Expert Analysis

• How Calif. Ruling Defines Drug Cos.' R&D Responsibilities

  

  The California Supreme Court's recent ruling in the Gilead Tenofovir Cases, which held that drugmakers have no duty to bring allegedly safer alternatives to market more quickly, is a win for pharmaceutical companies — but not a grant of blanket immunity for all early-stage drug development decisions, say attorneys at King & Spalding.

• Calif. Justices' Ruling Reshapes Midcase Appeal Strategy

  

  The California Supreme Court's recent decision in Maniago v. Desert Cardiology Consultants holds that voluntary dismissal cannot be used as a shortcut to appellate review of interlocutory orders, resolving a long-running appellate split and pushing litigants to use alternative procedural tools, says Josh Patashnik at Ashurst Perkins Coie.

• Midyear Trends, Takeaways As Securities Class Actions Surge

  

  High numbers of securities class actions through June suggest filings will stay elevated, with factors like changing enforcement attitudes, media scrutiny and the proliferation of potential defendants serving as both cause and effect in increased litigation involving AI-related disclosures, health and tech companies, and foreign issuers, say attorneys at Alston & Bird.

• Series

  Going To Hardcore Shows Makes Me A Better Lawyer

  

  While government contracts law and the hardcore scene may seem entirely unrelated, in my experience, both are about community, focus, being prepared for the unexpected and managing chaos, says Isaac Natter at Fluet.

• Brace For Expanding Scrutiny Of Dark Patterns In Healthcare

  

  Recent reporting and regulatory developments highlight growing concern surrounding so-called dark patterns in healthcare — user interface designs that improperly influence consumer decision-making — and represent an important evolution of how healthcare professionals should evaluate consent processes, say attorneys at Clark Hill.

• How Home Infusion Providers Can Adapt To Enrollment Pause

  

  Recent Centers for Medicare & Medicaid Services moratoria on new enrollments of home health agencies, medical equipment companies and hospices make home infusion providers' compliance obligations more complex and ambiguous, requiring new careful consideration of specific enrollment requirements and limitations, say attorneys at Quarles & Brady.

• AI Data Mining Is Changing FCA Enforcement

  

  With False Claims Act investigations increasingly emerging from statistical anomalies identified by data miners, companies need to consider what conclusions an outsider armed with artificial intelligence might draw from public-facing data and be ready to explain any anomalies if questions arise, say attorneys at Cohen & Gresser.

• Lessons From 5 Months Of DOJ Corporate Policy Deals

  

  Recent declinations and prosecution agreements between the U.S. Department of Justice and corporations since the March unveiling of the corporate enforcement and voluntary disclosure policy provide takeaways for management considering how to respond to corporate misconduct, says Brendan Quigley at Baker Botts.

• Opinion

  2nd Circ. Tylenol Ruling Misapplies Daubert Gatekeeping

  

  The Second Circuit's recent ruling in Rutledge v. Walgreen Co., holding that a lower court should not have excluded experts alleging links between prenatal acetaminophen use and autism, threatens to swallow the Daubert standard by limiting courts' consideration of scientific consensus in assessing reliability of expert testimony, say attorneys at Benesch.

• 5 Antitrust Lessons On Bundled Discounts After Medtronic

  

  The recent California federal court decision upholding a $381.7 million verdict against Medtronic offers practitioners a clearer road map for navigating bundled discount claims under Section 2 of the Sherman Act, and the practical implications are substantial, say attorneys at Norton Rose.

• Justices' FTC Ruling Weakens Qui Tam's Constitutional Base

  

  The U.S. Supreme Court’s holding in Trump v. Slaughter, expanding presidential control over those exercising executive power, suggests that courts may be receptive to arguments challenging the constitutional foundations of the False Claims Act’s qui tam mechanism, says Daniel Passeser at Wiggin.

• Series

  Being A Sommelier Makes Me A Better Lawyer

  

  Being a sommelier has quietly shaped how I practice law by changing the way I think, communicate and connect with people, and offers a constant reminder that expertise is about making your knowledge useful and accessible to others, says Kara Du at Sheppard.

• Calif. Drug Ruling Affirms Defect-Centric Liability Framework

  

  The California Supreme Court's decision in Gilead Tenofovir Cases this week rejects a novel duty-to-innovate theory of negligence that could have reshaped product liability exposure well beyond the pharmaceutical industry, instead signaling that negligence claims premised on nondefective products are unlikely to succeed, say attorneys at Dechert.

• DOJ's FCA Push Creates Risks For Construction Contractors

  

  The construction industry may be uniquely vulnerable to a new generation of False Claims Act enforcement driven by the U.S. Department of Justice's increasing usage of the FCA to target a much broader category of conduct than it has in decades past, specifically compliance certifications and regulatory representations, say attorneys at Cozen O'Connor.

• Feds' Mixed Cues On Medicaid Fraud Signal States To Step Up

  

  While the federal government has recently delivered four distinct and mutually inconsistent messages regarding Medicaid fraud enforcement, states should focus on improving enforcement, regardless of which federal posture proves correct, says Ken Levine at Stone & Magnanini.