Life science companies seeking FDA approval must not only establish a new medicine’s efficacy but also comply with rigorous safety protocols and procedures. The process is time-consuming and costly: the financial burden associated with developing and securing market approval for a new compound is estimated at $2.5 billion and can take over a decade, with failure possible at any stage in the process. Seeking to reduce the staggering cost and accelerate the approval time frame, many researchers are exploring an exciting, new methodology as an alternative to traditional pre-clinical studies: "organ-on-a-chip"

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

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.

The development of lithium-ion batteries, also known as “Li-ion” batteries, has brought game-changing portable, rechargeable power to a vast array of products, including modern-day smartphones and electric cars. The life science industry has taken notice: many medical devices, ranging from electric wheelchairs to defibrillators to oxygen concentrators, have been designed to work with lithium-ion batteries. While the efficiency and longevity of such batteries can be extremely beneficial and, in some cases, lifesaving, their use comes with safety trade-offs over traditional batteries. Medical device manufacturers must consider these trade-offs carefully when electing lithium-ion batteries as the power source for their products.

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.

As recently as January 23, 2024, the U.S. Food and Drug Administration (“FDA”) reiterated a previous public health advisory to consumers: do not purchase or use any product containing the illegal and potentially dangerous substance tianeptine. Products containing tianeptine are known colloquially as “gas station heroin” because they: (1) are readily available in gas stations, as well as in smoke shops, convenience stores, and even online; and (2) purportedly produce an opioid-like euphoria in users, especially in high doses. Yet, tianeptine, despite its broad availability, is a potentially dangerous substance not FDA-approved for any medical use.

It is no surprise that one of the most impactful health stories of 2023, as reported by Scientific American, is gene therapy, specifically the approval by the U.S. Food and Drug Administration (FDA) of a groundbreaking gene therapy treatment for sickle cell disease using a novel genome editing technology called CRISPR.

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.