Denver partner Dan Wittenberg and associate Kelly Smith recently published an article, “Clarifying the Difference Between Medical Device Servicing and Remanufacturing,” in DRI’s For the Defense. The article explores the longstanding divide in the medical device industry between device manufacturers and the third-party entities that service the devices. Wittenberg and Smith explain how the FDA […]
On December 18, 2018, the Arizona Supreme Court issued an opinion clarifying manufacturers’ duty to warn consumers under Arizona common law. The Court held that the federal Medical Device Amendments (“MDA”) impliedly preempted Arizona common law claims in a medical device context. The opinion also disavowed the Ninth Circuit’s preemption ruling in Stengel v. Medtronic, […]
The Arizona Supreme Court has issued an opinion adopting the learned intermediary doctrine in Arizona. The Supreme Court rejected the Arizona Court of Appeals’ earlier decision holding that the learned intermediary doctrine was incompatible with the Uniform Contribution Among Tortfeasors Act (“UCATA”). Although the Arizona Supreme Court specifically held that the doctrine applies to pharmaceutical […]
A fictional cyber-terrorist weaponizing a medical device by hacking into it has become a familiar plot premise in recent Hollywood dramas. Unfortunately, the risk of harm from medical device hacking has now become an actionable, real-world concern. In an unprecedented move, on July 31 the U.S. Food & Drug Administration issued an Alert to health care facilities to discontinue […]
On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket […]
What are the latest trends on product recalls in the United States? Stericycle ExpertSOLUTIONS writes an interesting and informative quarterly report on this data, and its detail on the first quarter of 2015 is here. Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls, particularly […]
Large or small, every life science or medical technology company will eventually have to deal with a products liability claim or event. A lack of adequate planning for such an occurrence can result in damage to the brand, loss of consumer confidence, harm to the business and trigger potential regulatory consequences as well as result in […]
The learned intermediary doctrine can be a legal defense against product liability claims. It is most commonly applied in cases involving drugs and medical devices. A learned intermediary is a medical expert, such as a prescribing physician, who can weigh the risks and benefits of a medication and make informed prescription decisions based on knowledge […]
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 […]