68 F.4th 380
8th Cir.2023Background
- From 2010–2017 Dr. Abdul and Wajiha Naushad ran pain clinics and injected patients with a non‑FDA‑approved version of Orthovisc while billing Medicare/Medicaid as if it were FDA‑approved Orthovisc.
- The non‑approved product cost substantially less; FDA and clinic employees warned the Naushads not to use it, but they continued and submitted reimbursement claims.
- A jury convicted the Naushads of conspiracy to commit offenses against the United States (18 U.S.C. § 371) and health care fraud (18 U.S.C. § 1347). They appealed, arguing insufficiency of the evidence and several trial‑level errors.
- Central legal dispute: whether the government was required (by indictment or jury instruction) to prove that the non‑approved Orthovisc is a “device” under the FDCA, and whether exclusion of certain evidence and instructions prejudiced the defense.
- The Eighth Circuit reviewed sufficiency de novo and evidentiary/instructional rulings for abuse of discretion, ultimately affirming the convictions.
Issues
| Issue | Plaintiff's Argument (Gov't) | Defendant's Argument (Naushads) | Held |
|---|---|---|---|
| Sufficiency of evidence for conspiracy and health‑care fraud and whether FDCA‑"device" classification was an element | Gov't: statutory elements do not include FDCA device classification; even if they did, testimony proved non‑approved Orthovisc is a device | Naushads: jury instructions/indictment required proof that the product is a FDCA "device," and evidence failed to show that | Held: review is against statutory elements (Musacchio); even if device were required, expert testimony sufficed to classify non‑approved Orthovisc as a device, so convictions stand |
| Exclusion of defense expert testimony arguing non‑approved Orthovisc works by chemical action (thus a "drug") | Gov't: district court reasonably excluded misleading or unsupported testimony under Rule 403 | Naushads: exclusion prevented them from presenting their classification theory | Held: Naushads waived a definitive ruling; in any event district court did not abuse discretion because the Notice did not definitively classify the product and the court properly limited misleading argument |
| Striking sentence from theory‑of‑defense instruction and limiting FDCA‑device argument | Gov't: the struck sentence was duplicative/misleading given other instructions and could confuse jury | Naushads: removal deprived them of a necessary defense instruction | Held: no prejudicial error—sentence was duplicative/misleading and its exclusion did not harm the defense |
| Denial of advice‑of‑counsel instruction | Gov't: Naushads failed to disclose material facts to their attorney, so instruction lacked foundation | Naushads: they relied on counsel and thus deserved the instruction | Held: district court properly denied instruction — defendants did not fully disclose material facts and so failed to meet the foundational requirements for the defense |
Key Cases Cited
- Musacchio v. United States, 577 U.S. 237 (2016) (sufficiency review applies to statutory elements, not to erroneous jury instructions)
- United States v. Ramos, 814 F.3d 910 (8th Cir. 2016) (discussing Musacchio and sufficiency review)
- United States v. Gross, 23 F.4th 1048 (8th Cir. 2022) (sufficiency reviewed against statutory elements when jury instructions add non‑statutory elements)
- United States v. Inman, 558 F.3d 742 (8th Cir. 2009) (no due process right to proof of non‑statutory elements charged to the jury)
- United States v. Golding, 972 F.3d 1002 (8th Cir. 2020) (reciting elements of conspiracy and health‑care fraud)
- United States v. Almeida‑Olivas, 865 F.3d 1060 (8th Cir. 2017) (standard for reviewing denial of judgment of acquittal)
- United States v. Morales, 684 F.3d 749 (8th Cir. 2012) (requiring a definitive ruling on evidentiary objections under Rule 103(a))
- Davis v. White, 858 F.3d 1155 (8th Cir. 2017) (admission/exclusion of evidence reviewed for abuse of discretion)
- United States v. Wilcox, 487 F.3d 1163 (8th Cir. 2007) (district court may prohibit misrepresentative or confusing arguments)
- United States v. Rice, 449 F.3d 887 (8th Cir. 2006) (foundation required for advice‑of‑counsel instruction)
- United States v. Petters, 663 F.3d 375 (8th Cir. 2011) (consulting an attorney does not immunize criminal conduct)
- United States v. DeFries, 129 F.3d 1293 (D.C. Cir. 1997) (contrasting precedent on advice‑of‑counsel instruction)
- United States v. Leon, 924 F.3d 1021 (8th Cir. 2019) (prejudice required to reverse an instructional error)
- United States v. Cornelison, 717 F.3d 623 (8th Cir. 2013) (instruction unnecessary if duplicative)