Can a court decision be simultaneously depressing and exhilarating? You might be surprised how often that happens. In United States v. Facteau, 2020 WL 5517573, (D. Mass. Sept. 14, 2020), the court upheld criminalization of off-label promotion, but did so in a way that might signal the end of an era in which pharmaceutical companies and their employees are prosecuted for truthful communications about off label uses.

The Facteau case has been around a long time. We blogged about this particular off-label promotion prosecution here. In the end – spoiler alert – the convictions remained in place. It is quite hard to overturn criminal convictions. Nobody would say so out loud, but the notion of sunk costs sometimes plays a role. (We were on the defense team in the notorious Florida tobacco trial that took two years to reach an absurd result, which was largely overturned by the appellate court. By the time the trial entered its third month – with many more to go – the plaintiff lawyer would engage in the most outrageous conduct, confident that the trial judge would not throw away all the time put in by the empaneled jury. Sadly, the plaintiff lawyer’s confidence was not misplaced.)

The court’s decision in Facteau shows an exhaustion, and maybe even an exasperation, with the government’s theory. We get that sense from the beginning of the opinion. The court tells us that the jury found the the CEO and Vice President of Sales of a medical device company guilty of misdemeanor adulteration and misbranding, while acquitting them of all the other charges, including felony misbranding and adulteration and securities fraud. That is, the defendants were acquitted of all the serious, intent-based felony charges and were convicted under only the strict liability misdemeanor misbranding and adulteration counts. The defendants filed post-trial motions for acquittal or a new trial.

Before announcing denial of those motions, the court gathered itself, took a breath, and then wrote this: “As no doubt evidenced by the time it has taken to resolve this motion, the Court finds the issues raised in these pleadings and at trial challenging. There is also a First Amendment overlay that further complicates the analysis. It seems clear that the statutory and regulatory scheme needs to be rethought. Currently there is no statute that specifically prohibits off-label marketing and yet the Government continues to prosecute the conduct by patching together the misbranding and adulteration regulations, thereby criminalizing conduct that it is not entirely clear Congress intended to criminalize.”

Amen.

But meanwhile, the court was stuck with a set of facts that seemed to support the jury finding that the device at issue was not well suited to the use for which it was cleared (treating sinusitis via a spacer with saline) and that the defendants’ plan was always to sell it for off-label use (promoting use of the spacer to elute steroids). The record included evidence of communications with doctors, via sponsored meetings, society get-togethers, training videos, training decks, sell sheets, and field ride alongs that focused on the off-label steroid use rather than the on-label saline use.

What about the First Amendment? The Facteau court offers a lengthy, and pretty decent for a defense loss, discussion of the First Amendment and truthful off-label promotion. The court takes us through Caronia and Amarin and acknowledges that there is First Amendment protection of truthful manufacturer speech about off-label use. But then the opinion seems at war with itself, allowing the prosecution to introduce truthful off-label promotion as “evidence of intent” when the counts for which the defendants were convicted were not intent based, although the acquitted charges were intent based. Moreover, it is unclear from the court’s opinion whether the defendants ever denied that they intended off-label sales. Look, as a former federal prosecutor, we get how proof of a crime can involve proofs of all sorts of things that are not, unto themselves, criminal acts. A defendant can be convicted of being part of a criminal drug-trafficking conspiracy based on an act that might seem innocent in isolation, such as writing a note, placing a telephone call, or renting a car. That innocent act might even enjoy First Amendment protection. Still, the overall context of the Facteau prosecution makes one wonder why the criminal division of the USAO burned calories bringing this case.

As mentioned in the Facteau court’s opening paragraph, the government sought to criminalize off label promotion by patching together the misbranding and adulteration regulations, putting a lot of weight on the “intended use” regulation. We have often (here, for example) disparaged this regulatory two-step. It is especially fishy when someone’s liberty is at stake. Nevertheless, the Facteau court concluded that the FDA’s “intended use” regulation was not unconstitutionally vague. Intended use requires objective evidence of such intent, and the Facteau court found ample objective evidence in the case, including external communications pushing the off label use. (By the way, last week the FDA issued a proposed new rule on the definition of “intended use” and how that would be ascertained for medical products. The new regulation would make things even worse and murkier for companies and their employees.)

The court also okayed corporate officer strict liability for the misbranding and adulteration offenses. The defendants argued that such liability was at odds with due process. The Facteau court rejected that argument, pointing to the SCOTUS opinion in the Park case. Thus, the terrifying Park doctrine remains as a big hammer in a prosecutor’s toolbox.

The defendants in Facteau also challenged the sufficiency of the evidence on the adulteration and misbranding counts. Sufficiency of the evidence is always a hard argument for a criminal defendant to win, and they didn’t win here. In addition, the defendants argued that the adulteration and misbranding convictions were mutually exclusive because one theory treated the device as a PMA product, while the other treated it as a 510(k) device. Inconsistency would not by itself undermine the convictions, but if guilt on one count would render guilt on the other impossible, the defendants might have a point. But the Facteau court saw no inconsistency in the case: “Failure to file a PMA is the crucial element of adulteration, and failure to file a 510(k) or a PMA are the key elements of misbranding. Defendants’ conduct could satisfy the elements of both crimes. The fact that adulteration and misbranding share some elements does not mean that Defendants can only be convicted of one or the other.”

The Facteau court also ruled that various evidentiary and trial issues did not rise to abuse of discretion. Most of these issues are case-specific and will not be of much service to practitioners. But one of the asserted errors was that the court let the government get away with presenting “misleading, unsupported, and inflammatory assertions” to the effect that the defendants’ conduct placed patients at risk. The court concluded that the government’s assertions either weren’t as bad as the defendants claimed, or were appropriate rebuttal, or were harmless. But the Facteau case is remarkable for its lack of any evidence, or even allegation, that anybody was injured as a consequence of the off-label use of this product.

In short, this long opinion produces sad result for the defendants. The only consolation – and it is cold consolation for the defendants – is that this case is far from a ringing endorsement of the government’s aggressive prosecution. It ends with more of a whimper than a bang. The defendants could not satisfy their heavy burden of undoing a jury verdict, but it is hard to believe that anyone, including the court, was very happy with this case. The Facteau decision marks the end (putting aside a possible appeal to the First Circuit) of an old prosecution that in all likelihood (fingers crossed) would not be brought today.