Expert Analysis

• New DNA Screening Standard Has No Clear Playbook

  

  Although the government has not yet released promised guidance intended to support its new standards for screening mail-order DNA, companies should not read this as a reprieve from the Oct. 13 compliance deadline because the delay shifts enforcement risk to statutes that need no new authority, including false statements, the False Claims Act and fraud, says Ashwin Ram at Buchalter.

• Texas Medicaid Fraud Decision Leaves 2 Open Questions

  

  The Texas Supreme Court's decision in Laboratory Corp. of America Holdings v. Texas and NPT Associates, holding that the Texas Medicaid Fraud Prevention Act's omissions provision requires proof of materiality, creates ambiguity about the materiality requirement and about how Texas courts will treat federal precedent going forward, say attorneys at Sidley.

• Testing AI's Promise For Large-Scale Document Review

  

  Our document-review comparison of attorneys' responsiveness and issue coding decisions versus predictions generated by artificial intelligence across 1,600 documents suggests that these tools can offer a reasonable and reliable basis for improved discovery workflows, provided lawyers understand where guardrails are needed, say attorneys at Redgrave.

• 3rd Circ. Ruling Shows ADA Limits Amid Worker Misconduct

  

  In Hileman v. West Penn Allegheny Health System, the Third Circuit recently rejected a wrongful termination claim under the Americans with Disabilities Act, illustrating that disability and leave laws don't automatically insulate employees from the consequences of prior workplace misconduct, say attorneys at Bond Schoeneck.

• 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.

• Preparing For Broader Calif. Rules On PE Healthcare Deals

  

  California's recent emergency regulations implementing expanded healthcare transaction review requirements, such as for private equity and hedge funds, represent a notable expansion of state oversight, including enhanced disclosures, wider definitions and new advance notice requirements, say attorneys at Simpson Thacher.

• DOJ Policy Creates New Defense For Physicians, Health Cos.

  

  The U.S. Department of Justice's recently revised enforcement policy governing agency guidance makes clear that Medicare guidance is not the law, potentially giving healthcare organizations a stronger basis to challenge certain enforcement theories, says Jose Vela at Clark Hill.

• $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.

• 8th Circ. Ruling Raises Bar For Seeking Disability Benefits

  

  The Eighth Circuit's recent ruling in Post v. Bisignano signals that claimants seeking Social Security disability benefits may need to offer convincing proof of functional restrictions beyond their treating doctors' opinions and illustrates that the court's proclaimant jurisprudence no longer prevails, says Mark DeBofsky at DeBofsky Law.

• FCA Ruling May Open Door To Redacting Defendants' Names

  

  A recent Florida federal court decision may signal a shift from the long-prevailing view that False Claims Act defendants' identities must always be revealed when qui tam actions are unsealed, potentially providing important protection for healthcare fraud defendants who may face career consequences from unproven allegations, say attorneys at Holland & Knight.

• 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.

• Tracking Trends In State-Level Regulatory Enforcement

  

  State-level enforcement now increasingly involves antitrust, artificial intelligence and data privacy issues, and the key for organizations to reducing risk is having the ability to respond across governance, public affairs, discovery and remediation in multiple states simultaneously, say consultants at FTI Consulting.