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
The United States Consumer Product Safety Commission (CPSC) recently announced a $5.8 million agreement with Keurig Green Mountain, Inc. settling claims that Keurig failed to report a product defect that posed an unreasonable...more
FDA’s MedWatch recently posted a voluntary recall issued by Cook Medical recalling 4.1 million catheters using Cook’s Beacon Tip technology. The recall was initiated after 30 Medical Device Reports were received by the FDA. ...more
The Los Angeles Times reports that in recent years, several devices, including certain reusable medical scopes, metal-on-metal hip replacements, transvaginal meshes, and lead wires in heart defibrillators have been recalled. ...more
On July 22, 2015, the U.S. Consumer Product Safety Commission and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip-over posed by 27 million chests...more
Yesterday the CPSC and major furniture company IKEA jointly announced a “repair program” to address the serious and complex hazard of furniture tip over posed by 27 million chests and dressers sold by the company. The repair...more
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,...more
One way in which next-generation manufacturing is impacting the automotive industry is the movement toward modular architecture. These designs use common underpinnings for various models across a variety of vehicle segments,...more
In August, NHTSA adopted numerous amendments to its recall and early warning reporting (EWR) regulations. (See 78 Federal Register 51382 (Aug. 20, 2013)). Several of these amendments – which impact all vehicle and equipment...more
This week, the Consumer Product Safety Commission (“CPSC”) will decide whether to hold a full Commission hearing to receive oral comments on a notice of proposed rulemaking on magnet set safety. If the meeting notice is...more
A unanimous U.S. Consumer Product Safety Commission (“CPSC”) announced that Ross Stores Inc. (“Ross”), a national discount retailer, agreed to pay a $3.9 million civil penalty to settle allegations that it failed to report...more
On February 22, 2013, the U.S. Food and Drug Administration (FDA) released a long-anticipated draft guidance document entitled Distinguishing Medical Device Recalls from Product Enhancements; Reporting Requirements. With the...more