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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.

• 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.

• 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.

• Justices Could Use Purdue To Resolve Related Circuit Split

  

  The U.S. Supreme Court will soon hear Harrington v. Purdue Pharma to determine the validity of nonconsensual third-party releases in bankruptcy, but justices should also take the opportunity to resolve a related circuit split over the constitutional authority of bankruptcy judges to issue final rulings on such releases, says Benjamin Feder at Kelley Drye.

• 2nd Circ. OT Ruling Guides On Pay For Off-The-Clock Work

  

  While the Second Circuit’s recent holding in Perry v. City of New York reiterated that the Fair Labor Standards Act obligates employers to pay overtime for off-the-clock work, it recognized circumstances, such as an employee’s failure to report, that allow an employer to disclaim the knowledge element that triggers this obligation, say Robert Whitman and Kyle Winnick at Seyfarth.

• Tips For Student Visa Applicants Mired In Processing Delays

  

  Notwithstanding procedural changes at the U.S. Department of State that provided hope for more timely and predictable visa processing outcomes, international student applications continue to risk becoming bogged down in administrative processing, but certain steps may improve the situation, say Carl Risch and Lauren Epstein at Mayer Brown.

• Bracing For Regulatory Delays As Shutdown Looms

  

  As a government shutdown looms, stakeholders should plan for regulatory delays and note that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act, say Matthew Shapanka and Holly Fechner at Covington.

• How A Gov't Shutdown Would Affect Immigration Processing

  

  While a government shutdown would certainly create issues and cause delays for immigration processing, independently funded functions would continue for at least a limited time, and immigration practitioners can expect agencies to create reasonable exceptions and provide guidance for navigating affected matters once operations resume, say William Stock and Sarah Holler at Klasko Immigration Law Partners.

• Smart Immigration Reform Can Improve Health Care Access

  

  With the U.S. health care crisis expected to worsen due to ongoing nationwide physician shortages, immigration reform can provide one short-term solution to bring more trained doctors to medically underserved areas, says Sarah Peterson at Fragomen.

• HIV Drug Case Against Gilead Threatens Medical Innovation

  

  The California Court of Appeals should dismiss claims alleging that Gilead should be held liable for not bringing an HIV treatment to market sooner, or else the biopharmaceutical industry could be disincentivized from important development and innovation, says James Stansel at Pharmaceutical Research and Manufacturers of America.