United States v. Naushad

68 F.4th 380

UNITED STATES of America, Plaintiff - Appellee v. Abdul NAUSHAD, M.D., Defendant - AppellantUnited States of America, Plaintiff - Appellee v. Wajiha Naushad, Defendant - Appellant

No. 22-2864

No. 22-2865

United States Court of Appeals, Eighth Circuit

Submitted: April 12, 2023

Filed: May 17, 2023

Appeal from United States District Court for the Eastern District of Missouri - St. Louis

Counsel who presented argument on behalf of the appellant and appeared on the brief was Joseph Alex Little, IV, of Nashville, TN. Counsel who appeared on the brief were Khalid Kahloon of Louisville, KY and Zack C. Lawson of Nashville, TN.

Counsel who presented argument on behalf of the appellee and appeared on the brief was Derek James Wiseman, AUSA, of Saint Louis, MO.

Before BENTON, GRASZ, and STRAS, Circuit Judges.

BENTON, Circuit Judge.

Dr. Abdul Naushad and Wajiha A. Naushad injected their patients with Orthovisc that was not approved by the Food and Drug Administration, while falsely representing it as FDA-approved. A jury convicted them of healthcare fraud and conspiracy to commit offenses against the United States. The Naushads appeal. Having jurisdiction under 28 U.S.C. § 1291, this court affirms.

I.

Dr. Abdul Naushad and Wajiha A. Naushad operate a collection of affiliated pain clinics. From 2010 to 2017, they injected non-FDA-approved Orthovisc into their patients while representing to Medicare and Medicaid that it was FDA-approved Orthovisc. The non-approved Orthovisc costs less than half of FDA-approved Orthovisc. The FDA and the Naushads' own employees cautioned them not to use the non-approved Orthovisc. Still, they continued to use it and submit reimbursement claims for it.

A jury convicted the Naushads of two counts: Count 1 (conspiracy to commit offenses against the United States in violation of 18 U.S.C. § 371), and Count 24 (health care fraud in violation of 18 U.S.C. §§ 1347(a)(1) and (2)). The Naushads appeal, alleging that the district court¹ erred by denying motions for judgment of acquittal on both counts and committing several reversible errors that warrant a new trial.

II.

The Naushads argue that the district court erred by denying their motions for judgment of acquittal on both the conspiracy and fraud convictions. "In reviewing a denial of a motion for a judgment of acquittal, we review the sufficiency of the evidence de novo, evaluating the evidence in the light most favorable to the verdict and drawing all reasonable inferences in its favor." United States v. Almeida-Olivas, 865 F.3d 1060, 1062 (8th Cir. 2017).

The Naushads do not contest that the evidence establishes each statutory element for each offense. See United States v. Golding, 972 F.3d 1002, 1005-06 (8th Cir. 2020) (reciting the elements of conspiracy to commit an offense against the United States under 18 U.S.C. § 371 and the elements of health care fraud under 18 U.S.C. § 1347(a) the government must prove beyond a reasonable doubt). They do argue that the jury instructions and the indictment required the government to prove that non-approved Orthovisc is a "device" under the Federal Food, Drug, and Cosmetic Act. See 21 U.S.C. § 321(h) (2023).

The government counters that the classification of non-approved Orthovisc as a device was not an element of either statute under which the Naushads were charged. This court does not "assess sufficiency under the instructions given to the jury. The Supreme Court has recently held that 'a sufficiency challenge should be assessed against the elements of the charged crime, not against the erroneously heightened jury instructions.' " United States v. Ramos, 814 F.3d 910, 916 (8th Cir. 2016), quoting Musacchio v. United States, 577 U.S. 237, 243, 136 S.Ct. 709, 193 L.Ed.2d 639 (2016). "A reviewing court's limited determination on sufficiency review thus does not rest on how the jury was instructed." Musacchio, 577 U.S. at 243, 136 S.Ct. 709.

The Musacchio case forecloses the Naushads' argument that the jury instructions added another element that the government was required to prove beyond a reasonable doubt. See id. See also United States v. Gross, 23 F.4th 1048, 1053 (8th Cir. 2022) ("[W]here jury instructions ask the jury to find something not required by the statutory elements of an offense, we review the sufficiency of the evidence based only on the statutory elements of the charged crime."), citing Musacchio, 577 U.S. at 243, 136 S.Ct. 709. "A defendant has no due process right . . . to proof beyond a reasonable doubt of elements not necessary to constitute the crime charged, including elements erroneously or unnecessarily charged to the jury." United States v. Inman, 558 F.3d 742, 748 (8th Cir. 2009). "If, for example, a jury is charged that it must find three statutory elements and a fourth element not required by applicable law, that the evidence is insufficient to prove the fourth non-statutory element does not mean that a conviction that is properly supported under the applicable law deprives the defendant of his right to due process." Id.

Musacchio left open the question "whether sufficiency of the evidence at trial must be judged by reference to the elements charged in the indictment, even if the indictment charges one or more elements not required by statute." Musacchio, 577 U.S. at 244 n.2, 136 S.Ct. 709. And even though Gross and Inman focused on non-statutory elements in the jury instructions, the Naushads may not be able to rely on non-statutory elements in an indictment. Cf. Gross, 23 F.4th at 1053 (reviewing "the sufficiency of the evidence based only on the statutory elements of the charged crime" (emphasis added)); Inman, 558 F.3d at 748 ("A defendant has no due process right . . . to proof beyond a reasonable doubt of elements not necessary to constitute the crime charged . . . ."); United States v. Dennis, 19 F.4th 656, 671 (4th Cir. 2021) (assessing sufficiency of the evidence against the elements of the underlying statute, not the conjunctive indictment); United States v. Iverson, 818 F.3d 1015, 1026 (10th Cir. 2016) (same). The Naushads offer no authority that the indictment may require the government to prove elements of an offense beyond those required by the statute. It is doubtful that sufficiency review exceeds the statutory elements of the offenses.

Regardless, even if the non-statutory "device" element were an essential element to each offense, the government presented sufficient evidence, viewed in the light most favorable to the verdict, that non-approved Orthovisc is a device under the FDCA. Two witnesses—Dr. Laurence Coyne, an FDA expert, and Mira Leiwant, vice president of the non-approved Orthovisc manufacturer—testified that non-approved Orthovisc is a device. This expert testimony was sufficient to show that non-approved Orthovisc meets the FDCA definition of device:

The term "device" . . . means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man . . . .

21 U.S.C. § 321(h) (2023).

Dr. Coyne testified about a 2018 FDA Notice. See Notice of Intent to Consider the Appropriate Classification of Hyaluronic Acid Intra-Articular Products, 83 Fed. Reg. 64844 (Dec. 18, 2018). According to the Naushads, Dr. Coyne's testimony establishes that non-approved Orthovisc is a "drug," rather than a "device," under the FDCA because it achieves its primary intended purpose through chemical action. But Dr. Coyne testified that the Notice created only

room for debate about the actual action by which hyaluronic acid injectables² achieve their effect. It did not state forthrightly that they act by chemical effect. If the agency had come to that conclusion, then these—then hyaluronic acid injectables would be—there would have been a proposed change to have these classified as drugs rather than devices.

What the [Notice] actually stated was that, for new indications for use or new formulations of hyaluronic acid injectables, that the applicant is recommended to submit a request for a designation or a prerequest for designation to the Office of Combination Products. So it's not a decision terming these products to be drugs.

The Notice did not definitively conclude that Orthovisc achieves its primary intended purpose of the treatment of pain through chemical action. The Notice, in fact, reflects uncertainty about how hyaluronic acid products like Orthovisc work:

Because the current published scientific literature supports that [hyaluronic acid] achieves its primary intended purpose of the treatment of pain in [osteoarthritis] of the knee through chemical action, and therefore, [hyaluronic acid] for this use may not meet the definition of a device, sponsors of [hyaluronic acid] products who intend to submit a [premarket approval application] or a supplement to a [premarket approval application] for a change in indications for use, formulation, or route of administration are encouraged to obtain an informal or formal classification and jurisdictional determination through a Pre-[Request for Designation] or Request for Designation, respectively, from FDA prior to submission.

Notice, 83 Fed. Reg. at 64845 (emphases added). The Notice thus shows that "scientific literature supports" the finding that hyaluronic acid "achieves its primary intended purpose . . . through multiple mechanisms . . . ." Id. at 64844 (emphases added). Dr. Coyne's uncontradicted testimony confirms this. The Naushads misread the...