AG Watch: Va. Vape Product Regulations Enter A New Phase

Virginia's new vape enforcement framework carries important implications related to product eligibility and certification requirements for businesses operating in the marketplace, representing the culmination of several years of legislative action, regulatory development, litigation and interagency planning, says Chuck Slemp at Cozen O'Connor.

Navigating A Key Inflection Point In Biosimilar Sector M&A

As biosimilar mergers and acquisitions gain notice amid U.S. Food and Drug Administration reforms, a maturing patent framework and a looming patent cliff, companies diversifying into the higher-growth biologics space should align their regulatory, intellectual property and transactional strategies, say attorneys at Skadden.

AI Meeting Recaps Pose New Discovery And Privilege Risks

The New York City Bar Association’s recent ethics opinion, cautioning attorneys not to record nonclient conversations with artificial intelligence tools, reflects an emerging view that AI meeting recaps are now a distinct business record category, meaning counsel should set meeting-level controls and apply framework-level updates, says William Wright at Faegre Drinker.

FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased importance of precision when drafting statutory rules in a post-Loper Bright landscape, as several minor errors in the text could lock in unintended results that will be difficult to repeal, say attorneys at Venable.

$95M Nev. Case Provides Clues On Wound Care Enforcement

Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an alleged $95 million Medicare billing scheme involving amniotic wound allografts, provides a clearer picture of an increasingly data-driven enforcement strategy that follows the entire wound care transaction, say attorneys at Bass Berry.

Beware Daubert Pitfalls With Technical Experts In Patent Suits

Recent decisions on Daubert motions in patent cases show that courts will exclude expert testimony that lacks a solid factual or methodological foundation, regardless of the expert's credentials — underscoring the importance of demonstrating reliability, say attorneys at Steptoe.

4 Tips On Expert Gatekeeping From J&J Talc Deal

Johnson & Johnson's successful campaign to exclude plaintiff-side oncologist testimony about whether its talcum powder caused ovarian cancer, which prompted the recent resolution of 70,000 claims, offers lessons on how product liability defendants can reshape risk calculation by rigorously applying expert admissibility rules, say attorneys at Hollingsworth.

Series

Playing Bid Whist Makes Me A Better Lawyer

As a child, I viewed bid whist as a family tradition and a source of friendly card game competition, but as a lawyer, I see it as a tool that has helped me cultivate skills like communication, teamwork, risk assessment and composure, says Keyonn Pope at Riley Safer.

Teva, Wyeth Show How Claimed Advances Shape Enablement

Two recent Federal Circuit decisions involving method-of-treatment claims — Teva v. Eli Lilly and Wyeth v. AstraZeneca — reached opposite enablement outcomes from strikingly similar procedural postures, but a closer comparison of the cases reveals a three-step framework for understanding the court's reasoning, says Kendall Gurule at Polsinelli.

Opinion

Calif. Bill Goes Too Far In Trying To Regulate Attorney AI Use

California’s first-in-the-nation act regulating how attorneys and arbitrators use generative artificial intelligence will likely soon become law, but read broadly, the provisions may dissuade lawyers from employing AI at all, thereby depriving them of key work tools, says Joshua Wurtzel at Schlam Stone.

AI Rise In Healthcare Demands New Cybersecurity Strategies

As artificial intelligence-related capabilities are increasingly integrated into medical devices and healthcare operations, organizations must adapt their compliance playbook to address evolving cybersecurity needs and implement lifecycle-based risk assessment approaches, say attorneys at Covington.

Hims & Hers Suit Spotlights Health Data-Sharing Privacy Risks

Regulators' complaint against telehealth company Hims & Hers alleging deceptive practices serves as a reminder that the privacy principles developed under consumer protection laws and predating omnibus statutes remain in force, and sensitive data governance continues to be a crucial component of compliance, say attorneys at Venable.

How Cannabis Rescheduling Is Reshaping Bankruptcy

As broader cannabis rescheduling awaits a recommended decision, cannabis companies continue to test the boundaries of the Bankruptcy Code, with the recent Cannabist Chapter 15 recognition order suggesting that governmental resistance may be reduced in future filings, say attorneys at Thompson Coburn.

Opinion

New CMS Medical Device Pathway May Have Limited Effect

The Centers for Medicare & Medicaid Services' new pathway for giving Medicare beneficiaries earlier access to certain medical devices bears similarities to previous programs that did not advance coverage significantly, and thus may only benefit certain manufacturers, say attorneys at King & Spalding.

How Cos. Can Avoid Infant Product False Advertising Suits

As lawsuits proliferate over products marketed for infant use and sold at a premium that are identical to cheaper general-use products, manufacturers should review related product lines, and scrutinize contextual cues that may contribute to the overall message received by consumers, say attorneys at Chamberlain Hrdlicka.