Tell us that that the feds prosecuted a doctor for using a medical device off-label, and the hairs on the back of our neck start to rise and do the samba. After all, off-label use can be good medicine, even the best. Then tell us that the same doctor also faced the music for using an “adulterated” device and our knees grow weak. The word “adulterated” gets thrown around an awful lot in the FDA regulations. You (and most jurors) might think of the old Upton Sinclair investigative journalism reports about fingers turning up in tubs of margarine, but “adulterated” can also refer to technical issues, such as labels that do not say quite enough. The recent case of U.S. v. Kaplan, 2016 WL 4709870 (9th Cir. Sept. 9, 2016), is arresting because it makes us wonder whether good facts (Bad facts? Weird facts?) might make bad law.
The defendant in the Kaplan case was a medical doctor accused of conspiring to violate 18 USC section 331(k) – using an adulterated medical device held for sale. Like the semi-adequate federal prosecutor we used to be, let’s start with the factual headline: this doctor reused single use prostate biopsy needles. Think for a moment about how prostate biopsy needles are used, then think about the impact of expert testimony to the effect that cleaning single use needles would not do the trick, and that the needles became discolored after use. Yuck. Then think about the effect of evidence that the doctor started reusing the single use needles for purely economic reasons, that he did not pass any savings along to the patients, and that other people in his medical practice told him to stop reusing the needles.
The main legal issues on appeal in Kaplan involved satisfaction of the “held for sale” element under section 331(k), whether the evidence showed the doctor knew the needles were adulterated, whether the court erred in refusing to instruct the jury that off-label use can be the proper practice of medicine, and whether the government had presented sufficient evidence of a conspiracy (agreement, overt act, criminal intent). The district court held, and the Ninth Circuit agreed, that a doctor’s use of a medical device is part of the product distribution chain and, thus, that the device is “held for sale” even though title to the device does not pass to the patient. As for knowledge/intent re adulteration, even though the defendant claimed he believed the cleaning process would work on single use needles, the court concluded that there was enough evidence for a rational jury to conclude that the doctor knew he was using an unproven process that risked contamination. Such an inference could also be supported by the doctor’s “attempt to conceal the truth from the public, the Nevada State Medical Board, and the FDA, by stating that reuse ended in January 2011, when in fact reuse continued into March.” [Apparently the doctor did not raise Buckman preemption, which would have been a creative reach in these circumstances.] The defendant’s proposed pro-off-label jury instructions were deemed unnecessary, because the instructions given did not suggest that off-label use constituted per se adulteration. Finally, the court saw enough evidence that the defendant agreed with others to reuse the needles, even after being notified by another doctor to stop the practice, to support a guilty verdict on conspiracy.
That last point is important. In our own experience in the U.S. Attorney’s office, a conspiracy count was useful for our client on the left side of the v (you know – the United States of America) because it permitted introduction of evidence that might otherwise not come in (e.g., coconspirator statements that would otherwise be hearsay), and it could keep alive conduct that might otherwise be barred by a statute of limitations. In our current practice, on the other side of the v, we are grateful for every day that passes where we have not confronted a civil plaintiff lawyer who has figured out a clever way to use a conspiracy claim. And now should we be grateful for every day that passes without an indictment along the lines of the Kaplan case? The Ninth Circuit drops a footnote that the case is not about the criminalization of malpractice. Rather, the facts in Kaplan are, one hopes, sui generis. And while we are talking about hopes, here’s hoping that prosecutorial discretion will play a beneficent role in cabining the Kaplan legal theory to those rare, appropriate cases. (The Kaplan case was brought in Nevada federal court, and it seems there has been some recent history of patients experiencing injuries in Nevada from reuse of single use devices. There may very well have been a strongly felt need to address this particular issue in this particular time and this particular place.) To be sure, the particular facts in Kaplan were nasty enough to result in a jury verdict of guilty beyond a reasonable doubt. Even more, those facts prompted the judge to depart upwards from the 37-41 month guideline and sentence the defendant to 48 months in prison. That is federal time, meaning the defendant will spend at least 80% of that time in stir. Here is our learned, scholarly analysis of that outcome: Wow.