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.

9th Circ. Ruling Raises Bar For Arbitration Pacts Via Email

The Ninth Circuit's recent holding in Rickes v. Thermo Fisher that the mere delivery of an email doesn't establish an employee's assent to the arbitration agreement underscores that rollout processes should both give employees notice of the agreement and create evidence of their assent, say attorneys at Sullivan & Cromwell.

A Road Map To Modernizing Clinical Lab Regulations

The Centers for Medicare & Medicaid Services' recent request for comments on potential changes to the Clinical Laboratory Improvement Amendments provides an early indication of where CLIA is headed, and the operational, compliance, reimbursement and enforcement issues those changes will create, says Jose Vela at Clark Hill.

Where AI Patent Risk Begins And How Records Can Help

The Federal Circuit's recent decision in Dental Monitoring v. Align highlights the importance of documenting how artificial intelligence-assisted inventions work, and how humans contributed, as such records can support inventorship, written description, eligibility and definiteness requirements, say attorneys at Sterne Kessler.