Expert Analysis

• A Primer On EU's Updated Human Substance Regulations

  

  The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

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  After Chevron: New Lines Of Attack For FCA Defense Bar

  

  Loper Bright has given defense counsel new avenues to overcome the False Claims Act elements of falsity and scienter, as any FCA claim based upon ambiguous statutory terms can no longer stand solely on agency regulations to establish the statute's meaning, which is itself necessary to satisfy the FCA's basic requirements, says Elisha Kobre at Bradley Arant.

• CFPB's Medical Debt Proposal May Have Side Effects

  

  The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.

• New NHTSA Fuel Economy Rule Adds Compliance Complexity

  

  The National Highway Traffic Safety Administration's recently announced final rule on new corporate average fuel economy standards for passenger cars and light trucks will create challenges for manufacturers, which must also comply with the EPA's multipollutant rule and California's zero-emission vehicle programs, say Joanne Rotondi and Hannah Graae at Hogan Lovells.

• Autonomy Execs' Acquittal Highlights Good Faith Instruction

  

  The recent acquittal of two former Autonomy executives demonstrates that a good faith jury instruction can be the cornerstone of an effective defense strategy in white collar criminal cases, in part because the concept of good faith is a human experience every juror can relate to, says Sara Kropf at Kropf Moseley.

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  Teaching Scuba Diving Makes Me A Better Lawyer

  

  As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.

• SolarWinds Ruling Offers Cyber Incident Response Takeaways

  

  The New York federal court's dismissal of all charges related to the 2019 Sunburst cyberattack is a devastating blow to the U.S. Securities and Exchange Commission's cybersecurity case against SolarWinds, but the well-reasoned opinion provides valuable lessons that may improve companies' defensive posture in the wake of a major cybersecurity incident, say attorneys at Troutman Pepper.

• A Guide To Long-Term, Part-Time Employee Determinations

  

  With final regulations under the Secure Act requiring 401(k) retirement benefits for long-term, part-time employees expected soon, Amy Sheridan and David Guadagnoli at Sullivan & Worcester look at how the proposed rules would shift the risk-reward calculus on excluding categories of employees, and what plan sponsors would need to consider when designing retirement plans.

• 3 Ways To Lower Insider Trading Risk After First 10b5-1 Case

  

  In light of the U.S. Department of Justice's insider trading prosecution against the former CEO of Ontrack based on alleged abuse of a Rule 10b5-1 safe harbor plan — designed to allow executives to sell their companies' securities without liability — companies and individuals should take steps to avoid enacting similar plans in bad faith, say attorneys at Jenner & Block.

• Lawyers Can Take Action To Honor The Voting Rights Act

  

  As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.

• Decoding CFPB Priorities Amid Ramp-Up In Nonbank Actions

  

  Based on recent Consumer Financial Protection Bureau enforcement actions and press releases about its supervisory activities, the agency appears poised to continue increasing its scrutiny over nonbank entities — particularly with respect to emerging financial products and services — into next year, say attorneys at Wiley.

• PE Firms Should Prepare For Increased False Claims Scrutiny

  

  The impact private equity firms may have over medical decisions and care is increasingly attracting potential liability under the False Claims Act and attention from states and the federal government, so investors should follow best practices including conducting due diligence both before and after acquisitions, say attorneys at K&L Gates.

• How 3rd Circ. Raised Bar For Constitutional Case Injunctions

  

  The Third Circuit's decision in Delaware State Sportsmen's Association v. Delaware Department of Safety & Homeland Security, rejecting the relaxed preliminary injunction standards many courts have used when plaintiffs allege constitutional harms, could portend a shift in such cases in at least four ways, say attorneys at Gibson Dunn.

• New Russia Sanctions Law: Bank Compliance Insights

  

  Financial institutions must familiarize themselves with the new reporting obligations imposed by the Rebuilding Economic Prosperity and Opportunity for Ukrainians Act, a recent law that authorizes seizures of Russian sovereign assets under U.S. jurisdiction, say attorneys at Seward & Kissel.

• 3 Healthcare FCA Deals Provide Self-Disclosure Takeaways

  

  Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.