jueves, 10 de enero de 2019

A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh Circuits

A Pair of FDC Act-Related Convictions Upheld on Appeal in the Eighth and Eleventh Circuits

Link to FDA Law Blog

Posted: 09 Jan 2019 06:19 PM PST
By JP Ellison —
In two unrelated cases, two U.S. Courts of Appeal affirmed FDC Act-related convictions earlier this week.  In United States v. Patino, the Eighth Circuit held that it was not an abuse of discretion to allow the government to introduce, in connection with a 2016 prosecution for illegal distribution of HGH, evidence of the defendant’s conviction for essentially the same crime in 1998.  Under the applicable Federal Rule of Evidence, the court concluded that that the evidence was: relevant to the issues of knowledge and intent, similar, not overly remote in time, supported by sufficient evidence, and more probative than prejudicial.  As to the last factor of prejudice, the court simply noted, “The district court gave two limiting instructions, mitigating any potential prejudicial effect. See United States v. Horton, 756 F.3d 569, 580 (8th Cir. 2014).”  While we have no reason to doubt the court’s conclusion regarding the efficacy of the limiting instruction, the ruling does demonstrate the evidentiary difficulty that faces any defendant threatened by the government with a successive prosecution for a similar crime, namely that at trial, the government will almost certainly seek to put the earlier conviction before the jury.

In the Eleventh Circuit, the court affirmed the conviction of a former medical device company salesperson on, among other charges, conspiracy to transport stolen prescription medical devices.  In brief, the government alleged a conspiracy to steal medical devices from the manufacturer and resell them to hospitals.  Among the arguments on appeal were due process and evidentiary issues arising out of what the defendant contended were inconsistent government theories.  Specifically, the defendant argued that in a 2007 trial against an alleged co-conspirator, the government claimed that the victim was the device manufacturer, but in the defendant’s trial, the government claimed that the victims were the hospitals to which the stolen devices were sold.  A different aspect of this case was the subject of a divided Supreme Court decision in 2014.  In this appeal, the defendant argued that the government’s separate prosecutions under inconsistent theories constituted a due process violation; and in the alternative, that the government’s prior statements were admissible as statements of a party-opponent, namely the U.S. Department of Justice.  The court rejected both arguments on the grounds that the government’s theories were not, in fact, inconsistent.  Because of this conclusion, the decision discusses—but does not decide—the interesting issues of when inconsistent government prosecutions run afoul of constitutional due process considerations, and when the government’s statements in those prosecutions can be admitted into evidence.  This is more than a theoretical issue for FDC Act regulated entities and individuals, as we’ve seen instances of the government taking enforcement action in one case under the theory that the product is a drug, but arguing that it’s a dietary supplement in another; or arguing the product is adulterated in one case, but misbranded in another.

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