The law prohibits driving in some cases. One situation is while under the influence of alcohol or drugs. Another happens when driving with “elevated blood alcohol content”. A person is “under the influence” if their ability to drive is affected by alcohol or drugs to an appreciable degree. This comes from (Infeld v. Sullivan, 151 Conn. 506 (1964)). This may get prosecuted with or without any direct evidence of their BAC.
A person has an elevated blood alcohol content if their BAC is at least .08% alcohol by weight. The law also makes it illegal for someone driving a commercial motor vehicle to have a BAC of .04% or more. Also, anyone under age 21 can’t drive with a BAC of .02% or more.
The DUI law applies to drivers operating motor vehicles anywhere. This includes their own property, and people operating snowmobiles and all-terrain vehicles (CGS § 14-227a(a)).
Before dismissing or reducing a DUI charge, a prosecutor must state their reasons in court (CGS § 14-227a(f)).
A police officer may measure a motorist’s BAC by testing the driver’s blood, breath, or urine. The law establishes a rebuttable presumption that a driver’s BAC at the time it is tested is the same as the BAC at the time they were stopped. The law requires two tests at least 10 minutes apart. If the result of the second test is .10% or less, and higher than the first test, the prosecution must demonstrate that the test results and analysis accurately reflect the driver’s BAC at the time of the alleged offense (CGS § 14-227a(b)).
A person convicted of DUI is subject to the criminal penalties listed in Table 1. In assessing these penalties, the law considers a subsequent conviction one that occurs within 10 years of a prior conviction for the same offense (CGS § 14-227a(g)).
In practice, the first conviction of a driver for DUI is usually for the driver’s second violation. By law, a first DUI offender may apply for admission to the Pretrial Alcohol Education Program. The applicant must state certain things under oath. They must not have used the program in the preceding 10 years. Or, if under age 21, has never been in the program. The court must dismiss the DUI charges if the driver satisfactorily completes the program.
The law allows the Department of Correction (DOC) commissioner to release an inmate sentenced for DUI. This happens after admission and conducting a risk and needs assessment, to the inmate’s home. The released offender cannot leave their home without authorization. They remain in DOC custody and supervision by DOC employees. The DOC commissioner can revoke the release and return the person to prison for violating release conditions (CGS § 18-100h(a)).
For second or subsequent DUI convictions, the law requires some things of an offender. First, they must submit to an alcohol or drug abuse assessment through the Judicial Branch’s Court Support Services Division (CSSD). Second, they must undergo a treatment program if ordered to do so by the court.
The license suspension gets stayed while a conviction gets appealed. For motorists driving under a special operator’s permit (described below) suspension periods double. In addition to these penalties, the court can order a driver to participate in an alcohol education and treatment program (CGS § 14-227a (j)).
Suspension for conviction of a criminal DUI charge is in addition to any previously imposed administrative license suspension under the implied consent law (see below). The Connecticut Supreme Court has held that an administrative license suspension is not a bar to criminal prosecution (State v. Hickam, 235 Conn. 614 (1995)).
If the court sentences someone to probation, it may require as a condition that the offender take part in a victim impact panel program approved by CSSD. The panel must provide a nonconfrontational forum for victims of alcohol or drug related offenses and offenders to share experiences on the impact of alcohol or drug related incidents on their lives. The nonprofit organization that conducts the panel may charge a fee of up to $75. This goes for any offender ordered to participate (CGS § 14-227a(l), as amended by PA 12-178).
Also, any conviction that occurs in another state for an offense that the court determines has substantially the same essential elements as Connecticut’s criminal drunk driving offenses, second degree manslaughter with a motor vehicle, or second degree assault with a motor vehicle, will constitute a prior conviction of the same offense for purposes of determining someone’s prior criminal history (CGS § 14-227a(g)).
The law imposes stricter rules on 16- and 17-year-old drivers driving under the influence of alcohol or drugs. This is also the case for these drivers driving with an elevated BAC (which for them is .02% or more). Under these conditions, the police officer must seize the driver’s license for 48 hours and have the vehicle removed. The license is considered suspended for 48 hours, starting when the arrest is made or the summons issued.
To regain the license, the 16- or 17-year-old and, unless they are an emancipated minor, their parent or legal guardian, must, after the 48-hour period ends, appear in person at the police department, state police barracks, or other designated location and sign a written acknowledgement of its return. No restoration fee may be charged for return of the license. The police officer who seized the license must send a written report of the violation and the suspension to the DMV commissioner (CGS § 14-36i(b)).
A driver under age 18 who is arrested for DUI is not eligible for youthful offender status (CGS § 54-76b).
Ignition interlock devices are installed in motor vehicles to prevent people from driving under the influence of alcohol. They require the driver to breathe into them to operate the vehicle. If the device detects a BAC above a certain threshold (.025% in Connecticut), it prevents the vehicle from being started. Interlock devices also require the driver to submit periodic breath samples while they are driving. Offenders must pay DMV a $100 fee before the device is installed; DMV uses this money to administer the interlock program. Offenders also must pay the costs of installing and maintaining the devices (CGS § 14-227a (i)).
By law, DMV must suspend the license of all people convicted of DUI for 45 days (except for drivers under age 21, whose license is suspended until that age, if longer than 45 days). The following interlock restrictions apply once the license suspension ends. (However, the commissioner may extend, through regulations she adopts, periods of required interlock use beyond those the law requires (CGS § 14-227a (i) (10)).
First-time offenders must drive only vehicles equipped with ignition interlocks for one year. Second-time offenders (age 21 or older) must drive only interlock-equipped vehicles for three years.
During the first year of the three-year period, second-time offenders may only drive interlock-equipped vehicles to or from (1) work, (2) school, (3) an alcohol or drug abuse treatment program, or (4) an ignition interlock service center. The commissioner must note this restriction on the driver’s electronic records (license and driving history), just as for other ignition interlock requirements.
First and second-time offenders must verify to the commissioner, in a manner she determines, that they have had the interlock devices installed (CGS § 14-227a(i), as amended by PA 12-178).
The law requires individuals convicted for a second or subsequent time of DUI to (1) submit to an alcohol or drug abuse assessment through CSSD and (2) undergo a treatment program if ordered to do so by the court (CGS § 14-111(i)(2), as amended by PA 12-178).
The law requires DMV to revoke the license of third-time and subsequent offenders, although, starting January 1, 2013, it allows the offender to request that DMV restore the license after two years. The commissioner may restore the license if she determines doing so does not endanger public safety, the individual has met certain requirements (including completing an alcohol and drug education program, see below), and on the condition the offender drives only vehicles equipped with interlocks for as long as they continue to drive. But the law also allows an offender to ask the commissioner to lift the interlock requirement after 15 years, and allows the commissioner to do so after a hearing and for good cause.
The same provisions apply through December 31, 2012, except that (1) an offender may apply for reinstatement after six, rather than two, years; (2) after reinstatement, the offender must drive only interlock-equipped vehicles for 10 years, rather than for as long as they drive; and (3) there is no provision allowing the commissioner to remove the interlock requirement.
Third-time and subsequent offenders also must submit to the same drug and alcohol assessment as second-time offenders.
Anyone who drives implicitly consents to the testing of their blood, breath, or urine. If the driver is a minor, their parents or guardians are considered to have given their consent.
4. Inform the driver that evidence of a refusal may be used against them in a criminal prosecution.


§ 41-7 Experts and staff.
§ 41-8 Powers and duties.
§ 41-9 Rules and regulations.
§ 41-10 Conflicts of interest.
§ 41-14 Citizens' Advisory Committee.
§ 41-19 List of property owners.
§ 41-22 Payment of taxes.
§ 41-24 Filing of copies.
Environmental Commission — See Ch. 25.
Zoning Board of Adjustment — See Ch. 66.
Development regulations — See Ch. 114.


text:
1. Whether the district court committed plain error by sentencing petitioner in accordance with 21 U.S.C. 841(b)(1)(C) (1994 & Supp. IV 1998), when the quantity of drugs that petitioner conspired to possess and distribute, in violation of 21 U.S.C. 846, was not alleged in the indictment or found by the jury.
2. Whether petitioner was denied his Sixth Amendment right to effective assistance of counsel when the district court admitted testimony connecting a witness to petitioner through their representation by the same attorney.
The opinion of the court of appeals (Pet. App. 1-3) is unpublished, but the decision is noted at 221 F.3d 1345 (Table).
The judgment of the court of appeals (Pet. App. 4) was entered on July 5, 2000. The petition for a writ of certiorari was filed on October 2, 2000. The jurisdiction of this Court is invoked under 28 U.S.C. 1254(1).
After a jury trial in the United States District Court for the District of Nebraska, petitioner was convicted of conspiracy to distribute and to possess with intent to distribute marijuana, in violation of 21 U.S.C. 841(a)(1) and 21 U.S.C. 846 (Count I), and of conspiracy to distribute and to possess with intent to distribute anabolic steroids, also in violation of 21 U.S.C. 841(a)(1) and 21 U.S.C. 846 (Count II). Pet. App. 1, 5-6. He was sentenced to 210 months' imprisonment, to be followed by five years' supervised release. Id. at 8-10. The court of appeals affirmed. Id. at 1-3.
1. Petitioner was the head of a multi-state drug distribution network that operated out of Omaha, Nebraska. The operation came to light when law enforcement officers seized a half-pound of marijuana from an individual who identified petitioner as his source. Gov't C.A. Br. 2-4.
The ensuing investigation revealed that petitioner often used couriers to transport marijuana. Three of the couriers agreed to cooperate in the investigation, including by providing the names of other couriers used by petitioner. They identified one of those couriers as John Britton, a resident of California, who had recently been arrested in Wyoming driving a rental car with 180 pounds of marijuana in the trunk. According to one of the cooperating couriers, the marijuana was destined for petitioner. Gov't C.A. Br. 9-10.
The investigation culminated in a search of petitioner's residence. Law enforcement officers seized approximately one kilogram of marijuana, anabolic steroids, and four firearms. They also found drug records and a ledger with the names of several persons, including two of the cooperating couriers and one Louis Palazzo. Gov't C.A. Br. 13-14.
2. A federal grand jury returned a two-count indictment charging petitioner with conspiring to distribute marijuana and steroids. The indictment did not allege a specific or threshold quantity of either substance. Pet. App. 5-6.
Before trial, the government subpoenaed John Britton, the alleged courier, as a potential witness. The government also filed a motion to compel Britton's testimony if he invoked his Fifth Amendment privilege against self-incrimination with respect to his Wyoming prosecution. Fifteen minutes after the government filed that motion, Louis Palazzo of Las Vegas, Nevada, filed an application for admission to the court pro hac vice to represent petitioner. Pet. App. 47, 49, 51.
On the morning that the trial was to begin, the district court learned that Palazzo had previously represented Britton. The court subsequently convened a hearing on whether Palazzo's representation of petitioner created a conflict of interest. Palazzo acknowledged that he had served as counsel to Britton in connection with his Wyoming arrest. Palazzo asserted that no conflict would exist in his representation of both petitioner and Britton, because any cross-examination of Britton in petitioner's case would be conducted by Palazzo's co-counsel. Pet. App. 46-52.
In response to questioning by the district court, petitioner stated that he wanted to be represented by Palazzo, that he would object if Palazzo was not allowed to remain as his counsel, and that he waived any potential conflict arising from Palazzo's previous representation of Britton. Pet. App. 53-54. The court therefore allowed Palazzo to remain as co-counsel in petitioner's case. Id. at 54.
The government called Britton as a witness at petitioner's trial. Britton, testifying under a grant of immunity, admitted that he knew petitioner. But Britton denied that the marijuana he was transporting at the time of his arrest was petitioner's. Gov't C.A. Br. 20-21.
The government then sought to link Britton to petitioner by establishing that they had the same attorney. The district court overruled petitioner's objection, based on Federal Rules of Evidence 402 and 403, to the introduction of testimony about Palazzo's representation of Britton. Pet. App. 55-58.1 During closing argument, the government suggested that Britton protected petitioner because they were both represented by Palazzo. Id. at 66.
The jury found petitioner guilty on both counts. At sentencing, the district court found that petitioner's crimes involved 868.3234 kilograms of marijuana and an undetermined amount of steroids. Pet. App. 17. The court sentenced petitioner to concurrent terms of 210 months' imprisonment on the marijuana count and 60 months' imprisonment on the steroid count. Id. at 8-9.
3. The court of appeals affirmed in an unpublished per curiam opinion. Pet. App. 1-3.
The court of appeals rejected petitioner's contention that he was denied his Sixth Amendment right to counsel because the jury was permitted to learn that one of his attorneys also represented a government witness. Pet. App. 2. At the outset, the court observed that petitioner "arguably" waived any right to challenge any alleged conflict of interest, because petitioner had "insisted * * * that he be permitted to have counsel of his choice" and had "expressly waived any potential or actual conflict." Ibid. The court acknowledged that the admission of testimony concerning Palazzo's dual representation of petitioner and Britton "was problematic" and the prosecutor's reference to the dual representation during closing argument "may have been inopportune." Ibid. But the court concluded, based on "the record as a whole," that the testimony and argument "could not have affected the jury's verdict and therefore did not deprive [petitioner] of a fair trial." Ibid.
The court of appeals rejected petitioner's challenge to the district court's calculation of the quantity of drugs involved in his offense. Pet. App. 3. The court found that "[t]here was sufficient, credible testimony regarding the amount of drugs involved in the crimes," and that "sufficient evidence linked the shipments of drugs to [petitioner]." Ibid.
1. Petitioner contends (Pet. 3-6), for the first time in this Court, that his sentence was imposed in violation of this Court's decision in Apprendi v. New Jersey, 120 S. Ct. 2348 (2000), because the jury was not required to find the quantity of drugs involved in his offenses. In Apprendi, the Court held that, as a matter of constitutional law, "[o]ther than the fact of a prior conviction, any fact that increases the penalty for a crime beyond the prescribed statutory maximum must be submitted to a jury, and proved beyond a reasonable doubt." Id. at 2362-2363.
b. Petitioner did not raise his constitutional claim in the courts below. His claim therefore may be considered only for plain error. Fed. R. Crim. P. 52(b); Johnson v. United States, 520 U.S. 461 (1997); United States v. Swatzie, 228 F.3d 1278, 1281 (11th Cir. 2000); United States v. Nordby, 225 F.3d 1053, 1060 (9th Cir. 2000); United States v. Meshack, 225 F.3d 556, 575 (5th Cir. 2000). The error in imposing a 210-month term of imprisonment based on quantity findings made by the district court at sentencing was "plain," in that it was "clear" or "obvious" after the decision in Apprendi. See Johnson, 520 U.S. at 467-468 ("where the law at the time of trial was settled and clearly contrary to the law at the time of appeal[,] it is enough that an error be 'plain' at the time of appellate consideration"). A showing that the district court committed "plain error" in sentencing petitioner will not entitle him to relief, however, unless he can also demonstrate that the error both "affect[ed] substantial rights" and "seriously affect[ed] the fairness, integrity, or public reputation of judicial proceedings." Johnson, 520 U.S. at 467.
Petitioner may be hard pressed to meet that standard given that the court of appeals has already found that "[t]here was sufficient, credible testimony regarding the amount of drugs involved in the crimes." Pet. App. 3. The quantity of marijuana found by the district court-868.3234 kilograms-is more than 17 times the amount necessary to trigger an enhanced sentence under Section 841(b)(1)(C). It is thus questionable whether the failure to require the jury to determine the amount of marijuana involved either affected substantial rights, see Neder v. United States, 527 U.S. 1, 7 (1999), or seriously affected the fairness, integrity, or public reputation of judicial proceedings, see Johnson, 520 U.S. at 470.
Nevertheless, it would be appropriate to allow petitioner an opportunity to make the requisite showings to the court of appeals in the first instance. The case should, therefore, be remanded for further consideration.
This case does not present the propriety under the Sixth Amendment of the admission of evidence of Palazzo's dual representation, which is the issue that petitioner seeks to raise in this Court. The court of appeals held the admission of that evidence, while "problematic," did not cause petitioner to "suffer such prejudice so as to warrant reversal of his conviction." Pet. App. 2. Based on its examination of "the record as a whole," the court concluded that the government's introduction and use of that evidence "could not have affected the jury's verdict and therefore did not deprive [petitioner] of a fair trial." Ibid.4 That fact-bound determination of the absence of prejudice does not merit this Court's review.
The petition for a writ of certiorari should be granted on question one only, the judgment below vacated, and the case remanded to the court of appeals for further consideration in light of Apprendi v. New Jersey, 120 S. Ct. 2348 (2000). In all other respects, the petition should be denied.
1 Petitioner cites (Pet. 9-11) a series of questions asked by the prosecutor about Britton's relationship with Palazzo. The district court sustained objections to several of those questions, disallowing any testimony on whether Britton paid for Palazzo's representation, whether Britton obtained Palazzo's name from petitioner, and how Britton chose Palazzo as his counsel. See Pet. App. 56-57; Trial Tr. 444.
2 Petitioner's 60-month sentence on count two is permissible under Apprendi. Under Section 841(b)(1)(D), a defendant is subject to a maximum term of five years' imprisonment for offenses involving any quantity of a Schedule III controlled substance, a category that includes steroids. See Pet. App. 5-6.
3 Instead, petitioner claims (Br. 15) that the decision below conflicts with the Eighth Circuit's own decision in Dawan v. Lockhart, 31 F.3d 718 (1994), a case that is readily distinguishable from this one on its facts. For example, the court of appeals found in that case (see id. at 721-722), unlike in this one (see Pet. App. 2), that defense counsel's conflict of interest actually detracted from his performance at trial. In any event, an intracircuit conflict, if one existed, would appropriately be left for resolution by the Eighth Circuit itself. See Wisniewski v. United States, 353 U.S. 901, 902 (1957) (per curiam).
4 The court of appeals also suggested that, because petitioner had expressly waived any conflict of interest arising from Palazzo's dual representation of petitioner and Britton, petitioner had "arguably" waived any Sixth Amendment challenge based on the jury's learning of that dual representation. Pet. App. 2.

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The people's voice in majority said "out". So be it; this is nothing but a democratic decision. It is also normal, that people cry out loud if their opinion is not followed. How will this effect Brits in Germany right now? Will they be kicked out? May they stay? I want to briefly discuss the legal consequences for immigration of the BREXIT – shortly before the "divorce" is final. What is now to be done? How do I maintain a legal status? What rules will be applicable for future relocations?
Before the BREXIT really kicks in, it is "life as usual" for all British residents and their non-European direct family members. Since the freedom of movement only ends, when BREXIT comes into force, your residential status has not ended just because Ms. May officially applied "for divorce". You are not yet in Germany but prefer to be here? What is keeping you back? If you do not relocate before BREXIT takes effect, you will have to stand in line as all the "other" nationals.
Britain's Prime Minister, Ms. May, has now formally given notice to the European Commission (art. 50 TFEU). In spite of any tug-of-war of "to brexit or not to brexit", the two-year period will end with the expiration of March 2019. Within this period, the European Union and UK have to come to a resolution on how the divorce will be realized. If nothing is negotiated inside that period, then EU membership automatically expires. Until then, it is life as usual – seen from immigration perspective. Assuming no resolution between UK and EU will be achieved then it is a full stop!
Britons and their non-European family members will automatically lose their freedom of movement and so any legal residential status as soon as BREXIT comes into effect. They no longer belong to the European Union. At first glance, this sounds harsh but there is a solution at hand. The persons now here on a temporary as well as a permanent status will maintain their status – upon application. As BREXIT deadline draws near, the question comes up, will BREXIT be soft or hard or at all. In the case of a hard BREXIT, Britons will immediately need a residence permit. Pursuant to §11 III FreizügG these persons living here previously shall retain their legal status – as is. However, you need to apply for this at your local immigration office.
Persons living here for more than five years will continue with permanent residency, a.k.a. settlement permit. Such British subjects having residence for less than five years will be treated as if they had had a (temporary) residence permit all along. So far, there is no reason to worry. However, the devil is in the details... Do not forget, we are talking of an event to happen on March 29, 2019!
So much to the consequences as they are – now. Pursuant to §7 I 2 AufenthG, those persons on a temporary status can expect to continue as a normal third-country national on grounds reflecting their reason to be here. Everybody will have some sort of concept / purpose of being in Germany and not anywhere else in the world. A student will receive a permit to study at the university pursuant to §16 I AufenthG; an employee pursuant to §18 AufenthG, and a person in business based on §21 AufenthG. Latest when a renewal is due, it can be assumed that they will be treated as a “normal” third country national. This means you are continuing with a head start. It is expected that you will have to show that you meet the requirements as every other non-European has to for your individual reason to be here.
Britons having had “permanent EU status” will change from §4a FreizgG to §9 AufenthG – maintaining permanent residency. The difference between both kinds of permanent status is only hidden. The most important difference will be in the time of permitted absence without jeopardizing one's permanent status. Pursuant to §4a VIII FreizgG, Europeans are allowed to be outside of Germany temporarily for two consecutive years. Third country nationals only have six consecutive months (§51 I no. 7 AufenthG) grace – both only for temporary purposes. So, if you have left for good then you are out for good. However, such persons living now under a settlement permit, will not lose their status if they have been in for 15 years when their financial livelihood (= basic need, health insurance, and accommodation) and no reasons for expulsion exist (§51 II AufenthG).
Another major difference between “normal” and “European” foreigner lies in the status quality. Europeans conceptually have the right to be in Germany. The threshold to end a European's residence is very high the longer this person lives in Germany. In contrast to that “normal” foreigners have to combat the authority to remain in Germany.
On October 29, 2018, the German Federal Government published the draft bill for the BREXIT transition period in regards to naturalization as German citizenship. British citizens that apply for naturalization in Germany before the end of the transition period will be able to retain their British citizenship based on §25 II 1 Citizenship Act. This transitional period lasts from March 2019 until December 31, 2020. This means applications for naturalization submitted until December 31st, 2020 are privileged in so far that British citizenship does not have to be renounced.
How to Prepare for after the BREXIT?
get Letters Of Interest from Germany-based business partners, when freelancing or self-employed, start working on your business plan.
Parallel to that apply for your new status in Berlin via the webpage "Departure of the United Kingdom from the European Union (Brexit)". If you live somewhere else in Germany, click this sentence to find your local immigration office.
N.B. This update reflects the legal situation as of March 05, 2019. Further updates will follow shortly after they are issued as law.


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On August 31, 2009, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Satinder K. Dang, M.D. (Respondent), of Fountain Valley, California. The Order proposed the revocation of Respondent's DEA Certificate of Registration, AD9234446, as a practitioner, as well as the denial of any pending applications to renew or modify her registration, "for reason that [Respondent's] continued registration would be inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f) and 824(a)(4)." ALJ Ex.1, at 1.
The Order specifically alleged that between January 2004 and July 2007, Respondent and her husband Surinder Dang, "who also possesses a DEA registration and shares [Respondent's] registered location," ordered "more than 5,000,000 dosage units of hydrocodone" and that Respondent "failed to properly account for, secure, and otherwise handle these controlled substances." Id. The Order alleged that on January 17, 2006, one of Respondent's "employees removed 30,000 dosage units of controlled substances" from her registered location and "attempted to take them to her residence." Id. The Order further alleged that on the same day, "DEA Special Agents seized another 10,000 dosage units of controlled substances from this employee's residence." Id. Continuing, the Order alleged that on March 16, 2006, "DEA Special Agents seized 50,000 dosage units more from this employee's residence." Id.
Next, the Order alleged that on March 16, 2006, DEA conducted an accountability audit of Respondent's handling of hydrocodone and that Respondent "could not account for more than 3,500,000 dosage units" that Respondent and her husband "had ordered"; the Order thus also alleged that Respondent "failed to keep accurate and complete records of each controlled substance received, sold, delivered, or otherwise disposed of as required by 21 U.S.C. 827(c) and 21 CFR 1304.01 et seq." Id. at 2. Finally, the Order alleged that, when Respondent "made dispensing records," she "frequently failed to indicate whether" she or her husband "actually dispensed the controlled substances as required by 21 CFR 1304.03(b)." Id.
By letter of October 2, 2009, Respondent, through her counsel, requested a hearing on the allegations. ALJ Ex. 2. The matter was then assigned to an Administrative Law Judge (ALJ), who conducted a hearing on March 2-3, 2010, in Santa Ana, California.
At the hearing, the Government called two witnesses to testify and introduced documentary evidence. Respondent testified on her own behalf. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law and argument.
On June 18, 2010, the ALJ issued her Recommended Decision (also ALJ). Therein, the ALJ considered the five public interest factors, see 21 U.S.C. 823(f), and concluded that Respondent's continued registration would be inconsistent with the public interest and recommended that her registration be revoked. ALJ at 29, 37-38.
As to the first factor--the recommendation of the appropriate State licensing board or professional disciplinary authority--the ALJ found "no evidence that the Medical Board of California has taken any action against the Respondent." Id. at 27. However, the ALJ recognized that under Agency precedent, "the fact that the Medical Board of California has currently authorized * * * Respondent to practice medicine is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest." Id. (citing Patrick W. Stodola, 74 FR 20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR 459, 461 (2009)). The ALJ then concluded that "this factor does not fall in favor of revocation." Id. Likewise, with respect to factor three--Respondent's record of convictions for offenses relating to the manufacture, distribution, or dispensing of controlled substances--the ALJ found that Respondent has not been convicted of such an offense and that this factor also did not "fall in favor of revocation." Id. at 27-28.
The ALJ then considered factors two and four--Respondent's experience in dispensing controlled substances and her compliance with Federal, State, and local laws relating to controlled substances-- together. Id. at 28-29. The ALJ found that the record was "replete with Respondent's lack of oversight concerning the use of her controlled substances registration." Id. at 28. Specifically, the ALJ found that: (1) Respondent's clinic was unable to provide a biennial inventory (or an inventory of any kind); (2) "Respondent was unable to account for any of the controlled substances ordered using her DEA registration number"; and (3) Respondent had admitted that "she did not maintain a key to the controlled substance cabinet" at her clinic. Id. at 28-29. Further, the ALJ found that an "audit revealed that the approximately 3,870,700 dosage units of hydrocodone were unaccounted for." Id. at 29. Based on these findings, the ALJ concluded that "Respondent failed to maintain adequate records." Id.
The ALJ rejected Respondent's argument that "the DEA's findings did not distinguish between the controlled substances prescribed or dispensed to Respondent's patients versus the patients of" her husband. Id. The ALJ found that "the missing controlled substances were ordered under both DEA registration numbers in a haphazard manner and subsequently mixed into an incoherent m[eacute]lange." Id. The ALJ reasoned that if "Respondent maintained some oversight of her controlled substances registration, then DEA would most likely be able to 'distinguish between controlled substances prescribed or dispensed to Respondent's patients versus' those of her husband." Id. Based on these findings, the ALJ concluded that "Respondent's circular reasoning does not absolve her [of] culpability." Id. The ALJ thus held that the Government's evidence under factors two and four "established prima facie grounds for revocation of * * * Respondent's DEA Certificate of Registration." Id.
office manager of the clinic where she practiced with her husband] to unlawfully distribute the drugs, [Respondent] would still be liable for the acts [R.K.] committed while being allowed to use [her] registration." Id. (citations omitted).
The ALJ further found incredible Respondent's testimony that "she was unaware of [R.K's] actions." Id. Noting Respondent's "admitted lack of supervision" over R.K.--including that Respondent would "tell [R.K.] which drug she wanted to dispense," R.K. "would retrieve the controlled substances from the steel cabinet and update the logbook," and "only [R.K.] had a key to the controlled substances cabinet"-- placed R.K. in a "position where she could take advantage of the lax security" of Respondent's controlled substances, the ALJ rejected Respondent's contention that these were "minor record-keeping violations" and held that she was "responsible for enabling [R.K.'s] acts of unlawful possession and distribution of the controlled substances that [R.K.] obtained under Respondent's registration." Id. (citing Harrell E. Robinson, M.D., 74 FR 61370, 61376-77 (2010)). The ALJ also found that Respondent is "still engaged in an ongoing working relationship with [R.K.]," id. at 32, and held that "[a] practitioner's failure to properly supervise patients or staff to prevent them from personally abusing controlled substances or selling them to others constitutes conduct 'inconsistent with the public interest' and can support * * * the revocation of an existing registration." Id. at 33 (citing Jeri Hassman, M.D., 75 FR 8194, 8227 (2010); Gonzales v. Oregon, 546 U.S. 243, 274 (2006)).
Noting that Respondent blamed her husband and R.K. for her misconduct, the ALJ further found that "Respondent's acceptance of responsibility has been minimal" and "weighs heavily against her continuing registration." Id. at 35. The ALJ further held that Respondent's "lack of cooperation with the DEA investigation nominally weighs against her continued registration." Id. at 36-37.
The ALJ also found that "the fact that [Respondent] still works alongside [R.K.] is an aggravating factor." Id. at 35. While noting Respondent had offered to file quarterly reports of her prescriptions with the Agency, the ALJ found that "Respondent's careless use of her DEA Certificate of Registration coupled with her lack of assurances that she will no longer enable others such as [R.K.] and her husband to abuse her controlled substances registration weighs heavily against her continuing registration." Id. at 37. The ALJ therefore recommended that "Respondent's DEA Certificate of Registration be revoked." Id. at 38.
On August 9, 2010, Respondent filed Exceptions to the ALJ's Decision, and on August 18, the ALJ forwarded the record to me for Final Agency Action. On September 10, 2010, the Government filed a motion with my Office to accept its response to Respondent's Exceptions. In its motion, the Government stated that Respondent's counsel had consented to its filing. Accordingly, by this Order I grant the Government's motion.
Respondent is the holder of DEA Certificate of Registration, AD9234446, which authorizes her to dispense controlled substances in schedules II through V, as a practitioner, at the registered location of 17150 Euclid 200, Fountain Valley, California. GX 1. While Respondent's registration was to expire on June 30, 2007, id., on June 4, 2007, Respondent filed an application to renew her registration. GX 2. Accordingly, her registration remains in effect pending the issuance of this Decision and Final Order. 5 U.S.C. 558(c); see also ALJ Ex. 3, at 2 (Prehearing Order; Stipulations).
Respondent currently holds a medical license issued by the Medical Board of California. Moreover, the Board has not taken any formal action to limit her ability to practice medicine or to prescribe controlled substances. ALJ Ex. 3, at 3. Also, Respondent has not been convicted of an offense related to the manufacture, distribution, or dispensing of controlled substances. Id. Respondent is married to Surinder Dang, M.D.\1\ He and Respondent practice medicine at Complete Medical Care, Inc. ("CMC"). Tr. 188- 189; GX 6, at 20. Their son, Sameer Dang, also works in the CMC office. Tr. 58, 188. At all relevant times (including through the date of the hearing), CMC's office manager was Ms. Rani K. (R.K.).\2\ Id. at 190- 91, 194-95, 203-04.
\1\ Dr. Surinder Dang holds DEA Certificate of Registration AD6122143; he is registered at the same address as Respondent. ALJ Ex. 3, at 2, GX 2 at 2.
\2\ In various documents R.K.'s first name was spelled as both Rani and Roni. Compare GX 5, at 7, with GX 6, at 1, 5, 9, 14-15, 18, 29; see also GX 10 at 1.
In November 2005, a Diversion Group Supervisor (GS) in DEA's Riverside Diversion Group reviewed ARCOS \3\ records which showed that large amounts of controlled substances, including hydrocodone,\4\ were being ordered under the DEA registration numbers of both Respondent and her husband.\5\ Tr. 30-32; GXs 3 & 4. Upon reviewing the ARCOS data, the GS contacted several of the firms that were distributing controlled substances to Respondent. See, e.g., GX 6, at 7. At several points throughout the investigation, these firms provided the GS with copies of various documents, including sales records, invoices, statements of account, delivery information, applications for credit, and correspondence. See generally GX 5 (records from Moore Medical, L.L.C.),\6\ GX 6 (record from Henry Schein, Inc.), GX 9 (records from ParMed Pharmaceuticals, Inc.).
\3\ Pursuant to 21 CFR 1304.33(c), manufacturers and distributors of various controlled substances including schedule III narcotics are required to report their distributions of controlled substances to DEA through the Automated Records and Consolidated Orders System (ARCOS). See also Tr. 33.
\4\ As a combination product, hydrocodone is a schedule III controlled substance. 21 CFR 1308.13(e)(1)(iv).
\5\ The ARCOS system reports the registration number used, but not necessarily the person who actually ordered the drugs. Tr. 114- 16.
\6\ Moore Medical Supply reported to DEA that CMC ordered excessive amounts of hydrocodone. Tr. 32-34; GX 5. The order to Moore was placed under Respondent's husband's DEA registration and R.K.'s name appears on a fax sheet sent to Moore Medical and related to CMC's account number. GX 5, at 7; Tr. 131.
The majority of the controlled substances ordered under Respondent's DEA registration were obtained from Anda Pharmaceuticals. GX 3; Tr. 130, 139. The GS obtained purchase records from Anda showing hydrocodone and other controlled substances purchases by both Respondent and her husband between 2000 and 2005. GX 8; Tr. 47-49. However, there is no evidence that Respondent ever personally ordered these controlled substances. Tr. 140.
the contact person for the Henry Schein account. Tr. 132-34.
In a letter dated November 7, 2005, Respondent's husband explained to Henry Schein that CMC would begin ordering controlled substances so that CMC's physicians could dispense medications directly to CMC's patients. GX 7; Tr. 46. This letter listed the CMC physicians as Surinder Dang, M.D.; Satinder Dang, M.D.; Robert Belanger, D.O.; Huey Lin, M.D.; and Davinder Singh, M.D. GX 7. The letter also stated: "We dispense medications to our patients only. Our practice has been growing." Id. However, none of the records obtained in the investigation show that controlled substances were ordered from Schein under the registrations of any of the doctors besides those of Respondent and her husband. GX 6, at 7; Tr. 176-79.
The DEA registration numbers of both Respondent and her husband were used to order controlled substances from Darby Medical Supply and ParMed Pharmaceuticals. GX 16; GX 9, 11; Tr. 51, 61-62. The Darby records show that Respondent ordered hydrocodone fourteen times. GX 16, at 1, 5, 7, 11. The ParMed records show that between December 29, 2005 and January 4, 2006, 88,800 dosage units of hydrocodone were ordered under Respondent's registration. GX 9, at 2. At one point, D.L., ParMed's Regulatory Affairs officer, reported to the GS that CMC's orders were "excessive and suspicious"; D.L. also identified R.K. as the point of contact for the clinic and that R.K. had opened the CMC accounts. Tr. 51-53.
\7\ The GS stated that he analyzed ARCOS data, distributors' sales records, audit inventories, patient files and dispensing logs when creating GX 15. Tr. 92-97.
Throughout the investigations, several of the firms also provided the GS with information regarding when various deliveries were to be made to Respondent's clinic. On December 14, 2005, the GS, who had received information from two different distributors (Henry Schein and Moore Medical) that controlled substances deliveries were to be made that day, conducted surveillance at the [Dangs'] clinic from approximately 9:00 a.m. until 6:00 p.m. Tr. 43, 67-68, 75. During the surveillance, the GS observed both deliveries and noted that "approximately no more than a dozen" people entered the clinic that day. Id. at 75.
On January 13, 2006, the GS conducted a second surveillance from approximately 9:00 a.m. until 3 p.m. Id. at 76-77. During the surveillance, the GS saw R.K. "tak[ing] boxes from the office and plac[ing] them in the trunk of her * * * SUV." Id. at 77.
On January 17, 2006, the GS, who had received notice of a controlled substance delivery from another distributor (ParMed Pharmaceuticals, Inc.), conducted another full-day surveillance. Id. at 77-78. Once again, Investigators observed R.K. "place numerous boxes in her vehicle that had been delivered to the clinic" and "put them in the back of her * * * SUV." Id. at 78. The GS observed R.K. drive away and notified the California Highway Patrol (CHP). Id. at 78, 80, 147-48. After observing R.K., who was driving forty miles per hour, operate her vehicle within five feet of the vehicle in front of her, the CHP officer conducted a traffic stop. Id. at 78; GX 10, at 2.
As he approached R.K., the CHP officer observed "cardboard boxes that were taped shut in the rear cargo area." GX 10, at 2. The CHP officer advised R.K. of the reason for the stop and requested her license, registration, and insurance. Id. He then asked R.K. "what the boxes were." Id. R.K. stated that the boxes held Vicodin, a schedule III controlled substance which contains hydrocodone. Id.; ALJ Ex. 3, at 1; 21 CFR 1308.13(e)(iv). When the CHP officer asked R.K. if she was a doctor, she stated that "she was the president of a medical facility and that she was going to give the Vicodin to the doctor at her facility." GX 10, at 2. The CHP Officer asked R.K. a second time if she was a doctor; R.K. again said "no" and became "extremely nervous." Id.
After the CHP Officer asked R.K. to step out of her car, he asked "why she had cases of Vicodin." Id. R.K. answered that she ran a medical office and handed him a business card listing her name and her position as "president." Id. R.K. further stated that "she received a delivery of Vicodin from a delivery company at about 1100 hours and that she needed to give it to" Respondent. Id. When the Officer asked R.K. if the Vicodin had been delivered "to her car or to her office," R.K. stated that it had been delivered to the office. Id. When the Officer asked if her office had a locker in which to store the Vicodin, R.K. answered "yes," but that she had to personally give the drugs to Respondent. Id.
The CHP Officer then asked how the Vicodin had ended up in her vehicle; R.K. stated that "she [had] carried the boxes to her vehicle around noon time and left them there," and that she had stayed in her office until about 5 p.m., at which point "she left * * * to get something to eat." Id. When the Officer told R.K. that he was "concerned that she was in possession of so much of a controlled substance," she said she would return it to the office. Id. R.K. then stated that Respondent was "doing a procedure at an unknown hospital and he would be returning at an unknown time to the office" and that she would then give him the Vicodin. Id.
The CHP Officer then "asked R.K. to open the boxes" to confirm that they contained Vicodin. Id. R.K. opened six boxes containing a total of 70 bottles of hydrocodone bitartrate/acetaminophen (hereinafter, hydrocodone/apap or hydrocodone). Id. at 2-3. Each of the bottles contained between 100 and 500 tablets (for a total of "approximately 31,000 tablets") in 7.5/500 mg, 10/500 mg, and 10/325 mg strengths. Id. The Officer then seized the Vicodin and gave R.K. a receipt for it. Id. at 3. After giving R.K. a citation, the officer allowed her to leave. Id.
The CHP Officer then contacted a DEA Task Force Officer (TFO) and arranged to transfer custody of the drugs to DEA; upon the TFO's arrival at the Officer's location, the drugs were transferred to the TFO. Id. The TFO gave the CHP Officer a receipt which confirms the figures in the latter's report.\8\ Id. at 6.
\8\ More specifically, there were 14 bottles of 500 count of hydrocodone/apap 7.5/500 mg; 10 bottles of 500 count hydrocodone/ apap 10/500 mg; 36 bottles of 500 count hydrocodone/apap 10/325 mg; and 10 bottles of 100 count hydrocodone/apap 10/500 mg. GX 10, at 6.
R.K. then drove to her residence in Anaheim Hills; Investigators followed her there in order to question her about the drugs that were found in her vehicle. Tr. 82. R.K. told the Investigators that she had taken the hydrocodone with her for safekeeping because Respondent was out of the office; she also maintained that she intended to return them to the office after she ate. Id. at 83. While R.K. initially claimed that this was the first time she had done this, upon being confronted with the fact that Investigators had on another occasion observed her placing boxes in her vehicle, R.K. admitted that this was the second time she had done so. Id.
R.K. stated that there were about five physicians who worked at Respondent's clinic, that they dispensed the pills in 30- and 60-count bottles, and that the clinic had approximately twenty to twenty-five patients per day. Id. at 84. R.K. further said that she used her personal credit card to purchase drugs from wholesalers and that Respondent would reimburse her. Id.
The Investigators then asked R.K. if she would consent to a search of her residence; she agreed. Id. According to the GS, the Investigators found approximately $69,500 in cash in an upstairs closet, a "quantity of hydrocodone and lorazepam in the house" (2000 lorazepam tablets and 1400 hydrocodone tablets), "money order receipts," and receipts of "payments made to the credit card companies by [R.K.]." Id. To explain the cash found at her residence, R.K. claimed the sum was a combination of money received from the sale of a house in India and a home-based business she had previously run. Id. at 85-86.
On February 24, 2006, Respondent's husband wrote a letter to CHP requesting the return of the hydrocodone which had been seized during the traffic stop of R.K. Tr. 88-89; GX 12. The letter asserted that R.K. was the clinic's "office manager," and had "informed CHP that the property was not hers, and instead belonged to her employer, Complete Medical Care Inc." GX 12.
On March 16, 2006, DEA executed search warrants at both Respondent's clinic and R.K.'s residence. Tr. 90, 104. At the clinic, the Investigators took an inventory of the controlled substances on hand and found 48,000 tablets of hydrocodone, which they seized; the Investigators also seized CMC's controlled substance purchasing records and dispensing log. Tr. at 90, 95. Later that day, Investigators went to Respondent's residence and sought consent to search her house. Tr. 103. Respondent declined to provide consent and refused to talk with Investigators without an attorney present. Id.
R.K. was present during the search of her residence and was interviewed. Id. at 104. R.K. stated that since January 17, 2006, she had stopped purchasing the drugs on her own, and that the drugs were being purchased by Respondent's husband, Dr. Surinder Dang. Id. at 105. R.K. stated that Respondent's husband was the clinic's "primary dispenser" of the drugs and that she "dispensed drugs to the patients under the direction of * * * Dr. Surinder Dang." Id.
On March 16, 2006, the Diversion Investigator (DI) interviewed several CMC employees, including A.N.,\9\ C.G.,\10\ L.Y.,\11\ and S.B.\12\ In April 2006, the GS interviewed Dr. B., a physician who had worked at CMC on a part-time basis since approximately 2004. Id. 109- 110. Dr. B. also worked at a facility for the local county government, but he saw some of his patients at CMC. Id. at 110. Dr. B. stated that while he worked at CMC, he rarely, if ever, prescribed or dispensed controlled substances to his patients. Id. at 111. He also stated that the patient load at CMC did not justify the quantities of controlled substances that were being purchased by the clinic. Id. at 114.
\9\ A.N. stated that Respondent, her husband, and R.K. handled drug deliveries when they came into CMC. Id. at 238-39. A.N. further stated that both Respondent and her husband kept records of dispensed drugs in the patient files and dispensing logs; she identified the writing in the patient log as R.K.'s. Id. at 239-40.
\10\ The transcript notes the coworker's initials as C.G.; however, other documents suggest that her initials are K.G. See Resp. Brief at 8. C.G. stated that both R.K and Respondent's husband ordered the drugs for CMC. Tr. 241, 249-250. R.K. usually accepted deliveries of drug orders; however, sometimes C.G. would sign for the delivery but not open the boxes. Id. at 241-42. C.G. further stated that she witnessed R.K. writing in the dispensing log the day before the search warrant was executed and heard R.K. comment that CMC's drug procedures had changed. Id. at 242.
\11\ According to L.Y., the clinic saw twenty to twenty-five patients per day. Id. at 244. L.Y. also stated that R.K. handled the drugs once they arrived. Id. at 243. When shown the dispensing log, L.Y. identified the handwriting as belonging to R.K. Id. at 243-44. She further stated that Respondent only wrote prescriptions. Id. at 250.
\12\ S.B. stated that R.K. and Respondent's husband handled the drugs that were dispensed directly to patients and that R.K. handled the drug inventory and payment for the drugs that were ordered. Id. at 246. S.B. also stated that R.K. handled the dispensing log. Id. at 247. S.B. further stated that CMC had approximately twenty-five patients per day, of whom ten saw Respondent. Id. According to S.B., both Sameer Dang and R.K. paid for the drugs. Id. She also stated that R.K. had access to the controlled substances received at the CMC office. Id. at 248.
Using the records seized during the search of Respondent's clinic and its patient files, ARCOS data, and information provided by several of the distributors,\13\ the GS conducted an audit of the hydrocodone ordered under both Respondent's and her husband's registrations between January 1, 2005 and March 16, 2006. Tr. 93-96, 67; GX 15. Because CMC did not maintain records of their inventory (notwithstanding Federal law requiring them to do so, see 21 U.S.C. 827(a) & (b)), the GS chose January 1, 2005 as the starting date and assumed that no controlled substances were then on hand; for the closing inventory, the GS used the inventory taken (48,000 tablets) when the search warrant was executed.\14\ Tr. 92-93, 95; GX 15. To this latter figure, the GS added the hydrocodone that was seized during the January 17, 2006 traffic stop of R.K. (31,000 tablets) and the 1,200 tablets\15\ found during the search of R.K.'s residence which occurred later that day. Tr. 95; GX 12, 15.
\13\ Moore Medical provided DEA with sales records under Respondent's registration for hydrocodone from late 2005 to early 2006. Tr. 34, 43; GX 5. ANDA provided DEA with a spreadsheet listing all sales under the registrations of Respondent and her husband from May 2000 through mid-October 2005. Tr. 47-49; GX 8. DEA also acquired sales records and a sales summary from ParMed which show Respondent's purchases of controlled substances between November 28, 2005 and January 4, 2006. Tr. 51-52; GX 9.
\14\ If any controlled substances were in fact on hand on the starting date of the audit period, assigning a zero starting inventory would reduce the size of any shortage.
\15\ I acknowledge that this figure differs from the quantity of 1,400 tablets which, according to the GS's testimony, was found in R.K.'s house. The difference, however, is inconsequential given the result of the audit.
Using both the ARCOS data and distributor invoices, the GS determined that 4,037,900 tablets of hydrocodone had been ordered during the audit period. Tr. 94; GX 15. The clinic's dispensing logs, which did not identify which doctor had authorized the various dispensings, see GX 14, showed that only 12,000 tablets had been dispensed; \16\ in addition, the GS reviewed the clinic's patient files and credited another 75,000 tablets as having been dispensed.\17\ Tr. 95-96; GX 15. Accordingly, CMC could only account for approximately 167,000 tablets of hydrocodone.\18\ Tr. 96-97; GX 15. While the DI combined the purchases of Respondent and her husband, the ARCOS data and distributor invoices did list whose registration was used to place the various orders. See, e.g., GXs 3 & 4. This evidence shows that in 2005 alone, 2,272,800 dosage units of hydrocodone were ordered under Respondent's registration. Accordingly, Respondent still could not account for more than two million dosage units.\19\ GX 3, at 13.
\16\ The dispensing logs also did not contain the name of the dispensing physician, the initials of the person dispensing the drugs, and the patient's address as required by 21 CFR 1304.22(c). Tr. 90; see also GX 14. Moreover, while there were some dispensing logs from 2003, the remaining logs only covered the period from February 28 through March 15, 2006. See GX 14.
\17\ The GS credited CMC with dispensing a total of 87,000 hydrocodone tablets; this calculation counted the prescriptions issued by Respondent or her husband, because the prescriptions may have been filled in the office. Tr. 100; GX 15.
\18\ Neither Respondent nor her husband had reported to DEA any thefts, losses, or destructions of controlled substances. Tr. 99- 101.
\19\ This calculation gives Respondent credit for all of the 167,000 tablets for which the GS could account.
number was being used to order large quantities of hydrocodone that were being delivered to CMC." Tr. 192. She asserted that she did not order any controlled substances between 2002 and March 16, 2006, and that she did not order any controlled substances after that period. Id. at 195-96. Specifically, she testified that she did not order Lorazepam in October 2006. Id.
Respondent testified that while during this time period, she was aware that her husband was ordering drugs for his pain management practice, she did not know how much he was ordering. Id. at 201. Respondent stated that she had no knowledge of the controlled substances being delivered to CMC during this time period; while she admitted to having seen boxes being delivered to the clinic, she claimed to not know what they contained. Id. 197-198. Respondent further stated that R.K. would open the boxes after they were delivered. Id. at 200.
Respondent further testified that she was unaware that R.K. had taken drugs from CMC to her residence until learning of it through these proceedings; she also stated that she was not sure if her husband had instructed R.K. regarding taking drugs to her residence. Id. at 204-205. However, the ALJ did not find credible Respondent's testimony that she was unaware of R.K.'s activities. ALJ at 30.
Regarding the controlled substance drug storage area, Respondent stated that she had "no idea" how the drugs were organized. Tr. 198- 99. Respondent testified that she did not pay attention to what was in that storage area, but then stated there was a basic cabinet that was locked at night and that she did not have a key. Id. at 200-01. According to Respondent, the key was either kept by R.K. or in a place where her husband could find it; Respondent also did not know if the storage cabinet was locked during the day. Id. at 234.
While Respondent testified on direct examination that she had not dispensed drugs at CMC, on cross-examination, she stated "I don't recall. I might have dispensed but I dispensed rarely." Id. at 195. Respondent then admitted dispensing, stating "maybe I might have given [hydrocodone] once or twice to my patients only." Id. She stated that other people had ordered these drugs that she dispensed. Id. at 229. On the occasions that she did dispense, Respondent asked R.K. for the drug. Id. at 230. R.K. would retrieve the controlled substances from the cabinet and give them to Respondent to hand to the patient. Id. In these instances, R.K. would record the dispensed controlled substances in a "separate log." Id. at 228.
"[T]hese factors are considered in the disjunctive." Robert A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one factor, or a combination of factors, and may give each factor the weight I deem appropriate in determining whether to revoke an existing registration or to deny an application. Id. Moreover, I am "not required to make findings as to all of the factors." Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005) (citing Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir. 2005)).
With respect to a practitioner's registration, the Government bears the burden of proving by a preponderance of the evidence that the continuation of a registration would be inconsistent with the public interest. 21 CFR 1301.44(d). However, where the Government satisfies its prima facie burden by showing that a registrant has committed acts which are inconsistent with the public interest, the burden then shifts to the applicant to demonstrate why he can be entrusted with a registration. Medicine Shoppe-Jonesboro, 73 FR 364, 380 (2008).
In this matter, having considered the entire record and all of the factors, I agree with the ALJ's conclusions that the Government's evidence under factors two, four, and five makes out a prima facie that Respondent has committed acts which render her registration inconsistent with the public interest.\20\ ALJ at 29. I further agree with the ALJ's conclusion that Respondent has not accepted responsibility for her misconduct and has thus not rebutted the Government's prima facie case.
\20\ I acknowledge that Respondent holds a valid medical license from the State of California. Moreover, the State Board has not taken action against her, nor made any recommendation in this matter (factor one). ALJ at 27.
Be that as it may, in enacting the CSA, Congress vested this Agency with "a separate oversight responsibility [apart from that which exists in state authorities] with respect to the handling of controlled substances." Mortimer B. Levin, 55 FR 8209, 8210 (1990). DEA has therefore long recognized that it has "a statutory obligation to make its independent determination as to whether the [continuation] of [a registration] would be in the public interest." Id. Accordingly, "a State's failure to take action against a registrant's medical license is not dispositive in determining whether the continuation of a registration is in the public interest." Jayam Krishna-Iyer, 74 FR 459, 461 (2009); see also Levin, 55 FR at 8210 (holding that practitioner's reinstatement by state board "is not dispositive" in public interest inquiry). Thus, that the Medical Board of California has taken no action with respect to Respondent's medical license is not dispositive in determining whether her continued registration is consistent with the public interest.
There is also no evidence that Respondent has been convicted of an offense related to the manufacture, distribution, or dispensing of controlled substances under either Federal or state law (factor three). ALJ at 27-28. However, while a history of criminal convictions for offenses involving the distribution or dispensing of controlled substances is a highly relevant consideration, there are any number of reasons why a registrant may not have been convicted of (or even prosecuted for) such an offense, and thus, the absence of such a conviction is of considerably less consequence in the public interest inquiry. Krishna-Iyer, 74 FR at 461; Edmund Chein, 72 FR 6580, 6593 n.22 (2007). Accordingly, that Respondent has not been convicted of an offense related to the distribution or dispensing of controlled substances is not dispositive of whether the continuation of her registration is consistent with the public interest.
tablets unaccounted for. In addition, law enforcement authorities found that R.K. had large quantities of hydrocodone in her possession during both a traffic stop and a search of her residence; Investigators also found a large quantity of cash in R.K.'s home.
At a minimum, the evidence clearly shows that Respondent violated the CSA's various recordkeeping provisions. Under Federal law, as soon as Respondent "first engage[d] in the * * * distribution or dispensing of controlled substances, and every second year thereafter," she was required "to make a complete and accurate record of all stocks thereof on hand." 21 U.S.C. 827(a)(1) (emphasis added); see also 21 CFR 1304.03(a)-(b), 1304.04(a), (g), 1304.11. However, as found above, during the audit, Respondent could not produce an inventory record for any of the controlled substances that were purchased under her registration.
Under Federal law, Respondent was also required to "maintain, on a current basis, a complete and accurate record of each such substance * * * received, sold, delivered, or otherwise disposed of by [her]." 21 U.S.C. 827(a)(3) (emphasis added). With respect to a practitioner who engages in dispensing, DEA regulations require that the record include "the number of units or volume of such finished form dispensed, * * * the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed and the written or typewritten name or initials of the individual who dispensed * * * the substance on behalf of the dispenser." 21 CFR 1304.22(c); see also id.; 21 CFR 1304.03(a)-(b), 1304.04(a), (g), 1304.21. However, as found above, while large quantities of controlled substances were purchased under her registration throughout 2004 and 2005, Respondent had no dispensing logs for these years and the 2006 logs covered only from February 28 through March 15. Moreover, the logs that were maintained lacked required information such as the name of the dispensing doctor, the initials/name of the person doing the dispensing, and the address of the patient. GX 14.
Recordkeeping is one of the central features of the CSA's closed system of distribution. See Paul H. Volkman, 73 FR 30630, 30644 (2008), pet. for rev. denied 567 F.3d 215, 224 (6th Cir. 2009). "[A] registrant's accurate and diligent adherence to this obligation is absolutely essential to protect against the diversion of controlled substances." Id. Given that millions of dosage units of a highly abused controlled substance that were ordered under Respondent's registration cannot be accounted for, her failure to comply with the CSA's recordkeeping requirements is egregious. This finding provides reason alone to conclude (with respect to factors two and four) that her continued registration "is inconsistent with the public interest." 21 U.S.C. 823(f); see also Volkman, 73 FR at 30644 (holding that recordkeeping violations alone supported denial of practitioner's application).
In her Exceptions to the ALJ's decision, Respondent argues that "she had no knowledge that her DEA Registration was being used by her husband or [R.K.] to order controlled substances" until DEA executed the search warrant on March 16, 2006. However, DEA has long held that a registrant is strictly liable for the misuse of her registration by a person to whom she entrusts her registration. See also Harrell E. Robinson, 74 FR 61370, 61377 (2009); Paul H. Volkman, 73 FR 30630, 30644 n.42 (2008); Rose Mary Jacinta Lewis, 72 FR 4035, 4041 (2007) (citing Anthony L. Capelli, 59 FR 42288 (1994)); Leonard Merkow, 60 FR 22075, 22076 (1995); Capelli, 59 FR at 49288. The record clearly supports the conclusion that Respondent entrusted her registration number to R.K. Thus, even if it were the case that Respondent was unaware of R.K.'s illegal activities, she is still strictly liable for R.K.'s misuse of her registration and her failure to properly monitor how her registration was being used. See Jacinta Lewis, 72 FR at 4041- 42; Robinson, 74 FR at 61377; Volkman, 73 FR at 30644 n.42; Capelli, 59 FR at 49288.
Contrary to Respondent's understanding, the purpose of this proceeding is to protect the public interest, and in determining whether a registrant has committed acts which render her registration "inconsistent with the public interest," 21 U.S.C. 824(a)(4), the standards of mens rea for imposing criminal liability are not controlling. Accordingly, the Government is not required to show that Respondent had knowledge that her DEA Registration was being used by her husband or R.K. to order controlled substances.
In any event, the ALJ did not find credible Respondent's testimony that she was unaware of R.K.'s activities. ALJ at 30. I agree. Given the duration and scope of R.K.'s activities, Respondent's denial of knowledge is implausible.
In her Exceptions, Respondent also argues that the ALJ's decision "fails to distinguish between the drugs ordered under Respondent's DEA Registration and the drugs ordered under her husband's." Res. Exc. at 22. This is true. However, as ultimate factfinder, I have reviewed the evidence and found that the ARCOS data shows that in 2005 alone, more than 2.27 million dosage units of hydrocodone were ordered under Respondent's registration, and that at most, 167,000 dosage units can be accounted for. Thus, Respondent is responsible for more than two million dosage units that cannot be accounted for and were likely diverted.
Respondent's misconduct thus clearly threatened public health and safety. See 21 U.S.C. Sec. 823(f)(5). Moreover, the scope of the diversion is egregious. I therefore conclude that the Government has satisfied its prima facie burden of showing that Respondent has committed acts which render her registration is "inconsistent with the public interest." 21 U.S.C. 824(a)(4); 823(f).
Under Agency precedent, where the Government has made out a prima facie case that a registrant has committed acts which render her "registration inconsistent with the public interest," she must "'present sufficient mitigating evidence to assure the Administrator that [she] can be entrusted with the responsibility carried by such a registration.' " Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). "Moreover, because 'past performance is the best predictor of future performance,' ALRA Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), this Agency has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for [her] actions and demonstrate that [she] will not engage in future misconduct." Medicine Shoppe-Jonesborough, 73 FR at 387.
During her testimony, Respondent continued to deny that she was responsible for the unaccounted-for hydrocodone and blamed her husband and R.K. Furthermore, the ALJ found incredible Respondent's denial that she had knowledge of R.K.'s illegal activities. DEA has repeatedly held that a registrant's lack of candor is a highly relevant consideration in determining the appropriate sanction. See Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005); Robert F. Hunt, 75 FR 49995, 50004 (2010); Rosemary Jacinta Lewis, 72 FR 4035, 4042 (2007). Respondent's lack of candor further supports the revocation of her registration.
(which was limited to the statements of counsel in a post-hearing brief and which do not constitute evidence, see INS v. Phinpathya, 464 U.S. 183, 186 n.6 (1984)), I conclude that none of the "favorable facts" cited by the ALJ provide any reason to impose a sanction less than revocation. Jayam Krishna-Iyer, 74 FR 459, 463 (2009). Indeed, none of Respondent's proposed remedial measures mitigate the egregious harm Respondent has caused to public health and safety.
I therefore conclude that it would be inconsistent with the public interest to grant her even a restricted registration. Accordingly, I will order that Respondent's registration be revoked and that any pending application be denied.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as by 28 CFR 0.100(b), I hereby order that DEA Certificate of Registration, AD9234446, issued to Satinder K. Dang, M.D., be, and it hereby is, revoked. I further order that any pending application of Satinder K. Dang, M.D., to renew or modify her registration be, and it hereby is, denied. This Order is effective September 22, 2011.

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