FDA’s exclusive enforcement powers prohibit plaintiffs from bringing what amount to private FDCA violation claims in the guise of private civil litigation. 21 U.S.C. §337(a). That is the foundation on which prescription drug and device preemption is built. However, preemption is about the interplay between federal and state law requirements and where the latter must
Lanham Act
Thorny Questions Raised by Lanham Act Claim Better Left to FDA
By Michelle Yeary on

It’s a Sunday night after an incredibly jam-packed weekend of activities. The family, mother, father and two teens, decide to end the weekend with a movie. A nice wind down before another hectic week begins. A few minutes in, the father remarks: don’t I know that actress from something else? To which mother offers –…
Court Dismisses Lanham Act Claims Brought By Device Manufacturer Against Competitor
By Andrew Tauber on

A Vaudeville act is supposed to leave the audience wanting more. Not so a judicial decision. But that is what we have today: a decision whose result—the dismissal of Lanham Act claims brought by a device manufacturer against a competitor—is underexplained.
The plaintiff in Impact Applications, Inc., v. Concussion Management, LLC, 2021 WL 978823…