Expert Analysis

• The Fate Of Biden-Era Clinical Study Guidance Under Trump

  

  Draft guidance about the study of sex and gender differences in medical product development issued by the outgoing Biden administration currently faces significant uncertainty and litigation potential due to the Trump administration's executive orders and other actions, say attorneys at Arnold & Porter.

• Biden-Era M&A Data Shows Continuity, Not Revolution

  

  While the federal antitrust agencies under former President Joe Biden made broad claims about increasing merger enforcement activity, the data tells a different story, with key claims under Biden coming in at the lowest levels in decades, say attorneys at Covington.

• 10 Issues To Watch In Aerospace And Defense Contracting

  

  This year, in addition to evergreen developments driven by national security priorities, disruptive new technologies and competition with rival powers, federal contractors will see significant disruptions driven by the new administration’s efforts to reduce government spending, regulation and the size of the federal workforce, say attorneys at Thompson Hine.

• Compliance Pointers For DOJ's Sweeping Data Security Rule

  

  A new Justice Department rule broadly restricts many common data transactions with the goal of preventing access by countries of concern, and with an effective date of April 8, U.S. companies must quickly assess practices related to employee, customer and vendor data, says Sam Castic at Hintze Law.

• Class Actions At The Circuit Courts: February Lessons

  

  In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses five federal appellate court class certification decisions and identifies practice tips from cases involving breach of life insurance contracts, constitutional violations of inmates and more.

• Series

  Competitive Weightlifting Makes Me A Better Lawyer

  

  The parallels between the core principles required for competitive weightlifting and practicing law have helped me to excel in both endeavors, with each holding important lessons about discipline, dedication, drive and failure, says Damien Bielli at VF Law.

• Axed ALJ Removal Protections Mark Big Shift For NLRB

  

  A D.C. federal court's recent decision in VHS Acquisition Subsidiary No. 7 v. National Labor Relations Board removed long-standing tenure protections for administrative law judges by finding they must be removable at will by the NLRB, marking a significant shift in the agency's ability to prosecute and adjudicate cases, say attorneys at Proskauer.

• 11th Circ. TCPA Ruling Signals Erosion Of Judicial Deference

  

  The U.S. Court of Appeals for the Eleventh Circuit recently came to the rescue of the lead generation industry, striking down new regulations that were set to go into effect on Jan. 27, a decision consistent with federal courts' recent willingness to review administrative decisions, say attorneys at Troutman.

• The Case For Compliance During The Trump Administration

  

  Given the Trump administration’s shifting white collar enforcement priorities, C-suite executives may have the natural instinct to pare back compliance initiatives, but there are several good reasons for companies to at least stay the course on their compliance programs, if not enhance them, say attorneys at Riley Safer.

• Opinion

  Undoing An American Ideal Of Fairness

  

  President Donald Trump’s orders attacking birthright citizenship, civil rights education, and diversity, equity and inclusion programs threaten hard-won constitutional civil rights protections and decades of efforts to undo bias in the law — undermining what Chief Justice Earl Warren called "our American ideal of fairness," says Reuben Guttman at Guttman Buschner.

• Dispelling 10 Myths About Health Provider-Based Compliance

  

  Congress appears intent on requiring hospitals to submit provider-based attestations for all off-campus outpatient hospital locations, so now is the time for hospitals to prepare for this change by understanding common misconceptions about provider-based status and proactively correct noncompliance, say attorneys at McDermott.

• A Look At HHS' New Opinion On Patient Assistance Programs

  

  A recent advisory opinion from the U.S. Department of Health and Human Services' Office of Inspector General follows a recent trend of blessing patient assistance program arrangements that implicate the Anti-Kickback Statute, as long as they are structured with appropriate safeguards to minimize the risk of fraud and abuse, say attorneys at Sheppard Mullin.

• How Ill. Ruling Could Influence Future Data Breach Cases

  

  The Illinois Supreme Court's recent decision in Petta v. Christie Business Holding, which was based solely on standing, establishes an important benchmark for the viability of Illinois-based lawsuits arising out of data security incidents that defendants can cite in future cases, say attorneys at Wilson Elser.

• Opinion

  Inconsistent Injury-In-Fact Rules Hinder Federal Practice

  

  A recent Third Circuit decision, contradicting a previous ruling about whether consumers of contaminated products have suffered an injury in fact, illustrates the deep confusion this U.S. Supreme Court standard creates among federal judges and practitioners, who deserve a simpler method of determining which cases have federal standing, says Eric Dwoskin at Dwoskin Wasdin.

• Virginia AI Bills Could Serve As Nationwide Model

  

  If signed into law, two Virginia bills focused on regulating the use of high-risk AI systems in the private and public sectors have the potential to influence similar legislation in other states, as well as the compliance strategies of companies operating in the commonwealth and across the U.S., say attorneys at Woods Rogers.