The National Law Forum

Clueless in the Cubicle

The Journal’s recent piece about managing employees with misperceptions about their employment self-worth reminds us once again why honest and timely performance feedback makes good business sense. I have written before about the benefit of candid performance reviews, even at the risk of hurt feelings. I have also defended performance evaluations as an important tool to mitigate potential liability for employment claims. The Journal’s piece states that nearly four in 10 employees who received the lowest grades from their managers last year rated themselves as highly valued by the organization based on almost two million assessments. If true, that represents an astounding disconnect between performance-related perception and reality.

Theory is one thing. Managers who are adept at giving feedback is another. While businesses are rightly focused on running the organization’s business, training managers how to deliver quality feedback is often assigned a low priority. Adding to that deficiency is the often unmet need for managers with the right EQ to deliver feedback. But despite those challenges, which exist even for employees who relish feedback, there are some important guidelines for managing employees with an inflated sense of employment worth. Here are a few suggestions for delivering feedback for performance-deniers, who clearly require a more exacting approach.

First, performance discussions (especially about the areas in which the employee is falling short) must be done regularly and ongoing, and especially promptly after an error or mistake is committed. Performance deniers will use a one-time annual review (even if negative) to point out the obvious: if they are falling so short, the manager would not have waited so long to deliver that message (and which, in their view, adds to the review’s inherent unreliability).

Second, managers should not shy away from a denier’s tendency to fight the feedback (they disagree with it, it is wrong, it is fake). Rather, managers should use the denier’s dispute to double down on feedback: the employee’s inability to accept criticism, consider it, and even hear it, are all key parts of an employee’s commitment to the organization to grow and do better. Growth requires introspection. The refusal to engage in that process is itself a performance deficiency.

Third, managers should not permit performance conversations to become a discussion about victimization, unfair treatment or perceived persecution (all of which may end up becoming a legal claim). Performance deniers are adept at deflecting: one key deflection is to blame others and make the discussion about things entirely outside performance parameters. Managers need to be empowered to insist on returning the feedback conversation back to the key and only focus: what is the employee doing well and how can (and must) the employee improve?

Finally, organizations need to assess the impact performance deniers have on employee morale. While not all employees will share the same perception, most people are aware when others aren’t pulling their weight – especially when they are tasked to pick up the pieces. Those on the downhill slope of these assignments – often the best performers because of the natural inclination to step up – may not stick around. The slippery slope here is clear and cluelessness at work is not a great look for the business or the employee.

The Race to Report: DOJ Announces Pilot Whistleblower Program

In recent years, the Department of Justice (DOJ) has rolled out a significant and increasing number of carrots and sticks aimed at deterring and punishing white collar crime. Speaking at the American Bar Association White Collar Conference in San Francisco on March 7, Deputy Attorney General Lisa Monaco announced the latest: a pilot program to provide financial incentives for whistleblowers.

While the program is not yet fully developed, the premise is simple: if an individual helps DOJ discover significant corporate or financial misconduct, she could qualify to receive a portion of the resulting forfeiture, consistent with the following predicates:

The information must be truthful and not already known to the government.
The whistleblower must not have been involved in the criminal activity itself.
Payments are available only in cases where there is not an existing financial disclosure incentive.
Payments will be made only after all victims have been properly compensated.

Money Motivates

Harkening back to the “Wanted” posters of the Old West, Monaco observed that law enforcement has long offered rewards to incentivize tipsters. Since the passage of Dodd Frank almost 15 years ago, the SEC and CFTC have relied on whistleblower programs that have been incredibly successful. In 2023, the SEC received more than 18,000 whistleblower tips (almost 50 percent more than the previous record set in FY2022), and awarded nearly $600 million — the highest annual total by dollar value in the program’s history. Over the course of 2022 and 2023, the CFTC received more than 3,000 whistleblower tips and paid nearly $350 million in awards — including a record-breaking $200 million award to a single whistleblower. Programs at IRS and FinCEN have been similarly fruitful, as are qui tam actions for fraud against the government. But, Monaco acknowledged, those programs are by their very nature limited. Accordingly, DOJ’s program will fill in the gaps and address the full range of corporate and financial misconduct that the Department prosecutes. And though only time will tell, it seems likely that this program will generate a similarly large number of tips.

The Attorney General already has authority to pay awards for “information or assistance leading to civil or criminal forfeitures,” but it has never used that power in any systematic way. Now, DOJ plans to leverage that authority to offer financial incentives to those who (1) disclose truthful and new information regarding misconduct (2) in which they were not involved (3) where there is no existing financial disclosure incentive and (4) after all victims have been compensated. The Department has begun a 90-day policy sprint to develop and implement the program, with a formal start date later this year. Acting Assistant Attorney General Nicole Argentieri explained that, because the statutory authority is tied to the department’s forfeiture program, the Department’s Money Laundering and Asset Recovery Section will play a leading role in designing the program’s nuts and bolts, in close coordination with US Attorneys, the FBI and other DOJ offices.

Monaco spoke directly to potential whistleblowers, saying that while the Department will accept information about violations of any federal law, it is especially interested in information regarding

Criminal abuses of the US financial system;
Foreign corruption cases outside the jurisdiction of the SEC, including FCPA violations by non-issuers and violations of the recently enacted Foreign Extortion Prevention Act; and
Domestic corruption cases, especially involving illegal corporate payments to government officials.

Like the SEC and CFTC whistleblower programs, DOJ’s program will allow whistleblower awards only in cases involving penalties above a certain monetary threshold, but that threshold has yet to be determined.

Prior to Monaco’s announcement, the United States Attorney’s Office for the Southern District of New York launched its own pilot “whistleblower” program, which became effective February 13, 2024. Both the Department-wide pilot and the SDNY policy require that the government have been previously unaware of the misconduct, but they are different in a critical way: the Department-wide policy under development will explicitly apply only to reports by individuals who did not participate in the misconduct, while SDNY’s program offers incentives to “individual participants in certain non-violent offenses.” Thus, it appears that SDNY’s program is actually more akin to a VSD program, while DOJ’s Department-wide pilot program will target a new audience of potential whistleblowers.

Companies with an international footprint should also pay attention to non-US prosecutors. The new Director of the UK Serious Fraud Office recently announced that he would like to set up a similar program, no doubt noticing the effectiveness of current US programs.

Corporate Considerations

Though directed at whistleblowers, the pilot program is equally about incentivizing companies to voluntarily self-disclose misconduct in a timely manner. Absent aggravating factors, a qualifying VSD will result in a much more favorable resolution, including possibly avoiding a guilty plea and receiving a reduced financial penalty. But because the benefits under both programs only go to those who provide DOJ with new information, every day that a company sits on knowledge about misconduct is another day that a whistleblower might beat them to reporting that misconduct, and reaping the reward for doing so.

“When everyone needs to be first in the door, no one wants to be second,” Monaco said. “With these announcements, our message to whistleblowers is clear: the Department of Justice wants to hear from you. And to those considering a voluntary self-disclosure, our message is equally clear: knock on our door before we knock on yours.”

By providing a cash reward for whistleblowing to DOJ, this program may present challenges for companies’ efforts to operate and maintain and effective compliance program. Such rewards may encourage employees to report misconduct to DOJ instead of via internal channels, such as a compliance hotline, which can lead to compliance issues going undiagnosed or untreated — such as in circumstances where the DOJ is the only entity to receive the report but does not take any further action. Companies must therefore ensure that internal compliance and whistleblower systems are clear, easy to use, and effective — actually addressing the employee’s concerns and, to the extent possible, following up with the whistleblower to make sure they understand the company’s response.

If an employee does elect to provide information to DOJ, companies must ensure that they do not take any action that could be construed as interfering with the disclosure. Companies already face potential regulatory sanctions for restricting employees from reporting misconduct to the SEC. Though it is too early to know, it seems likely that DOJ will adopt a similar position, and a company’s interference with a whistleblower’s communications potentially could be deemed obstruction of justice.

740,000 Reasons to Think Twice Before Putting a Company in Bankruptcy

A recent decision from a bankruptcy court in Delaware provides a cautionary tale about the risks of involuntary bankruptcy.

In the Delaware case, the debtor managed a group of investment funds. The business was all but defunct when several investors, dissatisfied with the debtor’s management, filed an involuntary Chapter 7 petition. They obtained an order for relief from the bankruptcy court, then removed the debtor as manager of the funds and inserted their hand-picked manager. So far, so good.

The debtor, who was not properly served with the involuntary petition and did not give the petition the attention it required, struck back and convinced the bankruptcy court to set aside the order for relief. The debtor then went after the involuntary petitioners for damages. After 8 years of litigation, the Delaware court awarded the debtor $740,000 in damages – all of it attributable to attorneys’ fees and costs.

If you file an involuntary petition and the bankruptcy court dismisses it, then a debtor can recover costs and reasonable attorneys’ fees. The legal fees include the amount necessary to defeat the involuntary filing. In addition, if the court finds that the petition was filed in bad faith, then the court also can enter judgment for all damages proximately caused by the filing and punitive damages. The Delaware court awarded the debtor $75,000 for defeating the involuntary petition.

The debtor also sought a judgment for attorneys’ fees in pursuit of damages for violating the automatic stay. The involuntary petitioners had replaced the debtor as manager without first obtaining leave from the court to do so. The investment fund was barely operating and had little income to support a claim for actual damages. Nevertheless, the Delaware court awarded $665,000 in attorneys’ fees related to litigating the automatic stay violation.

Because the debtor had no “actual” damages from the stay violation, the involuntary petitioners contended that the debtor was not entitled to recovery of attorneys’ fees. The Delaware court pointed out that “actual” damages (e.g., loss of business income) are not a prerequisite to the recovery of attorneys’ fees, much to the chagrin of the defendants. The court held that attorneys’ fees and costs are always “actual damages” in the context of a willful violation of the automatic stay.

The Delaware court also rejected defendants’ argument that the fee amount was “unreasonable” since there was no monetary injury to the business. In other words, the debtor should not have spent so much money on legal fees because it lost on its claim. The court held that defendants’ argument was made “with the benefit of hindsight” – at the end of litigation when the court had ruled, after an evidentiary trial, that debtor suffered no actual injury. The court pointed out that the debtor sought millions in damages for the loss of management’s fees, and even though the court rejected the claim after trial, it was not an unreasonable argument for the debtor to make. The court concluded that “the reasonableness of one’s conduct must be assessed at the time of the conduct and based on the information that was known or knowable at the time.”

The involuntary petitioners likely had sound reasons to want the debtor removed as fund manager. But by pursuing involuntary bankruptcy and losing, they ended up having to stroke a check to the debtor for over $700,000. Talk about adding insult to injury. The upshot is that involuntary bankruptcy is an extreme and risky action that should be a last-resort option undertaken with extreme caution.

Federal Court Strikes Down NLRB Joint Employer Rule

On March 8, 2024, just days before it was set to take effect, U.S. District Judge J. Campbell Barker of the Eastern District of Texas vacated the National Labor Relations Board’s (“NLRB’s”) recent rule on determining the standard for joint-employer status.

The NLRB issued the rule on October 26, 2023. It established a seven-factor analysis, under a two-step test, for determining joint employer status. Under the new standard, an entity may be considered a joint employer if each entity has an employment relationship with the same group of employees and the entities share or codetermine one or more of the employees’ essential terms and conditions of employment which are defined exclusively as:

Wages, benefits and other compensation;
Hours of working and scheduling;
The assignment of duties to be performed;
The supervision of the performance of duties;
Work rules and directions governing the manner, means and methods of the performance of duties and grounds for discipline;
The tenure of employment, including hiring and discharge; and
Working conditions related to the safety and health of employees.

Set to take effect on March 11, 2024, the NLRB’s decision would have rescinded the 2020 final rule which considered just the direct and immediate control one company exerts over the essential terms and conditions of employment of workers directly employed by another firm. The new rule would have expanded the types of control over job terms and conditions that can trigger a joint employer finding.

In the lawsuit, filed by the United States Chamber of Commerce and a coalition of business groups, the Chamber and coalition claimed that the NLRB’s rule is unlawful and should be struck down because it is arbitrary and capricious. Judge Barker agreed as he held that the NLRB’s new test is unlawfully broad because an entity could be deemed a joint employer simply by having the right to exercise indirect control over one essential term. Judge Barker faulted the design of the two-step test which says an entity must qualify as a common-law employer and must have control over at least one job term of the workers at issue to be considered a joint employer, finding that the test’s second part is always met whenever the first step is satisfied. The Court vacated the new standard and indicated it will issue a final judgment declaring the rule is unlawful.

The NLRB quickly responded to the Court’s ruling. In a statement on March 9, 2024 NLRB Chairman Lauren McFerran said the “District Court’s decision to vacate the Board’s rule is a disappointing setback but is not the last word on our efforts to return our joint-employer standard to the common law principles that have been endorsed by other courts.” According to the NLRB, the “Agency is reviewing the decision and actively considering next steps in this case.”

What Employers Need to Know

The legality of the NLRB’s joint-employer standard has been a contested issue since the October 2023 announcement. The rule will not go into effect as scheduled, but Judge Barker’s decision is unlikely to be the final word on the matter.

SEC Issues Long-Awaited Climate Risk Disclosure Rule

INTRODUCTION

On Wednesday, 6 March 2024, the Securities and Exchange Commission (SEC) approved its highly anticipated final rules on “The Enhancement and Standardization of Climate-Related Disclosures for Investors” by a vote of 3-2, with Republican Commissioners Hester Peirce and Mark Uyeda dissenting. Accompanying the final rules was a press release and fact sheet detailing the provisions of the rulemaking. The final rules will go into effect 60 days after publication in the Federal Register and will include a phased-in compliance period for all registrants.

This is likely to be one of the most consequential rulemakings of Chairman Gary Gensler’s tenure given the prioritization of addressing climate change as a key pillar for the Biden administration. However, given the significant controversy associated with this rulemaking effort, the final rules are likely to face legal challenges and congressional oversight in the coming months. As such, it remains unclear at this point whether the final rules will survive the forthcoming scrutiny.

WHAT IS IN THE RULE?

According to the SEC’s fact sheet:

“The final rules would require a registrant to disclose, among other things: material climate-related risks; activities to mitigate or adapt to such risks; information about the registrant’s board of directors’ oversight of climate-related risks and management’s role in managing material climate-related risks; and information on any climate-related targets or goals that are material to the registrant’s business, results of operations, or financial condition.
Further, to facilitate investors’ assessment of certain climate-related risks, the final rules would require disclosure of Scope 1 and/or Scope 2 greenhouse gas (GHG) emissions on a phased-in basis by certain larger registrants when those emissions are material; the filing of an attestation report covering the required disclosure of such registrants’ Scope 1 and/or Scope 2 emissions, also on a phased-in basis; and disclosure of the financial statement effects of severe weather events and other natural conditions including, for example, costs and losses.
The final rules would include a phased-in compliance period for all registrants, with the compliance date dependent on the registrant’s filer status and the content of the disclosure.”

NEXT STEPS

The final rules are likely to face significant opposition, including legal challenges and congressional oversight. It is expected that there will be various lawsuits brought against the final rules, which are likely to receive support from several industry groups, or potentially GOP-led state attorneys general who have been active in litigating against environmental, social and governance (ESG) policies and regulations. It is also possible that the final rules could face criticism from some climate advocates that the SEC did not go far enough in its disclosure requirements.

Further, it is expected that the House Financial Services Committee (HFSC) will conduct oversight hearings, as well as introduce a resolution under the Congressional Review Act (CRA), to attempt to block the regulations from taking effect. HFSC Chairman Patrick McHenry (R-NC) indicated that the Oversight and Investigations Subcommittee will hold a field hearing on March 18 and the full Committee will convene a hearing on April 10 to discuss the potential implications of the rules. If a CRA resolution were to pass the House and garner sufficient support from moderate Democrats in the Senate to pass, it would likely be vetoed by President Biden.

Ultimately, the SEC climate risk disclosure rules are unlikely to significantly change the trajectory of corporate disclosures made by multinational companies based in the U.S., most of whom have already been making sustainability disclosures in accordance with the Financial Stability Board’s Task Force on Climate-Related Financial Disclosures. The ongoing problem for investors is that such disclosures are not standardized and therefore are not comparable. Consequently, many of these large issuers may continue to enhance their sustainability disclosures in accordance with standards issued by the International Sustainability Standards Board and the Global Reporting Initiative as an investor relations imperative notwithstanding the SEC’s timetable for implementation of these final rules.

A more detailed analysis of the SEC rules is forthcoming from our Corporate and Asset Management and Investment Funds practices in the coming days.

President Biden Announces Groundbreaking Restrictions on Access to Americans’ Sensitive Personal Data by Countries of Concern

The EO and forthcoming regulations will impact the use of genomic data, biometric data, personal health care data, geolocation data, financial data and some other types of personally identifiable information. The administration is taking this extraordinary step in response to the national security risks posed by access to US persons’ sensitive data by countries of concern – data that could then be used to surveil, scam, blackmail and support counterintelligence efforts, or could be exploited by artificial intelligence (AI) or be used to further develop AI. The EO, however, does not call for restrictive personal data localization and aims to balance national security concerns against the free flow of commercial data and the open internet, consistent with protection of security, privacy and human rights.

The EO tasks the US Department of Justice (DOJ) to develop rules that will address these risks and provide an opportunity for businesses and other stakeholders, including labor and human rights organizations, to provide critical input to agency officials as they draft these regulations. The EO and forthcoming regulations will not screen individual transactions. Instead, they will establish general rules regarding specific categories of data, transactions and covered persons, and will prohibit and regulate certain high-risk categories of restricted data transactions. It is contemplated to include a licensing and advisory opinion regime. DOJ expects companies to develop and implement compliance procedures in response to the EO and subsequent implementing of rules. The adequacy of such compliance programs will be considered as part of any enforcement action – action that could include civil and criminal penalties. Companies should consider action today to evaluate risk, engage in the rulemaking process and set up compliance programs around their processing of sensitive data.

Companies across industries collect and store more sensitive consumer and user data today than ever before; data that is often obtained by data brokers and other third parties. Concerns have grown around perceived foreign adversaries and other bad actors using this highly sensitive data to track and identify US persons as potential targets for espionage or blackmail, including through the training and use of AI. The increasing availability and use of sensitive personal information digitally, in concert with increased access to high-performance computing and big data analytics, has raised additional concerns around the ability of adversaries to threaten individual privacy, as well as economic and national security. These concerns have only increased as governments around the world face the privacy challenges posed by increasingly powerful AI platforms.

The EO takes significant new steps to address these concerns by expanding the role of DOJ, led by the National Security Division, in regulating the use of legal mechanisms, including data brokerage, vendor and employment contracts and investment agreements, to obtain and exploit American data. The EO does not immediately establish new rules or requirements for protection of this data. It instead directs DOJ, in consultation with other agencies, to develop regulations – but these restrictions will not enter into effect until DOJ issues a final rule.

Broadly, the EO, among other things:

Directs DOJ to issue regulations to protect sensitive US data from exploitation due to large scale transfer to countries of concern, or certain related covered persons and to issue regulations to establish greater protection of sensitive government-related data
Directs DOJ and the Department of Homeland Security (DHS) to develop security standards to prevent commercial access to US sensitive personal data by countries of concern
Directs federal agencies to safeguard American health data from access by countries of concern through federal grants, contracts and awards

Also on February 28, DOJ issued an Advance Notice of Proposed Rulemaking (ANPRM), providing a critical first opportunity for stakeholders to understand how DOJ is initially contemplating this new national security regime and soliciting public comment on the draft framework.

According to a DOJ fact sheet, the ANPRM:

Preliminarily defines “countries of concern” to include China and Russia, among others
Focuses on six enumerated categories of sensitive personal data: (1) covered personal identifiers, (2) geolocation and related sensor data, (3) biometric identifiers, (4) human genomic data, (5) personal health data and (6) personal financial data
Establishes a bulk volume threshold for the regulation of general data transactions in the enumerated categories but will also regulate transactions in US government-related data regardless of the volume of a given transaction
Proposes a broad prohibition on two specific categories of data transactions between US persons and covered countries or persons – data brokerage transactions and genomic data transactions.
Contemplates restrictions on certain vendor agreements for goods and services, including cloud service agreements; employment agreements; and investment agreements. These cybersecurity requirements would be developed by DHS’s Cybersecurity and Infrastructure Agency and would focus on security requirements that would prevent access by countries of concern.

The ANPRM also proposes general and specific licensing processes that will give DOJ considerable flexibilities for certain categories of transactions and more narrow exceptions for specific transactions upon application by the parties involved. DOJ’s licensing decisions would be made in collaboration with DHS, the Department of State and the Department of Commerce. Companies and individuals contemplating data transactions will also be able to request advisory opinions from DOJ on the applicability of these regulations to specific transactions.

A White House fact sheet announcing these actions emphasized that they will be undertaken in a manner that does not hinder the “trusted free flow of data” that underlies US consumer, trade, economic and scientific relations with other countries. A DOJ fact sheet echoed this commitment to minimizing economic impacts by seeking to develop a program that is “carefully calibrated” and in line with “longstanding commitments to cross-border data flows.” As part of that effort, the ANPRM contemplates exemptions for four broad categories of data: (1) data incidental to financial services, payment processing and regulatory compliance; (2) ancillary business operations within multinational US companies, such as payroll or human resources; (3) activities of the US government and its contractors, employees and grantees; and (4) transactions otherwise required or authorized by federal law or international agreements.

Notably, Congress continues to debate a comprehensive Federal framework for data protection. In 2022, Congress stalled on the consideration of the American Data Privacy and Protection Act, a bipartisan bill introduced by House energy and commerce leadership. Subsequent efforts to move comprehensive data privacy legislation in Congress have seen little momentum but may gain new urgency in response to the EO.

The EO lays the foundation for what will become significant new restrictions on how companies gather, store and use sensitive personal data. Notably, the ANPRM also represents recognition by the White House and agency officials that they need input from business and other stakeholders to guide the draft regulations. Impacted companies must prepare to engage in the comment process and to develop clear compliance programs so they are ready when the final restrictions are implemented.

Kate Kim Tuma contributed to this article

FDA Takes Steps to Ensure Safety of Cinnamon Products Sold in the US

On March 6, 2024, the U.S. Food and Drug Administration (FDA) sent a letter to all cinnamon manufacturers, processors, distributors, and facility operators in the US, reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The Agency also recommended the voluntary recall of certain ground cinnamon products sold by a number of brands at six different retail chains that were found to contain levels of lead.
This letter follows the recent incidents associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children. As we have previously blogged, FDA’s investigation into the contaminated apple sauce pouches traced the contamination back to a manufacturer and cinnamon supplier in Ecuador.
FDA notified the distributors and manufacturers of products found to contain elevated levels of lead and recommended that the manufacturers voluntarily recall these products because prolonged exposure to them may be unsafe. The products were identified during an FDA-initiated sampling and testing effort to assess cinnamon sold across numerous retail stores. No illnesses or adverse events have been reported to date related to the ground cinnamon products listed in this news release, but the FDA is concerned that, because of the elevated lead levels in these products, continued and prolonged use of the products may be unsafe.
Since the issuance of the letter, recipient companies El Chilar and Raja Foods, as well as Stonewall Kitchen and Colonna, have issued voluntary recalls for some of their cinnamon products.
FDA continues to work with the Center for Disease Control and Prevention (CDC), as well as state and local partners, to investigate elevated lead and chromium levels in individuals with reported exposure to apple cinnamon fruit puree pouches.

The Antitrust Investigator Will See You Now: What Healthcare And Pharma Should Expect In A World Of Enhanced Antitrust Scrutiny

Highlights

Healthcare entities should expect heightened government scrutiny of mergers, acquisitions, and business behaviors that could be construed as restricting competition in healthcare and pharma
The FTC, DOJ, and HHS have advanced a “whole-of-government approach,” including data sharing, cooperative enforcement, and enhanced antitrust training
Businesses should take note of practices that are likely to trigger investigatory and enforcement actions

According to media reports, the Department of Justice (DOJ) has opened an antitrust investigation into UnitedHealth Group, which is the owner of the United States’ largest health insurer, UnitedHealthcare. The focus of the inquiry appears to be the relationship between the UnitedHealthcare insurance plan and one of its health services divisions, Optum, and the potential impact on rivals and consumers.

While tech giants have grabbed most of the headlines when it comes to enhanced antitrust scrutiny, this new matter is the DOJ’s second antitrust investigation into UnitedHealth Group in recent years, giving teeth to the administration’s claim that it has an aggressive antitrust policy in the healthcare sector.

In another example of increased antitrust scrutiny, the Federal Trade Commission (FTC) recently announced a new initiative in partnership with the DOJ and Department of Health and Human Services (HHS) to address what they consider to be the effects of anticompetitive behavior in the healthcare and pharmaceutical spaces. According to the government, these new efforts are aimed at lowering consumer costs and will include “partnering on new initiatives which include a joint Request for Information to seek input on how private-equity and other corporations’ control of health care is impacting Americans.”

Although interagency cooperation is the focus of the recent push to ramp up antitrust investigations and enforcement, each agency will still spearheaded their own regulatory activity.

Federal Trade Commission

FTC Chair Lina Khan has made it clear that her agency will devote more resources to enforcement in the healthcare industry, and emphasized that “safeguarding fair competition and rooting out unlawful business practices in health care markets is a top priority for the FTC.” In furtherance of these priorities, the commission has recently taken the following actions:

Orange Book Policy: The FTC challenged more than 100 patents held by pharmaceutical companies that they claim are inaccurately or improperly listed in the FDA’s Orange Book. The commission also released a policy statement explaining its renewed focus on Orange Book infractions.
Proposed Non-compete Rule: The FTC presented a new rule that would place a ban on non-compete clauses in employee contracts.

U.S. Department of Justice

Jonathan Kanter, Assistant Attorney General of the DOJ’s Antitrust Division, highlighted the division’s emphasis on the healthcare space when he said, “we are committed to weeding out anticompetitive practices and market consolidation that hinder Americans’ access to quality care at affordable rates, or deprive health care workers of fair wages and opportunity.” The following are just a few examples of how the DOJ has implemented this renewed focus:

Criminal Penalties: Recently, the DOJ’s Antitrust Division successfully secured a deferred prosecution agreement against Teva Pharmaceuticals, obtaining the largest monetary penalty ever (over $200 million) against a purely domestic producer that was allegedly operating an antitrust cartel.
Blocked Mergers: The Antitrust Division filed a suit to stop Aon plc’s $30 billion proposal to acquire Willis Towers Watson, two of the three largest brokers of health insurance and retirement benefits consulting. The companies later ceased their pursuit of the merger.

U.S. Department of Health and Human Services

HHS Secretary Xavier Becerra made his agency’s priorities clear when he recently stated that “the Biden-Harris Administration remains laser-focused on increasing access to high-quality, affordable health care for all Americans, like by making hearing aids available for sale over the counter and lowering prescription drug costs through the Inflation Reduction Act.” The department’s initiatives have included:

Ownership Transparency: For the first time, HHS, via the Centers for Medicare & Medicaid Services, made ownership data available on federal qualified health centers and rural health clinics on data.cms.gov. HHS hopes the release of this data will help catalyze enforcement actions by identifying common ownership.
Medicare Advantage Marketing: HHS also announced new efforts to crack down on what it considers “predatory marketing” that seeks to steer patients towards Medicare Advantage plans that “may not best meet their needs.”

Takeaways

In light of the government’s renewed focus on increased competition, expanded enforcement actions, access to quality care, more affordable services and products, and transparency of ownership in the healthcare and pharmaceutical industries, legal and compliance departments should consider being proactive about conducting thorough reviews of current practices. This is particularly true for mergers and acquisitions, competitive strategies, and pricing decisions, which are the business activities most likely to conflict with these recently energized regulatory bodies. Even healthcare providers with stellar compliance programs should expect to receive more frequent and targeted requests for information from enforcement authorities about their business partners, payors, and marketing practices.

Concussions and Their Impact: Recognizing the Signs and Seeking Help

A concussion is a mild form of traumatic brain injury and is usually caused by blunt force to the head. In some cases, it can result from a back-and-forth jerking of the head, resulting in the brain matter being dashed against the skull wall. It’s a pretty common injury in children, individuals engaged in contact sports, and Michigan car accidents.

Most concussions are not life-threatening. However, some cases can develop complications that could significantly impact a victim’s life. So, the first step in getting timely treatment is understanding its symptoms and what you ought to do after suffering an injury.

Signs and Symptoms of a Concussion

Symptoms and signs of a concussion fall into three categories: physical, cognitive, and psychological or emotional.

PHYSICAL SYMPTOMS

Where a significant blow to the head causes a concussion, the victim could pass out for a few seconds. However, this is not always the case, so you cannot use passing out as the litmus test for concussions. Often, patients exhibit symptoms like headaches, nausea and vomiting, blurred vision, dizziness, loss of balance, slurred speech, fatigue, ringing ears, tingling in the hands, loss of taste or smell, etc.

COGNITIVE SYMPTOMS

With a concussion being a brain injury, it is unsurprising that it may cause problems with brain function. In some patients, a concussion will cause problems with concentration, confusion, forgetfulness, feeling slowed down in your thinking, and trouble finding words.

EMOTIONAL SYMPTOMS

A concussion can, in some patients, cause emotional problems, resulting in a deviation from a person’s normal behavior. For example, patients may become easily irritable, report feeling foggy or “out of it,” experience immense sadness, and have anxiety.

When to See a Doctor

In most cases, symptoms of a concussion will start to show immediately after an accident, in which case seeing a doctor makes absolute sense. However, concussions are among the few types of injuries that tend to have delayed onset. In some cases, it can take up to 72 hours or even more for the first signs of a concussion to show.

If you are in an accident where you have suffered a blow to the head or are violently shaken, it is always a good idea to see a doctor. You may not have to call 911 if your symptoms are not as severe, but it is best to see a doctor on the same day or within 72 hours of an accident at most.

Timely medical interventions help in several ways. It helps stop the deterioration of an injury, shortens recovery time, and provides the documentation necessary for filing a personal injury claim if you intend to seek compensation.

What to Do To Recover Damages

Once your health is taken care of, focus on evidence gathering, starting with scene documentation in pictures and video. If there were any witnesses to the incident, talk to them, record their statements, and get their contacts so you can easily trace them if you need help with your case. If it is a car accident, you will need to get the other driver’s insurance and vehicle registration details.

Besides evidence, you need to prepare for the legal battle. It doesn’t always have to go all the way to court, but you will still need to work with a personal injury lawyer to get the best chances at recovering fair compensation.

Personal injury lawyers bring knowledge, investigation and evidence-gathering skills, negotiation skills, and respect, which altogether help you in mitigating mistakes and increasing your chances of getting a fair outcome.

Nevada Reaffirms Inquiry Notice Standards for Medical Malpractice Statutes of Limitations

Igtiben v. Eighth Jud. Dist. Ct., 140 Nev. Adv. Op. 9 (App. Feb. 22, 2024), concerned a prisoner who was transported to a hospital for medical treatment and died in the hospital after treatment began. At the time, the applicable statute of limitations contained in NRS 41A.097(2) was “1 year after the plaintiff discovers or through the use of reasonable diligence should have discovered the injury….” This also is known as inquiry notice.

Applied here, the prisoner’s mother obtained his complete hospital medical chart six weeks after the death. Approximately fourteen months after the death, a forensic pathologist the family hired concluded professional negligence contributed to the death. The family filed their lawsuit eight months after receiving the forensic pathologist’s report. The hospital and physician moved to dismiss, arguing the family’s one-year statute of limitations had expired. The district court denied the motion, concluding a genuine issue of material fact was present because the family filed suit within eight months of the pathologist’s report.

Nevada’s Court of Appeals reversed and directed the district court to dismiss the complaint. In Nevada, inquiry notice for potential medical malpractice begins when the plaintiff or the plaintiff’s representative receives “all relevant medical records.” Applied here, the only relevant medical records were the hospital records. Thus, the family had the information necessary to investigate the care and treatment and trigger inquiry notice just six weeks after the death. The date that the forensic pathologist provided his report was irrelevant.

Igtiben might provide greater certainty to providers and patients as they evaluate potential professional negligence claims. However, it underscores the importance of careful responses to requests for medical records because if other “relevant” records existed but were not provided, inquiry notice might not be triggered.

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