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Sometime last year, one of our esteemed bloggers wrote: “The qui tam provision of the FCA, which permits private plaintiffs – sorry, relators – to steer FCA claims presents marvelous opportunities for mischief.” We couldn’t have said it any better, so we won’t try.  Moreover, mischief makes us think of the Marauder’s Map (Harry

And patience is a virtue…all great achievements require time…trust the process.  All easier said than done.  Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery.  Especially when the result after all

On March 5, Dechert is proud to host 2025 Life Sciences Day, an interdisciplinary program designed for in-house counsel, chief officers, and strategic investors. This dynamic half-day event offers a fantastic opportunity to network with industry leaders and delve into the latest trends and insights shaping the life sciences sector.

The event will

Prescription drug warnings require FDA approval which dictates what the manufacturer can say in the product’s labeling.  An exception to the FDA-approval rule is the Changes Being Effected (CBE) regulation which allows a manufacturer to unilaterally change a drug’s warnings “to reflect newly acquired information” and where the revision would “add or strengthen a contraindication

Yes, we are the Drug and Device Law Blog.  Yes, we at times stray into other areas when we think a decision has application to our DDL world.  Yes, today’s case is about a “drug” product.  No, today’s case is not about a drug for humans.  In fact, it really isn’t about a drug at

Do kids still do connect-the-dots?  Back before tablets, smart phones, laptops, and even computers, when you went on a long car trip you passed the time playing license plate bingo, punch buggy, annoying your parents, and maybe you had an “activity book.”  An actual paperback book filled with coloring pages, mazes, word scrambles, seek-a-word, and

Defendant in Beavan v. Allergan U.S.A., Inc., 2014 N.J. Super. Unpub. LEXIS 2898 (N.J. App. Nov. 21, 2024) made two solid arguments for summary judgment – preemption based on the FDCA’s recall regulations and plaintiff’s lack of admissible expert testimony.  The trial court rejected both.  The appellate court, however, saw the merit in the