Expert Analysis

• FDA Warning Letter Tightens Reins On 'Research Only' Labels

  

  A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

• Assigning Liability In Key Bridge Collapse May Be Challenging

  

  In the wake of a cargo ship's collision with Baltimore's Key Bridge last month, claimants may focus on the vessel's owners and the agencies responsible for the design and maintenance of the bridge — but allocating legal liability to either private or governmental entities may be difficult under applicable state and federal laws, says Clay Robbins at Wisner Baum.

• Strategies For Challenging A Fla. Grand Jury Report's Release

  

  A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

• NC Rulings Show Bankruptcy Isn't Only For Insolvent Debtors

  

  Two recent rulings from a North Carolina bankruptcy court show that lack of financial distress is not a requirement for bankruptcy protection, particularly in the Fourth Circuit, but these types of cases can still be dismissed for other reasons, say Stuart Gordon and Alexandria Vath at Rivkin Radler.

• Series

  Whitewater Kayaking Makes Me A Better Lawyer

  

  Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

• AI In The Operating Room: Liability Issues For Device Makers

  

  As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

• 3 Lessons From Family Dollar's Record $41.7M Guilty Plea

  

  Family Dollar's recent plea deal in connection with a rodent infestation at one of its distribution facilities — resulting in the largest ever monetary criminal penalty in a food safety case — offers key takeaways for those practicing in the interconnected fields of compliance, internal investigations and white collar defense, says Jonathan Porter at Husch Blackwell.

• This Earth Day, Consider How Your Firm Can Go Greener

  

  As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.

• Circumstantial Evidence Requires A Pointillist Approach

  

  Because complex cases with sophisticated defendants are unlikely to reveal much, if any, direct evidence, attorneys must aggregate many pieces of circumstantial evidence into a cohesive narrative — much like the painting technique of pointillism, says Reuben Guttman at Guttman Buschner.

• Benzene Contamination Concerns: Drugmakers' Next Steps

  

  After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.

• Opinion

  States Should Follow Federal Lead On Expert Evidence Rules

  

  The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.

• Back Labels In False Ad Cases Get Some Clarity In 9th Circ.

  

  Courts in the Ninth Circuit have recently delivered a series of wins to advertisers, making clear that any ambiguity on the front of a product's package can be resolved by reference to the back label — which guarantees defendants a powerful tool to combat deceptive labeling claims, say attorneys at Patterson Belknap.

• Opinion

  Federal MDL Rule Benefits From Public Comments

  

  The new Federal Rule of Civil Procedure concerning multidistrict litigation that was approved this week by the Advisory Committee on Civil Rules incorporates ideas from public comments that will aid both plaintiffs and defense attorneys — and if ultimately adopted, the rule should promote efficient, merits-driven MDL case management, say Robert Johnston and Gary Feldon at Hollingsworth.

• Practicing Law With Parkinson's Disease

  

  This Parkinson’s Awareness Month, Adam Siegler at Greenberg Traurig discusses his experience working as a lawyer with Parkinson’s disease, sharing both lessons on how to cope with a diagnosis and advice for supporting colleagues who live with the disease.

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  Playing Hockey Makes Me A Better Lawyer

  

  Nearly a lifetime of playing hockey taught me the importance of avoiding burnout in all aspects of life, and the game ultimately ended up providing me with the balance I needed to maintain success in my legal career, says John Riccione at Taft.