering in place as often as you can,” said the Governor, in the same breath that he gave businesses the green light to open up to the general public without input from local officials.

With clear and consistent guidelines like this, what could possibly go wrong, right?

Kemp Executive Order April 20, 2020 [Georgia.gov]
Gov. Kemp Updates Georgians on COVID-19 [Georgia.gov]

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Elizabeth Dye (@5DollarFeminist) lives in Baltimore where she writes about law and politics.

If you want to play in the National Basketball Association, then you must be one year removed from high school. In 2020, there is no workaround to the aforesaid requirement, which is referred to as the one-and-done rule. However, nowhere in the one-and-done rule does it require that athletes spend that one year between high school and the NBA at an institution of higher education. It simply has become the traditional route that a prominent athlete will take as he waits his ultimate payday.

Yet, the system that developed, and made it standard for athletes to spend at least one year in college, seems to be crumbling.

In mid-April, potential 2021 top pick Jalen Green announced his decision to play for a year in the NBA’s developmental league — the G League — instead of going to school. His earning potential will be capped at under seven figures, but at least he will be able to earn a living based on his on-court talents. The NCAA would not even allow Green to earn compensation off the court, through the exploitation of his name, image, and likeness, had he decided to enroll at a university. That could be changing, but it remains the official stance of the NCAA while states like California and Florida add pressure on the Association by passing legislation that circumvents the relevant NCAA bylaw.

Green’s decision was quickly followed by Isaiah Todd’s statement that he would also forego playing college basketball in favor of earning a salary in the G League. Todd, another highly touted basketball player, had planned to attend Michigan, but is instead opting for a position that will pay him up to $500,000.

Two of the most prominent basketball athletes have spurned the idea of one-and-done meaning that they must spend a year at an academic institution where they are prohibited from earning any compensation, whether it be in the form of a salary or related to off-court opportunities. Their bold stances are expected to lead to many other top prospects deciding that it makes more sense to start earning money now as opposed to enrolling in an academic institution only to be mainly focused on their future professional careers, picking up and leaving campus after a mere year of jumping through the hoops.

The opportunity to attend a university or take classes away from a college campus will always be there for these individuals who often come from poor socioeconomic backgrounds and desperately wish to do whatever they can, as soon as possible, to start earning money for themselves and their families. They are not missing out on receiving their education nor the college experience; realistically, their one year at academic institutions would have revolved around the athletic departments trying to extrapolate any value that they could receive from these prized individuals, with little care for the educational value received by the players during that one year on campus.

It makes one wonder why there should be a one-and-done rule at all. Why not allow individuals who graduate from high school go directly to the NBA without passing through the G League, going overseas to play for a foreign team as RJ Hampton and LaMelo Ball did or attend a university for one year?

The theory behind the one-and-done rule is that an 18-year-old, with no college experience, is not mature enough to be a professional basketball player in the NBA. However, with more players deciding to play professional basketball, whether it be in the G League or elsewhere, that theory is being laid to rest. Even setting aside the fact that more players will follow in the footsteps of Green and Todd, the system is broken, as recognized by an independent Commission on College Basketball formed by the NCAA and led by former Secretary of State Condoleezza Rice. An article on the NCAA’s own website admits as much.

“Elite high school players with NBA prospects and no interest in a college degree should not be ‘forced’ to attend college, often for less than a year,” stated the Commission on College Basketball in a report on the subject.

Dan Gavitt, NCAA senior vice president of basketball, recognizes a need for change as does NBA Commissioner Adam Silver, who said in 2019 that the one-and-done rule is no longer good policy, but added that a change is probably a few years away.

“I think the general feeling is that some of the challenges that come with the current one-and-done rule … together with the reality that, academically, those prospects are only attending school and making progress toward their degree for one year, is not consistent with everything else college athletics is about,” Gavitt said. “I think the feeling is, it’s just time for that progression to happen.”

Unfortunately for Green, Todd, and any other basketball players who follow in their footsteps, any change to the one-and-done rule did not come fast enough for them to take advantage of it and go straight to the NBA. However, their decisions should carry weight in speeding up the change described by Silver, which seems to be coming but not as quickly as prospects like Green and Todd would have liked.

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Darren Heitner is the founder of Heitner Legal. He is the author of How to Play the Game: What Every Sports Attorney Needs to Know, published by the American Bar Association, and is an adjunct professor at the University of Florida Levin College of Law. You can reach him by email at heitner@gmail.com and follow him on Twitter at @DarrenHeitner.

According to a recent survey conducted by Brightfield Group, the e-commerce sales of cannabidiol (CBD), including hemp-derived CBD products, have ramped up in response to the coronavirus pandemic.

Unfortunately, during these uncertain times, a handful of CBD companies have been taking advantage of people’s fear and anxiety over the spread of the virus, making certain claims that CBD can treat and even cure the virus.

A few weeks ago, the FDA issued a round of warning letters to companies making dubious statements pertaining to COVID-19, several of which sold and marketed CBD products (i.e., CBD Online Store, Herbal Amy Inc, and NeuroXPF).

For the past few years, CBD companies have continuously received a fair amount of scrutiny from the FDA, especially manufacturers and distributors who sell and advertise CBD products with unsubstantiated therapeutic claims. The FDA’s main concern is that these products have not been shown to be either safe or effective, and ultimately fears that “deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

Although the CBD industry is well aware of the legal risk of making unproven medical claims regarding this particular cannabinoid, confusion remains regarding what exactly constitutes over-the-line claims that actually put CBD companies at risk of FDA enforcement actions.

To do this analysis, you need to know what medical claims are, and you have to lay out the nature of the claims being made related to CBD that the FDA ostensibly will not tolerate, which is a moving target at best.

The FDA’s jurisdiction is triggered by a product’s intended use. Generally, the FDA determines intended use based on claims made by the product’s manufacturers and distributors, which are often contained on the product’s labeling or in promotional or advertising materials. If a company expressly or implicitly states that its product can be used to diagnose, cure, mitigate, treat, or prevent a disease, or affects the bodily structure or function of the end-use consumer, the FDA will likely conclude that the product is a drug under the Food, Drug and Cosmetic Act (FDCA).

Drugs are tightly regulated by the FDA. Federal law mandates that all new drugs in the United States be shown to be safe and effective for their intended use prior to marketing. In June 2018, the FDA approved CBD as the active ingredient in Epidiolex, a prescription drug used for treating epilepsy. However, the approval of CBD in Epidiolex did not result in the approval of CBD in other drugs or product categories, such as foods, dietary supplements, or cosmetics. In its statement announcing the approval of Epidiolex, the FDA warned that it was “prepared to take action when [it] see[s] the illegal marketing of CBD-containing products with serious, unproven medical claims.”

Since 2015, the FDA has sent a number of warning letters to manufacturers and distributors of CBD that made various medical claims about their CBD products. In those letters, the FDA took the position that those medical claims rendered the subject CBD products unapproved drugs that violated the FDCA.

The offending claims on these companies’ product labels, websites, and social media accounts, included the following:

• “CBD…Inhibits cancer cell growth […] Treats psoriasis.”
• “CBD has demonstrable neuroprotective and neurogenic effects, and it’s anticancer properties are currently being investigated at many academic and independent research centers in the United States and worldwide.”
• “The Benefits of CBD Oil for ADHD . . . It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”
• “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
• “Helps reduce…Inflammation…Arthritis…Back Pain…Muscle Aches…Joints.”
• “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”
• “Can CBD help with Corona Virus? Possibly! But one thing is for sure, it will help you relax when everyone else is panicking.”

The foregoing disease and/or bodily structure/function claims and their wide range of being very specific to fairly generic demonstrates how little it takes to turn a CBD product into a drug for FDA enforcement purposes.

Nevertheless, many CBD companies continue to make unsubstantiated medical claims about their CBD products based on the assumption that FDA enforcement actions are strictly limited to issuing warning letters at this point. Though factually true to date, these letters are not without force. An FDA warning letter will lead to further and more significant headaches, including litigation and major fines and penalties. In addition, there are other claims that may result from an FDA warning letter, including state law consumer protection claims based on prohibiting unfair and deceptive trade practices, claims under the Lanham Act for false and misleading advertising, consumer and shareholder actions relating to CBD (think of Curaleaf Inc.) and  even personal injury claims.

If CBD companies want to keep the 800-pound gorilla that is the FDA off their back, they should not make any medical claims whatsoever, expressed or implied, at least until the FDA forges a legal regulatory path for the sale and marketing of CBD products, which it is inevitably fated to do — it is just a matter of when.

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Nathalie Bougenies practices in the Portland office of Harris Bricken and was named a “2019 Rising Star” by Super Lawyers Magazine, an honor bestowed on only 2.5% of eligible Oregon attorneys. Nathalie’s practice focuses on the regulatory framework of hemp-derived CBD (“hemp CBD”) products. She is an authority on FDA enforcement, Food, Drug & Cosmetic Act and other laws and regulations surrounding hemp and hemp CBD products. She also advises domestic and international clients on the sale, distribution, marketing, labeling, importation and exportation of these products. Nathalie frequently speaks on these issues and has made national media appearances, including on NPR’s Marketplace. Nathalie is also a regular contributor to her firm’s Canna Law Blog.

If there’s anything at all that has been learned thus far from the coronavirus crisis, it’s that cost-cutting measures are coming for all of us. Even well-known firms at the very top of the Biglaw heap have implemented austerity measures.

We’ve now learned that DLA Piper — a firm with almost 4,000 lawyers and $2,835,986,000 gross revenue in 2018 — which currently sits at #4 on the latest Am Law 100 rankings, has taken steps to control its costs going forward. While associates in America were told just last week that there would be no layoffs or salary cuts, it seems like it’s a very different story in the firm’s offices in Europe, the Middle East, Asia, and Africa.

In an announcement from global co-CEO and managing partner Simon Levine, the following actions were disclosed in an effort to be “open and honest about the challenge our business faces in such difficult economic conditions”:

• Partners’ monthly draws will be reduced beginning on May 1, and partners will defer quarterly distributions for three months. Further, the firm’s reduced profits due to the coronavirus crisis will have an impact on partner pay going forward in 2020.
• Pay raises will not be awarded for the first half of the 2020-2021 financial year, and possibly for the entire year, but this will be reviewed in November.
• Bonus payments will be delayed, and a decision won’t be made on when such awards will be paid until June.
• The firm may ask some people to temporarily reduce their working hours or take sabbaticals.

We reached out to DLA Piper for comment, but have yet to hear back.

As noted by Levine, “we must all take the required steps to preserve jobs wherever possible and protect our firm.” Hopefully this is what it takes to avoid layoffs.

(Flip to the next page to see the full memo from DLA Piper.)

If your firm or organization is slashing salaries, closing its doors, or reducing the ranks of its lawyers or staff, whether through open layoffs, stealth layoffs, or voluntary buyouts, please don’t hesitate to let us know. Our vast network of tipsters is part of what makes Above the Law thrive. You can email us or text us (646-820-8477).

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Staci Zaretsky is a senior editor at Above the Law, where she’s worked since 2011. She’d love to hear from you, so please feel free to email her with any tips, questions, comments, or critiques. You can follow her on Twitter or connect with her on LinkedIn.