After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion. The agency asserted that comments made on the show constituted promotional speech and resulted in Aegerion’s cholesterol lowering drug, Juxtapid, being misbranded. According to […]
Reprinted with the permission of the Record Reporter, originally printed as “The Future of Medical Recalls” on November 15, 2013. Many medical devices will soon carry a unique identity code, under a new rule recently published by the U.S. Food and Drug Administration (FDA). The FDA refers to this as the Unique Device Identifier (UDI) rule. A […]
Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps[1] will be regulated by the FDA and who will be required to comply with the regulations. The […]
Does your business operate a website, online service, application or database? California has a group of privacy and data security laws that apply to those types of businesses. Because most websites, applications and databases involve California residents, such laws effectively set a nationwide baseline. Here are four California laws on privacy and what they mean for businesses: 1. […]
In Pounders v. Enserch E&C, Inc., decided on August 21, 2013, the Arizona Supreme Court gave a fresh examination to the application of choice of law principles to product liability lawsuits, in particular actions involving long-latency diseases. The Court ruled that, even though Plaintiff resided in Arizona and his injury became manifest in that state, […]
Snell & Wilmer attorney Vaughn Crawford represented Ford Motor Company in a case tried in the United States District Court for the Western District of Texas in El Paso. The case was filed by a husband and wife involved in a single-vehicle rollover near Sweetwater, Texas in 2009. The wife, who was the right front […]
What’s the latest news on Arizona’s civil defense verdicts? Here’s a preview of some interesting 2013 defense verdicts: Yanovskaya v. State of Arizona. This was a road design case. Yanovskaya’s vehicle crashed on a freeway and she alleged that the median’s slope caused her to travel under the cable barrier and into oncoming traffic. She […]
Unmanned Aircraft Systems (UAS), more popularly known as “drones,” have evolved beyond overseas battlefield and clandestine operations and are increasingly being utilized inside the United States. As with any product used in the domestic market, product liability considerations apply to their design, manufacture, sale and operation. Therefore, now is an appropriate time to examine UAS […]
The District of Arizona recently denied a motion to dismiss by Medtronic Inc., rejecting the argument that federal law preempted a plaintiff’s personal injury claims related to a product that had obtained premarket approval. Infuse is a bio-engineered liquid bone graft substitute. It is classified as a Class III device under the Medical Device Amendments […]
The Product Liability Desk Reference is one of the most useful and comprehensive books available on product liability law. It is a state-by-state reference that provides the most recent statutory and case law developments on product liability laws. It covers all 50 U.S. states and the District of Columbia. Kelly MacHenry, Sara Athen and Patrick […]
