Expert Analysis

• Opinion

  FDA And Companies Must Move Quickly On Drug Recalls

  

  When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.

• The Case For Post-Bar Clerk Training Programs At Law Firms

  

  In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.

• 10 Takeaways From New HHS Federal Compliance Guidelines

  

  The U.S. Department of Health and Human Services' recently issued general compliance program guidance is the first of its kind that would apply across all health care stakeholders, and signals the agency’s first step to improve and update existing compliance guidance, says Melissa Wong at Holland & Knight.

• Ohio Voters Legalize Cannabis — What Comes Next?

  

  This month, voters approved a citizen-initiated statute that legalizes marijuana for recreational use in Ohio, but the legalization timeline could undergo significant changes at the behest of the state's lawmakers, say Daniel Shortt and David Waxman at McGlinchey Stafford.

• Opinion

  A Telecom Attorney's Defense Of The Chevron Doctrine

  

  The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.

• 2 HHS Warnings Highlight Anti-Kickback Risks For Physicians

  

  Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.

• Attorneys Have An Ethical Duty To Protect The Judiciary

  

  The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.

• Cross-Market Implications In FTC's Anesthesia Complaint

  

  The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.

• FTC Orange Book Move Signals New Pharma Patent Scrutiny

  

  The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.

• AI Can Help Lawyers Overcome The Programming Barrier

  

  Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.

• Cos. Must Adapt To Calif. Immigration Data Privacy Law

  

  California’s recently signed A.B. 947 expands the California Consumer Privacy Act and brings the state in line with other comprehensive privacy laws that address immigration status, meaning companies should make any necessary updates to their processes and disclosures, say Kate Lucente and Matt Dhaiti at DLA Piper.

• How Legal Teams Can Prep For Life Sciences' Tech Revolution

  

  The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.

• Looking For Defense Contract Appeal Trends In Annual Report

  

  A deep dive into the Armed Services Board of Contract Appeals annual report for the 2023 fiscal year reveals increases in the number of cases filed, pending motions and expedited or accelerated cases, while the board disposed of fewer cases than in prior fiscal years, say Scott Flesch and Alexandra Prime at Miller & Chevalier.

• Preparing Law Students For A New, AI-Assisted Legal World

  

  As artificial intelligence rapidly transforms the legal landscape, law schools must integrate technology and curricula that address AI’s innate challenges — from ethics to data security — to help students stay ahead of the curve, say Daniel Garrie at Law & Forensics, Ryan Abbott at JAMS and Karen Silverman at Cantellus Group.

• Consider Immigration Issues When Hiring Int'l Medical Grads

  

  As health systems across the U.S. struggle to meet patient demand, recruiting international medical graduates can help alleviate some strain, although sorting through the requisite visa processes may require some extra legwork depending on the qualifications of both the graduate and the employer, say Nora Katz and Vinh Duong at Holland & Knight.