More Healthcare Coverage

Expert Analysis

• 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.

• 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.

• A Look At DOJ's New Nationwide Investment Fraud Approach

  

  Investment fraud charges are increasingly being brought in unlikely venues across the country, and the rationale behind the U.S. Department of Justice's approach could well be the heightened legal standards in connection with prosecuting investment fraud, says Jonathan Porter at Husch Blackwell.

• FDA's Off-Label Comms Guidance Is A Reluctant Step Forward

  

  The U.S. Food and Drug Administration's latest draft guidance expands its safe harbor for health care providers that communicate information about their products' off-label uses, but does not fully resolve the First Amendment disconnect between federal courts and the agency's regulatory goals, say Jeffrey Shapiro and Lisa Dwyer at King & Spalding.

• How Biden's AI Order Stacks Up Against Calif. And G7 Activity

  

  Evaluating the federal AI executive order alongside the California AI executive order and the G7's Hiroshima AI Code of Conduct can offer a more robust picture of key risks and concerns companies should proactively work to mitigate as they build or integrate artificial intelligence tools into their products and services, say attorneys at Jenner & Block.

• ITC Ban On Apple Watch Could Still Be Reversed

  

  The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.

• Class Action Defense: Don't Give Up On Bristol-Myers Squibb

  

  Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.

• State Regs Sow Discord Between Cannabis, Hemp Industries

  

  Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.

• Questions Linger After FDA's Lab-Developed Tests Proposal

  

  The U.S. Food and Drug Administration's recently proposed rule regarding its plan to regulate lab-developed tests is light on details, leaving many fundamental questions about the agency's authority and ability to execute its plans, say attorneys at Covington.

• Lessons For Biosimilar And Biologic Antitrust Litigation

  

  Aaron Marks at Cohen Milstein considers emerging ways in which biosimilar markets differ from traditional small-molecule drug markets, and recommends how pharmaceutical antitrust litigators can account for these market dynamics in biosimilar-delay cases.