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Expert Analysis

• 2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement

  

  Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.

• Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

  

  In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

• Bribery Settlement Gives Insight On DOJ Policies

  

  Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

• Waiving COVID-19 IP Protections Would Harm US Industry

  

  President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

• In The CFPB Playbook: Rulemaking Rush Before Election Year

  

  In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

• What The Law Firm Of The Future Will Look Like

  

  As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• 10 Privacy Compliance Areas To Focus On In 2024

  

  The fast pace of change in the cybersecurity realm means reactive approaches to new laws, regulations and enforcement actions are not effective ways to build or scale privacy programs, so companies should plan strategically and prepare for a few emerging risks and requirements in the first half of this year, says Sam Castic at Hintze Law.

• AI Executive Order's Life Science, Healthcare Industry Effects

  

  The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

• NY Wrongful Death Law Revamp Retains Original's Drawbacks

  

  If approved by New York Gov. Kathy Hochul, the Grieving Families Act will transform the landscape of wrongful death law in New York by increasing the potential for damages, raising insurance premiums, burdening hospitals and courts, stifling the economy and subjecting parties to the unsettling effects of retroactive legislation, say attorneys at Shaub Ahmuty.

• 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

  

  A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.

• Lessons Learned From 2023's Top ADA Decisions

  

  This year saw the courts delving into the complexities of employee accommodations under the Americans with Disabilities Act in the post-pandemic workplace, going beyond bright-line rules with fact-intensive inquiries that are likely to create uncertainty for employers, says Linda Dwoskin at Dechert.

• New Pharma Guidelines Bring Pitfalls For Compounders

  

  New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.

• What Happens If High Court Rejects Releases In Purdue Ch. 11

  

  Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.