Most of us understand that the facts that give rise to the legal issues we face are sometimes sewn far in advance. This is certainly true in the area of product claims or statements. As is discussed below, careful consideration…
Yearly Archives: 2016
Words Matter: Product Claims Can Trigger Regulatory Application And Corrective Action
Tagged with: essential oils, FDA warnings, FDCA, labeling, natural ingredients, organic products
Posted in FDA
Posted in FDA
Creating and Maximizing Enforceable Settlements
Settling a case may be the culmination of years of litigation or a strategic move at the outset to avoid litigation costs. Many times, settlement occurs at some point in between. Regardless of when the settlement occurs, it’s important to…
The Harbor Might Not Be Safe: Failure To Update Generic Drug Labels Can Invite a Storm of State-Law Claims
The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1] Under the Federal Food, Drug,…
Posted in FDA
FDA Issues New Draft Guidance Requiring Modifications to Medical Device Tracking Labels
The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”. The draft guidance is intended to assist…
Posted in FDA
“Auto-Pilot” May Not Be Perfect, But It May Be Better
Virtually every day there are media reports regarding the introduction of driverless cars to mainstream consumers. As driverless cars rapidly accelerate from concept to commercialization, it is becoming increasingly apparent that technological refinements remain necessary and are ongoing in response…
Posted in Automotive
New FDA Draft Guidance on Updates to Certain Generic Labeling
On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or…
Posted in FDA
New Weapon For Manufacturers: Defend Trade Secrets Act of 2016
On May 11, 2016, President Barack Obama signed the Defend Trade Secrets Act of 2016 (the “DTSA”), which provides a federal civil cause of action to manufacturers for the misappropriation of trade secrets under the Economic Espionage Act. While the…
Posted in Manufacturer, Trade Secrets
FDA Issues Final Ruling Allowing Medical Device Manufacturers to Use Stand-Alone Symbols on Labels
This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent…
Posted in FDA
U.S. DOT Moving Closer to Certification of Driverless Cars
Motor vehicle design continues to make significant technological leaps incorporating a number of automated features, with many manufacturers pioneering the concept of driverless cars. What was once the stuff of science fiction is making significant headway towards full-scale production and…
Posted in Automotive
Olympus Duodenoscope Recall: Lessons Learned on How to Manage a Class II Device Failure
Earlier this year Olympus Corp. (“Olympus”) announced that it would recall and redesign its TJF-Q180V duodenoscope following its link to deadly patient infections in the United States and abroad. This situation presents an important cautionary tale and one that is…
