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 1 of this series will focus on Multi-District Litigation (MDL) and nuclear verdicts and their impact on product liability cases of interest to life science organizations.
Researchers studying litigation in the United States over the past several decades have coined the phrase "nuclear” verdict to mean a jury award exceeding $10 million. There is no question that over the past twenty-plus years, the number of nuclear verdicts, and the amounts awarded, have increased exponentially, to the extent that one self-described independent communications and research firm, Marathon Strategies, has coined the term “thermonuclear” verdict, which is a jury award that surpasses $100 million. Researchers speculate that such verdicts can drive up the price of goods and services, adversely affect the cost and availability of insurance, and undermine fundamental fairness and predictability in the rule of law.
Wearable devices have come a long way from the 13th century’s invention of eyeglasses. The first wearable computer was created in 1960, launched by the notable brand Casio which marketed the first calculator wristwatch. Fast forward to today, where wearable devices can now gather extensive data, specifically about our bodily systems, including exercise, food consumption, weight, sleep, noise exposure, heart rate, skin temperature, and respirations. It is more than just our location using GPS. What’s more, this data is compiled and exchanged with little to no user involvement—in many instances, users are not even aware this information is being tracked. Do you now have a potential new witness to “interview” in your litigated claims? Yes, you do.
