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
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
The Third Circuit breathed new life into claims asserted by four of the nine named plaintiffs in a proposed class action over Bayer’s 2021 recall of benzene-contaminated antifungal sprays, finding they had sufficiently...more
Manufacturers should add “possible class action defense” to the list of considerations when evaluating whether to conduct a voluntary recall of a consumer product, particularly when class action litigation is threatened or...more
Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
A comprehensive guide to the latest developments affecting non-prescription drug products under Monograph Reform. American Conference Institute’s Advanced Legal, Regulatory and Compliance Forum on Over-the-Counter Drugs will...more
The commercial and legal environment on product safety in vehicles, auto parts and other products has substantially changed in Mexico in 2018. Manufacturers carrying out business activities in Mexico should now be...more
Manufacturers of components incorporated into consumer products increasingly find themselves involved in product liability class action lawsuits. Manufacturers can be drawn into these types of lawsuits when their own customer...more