Insights

On April 2, 2025, the U.S. Supreme Court extended the reach of Section 1964(c) of the Racketeer Influenced and Corrupt Organizations (RICO) Act by holding that a plaintiff may seek treble damages for a business or property loss resulting from a personal injury.[1] The 5-4 decision has resolved a 3-2 circuit split over whether the RICO statute precludes relief for losses stemming from a personal injury.

When a company learns that it may wind up as a defendant in a multidistrict litigation (or MDL), it may initially feel like a disaster. Between expensive, drawn out, and complicated legal proceedings and the possibility of outsized damages and company-threatening liability, it is difficult to imagine the upside. However, MDLs may not be as unfavorable a forum for defendants as they initially seem.

Artificial intelligence (AI) and machine learning (ML) have become ubiquitous across industries, and the pharmaceutical industry is no exception. AI and ML are already influencing drug development and manufacturing, but these innovations present unique regulatory challenges. For example, if a ML algorithm can change a CGMP-compliant manufacturing process on its own to increase efficiency, how does the drug manufacturer ensure that the updated, machine-created process is CGMP-compliant? If researchers use AI to identify ideal candidates to participate in a drug trial, how do they account for biases in the data underlying the AI’s decision-making? FDA recently released a discussion paper[1] requesting input from pharmaceutical industry stakeholders on how to tackle such issues. Stakeholders should seize this opportunity to provide input to FDA as the agency develops the applicable regulatory landscape.