Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
On August 5, 2025, Royal Sovereign International, Inc. reached a civil and criminal resolution with the United States Department of Justice (DOJ) that includes a $16.025 million civil penalty—the maximum authorized under the...more
Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...more
The medications we take are supposed to protect our health and help us recover from serious illnesses and injuries. Unfortunately, this doesn’t always happen. Some medications cause more harm than good. Dangerous and...more
Defective medical devices present serious risks for patients. Just how big—and how severe—is the problem? Consider this from the U.S. Food and Drug Administration (FDA): “Each year, the FDA receives over two million medical...more
A report arguing for raising taxes on alcohol and sugar-sweetened beverages, a law requiring labels to disclose if an animal was harmed during production, a lawsuit calling grain alcohol "inherently dangerous," and more. It...more
Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is subject to an active recall, it will be important to make sure you know what this means for your health...more
Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to software, labeling, manufacturing processes, and design are a natural part of the...more
On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members involved in the...more
Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact the drug, biologics and...more
In product liability litigation, plaintiffs often treat a product recall as though it is conclusive proof that the product is defective or that its warnings are inadequate. Some plaintiffs even cite clearly inapplicable...more
As noted in our recent client alert, the U.S. Consumer Product Safety Commission (CPSC) continues to aggressively pursue enforcement actions for violations of the Consumer Product Safety Act (CPSA) against foreign...more
Consumer product companies are facing unprecedented scrutiny as the Consumer Product Safety Commission (CPSC) intensifies its regulatory oversight. With heightened civil penalties, increased monitoring of e-commerce...more
In 2024, Ontario’s highest court affirmed the principle that a certifiable tort claim requires a plaintiff to provide some basis in fact for a present, materialized injury that is “sufficiently serious.” A legally compensable...more
Searcy Denney recently became aware of safety concerns with the seats used in Bass Pro’s bass boats. According to the Coast Guard’s safety alert, the casting seats break at the connection between the seatback and base, which...more
On May 15, 2025, the Consumer Product Safety Commission (CPSC or Commission) announced a “record-breaking week” of enforcement actions against “foreign violators.”[1] Namely, the Commission announced 28 separate product...more
Share on Twitter Print Share by Email Share Back to top Over the past year, manufacturers, importers, distributors, and retailers of consumer products containing button cell and coin batteries (or products intended to contain...more
Unsafe product recalls are alarmingly common. While all companies have a legal obligation to ensure that their products are safe for use or consumption, companies fail to meet this obligation far too often. In many cases,...more
Plutocrats reigned. The gulf between rich and poor was huge. Nativist extremists, populist politicians, and major elements of the media clamored about the waves of immigrants flooding into America. And health challenges...more
Mass tort cases present unique challenges for both plaintiff’s and defense counsel. Unlike a class-action case, where a representative plaintiff stands in for the other members of the class, each plaintiff in a mass tort case...more
On March 14, 2025, Amazon filed suit against the Consumer Product Safety Commission (CPSC) in the U.S. District Court for the District of Maryland, challenging CPSC’s July 29, 2024, and January 16, 2025, orders determining...more
The food and beverage industry is in the midst of a dynamic and challenging time, marked by more regulatory scrutiny, evolving consumer awareness, and unrelenting litigation. Three key trends could potentially drive...more
This second installment of our series highlights the Consumer Product Safety Commission’s (CPSC) presence and guidance at this year’s ICPHSO annual symposium. CPSC had a notably smaller presence this year. Agency...more
The consumer-packaged goods and restaurant industries play a crucial role in the global food supply chain, providing a wide variety of food options that consumers rely on for their daily nourishment. However, the integrity of...more
On December 19, 2024, the Consumer Product Safety Commission (CPSC) unilaterally issued a warning to consumers to stop using Sport Nets 4’ x 8’ portable soccer goals. According to CPSC, an exposed metal tip at the top of the...more
In recent years, the Consumer Product Safety Commission (CPSC) has increased pressure on consumer product companies through various enforcement mechanisms. The increase in the frequency and amount of civil penalties sought by...more