Author: National Law Forum

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Biden Administration Proposes That Federal Contractors Must Disclose GHG Emissions

Last Thursday, the Biden Administration proposed that all federal contractors (except those receiving less than $7.5 million annually in contracts) be required to, among other things, disclose their GHG emissions.  Specifically, according to the press release issued by the White House, “Federal contractors receiving more than $50 million in annual contracts would be required to publicly disclose Scope 1, Scope 2, and relevant categories of Scope 3 emissions, disclose climate-related financial risks, and set science-based emissions reduction targets” and “Federal contractors with more than $7.5 million but less than $50 million in annual contracts would be required to report Scope 1 and Scope 2 emissions.”  The Biden Administration further announced that “[t]his proposed rule leverages widely-adopted third party standards and systems . . . including the CDP environmental reporting system, the Task Force on Climate-Related Financial Disclosures (TCFD) Recommendations, and the Science Based Targets Initiative (SBTi) criteria.”  It should be noted that this proposed rule is also quite similar to the climate disclosures proposed by the SEC–an unsurprising observation, as both were proposed by the Biden Administration and relied upon the same third-party standards (e.g., the TCFD).

The significance of this proposed rule–beyond the regulatory burden imposed upon federal contractors, which is substantial–is that the Biden Administration is signaling its commitment to, and reliance upon, climate-related financial disclosures as a key tool to address the challenge of climate change.  Thus, regardless of the legal challenges that the SEC proposal (and any similar regulatory rule) will be subject to, it is clear that the impetus for these types of disclosures will continue, including through other means at the government’s disposal.  Bearing this in mind, it would be rational for companies to take steps to generate the information necessary for these sort of disclosures, and to prepare to issue them–as this regulatory pressure is unlikely to dissipate soon.

“Today, the Biden-Harris Administration is taking historic action to address greenhouse gas emissions and protect the Federal Government’s supply chains from climate-related financial risks. In support of President Biden’s Executive Orders on Climate-Related Financial Risk and Catalyzing Clean Energy Industries and Jobs Through Federal Sustainability, the Administration is proposing the Federal Supplier Climate Risks and Resilience Rule, which would require major Federal contractors to publicly disclose their greenhouse gas emissions and climate-related financial risks and set science-based emissions reduction targets.”

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©1994-2022 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

Colorado Legalizes Therapeutic Psychedelics – Now What?

Ten years after Coloradans voted for their state to be one of the first to legalize recreational cannabis, Colorado is again making history as the second state in the country to legalize therapeutic psychedelics for adults.

Colorado voters narrowly approved Proposition 122 with nearly 53% of the votes (as of the morning of November 14th 97% of the votes have been counted). Their vote thus enacted the Natural Medicine Health Act of 2022 (NMHA) which legalizes supervised or facilitated therapeutic sessions for adults twenty-one years and older using certain psychedelic plants and fungi. Click here for our initial takeaways and a high-level summary of key provisions of the NMHA.

Now that therapeutic psychedelics are legal in Colorado, what should be expected next? Below are key dates and next steps as Colorado navigates implementation of the NMHA.

  • The Colorado Department of Regulatory Agencies (DORA) must establish the Natural Medicine Advisory Board (Board) and appoint initial members to the Board by January 31, 2023. The Board must have 15 members who will be appointed by the Governor with the consent of the Colorado Senate. The primary role of the Board is to advise DORA as to implementation of the NMHA program.
  • By September 30, 2023, and annually thereafter, the Board must make recommendations to DORA on certain areas related to natural medicine, such as recommendations related to product safety, herm reduction, and cultural responsibility, training programs, educational and experiential qualifications for facilitators, regulatory considerations for each type of natural medicine and the rules to be promulgated by DORA.
  •  DORA has until January 1, 2024 to adopt rules and establish the qualifications, education and training requirements that facilitators must meet prior to providing natural medicine services to participants.
  • By September 30, 2024, DORA must adopt rules to implement the NMHA program and begin accepting applications for licensure of facilitators, healing centers, entities to test natural medicines, and any categories of licensure as determined by DORA.
  • Once applications are accepted, DORA must make decisions on licensure applications within 60 days of receiving an application.
  • From the launch of the NMHA program until June 1, 2026, “natural medicines” are limited to psilocybin and psilocyn. After June 1, 2026, upon recommendation by the Board, DORA may add one of more of the following to types of natural medicines that can be provided under the NMHA program: dimethyltryptamine, Ibogaine, and Mescaline (excluding peyote).

A notable takeaway and something to watch for in the forthcoming rules is a focus on social equity. Seemingly applying lessons learned from the rollout of the state’s cannabis program, the NMHA expressly requires DORA to prioritize equity and inclusivity as it establishes rules to implement the NMHA program. Specifically, DORA is required to adopt rules which: (i) establish procedures, policies and programs to ensure the NMHA program is equitable and inclusive; (ii) promote the licensing of and provision of natural medicine services to (a) persons from communities that have been disproportionally harmed by high rates of controlled substances (including cannabis); (b) persons who face barriers to access to health care; (c) persons who have traditional or indigenous history with natural medicines; and (d) persons who are veterans by, offering, at a minimum reduced fees for licensure and training, incentivizing the provision of natural medicine services at a reduced cost to low income individuals, and incentivizing geographic and cultural diversity in licensing and the provision of and availability of natural medicine services.

In addition, DORA is prohibited from imposing unreasonable financial or logistical barriers that would prevent individuals with lower income from applying for a license and individuals are limited to having a financial interest in five healing centers. Currently, the definition of “individuals” does not include corporations. However, DORA could establish a rule which includes corporations in this limitation and would arguably level the playing field in this budding market.

We will continue to monitor developments and closely follow the rulemaking process as Colorado designs and implements this historical new program.

Article By Lauren P. Carboni of Foley & Lardner LLP

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

© 2022 Foley & Lardner LLP

Attorney Mindfulness When Addressing Emails and Texts: ABA Formal Opinion Provides Ethical Guidance to Lawyers on Electronic Communications

In their roles as advisors, advocates, counselors, negotiators, and client representatives, lawyers communicate extensively though electronic means, particularly email and increasingly text messages. However, the fact that use of these electronic communication tools is commonplace in legal practice doesn’t mean that attorneys shouldn’t exercise caution when crafting their communications. The American Bar Association (“ABA”) Standing Committee on Ethics and Professional Responsibility published a formal opinion this month that advises lawyers to refrain generally from including their clients on emails and texts sent to opposing counsel.

ABA Formal Opinion 503 focuses on ABA Model Rule 4.2, often referred to as the “no-contact” rule. Under this model rule, a lawyer who is representing a client may not communicate about the subject of the representation with a represented person absent the consent of that person’s lawyer unless the law or court order authorizes such as communication. Most states’ codes of professional legal ethics draw heavily upon the ABA Model Rules, so many states have similar “no-contact” rules for lawyers.

The new formal opinion states that lawyers would not be deemed to violate ABA Model Rule 4.2 if they send a “reply all” response to a group email or text sent by an opposing counsel, even if that communication includes the opposing counsel’s client. The opinion states that, “[a]bsent special circumstances, lawyers who copy their clients on emails or other forms of electronic communication to counsel representing another person in the matter impliedly consent to a ‘reply all’ response from the receiving counsel,” the opinion said. “Accordingly, the reply all communication would not violate Model Rule 4.2.”

As a practical matter, Formal Opinion 503 provides a number of options to lawyers who wish to avoid creating an implied presumption of consent to such “reply all” communications from opposing counsel to their clients. These options include:

  • forwarding the electronic communication separately to the client without including opposing counsel as an addressee,
  • informing receiving counsel expressly and in advance that including the client on the electronic communication does not constitute a consent to a “reply all” response, or
  • sending the communication through other means (such as a mailed hard copy letter) where different norms are in place regarding responding to all addressees.

The full text of ABA Formal Opinion 503 is available here.

Article By Electronic Discovery at K&L Gates

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

Copyright 2022 K & L Gates

What Brokers, Company Insiders, and Others Need to Know about Securities Litigation

Individuals, companies, and firms involved in all aspects of the securities industry face litigation risks daily. From whistleblower lawsuits and U.S. Securities and Exchange Commission (SEC) enforcement actions to Financial Industry Regulatory Authority (FINRA) arbitration and private-right-of-action cases under the Securities Exchange Act of 1934, all types of securities litigation present risks for civil liability. In some cases, securities litigation can present risks for criminal penalties as well.

With this in mind, there is a lot that brokers, company insiders, investment advisers, and others need to know when targeted in lawsuits and investigations. When brokers, company insiders, and others make informed decisions based on the advice of experienced counsel, they can significantly mitigate their risk in both private and governmental securities litigation.

“Securities litigation can present substantial risks for individuals, companies, and firms. Whether facing allegations in civil litigation, SEC enforcement proceedings, or FINRA arbitration, the key to mitigating these risks is to build and execute a comprehensive, strategic and forward-thinking defense.” – Dr. Nick Oberheiden, Founding Attorney of Oberheiden P.C. law firms.

Answers to 10 Frequently Asked Questions (FAQs) about Securities Litigation

Here are answers to 10 frequently asked questions (FAQs) about securities litigation:

1. What Are Some of the Most Common Claims Against Brokers and Brokerage Firms in Securities Litigation?

Brokers and brokerage firms have faced a growing volume of litigation in recent years. This includes private litigation involving individual investors as well as litigation involving the SEC. Investigations, lawsuits, and arbitration filings targeting brokers and brokerage firms primarily focus on acts and omissions constituting investor fraud, though brokers and brokerage firms can face a variety of other claims in securities litigation as well.

Some examples of common claims against brokers and brokerage firms in securities litigation include:

  • Making unsuitable investment recommendations

  • Unauthorized trading and account churning

  • Charging excessive fees and commissions

  • Failing to disclose or misconstruing material information (especially in connection with structured products and other high-risk investments)

  • Failure to supervise or implement adequate internal controls

2. What Are Some of the Most Common Claims Against Company Insiders and Issuers in Securities Litigation?

Securities fraud lawsuits and enforcement actions targeting company insiders and securities issuers can also involve an extremely broad range of allegations. These cases are typically very different from those targeting brokers and brokerage firms; and, while both falls under the umbrella of “securities litigation,” the resemblances between the two categories are minimal. Some examples of common claims against company insiders and issuers in securities litigation include:

  • Accounting and recordkeeping violations

  • Submitting false SEC filings

  • Insider trading

  • Market manipulation

  • Selling unregistered securities and conducting unregistered IPOs

3. What Are Some of the Most Common Triggers for Securities Fraud Lawsuits and Investigations?

Many securities fraud lawsuits and investigations result from investor complaints. Typically, investors will have concerns about losses in their portfolios that they believe cannot be explained by ordinary market forces. These concerned investors will contact plaintiffs’ lawyers to help them file claims alleging fraud in federal courts, district courts or FINRA arbitration.

In some cases, concerned investors will file whistleblower claims with the SEC. The SEC has an obligation to investigate all whistleblower complaints that meet the basic filing requirements, and SEC whistleblowers can receive substantial compensation awards.

The SEC also initiates investigations on its own. Questionable EDGAR filings, market activity, media reports, and referrals from other federal law enforcement agencies can all trigger SEC investigations that may lead to civil or criminal enforcement action. The SEC also monitors activity on social media and other online platforms, and activity on these platforms is increasingly serving as the basis for SEC enforcement activity.

4. What Types of Claims Are Most Likely to Lead to Class Action Securities Litigation?

While all securities litigation presents liability risks for the individuals or entities targeted, companies and firms targeted in class action litigation face risk on an entirely different scale. Class action lawsuits lead to devastating liability that can threaten companies’ and firms’ viability as a going concern.

The types of claims that are most likely to lead to class action securities litigation are those that involve violations affecting large groups of investors. Inadequate brokerage controls that lead to systemic unsuitable investment recommendations, omitting material information from companies’ 10-K or 10-Q filings, mismanagement of investors’ funds, and market manipulation resulting in widespread losses are all examples of issues that can lead (and have led) to securities-related class action lawsuits.

5. How Does the SEC’s Whistleblower Program Work?

The SEC’s Office of the Whistleblower accepts tips from company employees, investors, and others who believe they have information about securities fraud. When a whistleblower complaint spurs enforcement action resulting in sanctions of $1 million or more, the whistleblower can receive between 10% and 30% of the amount collected.

As a result, individuals have a strong financial incentive to come forward and work with the SEC. Additionally, even if the SEC declines to pursue enforcement action based on a whistleblower’s tip, the whistleblower can still choose to pursue a claim directly, and whistleblower compensation awards are higher in these cases. Due to these incentives, whistleblower litigation is a key component of the SEC’s overall securities law enforcement strategy.

6. When Is It Advantageous to Settle a Securities Fraud Lawsuit or Arbitration Claim?

When facing substantiated allegations of securities fraud, settling will often prove to be the most cost-effective solution. However, targeted individuals and entities must be careful not to settle too soon, as there are numerous ways to fight securities fraud allegations even in scenarios that seem highly unfavorable (more on this below).

So, when is it advantageous to settle? Simply put, the costs of settling need to be less than the costs of any other alternative. This includes not only legal costs and any potential judgment liability, but reputational and administrative (i.e. suspension or debarment) costs as well.

7. When Can the U.S. Department of Justice Pursue Criminal Securities Fraud Litigation?

The U.S. Department of Justice (DOJ) pursues criminal securities fraud litigation in cases involving intentional (or apparently intentional) securities law violations. According to the DOJ’s website, the Department’s Market Integrity and Major Frauds (MIMF) Unit, “focuses on the prosecution of complex securities, commodities, cryptocurrency, and other financial fraud and market manipulation cases.” In criminal securities fraud cases, the DOJ can seek penalties ranging from substantial fines to long-term imprisonment for company executives and other insiders.

8. What Remedies Can Investors Seek in Securities Litigation?

In private securities litigation and FINRA arbitration, retail investors can seek compensatory damages for their fraudulent investment losses. An investor’s losses may be deemed fraudulent if they result from either: (i) broker fraud or mismanagement (i.e., making unsuitable investment recommendations), or (ii) a drop in the value of their securities that is not attributable to ordinary market forces. Along with the recovery of their lost principal and investment earnings, investors can seek to recover interest, fees, and other costs as well.

9. What Remedies Can the SEC Seek in Securities Litigation?

When pursuing enforcement actions against brokers, brokerage firms, company insiders, and issuers, the SEC can seek a range of civil and administrative penalties. These include fines, disgorgement, and restitution as well as cease-and-desist orders, suspension, and debarment from the securities industry.

10. What Defenses Can Individuals, Companies, and Firms Use to Protect Themselves in Securities Litigation?

While securities litigation can involve a broad range of allegations and present substantial risk for liability and other penalties, targeted individuals and entities may be able to successfully defend themselves by several means. Whether securing a favorable result means avoiding liability entirely or negotiating a favorable settlement, the key to success is making informed decisions in light of the available opportunities.

For brokers and brokerage firms, some examples of potential defenses include:

  • Misguided Allegations – In many cases, investors (and their counsel) simply lack an adequate understanding of the law. Demonstrating that an investor’s allegations are misguided can serve as an efficient and complete defense against liability.

  • Investor Authorization – One particular area of confusion for many investors is the area of authorization (including discretionary authorization). If an investor is challenging a trade that he or she authorized, providing documentation of authorization can be sufficient to avoid liability.

  • Statutory and Regulatory Compliance – Brokers and brokerage firms will also be able to successfully defend against securities fraud allegations by demonstrating compliance with the relevant statutes, regulations, or FINRA rules.

For company insiders and issuers, some examples of potential defenses include:

  • Compliance with Pre-Arranged Trading Plans – In cases involving insider trading allegations, company insiders can avoid liability by demonstrating compliance with a pre-arranged trading plan.

  • Good-Faith Disclosure – Issuers accused of withholding material information or publishing incomplete or misleading information can often defend against fraud allegations by demonstrating good-faith efforts to maintain disclosure compliance.

  • Qualifying for a Registration Exemption – Issuers can qualify for registration exemptions in various scenarios. If security is exempt, then offering security without registration is 100% permissible.

The fact that these are just examples cannot be overemphasized. Securities litigation can involve an extraordinarily broad range of allegations under numerous laws, rules, and regulations. In many cases, targeted companies and individuals will be able to assert a successful defense by focusing on discrete elements of the plaintiff’s or SEC’s burden of proof. From asserting the applicable statute of limitations to preventing class certification, several technical defenses can prove highly effective in securities litigation as well. As with all types of litigation, the key is to explore all viable defenses, build a comprehensive and cohesive defense strategy, and then execute that strategy while remaining prepared to adapt as necessary.

Article By Dr. Nick Oberheiden of Oberheiden P.C.

For more securities and SEC legal news, click here to visit the National Law Review.

Oberheiden P.C. © 2022

Lawyer Career Change: Everything to Know

Burnout, stress, or the curiosity of exploring a new career path are some of the most common reasons lawyers change careers. After all, for some, the idea of being a lawyer might have turned out to be pretty different than the reality of working at a firm.

Before making any immediate changes, be as clear as possible about why you’re looking for a career shift and what you’re looking for in your next role. With these insights at hand, you’ll be better positioned to strategically move forward — and even keep one foot in the door behind you as you go.

Find out everything you should know about making a career change as a lawyer.

When to Change Careers as a Lawyer

Being a lawyer can consume much of your time and energy. Maybe you’re facing a big life change and looking for more work/life balance or you’re tired of big law and considering solo practice. Alternatively, your talents and personality may be better suited for another field entirely.

When considering your need for a change, ask yourself these questions:

  • What do I enjoy about my work in law?

  • What depletes my energy as a lawyer? What do I enjoy least?

  • What are my passions? When do I feel most fulfilled or energized?

  • What is my ideal work culture? Management style? Company culture?

Then, comb through your skillset. Reflect on your strengths as a lawyer. You might excel at analysis and research, or you could also be an expert persuasive communicator.

This way, you can start thinking about other careers that might match well, or even better, with those in-demand skills. A strong negotiator could be well suited for a sales career or even running a company. Skilled researchers could become regulatory investigators or corporate analysts. Practicing law develops a host of skills that can readily transfer to many careers in the public and private sectors.

Alternative Careers for Lawyers

The list goes on and on for viable alternative careers for lawyers. As you shift away from legal practice, here are a few career paths to consider:

  • Legal consulting: This path lets you continue working on your lawyer skill set at a distance from the courtroom. You could be a consultant for a company or private individuals, advising clients on tricky legal issues and offering recommendations.

  • Legal project management: Legal project managers get to be involved with legal cases, but from the higher level of a practice manager. They ensure that the firm stays on top of all legal tasks, monitoring the firm’s processes for inefficiencies, and implementing strategies to improve client satisfaction and drive revenue.

  • Legal writing: As a legal writer, you could work anywhere from a law firm to a government agency to a marketing company or even a newspaper. If you like uncovering stories and informing the public, journalism could make a good fit. If you don’t want to walk out of a law practice entirely, you could focus on case research and write legal documents.

  • Legal billing specialist: If numbers are your sweet spot, consider legal billing. You’ll research any issues related to billing, prepare invoices and proformas, and ensure a firm gets paid for its services.

Pro Tip: No matter the legal profession track, having a working knowledge of law practice management software can give you a competitive edge in the market.

How to Change Careers as a Lawyer

Changing careers is about more than figuring out your dream job, of course. Once you have a better sense of your transferable skills and what you enjoy doing most, it’s time to tap into your network.

If you have professional relationships and friendships outside of the law, it’s time to leverage them. These relationships will not only give you a fresh perspective on life outside of a law career, but they could also provide valuable insight and leads on your next career move. Be prepared to let your network know that you’re shifting gears and what you’re looking for next. To ensure that you don’t lose your connection to legal practice entirely, consider working pro bono as you figure out your next options or after you change careers. This way, you can do fulfilling work and keep your legal skills fresh.

Article By Nina Lee of PracticePanther

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

© Copyright 2022 PracticePanther

Voters in Two States Approve Marijuana Ballot Initiatives on Election Day 2022

Voters in Maryland and Missouri approved laws to legalize recreational marijuana on Election Day 2022.  Recreational marijuana ballot initiatives did not pass in Arkansas, North Dakota and South Dakota.

Maryland

Maryland voters approved a state constitutional amendment that will allow the use of cannabis by anyone over the age of 21 on or after July 1, 2023, subject to the General Assembly passing legislation concerning the regulation, distribution, possession and taxation of marijuana.

Missouri

Missouri voters also approved an amendment to the state constitution.  The amendment addresses both medical marijuana and recreational marijuana.

The medical marijuana law will permit nurse practitioners to recommend medical marijuana use to their patients in addition to physicians.  It also will permit the use of “marijuana-infused products,” i.e., products that are infused, dipped, sprayed, coated or mixed with marijuana or marijuana extracts.  Those products may be vaporized or smoked, or may consist of edible products, ingestible products, topical products, suppositories, and “infused pre-rolls” (a type of consumable or smokable product).  Medical marijuana cards will be valid for three years.  While the medical marijuana law does not permit operation of a motor vehicle while under the influence of marijuana, the law is now revised to say that the arrest or conviction of a medical marijuana user will require evidence that the user was in actual physical control of the motor vehicle and may not rely solely on the presence of THC or THC metabolites in the person’s system.

The medical marijuana law still prohibits legal claims against employers based on an employer’s prohibition of being under the influence of marijuana while at work.  However, new provisions state that employers may not discriminate against medical marijuana users unless:  failure to do so would result in the loss of a monetary or licensing-related benefits under federal law, or unless the person was under the influence of marijuana on the employer’s premises or during work hours.

The constitutional amendment also permits the recreational use of marijuana by adults age 21 and older.  Employers are not required to permit or accommodate the use of marijuana at work or on the employer’s property.  Employers are permitted to take adverse employment actions if a person is working while under the influence of marijuana.

The law does not define the phrase “under the influence of marijuana” so it is unclear whether employers may rely on positive drug test results for marijuana to prove an employee was “under the influence.”

Finally, the new law will allow individuals who are serving prison sentences for certain crimes including possession of up to three pounds of marijuana to petition the sentencing court to vacate the sentence, order immediate release and expunge the government’s records.  There are additional provisions addressing expungement of criminal records for those who previously served prison sentences related to certain marijuana-related crimes.

The Missouri constitutional amendment will take effect thirty days after the election.

Employers in Maryland and Missouri should review their drug and alcohol policies to ensure compliance with these new laws.

Article By Kathryn J. Russo of Jackson Lewis P.C.

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

Jackson Lewis P.C. © 2022

Federal Reserve Issues Latest Financial Stability Report

At the end of last week, the Federal Reserve Board (“FRB”) issued its semi-annual Financial Stability Report.

In a statement issued with the report, FRB Vice Chair Lael Brainard stated that over the past six months, “household and business indebtedness has remained generally stable, and on aggregate households and businesses have maintained the ability to cover debt servicing, despite rising interest rates.” She also noted that “[t]oday’s environment of rapid synchronous global monetary policy tightening, elevated inflation, and high uncertainty associated with the pandemic and the war raises the risk that a shock could lead to the amplification of vulnerabilities, for instance due to strained liquidity in core financial markets or hidden leverage.”

The Report notes that the FRB’s monitoring framework “distinguishes between shocks to, and vulnerabilities of, the financial system,” and “focuses primarily on assessing vulnerabilities, with an emphasis on four broad categories and how those categories might interact to amplify stress in the financial system.” The four categories of vulnerabilities are (1) valuation pressures, (2) borrowing by businesses and households, (3) leverage within the financial sector, and (4) funding risks. The overview of the Report notes that since the May report was released, “the economic outlook has weakened and uncertainty about the outlook has remained elevated, noting that “[i]nflation remains unacceptably high in the United States and is also elevated in many other countries.”

Related to the funding risk vulnerability (and perhaps showing some prescience to our lead story on FTX this week), the Report noted that stable coins remained vulnerable to runs. The Report included a highlighted discussion of digital assets and financial stability noting trouble and volatility in the crypto market in the spring of this year. That discussion noted that the “[t]he turmoil in the digital asset ecosystem did not have notable effects on the traditional financial system because the digital assets ecosystem does not provide significant financial services and its interconnections with the broader financial system are limited.” However, the report noted that as digital assets grow, so too will the risks to financial stability, and cited the October FSOC Report on Digital Asset Financial Stability Risks and Regulation in addressing those risks and regulatory gaps.

The Report identified several near-term risks that “could be amplified” through the four financial vulnerabilities, including high inflation, geopolitical risks (noting Russia’s invasion of Ukraine), market fragilities, and possible shocks caused by a cyber event.

Article By Daniel Meade of Cadwalader, Wickersham & Taft LLP

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

© Copyright 2022 Cadwalader, Wickersham & Taft LLP

Comparison of Three Federal Fraud and Abuse Laws

In the post-COVID era, health care fraud and abuse issues will be aggressively and swiftly enforced by the government. The legal framework and regulations in the health care space can be intimidating. Below is a comparison of three of the big federal fraud and abuse laws that the government actively enforces; but they are not an exclusive list.  The summary below is a primer on the three main federal fraud and abuse laws and is intended to increase your basic understanding of these laws.

False Claims Act (FCA)

PROHIBITIONS:

  • Prohibits the submission of false or fraudulent claims, false statements material to a false claim, and conspiracy to commit violation
  • Prohibits concealing or avoiding obligation to repay money to government (failure to return overpayments)
  • Claims that violate AKS or Stark can also be considered false claims
  • Common false claims include lack of medical necessity; quality of care; billing/coding issues; off-labeled marketing; retention of overpayments

EXCEPTIONS:

  • n/a

PENALTIES:

  • Treble damages and as of May 9, 2022 per claim penalties between $12,537 and $25,076
  • Regulated by the DOJ

Physician Self-Referral (Stark)

PROHIBITIONS:

  • Prohibits referrals of designated health services by a physician (or an immediate family member) if the physician has a financial relationship with the entity performing the designated health service
  • Regulates financial relationships with physicians (and physician’s immediate family members) only

EXCEPTIONS:

  • The arrangement must completely satisfy an exception or it violates the Stark law

PENALTIES:

  • No criminal enforcement; CMP enforcement for knowing violations: per violation penalties– 3x claims and/or per circumvention scheme penalties; Nonpayment of claims arising from prohibited arrangement; Recoupment of amounts received; Exclusion from federal health programs; FCA liability
  • Regulated by CMS

Anti-Kickback Statute (AKS)

PROHIBITIONS:

  • Prohibits offers of, solicitation of, or payment or receipt of remuneration intended to induce referrals for health care services covered by a government program
  • Covers provision of anything of value to a person who refers, orders/purchases or recommends

EXCEPTIONS:

  • Voluntary safe harbors exist, but arrangements are not required to fit within a safe harbors

PENALTIES:

  • Applies to either party involved in an arrangement that violates AKS; Criminal penalties $100,000 /violation, up to 10 years imprisonment); Civil penalties (CMP3x unlawful remuneration and $100,000/violation); Exclusion from federal health programs; FCA liability
  • Regulated by the OIG

Providers should also be aware of other enforcement statutes such as the Eliminating Kickbacks in Recovery (“EKRA”), the Civil Monetary Penalties Act (“CMP”), and the Travel Act, to name a few, in addition to being well versed in the relevant state health care fraud and abuse frameworks.

Article By Courtney G. Tito of Nelson Mullins

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

Copyright ©2022 Nelson Mullins Riley & Scarborough LLP

Pair of Lawsuits Target Mint Flavored Products

  • Spencer Sheehan, a well-known class-action attorney, has filed a pair of class-action lawsuits in the U.S. District Court for the Northern District of Illinois, alleging that mint flavored products which do not contain mint are deceptively labeled.
  • The first lawsuit alleged that a “mint chocolate chip ice cream” statement of identity is misleading to consumers where the product’s flavor is derived from “natural flavor” and not any mint or mint-containing ingredient. The product also contains images of mint leaves on the front panel. As support for the allegation that the lack of mint is deceptive, the complaint cites to the ice cream flavoring regulation (21 CFR 135.110(f)(2)), which requires that the term “flavored” (e.g., mint flavored) be used where a product contains a natural flavor which predominates.
  • The second lawsuit alleged that consumers are misled by a gum product which is labeled as “original flavor” with a backdrop of what appears to be a blue mint leaf, but which only contains “natural and artificial flavor,” and no mint-based ingredients. Plaintiff, citing to the general flavoring regulation (21 CFR 101.22), alleged that the product should have been labeled as “naturally and artificially flavored mint” and that the failure to disclose the flavor or include the other qualifiers is misleading.
  • Although Plaintiffs have alleged technical violations of FDA’s labeling regulations, courts have consistently held that a reasonable consumer may not be aware of the intricacies of FDA’s labeling regulations and that therefore a technical labeling violation is not in itself sufficient to show that a reasonable consumer would be misled.

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

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

© 2022 Keller and Heckman LLP

Upcoming Proposed Changes to DOL’s Independent Contractor and Overtime Rules

The Department of Labor’s Wage and Hour Division is expected to propose new rules on independent contractor classification and overtime entitlement requirements in the coming weeks.  The proposals would alter the qualifications for certain employees to receive overtime payments under the Fair Labor Standards Act when they work in excess of 40 hours in one week.

The Fair Labor Standards Act (“FLSA”) grants the Department of Labor authority regarding overtime eligibility under the statute.  Currently and among other considerations, employees are non-exempt under the FLSA when they earn less than a guaranteed $684 per week or $35,568 per year.  If the DOL raises this salary threshold, as it is considering, an even larger swath of the workforce could be entitled to overtime payments.

The proposals follow President Biden’s withdrawal of former President Trump’s independent contractor rule in May 2021, which had not yet taken effect when President Biden took office.  However, United States District Judge Marcia A. Crone held in March 2022 that the DOL had not properly followed the requirements for withdrawal as set forth in the Administrative Procedure Act.  In so holding, Judge Crone gave the Trump administration’s independent contractor rule the effect of law as if it had gone into effect in March 2021, as scheduled. The Biden administration’s proposed changes to the existing rule will likely affect the salary basis and exemption requirements of the employee versus independent contractor misclassification analysis under the FLSA.  Employers should prepare for these upcoming changes by reviewing their employee job descriptions and time record procedures.  Employers should also engage counsel to re-examine their employee classifications at large to ensure their exempt employees are truly exempt under the current rules and that they understand that changes may need to be implemented when the new rules take effect.

Article By Holly H. Williamson and Savannah R. Gibbs of Hunton Andrews Kurth

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