Summary
This Second Circuit opinion reviews the convictions and sentences of defendants who conspired to manufacture and distribute unapproved performance-enhancing drugs for racehorses in violation of the Food, Drug, and Cosmetic Act. The court held that the FDCA does not restrict the 'intent to defraud or mislead' element to specific victims, affirmed the admission of prior investigation evidence, and upheld the district court's use of defendant gains as a proxy for loss in sentencing. However, the court vacated the restitution order to racetracks due to lack of proven pecuniary loss and reversed the forfeiture order, determining the relevant FDCA section is not a civil forfeiture statute.
Topics
Practice areas
Questions Presented
- Whether 21 U.S.C. § 333(a)(2) limits the persons or entities who may be the targets of the required intent to defraud or mislead.
- Whether the district court properly admitted evidence concerning the 2011 Delaware regulatory investigation under Federal Rules of Evidence 404(b) and 403.
- Whether the district court properly used Fishman's gain as an alternative measure of loss under U.S.S.G. § 2B1.1(b)(1).
- Whether the district court properly ordered Fishman to pay restitution to racetracks when the racetracks did not establish actual pecuniary loss.
- Whether 21 U.S.C. § 334 is a civil forfeiture statute permitting criminal forfeiture and substitute-property forfeiture under 28 U.S.C. § 2461(c) and 21 U.S.C. § 853(p).
Holdings
- Section 333(a)(2) does not categorically limit the target of the requisite intent to defraud or mislead to consumers, purchasers, the FDA, or other specified victims. The intent must instead be connected to the underlying misbranding or adulteration violation, and state horse-racing regulators may be targets of that intent.
- The district court did not err in admitting evidence relating to the 2011 Delaware investigation, other than evidence of the racehorse's death that the court excluded. The evidence was intrinsic to the charged conspiracy because it concerned conduct within the conspiracy period and was also probative of Giannelli's knowledge, intent, and notice.
- The district court did not clearly err or commit plain error by finding actual loss to competitors and using Fishman's gain as an alternative measure of loss under U.S.S.G. § 2B1.1(b)(1), because actual loss existed but could not reasonably be determined.
- The district court abused its discretion by ordering Fishman to pay restitution to racetracks based on prize winnings because the racetracks would have paid prize money to someone regardless of the doping and therefore were not shown to have suffered actual pecuniary loss.
- Section 334 of the FDCA is not a civil forfeiture statute within the meaning of 28 U.S.C. § 2461(c). The district court therefore could not impose criminal forfeiture or substitute-property forfeiture under 21 U.S.C. § 853(p) based on the value of the adulterated or misbranded drugs.
Key quotations
“We thus affirm both Fishman’s and Giannelli’s convictions, affirm Fishman’s sentence, vacate Fishman’s restitution order and remand for further proceedings, and vacate Fishman’s forfeiture order.” (at 4-7)
“Section 333(a)(2) does not categorically exclude state horse racing regulators as targets of the required intent to defraud or mislead.” (at 26-27)
“We thus conclude that 21 U.S.C. § 334 is not a civil forfeiture statute within the meaning of § 2461(c) and that the district court therefore erred by imposing a criminal forfeiture order pursuant to § 2461(c).” (at 57-58)
Factual background
Seth Fishman, a veterinarian, developed and manufactured unapproved performance-enhancing drugs for racehorses and sold them to trainers, including Jorge Navarro. Lisa Giannelli served as a salesperson for Fishman's company and sold the drugs to horse trainers. The drugs were adulterated or misbranded, were designed to evade detection, and were administered to racehorses to gain competitive advantages. Fishman and Giannelli also engaged in deceptive conduct, including misleading labels, secretive client screening, and falsified customs forms.
Procedural history
Fishman and Giannelli were charged in separate trials with conspiracies to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead under the Food, Drug, and Cosmetic Act. Both were convicted in the Southern District of New York. Fishman received a 132-month sentence, restitution, and forfeiture; Giannelli received a 42-month sentence and forfeiture. The Second Circuit affirmed both convictions and Fishman's sentence, vacated Fishman's restitution order and remanded for reconsideration, and vacated Fishman's forfeiture order.
Remand instructions
The district court must reconsider Fishman's restitution order in light of the Second Circuit's conclusion that the racetracks were not shown to have suffered actual pecuniary loss. Fishman's forfeiture order is vacated, with no substitute-property forfeiture authorized under the cited statutes.