Recently, Magna Legal Services, a company that provides legal support and consulting services, interviewed Berkley Life Sciences Cynthia "Cindy" Khin, Life Sciences Casualty Resolution Director. The following is their conversation about Cindy’s career path and the importance of mock trials.
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In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (the "Draft Guidance"). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling of approved/cleared medical products ("firms") to respond to internet-based posts and comments in a manner consistent with existing product labeling and advertising laws.
Both Ethylene Oxide (EtO) and gamma radiation are highly effective sterilizers for medical devices, but they face significant supply chain vulnerabilities that have already led to shortages within the United States. To mitigate these risks and bolster the sterilization supply chain, the FDA recently approved a new “Established Category A” sterilization method and implemented three key programs designed to encourage medical device manufacturers to adopt alternative methods, all within the last five years (FDA, 2024).
Digital health technology is experiencing a period of unprecedented growth and innovation. The global digital health market is projected to expand from $309B in 2023 to $1,019B by 2032 with a Compound Annual Growth Rate (CAGR) of 12%. Europe is reportedly the largest market, while Asia Pacific is the fastest-growing region. Although many factors contribute to this significant market growth, advancements in robotics, artificial intelligence, and remote monitoring devices stand out as primary driving forces.
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.
You may remember the internet postings during the height of the COVID pandemic touting hydroxychloroquine, a drug approved by the Food and Drug Administration (FDA) for the treatment of malaria and rheumatologic disease, as a prophylactic or even a cure-all for COVID-19. The postings, many initiated by celebrities such as Elon Musk and Dr. Oz and by social media “influencers,” referenced a now discredited, nonrandomized, 36-patient study on YouTube. COVID misinformation campaigns like this, trumpeting off-label use of an approved drug, took a deadly turn, as some infected patients elected to reject physician-recommended treatments or vaccination based upon the belief, encouraged by social media, that hydroxychloroquine and similar unproven treatments such as ingesting borax, were the ultimate answer.
Occupational Exposure Banding (OEB), also known as hazard banding, is a process used for assigning chemicals into categories based on toxicological potency and potential health hazard. OEB has been used to help organizations define and identify worker health exposures since the mid-1990s and has primarily focused on small-molecule chemicals, which make up most market pharmaceuticals. However, new modalities have been developed, and with increasing use across segments such as oncology, cardiovascular conditions, and autoimmune diseases, these modalities often lack occupational exposure limits.
As a startup life science company, you are excited by the promising laboratory results for your novel drug, but you must first test the product’s safety and efficacy through clinical trials. To expedite the process, you work with a clinical research organization to conduct trials outside the United States.
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.
Melatonin was first identified by Aaron B. Lerner, an American physician and dermatologist at Yale University, in 1958. Dr. Lerner and his colleagues were initially investigating a cure for vitiligo, an autoimmune disorder characterized by the loss of skin pigmentation. Although the experimentation failed to find a cure for skin disorders, subsequent research revealed that the compound melatonin did have a profound impact on the brain and neuroendocrine systems. The discovery paved the way for melatonin's widespread use as a sleep aid for humans.