Chein v. Drug Enforcement Admin.

Citation533 F.3d 828
Decision Date22 July 2008
Docket NumberNo. 07-1051.,07-1051.
PartiesEdmund CHEIN, M.D., Petitioner v. DRUG ENFORCEMENT ADMINISTRATION et al., Respondents.
CourtUnited States Courts of Appeals. United States Court of Appeals (District of Columbia)

Jonathan W. Emord argued the cause for the petitioner. Charles M. Sevilla was on brief.

Teresa A. Wallbaum, Attorney, United States Department of Justice, argued the cause for the respondent.

Before: SENTELLE, Chief Judge, and HENDERSON and RANDOLPH, Circuit Judges.

Opinion for the court filed by Circuit Judge HENDERSON.


Edmund Chein (Chein) seeks review of the revocation of his practitioner's registration and the denial of his application for a registration to export Schedule III non-narcotic and Schedule IV controlled substances—both actions taken by the United States Drug Enforcement Administration (DEA). The DEA Deputy Administrator (DA) found that it was not in the public interest to renew Chein's practitioner's registration or to grant him an export registration because he provided several undercover agents with anabolic steroids to enhance athletic performance; committed a number of record keeping violations; ordered controlled substances using an unauthorized DEA registration number; illegally imported controlled substances from an unregistered Mexican pharmacy and illegally shipped controlled substances to hundreds of overseas patients without a DEA export registration. Moreover, the DA found that Chein continued to dispense controlled substances even after his DEA registration had been suspended and continued to export controlled substances even after being informed by DEA that it was illegal to do so. For the reasons set forth below, we deny his petition.


Chein is the owner of the Palm Springs Life Extension Institute (PSLEI) in Palm Springs, California. He is a physician, having graduated in 1980 from the American University of the Caribbean School of Medicine. He also holds a law degree. Edmund Chein, M.D.; Revocation of Practitioner's Registration, Denial of Application for Exporter's Registration, 72 Fed. Reg. 6580, 6582 (Feb. 12, 2007). Chein is licensed to practice medicine in California and in Utah and was, before the proceeding under review, registered with DEA to dispense controlled substances (Schedules II through V). See Gov't Ex. (GX) 2. Chein purports to be "one of the world's leading authorities in the field of anti-aging medicine." Chein Br. 8. He believes that "every adult experiences hormone level reductions over time and those reductions coincide with outward and inward signs of aging." Id. Chein claims that "through gradual increases in hormones to those approximating youthful levels, along with exercise and diet modification, individuals can slow the process of aging and delay the onset of, or prevent, age-related conditions." Id. This is accomplished through the "administration of very low doses of hormones over an extended period of time, accompanied by continued monitoring of baseline hormone levels until they slowly rise to approximate levels of a healthy young adult." Id. at 9. Chein calls the practice "total hormone replacement therapy." (THRT). Id. at 8. According to Chein, THRT differs from traditional gastroenterology in that "[a physician] administers hormones when they are less than those common in people of comparable age; [in] THRT, by contrast, [a physician] administers hormone[s] when levels drop below those of a typical healthy young adult." Id. at 8-9. He asserts that "[n]o patient has ever complained" about his practice. Id. at 9.

Chein has had a tense history, however, with the California Medical Board (CMB), DEA and law enforcement in general.1 The CMB has taken action against Chein's medical license three times. In 1995, the CMB revoked Chein's license, stayed the revocation and put him on probation for "failing to obtain a ... business license and for falsely advertising himself as a physician and lawyer when he had never obtained a license to practice law." Chein v. Med. Bd. of Cal., No. 00CS00319, at 4 (Cal.Super.Ct. Nov. 9, 2000); GX 125. In 2000 the CMB again revoked Chein's medical license, charging that he had "prescribed human growth hormone for a patient without medical indication and ... had made false and misleading statements in certain publications and advertisements about hormone replacement therapy." Id. at 1. Chein challenged the revocation in state court and was successful in part. Id. at 17. The CMB and Chein ultimately entered into a settlement agreement revoking Chein's license, staying the revocation and suspending Chein from the practice of medicine for 10 ½ months "with credit for 10½ months already served." GX 113, at 4; GX 125, at 2.

In 2002, the CMB initiated a third disciplinary action against Chein alleging, inter alia, that he had "prescrib[ed] ... [human growth hormone] without a good faith examination and medical indication," "fail[ed] to maintain adequate and accurate records," "obtained controlled substances by deceit, misrepresentation and subterfuge" and "dispensed controlled substances without proper privileges." In re Edmund Chein, M.D., No. 19-2000-107723, Accusation ¶¶ 18, 21-23, 31 (filed Aug. 15, 2002). The CMB and Chein eventually settled this dispute as well, noting that the settlement "[was] intended to resolve," in addition to the CMB's disciplinary action, "any disciplinary action taken by another state or the federal government based on the conduct alleged in the [August 15, 2002 Accusation]." In re Edmund Chein, M.D., No. 19-2000-107723, Stipulated Settlement & Disciplinary Order 2-3 (filed Sept. 22, 2005). Under the settlement, the CMB revoked Chein's medical license, stayed the revocation and placed Chein on probation for five years.2

Chein has also had a long history with DEA. In 1994 and 1995, investigators from DEA, the Food and Drug Administration (FDA) and the United States Customs Service (Customs) conducted a series of undercover visits to PSLEI. During the visits Chein dispensed and prescribed Human Growth Hormone (HGH) and anabolic steroids3 to the investigators ostensibly to improve athletic performance.4 On May 23, 1996, FDA obtained a search warrant for PSLEI. See Search Warrant 1, No. 96-1101 (May 23, 2006). FDA and DEA investigators who conducted the search seized various anabolic steroids. Tr. 132. Although DEA regulations require a registrant to maintain purchase records, an inventory and a dispensing log at his registered address; see, e.g., 21 C.F.R. §§ 1304.03-.04, no such records were found during the search. Tr. 134.5

On July 20, 2000, Chein applied to renew his DEA practitioner's registration. See GX 1. Because Chein's California medical license was revoked at the time, his application received close scrutiny. On January 31, 2001, DEA Diversion Investigator (DI) Doris DeSantis, accompanied by DI Linda Martin, visited PSLEI to interview Chein, inspect his clinic and review his records. Tr. 263. Chein was not there at the time and the two met instead with Darryl Garber—another physician practicing at PSLEI. Garber informed DI DeSantis that he could not provide the biennial inventory and dispensing logs because they were stored electronically and none of the employees on duty knew how to access PSLEI's computer system. Id. at 268-69. Another PSLEI employee informed DI DeSantis that the purchase invoices were stored off-site with PSLEI's accountant. Id. at 273. Garber was eventually able to provide only two invoices, both for the purchase of phentermine (a Schedule III controlled substance). Id. at 275-76. DI DeSantis informed Garber that DEA regulations require records to be readily available for inspection and copying and that invoices be stored on-site. Id. at 274; see also infra note 6.

Five days later, DI DeSantis and DI Martin returned to PSLEI to review the records that were not available during their earlier visit. Id. at 277. Again, Chein was not present. Id. at 279. Garber asked the investigators to wait while he retrieved the records. After two or three hours he returned with a one-page computer generated inventory report, id. at 281; GX 8, dispensing logs for phentermine and various forms of testosterone, id. at 284; GX 9-16, and four purchase invoices for phentermine, id. 331-33; GX 17.6 The documents revealed several irregularities. DEA regulations require a registrant to maintain most records for two years "for inspection and copying" by DEA employees, 21 C.F.R. § 1304.04(a); however, the dispensing logs Garber produced covered only the seven-month period from July 1, 2000 to February 5, 2001. See Tr. 286-87; GX 9-16. In addition, the dispensing logs indicated that during the seven-month period, PSLEI physicians had dispensed controlled substances 317 times to patients in foreign countries, including France, Germany, Great Britain, Spain, Switzerland, China (Hong Kong), Indonesia, Japan, South Korea and Canada; see GX 10-12, 15, 16. Neither Chein nor Garber had an export registration required to dispense overseas. See GX 2; see also 21 U.S.C. §§ 957 & 958. Moreover, some shipments went to countries where the products were illegal. See, e.g., GX 38(c) (Garber acknowledged that "[i]n Japan and Korea it is against the law to prescribe Anabolic Steroids and Phentermine for the purpose of Anti-Aging Medicine." (citations omitted)); see also 21 U.S.C. § 953(e) (registered exporter required to file export declaration with DEA indicating "importation is not contrary to the laws or regulations of the country of destination" for each shipment). The dispensing logs Garber produced indicated that PSLEI physicians regularly dispensed various forms of testosterone, see GX 9-16, but Garber did not provide any purchase invoices therefor. Tr. 334. Finally, the four phentermine purchase invoices indicated that PSLEI employees had been...

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