In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices.
Medical device manufacturers...more
On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more
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...more
As product liability multidistrict litigation becomes more prevalent, it is important for manufacturers to understand how the bellwether trial process works and how to use it to their advantage. The ongoing bellwether trials...more
5/3/2016
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Bellwether Verdicts ,
Causation ,
Complex Litigation ,
Criminal Investigations ,
Department of Justice (DOJ) ,
Department of Transportation (DOT) ,
Discovery ,
General Motors ,
Litigation Strategies ,
Manufacturers ,
Multidistrict Litigation ,
Wrongful Death
One of the tasks manufacturing companies frequently face is having their products inspected and tested as part of the pre-litigation or litigation process. While this may sound routine, it is important to have a detailed...more