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…
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…
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 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,…
The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier)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 The draft guidance is intended to assist…
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…
On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or…
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…
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…
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…
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…