Opinion ID: 3204308
Heading Depth: 2
Heading Rank: 2

Heading: Sufficiency of the Evidence of Specific Intent

Text: Dessart next challenges the sufficiency of the evidence underlying his convictions. He argues that the government failed to present sufficient evidence that he acted with deceptive intent, a necessary factual predicate for felony penalties. As we’ve noted, violations of § 331 are ordinarily strict-liability misdemeanors, but if the defendant “commits such a violation with the intent to defraud or mislead,” the offense converts to a felony and harsher penalties apply. § 333(a)(2). The statute is silent as to the object of the deception, but the consensus among the circuits is that § 333(a)(2) applies if the defendant intended to deceive either consumers or the FDA or both. See United States v. Andersen, 45 F.3d 217, 219 (7th Cir. 1995) (rejecting in the context of Food, Drug, and Cosmetic Act violations committed with the intent to defraud the FDA the defendant’s argument “that fraud on a regulatory agency does not support the use of § 2F1.1,” the sentencing enhancement for “offense[s] involv[ing] fraud”); United States v. Ellis, 326 F.3d 550, 554 (4th Cir. 2003) (“The inquiry, therefore, is whether the defendant designed his conduct to avoid the regulatory scrutiny of the FDA.”); United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir. 1988) (“[T]he structure of the statutory scheme, the purpose of the statute, and the case law persuade us that Congress meant to encompass conduct intended to defraud government enforcement agencies.”). Any challenge to the sufficiency of the evidence comes with “a heavy, indeed, nearly insurmountable, burden.” United States v. Warren, 593 F.3d 540, 546 (7th Cir. 2010). To prevail, Dessart “must convince us that even after viewing No. 14-2686 13 the evidence in the light most favorable to the prosecution, no rational trier of fact could have found him guilty beyond a reasonable doubt.” Id. (quotation marks omitted). To recap the charges, in Count 1 Dessart was accused of operating an unregistered drug-manufacturing business in violation of § 331(p). 3 In Counts 2 through 12, he was accused of introducing misbranded drugs into interstate commerce in violation of § 331(a). In Counts 13 through 23, he was accused of misbranding drugs held for sale after shipment in interstate commerce in violation of § 331(k). Each count carried the § 333(a)(2) “with intent to defraud or mislead” enhancer. The evidence of Dessart’s intent to mislead the FDA was ample and easily sufficient to support the jury’s verdict. The government adduced substantial evidence that Dessart was fully aware of the requirements of the Act and took affirmative steps to evade compliance. As we’ve explained, the government introduced extensive evidence establishing that Dessart was operating an online “pharmacy” out of his home by manufacturing and selling various prescription drugs to weight lifters, bodybuilders, and others seeking to enhance their physical appearance or performance. The government presented evidence of the items seized in Dessart’s home—e.g., raw drug ingredients from overseas, flavorings, colorings, manufacturing equipment, packaging materials and labels, ready-to-use postal shipping packages—and also testimony from Dessart’s customers. The drugs were, in fact, human prescription drugs and were specifically marketed and intended for that use, but Dessart affixed 3 The registration duty is found in 21 U.S.C. § 360. 14 No. 14-2686 the label “for research only,” both on his website and on the drug packaging itself. And EDS-Research.com carried a lengthy and detailed disclaimer explicitly discussing the Act and its prohibitions on introducing unapproved new drugs into interstate commerce. Among other things, the disclaimer stated that the products offered for sale were not to be used as “drugs … for humans or animals or for commercial purposes” and should not “be considered to be food, drugs, medical devices, or cosmetics.” This factual foundation is easily sufficient to support a reasonable inference that Dessart was aware of his obligations under the Act and was intentionally trying to evade the regulatory authority of the FDA. Indeed, it would have been surprising had the jury not drawn that inference. There is no other explanation for affixing a “for research only” disclaimer on drugs sold for human consumption.