Expert Analysis

• The Regulatory Headwinds Facing Lab-Developed Tests

  

  Though the U.S. Food and Drug Administration's final rule regarding regulation of laboratory-developed tests outlines a four-year plan for ending enforcement discretion, and though this rule is currently being challenged in courts, manufacturers should heed compliance opportunities immediately as enforcement actions are already on the horizon, say attorneys at Kirkland & Ellis.

• 3 High Court Rulings May Shape Health Org. Litigation Tactics

  

  Three separate decisions from the U.S. Supreme Court's most recent term — Loper Bright, Corner Post and Jarkesy — will likely strengthen healthcare organizations' ability to affirmatively sue executive agencies to challenge regulations governing operations and enforcement actions, say attorneys at McDermott.

• Opinion

  The Big Issues A BigLaw Associates' Union Could Address

  

  A BigLaw associates’ union could address a number of issues that have the potential to meaningfully improve working conditions, diversity and attorney well-being — from restructured billable hour requirements to origination credit allocation, return-to-office mandates and more, says Tara Rhoades at The Sanity Plea.

• Opinion

  It's Time For A BigLaw Associates' Union

  

  As BigLaw faces a steady stream of criticism about its employment policies and practices, an associates union could effect real change — and it could start with law students organizing around opposition to recent recruiting trends, says Tara Rhoades at The Sanity Plea.

• Why DOJ's Whistleblower Program May Have Limited Impact

  

  The U.S. Department of Justice’s new whistleblower pilot program aims to incentivize individuals to report corporate misconduct, but the program's effectiveness may be undercut by its differences from other federal agencies’ whistleblower programs and its interplay with other DOJ policies, say attorneys at Milbank.

• CFPB's Earned Wage Access Rule Marks Regulatory Shift

  

  The Consumer Financial Protection Bureau's newly issued interpretive rule on earned wage access products, classifying them as extensions of credit, marks a significant shift in their regulatory landscape and raises some important questions regarding potential fringe cases and legal challenges, say Erin Bryan and Courina Yulisa at Dorsey & Whitney.

• How Calif. Justices' Prop 22 Ruling Affects The Gig Industry

  

  The California Supreme Court's recent upholding of Proposition 22 clarifies that Uber, Lyft, DoorDash and other companies in the gig industry can legally classify their drivers as independent contractors, but it falls short of concluding some important regulatory battles in the state, says Mark Spring at CDF Labor.

• Look For Flags On Expert Claims After Sunday Ticket Reversal

  

  A California federal judge’s recent reversal of a jury’s $4.7 billion antitrust verdict in the NFL Sunday Ticket case indicates that litigants may be inclined to challenge expert testimony admissibility under Rule 702 of the Federal Rules of Evidence, and that judges may increasingly accept such challenges, say attorneys at Kutak Rock.

• How Justices Upended The Administrative Procedure Act

  

  In its recent Loper Bright, Corner Post and Jarkesy decisions, the U.S. Supreme Court fundamentally changed the Administrative Procedure Act in ways that undermine Congress and the executive branch, shift power to the judiciary, curtail public and business input, and create great uncertainty, say Alene Taber and Beth Hummer at Hanson Bridgett.

• How Corner Post Affects Enviro Laws' Statutes Of Limitations

  

  The U.S. Supreme Court's recent ruling in Corner Post v. Federal Reserve Board has helped to alter the fundamental underpinnings of administrative law — and its plaintiff-centric approach may have implications for some specific environmental laws' statutes of limitations, say Chris Leason and Liam Martin at Gallagher and Kennedy.

• Opinion

  DOL's Impending Mental Health Act Regs Should Be Simplified

  

  The U.S. Department of Labor should consider revising these six issues in its forthcoming Mental Health Parity and Addiction Equity Act regulations to ease the significant compliance hurdles for group health plan sponsors, says Alden Bianchi at McDermott.

• Parsing FY 2024 DOJ Criminal Healthcare Fraud Enforcement

  

  While the U.S. Department of Justice's Criminal Division's strike force on healthcare fraud enforcement action shows an impressive doubling of criminal indictments, a closer look at the data offers important clues about underlying trends, including the comparably modest, accompanying increase in associated intended loss, say Roderick Thomas and Kathleen Cooperstein at Wiley.

• Haste Is Priority For Participation In New Green Card Program

  

  Immigration practitioners should determine their clients' eligibility under the Biden administration’s new policy to help certain noncitizens, particularly those married to U.S. citizens, to apply for green cards, and do so without delay given uncertainty tied to the upcoming election, says Brad Brigante at Brigante Law.

• How Gov't AI Protections May Affect Contractors' Data Rights

  

  The U.S. Senate’s proposed National Defense Authorization Act for 2025, which includes provisions to maintain the government's data rights when contracting for artificial intelligence, should prompt contractors to examine how to protect their own rights when the current data rights framework is applied to AI, say Tyler Evans and Caitlin Conroy at Steptoe.

• Jarkesy May Thwart Consumer Agencies' Civil Penalty Power

  

  The U.S. Supreme Court's ruling in U.S. Securities and Exchange Commission v. Jarkesy not only implicates future SEC administrative adjudications, but those of other agencies that operate similarly — and may stymie regulators' efforts to levy civil monetary penalties in a range of consumer protection enforcement actions, say attorneys at Holland & Knight.