SEC’s Office of Compliance Inspections and Examinations Releases 2019 Examination Priorities

On Dec. 20, 2018, the Office of Compliance Inspections and Examinations (OCIE) of the U.S. Securities and Exchange Commission (SEC) issued its annual Examination Priorities for 2019 (Exam Priorities), which is available for download here. The Exam Priorities focus around six thematic areas: (1) Retail Investors, including seniors and those saving for retirement; (2) Registrants responsible for critical market infrastructure; (3) FINRA and MSRB; (4) Digital Assets; (5) Cybersecurity; and (6) Anti-Money Laundering (AML) Programs.

As in the past, OCIE notes that their priorities are not exhaustive. The scope of any examination is determined through a risk-based approach that includes analysis of the registrant’s operations and products offered. For example, OCIE typically examines the disclo­sure of services, fees, expenses, conflicts of interest for investment advisers, and trading and execution quality issues for broker-dealers. OCIE is continually evaluating changes in market conditions, industry practices, and investor preferences to assess risks to both investors and the markets.

In connection with OCIE’s priority to protect retail investors, OCIE reviews retail fees and expenses paid by investors, conflicts of interest of industry personnel, treatment of senior investors and the advertising and suitability of retirement products, portfolio management and trading, operations of and the selection of mutual funds and ETFs, procedures of municipal advisors, procedures for broker-dealers entrusted with customer assets, and microcap securities.

OCIE also continues to prioritize critical market registrants impacting the safety and operation of our financial markets, including clearing agencies, entities subject to Regulation SCI, transfer agents, and national securities exchanges.

Finally, OCIE will prioritize examinations of the effectiveness of FINRA and MSRB, which are assigned the responsibility for certain aspects of investor protection. OCIE also will conduct inspections to gather information and evaluate practices affecting digital assets, cybersecurity, and AML programs (especially broker-dealers subject to express obligations and SAR filing obligations).

Overall, OCIE noted that although changes to its priorities may be continual, OCIE’s analytic efforts and examinations remain firmly grounded in its four pillars: promoting compliance, preventing fraud, identifying and monitoring risk, and informing policy.

 

©2019 Greenberg Traurig, LLP. All rights reserved.
This article was written by Arthur Don and Vincent Lewis of Greenberg Traurig, LLP.

Lapse in Government Funding Continues to Affect FDA, USDA

As previously covered on this blog, without either a fiscal year 2019 appropriation or a Continuing Resolution, a partial government shutdown, which began on December 22, 2018, has continued to impact both the U.S. Department of Agriculture and the U.S. Food and Drug Administration. As of the time of this blog’s publication, the government has been partially shut down for over 20 days.

Most recently, in a Twitter thread, FDA Commissioner Scott Gottlieb noted that the agency stopped a limited number of domestic food inspections because of the shutdown, but the agency is, “taking steps to expand the scope of food safety surveillance inspections we’re doing during the shutdown to make sure we continue inspecting high risk food facilities.” Several commodities are deemed “high risk” and include: seafood, soft cheeses, fresh fruits and vegetables, spices, shell eggs, infant formula and medical foods. Gottlieb noted that the mechanism to expand the domestic inspections will be in place beginning the week of January 14.

As for the USDA, Senator Debbie Stabenow submitted a letter to the Secretary of Agriculture on January 9 requesting information on the impact that the shutdown is having on the agency, including the delay in implementing the recently-passed Farm Bill. As of the time of this publication, the Secretary has yet to respond. USDA put out a press release at the end of 2018 regarding activities that would be affected by the shutdown, but the department has not updated it since that time.

 

© 2019 Keller and Heckman LLP.
This post was contributed by Food and Drug Law at Keller and Heckman.
For more legal news on the Food and Drug Administration check out the National Law Review’s Biotech Food and Drug Type of law page.

Partial Government Shutdown Causes Full-Blown Headache for Employers Using E-Verify

If you are an employer that is obligated to or has chosen to use E-Verify, then you have probably already received this message from the E-Verify website: “NOTICE: Due to the lapse in federal funding, this website will not be actively managed. This website was last updated on December 21, 2018, and will not be updated until after funding is enacted. As such, information on this website may not be up to date. Transactions submitted via this website might not be processed, and we will not be able to respond to inquiries until after appropriations are enacted.”

But what does this notice actually mean for your business? As long as the shutdown remains in effect, you will not be able to:

  • enroll in the program

  • access your E-Verify account

  • create a case in E-Verify

  • take action on a case you previously submitted

  • add, delete, or edit accounts

  • terminate accounts

  • run reports

Also during this time, your employees will not be able to resolve any E-Verify Tentative Nonconfirmations (TNCs) they received prior to the shutdown. Indeed, the number of days E-Verify is not available will not count toward the days employees have to begin the process of resolving their TNCs.

So, what should you do with your new hires given that you cannot create a case in E-Verify within the three business days required?

  • Make sure you are still completing I-9s in a timely manner. The shutdown does not affect the three business days you have to obtain and verify documentation in Section 2 or any other I-9 obligations.

  • Do not take any adverse action against employees who have open cases in E-Verify.

  • Create a list of all employees hired during the time period E-Verify has been inoperable, and make a notation that the reason the employees were not run through E-Verify is due to the government shutdown.

  • Take the time now to establish a system for running these employees through E-Verify once the system becomes available. Absent other instructions from USCIS, you will most likely be choosing the “other” drop-down field when asked why the case was not created within three days and typing in “government shutdown.”

  • If you’re a federal contractor with a Federal Acquisition Regulation E-Verify clause, think about getting confirmation in writing from your contracting officer that the E-Verify deadlines are extended. Or, if the officer is not available, at least create documentation that you have inquired about this.

© 2019 Jones Walker LLP
This post was written by Laurie M. Riley and Mary Ellen Jordan of Jones Walker LLP.

FDA 2018 Year in Review

The US Food and Drug Administration’s (FDA’s) 2018 regulatory agenda spurred significant activity throughout the year, including implementation of several initiatives and mandates required by the 21st Century Cures Act (Cures Act). FDA continues to take measures to reduce regulatory barriers to market entry for innovative products, and it is leveraging traditional administrative processes, such as the citizen petition process, to advance its policy goals, including increasing generic competition. FDA initiated targeted enforcement actions in areas of traditional focus, such as good manufacturing practice (GMP) compliance, but it also signaled renewed focus on tobacco advertising, unapproved stem cell procedures, and compounding. FDA also issued important guidance documents throughout 2018.

This Special Report reviews notable actions that shaped FDA-regulated industries and products last year and offers insight into the agency’s 2019 priorities and expected actions.

  1. Drugs

  2. Digital Health

  3. Drug Quality Security Act Implementation

  4. Drug Supply Chain Security Act

  5. Medical Devices

  6. Laboratory-Developed Tests and Precision Medicine

  7. Food

  8. Tobacco

  9. Cannabis

  10. Advertising and Promotion

  11. Clinical Investigations

  12. Manufacturing and Good Manufacturing Practice

  13. Enforcement

The Year Ahead

FDA’s activities and initiatives in 2018 suggest that 2019 will bring greater focus on data strategy; patient perspectives; and innovative ways to leverage data to influence product development, risk management and regulatory decisions. The agency’s focus on data may lead to greater emphasis and renewed focus on data integrity and data quality issues throughout the product lifecycle, from clinical research to manufacturing. The continued focus on novel products and new expedited review processes for digital health, regenerative therapies and novel devices may mean fewer barriers to market entry for novel products, but it may also mean more significant post-market data collection and surveillance requirements. Policy and regulatory initiatives on cybersecurity and interoperability suggest the possibility of increased enforcement and scrutiny of these issues in standard quality and cGMP inspections. While warning letters and other FDA enforcement actions remain static, the agency appears to be leveraging procedural and administrative processes to influence broader policy objectives in areas such as drug pricing and generic competition. Life sciences companies may benefit from greater flexibility regarding the use of data from nontraditional sources to drive product development, advertising and promotion and quality. They may also benefit from the availability of a number of means to engage in pre-development and pre-submission discussions with the agency.

 

© 2019 McDermott Will & Emery

How Manufacturers Can Work With Social Media Influencers

It’s a typical marketing story: Not too long ago, manufacturers marketed coconut oil as a heat-tolerant alternative to other cooking oils. They further promoted it by noting that it was more sustainably harvested than palm oil and could replace butter for people avoiding dairy.

But then coconut oil marketing took a turn. People—not the manufacturers but social media influencers—started to talk about coconut oil in a different way. Influencers claimed that coconut oil was a “miracle cure” for a variety of health and other problems.

Then the influencers’ claims were challenged. In August 2018, Harvard public health professor Karin Michels called coconut oil “pure poison.” Professor Michels blamed the oil for raising levels of LDL cholesterol and increasing the risk of heart disease.

This situation raises an important question: How can manufacturers work with social media influencers to enjoy the benefits of viral promotion while maintaining control of messaging and avoiding the consequences of influencers going rogue?

Going Viral Through Virtual Influencers

Social media influencers use their perceived authority to convince followers to buy the products they endorse. Some influencers partner with manufacturers, which pay them to market a product. In 2017, 12.9 million posts on Instagram were brand-sponsored.

Other influencers, however, make unsolicited claims about products, many of which the company doesn’t approve. Their followers may overlook this fact and buy the product because they trust the influencer as they would a friend. In fact, 92 percent of consumers use products recommended by people they know – or feel that they know through social media.

What can manufacturers do to leverage the social media explosion but still control product marketing? First, they can establish partnerships with influencers, who then promote the product as the manufacturer intends in exchange for a “#sponsored” hashtag. Data show that consumers see sponsored posts as more like typical user content than like marketing. That makes the posts more effective than traditional advertisements.

Some manufacturers have also chosen to use “brand ambassadors,” recruiting some of the first fans of a new product to grow both the brand’s and the promoter’s social presence organically – and on the manufacturer’s terms. Brand ambassador jobs have cropped up on job search engines, and sometimes the brand’s websites will include links encouraging people who already love the products to apply.

When Influencers Go Rogue

Where influencers “go rogue” and promote a manufacturer’s products on their own terms, their messaging may morph into “miracle cure” claims that do not reflect the manufacturer’s claims. The small blue check mark by influencers’ usernames denotes them as “verified” public figures, which means that an account is the authentic presence of the public figure, celebrity, or brand it purports to represent. Followers of verified accounts may treat this advice with as much weight as a medical doctor’s signature on a prescription. Manufacturers are left picking up the pieces of a problem they did not create.

But manufacturers can offset potential challenges of influencer-led advertising, even without working directly with influencers. First, manufacturers can proactively include disclaimers – in the form of warning labels or in advertisements – addressing known potential risks of use or misuse of a product. Social media influencers have recently hailed activated charcoal, for example, for its toxin-removing qualities if ingested. Partly because of the media attention, activated charcoal has moved from poison control wards into juice shops as a “detox” drink. But since activated charcoal’s absorptive qualities may counteract the effects of certain prescription medications, some manufacturers may consider warning people taking birth control pills or antidepressants to consult with a doctor before using it.

Second, manufacturers can partner with influencers who have already promoted their products to continue reaching the influencers’ audience while modulating the messaging. Recently, for example, influencers have promoted the use of adaptogens – non-toxic plants used for stress relief – in their morning drink elixirs. Manufacturers had previously been promoting the stress-relieving qualities of adaptogens, but it was not until recently that these messages started cropping up on social media pages – which made the product turn up in more stores and cafes. By partnering with influencers who have already promoted adaptogens, manufacturers can help shape their messaging and avoid the risk that influencers will tout products as something they are not.

Manufacturers can help dispel myths by engaging with their consumers – especially social media influencers – who talk about them. Manufacturers involved in messaging at the ground level have a much better chance of stopping unrealistic claims before they spread. By working with customers to share proper use and benefits of their products, manufacturers can manage expectations and keep their consumer base happy.

 

© 2019 Schiff Hardin LLP
This post was written by Derin Kiykioglu and Jill Berry of Schiff Hardin LLP.
Read more Products Liability legal news at the National Law Review’s Product Liability page.

Export Sanctions List: Know Your Customer

If your company sells products to customers or distributors located in foreign countries during this time of sanctions and export controls, you should consider the surprising case of Cobham Holdings Inc. a cautionary tale.

The U.S. Treasury Department’s Office of Foreign Asset Control (“OFAC”) publishes a sanctions list of foreign individuals and entities to which U.S. companies may not sell goods or services without first obtaining an export license. OFAC may fine the U.S. companies that violate these sanction regulations. Prudent companies check the OFAC sanctions list before selling products to foreign customers. In fact, many companies have purchased software that searches the sanctions list for prohibited individuals and entities. If your foreign customer is not found on the sanctions list, your company is free to sell products to that customer.

That’s what Cobham Holdings Inc. thought, but on November 27, 2018 they settled a case with OFAC that involved sales to a foreign customer that was not on the sanctions list. Cobham agreed to pay a fine of $87,507 for exporting approximately $745,000 worth of silicon switches to Almaz Antey Telecommunications LLC in Russia between 2014 and 2015 when that entity was not named on OFAC’s list of “Specifically Designated Nationals and Blocked Persons”. Cobham used software to search for OFAC sanctions, the customer came up clean, and Cobham shipped the goods.

Cobham used the software to search for “Almaz Antey Telecom” but not “Almaz Antey.” If it would have searched for the latter, there were numerous hits for entities under the Almaz Antey umbrella, including the entity allegedly responsible for providing the missile that shot down Malaysia Airlines Flight MH17 over Ukraine in 2014. Upon further investigation, OFAC determined that Almaz Antey owned 51% of Almaz Antey Telecommunications LLC. As a result, OFAC initially informed Cobham that it would face potential fines up to $1.9 million.

Cobham was able to reduce the potential fine by agreeing to utilize new and improved screening software, along with a business intelligence tool and new internal checks for high risk transactions. Given that companies now know (or should know) of the potential pitfalls of using these software solutions as a stand-alone procedure, OFAC may not be so generous to the next company to run afoul of its sanctions and export controls through negligence or inadvertent software errors.

This case highlights not only the dangers of exclusively relying on software solutions to search the combined sanctions list, but the inherent risk of the vast number of related entities and the difficulty of understanding their ownership structure. Even if your customers come up clean on the sanctions search, if they are owned more than 50% by a sanctioned entity, then the transaction is still prohibited. Best efforts must be used to ensure that neither the foreign customer nor its majority owner is on the OFAC sanctions list, and a simple software solution or minimal approach may not be enough. A thorough analysis of all relevant facts and information related to your customers and sanctioned entities is vital to ensure your company will not run into the same snare as Cobham.

 

©2019 von Briesen & Roper, s.c
Read more legal news at the National Law Review.

Los Angeles Living Wage Ordinance Amended With Annual Increases

Any employer working with the city of Los Angeles should be aware of recent amendments to the Los Angeles Living Wage Ordinance, which lays out annual cash wage increases, time off and health benefits.

The Los Angeles Living Wage Ordinance (LWO) applies to city contractors and ensures that employees working on city contracts are paid the city’s set living wage (which consists of a cash wage rate and an employer’s health related benefits contribution) and are provided with time off as required by the LWO (at least 96 compensated hours off and 80 uncompensated hours off).

Effective October 15, 2018, the city amended the ordinance to require employer contractors to pay their non-airport employees the following wage going forward:

  • On July 1, 2019, the wage rate for an Employee shall be no less than $14.25 per hour.
  • On July 1, 2020, the wage rate for an Employee shall be no less than $15.00 per hour.
  • July 1, 2022, and annually thereafter, the hourly wage rate paid to an Employee to be adjusted.

In addition to the above base wage, employers must provide health benefits of at least $1.25 per hour to employees towards the provision of health care benefits for employees and their dependents.

For example, if an employer does not currently provide an employee with health benefits as provided in Section 10.37.3 of this article, the employee must be paid an additional wage rate of $1.25 per hour for a total of $14.50 per hour (based on the current $13.25 per hour base rate).

Employers working with Los Angeles Airport Employees must comply with separate wage rates. Effective July 1, 2018 (and adjusted annually thereafter), airport employees must be paid at minimum $13.75 per hour in cash wages and $5.24 per hour in health benefits, for a total economic package of $18.99. The term “total economic package” is not defined in the ordinance. However, it is traditionally interpreted to mean “health related” benefits. “Health related” is defined liberally to include vacation time, health insurance, sick pay, etc.

Because the LWO’s wage rate increases annually, California employers thinking about entering into collective bargaining agreements should consider including flexible language around the annual rate increase.

 

© 2019 Barnes & Thornburg LLP
This post was written by Michael Lee and Barnes & Thornburg LLP.

26th Annual Marketing Partner Forum in January 2019

In January 2019, Marketing Partner Forum descends upon The Ritz-Carlton, Laguna Niguel in Dana Point, California for a three-day summit on law firm marketing and business development designed for the industry’s top business professionals and rainmakers. Conveniently situated near John Wayne Airport, Orange County (SNA), Laguna Niguel is the ideal backdrop to launch a new era of industry-leading content focused on profitability and client development in a dynamic and competitive legal services market.

Why You Should Attend:

 

  • Marketing Partner Forum is designed for client development partners, rainmakers, and the senior-most legal marketing and business development leaders across the profession.
  • Our content reflects the experience and sophistication of our international audience in terms of rigor, ambition and scope.
  • Attendees can engage venerable thought leaders both within and outside of the legal industry.
  • Our program offers ample networking opportunities and the stunning scenery, golf course, spa and hiking trails at one of California’s most idyllic resorts.
  • Participants can take advantage of our law firm partner conference track, consisting of several compelling sessions designed specifically for legal practitioners.
  • We have also created a brand new solo & small law firm track, with sessions designed for business development executives & partners alike.
  • Finally, attendees can interact directly with senior clients and network for new business;
  • Refresh & reflect at our Wednesday Welcome Luncheon and Friday Bloody Mary Brunch;
  • And depart the event with practical takeaways to share with peers and firm leadership.

 

Please Save the Date! Online registration now open.

Information about our conference venue and nearby airports is available here.

For questions about this event, please call 1-800-308-1700

Learn more and register here.

 

Adequacy of Explanation Remains Key Area of PTAB Reversal

In Vivint, Inc. v. Alarm.com, Inc., the Federal Circuit reversed a claim construction by the Patent Trial and Appeal Board (“PTAB”) which “suggest[ed] the opposite” of the teachings of the patents at issue, and gave guidance to practitioners on when the Board’s reliance on expert testimony entitles the Board’s construction to deference. The Court’s non-precedential opinion is consistent with a string of recent decisions stressing the PTAB’s obligation to adequately explain its decisions.

Vivint’s patents are directed to systems and methods for remotely monitoring home equipment, such as an HVAC system. “Communication device identification codes” are assigned to the user’s remote devices, and the system notifies a particular user in case of the equipment’s malfunction through “message profiles” (e.g., settings to notify different users if a malfunction occurs during the day versus at night). The Board construed “communication device identification codes” as “something ‘capable of uniquely identifying communication devices,’” which the Board found included either a device ID or a serial number of a device (variables from one of Vivint’s patent’s figures), but excluded phone numbers and email addresses.

The Federal Circuit reversed the Board’s construction, pointing out that Vivint’s patents did not define “communication device identification codes,” and that the exclusion of phone numbers or email addresses as identification codes “defie[d] the patents’ teachings” which “expressly [taught] that a phone number can uniquely identify a . . . communication device.” The Court explained:

Even assuming [the Board’s construction] is correct, however, the Board’s conclusion that a phone number or email address cannot uniquely identify a communication device defies the patents’ teachings. For example, both patents explain that a mobile identification number refers to a device in the same way that a phone number refers to a cellular phone, i.e. a communication device. . . . But the Board’s construction suggests the opposite. . . . That the ’123 patent includes “Device ID” and “Serial Number” variables in a particular figure, for example, suggests these variables might also be used to identify communication devices. It does not suggest that phone numbers and email addresses cannot also do so.

The Court also rejected Vivint’s assertion that the Board’s construction was “entitled to deference because it relied on extrinsic evidence,” Vivint’s expert testimony. The Court found that the Board’s construction was “without reference to any extrinsic evidence,” finding that although “[t]he Board did credit Vivint’s expert,” it did so “only in applying its construction . . . to the prior art.” As further support, the Court pointed to the Board’s statement that its construction was “[b]ased on [its] review of the claims and Specification of the ’601 patent.”

Takeaways:

Vivint clarifies for practitioners that expert testimony applying a construed term may not constitute a factual finding entitled to deference on appeal, as opposed to expert testimony that is cited in support of the proper construction itself. This distinction may be especially impactful in view of the Court’s “substantial evidence” standard of review for findings of fact, which is “such relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”

Vivint is also in line with a string of recent Federal Circuit decisions stressing the PTAB’s obligation to “set forth a sufficiently detailed explanation of its determinations both to enable meaningful judicial review and to prevent judicial intrusion on agency authority.” Rovalma, S.A. v. Böhler-Edelstahl GmbH & Co. KG, 856 F.3d 1019, 1024 (Fed. Cir. 2017). See, e.g., Icon Health & Fitness, Inc. v. Strava, Inc., 849 F.3d 1034, 1042-48 (Fed. Cir. 2017) (finding Board’s adoption of petitioner’s brief did not “transform [the petitioner’s] attorney argument into factual findings or supply the requisite explanation that must accompany such findings”); In re Van Os, 844 F.3d 1359, 1361 (Fed. Cir. 2017) (Board’s finding that it would have been intuitive to combine prior art lacked the requisite reasoning because “[a]bsent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’”); Emerson Elec. Co. v. SIPCO, LLC, No. 2017-1866, 2018 U.S. App. LEXIS 24499, at *1 (Fed. Cir. Aug. 29, 2018) (non-precedential) (“Because the Board did not adequately explain its reasoning on a point that was central to its analysis and its conclusion on that point was contrary to another Board opinion on nearly identical facts, we vacate the Board’s determination as to the appealed claims and remand for further proceedings.”). Practitioners preparing an appeal strategy would do well to keep in mind the Court’s focus on the PTAB’s obligation to fully explain its determinations.

CitationVivint, Inc. v. Alarm.com, Inc., ___ F.3d ___, 2018 U.S. App. Lexis 35817 (Fed. Cir. Dec. 20, 2018).

© Copyright 2019 Brinks Gilson & Lione.

This post was written by Jafon Fearson and James Naughton of Brinks Gilson & Lione.

Get a Head Start in 2019 – Leveraging Your Cyber Liability Insurance

As 2019 begins, companies should seriously consider the financial and reputational impacts of cyber incidents and invest in sufficient and appropriate cyber liability coverage. According to a recent published report, incidents of lost personal information (such as protected health information) are on the rise and are significantly costing companies. Although cyber liability insurance is not new, many companies lack sufficient coverage. RSM US LLP, NetDiligence 2018 Cyber Claims Study (2018).

According to the 2018 study, cyber claims are impacting companies of all sizes with revenues ranging from less than $50 million to more than $100 billion.  Further, the average total breach cost alone is $603.9K. This does not include crisis services cost (average $307K), the legal costs (defense = $106K; settlement = $224K; regulatory defense = $514K; regulatory fines = $18K), and the cost of business interruption (all costs = $2M; recovery expense = $957K).  In addition to these financial costs, reputational impact stemming from cyber incidents can materially set companies back for a long period of time after the incident.

Companies can reduce risk associated with cyber incidents by developing and implementing privacy and security policies, educating and training employees, and building strong security infrastructures.  Nevertheless, there is no such thing as 100% security, and thus companies should consider leveraging cyber liability insurance to offset residual risks.  With that said, cyber liability coverages vary across issuers and can contain many carve-outs and other complexities that can prevent or reduce coverage.  Therefore, stakeholders should review their cyber liability policies to ensure that they understand the terms and conditions of such policies. Key items to evaluate can include: coverage levels per claim and in the aggregate, retention amounts, notice requirements, exclusions, and whether liability arising from malicious third party conduct are sufficiently covered.

While cyber liability insurance will not practically reduce risk or a cyber incident, it is increasingly a critical component of a holistic risk mitigation strategy given the world we live in.

©2019 Epstein Becker & Green, P.C. All rights reserved.
This post was written by Alaap B. Shah and Daniel Kim from Epstein Becker & Green, P.C.