Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
The Federal Rules of Evidence (“FRE”) currently provide a framework for authenticating evidence in court, but rapid advancements in artificial intelligence (AI) have raised concerns about the sufficiency of these rules in...more
When scientific evidence is in play, it is often assumed that the most frequently cited articles are published in the most elite journals. However, this is not necessarily true. A journal is ranked according to its impact...more
Greenwire (subscription required) had an article yesterday with the breathless headline “Post-Chevron era tests courts’ readiness to tackle science.” The article noted that, in the recent Supreme Court decision in Ohio v....more
Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more
This week, Heather and Matthew welcome Dr. Fridriksson, a Neuroscientist, Professor, and the Vice President of Research at the University of South Carolina. Dr. Fridiksson is a veteran scientist and has spent much of his...more
On December 1, 2023, the Federal Rules of Evidence (FRE) 702 will undergo several changes designed to reinforce federal judges’ role as gatekeepers for admitting expert testimony. The changes reinforce the preponderance of...more
The U.S. Food and Drug Administration ("FDA") has issued a revised draft guidance that seeks to address questions and provide recommendations regarding the sharing of scientific information with health care providers ("HCPs")...more
On Oct. 23, the FDA issued draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses [SIUU] of Approved/Cleared Medical Products: Questions and Answers,”...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
After reports were made regarding the presence of nitrosamines in certain pharmaceutical products in 2018 and 2019, and subsequent precautionary regulatory action was taken, an avalanche of litigation commenced in Canada and...more
We begin with an update on a trilogy of privacy class actions appeals in which plaintiffs sought, unsuccessfully, to expand the tort of intrusion upon seclusion. Next, we canvass the various approaches of Ontario courts...more
The Court of Appeal for Ontario in Levac v James, 2023 ONCA 73 [Levac] has unanimously upheld a trial judgment in a common issues trial regarding an infectious disease outbreak in respect of which the allegedly negligent...more
On April 13, 2023, the Federal Trade Commission (FTC) sent approximately 670 notices of penalty offenses to various companies involved in the marketing of OTC drugs, homeopathic products, dietary supplements, and functional...more
It’s common that rear-end collisions result in symptoms of whiplash. To determine how these symptoms develop, we must first consider the laws of physics. Newton’s first law of motion states that a body at rest will remain at...more
On December 20, 2022, the Federal Trade Commission (FTC) issued its Health Products Compliance Guidance (“Health Products Guidance”). This is the first update in nearly 25 years to FTC’s guidance regarding advertising claims...more
The Federal Trade Commission (FTC) has issued a new Health Products Compliance Guidance document to provide guidance to businesses on how to ensure that claims about the benefits and safety of health-related products are...more
Just in time for your health-focused new year’s resolutions, the FTC released an updated guide for marketers: The Health Products Compliance Guidance. This guide last issued in 1998 under a more narrow title, focusing on...more
In 1998, the Federal Trade Commission (FTC) issued “Dietary Supplements: An Advertising Guide for Industry,” and for years that document served as an important starting point for analyzing health claims for dietary...more
In a recent decision on an asbestos exposure case, a New Jersey court once again reminded us that the admissibility of an expert opinion hinges upon the substance of the opinion, rather than the conclusions of the expert...more
In the last few years, we have seen an uptick in behavioral health groups focused on psychedelic treatments. There are now at least five (5) psychedelic-assisted therapy platforms traded on NASDAQ with numerous others listed...more
Although the 2018 Farm Bill carved out hemp from the federal Controlled Substances Act, few court rulings have addressed the legal distinction between federally-legal hemp and federally-illegal cannabis. A new opinion from...more
A Third Circuit panel recently affirmed a Pennsylvania district court decision in favor of defendant Innovative Designs (“IDI”) in an advertising challenge by the FTC. We previously blogged about the district court decision,...more
The Federal Circuit Court of Appeals recently tangled with a patent application for an invention that did not have scientific support. The court affirmed a decision of the Patent Trial and Appeal Board rejecting a patent...more
In the face of extraordinary challenges, 2020 has yielded profound developments within the scientific community: from the accelerated development and approval of highly effective and safe vaccines normally years in the making...more
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could...more