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

  A New Way Forward For COVID Vaccine Lawsuit Immunity

  

  As Public Readiness and Emergency Preparedness Act protections for COVID-19 vaccines wane, adding those vaccines to coverage by the National Vaccine Injury Compensation Program would bolster defenses for administrators and manufacturers while also providing stronger remedies for those injured by vaccines, says Altom Maglio at MCT Law.

• 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.

• 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.

• 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.

• 9th Circ. Ruling Flags Work Harassment Risks Of Social Media

  

  The recent Ninth Circuit ruling in Okonowsky v. Garland, holding an employer could be liable for a co-worker's harassing social media posts, highlights new challenges in technology-centered and remote workplaces, and underscores an employer's obligation to prevent hostile environments wherever their employees clock in, say Jennifer Lada and Phillip Schreiber at Holland & Knight.

• Vendor Rights Lessons From 2 Chapter 11 Cases

  

  A Texas federal court’s recent critical vendor order in the Zachry Holdings Chapter 11 filing, as well as a settlement between Rite Aid and McKesson in New Jersey federal court last year, shows why suppliers must object to critical vendor motions that do not recognize creditors' legal rights, says David Conaway at Shumaker.

• How Cos. With Chinese Suppliers Should Prep For Biotech Bill

  

  A proposed bill to prohibit government-affiliated life sciences companies from contracting with Chinese biotech companies of concern may necessitate switching to other sources for research and supplies, meaning they should begin evaluating supply chains now due to the long lead times of drug development, say John O'Loughlin and Christina Carone at Weil Gotshal.

• Mirror, Mirror On The Wall, Is My Counterclaim Bound To Fall?

  

  A Pennsylvania federal court’s recent dismissal of the defendants’ counterclaims in Morgan v. Noss should remind attorneys to avoid the temptation to repackage a claim’s facts and law into a mirror-image counterclaim, as this approach will often result in a waste of time and resources, says Matthew Selmasska at Kaufman Dolowich.

• Can Chapter 15 Bankruptcy Help Cannabis Businesses?

  

  Attorneys at Fox Rothschild consider whether Chapter 15 may be used as a tool to liquidate U.S. assets of cannabis companies in foreign bankruptcy proceedings, and look at the statutory provisions that may have a bearing on the successful liquidation of assets under the Bankruptcy Code.

• FTC's Drug Middlemen Probe Highlights Ongoing Scrutiny

  

  The Federal Trade Commission's interim staff report on its inquiry into pharmacy benefit managers suggests that the industry will remain under an enforcement microscope for the foreseeable future due to concerns about how PBMs affect drug costs and accessibility, say attorneys at Arnold & Porter.