United States v. Zhou

Court of Appeals for the Tenth Circuit·Decided June 10, 2013·No. 11-1261·Published

Opinion

FILED

United States Court of Appeals Tenth Circuit

June 10, 2013

Elisabeth A. Shumaker

Clerk of Court

PUBLISH

UNITED STATES COURT OF APPEALS TENTH CIRCUIT

UNITED STATES OF AMERICA, Plaintiff-Appellee, v. No. 11-1261 SHENGYANG ZHOU a/k/a TOM, Defendant-Appellant.

Appeal from the United States District Court for the District of Colorado (D.C. No. 1:10-CR-00226-PAB-1)

Jessica E. Yates of Snell & Wilmer L.L.P. , Denver, Colorado, for Defendant- Appellant.

James C. Murphy, Assistant U.S. Attorney (John F. Walsh, United States Attorney, with him on the brief), Denver, Colorado, for Plaintiff-Appellee.

Before KELLY, SEYMOUR, and TYMKOVICH, Circuit Judges.

SEYMOUR, Circuit Judge.

Mr. Shengyang Zhou pled guilty to trafficking and attempted trafficking of counterfeit goods in violation of 18 U.S.C. § 2320 and § 2. He was sentenced to eighty-seven months’ imprisonment and three years’ supervised release, and he was ordered to pay restitution of $507,567. Mr. Zhou contends the district court made a number of errors in sentencing him. We disagree and affirm.

I.

Mr. Zhou’s plea agreement set forth a lengthy statement of facts which the parties agreed the government’s evidence would establish. The following facts are taken from the plea agreement or from undisputed portions of the presentence report, which the district court adopted. See F ED . R. C RIM . P. 32(i)(3) (“At sentencing, the court: (A) may accept any undisputed portion of the presentence report as a finding of fact. . . .”).

Between December 2008 and March 2009, the Food and Drug Administration (FDA) issued a series of nationwide broadcast alerts on its website advising the public that the agency had identified over seventy-two purported weight loss products containing undeclared active pharmaceutical ingredients (APIs) that could put consumers’ health at risk. One of the undeclared APIs was Sibutramine, a Schedule IV non-narcotic controlled substance that was at the time approved by the FDA only for the treatment of obesity in a patented drug commonly known as “Meridia.” The alerts stated that the listed products posed serious health risks and advised consumers to immediately stop taking them and

to consult a medical professional.

Starting in January 2010, the FDA issued a separate series of broadcast alerts on its website regarding the marketing and sales of counterfeit versions of a weight loss product known by its brand name, “Alli,” which had also been found to contain dangerous levels of Sibutramine. The genuine product is manufactured by the pharmaceutical company Glaxo Smith Kline (GSK) and contains Orlistat as its API, not Sibutramine, and is approved by the FDA for over-the-counter sales. The alerts indicated that the counterfeit Alli was typically being sold to consumers on internet auction websites and looked similar to the authentic Alli weight loss drug, including the Alli name and trademarks, but contained certain enumerated defects. The alerts further warned that consumers who took counterfeit versions of the drug in accordance with the GSK dosing directions for genuine Alli could be ingesting up to twice the recommended maximum dosage for Sibutramine, resulting in a myriad of health risks.

During all periods relevant to this case, the name “Alli” and certain stylized versions of that name were trademarks registered by GSK on the principal register of the United States Patent and Trademark Office. GSK used these registered trademarks on the labels affixed to the bottles in which the Alli capsules were contained, on the associated boxes and related packaging, and on patient literature enclosed with the product.

The investigation of Mr. Zhou was initiated by federal agents from the FDA

Office of Criminal Investigations (OCI), Immigration and Customs Enforcement (ICE), and the Postal Inspection Service after a controlled delivery in April 2009 to a Broomfield, Colorado resident identified as J.K. The parcel contained hundreds of boxes of “Super Slim” and “Meizitang,” two of the purported weight loss products listed in the FDA alerts as containing undeclared APIs. J.K. advised the agents that he operated an internet-based business selling these purported weight loss products to consumers throughout the United States. He informed the agents that one of his suppliers was a Chinese national ultimately identified by the agents as Mr. Zhou. J.K. told the agents that he had previously purchased from Mr. Zhou commercial quantities of these products, as well as “2 Day Diet,” another product listed in the FDA alerts. He admitted that he had continued to purchase these products after learning about the FDA warnings and corresponding with Mr. Zhou about the alerts.

Starting in August 2009, an FDA-OCI undercover agent began contacting Mr. Zhou through email, first portraying himself as J.K. and then also as J.K.’s business partner. In November 2009, the undercover agent placed an order with Mr. Zhou for 500 boxes of Super Slim. Mr. Zhou filled this order during late November and early December by causing six parcels to be mailed from various addresses in China to an undercover address in Littleton, Colorado. The parcels contained more than 18,000 capsules of Super Slim in blister packs, samples of which were determined in FDA laboratory testing to contain Sibutramine. In

exchange, agents paid Mr. Zhou $2,500 via two Western Union payments sent to an individual in China later identified by Mr. Zhou as his girlfriend.

In January 2010, the undercover FDA-OCI agent, acting as J.K.’s business partner, placed a second order with Mr. Zhou for 200 boxes of Super Slim and 100 boxes each of Meizitang and 2 Day Diet. In addition, having learned that Mr. Zhou also sold commercial quantities of purported Alli, the agent requested fifty boxes of Alli. Mr. Zhou fulfilled this order, causing five parcels containing the requested quantities of the drugs and accompanying packaging and leaflets to be mailed from China to the undercover address in Littleton, Colorado. Tested samples from these parcels were determined to contain Sibutramine.

One of these five parcels contained approximately 6,000 capsules of purported Alli, along with fifty folded boxes, bottles, and consumer product literature bearing the registered trademarks and other markings of the authentic Alli product (each bottle and corresponding box were to contain 120 capsules). On close inspection, the capsules, bottles, and related packaging and literature were found to share the same defects and errors detected in the counterfeit Alli products that were the subject of the FDA warnings. The agents paid Mr. Zhou $4,000 for these shipments via Western Union wire transfers to Mr. Zhou’s girlfriend in China.

In February 2010, Mr. Zhou agreed to meet with the FDA-OCI undercover agent in Bangkok, Thailand for the ostensible purpose of negotiating future sales

of larger volumes of counterfeit weight loss products, as well as to introduce Mr. Zhou to a second undercover agent, a Postal Inspector, posing as the owner of a chain of grocery and health food stores in the United States. During the meetings, which were video and audio recorded, Mr. Zhou portrayed himself as the manufacturer and supplier of the counterfeit weight loss products and acknowledged that they contained Sibutramine and were the subject of FDA alerts in the United States. He told the agents that he sold commercial quantities of these products to various re-distributors in the United States, including in Colorado and Pennsylvania. Mr. Zhou and the agents discussed the various defects in his last batch of counterfeit Alli, and Mr. Zhou promised to correct these problems in the next batch of 10,000 boxes he planned to manufacture.

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