More Healthcare Coverage

Expert Analysis

• 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

  

  A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.

• Lessons Learned From 2023's Top ADA Decisions

  

  This year saw the courts delving into the complexities of employee accommodations under the Americans with Disabilities Act in the post-pandemic workplace, going beyond bright-line rules with fact-intensive inquiries that are likely to create uncertainty for employers, says Linda Dwoskin at Dechert.

• New Pharma Guidelines Bring Pitfalls For Compounders

  

  New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.

• What Happens If High Court Rejects Releases In Purdue Ch. 11

  

  Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.

• How AI Executive Order Aims To Compete For Foreign Talent

  

  Immigration provisions within the Biden administration's executive order on artificial intelligence take a strategic approach to promoting the U.S. as a destination for AI and STEM talent by streamlining visa processing, enhancing educational and exchange programs, and improving current visa programs and pathways to permanent residency, says Eric Bord at Morgan Lewis.

• Reading The Fine Print On FDA's Prescription Drug Ad Rule

  

  The U.S. Food and Drug Administration's new final rule regarding the disclosure of risks and side effects in ads for prescription drugs includes some broad and potentially subjective language, and some missed opportunities to address how traditional media formats have changed in recent years, say attorneys at Ropes & Gray.

• Insurance Considerations For Cos. Assessing New AI Risks

  

  Because no two businesses will have the same artificial intelligence risk profile, they should consider four broad risk categories as a baseline for taking a proactive approach to guarding against AI-related exposures, say attorneys at Hunton.

• Why Criminal No-Poach Cases Can Be Deceptively Complex

  

  Mark Rosman at Wilson Sonsini discusses the reasons many criminal no-poach cases that appear simple are actually more complicated than they seem, following several jury trial acquittals and two dismissed cases.

• Kochava Ruling May Hint At Next Privacy Class Action Wave

  

  The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.

• 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.

• 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.

• 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.

• 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.