For most of you, it has been a long time since you thought much about criminal law. Do you remember the hypothetical about the murder victim who perished on a desert hike and it was difficult to pinpoint the criminal(s) because one person had poisoned the water in the victim’s canteen, one had replaced the water with sand, and another had drilled a hole in the bottom of the canteen? Is it possible that you have forgotten the doctrines of legal and factual impossibility? Get ready for some law school nostalgia, as we discuss an interesting recent criminal case with rulings on legal impossibility and Due Process/vagueness involving the scope of FDA authority.

We never pass up an opportunity to blog about a criminal case. Criminal cases bring us back to our old prosecutor days. They are also inherently juicier cases. That’s why there are heaps of tv shows and movies about criminal matters, and very few focusing on answering interrogatories. The district court in United States v. Conigliaro, 2019 U.S. Dist. LEXIS 96453 (D. Mass. June 7, 2019), sets up the background nicely: “Once a promising niche drug business, the now defunct New England Compounding Center (NECC) willfully deviated from pharmaceutical industry safety standards in a mad pursuit of profits. Scores died and hundreds were injured when three contaminated batches of injectable methylprednisolone acetate (MPA) triggered a national outbreak of fungal meningitis.” The defendants in this case were employees of NECC who had been convicted of conspiring to defraud the United States in violation of 18 U.S.C. section 371. (We do not know whether the lead defendant was in any way related to the great and tragic Tony C of the Red Sox.)

What exactly was the alleged fraud? The government’s theory was that NECC falsely held itself out as a small-time compounder that was more like a retail pharmacy than a full-scale manufacturer, thereby eluding FDA regulation. The defendants argued that it was legally impossible for the FDA to be defrauded in the manner alleged, because the FDA did not have jurisdiction over compounding pharmacies at the time of the relevant events. That defense of legal impossibility, so goes the argument, saves the day for the defendants even if the defendants uttered false statements in the mistaken belief that the FDA had authority it actually lacked.

At this point, the Conigliaro court offered a mini-treatise on the legal defense of impossibility, breaking the concept down into factual and legal impossibility. The Conigliaro court is even more fond of strange hypotheticals than your criminal law professor was. Typical examples of factual impossibility include trying to pick an empty pocket or pulling the trigger of an unloaded gun. Factual impossibility is not a good defense against charges of inchoate crimes such as attempt or conspiracy. We once prosecuted a case in which actual Sherpas (that was their name) were caught bringing suitcases of heroin into LAX. Their defense? They thought they were smuggling counterfeit money. That was a clever ploy, because the sentence for distributing counterfeit money was much less severe than distributing narcotics. By the way, it didn’t work.

By contrast, legal impossibility applies to cases if facts are as the defendant believes them to be, but the completed act is not legally a crime. For example, someone who sneaks a smoke of marijuana in Massachusetts thinking it illegal when, in fact, it isn’t, cannot be charged with a crime. But the factual-legal impossibility division is hardly neat. It often ends up as a pure matter of semantics. The Conigliaro court almost gleefully takes us through perplexing examples, such as the hapless hunter who shot a stuffed deer out of season (we mean out of actual, live deer season – there is no seasonal restriction on shooting stuffed deer), or the defendant who purchased what he thought was stolen cloth, though the cloth had actually been recovered by the thief, returned to the rightful owner, and then borrowed by the police to set up the buy-bust. These cases often turn on whether the focus is on the defendant’s mens rea or the real world actus reus. (We warned you that we would be tugging you back to law school.). Other examples abound in the Conigliaro case, and the opinion is good reading,

But let’s cut to the chase. With all the doctrinal complexities, the Conigliaro court decided that one cannot be convicted of conspiring to do something that is lawful. The problem in the case was that the FDA’s power to regulate compounders – even big-time operations like NECC, which was not merely doing the compounding on an as-ordered basis – was far from clear. In a way, the Conigliaro court did not so much decide that the impossibility defense worked here; it really decided that it was such a close, murky question that the prosecution was too vague. The issue of whether the FDA could regulate compounders was too vague for the defendants to figure out. It was even too vague for the FDA to figure out. The Conigliaro court cited several instances of high-up FDA officials confessing that the regulatory scheme never anticipated the development of large-scale compounders. Those officials admitted that the line was “blurry,” not “bright.” If the FDA was unsure of the scope of its authority, how could the defendants know for sure? The vagueness of whether what happened was a crime at all, coupled with the lenity principle, meant that the criminal convictions for conspiring to defraud the FDA had to be reversed.

We have blogged before about Due Process in the context of vague and ambiguous FDA statements. When the FDA is confused or confusing about its authority, other people of “common intelligence” are left to guess. Such guesswork should not lead to criminal convictions – or, for that matter, civil liability. Let’s leave it at this: we can think of many other drug and device litigations, some going on right now, where more clarity from the FDA and other agencies could have avoided problems and litigation.