Case: 14-20307      Document: 00513089484         Page: 1    Date Filed: 06/23/2015




           IN THE UNITED STATES COURT OF APPEALS
                    FOR THE FIFTH CIRCUIT
                                                                            United States Court of Appeals
                                                                                     Fifth Circuit

                                                                                   FILED
                                      No. 14-20307                             June 23, 2015
                                                                              Lyle W. Cayce
UNITED STATES OF AMERICA,                                                          Clerk


                                                 Plaintiff - Appellee

v.

MOHAMMAD JAMAL RASHID,

                                                 Defendant - Appellant



                   Appeal from the United States District Court
                        for the Southern District of Texas
                              USDC No. 4:13-CR-579


Before JONES, SMITH, and COSTA, Circuit Judges.
PER CURIAM:*
       Mohammad Jamal Rashid (Rashid) pled guilty to one count of receiving
in interstate commerce and delivering or proffering for delivery, drugs that
were misbranded, for pay or otherwise, with intent to defraud and mislead, in
violation of 21 U.S.C. §§ 331(c) and 333(a)(2). He also pled guilty to one count
of conspiracy, inter alia, to import counterfeit goods. 18 U.S.C. § 371. The
district court applied a two-level enhancement under U.S.S.G. § 2B5.3(b)(6)(A)
and imposed a sentence of 27 months’ imprisonment on both counts, to run


       * Pursuant to 5TH CIR. R. 47.5, the court has determined that this opinion should not
be published and is not precedent except under the limited circumstances set forth in 5TH
CIR. R. 47.5.4.
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                                      No. 14-20307
concurrently, as well as separate terms of supervised release on each
conviction. Rashid appeals the application of the risk enhancement under
§ 2B5.3(b)(6). We find the evidence insufficient to support the district court’s
implicit finding under this guideline that Rashid’s conduct created a risk of
death or serious bodily injury. Accordingly, we VACATE Rashid’s sentence
and REMAND.
                                             I.
       Rashid entered into an agreement with Ashiq Ali Ghulan-Haider, also
known as “Tina,” and an individual known as Zalfiqar to import misbranded,
counterfeit drug tablets from China into the United States.                  Specifically,
Rashid agreed to receive at his home a package containing counterfeit drugs
labeled as Viagra® and Cialis® tablets. In return for Rashid’s cooperation,
Tina agreed to forgive a $300 debt Rashid owed to him.                     The package,
addressed to a false name at Rashid’s address, was seized by United States
Customs and Border Protection Officers. It contained 7,200 counterfeit and
misbranded tablets of Viagra and Cialis. An undercover federal agent then
delivered the seized package to Rashid’s home, where Rashid purported to be
the person whose name was listed on the package and told the agent that he
had been expecting its arrival. After Rashid accepted the package, the agent
detained him for questioning.
       During questioning, Rashid detailed his agreement with Tina and
Zulfiqar and agreed to cooperate with the investigation.                 Samples of the
counterfeit tablets were sent to the Food and Drug Administration (“FDA”),
Pfizer, and Eli Lilly for testing; 1 the tests confirmed that the tablets were
counterfeit and misbranded. The packages of Viagra purported to contain



       1Pfizer is the exclusive manufacturer and distributor of Viagra in the United States,
and Eli Lilly is the exclusive manufacturer and distributor of Cialis in the United States.
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100 milligrams of sildenafil citrate, but testing revealed that each tablet
contained less than 100 milligrams of the ingredient. The Cialis tablets also
contained sildenafil citrate, though the package claimed that the tablets
contained 20 milligram of tadalafil, the active ingredient in Cialis.
      After Rashid pled guilty, the probation officer determined a base level of
eight for Rashid’s offense, recommended several enhancements in the
presentence report (“PSR”), including a two-level enhancement under U.S.S.G.
§ 2B5.3(b)(6)(A) for an offense that “involved a conscious or reckless risk of
death or serious bodily injury,” and calculated the advisory guidelines range at
33 to 41 months’ imprisonment. Rashid objected to the enhancement under
§ 2B5.3(b)(6)(A) as unwarranted because the PSR contained no evidence that
the tablets were capable of causing death or serious bodily injury. In an
addendum to the PSR, the probation officer replied that “the offense, by its
nature, and on the instant facts given the incorrect pharmaceutical ingredients
in the tables, involves the conscious or reckless risk of death or serious bodily
injury to prospective customers.” The government submitted “victim impact
statements” from Eli Lilly and Pfizer. Each company’s statement included
approximately one paragraph warning about the potential risks that drugs like
Viagra or Cialis can pose.
      At sentencing, the court overruled all of Rashid’s objections, adopting the
PSR and its addenda. The district judge made no specific findings regarding
§ 2B5.3(b)(6)(A), but stated only that “of course, these drugs could only be
selected by a lawfully – by written prescription, and I think the response
speaks for itself.” The district judge also suggested the possibility that the
counterfeit tablets also contained “fillers,” such as “industrial stuff.” Defense
counsel objected to the suggestion as “wildly inappropriate” speculation, and
the judge noted that he would not consider it when making his sentencing
decision. The court imposed a sentence, slightly below the guidelines range, of
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27 months’ imprisonment on both counts concurrently. Rashid did not again
object to the sentence, but filed a timely notice of appeal.
                                              II.
       We review a district court’s application of the sentencing guidelines de
novo, and its factual findings for clear error. See United States v. Garcia-
Guerrero, 

, 895 (5th Cir. 2002). Rashid challenges the district
court’s application of § 2B5.3(b)(6)(A), asserting that the evidence does not
support the finding that the tablets he received were capable of causing death
or serious bodily injury, nor does it support a finding that he was consciously
aware of any risk of death or serious bodily injury, or that any such risk would
have been obvious to a reasonable person.
       The application of the § 2B5.3(b)(6)(A) risk enhancement is one of first
impression in this court. U.S.S.G. § 2B5.3(b)(6), Criminal Infringement of
Copyright or Trademark, provides:
       [i]f the offense involved (A) the conscious or reckless risk of death
       or serious bodily injury . . . increase by 2 levels.” 2


§ 2B5.3(b)(6). Rashid maintains that the enhancement was conjectural and
thus clearly erroneous because the government did not show that the
counterfeit tablets in fact posed a risk of death or serious bodily injury. He
also challenges the implication that generalized statements about the dangers
associated with counterfeit drugs can be sufficient to establish risk.
       The 2011 Guidelines define a “serious bodily injury” as an “injury
involving extreme physical pain or the protracted impairment of a function of
a bodily member, organ, or mental faculty; or requiring medical intervention


       2The PSR used the 2011 edition of the Guidelines. In November 2013, the Guidelines
were amended and the risk enhancement provision was renumbered § 2B5.3(b)(6)(A). For
the purposes of simplicity, all citations in this opinion will be to the provision as designated
under the current Guidelines.
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such as surgery, hospitalization, or physical rehabilitation.” U.S.S.G. § 1B1.1,
comment n.1(L). At sentencing, the district court did not explain why Rashid’s
conduct created a risk of serious injury sufficient to justify the risk
enhancement, saying only that the presence of counterfeit Viagra and Cialis
“speaks for itself.” This finding is premised on a belief that counterfeit drugs
are per se risky and pose an inherent risk of serious bodily injury. With regard
to the application of sentence enhancements, however, this court has
emphasized that bright-line tests are not necessarily appropriate. See United
States v. Bailon, 444 F. App’x 55, 61 (5th Cir. 2011) (“[A] single, bright-line test
is not necessarily appropriate for a guideline that must be applied to a wide
variety of factual settings.”) (quoting Zuniga-Amezquita, 

, 889
(5th Cir. 2006)). Because § 2B5.3(b)(6) may apply to innumerable counterfeit
drugs, it is best defined through careful application to the specific facts of a
case. See Bailon, 444 F.App’x at 61 (refusing to adopt a blanket rule that giving
any drug to a minor who is not one’s child carries an inherent risk of serious
bodily injury). Relevant factors a district court may consider in cases involving
counterfeit drugs may include the nature of the particular drug involved, all of
its active and inactive ingredients, the intended uses, the individuals for whom
the drug is designed, and the FDA-issued warnings about the drug.
      In Zhou, for example, the Tenth Circuit held the enhancement was
proper where the defendant’s production and distribution of counterfeit Alli®,
a weight loss drug, created the risk of serious bodily injury. United States v.
Zhou, 

(10th Cir. 2012). The risk of injury was established by
FDA alerts “describing the serious health risks posed generally by drugs
containing Sibutramine . . . and warnings specifically addressing the health
risks of the counterfeit Alli [the defendant] was producing and distributing.”
Zhou, 

, 1151-52. Specifically, there was evidence in Zhou that
individuals taking counterfeit Alli “may have been taking three times the usual
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                                   No. 14-20307
daily dose . . . . [Those doses cause] anxiety, nausea, heart palpitations,
tachycardia (a racing heart), insomnia and small increases in blood pressure
in healthy people. In those with a history of cardiovascular disease, it could
lead to elevated blood pressure, stroke, or heart attack.” 

n.5. Notably, the inquiry in Zhou was not whether the particular risk
was inherent in all counterfeit drugs, nor was it limited to the question of
whether the defendant’s specific counterfeit drugs posed the requisite risk.
Instead, the court focused on whether the type of drug was generally associated
with such risk and if so, whether counterfeiting the drug compounded the
likelihood of the risk.
      In this case, the PSR relied only on general statements regarding the
importance of FDA oversight and the government’s “victim impact statements”
provided on behalf of Pfizer and Eli Lilly. The PSR noted, without further
explanation, that “the offense, by its nature, and on the instant facts given the
incorrect pharmaceutical ingredients in the tablets, involves the conscious or
reckless risk of death or serious bodily injury to prospective customers.” The
“victim impact statements” from Eli Lilly and Pfizer were equally vague. Each
company’s statement includes only one paragraph that mentions potential
health concerns associated with the drugs. Indeed, the extent of the warnings
contained in Pfizer’s statement are as follows:
      Pharmaceutical drugs like VIAGRA® are substances that must be
      carefully handled and transported in specific ways and under
      specific conditions. When the supply chain is compromised or
      counterfeit drugs are sold patients may receive drugs that are
      ineffective or unsafe.

Similarly, Eli Lilly’s statement declares that:

      Counterfeit drugs pose an inherent risk of death or serious bodily
      injury. Approved pharmaceutical manufacturers are subject to
      FDA oversight and inspection of their manufacturing processes as

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                                      No. 14-20307
       well as strict packaging and labeling requirements . . . . Lilly’s
       manufacturing processes are tightly controlled in order to prevent
       inadvertent or knowing adulteration of its pharmaceutical
       products. Offenses involving counterfeit drugs circumvent these
       processes and pose a grave threat to public health and safety.

Unlike in Zhou, where the FDA had issued warnings about the dangers of
ingesting Alli and counterfeit Alli products, none of the evidence here suggests
that a similar danger of serious bodily injury or death is associated with
Viagra, Cialis, or their counterfeit counterparts.
       To justify applying the § 2B5.3(b)(6) enhancement for a counterfeit drug
offense, the government must provide at least some evidence that the
particular drug or the particular counterfeit version poses a threat of serious
bodily injury or death. Without more, generalized statements about the safety
concerns associated with counterfeit drugs are insufficient to support a two-
level increase under § 2B5.3(b)(6)(A). See 

.
       Neither the PSR nor the “victim impact statements” support a finding
that drugs like Viagra, Cialis, and their counterfeits, are associated with an
increased risk of death or serious bodily injury. The district court’s application
of the enhancement provision under § 2B5.3(b)(6) was error. The record is
unclear as to whether the district court would have imposed the same sentence
under the lower advisory guidelines range calculated without reference to this
enhancement.       Because there is a possibility that Rashid’s sentence was
influenced by the erroneous guidelines calculation, the error is not harmless. 3
Accordingly, we VACATE Rashid’s sentence and REMAND for resentencing
consistent with this opinion.



       3Having concluded that the application of the enhancement was error based on the
analysis of risk, we need not reach Rashid’s additional arguments discussing his subjective
awareness of the risk or the contention that the risk would have been obvious to a reasonable
person.
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