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 May 16, 2024, the United States Consumer Product Safety Commission (CPSC) took an unconventional action, unilaterally issuing a recall announcement urging consumers to dispose of CHZHVAN Combination Smoke and Carbon...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
The risk of a product recall has increased in recent years due to changing global regulatory standards. Contributing factors include geographically widespread supply chains and different manufacturing protocols among nations...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
Exactech is a manufacturer of medical implants, including ankle, knee, hip and shoulder replacement devices. Unfortunately, due to poor manufacturing practices and quality control issues, Exactech has been forced to recall...more
If you have had problems with an Exactech ankle, knee, hip or shoulder implant, you are not alone. At the request of the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective ankle,...more
Exactech is a medical device company that has faced numerous lawsuits in recent years. These lawsuits have focused on various issues with the company’s implantable medical devices, including issues that the company has...more
Exactech is a medical device company that manufactures implantable joint replacements. It is also a company that has faced numerous lawsuits related to its products in recent years. In many cases, Exactech has acknowledged...more
Join us over the next few months as we spotlight select chapters of Venable’s popular Advertising Law Tool Kit, which helps marketing teams navigate their organization’s legal risk....more
Increasing globalization of product markets brings tremendous opportunities for product manufacturers. New technologies enable companies to reach consumers in markets all around the world, and rapid geographical expansion is...more
Leibig v. MTD Products, Inc., Civ. No. 22-4427, 2023 WL 3689983 (E.D. Pa. May 25, 2023) - The plaintiff, a Pennsylvania citizen, brought suit in Philadelphia County, claiming injuries suffered from a defective snow thrower...more
The rising lithium-ion battery demand is creating challenges for manufacturers. It is important to understand how to mitigate risk. The rising demand to reduce our reliance on fossil fuels has driven product manufacturers to...more
Data from U.S. Consumer Products Safety Commission (CPSC) shows that more consumer products are being recalled now than they have been in recent years. The U.S. PIRG Education Fund published a report on February 2, 2023...more
Believe it or not, there are just six more weeks until spring. As the weather warms up and humidity rises, homeowners will start to use their portable dehumidifiers. The use of portable dehumidifiers poses a significant fire...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
What formula brands are affected? This recall only relates to the following Similac®, Alimentum®, and EleCare® powdered formula produce at the Abbott Nutrition plant in Sturgis, Michigan...more
Regulatory challenges and legal threats facing product manufacturers change at a rapid pace, and this is especially true in a COVID-19 world. Join Bricker attorneys and distinguished experts as we cover a myriad of topics...more
The U.S. Consumer Product Safety Commission (CPSC) is an independent federal agency that regulates the manufacture, distribution, and sale of consumer products in the United States. Specifically, the Commission is tasked with...more
Recalls have always been a bit of a double-edged sword. Obviously, companies hate recalls because a recall means their products are defective in some manner, potentially putting users at risk and damaging the brand. They...more
In very simple terms, product liability holds a person or company legally and financially liable for harm that is caused when their product is defective. In the U.S. in 2020, nearly 11 million people were treated in hospital...more
Two pharmaceutical companies have issued recalls in December due to manufacturing issues that may impact the safety and quality of their drug products. ...more
Over 400,000 COVID-19 rapid test kits have been recalled by Australian manufacturer Ellume. The reason? Way too many false positive results. “At Ellume, we understand that trust is central to fulfilling our purpose...more
Key Takeaways - The FDA’s Patient Engagement Advisory Committee, organized under the Center for Devices and Radiological Health (“CDRH”), held a public meeting on October 6, 2021, to discuss issues surrounding the...more