Photo of Michelle Yeary

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 – wasn’t she the one who did the thing in that other movie.  Father:  No, no.  I think she was on Law and Order (as if that narrows it down).  After a few similar volleys ranging from Downton Abbey to The Fast and the Furious, the teens can no longer hold their tongues.  They’ve got the answer from Google, IMDB, Wikipedia and any other number of sources readily accessible via that device that is never out of reach.  The parents could have done that too and would have eventually.  But where’s the fun in that?  The fun in seeing if you can pull the memory from some dark and dusty corner of your brain.  Afterall, when the parents were teens that was the only option.  Which often led to heated debate based on nothing more than vague recollections.  That’s fine when the topic of discussion is who played Ramona Flowers in Scott Pilgrim vs. the World.  But it’s not okay when the question is what the FDA would do.

That’s a question the court in Azurity Pharms, Inc. v. Edge Pharma, LLC, 2021 U.S. Dist LEXIS 95300 (D. Mass. May 18, 2021) was unwilling to guess at.  Plaintiff is the manufacturer of an antibiotic.  Defendant is a compounder – a facility that mixes or combines ingredients to make medication.  However, the FDA prohibits compounders from compounding drugs that are “essentially a copy of an FDA-approved drug.”  Id. at *2.  That is what plaintiff said defendant was doing – copying one of their antibiotics and falsely marketing that defendant was complying with FDA regulations.  Id. at *1.  Plaintiff claimed that the false statement gave rise to an action under the Lanham Act and the Massachusetts consumer protection statute.

In other words, plaintiff wanted the court to decide whether defendant was violating the FDCA by compounding a drug that was “essentially a copy” of plaintiff’s product.  Id. at *4.  Importantly, that’s a question the FDA has not addressed.  The FDA has not issued any decision finding the defendant is non-compliant with the compounding regulations.  Because enforcement of the FDCA is “largely committed to the FDA,” this is a circumstance where the FDCA precludes a Lanham Act claim:

Because the FDCA forbids private rights of action under that statute, a private action brought under the Lanham Act may not be pursued when, as here, the claim would require litigation of the alleged underlying FDCA violation in a circumstance where the FDA has not itself concluded that there was such a violation.

Id. at *5 (quoting PhotoMedex, Inc. v. Irwin, 601 F.3d 919, 924 (9th Cir. 2010)).  It’s not preemption because the Lanham Act is a federal statute, but the underlying basis – private attempts to enforce the FDCA are prohibited – is an issue near and dear to our hearts.  The court was not willing to resolve the “thorny question” of what constitutes an “essential copy” under the FDCA.  That’s an issue for FDA expertise.  Id. Because plaintiff’s consumer protection claims were premised on the same allegations, they likewise were dismissed.  Id. at *6.

And, if you are wondering who played Ramona Flowers (and haven’t googled it already) it is Mary Elizabeth Winstead.  Which happens to have led to a whole conversation about actresses named Mary who go by three names – Louise Parker, Elizabeth Mastrantonio, Tyler Moore, Stuart Masterson, Kay Place.  You can decide who your favorite is.