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.