LS Litigation

Previously on the blog, we focused on the regulatory and compliance risks surrounding compounded GLP‑1 products, particularly misbranding, quality concerns, and how quickly the enforcement landscape has evolved. Continuing this discussion, we broaden the lens to the developing litigation environment and additional regulatory scrutiny that can affect manufacturers, pharmacies, telehealth providers, and other stakeholders across the GLP‑1 ecosystem.

In 2023, Berkley Life Sciences published a blog post titled PFAS “Forever Chemicals” in Medical and Life Sciences Products – Who Should Be Worried?. At that time, most per- and polyfluoroalkyl substances (PFAS) litigation to date focused on lawsuits against PFAS manufacturers, alleging personal injury from PFAS exposure. Since then, PFAS litigation has evolved, and both the U.S. Food and Drug Administration (FDA) and European Chemicals Agency (ECHA) have issued updates, warranting a fresh look at this topic.

Last year, Berkley Life Sciences’ Blog featured an important post on Preventing Medical Device Shortages Through Improving the United States Sterilization Supply Chain. That article highlighted potential supply chain constraints caused in-part by sterilization facility shutdowns and regulatory requirements to install or upgrade emission control equipment. What that post did not address—and what this article will explore—is the nationwide litigation that has impacted the sterile medical device industry over the past five years.

Through the month of June and into the week of July 4th, 2025, national attention was largely focused on a sweeping federal spending bill moving through Congress as part of the budget reconciliation process. But while media and public attention was centered on healthcare and social welfare funding, most Americans were not aware that the bill also briefly included a contentious litigation finance tax proposal.

Mass tort and class action settlements totaled over $40 billion for the third year in a row. While this number is staggering, unlocking its history provides key considerations to dial back this billion-dollar settlement trend. Mass tort litigation has been a part of the American legal system for decades. Settlements have been the end of a long road of bellwether trials, ultimately resolving the litigation.

This blog post discusses the origin of benzene litigation, how third-party research and subsequent citizens petitions drive modern benzene claims, and steps manufacturers can consider in assessing risk and preparing to defend against potential benzene lawsuits.

Innovator liability is a legal theory under which a consumer seeks to hold the brand-name manufacturer of a drug (the “innovator”) responsible for an injury that was caused by the generic version of that drug. This novel approach to injury culpability has gained modest ground in recent years, despite its departure from long-standing product liability principles and case precedent. The following feature offers a general overview of the concept of innovator liability, its origins and legal status in the U.S., arguments for and against its use and success, and its potential impacts on drug manufacturers and the pharmaceutical industry.

Our last gene therapy article highlighted several novel cures for rare, life-threatening illnesses using gene therapy technology. Many more treatments based on gene therapy are in the clinical trial phase. Despite the remarkable results thus far, significant challenges lie ahead. As with any new treatment modality, scientists must be cautious in their approach, carefully studying the potential side effects in the short and long term. Unlike conventional treatments, gene therapy research raises unique economic, distribution, and manufacturing concerns. Below, we will discuss the medical and social hurdles posed by gene therapy research and commercialization, and the nascent regulatory response underway to help move this new frontier of medicine forward in a safe and ethical manner.

The final article of this three-part series will focus on recalls, regulatory updates, and what to watch for in 2024.

Part Two of this series will focus on defense decisions and key case law developments