United States v. Vinod Patwardhan , 422 F. App'x 614 ( 2011 )

FILED
NOT FOR PUBLICATION MAR 18 2011
MOLLY C. DWYER, CLERK
UNITED STATES COURT OF APPEALS U .S. C O U R T OF APPE ALS
FOR THE NINTH CIRCUIT
UNITED STATES OF AMERICA, No. 09-50487
Plaintiff - Appellee, D.C. No. 5:08-cr-00172-VAP-1
v.
MEMORANDUM *
VINOD CHANDRASHEKM
PATWARDHAN,
Defendant - Appellant.
Appeal from the United States District Court
for the Central District of California
Virginia A. Phillips, District Judge, Presiding
Argued and Submitted February 8, 2011
Pasadena, California
Before: PREGERSON, WARDLAW, and BEA, Circuit Judges.
Vinod C. Patwardhan appeals his conviction following a jury trial for (1)
conspiracy, 18 U.S.C. § 371, (2) introducing misbranded drugs into interstate
commerce with intent to defraud or mislead, 21 U.S.C. §§ 331(a), 333(a)(2),
352(c), 352(f)(1), (3) smuggling goods into the United States, 18 U.S.C. § 545, (4)
*
This disposition is not appropriate for publication and is not precedent
except as provided by 9th Cir. R. 36-3.
aiding and abetting smuggling, 18 U.S.C. § 2(a), (b), and (5) criminal forfeiture, 18
U.S.C. §§ 981(a)(1)(C), 982(a)(2)(B), 21 U.S.C. § 853(p), 28 U.S.C. §§ 853(p),
2461(c). We have jurisdiction under 28 U.S.C. § 1291, and we affirm.1
I. Conviction of Introducing Misbranded Drugs into Interstate Commerce
Patwardhan was convicted of introducing misbranded drugs into interstate
commerce with intent to defraud or mislead. 21 U.S.C. §§ 331(a), 333(a)(2),
352(c), 352(f)(1). We reject Patwardhan’s argument that he cannot be convicted of
these charges.
Under the relevant statutory scheme, prescription drugs are per se
misbranded. See 21 C.F.R. § 201.5; see also Evers v. United States, 643 F.2d
1043, 1051 (5th Cir. 1981) (accepting the FDA’s assertion that “since a
prescription drug by definition can be used only under a physician’s supervision . .
. it is impossible to provide ‘adequate directions for use’ to a layman”) (citing
United States v. Articles of Drug, 625 F.2d 665, 673-75 (5th Cir. 1980)).
Prescription drugs legally flow through interstate commerce only when they fall
1
Because the parties are familiar with the facts of the case, we repeat them
here only to the extent necessary to explain our decision.
2
under one of two exceptions.2 See 21 C.F.R. §§ 201.100, 201.115; 21 U.S.C. §
353(b)(2); see also Evers, 643 F.2d at 1051.
Patwardhan does not argue, nor does an independent review of the record
support the conclusion, that the non-FDA approved foreign medicine he brought
into the United States for later distribution to his patients qualifies for either
exception. Thus, Patwardhan can be convicted of introducing misbranded drugs
2
Exception 1: Under 21 C.F.R. §§ 201.100, 201.115, a prescription drug is
not considered misbranded if the drug is in the possession of someone who can
lawfully engage in the dispensing of drugs, and the label contains, inter alia, the
statement “Rx only,” the recommended dosage, the route of administration, the
amount of each active ingredient, the names of inactive ingredients (if the drug is
for oral use), and a lot or control number.
Exception 2: Under 21 U.S.C. § 353(b)(2), “[a]ny drug dispensed by filling or
refilling a written or oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of [21 U.S.C. § 352]. .
. if the drug bears a label containing the name and address of the dispenser, the
serial number and date of the prescription or of its filing, the name of the
prescriber, and, if stated in the prescription, the name of the patient, and the
directions for use and cautionary statement, if any, contained in such prescription.”
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into interstate commerce in violation of 21 U.S.C. §§ 331(a), 333(a)(2), 352(c),
352(f)(1).3
Further, there was sufficient evidence presented at trial, viewed in the light
most favorable to the prosecution, for “‘any rational trier of fact [to find] . . .
beyond a reasonable doubt’” that Patwardhan acted with the intent to defraud or
mislead. United States v. Nevils, 598 F.3d 1158, 1161 (9th Cir. 2010) (quoting
Jackson v. Virginia, 443 U.S. 307, 319 (1979) (emphasis in original)). Patwardhan
told his staff not to give patients foreign medicine for at-home use after a patient’s
mother expressed concern about one label, which was written in Hindi.
Patwardhan never informed his patients that the drugs administered to them during
in-office treatments were not FDA-approved. To the contrary, the IV bags used to
administer the foreign medicine contained only the names of the FDA-approved
counterparts. Additionally, there was evidence that Patwardhan’s staff hid foreign
medicine during an audit, and used the codes corresponding to the FDA-approved
3
Patwardhan relies on the Fifth Circuit’s decision in Evers, 643 F.2d 1043, to
argue that it is legally impossible for a physician who administers prescription
medicine to his patients to be convicted under the misbranding statute. His
reliance is misplaced. Evers was charged under a different provision, section
331(k), which prohibits causing a drug to become misbranded while held after
shipment in interstate commerce. In contrast, Patwardhan was charged with
introducing misbranded drugs into interstate commerce under section 331(a).
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drugs, not the foreign medicines that had actually been used, when billing
Medicare for reimbursement.
II. Expert Testimony
We also conclude that the district court’s mid-trial ruling excluding the
testimony of expert witness Patrick Egan after that testimony was referenced in the
defense opening statement does not warrant a new trial. “Evidentiary rulings will
be reversed for abuse of discretion only if such nonconstitutional error more likely
than not affected the verdict.” U.S. v. Hankey, 203 F.3d 1160, 1167 (9th Cir.
2000). Patwardhan, however, has not demonstrated that he was prejudiced by the
district court’s ruling.
Overwhelming evidence supported the guilty verdict, and thus the district
court’s ruling did not affect the outcome of the trial. See id. Moreover, United
States v. Gonzalez-Maldonado, 115 F.3d 9 (1st Cir. 1997), upon which Patwardhan
relies to argue that he suffered prejudice as a result of the district court’s mid-trial
ruling, is distinguishable. In Gonzalez-Maldonado, the district court’s mid-trial
ruling prevented the defense from introducing important impeachment testimony
of the prosecution’s key witness, testimony that defense counsel had promised in
his opening statement the jury would hear. In contrast, Egan’s testimony was not
5
critical to Patwardhan’s defense, because Patwardhan never suggested that he was
confused by the particular laws Egan was going to address. Defense counsel
mentioned Egan only briefly in his opening statement, and the district court
prohibited the prosecution from arguing that defense counsel had broken its
promise by failing to introduce Egan’s testimony. Thus, Patwardhan has not
demonstrated that the district court’s mid-trial decision to exclude Egan’s
testimony prejudiced him as to require a new trial.
AFFIRMED.
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