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By their very nature, prescription only medical devices—particularly those that require surgical implantation—are complex products, the design and manufacture of which are not lay person knowledge. So, if you are going to claim such a device malfunctioned, you are going to have to prove it with expert evidence.  This is a well-known legal concept.  Yet

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