United States v. Jackson, 2025 U.S. App. LEXIS 1261, 2025 WL 249109 (4th Cir. Jan. 21, 2025), is a criminal case involving off-label use of a medical device. The Fourth Circuit affirmed the conviction of a doctor for violating the Food, Drug, and Cosmetic Act, aggravated identity theft, and related offenses. The court sentenced the doctor to 25 years of imprisonment.  There are plenty of violent criminals who do not get sentences that severe, so to the Jackson court, we say: You have our attention. 

This blog has many times discussed how off label use can be benign. Indeed, off label use can be the standard of care   Thus, the prospect of a quarter of a century behind bars for off label use would seem to be extraordinary. But the facts in the Jackson case are not good for the defendant, and that mattered. Those bad facts mattered both to the court’s reasoning and, no doubt, to the decision to prosecute the case.  The prosecutors in Jackson clearly believed there was nothing remotely benign about the doctor’s off-label use. 

There is prosecutorial discretion and there are also office guidelines.  The reality is that federal prosecutors cannot indict every violation of federal criminal statutes. Out in the streets, in boardrooms, and even in medical offices, crimes are happening.  There are too many to catch, too many to prosecute, and too many to convict. Enter prosecutorial guidelines. For example, when we worked in the United States Attorney’s Office in Los Angeles, we indicted narcotics cases only if there was a certain minimum amount (which was pretty high) of drugs distributed.  For other crimes, we looked for aggravating circumstances.  Here is another example: while it is a federal crime under 8 U.S.C. Section 1326 for an alien who has been convicted of a felony and then deported to return to the United States, we would not indict unless there were multiple convictions and multiple deportations. If you think about it, that is remarkable and scary.  In any event, if our office guidelines were not met, prosecution was left to the locals.  

There were aggravating circumstances in the Jackson case.  Those aggravating circumstances draw a stark contrast to the rather vanilla, even rote, accusations of off label use and adulteration that get tossed around casually in civil cases. Plaintiff lawyers insert accusations of off label promotion and adulteration in personal injury complaints to make things sound bad. But the reality is usually quite benign.  Not so in Jackson. 

It takes a lot of serious convictions to get to 25 years.  The jury found the defendant guilty of several crimes:

– The doctor in Jackson was convicted under 21 U.S.C section 331(k) for reusing an “adulterated” single-use device. The device was a sinus dilation tool. The use was off-label because the dilator was not supposed to be reused. By reusing the device, the doctor made more money.  The government also alleged that reuse of he device subjected patients to health risks. Cleaning the dilators was not good enough. The defendant doctor was a large-scale user of the device in connection with government reimbursed operations.  

– The doctor was also convicted of violating the anti-kickback statute, 42 U.S.C. section 1320a-7b, because she billed Medicare without advising patients of their copayment responsibilities.  

– During a Medicare audit, the doctor falsified billing records.  She submitted declarations from patients that were phony.  They contained false notarizations and forged signatures.  This conduct supported convictions for making materially false statements, 18 U.S.C. section 1035(a)(2), and for aggravated identity theft, 18 U.S.C. section 1028(a), as well as mail fraud, 18 U.S.C. sections 1341 and 1349. 

– The doctor was also convicted of conspiring to commit the above crimes.  

The defendant challenged all her convictions, but we will discuss only the most interesting issues here. She argued that the government had not satisfied the “held for sale” requirement under 21 U.S.C. section 331(k). Her point was that the patients did not actually purchase the medical devices at issue. (In an odd, almost perverse way, the reuse of the devices supported her point.) The Jackson court pointed to a Ninth Circuit ruling that the “held for sale” element was satisfied whenever a physician used the item in the course of treating patients, “given the commercial nature of a physician’s treatment of patients.”  Single-use devices are considered “consumed” in treating a patient, and are thus “held for sale” as contemplated by the statute.  Mind you, the Jackson court did not say that the Ninth Circuit decision was correct.  No, all the Jackson court said was that the Ninth Circuit decision was not crazy.  And because there was no contradictory authority anywhere, including in the Fourth Circuit, the trial court’s decision to follow the Ninth Circuit could not constitute plain error.  The plain error standard applied because the defendant had not raised the “held for sale” issue below.  Consequently, Jackson is a case in which the standard of review was dispositive. (Jackson is an object lesson in why it is good to have at least one person on the trial team focused on preserving appellate issues, whispering in your ear or passing notes telling you to make objections.) 

The other main argument by the defendant on appeal was that 21 U.S.C. section 396 condones off label use. But the Jackson court held that off-label use, as allowed by §396, does not apply to off-label use of devices that are not “legally marketed” in the first place.  Adulterated devices cannot be legally marketed.  Physicians may engage in the off-label use of unadulterated products, but not adulterated products.  

This holding in Jackson could have created a substantial limit on off-label use, but the decision made clear that the “adulteration” in this case was not merely a technical application of the statutory definition of “adulteration.”  Rather, and quite unlike virtually all the civil product liability cases we encounter, the “adulteration” status of the devices in Jackson was based on actual evidence of risk of harm.  Mere off-label reuse of a single-use device is not, per se, adulteration, but ample evidence showed that the reused devices here were not kept in sanitary condition.  (At the same time, the defendant argued that the trial court erred by excluding evidence that no patient had actually been harmed by a reused sinus dilator.  That evidentiary ruling was held not to be an abuse of discretion.  Once again, the standard of review was a very big deal.)

The conviction in Jackson was not based on the fact of the FDA’s single-use approval, which was not mentioned in the relevant jury instructions.  The single-use aspect was relevant to the government being defrauded by being charged several times for a single device. 

The defendant’s appeal also attacked the government’s use of the so-called Golden Rule argument in its closing.  Golden Rule arguments improperly “encourage the jury to depart from neutrality and to decide the case on the basis of personal interest and bias rather than on the evidence.”  In the mass torts space, we call such things Reptile arguments. In Jackson, the prosecutor did at one point ask the jurors to consider whether they would prefer a sterile device to an adulterated one. That was getting very close to the line, if not quite crossing it. But, again, the plaintiff error standard rode in to the government’s rescue.  The court pointed out that the Golden Rule ditty took up only “three lines in a closing argument that spans some thirteen pages devoted just to Count 1.”  The Fourth Circuit refused to overturn the conviction on that basis.  

We conclude with a practice pointer. If you read enough cases in which appeals claim error in closing arguments, you will see the sort of mathematical, word counting calculation employed by the Jackson court. When we prosecuted a case and got in a piece of evidence that was iffy (such as a prior similar crime under Fed. R. Evid. 404(b)) or deployed an argument that veered toward the prejudicial, it was important not to start with it, or finish with it, or do too much with it.  Use it. Plant a seed.  But do not linger. The key was to make it easy for an appellate court to conclude that the claimed error probably did not make a difference.