News and Blog

Beginning in the 1960s, medical facilities, blood banks, and other public providers of blood products began seeing limited statutory protections arise in most states through what has become known as “blood shield laws.”

Psychedelic drugs have long fascinated humanity, from use in ancient rituals to potential therapeutic benefits. Among these, psilocybin, the active compound in "magic mushrooms," stands out for its historical significance and promising future. This article delves into the legal status, clinical trials, history, and future of psychedelic drugs, with a particular focus on psilocybin.

Not so long ago, genetic testing was aspirational, a process more common to science fiction than accepted medical research. Over the past several decades, however, genetic testing and gene therapy have become mainstream. 

Orthopedic and oral/maxillofacial implants currently represent a combined $2.8 billion market, a figure expected to experience significant and continued growth. Although traditional permanent implants have proven clinically efficacious, they are also associated with several drawbacks, including secondary surgeries, infection, and rejection.

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.

In a previous post, we discussed the FDA’s July 2024 Draft Guidance entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers" (the "Draft Guidance"). The Draft Guidance suggests a purportedly voluntary pathway for drug and device sponsors, manufacturers, distributors, and other stakeholders legally responsible for the labeling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.