Tag: business

A Lawyer’s Guide to Integrated Marketing

Like many lawyers, I did not learn about marketing in law school. I knew nothing about communications or media relations before law school, either. When I graduated and began practicing at a boutique matrimonial law firm, there was no internal or external marketing resource, and no direct conversations or plans about public relations or branding. One founding partner talked about the importance of reputation for connecting with potential clients and how his connections in the legal community resulted in many referrals, but he never mentioned marketing.

Yet, as I tagged along to bar association meetings, drafted articles that the partner published in a legal journal, and received encouragement to network at Inns of Court sessions, I saw this side of legal practice come to light. We didn’t call it marketing, or PR, and it was well before social media, but I understood that the partner was intentionally marketing the practice and generating awareness of the firm’s experience — an effort that resulted in new client engagements.

When I decided to leave law after a few years, I enrolled in a New York University course about marketing for professional services. As luck would have it, the instructor was Deborah Brightman Farone, an extraordinary legal marketer then and now — she was inducted into the Legal Marketing Association’s Hall of Fame at the organization’s 2022 annual conference. Deborah introduced me to the field of law firm marketing, and since then, I have worked with hundreds of lawyers and professional marketers on business development and integrated marketing plans, and have helped them make marketing part of their daily practice.

Most lawyers need to understand what this marketing thing is all about. I see firsthand their appreciation for the importance of building client relationships, cross-selling expertise within the firm, and networking. However, I don’t see an understanding of the terms and tactics of legal marketing as often. I think that with so much to learn in law school, there just isn’t time to learn the business side of law. Once a lawyer is practicing law, there may be little direction about how to reach prospects and referral sources, stand apart from other lawyers doing similar work, and find time to “market oneself.”

I frequently read articles where lawyers describe their routes to becoming partner or managing a practice or office. The words “PR” or “marketing” may not appear in their answers, but as someone who has advised lawyers about practice growth for more than 20 years, I know that positioning themselves as knowledge leaders played a role in the success of their relationship-building and practice development. And that, of course, is marketing.

This article will take you through five steps I always examine with lawyers who are just getting started with marketing, or participating in a firmwide marketing program.

  1. Acknowledge the Need for Education

Earning a JD and passing the bar exam prepare a lawyer for the practice of law, but not the business of law. My colleague Vivian Hood recently wrote, “Law schools focus on teaching the art of law, and not so much on the art of connections.” Courses about marketing, public relations, or social media are not part of the law school curriculum. Rather, law school teaches students to read cases and apply precedent, analyze facts and frame arguments, and spot the real issues and see the red herrings. Likewise, legal writing courses, moot court competitions, internships, and other hands-on work prepare them for practicing law. Their understanding of marketing may extend to billboards they see on their way to work, law firm ads in legal journals, or networking events with bar associations.

Lawyers know how to practice law, but do not know what marketing is or how it supports business development and revenue. Education is the first step to heightening awareness. On many occasions, I have explained how PR works so lawyers understand the events that result in being quoted in a trade publication, or the behind-the-scenes steps that go into earning a speaking engagement at an industry event.

  1. Discuss Perceptions of Marketing

The only way to know how an attorney perceives marketing is to ask, and then provide guidance about worthwhile and suitable marketing efforts.

Lawyers often shy away from marketing because they associate it with sales. My colleague Glennie Green explains, “Most attorneys envision some sort of sales when the idea of marketing and business development comes up. They see car salespeople, or aggressive pitches for timeshares. But that is the wrong mindset. Business development is not sales. Business development is cultivating and nurturing relationships.”

Relationships can be built in many ways. A common misconception is that marketing success is based on the ability to be a natural rainmaker who can walk into any room and instantly make connections for the firm. That belief can create unrealistic expectations and undue stress, because rainmakers are few and far between. Relationships can be built and nurtured without that unique rainmaker quality. Everyone adapts to situations differently ­— some of us are introverts, others extroverts, or a combination of traits.

  1. Assess the Impact of Previous Experiences

Lawyers may base their perceptions of marketing on prior experiences. Lawyers have told me, “I wrote many articles in the past, and they never amounted to any new business.”

“I traveled to speak at a conference, and not a single attendee turned out to be a new client.”

“I did an interview with a reporter who misquoted me.”

“I have a LinkedIn profile, but I’m not interested in doing anything with it; it’s just like Facebook.”

Many people fear failure, and many transactional lawyers and litigators are driven by winning. It is no surprise, then, that lawyers question the value of something that has not been a winner in the past. Understanding and acknowledging these hesitations can lead to productive discussions about marketing and, more specifically, about techniques that may be better suited for the lawyer.

  1. Discuss the Time Commitment

The billable-hour model of legal practice can affect a lawyer’s availability to market their practice. Too many business-driving commitments will inevitably frustrate a lawyer and diminish the success of marketing. It’s better to work with a distinct set of action items that can take only a few minutes a day rather than many hours each week.

Glennie Green has helped lawyers identify their advocates — assistants, paralegals, the firm’s librarians; people they can partner with to achieve their action items. One managing partner with a busy practice serves as an example of this effort. “He has made a commitment to conduct a certain number of meetings a month with current and potential referral sources,” she says. “He enlists a paralegal in the office to help schedule those meetings, as well as maintain his ‘marketing’ calendar. This allows him to keep his focus on his practice and manage the firm. He regularly checks his calendar for new appointments, and he says he looks forward to seeing whom he will meet with next. Once he realized that he didn’t have to do it all and enlisted some help, his plan and marketing goals became not only manageable but systematic.”

  1. Find the Comfort Zone

Marketing efforts must be tailored to a lawyer’s personality and interests. Everyone has a different comfort level. Some lawyers love to speak at conferences, and others would rather research a case and write an analysis for a journal. One lawyer may already enjoy engaging on social media, and another may feel crushed for time but would be amenable to doing a 30-minute interview with a reporter. Perhaps a lawyer may enjoy participating in an association’s events or committees. Green explains, “Knowing a lawyer’s areas of confidence, and recognizing what causes any discomfort, is crucial to establish the right marketing plan with the flexibility to change direction as needed.”

The avenues for marketing include website content and branding, social media posts and engagement, media relations, published quotes and articles, rankings submissions and awards, conferences and speaking opportunities, networking, events, and more. The questions and conversations I’ve provided lead to more precise choices of marketing tactics, as well as more informed expectations of results. An integrated marketing and business development program offers lawyers a selection of tactics, with deliberate matching to their preferences and the flexibility to change as needed.

Article By Liz Bard Lindley of Jaffe

For more business of law legal news, click here to visit the National Law Review.

© Copyright 2008-2022, Jaffe Associates

Cryptocurrency As Compensation: Beware Of The Risks

A small but growing number of employees are asking for cryptocurrency as a form of compensation.  Whether a substitute for wages or as part of an incentive package, offering cryptocurrency as compensation has become a way for some companies to differentiate themselves from others.  In a competitive labor market, this desire to provide innovative forms of compensation is understandable.  But any company thinking about cryptocurrency needs to be aware of the risks involved, including regulatory uncertainties and market volatility.

Form of Payment – Cash or Negotiable Instrument

The federal Fair Labor Standards Act requires employers to pay minimum and overtime wages in “cash or negotiable instrument payable at par.”  This has long been interpreted to include only fiat currencies—monies backed by a governmental authority.  As non-fiat currencies, cryptocurrencies therefore fall outside the FLSA’s definition of “cash or negotiable instrument.”  As a result, an employer who chooses to pay minimum and/or overtime wages in cryptocurrency may violate the FLSA by failing to pay workers with an accepted form of compensation.

In addition, various state laws make the form of wage payment question even more difficult.  For example, Maryland requires payment in United States currency or by check that “on demand is convertible at face value into United States currency.”  Pennsylvania requires that wages shall be made in “lawful money of the United States or check.”  And California prohibits compensation that is made through “coupon, cards or other thing[s] redeemable…otherwise than in money.”  It is largely unclear whether payment in cryptocurrency runs afoul of these state requirements.

Of note, the U.S. Department of Labor (“DOL”) allows employers to satisfy FLSA minimum wage and overtime regulations with foreign currencies as long as the conversion to U.S. dollars meets the required wage thresholds.  But neither the DOL nor courts have weighed in on whether certain cryptocurrencies (e.g., Bitcoin) are the equivalent, for FLSA purposes, of a foreign currency.

Volatility Concerns

When compared to the rather stable value of the U.S. dollar, the value of cryptocurrencies is subject to large fluctuations.  Bitcoin, for example, lost nearly 83% of its value in May 2013, approximately 50% of its value in March 2020, and recently lost and then gained 16% of its value in the span of approximately 15 minutes one day in February 2021.

Such volatility can give payroll vendors a nightmare and can, in some instances, lead to the under-payment of wages or violation of minimum wage or overtime requirements under the FLSA.

Tax and Benefits Considerations

Aside from wage and hour issues, the payment of cryptocurrency implicates a host of tax and benefits-related issues.  The IRS considers virtual currencies to be “property,” subject to capital gains tax rates.  It has also confirmed in guidance materials that any payment to employees in a virtual currency must be reported on a W-2 based upon the value of the currency in U.S. dollars at the time it was delivered to the employee.  This means that cryptocurrency wage payments are subject to Federal income tax withholding, Federal Insurance Contributions Act (FICA) tax, and Federal Unemployment Tax Act (FUTA) tax.

For 401k plan fiduciaries, the Department of Labor recently issued guidance that should serve as a stern warning to any fiduciary looking to invest 401k funds into cryptocurrencies.  Specifically, the DOL wrote: “[a]t this early stage in the history of cryptocurrencies, the Department has serious concerns about the prudence of a fiduciary’s decision to expose a 401(k) plan’s participants to direct investments in cryptocurrencies, or other products whose value is tied to cryptocurrencies.”  Given the risks inherent in cryptocurrency speculation, the DOL stated that any fiduciary allowing such investment options “should expect to be questioned [by the DOL] about how they can square their actions with their duties of prudence and loyalty in light of the risks.”

Considerations for Employers

Given the combination of uncertain and untested legal risks, employers should consider limiting cryptocurrency compensation models to payments that do not implicate the FLSA or applicable state wage and hour laws.  For example, an employer might provide an exempt employee’s base salary in U.S. dollars and any annual discretionary bonus in cryptocurrency.

Whether investing in cryptocurrencies themselves to pay employees or utilizing a third-party to convert US dollars into cryptocurrency, employers should also stay abreast of the evolving tax and benefits guidance in this area.

Ultimately, the only thing that is clear about cryptocurrency compensation is that any decision to provide such compensation to employees should be made with a careful eye towards the unique wage, tax, and benefits-related issues implicated by these transactions.

Article By Daniel J. Butler and Kevin J. White of Hunton Andrews Kurth

For more cryptocurrency and finance legal news, click here to visit the National Law Review.

Copyright © 2022, Hunton Andrews Kurth LLP. All Rights Reserved.

Apple Smartwatch Antitrust Case Survives, Showing ‘Freedom of Design’ is Not Absolute

Judge Cites ‘Associated’ Anticompetitive Conduct Claims

It’s a case that challenges the limits of the “freedom of design” usually enjoyed by companies accused of product design changes alleged to harm competition. Ordinarily, a design change is not the kind of conduct that runs afoul of the antitrust laws, but on March 21, U.S. Judge Jeffrey S. White from the Northern District of California denied Apple Inc.’s motion to dismiss an antitrust case brought against it by AliveCor Inc. The suit alleges that Apple unlawfully maintained its monopoly in the market for heart rate analysis apps by updating WatchOS, the Apple Watch operating system on which AliveCor’s heart rate analysis app runs. (AliveCor, Inc. v. Apple Inc., No. 21-cv-03958-JSW, N.D. Calif.).

Heart rate analysis apps analyze the user’s heart rate in real time using a sensor close to the user’s wrist and determine whether the user’s heart rate is normal or irregular. The app runs constantly while the device is worn and alerts the user when a situation arises requiring an ECG recording and medical analysis. AliveCor also sells an electrocardiogram-capable wrist band for the Apple Watch and related WatchOS software that analyzes reading from the band. AliveCor claims that its products—the ECG-wristband hardware and software and its heart rate analysis app—“helped change the perception of the Apple Watch from an accessory to a personal health monitoring tool.”

AliveCor calls its heart rate monitoring app “SmartRhythm.” According to AliveCor, when sales of SmartRhythm took off Apple was inspired to announce an update to WatchOS with its own heart monitoring app designed to exclude AliveCor from the U.S. market for WatchOS heart rate analysis apps.

SmartRhythm works by using data from the Apple Watch’s heart rate algorithm. According to the complaint, Apple’s update to WatchOS altered the heart rate algorithm in a way that prevents third-party developers from being able to detect heart rate fluctuations and irregularities. As a result of these changes, SmartRhythm could not provide accurate heart rate analysis, and AliveCor removed it from the market.

Consequently, Apple is a monopolist in the WatchOS heart rate analysis app market, which AliveCor claims Apple is maintaining with exclusionary design changes to WatchOS, in violation of Section 2 of the Sherman Act, California’s Unfair Competition Law, and Section 17200 of California Business and Professions Code.

The court denied Apple’s motion to dismiss AliveCor’s monopolization claim in what it characterized as the “[single brand] aftermarket for WatchOS apps.” Applying the factors enumerated by the court in Newcal Indus., Inc. v. Ikon Office Sol., 513 F.3d 1038, 1044 (9th Cir. 2008), the court found that the WatchOS app aftermarket was wholly derivative from the primary smartwatch market, the alleged restraint applied only to the aftermarket, Apple’s aftermarket power was not obtained through contract terms reached in the primary market, and that competition in the smartwatch market does not discipline anticompetitive practices in the WatchOS app aftermarket. Accordingly, the court ruled that AliveCor’s market definition met the Newcal standards for a “single product” relevant market.

Apple argued that a company that improves a product to the benefit of consumers does not violate antitrust laws “absent some associated anticompetitive conduct,” citing the leading “freedom of design” case of Allied Orthopedic Appliances Inc. v. Tyco Health Care Group LP, 592 F.3d 991, 998-99 (9th Cir. 2010). The court quoted the holding of Allied: “If a monopolist’s design change is an improvement, it is necessarily tolerated by the antitrust laws, unless the monopolist abuses or leverages its monopoly power in some other way when introducing the product.”

Apple argued that its update to WatchOS was purely a design change that benefitted users, with no associated anticompetitive conduct. It observed that AliveCor hadn’t established that consumers use Apple’s app instead of some third-party app, or that Apple rejected any third-party apps, or that no other third-party heart apps are available to Apple Watch users. But the court rejected those arguments, noting that Apple failed to provide any legal authority that would require such allegations.

Apple ignored AliveCor’s allegations that Apple abused or leveraged its monopoly power “in some other way” by changing its heart rate algorithm to make it effectively impossible for third parties to inform a user when to take an ECG. AliveCor contended that Apple’s updated heart rate algorithm, which was pushed out to all earlier Apple Watch models, did not improve user experience. Its purpose was to prevent third parties from identifying irregular heart rates and offering competing apps based on that data. “These allegations present the type of ‘associated conduct’ that makes product design changes cognizable under antitrust law. Plaintiff’s allegations plausibly establish that Apple’s conduct was anticompetitive,” Judge White held. A case management conference set for May 20.

Commentary

It is truly difficult to see how some separate, “associated” conduct by Apple other than its design change to WatchOS violates Section 2. It seems more straightforward to consider the design change itself to be a cognizable anticompetitive act. It may be time to drop the fiction maintained in Allied v. Tyco that design changes are “never” antitrust violations unless accompanied by some “other” conduct. Here, Apple has created the market itself in the form of an OS platform used by millions of consumers who depend on it to access all manner of competing complementary products. Under those circumstances, it should be uncontroversial to hold a platform operator liable under the antitrust laws for design changes that exclude competitors or foreclose participants from the market, without indulging in the fiction of “associated” conduct.

Article By Jonathan Rubin of MoginRubin

For more antitrust legal news, click here to visit the National Law Review.

© MoginRubin LLP

FTC Imposes Record-Setting $10M Fine Against Multistate Auto Dealer, Settling Charges of Racial Discrimination and Unauthorized Charges

On March 31, the FTC and Illinois State Attorney General announced a settlement of charges against a large, multistate auto dealer that allegedly discriminated against black consumers and included illegal junk fees for unwanted “add-ons” in customers’ bills.

Citing violations under the FTC Act, TILA, ECOA, and comparable Illinois laws, the complaint alleged that eight of the dealerships and two general managers of Illinois dealerships tacked on illegal fees for unwanted products to customers’ bills, often at the end of hours-long negotiations. These add-ons were allegedly buried in the consumers’ purchase contracts, which were sometimes upwards of 60-pages long, and sometimes added despite consumers specifically declining the products.

In addition, employees of the auto dealership also allegedly discriminated against black consumers during the process of financing vehicle purchases.  On average, black customers at the dealerships were charged $190 more in interest and paid $99 more for similar add-ons than comparable non-Latino white customers.

The multistate dealer will have to pay $10 million to settle the lawsuit per the stipulated order, the largest monetary judgment ever required in an FTC auto lending case.

Putting it into Practice:  From FTC Chair Lina Khan and Commissioner Rebecca Slaughter, the FTC appears poised to allege violations of the FTC Act’s prohibition on unfair acts or practices in light of discrimination found to be based on disparate treatment or having a disparate impact.  Their statement discusses how discriminatory practices can be evaluated under the FTC’s three-part unfairness test and concludes that such conduct fits squarely into the kind of conduct that can be addressed by the FTC’s unfairness prong.  This joint statement echoes similar announcements by CFPB Director Chopra about the use of unfairness to combat discrimination more broadly (we discussed Director Chopra’s statement and updates to the CFPB’s exam procedures in a recent Consumer Finance and FinTech blog post here).

The size of the financial judgment in this case underscores the seriousness with which the FTC takes discriminatory practices in consumer credit transactions entered into by entities over which they have authority, which includes auto dealerships.  As the FTC becomes increasingly focused on enforcement of key laws to protect consumers against discriminatory conduct, companies should use these latest agency pronouncements as a reason to be on high alert for potential discriminatory outcomes in their business activities, even if unintentional.

Article By Moorari Shah, A.J. S. Dhaliwal, and Katie Daw of Sheppard, Mullin, Richter & Hampton LLP

For more antitrust legal news, click here to visit the National Law Review.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.

The DOJ Throws Cold Water on the Frosties NFT Founders

The U.S. Attorney’s Office for the Southern District of New York recently charged two individuals for allegedly participating in a scheme to defraud purchasers of “Frosties” non-fungible tokens (or “NFTs”) out of over $1 million. The two-count complaint charges Ethan Nguyen (aka “Frostie”) and Andre Llacuna (aka “heyandre”) with conspiracy to commit wire fraud in violation of 18 U.S.C. § 1349 and conspiracy to commit money laundering in violation of 18 U.S.C. § 1956.   Each charge carries a maximum sentence of 20 years in prison.

The Defendants marketed “Frosties” as the entry point to a broader online community consisting of games, reward programs, and other benefits.  In January 2022, their “Frosties” pre-sale raised approximately $1.1 million.

In a so-called “rug pull,” Frostie and heyandre transferred the funds raised through the pre-sale to a series of separate cryptocurrency wallets, eliminated Frosties’ online presence, and took down its website.  The transaction, which was publicly recorded and viewable on the blockchain, triggered investors to sell Frosties at a considerable discount.  Frostie and heyandre then allegedly proceeded to move the funds through a series of transactions intended to obfuscate the source and increase anonymity.  The charges came as the Defendants were preparing for the March 26 pre-sale of their next NFT project, “Embers,” which law enforcement alleges would likely have followed the same course as “Frosties.”

In a public statement announcing the arrests, the DOJ explained how the emerging NFT market is a risk-laden environment that has attracted the attention of scam artists.  Representatives from each of the federal agencies that participated in the investigation cautioned the public and put other potential fraudsters on notice of the government’s watchful eye towards cryptocurrency malfeasance.

This investigation comes on the heels of the FBI’s announcement last month of the Virtual Asset Exploitation Unit, a special task force dedicated to blockchain analysis and virtual asset seizure.  The prosecution of the Defendants in this matter continues aggressive efforts by federal agencies to reign in bad actors participating in the cryptocurrency/digital assets/blockchain space.

Article By Matthew G. Lindenbaum, Robert L. Lindholm, and Daniel Curran of Nelson Mullins

For more crypto and cybersecurity legal news, click here to visit the National Law Review.

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

FDA and FTC Issue Warning Letters to CBD Companies

  • On March 28, 2022, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) jointly issued seven warning letters to companies marketing cannabidiol (CBD) products with COVID-19 related claims.
  • Specifically, the agencies warned the following companies regarding the promotion of their respective products with claims that they cure, mitigate, treat or prevent COVID-19: Cureganics, Heaven’s Organics LLC, Functional Remedies, LLC D/B/A Synchronicity Hemp Oil, Greenway Herbal Products LLC, CBD Social, UPSY LLC, and Nature’s Highway. Examples of claims include: “Our research suggest that CBD . . . can block SARS-Cov-2 infection at early and even later stages of infection. . .”, “Studies Show CBD Compounds Prevent COVID Cells From Replicating”, and “Can CBD Help with the Fight Against COVID? Some of the worst effects of COVID are caused by inflammation, and CBD is a potent anti-inflammatory.”
  • By way of background, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), products intended to cure, treat, mitigate, or prevent disease are considered drugs and are subject to the requirements that apply to drugs. Therefore, the agencies classified the products as unapproved and misbranded drugs that may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA.
  • The letters included a cease-and-desist demand from FTC, prohibiting the companies from making such COVID-19 related claims. The companies were provided with 48 hours to respond with specific steps that were taken to correct the violations.

Article By Food and Drug Law Practice Group at Keller and Heckman LLP

For more food and drug law legal news, click here to visit the National Law Review.

© 2022 Keller and Heckman LLP

EPA Will Propose to Ban Ongoing Uses of Asbestos

The U.S. Environmental Protection (EPA) announced on April 5, 2022, that it will propose to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. EPA notes that the proposed rule will be “the first-ever risk management rule issued under the new process for evaluating and addressing the safety of existing chemicals under the Toxic Substances Control Act (TSCA) that was enacted in 2016.” EPA will propose to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for all ongoing uses of chrysotile asbestos. EPA will also propose targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). EPA has posted a pre-publication version of the proposed rule. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.

Background

As reported in our January 4, 2021, memorandum, EPA released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos (Asbestos RE Part 1). Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six chrysotile asbestos use categories. EPA found no unreasonable risk to the environment. According to the final risk evaluation, chrysotile is the prevailing form of asbestos currently mined worldwide, and “so it is assumed that a majority of commercially available products fabricated overseas that contain asbestos are made with chrysotile. Any asbestos being imported into the U.S. in articles is believed to be chrysotile.” The other five forms of asbestos are now subject to a significant new use rule (SNUR), as reported in our April 18, 2019, memorandum, “EPA Announces Final SNUR for Asbestos Will ‘Close Loophole and Protect Consumers.’”

Proposed Rule

EPA will propose a rule under TSCA Section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA will propose that these prohibitions take effect two years after the effective date of the final rule.

EPA will also propose pursuant to TSCA Section 6(a) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos-containing brake blocks used in the oil industry, aftermarket automotive chrysotile asbestos-containing brakes/linings, other chrysotile asbestos-containing vehicle friction products (not including the National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA will propose that these prohibitions take effect 180 days after the effective date of the final rule.

EPA will further propose pursuant to TSCA Section 6(a) to prohibit manufacture (including import), processing, and distribution in commerce of: aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and commercial use of other chrysotile asbestos-containing gaskets for consumer use. EPA will propose that these prohibitions take effect 180 days after the effective date of the final rule.

EPA will also propose disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. EPA states that it does not intend the proposed prohibitions on processing or distribution in commerce to prohibit any processing or distribution in commerce incidental to disposal of the chrysotile asbestos waste in accordance with the proposed requirements.

According to EPA, because a determination has been made that chrysotile asbestos presents an unreasonable risk to health within the United States or to the environment of the United States, pursuant to TSCA Section 12(a)(2), the proposed rule would apply to chrysotile asbestos even if being manufactured, processed, or distributed in commerce solely for export from the United States.

Commentary

Bergeson & Campbell, P.C. (B&C®) commends EPA on this historical achievement. Unsurprisingly, there are aspects of this precedent-setting proposed rule that invite discussion and warrant comment from affected parties. Key among these issues is a potential significant legal vulnerability in the underlying risk evaluation (i.e., Asbestos RE Part 1) for the proposed rule, an issue that may overshadow this historic achievement in a manner reminiscent of EPA’s failed ban of asbestos in 1991 (Corrosion Proof Fittings v. EPA, 947 F.2d 1201 (5th Cir., 1991)).

EPA proposed that the prohibition on specific conditions of use (e.g., chrysotile asbestos diaphragms used in the chlor-alkali industry) would take effect two years after the effective date of the final rule. EPA stated that it “believes an aggressive transition away from chrysotile asbestos will spur adoption of superior technology [e.g., membrane cells with increased concentrations of per- and polyfluoroalkyl substances (PFAS)].” The clear need to consider EPA’s intended action on asbestos in the context of its ongoing actions on PFAS is of course not lost on the Agency. EPA acknowledged that “the transition away from asbestos-containing diaphragms could result in greater usage and release of PFAS.”

B&C notes that innovative new technologies, such as alternative membrane cells, may be available in the future, but those technologies must be proven to be economically and technically viable. Once proven effective, the underlying chemical substances must be reviewed as new chemicals if so classified under TSCA. The development, review, and approval are all on indeterminate timelines, so it is speculative when novel, non-PFAS-based technologies will be commercially available and, of course, whether that time will be prior to the effective date of EPA’s proposed ban on asbestos.

EPA requested comment on specific aspects of the proposed rule that B&C encourages potentially impacted parties to consider. For example, EPA discussed its authority under TSCA Section 6(g) to grant a time-limited exemption for a specific condition of use, such as the chlor-alkali industry, where EPA finds “that compliance with the proposed requirement would significantly disrupt the national economy, national security, or critical infrastructure.”

EPA also requested comment on a primary alternative regulatory option that EPA discussed for the chlor-alkali diaphragm and sheet gasket categories that would allow a prohibition to take effect five years after the effective date of the final rule. As part of this option, EPA would include establishment of a risk-based performance standard known as an existing chemical exposure limit (ECEL). EPA developed an eight-hour time-weighted average (8-hr TWA) ECEL of 0.005 fibers/cubic centimeter (f/cc) for inhalation exposures to chrysotile asbestos as an eight-hr TWA ECEL-action level of 0.0025 f/cc, with associated requirements for initial and periodic monitoring and respirator usage/type if exceedances are found.

As part of the monitoring requirements, EPA stated that it would “require use of appropriate sampling and analytical methods to determine asbestos exposure, including: … Compliance with the Good Laboratory Practice Standards at 40 CFR Part 792,” despite the fact that EPA acknowledges that other standards, such as Industrial Hygiene Laboratory Accreditation Program (IHLAP), are more appropriate for industrial hygiene monitoring. EPA’s TSCA Section 5(e) order template states the following under Section III.D:

Compliance with TSCA GLPS, however, is not required under this New Chemical Exposure Limit Section where the analytical method is verified by a laboratory accredited by either: the American Industrial Hygiene Association (“AIHA”) Industrial Hygiene Laboratory Accreditation Program (“IHLAP”) or another comparable program approved in advance in writing by EPA.

EPA devoted one paragraph in the proposed rule to “TSCA section 26(h) considerations.” EPA stated, in part, that its unreasonable risk determination “was based on a risk evaluation, which was subject to peer review and public comment, was developed in a manner consistent with the best available science and based on the weight of the scientific evidence as required by TSCA sections 26(h) [and 26(i)] and 40 CFR 702.43 and 702.45.”

B&C notes that EPA stated in the Asbestos RE Part 1 the following:

TSCA § 26(h) and (i) require EPA, when conducting Risk Evaluations, to use scientific information, technical procedures, measures, methods, protocols, methodologies and models consistent with the best available science and base its decisions on the weight of the scientific evidence. To meet these TSCA § 26 science standards, EPA used the TSCA systematic review process described in the [2018] Application of Systematic Review in TSCA Risk Evaluations document [citation omitted] [2018 SR Document].

Prior to completing Asbestos RE Part 1, EPA requested the National Academies of Science, Engineering, and Medicine (NASEM) to review the 2018 SR Document. In February 2021, NASEM released its consensus study report on EPA’s 2018 SR Document and concluded that it did not meet the criteria of “comprehensive, workable, objective, and transparent” and that “The OPPT approach to systematic review does not adequately meet the state-of-practice.”

NASEM recommended that “With regard to hazard assessment for human and ecological receptors, OPPT should step back from the approach that it has taken and consider components of the OHAT, IRIS, and Navigation Guide methods that could be incorporated directly and specifically into hazard assessment.”

In response to the NASEM review, EPA revised its systematic review method. On December 20, 2021, EPA released the “Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances” (2021 Draft Protocol) for public comment. EPA acknowledged in the 2021 Draft Protocol that:

Previously [in the 2018 SR Document], EPA did not have a complete clear and documented TSCA systematic review (SR) Protocol. EPA is addressing this lack of a priori protocol by releasing [the 2021 Draft Protocol].

EPA further stated that the:

[2021 Draft Protocol] is significantly different [from the 2018 SR Document] in that it includes descrition [sic] of the Evidence Integration process…, which was not previously included in the [2018 SR Document].

B&C recognizes that the scientific methods used to inform systematic review are not static and that updates will be required as the science evolves. In this instance, however, many of the documents cited as supporting information for updating the 2021 Draft Protocol (e.g., Office of Health Assessment and Translation (OHAT), 2015) were available prior to EPA issuing the 2018 SR Document. Rather than utilizing these documents at the time, EPA developed the 2018 SR Document de novo. In other words, EPA chose to develop its own methodology in 2018 rather than incorporating and adapting existing methodologies that represented the best available science at the time.

These issues raise interesting procedural questions and issues around whether EPA demonstrated that Asbestos RE Part 1 was based on the best available science and weight of scientific evidence, as required under TSCA Sections 26(h) and 26(i) and the implementing regulation under 40 C.F.R. Part 702.

B&C encourages stakeholders to review EPA’s proposed risk management rule on chrysotile asbestos, even for entities that do not manufacture, process, distribute, or use this substance. We urge this review because of the precedential nature of EPA’s decisions. B&C also encourages interested parties to provide public comments on the proposed rule, given that risk management decisions in the proposed rule will likely serve as a basis from which EPA regulates other chemical substances EPA is evaluating under TSCA Section 6.

Article By: the Government Regulation practice at Bergeson & Campbell, P.C.

For more environmental legal news, click here to visit the National Law Review.

©2022 Bergeson & Campbell, P.C.

Vehicle Sales Continue Their Depression

Anyone want to buy a vehicle? A better question might be: anyone got a vehicle for sale? Whether because of supply side issues, demand side issues, other issues, or all of the above, the fact remains that the first quarter of 2022 was not a good quarter for vehicle sales.  Just ask the manufactures who saw double digit drops in new light-vehicle sales: 23% for Honda; 20% for GM; 17% for Ford; 15% for Toyota; and 14% for Stellantis. While the numbers sound like doom and gloom, the manufacturers were not dour. Honda was quite positive about its numbers, noting that demand was strong and they just could not make enough vehicles to sell more, “we’re riding a bit of a roller coaster due to fluctuating parts supply issues, but strong March sales for Honda and Acura speak to the fact that demand remains strong and our retail deliveries are based primarily on what we can supply to our dealers.”

Some other interesting tidbits from sales data:

As a result, LMC Automotive and Cox Automotive each reduced their full-year U.S. light-vehicle sales forecast to 15.3 million units, citing a slower pace to recovery from market constraints. LMC referred to inventory levels as “critically low.”  Cox led its report by noting that not only are inventories low, but prices are high and sales incentives have vanished (note – this is how that entire supply/demand thing works).  Cox laid it all at the feet of supply: “Auto sales will basically be stuck at the current level until more supply arrives.”

Globally, the pandemic is not over. This continues to have the potential to drastically impact global vehicle volumes, especially in China. Global vehicle production could lose up to 1.5 million units this year if China’s COVID-Zero policy is maintained, according to estimates from Fitch Solutions quoted in Bloomberg. Most recently, phased lockdowns in Shanghai in response to COVID-19 outbreaks disrupted production for several major automakers and suppliers.

Add to that, the ongoing microchip shortage (for which no end appears in sight) is causing production downtime at various plants: Jeep production at Stellantis’ Mack Assembly plant in Detroit and Belvidere Assembly plant in Illinois; Chevrolet Silverado 1500 and GMC Sierra 1500 production at GM’s Fort Wayne Assembly plant; and Mustang production at Ford’s Flat Rock Assembly plant. Let’s not forget the war in Ukraine, leading to German automakers potentially losing up to 150,000 units of production in March due to supply disruptions.

Oddly, the industry feels both healthy (revenue, profits, margins, etc.) and stressed with an unceratin future (see above) all at the same time.  Also oddly, but strangely not so oddly, nothing about this situation feels new.  Is this the new normal?

Article By Jeffrey A. Soble of Foley & Lardner LLP

For more transportation legal news, click here to visit the National Law Review.

© 2022 Foley & Lardner LLP

Judge Ketanji Brown Jackson Confirmed to U.S. Supreme Court

Judge Ketanji Brown Jackson will become the first Black woman and the third Black Justice to serve on the U.S. Supreme Court.

With support of only a handful of Republican senators, a Senate majority voted to confirm Judge Jackson’s nomination to the Supreme Court, 53-47, on April 7, 2022. Judge Jackson will fill the vacancy left by Justice Stephen Breyer, who will retire at the end of the Court’s current term.

During Judge Jackson’s distinguished legal career, she served as a federal district judge from 2013 to 2021, a judge on the U.S. Court of Appeals for the D.C. Circuit from 2021 to 2022, assistant special counsel and then vice chair on the U.S. Sentencing Commission, a federal public defender, and a private practice attorney.

Despite bringing a new perspective to the bench, Judge Jackson is unlikely to affect the current composition of the Court. Her decisions as a district and appellate judge suggest that, like Justice Breyer, she takes a pragmatic approach to the law.

Judge Jackson’s legal methodology will become apparent shortly after she takes her seat for the 2022-2023 term, which begins on October 3, 2022. The Court is scheduled to hear oral arguments on three cases touching on contentious issues during Judge Jackson’s first term. Judge Jackson, who serves on Harvard University’s board of overseers, has stated she will recuse herself from hearing Students for Fair Admissions, Inc. v. President & Fellows of Harvard, a case involving the use of race in college admissions. However, she will participate in 303 Creative LLC v. Elenis, which asks the Court to decide on the constitutionality of a Colorado state law that prohibits business owners from refusing to provide service to people on the basis of sex, including sexual orientation and gender identity. Judge Jackson also will participate in the Court’s hearing of Merrill v. Millgan, which asks the Court to weigh in on whether Alabama’s proposed congressional district plan violates Section 2 of the Voting Rights Act of 1965.

Judge Jackson is expected to be sworn in before the start of the 2022-2023 term.

Article By Stephanie L. Adler-Paindiris and Stephanie E. Lewis of Jackson Lewis P.C.

For more litigation legal news, click here to visit the National Law Review.

Jackson Lewis P.C. © 2022

HIPAA Enforcement Continues Under Right of Access Initiative

On March 28, 2022, the Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced the resolution of two additional cases as part of OCR’s HIPAA Right of Access Initiative.

The Right of Access Initiative was launched by OCR in 2019 “to support individuals’ right to timely access their health records at a reasonable cost under the HIPAA Privacy Rule” as explained by OCR. In the March 28 announcement, OCR indicated its continuing commitment to enforce compliance with the HIPAA Rules, including the “foundational” Right of Access provision. With the two most recent cases, there have now been 27 investigations and settlements under the Right of Access Initiative (see full chart below).

Nearly all of the investigations in the Right of Access Initiative involve a single individual unable to obtain a copy of some or all of their protected health information from a health care provider or to do so within the timeframe required or in accordance with fees permitted by the HIPAA Privacy Rule. In some cases, additional issues found during the investigation, such as failure to have conducted a HIPAA risk assessment or lack of HIPAA policies, are part of the settlement.  In all cases, in addition to the monetary penalty, the settlement has included a Corrective Action Plan imposing various obligations, such as policy development, training, and mandatory reporting to OCR.

The Right of Access Initiative remains one of the most active areas of HIPAA enforcement. In its most recent Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance, OCR noted that right of access was the third most common issue of complaints resolved. Moreover, the Right of Access Initiative coordinates with the ONC 2020-2025 Federal HIT Strategic Plan and the goal of “Providing patients and caregivers with more robust health information.” It is a core tenant of the Federal HIT Strategic Plan that access to health information will “better support person-centered care and patient empowerment.”

Article By Allen R. Killworth and Zeina Abu-Hijleh of Epstein Becker & Green, P.C.

For more health law legal news, click here to visit the National Law Review.

©2022 Epstein Becker & Green, P.C. All rights reserved.