Expert Analysis

• 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.

• Balancing Justice And Accountability In Opioid Bankruptcies

  

  As Rite Aid joins other pharmaceutical companies in pursuing bankruptcy following the onslaught of state and federal litigation related to the opioid epidemic, courts and the country will have to reconcile the ideals of economic justice and accountability against the U.S. Constitution’s promise of a fresh start through bankruptcy, says Monique Hayes at DGIM Law.

• Louisiana's Toxic Tort Barrier May Be Weakening

  

  Louisiana's short prescriptive period to bring a survival action has long served as an important barrier against toxic tort claims, but the plaintiffs bar will likely rely on the recent Fifth Circuit decision in Jack v. Evonik to argue that anyone who arguably suffered injury based on exposure to some toxic substance may have a claim, say attorneys at Kirkland.

• How To Navigate The FTC's New Private Equity Frontier

  

  The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.

• Opinion

  Newman Suspension Shows Need For Judicial Reform

  

  The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.

• When And How Companies Should Build An AI Strategy

  

  Once a company has decided to engage with artificial intelligence, there are myriad steps that need to be taken, beginning with the creation of an AI leadership team that has deep knowledge about the company's business risks and is highly respected by senior management, say Judith Rinearson and Corey Bieber at K&L Gates.

• An Overview Of Congress' Proposed Drug Shortage Solutions

  

  Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.

• 5th Circ. Ruling Shows Need For Proffer Terms Negotiation

  

  The Fifth Circuit’s recent U.S. v. Shah decision, holding that a defendant breached his proffer agreement, illustrates why defense attorneys should insist on negotiating the terms of such agreements with prosecutors to protect their clients at trial, say attorneys at Haynes Boone.

• Data Furnishers Should Watch CFPB Plans For Class Actions

  

  Companies should follow the Consumer Financial Protection Bureau’s rulemaking process as it considers allowing class actions against data brokers that provide incorrect consumer information to credit reporting agencies, a move that could rewrite the legal risks of participating in the consumer reporting ecosystem, say attorneys at Troutman Pepper.

• Considerations And Calculations For DOJ Clawback Program

  

  The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.

• SEC's Life Sciences Actions Utilize Novel Tools And Theories

  

  Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.

• Series

  ESG Around The World: Japan

  

  Japan is witnessing rapid developments in environmental, social and corporate governance policies by making efforts to adopt a soft law approach, which has been effective in encouraging companies to embrace ESG practices and address the diversity of boards of directors, say Akira Karasawa and Landry Guesdon at Iwata Godo.

• How And Why Your Firm Should Implement Fixed-Fee Billing

  

  Amid rising burnout in the legal industry and client efforts to curtail spending, pivoting to a fixed-fee billing model may improve client-attorney relationships and offer lawyers financial, logistical and stress relief — while still maintaining profit margins, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• Potential Broader Effects Of FDA's Lab-Developed Test Rule

  

  Though it's unclear whether the U.S. Food and Drug Administration's proposed rule for regulating lab-developed tests will ever go into effect, it nonetheless functions as a threatened hammer that may make legislative efforts to regulate such tests more palatable, say attorneys at King & Spalding.

• A Guide For Landlords Pivoting To Medical Office Buildings

  

  The current commercial real estate landscape presents a unique opportunity for landlords, real estate developers and investors to accommodate the growing health care industry's need for office buildings, though proper navigation of complex regulations and leasing concerns is necessary, says Mehdi Sinaki at Michelman & Robinson.