When Bexis sends around his weekly list of potentially bloggable cases, we always lunge for the criminal matters, which are fairly rare. Cases brought under Title 21 bring us back to our days at the U.S. Attorney’s office, where we knew nothing of billable hours, MDL case management orders, fancy office coffee machines, or an army of young lawyers available to help with research and drafting. When we represented the United States of America, we were often in court, often on our own, and yet often dealing from positions of strength.  We miss every bit of that job, except the paycheck. 

We are even more likely to blog about a case if it follows up on an earlier decision about which we scribbled.  Such is the case with United States v. Facteau, 2023 WL 8641918 (1st Cir. Dec. 14, 2023). In this latest and greatest entry in the Facteau saga, the First Circuit affirmed criminal convictions of corporate executives for off-label promotion over a strong first amendment challenge.  We have blogged about this prosecution twice before. Our take was that criminal prosecutions that largely rest on truthful off label promotions are pretty iffy from the perspective of first amendment concerns, and the courts in Facteau seem to acknowledge the legitimacy of such concerns even whilst giving the prosecutors a grudging okay.  The First Circuit’s decision has not changed our mind about that. 

Our earlier posts go through the background of the Facteau case, but here’s a brief refresher in case holiday dissipations or indolence prevent you from clicking on the links:  Two former executives at a medical device manufacturer were charged with commercially distributing an adulterated and misbranded medical device in violation of 21 U.S.C. section 331(a).  The device was envisioned as a way of delivering a steroid to reduce sinus inflammation, but the original section 510(k) clearance was limited to using the device as a post-surgical spacer capable of releasing saline.  The plan was to pursue a later, second 510(k) clearance for the steroid delivery function.  But that later 510(k) clearance never happened.  The FDA took the position that such a 510(k) clearance would involve a combination drug/device product.  Presumably, such an application would have been a big deal.  Instead, it was no deal. For whatever reason, the company did not submit the paperwork for the clearance.  Nevertheless, according to the government, the company went ahead and marketed the device for the unapproved steroid delivery application. The company sponsored conference panels about the steroid delivery application, and also trained sales reps and surgeons on that aspect of the device. The FDA believed that the defendants were marketing the device for an “intended use” that was a “major change or modification” from the cleared use.  Such a departure from the scope of clearance would render the device adulterated and misbranded.  So we got this prosecution, a trial, a verdict, and some interesting motions.     

After a thirty day jury trial, the two executives were found guilty of multiple misdemeanor violations of the Food, Drug, and Cosmetic Act, but were acquitted of the felony accounts.  After the verdict, the defendants filed post trial motions challenging the convictions as violations of the executives’ first amendment rights.  The motions relied “on an emerging body of law protecting commercial speech that promotes off-label uses of medical products.”  The executives also raised due process under the fifth amendment and various other grounds in challenging the convictions, including insufficiency of the evidence.  The trial court denied the defendants’ post-trial motions (we wrote about that decision here), and subsequently appealed to the First Circuit.

The First Circuit affirmed the convictions.  The defendants had asked the trial court for a jury instruction preventing the jury “from considering any truthful, non-misleading promotional speech as evidence of the intended use” of the device.  The trial court refused to give such an instruction.  The First Circuit upheld that refusal, reasoning that the Supreme Court allows use of protected (i.e. truthful) speech as evidence of elements of a crime.  Use of truthful promotion here (the misdemeanors for which the defendants were convicted were strict liability) was not de facto criminalization of protected speech.  The defendants relied on the Second Circuit’s decision in Caronia (we would have done the same, and the Facteau court said that the reliance on Caronia was “understandable”).  But the Facteau court distinguished Caronia, because in Caronia the majority “was not persuaded that the government’s use of speech was limited to evidentiary purposes in that case.”  Moreover, Caronia involved a lowly sales representative, “whose sole purpose was to make promotional statements about the product.”  In other words, the gist of the Caronia case really does seem to have been based on protected speech.  By contrast, Facteau involved medical device corporate executives, and the record contained considerable non-speech evidence (internal corporate documents, regulatory history, sales rep training and experience, surgeon training).  The jury could reasonably have found this evidence of conduct to constitute the deliberate creation of a medical device that was designed for only off-label use as opposed to the “intended use” stated in its section 510(k) submission.  (Despite the chorus of criticism of recent Congressional testimony by a trio of tone-deaf college presidents, there really is a valid, if sometimes difficult, distinction between speech and conduct.)  Also, the crime at issue in Facteau was marketing without proper section510(k) clearance, not for inadequate directions for use, which was at issue in Caronia and is more intertwined with speech.  Thus, the First Circuit concluded that the defendants in Facteau were not convicted solely, or even primarily, based on protected speech.  

The defendants in Facteau also relied on two FDA guidance documents that, they argued, created a safe harbor policy that burdened speech excluded from the safe harbor by subjecting only such “disfavored” speech to the peril of being used as evidence of intended use.  That is, the defendants argued that the FDA’s safe harbor was content-based discrimination that could not withstand strict scrutiny.  The First Circuit disagreed with the defendants’ argument.  The FDA’s safe harbor for off label speech did not discriminate based on conduct and reduced rather than increased speech related restrictions. At most, the safe harbor put sellers of medical products “on notice about which of their statements the government deems most probative of that product’s intended use.”  Could such “notice” have a chilling effect?  Yes, of course. But the First Circuit saw such chilling as one of the “incidental effects” of regulation of non-speech conduct.     

The defendants argued that the lower court erred by not instructing the jury that evidence of intent could be gleaned only from external promotional statements.  The First Circuit rejected the premise of the defense argument. Labeling and promotions are certainly helpful in ascertaining intended use, but there is no reason to deem them the only admissible evidence. 

Perhaps more to the point was the defendants’ argument that the notion of “intended use” is unconstitutionally vague.  But the First Circuit held that the prosecution in this case could not be vague, since the back and forth between the company and the FDA, as well as the history of product development and marketing efforts made it quite clear that the company intended the product to be used for delivery of the steroid, not merely as a spacer with saline as set forth in the section 510(k) clearance.  The First Circuit was more interested in the actual record in the case, not interesting and clever abstractions:  “Whatever indeterminacy there might be about how much and what kinds of evidence would be sufficient to prove a new intended use in a close case, appellants cannot rely on that hypothetical indeterminacy to make a vagueness claim here.”  The defendants also complained of lack of fair warning, based on the government’s “interpretive pivot” in “expanding its definition of intended use to account for the fact that post-Caronia it may be more difficult to carry a conviction based on promotional statements alone.”  We have a lot of sympathy for the defense position on this point.  Commercial speech doctrine, particularly its application to truthful statements regarding off-label use of prescription products, has evolved, wandered, zigged and zagged.  It has produced uncertainty.  But the Facteau court essentially said that uncertainty is inevitable in the legal world, so stop whinging.  (We’ll never stop whinging about doctrinal inconsistency and uncertainty.  But it is easy for us; we’re not facing a criminal conviction or presentence report.)

As we noted in our earlier blogposts, there were other arguments raised by the defendants (such as sufficiency of the evidence, which is almost always a stone cold loser), and those arguments might hold significant interest for criminal law practitioners, as we once were, but they are not nearly as interesting for drug and device law drudges.