News and Blog

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.

AI appeared to burst onto the scene in early 2023 and seems to be everywhere, all at once. In reality, AI technology has been integrated into our daily lives for a number of years, most visibly as experienced through the virtual assistants, Siri and Alexa, and its use in medical diagnostic software systems.

Most life science organizations depend on efficient and uninterrupted supply chains. Manufacturers of pharmaceuticals, biologics, supplements, and devices rely on third-party relationships for component parts, active pharmaceutical ingredients, warehousing, and distribution services. Perhaps your organization depends solely on the manufacturing of your products by a third-party vendor. Research and Development operations rely on third-party relationships to provide crucial supplies such as specialized equipment, cell cultures, and genetically modified organisms.

In honor of National Hispanic Heritage Month, we asked Ioanis González-Rodríguez, better known as E, a Life Sciences Associate here at BLS, if he would share his experiences about his Hispanic background and what this month means to him.