On April 5, the Court of Appeals for the Eighth Circuit wiped out a jury verdict in a products liability action and $13 million punitive damages award against a manufacturer and its wholly owned subsidiary on the basis that...more
On April 12, the FDA released draft guidance discussing an expansion of its Abbreviated 510(k) program for medical devices. This new guidance would allow a submitter to establish substantial equivalence by demonstrating that...more
On July 13, 2017, the U.S. House of Representatives passed a bill that would triple the amount of time in which medical device manufacturers are required to report certain malfunctions of some products to the Food and Drug...more
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....more
In June, the U.S. Food and Drug Administration released draft guidance to clarify the benefit and risk factors it may consider in compliance and enforcement actions involving medical devices.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On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for...more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
/ Automobile Recall ,
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
You are general counsel to a company, and your CEO steps into your office, clutching his iPhone in one hand and wiping sweat from his brow with the other, and tells you that a compromising photograph of him was stolen from...more
9/25/2014
/ Celebrities ,
CEOs ,
Copyright ,
Copyright Infringement ,
Corporate Counsel ,
Cybersecurity ,
Data Breach ,
FBI ,
Hackers ,
iPhone ,
Law Enforcement ,
Photographs ,
Popular ,
Privacy Laws ,
Takedown Notices