Expert Analysis

• Assessing HHS' Stance On Rare Disease Patient Assistance

  

  The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.

• Opinion

  Feds' Biotech Enforcement Efforts Are Too Heavy-Handed

  

  The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.

• Del. Ruling Highlights M&A Deal Adviser Conflict Disclosures

  

  The Delaware Supreme Court recently reversed the Court of Chancery's dismissal of challenges to Nordic Capital's acquisition of Inovalon, demonstrating the importance of full disclosure of financial adviser conflicts when a going-private merger seeks business judgment rule review, say attorneys at Debevoise.

• Action Steps To Address New Restrictions On Outbound Data

  

  Companies should immediately assess all their data-based operations so they can consider strategies to effectively mitigate new compliance risks brought on by recently implemented transaction restrictions, including a Justice Department proposal and landmark data legislation, say attorneys at Wiley.

• E-Discovery Quarterly: Recent Rulings On Text Message Data

  

  Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.

• What CRA Deadline Means For Biden Admin. Rulemaking

  

  With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.

• Are Concessions In FDA's Lab-Developed Tests Rule Enough?

  

  Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.

• 8 Questions To Ask Before Final CISA Breach Reporting Rule

  

  The Cybersecurity and Infrastructure Security Agency’s recently proposed cyber incident reporting requirements for critical infrastructure entities represent the overall approach CISA will take in its final rule, so companies should be asking key compliance questions now and preparing for a more complicated reporting regime, say Arianna Evers and Shannon Mercer at WilmerHale.

• Series

  Swimming Makes Me A Better Lawyer

  

  Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.

• Mid-2024 FCA Enforcement And Litigation Trends To Watch

  

  Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.

• A Recipe For Growth Equity Investing In A Slow M&A Market

  

  Carl Marcellino at Ropes & Gray discusses the factors bolstering appetite for growth equity fundraising in a depressed M&A market, and walks through the deal terms and other ingredients that set growth equity transactions apart from bread-and-butter venture capital investing.

• What 100 Federal Cases Suggest About Changes To Chevron

  

  With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.

• Notable Q1 Updates In Insurance Class Actions

  

  Mark Johnson and Mathew Drocton at BakerHostetler discuss notable insurance class action decisions from the first quarter of the year ranging from salvage vehicle titling to rate discrimination based on premium-setting software.

• New Federal Bill Would Drastically Alter Privacy Landscape

  

  While the recently introduced American Privacy Rights Act would eliminate the burdensome patchwork of state regulations, the proposed federal privacy law would also significantly expand compliance obligations and liability exposure for companies, especially those that rely on artificial intelligence or biometric technologies, says David Oberly at Baker Donelson.

• The Fed. Circ. In April: Hurdles Remain For Generics

  

  The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.