Registrant Actions - 2010
[Federal Register: December 16, 2010 (Volume 75, Number 241)]
[Notices]
[Page 78745-78754]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de10-79]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-43]
Ronald Lynch, M.D.; Revocation of Registration
On April 4, 2008, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Ronald Lynch, M.D. (Respondent), of Sanford,
Florida. The Show Cause Order proposed the revocation of Respondent's
DEA Certificate of Registration, BL6686541, and the denial of any
pending applications to renew or modify his registration, on the ground
that Respondent's "continued registration is inconsistent with the
public interest, as that term is defined in 21 U.S.C. Sec. Sec.
823(f), 824(a)(4)." ALJ Ex. 1, at 1.
The Show Cause Order alleged that Respondent "authorized
controlled substance prescriptions for Internet customers throughout
the United States from approximately June 2002, through September 2004,
on the basis of online questionnaires and/or telephone consultations."
Id. The Order alleged that Respondent "issued these prescriptions
without a legitimate medical purpose and outside the usual course of
professional practice, in violation of 21 CFR 1306.04(a) and 21 U.S.C.
841(a)(1)." Id. The Order further alleged that, while Respondent
authorized controlled substance "drug orders" for "online customers
throughout the United States," he is only licensed to practice
medicine in the State of Florida and that he "violated state laws that
prohibit the unauthorized practice of medicine, including unlicensed,
out-of-state physicians issuing controlled substance prescriptions to
state residents." Id. at 2 (citations omitted). Finally, the Order
alleged that Respondent "violated Florida law and regulation
prohibiting licensed physicians from issuing controlled substance
prescriptions in excessive or inappropriate quantities, and from
issuing prescriptions via the Internet without a documented patient
evaluation and discussion between the physician and patient regarding
treatment options." Id. (citing Fla. Stat. Sec. 458.331(q) and Fla.
Admin. Code Ann. r. 64B8-9.014).
On May 7, 2008, Respondent's counsel requested a hearing on
allegations, ALJ Ex. 2, and the matter was placed on the docket of the
Agency's Administrative Law Judges (ALJs). On March 24-25, 2009, a
hearing was held in Arlington, Virginia.
At the hearing, the Government called several witnesses (including
the Respondent) to testify and introduced documentary evidence.
Respondent also testified on his own behalf. Following the hearing,
both parties filed briefs containing their proposed findings of fact,
conclusions of law, and argument.
On September 18, 2009, the ALJ issued her recommended decision
(also ALJ). Therein, the ALJ, after considering the five public
interest factors, see 21 U.S.C. 823(f), concluded that "Respondent has
misused his DEA registration [in] the past and has not shown any
indication that he will not do so in the future." ALJ at 46. The ALJ
thus recommended that Respondent's "registration be revoked and that
any pending applications be denied." Id.
As to the first factor--the recommendation of the appropriate state
licensing board--the ALJ found that Respondent's continued licensure by
the State of Florida "throughout the relevant time period" weighed
"in favor of a finding that his continued registration would not be
inconsistent with the public interest." Id. at 34. However, the ALJ
also noted that "state licensure is a necessary but not sufficient
condition for [holding a] DEA registration" so that "this factor is
not dispositive." Id.
Examining factors two and four together--Respondent's experience in
handling controlled substances and his compliance with applicable
Federal, State or local laws--the ALJ determined that "both the
Controlled Substances Act and the Florida telemedicine standards
require that the prescribing physician or a provider under his
supervision personally conduct a physical examination." Id. at 38-39.
The ALJ found that because Respondent failed to perform such
examinations, "he did not establish a proper doctor-patient
[[Page 78746]]
relationship" and, as a result, "was not a practitioner 'acting in
the usual course of his professional practice'" and thus "violated
21 U.S.C. 841(a)(2)." \1\ Id. at 39. The ALJ also concluded that
Respondent's "failure to review medical records prior to prescribing
controlled substances was a violation of Florida standards for
telemedicine" and that he therefore "failed to satisfy the
requirements for a doctor-patient relationship; did not act in the
usual course of his professional practice; and thereby violated the
Controlled Substances Act." Id. at 40.
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\1\ This appears to be a typographical error given that there is
no evidence that Respondent was unlawfully distributing or
dispensing "a counterfeit substance." 21 U.S.C. 841(a)(2). The
correct provision is section 841(a)(1).
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The ALJ further found that Respondent had permitted "Ken Drugs to
use a rubber stamp bearing his signature to issue prescriptions for
controlled substances" and that this constituted a violation of 21 CFR
1306.05(a), which generally requires that prescriptions "be manually
signed by the practitioner." Id. at 40-41; 21 CFR 1306.05(a). Next,
the ALJ found that "Respondent authorized refills for controlled
substance prescriptions without a legitimate purpose" such that "the
decision whether or not to dispense these refills was made by Ken Drugs
personnel, and not by Respondent," thereby violating Florida
Administrative Code r. 64B8-9.014. ALJ at 41. The ALJ therefore
concluded that "factors two and four weigh in favor of a finding that
Respondent's continued registration would be inconsistent with the
public interest." Id. at 43.
With respect to the third factor--Respondent's conviction record
under Federal or state laws relating to controlled substances--the ALJ
found that "Respondent has never been convicted" of an offense
related to the manufacture, distribution or dispensing of controlled
substances. Id. However, the ALJ also noted that this factor was not
dispositive. Id.
As for factor five--other conduct which may threaten public health
and safety--the ALJ found that "Respondent maintained throughout the
hearing . . . that any shortcomings involving Ken Drugs' Internet
patients were due largely to the system set up by the Kennedee Group,
and not to any irresponsibility on his part." Id. Noting that "[a]s a
DEA registrant, Respondent bears full responsibility for understanding
his obligations under the Controlled Substances Act and related Federal
regulations," the ALJ found that Respondent's "claims merely
demonstrate [his] unwillingness to accept his responsibilities as a DEA
registrant" and that his "refusal or inability to acknowledge
outright that he acted improperly in basing prescriptions on these
telephone conversations suggests an unwillingness to recognize that he
abrogated his responsibilities as a DEA registrant." Id. at 43 & 44.
The ALJ thus found that Respondent had failed "to accept
responsibility for his actions" and that his continued registration
"poses a threat to the public health and safety." Id. at 45. She thus
concluded that factor five also supported "a finding that Respondent's
continued registration would be inconsistent with the public
interest." Id.
Neither party filed exceptions to the ALJ's recommended decision.
Thereafter, the ALJ forwarded the record to me for final agency action.
Having considered the entire record in this matter, I adopt the
ALJ's findings of fact including those related to the credibility of
the witnesses. I also adopt her conclusions of law except for her
conclusion that under the Florida telemedicine rule, Respondent, as the
prescribing physician, was required to conduct the physical examination
or to direct another health care provider in the performance of the
examination. See ALJ at 38. However, I agree with the ALJ's conclusion
that Respondent violated the Florida telemedicine rule in those
instances when he prescribed without having obtained a documented
patient evaluation, id., and that Respondent has failed to accept
responsibility for his misconduct. I further conclude that Respondent
violated various state laws and the Controlled Substances Act by
prescribing controlled substances to residents of States where he was
not authorized to practice medicine, as well as by prescribing
controlled substances without having performed a physical exam on the
residents of various States, whose laws require a prescribing physician
to have personally performed a physical exam of his patient. I
therefore adopt the ALJ's recommendation to revoke Respondent's
registration and to deny any pending applications. I make the following
factual findings.
Findings
Respondent is a physician who is board-certified in family practice
and holds a medical license issued by the State of Florida.\2\ Tr. 191
& 279. In 1999, Respondent also obtained a license to practice medicine
in the State of New York; however, he believes that this authority has
now expired. Id. at 191-92. He is not, and never has been, licensed in
any other State. Id. at 193.
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\2\ Respondent testified that he is a member of the American
Academy of Environmental Physicians. Tr. 282.
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Respondent currently holds DEA Certificate of Registration
BL6686541, which was last renewed on March 8, 2006 and was due to
expire on March 31, 2009. GX 1. However, on February 9, 2009,
Respondent submitted an application to renew his registration.
Accordingly, because Respondent's application was timely submitted in
accordance with the Agency's rule, his registration has remained in
effect pending the issuance of this Decision and Final Order. See 5
U.S.C. 558(c); 21 CFR 1301.36(i).
In 2002, Respondent began working for the Kennedy Medical Clinic,
Inc.,\3\ as a family physician.\4\ Id. at 194. On April 8, 2002,
Kenneth Shobola, a Florida-registered pharmacist, incorporated Kennedy
Medical Clinic, Inc., under the laws of the State of Florida; Shobola
is the president and registered agent of the corporation, which
operated two medical clinics in Tampa, Florida. GX 2, at 8.
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\3\ Throughout this proceeding, the clinic was referred to
simply as the "Kennedy Clinic."
\4\ At some point while he was working for the Kennedy Clinic,
Respondent also started his own practice, Integrative Natural
Solutions. Id. at 68, 73, 194. Integrative Natural Solutions
occupied one floor of an office building at the same address as the
Kennedy Clinic in Kissimmee, Florida when, on September 21, 2004, a
search warrant was executed at both offices, as well as at other
locations. Id. at 16, 68.
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On the same date, Shobola also incorporated Ken Drugs, Inc. Id. at
7. Shobola also served as president of this entity and was its sole
shareholder. Id. This entity owned four pharmacies, three of which were
located in Tampa, the other in Kissimmee, Florida. Id. at 7-8.
Shobola also incorporated and was the president of the Kennedee
Group, Inc.\5\ Id. at 8. Two websites, medsviaweb.com and
medsviaweb.net, were registered to the Kennedee Group at the address of
1612 W. Waters Ave., Tampa, Florida; this was also the address of one
of the Ken Drugs pharmacies. Id. at 7.
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\5\ This entity was previously named Kenadee Group, Inc., and
was also known as the Kenaday Group. GX 2, at 8.
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In September 2002, the DEA Tampa Diversion Group received
information that prescriptions for hydrocodone, a schedule III
controlled substance, were being sent to another pharmacy through the
medsviaweb.com website and that refills of these prescriptions were
being filled by the Ken Drugs pharmacy
[[Page 78747]]
located on W. Waters Ave. in Tampa. Id. at 9-10. Moreover, "the vast
majority of clients seeking hydrocodone were from states other than
Florida." Id. at 10.
Based on this information, DEA opened an investigation. During the
investigation, DEA, along with personnel from the Florida Department of
Law Enforcement, the Florida Department of Health, the Kentucky State
Police, and the Tampa Police Department made seventeen undercover
purchases through either the medsviaweb.com website or through Ken
Drugs of such drugs as hydrocodone and Xanax (a schedule IV controlled
substance). Id. at 11.
The Investigators obtained the drugs by filling out an online
questionnaire, giving names, addresses, credit card information, dates
of birth and purported medical conditions. Tr. 15; GX 2, at 10; see
also GXs 6 & 10. After providing this information, a clerk from Ken
Drugs' Tampa, Florida headquarters would call the Investigator and
shortly thereafter, connect him/her with one of five different
physicians employed by the Kennedee Group. Tr. 15; GX 2, at 11. A brief
telephone consultation would occur with a physician who then issued a
prescription for a controlled substance. Tr. 15; see also GX 2, at 11
("After the receipt of consultation payment * * *. the undercover
purchaser would talk by telephone to an employee of Kennedee Group * *
* who advised that the purchaser would have to telefax a medical record
accompanied by a photocopy of his or her driver's license. Regardless
of these requirements, the employee of Kennedee Group * * * customarily
resumed telephonic contact with the aspirant purchaser immediately
after payment of the $120 or $125 fee to advise that a doctor was
available for an expeditious medical consultation soon after which,
according to the employee, the controlled substances prescribed would
be delivered to the purchaser by UPS or FedEx.").
According to a DEA Diversion Investigator (DI), 97 percent of the
prescriptions were for hydrocodone, with the other 3 percent being for
the schedule IV controlled substances alprazolam (generic for Xanax),
and occasionally, diazepam (generic for Valium). See 21 CFR 1308.14(c);
Tr. 15; see also GX 2, at 23 ("Between June 17 and September 9, 2004,
a review of the Ken Drugs pharmacy records revealed that 4,842
prescriptions were written for Schedule[] II, III, and IV controlled
substances.\6\ The vast majority of the prescriptions were for
hydrocodone and only a small number were for other controlled
substances such as diazepam (Valium) and alprazolam (Xanax)"). The
prescriptions were filled at one of Shobola's Ken Drug pharmacies in
either Tampa or Kissimmee and then shipped to the customer. Tr. 16.
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\6\ According to an affidavit prepared by an IRS Special Agent
who participated in the investigation, "[a] review of the
prescriptions filled by the KEN DRUGS pharmacy on Waters Avenue in
Tampa, Florida, from June of 2002 through of 2003, reveals that
50,237 Schedule II, III, and IV prescriptions were filled. Further,
that 48,793 prescriptions were written by Hameed, Lynch, Oluwole,
Osuji, and Shyngle, and the vast majority were for hydrocodone." GX
2, at 23.
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In February 2004, the DI, using the undercover name "Michael
Patrick," made an undercover purchase from Ken Drugs. Id. at 39 & 44.
Upon accessing http://www.medsviaweb.com, the DI registered as a
patient and provided "biographical data, credit card data, address
data, information about allergies, [and] medical conditions." Id. at
49-50; see GX 6 (screens printed out from medsviaweb.com). Next,
because he lacked an undercover credit card, the DI called Ken Drugs in
Tampa to ask whether he could purchase the controlled substance he was
seeking with a postal money order; an employee of Ken Drugs approved
this arrangement. Tr. 50.
On February 6, the DI purchased the money order for $125 and sent
it to Ken Drugs; several days later, the DI received a telephone call
from Ken Drugs during which he was told that a medical consultation
would follow if he would send a copy of his driver's license and
medical records. Id.; see GX 8, at 1. While the DI could not remember
whether he sent in a copy of his undercover driver's license, he did
not send in any medical records. Tr. 50.
The Government then played into the record Government Exhibit 7, an
audio recording of the DI's telephone consultation with a Kennedee
Group physician. A speaker, who identified herself as Jennifer,
arranged for the consultation once she had confirmed that the DI's
money order had been received. Tr. 31-32. Jennifer then asked the DI
whether he had faxed his driver's license and medical records; the DI
answered, "Yes." Id. at 34. Jennifer then put the DI through to an
individual who identified himself as Respondent. Id.
The DI stated that he suffered "back pain from an automobile
crash" and requested "Vicodin extra strength." Id. He further
explained that several years earlier another physician had
"recommended" Vicodin and that it had "helped." Id. at 35. He also
stated that he had not used Vicodin in several months. Id.
Respondent recommended Lortab because it was something with less
"Tylenol." \7\ Id. He then inquired as to the extent of the DI's back
pain. Id. at 35-36. The DI stated that the back pain "interfere[d]
with [his] sleeping, can last for hours some days and for minutes in
[sic] other days," and amounted to "a little bit of interference."
Id. at 36. The DI further offered that prior x-rays indicated that
there was no structural damage. Id. Respondent then asked the DI how
many pills he thought he would need per day; the DI responded two to
three per day. Id. at 37. Respondent then stated: "Let's say two, two
would be fine," and indicated that the DI would be sent "something
that's actually a little safer for you and better than what you were
asking for." Id. at 37-38.
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\7\ Respondent testified that the voice on this recording
sounded like his own. Tr. 223. As indicated infra, the prescription
label on the vial identified the prescribing physician as Dr. Ronald
Lynch. I therefore find that the individual identifying himself as
Dr. Lynch in the telephone conversation recorded in Government
Exhibit 7 is Respondent.
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On February 12, 2004, the DI picked up the Lortab in person at Ken
Drugs 3, which was located at 4730 North Havana Avenue in
Tampa. Id. at 44. He received sixty tablets of hydrocodone/apap (10/
500), a drug which combines 10 mgs. of hydrocodone with 500 mgs. of
acetaminophen in each tablet. Id. at 46; GX 8, at 2, 4. Laboratory
testing confirmed that the tablets contained hydrocodone. Tr. 47. The
label identified the prescribing physician as Respondent. GX 8 at 2, 4.
The DI further testified that no physical examination was
performed, that he did not know whether Respondent had a copy of the
online questionnaire in front of him when he prescribed the Lortab, and
that Respondent did not take a medical "history" or give him a
"treatment plan." Tr. 41, 77-78.
At DEA's request, on July 20, 2004, a Medical Quality Assurance
Investigator with the Florida Department of Health (DOH) made an
undercover purchase of hydrocodone through the website
modernlifestylemeds.com; this prescription was also authorized by
Respondent. Tr. 148; GX 9. According to the DOH Investigator, he
registered as a customer, giving his undercover name of "Donald
Huntley," date of birth, home address, telephone number, and a medical
complaint; he then requested Percodan. Tr. 149, 152-53; GX 9, at 1. On
July 29, the DOH Investigator filled out a medical history form and
received an e-mail confirming his name, date of birth, phone number,
and his medical complaint. Tr. 150-152; GX 9, at 1. The
[[Page 78748]]
following day he received a telephone call from "Jasmine at Modern
Lifestyles," who asked "what type of medication [he] was trying to
obtain." Tr. 152; GX 9, at 1. After the DOH Investigator told her that
he wanted Percodan, Jasmine replied that he could not get this drug
(which is a schedule II controlled substance), but that he would be
able to get Lortab at a cost of $177 for a thirty-day supply; she also
instructed him to send in a copy of his driver's license and his
medical records. Tr. 152; GX 9, at 1.
On August 1, the DOH Investigator faxed a copy of his undercover
driver's license but not his medical records, and on August 2, Jasmine
called again to confirm that he wanted Lortab. Tr. 153; GX 9, at 1.
Jasmine told the Investigator that he could not personally pick up the
medication and that he would need to pay by credit card; he then gave
her his undercover credit card information. GX 9, at 1. Jasmine did not
ask about the medical records which the Investigator had failed to
provide; she then put the Investigator through to an individual who
identified himself as Respondent. GX 9, at 1; Tr. 154, 157.
Respondent \8\ asked the Investigator his age and the cause of his
pain. Tr. 154; GX 9, at 1. The Investigator responded that he was sixty
years old and that he had injured his back some four to five years
earlier while helping his son move furniture. Tr. 155; GX 9, at 1.
Respondent further asked about other medications that the Investigator
was taking and about whether he had any liver damage; the latter
responded that he was taking Vicodin and Lortab and did not have liver
damage. Tr. 155; GX 9, at 1. Respondent then asked the Investigator to
provide the name of the physician he was currently seeing; the
Investigator named a Dr. Cichon. Tr. 155; GX 9, at 1. After some three
to five minutes, the conversation ended with Respondent stating that he
would prescribe Lortab with three refills. Tr. 156; GX 9, at 1.
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\8\ At this point in the hearing, counsel for Respondent
objected to the witness referring to this individual as Dr. Lynch,
the Respondent. Tr. 155. The ALJ overruled this objection. Id. In
his testimony, Respondent did not dispute that he had prescribed to
either the DEA or DOH Investigators. Moreover, the prescription
label for the medication that was dispensed to the Investigator
indicated that the prescribing physician was Dr. Ronald Lynch. GX
10, at 2-3. I therefore find that Respondent was the individual who
identified himself as Dr. Lynch.
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In his testimony, the Investigator stressed that he never sent the
required medical records, never met Respondent in person, and never
underwent a physical examination by Respondent or anyone associated
with the website he had accessed to obtain the medication. Tr. 157-158;
see also GX 9, at 1-2.
On August 4, the Investigator received a vial which contained
hydrocodone/apap 10/500. Tr. 156; GX 9, at 2. The prescription was
dispensed by Ken Drugs, Inc.'s pharmacy 3, which was located
at 4730 North Habana Avenue in Tampa, Florida. Tr. 158; GX 9, at 2. The
label on the vial indicated that it contained ninety pills and that
Respondent was the prescribing physician. Tr. 159-60; GX 9, at 2; GX
10, at 2, 3.
On September 21, 2004, DEA executed a search warrant at seven
locations associated with Ken Shobola and his Ken Drugs enterprise, two
in Kissimmee and five in Tampa, including Respondent's Integrative
Natural Solutions business, which was located at the same address as
one of the Kennedy Clinic's offices. Tr. 16, 68, 73. As part of the
search, the Investigators "imaged [and] downloaded" the files on
thirty-three computers; they also seized another computer and sent it
to the DEA forensics laboratory for analysis. Id. at 17.
Among the items seized were records of ten controlled substance
prescriptions which Respondent issued to residents of California, Ohio
and Tennessee. Id. at 67; GX 18. Only one prescription bore
Respondent's actual signature; this prescription was clearly faxed to
the Kennedee Group. Tr. 226, GX 18, at 6. The other prescriptions bore
a stamped signature and were electronically transmitted by Respondent.
Tr. 226; GX 18, at 5-6.
Three of the prescriptions were dispensed to residents of
California; all of these prescriptions were for 90 tablets of
hydrocodone/apap, containing either 7.5 or 10 mgs. of hydrocodone per
tablet. GX 18, at 1-6. Six prescriptions were dispensed to residents of
Tennessee; four of these were for 90 tablets of hydrocodone/apap
containing 10 mgs. of hydrocodone, one was for 90 tablets of
alprazolam, and one was for 60 tablets of diazepam. Id. at 7-10, 13-18.
The remaining prescription, which was dispensed to a customer in Ohio,
was for 90 hydrocodone/apap (10/500). Id. at 11-12.
At least three physicians who worked for Shobola's scheme were
interviewed by DEA Investigators. The lead DI testified that on October
20, 2004, he interviewed a Dr. Ladapo Shyngle at his Tampa residence.
Tr. 23; GX 2, at 9. During the interview, Dr. Shyngle stated that he
did not have face-to-face meetings with the Ken Drugs customers he
prescribed hydrocodone to; he also admitted that he did not review the
customers' medical records in every case before prescribing controlled
substances to them. Tr. 24; GX 5, at 15-16, 20; GX 17, at 2.
Dr. Shyngle further admitted that as the number of Ken Drugs'
customers increased, he saw their medical records before prescribing
only approximately thirty percent of the time. GX 5, at 20-21; GX 17,
at 1-2. According to Shyngle, Ken Drugs "hired an institution" that
performed physical examinations for them. GX 5, at 25. Shyngle
admitted, however, that the physicians were "not always" "actually
able to look at the information" documenting those physical exams
before they prescribed. Id.
The DI also testified that on November 17, 2004, he interviewed a
Dr. Chuma Osuji, Director of Medicine for Ken Drugs.\9\ Tr. 19-20, 82;
GX 2, at 8; GX 4, at 5. The Government entered into evidence a
transcript of the taped 2-hour interview of Dr. Osuji; the DI also
testified as to the substance of the interview. Tr. 20-22; GX 4.
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\9\ According to Dr. Osuji, although he was to be the medical
director from the initial plans with Ken Shobola, there turned out
to be "many medical directors" so that Dr. Osuji ultimately was
not in charge of "oversee[ing]" the operation. GX 4, at 7.
Apparently, there were a total of six medical directors. Id. at 42.
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In the interview, Dr. Osuji admitted that he did not see the
patients to whom he prescribed controlled substances; \10\ that most of
the prescriptions he wrote were for hydrocodone; that, while he
sometimes saw the medical records prior to, or at the time of
prescribing, he "frequently" did not; and that all of the
prescriptions authorized by the physicians retained by the Kennedee
Group were filled at pharmacies owned by Ken Shobola. Tr. 20-21; GX 4,
at 9-10, 30.
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\10\ According to Dr. Osuji, the customers were supposedly seen
by "doctors, nurses, and [physicians assistants]" before he spoke
with them. GX 4, at 8.
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Dr. Osuji also stated that he issued prescriptions by completing a
form authorizing the prescription and faxing it to one of the Ken Drugs
pharmacies for filling; the authorization was not "manually" signed.
Tr. 88-89; GX 4, at 29-30. Dr. Osuji stated that Ken Drugs contracted
with another company which was supposed to provide physical
examinations of patients so Dr. Osuji assumed that the customers had
undergone physical examinations prior to his prescribing to them. GX 4,
at 25, 38. Also according to Dr. Osuji, one or two months earlier, he
had learned that patients were not getting physical examinations
(apparently after someone complained that he had paid for a physical
and not received one). Tr. 21; GX 4, at 38-40, 47.
[[Page 78749]]
Another DI testified that she participated in an interview of
Respondent on the day the search warrant was executed. Tr. 168-69. She
testified that Respondent conducted two different kinds of medical
practice, the first an "individual practice, which involved holistic
medicine" and was named Integrative Natural Solutions; the other was
an "internet pharmacy business, which was connected to the Ken Drugs
business." Id. at 169.
Respondent was hired by Shobola to write prescriptions for the
Kennedee Group and was paid $30 per telephone consultation. Id. at 173.
However, Respondent admitted that he was not paid if he did not
authorize a prescription. Id. at 198. Respondent stated that he
conducted approximately fifty consultations per week, "usually no more
than about 10 a [sic] day." Id. Respondent primarily prescribed
hydrocodone. Id. at 171. The prescriptions were always filled by Ken
Drugs. Id.
Respondent contacted the customers by accessing the website
"through the Kenned[ee] Group Corporation" and then did telephone
consultations with them. Id. at 170, 172-73. Respondent stated that he
"talk[ed] with the patient [sic] regarding their medical concern,
their medical need, if they had any problems, liver damage, if they had
been taking medication, [and] what drugs or medication in particular
they were seeking." Id.
Respondent maintained that the customers' medical records were
filed at the corporate offices of the Kennedee Group and that he would
"periodically" look at the records to determine patients' medical
needs. Id. Respondent admitted, however, that his examination of the
records did not "necessarily" occur "before he dispensed the
medication." Id. Respondent allowed the corporate office to "use a
rubber stamp with his signature, a custom stamp," to complete
prescription authorizations. Id. at 172. He also told the Investigators
that he was electronically transmitting the prescriptions to the
pharmacy. Id. at 181.
During the interview, Respondent stated that he "believed that
what he was doing was in line, because he thought that the Kenned[ee]
Group were [sic] known. They [sic] had a big business and he felt he
was doing what he thought was appropriate." Id. at 177. Respondent
also stated that he believed that Shobola "had looked into the
legalities of the business[;] and he felt that with the size of the
business, surely, what they were doing could not be wrong. He trusted
the insight of Ken Shobola." Id. at 185.
The Government also called Respondent to testify. The ALJ found,
however, that Respondent's "testimony was frequently at odds with that
of the [other] Government witnesses" and that he "displayed a lack of
candor and appeared to shade his testimony to support his position on
the issues." ALJ at 32. She accordingly found "the [other] Government
witnesses more credible." Id.
According to Respondent, the Ken Drugs corporate center was
designed for telemedicine and not for the physical receiving and
treating of patients. Id. at 202. He described the business as "a
nation-wide endeavor" in which patients were serviced by regional
staff which conducted home visits to ascertain such matters as whether
the customers were minors. Id. at 203-04.
In his testimony, Respondent admitted that the Ken Drugs scheme
"[o]bviously[] did not lend itself to do[ing] any physical
examination." Id. at 212-13. He further maintained that "[v]ery
often, the majority of the time * * * [a]t least 75 to 85 percent of
the time" he conducted his telephone consultations with the customers'
medical records in front of him. Id. at 206. The ALJ did not find this
testimony credible in light of his admission during the September 21,
2004 interview that he did not necessarily review the records before he
prescribed. ALJ at 39. Moreover, both the DEA and DOH Investigators
testified that they did not send in their medical records prior to
Respondent's prescribing hydrocodone to them. For the same reason, the
ALJ did not credit Respondent's testimony that he would have to turn
away Internet patients who did not provide medical records.\11\
As to the potential for fraud in prescribing to persons he never
met, Respondent admitted that "the real doctor/patient relationship is
based upon honesty," and that if the patients "were liars" "they
could break through." Id. at 206-07. Respondent then testified that
the Shobola scheme used "the team approach" and that other employees
were responsible for confirming the customers' identities and screening
the required medical records and physical examination before he did his
telephone consultations with them. Id. at 206-07, 220. According to
Respondent, prior to his contacting the customers, the other employees
obtained the required medical records, imaging studies, and sometimes,
documentation of an actual in-person consultation with what he called a
"mid-level provider." Id. at 199-200. This was so Respondent would
not have "to waste [his] time with being a police agent or * * * a
lawyer." Id. at 208.
He also maintained that customers "wouldn't get me on the phone
until they had gone through some of these hurdles." Id. at 208. Here
again, Respondent's testimony is contradicted by the purchases made by
the DEA and DOH Investigators, both of whom obtained hydrocodone
without sending in their medical records.
Later in his testimony, Respondent claimed that he could make a
"judgment" that persons were either drug abusers or drug seekers
based on their "voice," "diction," and "answers to some of the
questions that I might have posed to them." Id. at 230. However, he
then admitted that this "is, by no means, any criteria to determine
who is being evasive and who is being under-handed or who is
legitimately seeking a substance. It is very, very less than perfect."
Id. at 231.
Respondent further maintained that "[t]here was not one letter,
not one comment from any medical quality boards or anyone, regarding
safety, regarding guidance in any way" as to "the practice of
telemedicine." Id. at 209. However, as explained below, at the time
Respondent issued the prescriptions, substantial guidance was available
as to the legality of this practice. Respondent further claimed that he
was "very glad that since that faithful [sic] day in September 2004"
(apparently the date on which the search warrant was executed) he had
"not returned to internet medicine because [he] do[es] think it does
have some holes in it." Id.
Respondent also asserted that he visited the Ken Drugs corporate
headquarters to meet the clerks and the personnel handling the
telephone consultation transfers because he "need[ed] to talk to them
and find out that everything [was] happening legitimately and
appropriately." Id. at 202. The record, however, contains no evidence
that Respondent sought to independently determine whether the practices
he was engaging in were legal. Moreover, the ALJ found Respondent's
"asserted reliance on Ken Drugs' administrative personnel disingenuous
at best." ALJ at 44.
Respondent further maintained that he kept medical records "of
every conversation or most of the conversations" in one of his
notebooks. Tr. 210. However, when asked whether he wrote the
prescriptions contained in Government Exhibit 18, Respondent stated
that he did not bring his records with him to the hearing. Id. at 225-26.
[[Page 78750]]
Respondent further asserted that he discussed the patients'
diagnoses with the patients and that he "absolutely" discussed
alternative treatments such as physical therapy, magnetic therapy,
acupuncture and eating "certain anti-inflammatory foods." Id. at 210,
214-15. He also maintained that he discussed the risks and benefits of
treatment with controlled substances, i.e., the risk of "habituation
and the risk of acetaminophen damage," the latter concern compelling
him to inquire always about blood tests, liver damage and kidney
function. Id. at 216-17.
While the evidence pertaining to the undercover purchases indicates
that Respondent did discuss the risks to liver function caused by
taking too much acetaminophen, there is no evidence that he discussed
the risk of addiction caused by taking narcotics with either
Investigator. Nor did Respondent even discuss, let alone recommend, to
the DEA and DOH Investigators that they try alternative treatments.
For Florida residents, Respondent claimed that he provided outside
referrals and that it was "fairly infrequent" that customers did not
have "background" MRIs, blood work, or x-rays. Id. at 213-14.
However, he claimed that he could not do this for his out-of-state
patients. Id. at 213.
According to Respondent, the audio recording of his telephone
consultation with the DEA DI was "[n]ot necessarily" representative
of his typical consultation, as it was the "minority of the time"
that he participated in a consultation without the medical records in
front of him; he also claimed that he would later review the medical
record if it was not available at the time of the consultation. Id. at
224-25. He also maintained that he was "[s]ometimes" available to
customers to review the "course and efficacy of the treatment." Id.
at 218.
As for the prescriptions identified in Government Exhibit 18,
Respondent maintained that he had actually signed only one of them. Tr.
226 (discussing GX 18, at 6). As for the others, Respondent stated that
they looked like they had been stamped. Id. at 228. However, he
admitted that the stamp was a facsimile of his signature and that he
"may have" provided the Kennedy clinic with a stamp containing his
signature. Id. He then stated that while "it was [his] practice to
sign" the prescriptions "when he could," he had granted "the
pharmacist" at Ken Drugs "some permission to use the stamp, if [he]
was not able to do that" himself. Id. at 229. With respect to those
prescriptions which were stamped, Respondent could not even address
whether he did "indeed, * * * have a consultation with these * * *
individuals." Id. at 228.
Respondent also testified on his own behalf. Respondent primarily
testified about his professional background and that in 2006, he had
attended a course offered by the American Academy of Pain Management
which included classes about DEA, controlled substances, and the use or
misuse of opioids.\12\ Id. at 281-84. Respondent also further asserted
that he has identified drug seeking patients in his "current
practice" and that he handles them by discharging them. Id. He further
testified that from 2005 on, he sees 100 percent of his patients in "a
face to face setting," and that he will diagnose a person he does not
know over the telephone only in an emergency. Id. at 290.
---------------------------------------------------------------------------
\12\ His testimony as to what subjects were covered was vague.
---------------------------------------------------------------------------
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to "dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section." 21 U.S.C.
824(a)(4). In the case of a practitioner, Congress directed that the
following factors be considered in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The [registrant's] experience in dispensing * * * controlled
substances.
(3) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and give each factor the weight I deem
appropriate in determining whether to revoke or renew an existing
registration. Id. Moreover, I am "not required to make findings as to
all of the factors." Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir.
2005); see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009).
In this matter, I acknowledge that the State of Florida has taken
no action against Respondent's medical license (factor one) and that
Respondent has not been convicted of an offense related to controlled
substances (factor three). However, under settled Agency precedent,
"neither of these factors is dispositive." Joseph Gaudio, 74 FR
10083, 10090 n.25 (2009) (citing Edmund Chein, 72 FR 6580, 6590 n.22
(2007) and Mortimer B. Levin, 55 FR 8209, 8210 (1990)).
Rather, the gravamen of the Government's case is that Respondent
violated the CSA and numerous state laws by: (1) Prescribing controlled
substances to persons whom he never met and physically examined, and
(2) by engaging in the unauthorized practice of medicine because he
lacked the state licenses required to prescribe to the residents of
various States. Gov. Br. at 5-9 (discussing factors two and four). The
Government further argues that Respondent's conduct in prescribing over
the Internet creates an extraordinary threat to public health and
safety. Id. at 9-10. While Respondent offered some testimony as to
changes he has made in his medical practice, as explained below, I
agree with the ALJ's finding that his testimony was evasive and that he
repeatedly failed to accept responsibility for his misconduct.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and His Record of Compliance With Applicable Controlled
Substance Laws
Under a longstanding DEA regulation, a prescription for a
controlled substance is not "effective" unless it is "issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice." 21 CFR 1306.04(a). This
regulation further provides that "an order purporting to be a
prescription issued not in the usual course of professional treatment *
* * is not a prescription within the meaning and intent of [21 U.S.C.
829] and * * * the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law relating to controlled
substances." Id.
As the Supreme Court recently explained, "the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse. As a corollary, [it] also bars doctors from peddling to patients
who crave the drugs for those prohibited uses." Gonzalez v. Oregon,
546 U.S. 243, 274
[[Page 78751]]
(2006) (citing United States v. Moore, 423 U.S. 122, 135 (1975)).
Under the CSA, it is "fundamental" that a practitioner must
establish a bonafide doctor-patient relationship to act "in the usual
course of * * * professional practice" and to issue a prescription for
a "legitimate medical purpose." Gaudio, 74 FR at 10090 (citing Moore,
423 U.S. at 141-43). Moreover, at the time of the events at issue here,
whether a doctor and patient have established a bona fide doctor-patient relationship under the CSA was generally a question of state
law. Id.; see also Kamir Garces-Mejias, 72 FR 54931, 54935 (2007);
United Prescription Services, Inc., 72 FR 50397, 50407 (2007);
Dispensing and Purchasing Controlled Substances Over the Internet (DEA
Guidance Document), 66 FR 21181, 21182-83 (2001).
Moreover, "[a] physician who engages in the unauthorized practice
of medicine" under state law "is not 'a practitioner acting in the
usual course of * * * professional practice'" under the CSA. Gaudio,
74 FR at 10090 (quoting United Prescription Services, 72 FR at 50407).
As the Supreme Court explained shortly after the CSA's enactment, "in
the case of a physician," the CSA "contemplates that he is authorized
by the State to practice medicine and to dispense drugs in connection
with his professional practice." Moore, 423 U.S. at 140-41. This rule
derives from the plain text of the statute which defines the term
"practitioner" to mean "a physician * * * licensed, registered, or
otherwise permitted, by the United States or the jurisdiction in which
he practices * * * to * * * dispense a controlled substance," 21
U.S.C. 802(21), and the term "dispense" to mean "to deliver a
controlled substance to an ultimate user * * * by, or pursuant to the
lawful order of a practitioner." 21 U.S.C. 802(10). Thus, a
controlled-substance prescription issued by a physician who lacks the
license or other authority necessary to practice medicine within a
State is unlawful under the CSA. See 21 CFR 1306.04(a); Cf. 21 CFR
1306.03(a)(1) ("A prescription for a controlled substance may be
issued only by an individual practitioner who is * * * [a]uthorized to
prescribe controlled substances by the jurisdiction in which he is
licensed to practice his profession.").
The record establishes that Respondent repeatedly violated the CSA
when he prescribed controlled substances for the customers of the
Kennedee Group. He did so for two reasons: (1) He failed to establish a
bona fide doctor-patient relationship as required by the laws of the
States where the patients resided, and (2) because he was licensed only
in Florida (and possibly New York at the time), he engaged in the
unauthorized practice of medicine in those States (other than Florida
and possibly New York) where the customers lived. Nor can Respondent
credibly claim that "[t]here was not one letter, not one comment from
any medical quality boards or anyone, regarding safety, regarding
guidance in any way" as to the practice of telemedicine." Id. at 209.
As found above, Respondent issued three prescriptions for schedule
III controlled substances containing hydrocodone to residents of
California. However, in 2000, California enacted a provision which
prohibits the prescribing or dispensing of a dangerous drug "on the
Internet for delivery to any person in this state, without an
appropriate prior examination and medical indication therefore." Cal.
Bus. & Prof. Code Sec. 2242.1. Moreover, in 2003 (and prior to the
three prescriptions identified in GX 18), the Medical Board of
California (MBC) revoked a physician's medical license when he engaged
in practices similar to those of Respondent. See In re Steven Opsahl,
M.D., Decision and Order, at 3 (Med. Bd. Cal. 2003) (available by query
at http://publicdocs.medbd.ca.gov/pdl/mbc.aspx).
In Opsahl, the MBC explained that "[b]efore prescribing a
dangerous drug, a physical examination must be performed." Id. The MBC
held that a physician "cannot do a good faith prior examination based
on a history, a review of medical records, responses to a
questionnaire, and a telephone consultation with the patient, without a
physical examination of the patient." Id. The MBC also held that a
"medical indication" is determined only after the taking of a
history, the conducting of a physical examination, and an assessment of
"the patient's condition." Id. The MBC further explained that "[a]
physician cannot determine whether there is a medical indication for
prescription of a dangerous drug without performing a physical
examination." Id.
In approximately the same time-frame, MBC also issued numerous
Citation Orders to out-of-state physicians for prescribing over the
Internet to California residents. These Orders cited both the
physicians' failure to conduct "a good faith prior examination" and
their lack of "a valid California Physician and Surgeon's License to
practice medicine in California." Citation Order, Martin P. Feldman
(Aug. 15, 2003); see also Citation Order, Harry Hoff (June 17, 2003);
Citation Order, Carlos Gustav Levy (Jan. 28, 2003); Citation Order,
Carlos Gustav Levy (Nov. 30, 2001).
As the evidence shows, Respondent has never held a California
Physician and Surgeon's license. Moreover, given Respondent's admission
that the scheme "[o]bviously, did not lend itself to do any physical
examinations," Tr. 212-13, I conclude that Respondent did not conduct
a physical examination of any of the three California residents he
prescribed to (and who were identified in GX 18). Accordingly, I
conclude that in prescribing to these three persons, Respondent
violated California law by engaging in the unauthorized practice of
medicine and by prescribing "without an appropriate prior examination
and medical indication therefore." Cal. Bus. & Prof. Code Sec.
2242.1. I further hold that these prescriptions lacked a "legitimate
medical purpose" and were issued "outside of the usual course of
[his] professional practice" and therefore violated the CSA as well.
21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
Respondent issued a prescription for hydrocodone to an Ohio
resident. As does every State, Ohio prohibits the practice of medicine
without a state license. Ohio Rev. Code Ann. Sec. 4731.41 (1998).
Moreover, Ohio has enacted a statute which defines "telemedicine" as
"the practice of medicine in this state through the use of any
communication, including oral, written, or electronic communication, by
a physician outside th[e] state" and requires that a physician obtain
a "telemedicine certificate" to lawfully prescribe within the State,
id. Sec. 4731.296 (effective 4-10-01), and a "special activity
certificate." Id. Sec. 4731.294 (effective 4-10-01). Moreover, in
2002, Ohio adopted a regulation which, except for in circumstances not
at issue here, prohibits the dispensing of controlled substances "to a
person who the physician has never personally examined and diagnosed."
Ohio Admin. Code Sec. 4731-11-09(A).
Respondent did not possess either an Ohio medical license or Ohio
"telemedicine certificate" and thus, he was not authorized to
prescribe to an Ohio resident. Moreover, because Respondent did not
perform a physical examination of the Ohio resident as required by the
State's rule, he did not establish a legitimate doctor-patient
relationship with this person. In prescribing hydrocodone to this
person, not only did Respondent violate Ohio law and regulation, he
also acted outside of the usual course of professional practice and
lacked a legitimate medical purpose and
[[Page 78752]]
therefore violated the CSA as well. 21 CFR 1306.04(a); 21 U.S.C.
841(a)(1).
Respondent issued six prescriptions for controlled substances
(which included hydrocodone, as well as alprazolam and diazepam), to
residents of Tennessee. Tennessee law prohibits the practice of
medicine within the State without a license issued by the State. Tenn.
Code Ann. Sec. 63-6-201(a) (2002); see also id. Sec. 63-6-204 (2002)
(defining "a person [who is] regarded as practicing medicine" as one
"who treats, or professes to diagnose, treat, operate[] on or
prescribes for any physical ailment or any physical injury to or
deformity of another"). Like Ohio, Tennessee also provides for
"restricted licenses and special licenses based upon licensure to
another state for the limited purpose of authorizing the practice of
telemedicine." Id. Sec. 63-6-209(b) (1996).
Prior to the prescribings at issue here, Tennessee had also
promulgated a regulation which provided clear notice that, prior to
issuing a prescription for a controlled substance "by electronic means
or over the Internet or over telephone lines," a physician must
"[p]erform[] an appropriate history and medical examination,"
"[m]a[k]e a diagnosis based upon the examinations and all diagnostic
and laboratory tests consistent with good medical care,"
"[f]ormulate[] a therapeutic plan," and "[i]nsure[] availability of
the physician or coverage for the patient for appropriate follow-up
care." Tenn. Comp. R. & Regs. 0880-2-14.(7)(a) (2002). Here again,
Respondent did not possess a Tennessee license and violated state law
when he issued the six prescriptions to Tennessee residents. He also
violated Tennessee's regulation because he did not perform a medical
examination of the persons he prescribed to. Because Respondent did not
establish a legitimate doctor-patient relationship and lacked the
necessary State license, in issuing these prescriptions, he acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose and therefore violated the CSA as well.\13\
---------------------------------------------------------------------------
\13\ In addition to these statute and rules, which had been
promulgated prior to his conduct, in April 2001, DEA published a
guidance document entitled Dispensing and Purchasing Controlled
Substances over the Internet, 66 FR 21181. The Agency's 2001
Guidance expressly stated that "[u]nder Federal and state law, for
a doctor to be acting in the usual course of professional practice,
there must be a bona fide doctor/patient relationship." 66 FR at
21182. Continuing, the Guidance observed that "[f]or purposes of
state law, many state authorities, with the endorsement of medical
societies, consider the existence of the following four elements as
an indication that a legitimate doctor/patient relationship has been
established:
A patient has a medical complaint;
A medical history has been taken;
A physical examination has been performed; and
Some logical connection exists between the medical complaint;
the medical history, the physical examination, and the drug
prescribed.
Id. at 21182-83. The Guidance further stated that "[c]ompleting
a questionnaire that is then reviewed by a doctor hired by the
internet pharmacy could not be considered the basis for a doctor/
patient relationship." Id. at 21183.
Of further relevance, the Guidance explained that "[o]nly
practitioners acting in the usual course of their professional
practice may prescribe controlled substances. These practitioners
must be registered with DEA and licensed to prescribe controlled
substances by the State(s) in which they operate." Id. at 21181
(emphasis added).
---------------------------------------------------------------------------
Respondent also violated both Florida's telemedicine regulation
(which was promulgated in September 2003) and the CSA when he
prescribed hydrocodone to the DEA and DOH Investigators. The Florida
rule defines "the term 'telemedicine'" to include the "prescribing
[of] legend drugs" made to patients via the internet, telephone, or
facsimile. Fla. Admin. Code Ann. r. 64B8-9.014(5). The rule provides
that prescribing medications solely on the basis of an electronic
questionnaire "constitutes the failure to practice medicine with that
level of care, skill, and treatment which is recognized by reasonably
prudent physicians as being acceptable under similar conditions and
circumstances, as well as prescribing legend drugs other than in the
course of a physician's professional practice." Fla. Admin. Code Ann.
r. 64B8-9.014 (emphasis added). The rule further provides that
physician shall not issue a prescription, through electronic or other
means, unless following are done:
(a) A documented patient evaluation, including history and
physical examination to establish the diagnosis for which any legend
drug is prescribed.
(b) Discussion between the physician * * * and the patient
regarding treatment options and the risks and benefits of treatment.
(c) Maintenance of contemporaneous medical records meeting the
requirements of [Fla. Admin. Code] Rule 64B8-9.003.
Id. r. 64B8-9.014(2).
In her recommended decision, the ALJ noted that "the Florida
regulation governing telemedicine standards does not specify who must
conduct the physical examination." ALJ at 38. Rather than research
whether the Florida Medical Board had resolved this apparent ambiguity,
the ALJ found "it reasonable to infer that the examination must be
conducted by the prescribing physician or a health care provider under
his direction (such as a nurse or physician assistant)." Id.
The ALJ did not, however, cite any authority such as an
administrative or judicial opinion of the Florida Board of Medicine,
the Florida Attorney General, or the Florida courts definitively
construing the regulation as imposing this requirement. Moreover, as
the Supreme Court has made clear, while DEA has authority under the
public interest standard to determine whether a physician has complied
with state law, it does not have the power to "authoritatively
interpret" ambiguous provisions of State law. Gonzales v. Oregon, 546
U.S. 243, 264 (2006) (noting "the obvious constitutional problems"
were the Attorney General to "do[] so"). Thus, while it may be
reasonable to construe the regulation as the ALJ did, absent either an
administrative or judicial decision interpreting the regulation in this
manner, I am compelled to reject the ALJ's conclusion that Florida's
telemedicine rule "require[s] that the prescribing physician or a
provider under his supervision personally conduct a physical
examination." ALJ at 38-39.
In any event, whatever the rule requires as far as who can perform
the physical exam, it does not matter because the rule clearly requires
that a physician cannot prescribe a drug unless there is "[a]
documented patient evaluation" and neither the DEA nor DOH
investigator provided any medical records to Ken Drugs.\14\ Thus, it is
clear that Respondent violated the Florida rule when he prescribed
hydrocodone to the DEA and DOH investigators. Moreover, it is clear
that Respondent acted outside of the usual course of professional
practice and lacked a legitimate medical purpose and thus violated the
CSA.\15\ 21 CFR 1306.04(a); 21 U.S.C. 841(a)(1).
---------------------------------------------------------------------------
\14\ The ALJ also found that "the record establishes that
Respondent failed to review medical records for most, if not all, of
his patients." ALJ at 38. While there is evidence that Respondent
failed to review the medical records of the DEA and DOH
Investigators, and there is evidence that other doctors admitted
that in many instances they did not review medical records before
prescribing, it is not necessary to decide whether the ALJ's finding
is supported by substantial evidence. Given that: (1) the
Investigators obtained prescriptions without providing medical
records, and (2) even putting aside the ALJ's finding that
Respondent's testimony that he had the medical records in front him
"[a]t least 75 to 85 percent of the time," Tr. 206, was not
credible, ALJ at 39; it is still clear that Respondent frequently
prescribed without reviewing a person's medical record. Beyond this,
given the clear requirements of California, Ohio, and Tennessee that
the prescribing physician must perform the physical examination,
whether he reviewed medical records of these persons is immaterial.
\15\ In his brief, Respondent argues that "there is no
requirement that the prescribing physician personally conduct a
physical examination of a patient for a valid doctor-patient
relationship to exist." Resp. Br. at 10 (citing Forlaw, M.D. v.
Fitzer, 246 So.2d 432, 435 (Fla. 1984)). However, as explained
above, in California, Ohio and Tennessee there is such a
requirement. Moreover, with respect to the undercover purchases, the
argument provides no comfort to Respondent because he prescribed
without obtaining a "documented patient evaluation, including [a]
physical examination" and the Florida rule expressly provides that
such prescribing is not "in the course of a physician's
professional practice." Fla. Admin. Code Ann. R. 64B8-9.014.(1) &
(2).
Respondent also testified that Ken Drugs had "other locations
that were designed for seeing patients" and that the patients
"would be directed to an office where they could get a physical
examination, where they could go through getting their vital signs
and so forth." Tr. 203. Respondent did not, however, produce any
evidence showing that any of the patients identified in Government
Exhibit 18 were physically examined at these "other locations."
Nor did he offer any evidence showing that the so-called regional
staffers were qualified to perform physical exams and diagnose
patients. Finally, Respondent does not cite to any law or regulation
of the States of California, Ohio or Tennessee authorizing this
practice.
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[[Page 78753]]
In his testimony, Respondent appeared to deny having personally
issued all but one of the prescriptions contained in Government Exhibit
18. Tr. 228-29. However, as found above, in an interview, Respondent
admitted that he was electronically transmitting prescriptions to Ken
Drugs, and in his testimony, Respondent admitted that he had provided a
stamp with his signature to at least one of the Ken Drugs pharmacies.
Thus, it is clear from his testimony that Respondent's intent in doing
so was to authorize Ken Drugs to dispense prescriptions under his
registration number. Id. at 229 ("It was my practice to sign them when
I could and when everything was variable and proper and there would be
some permission to use the stamp, if I was not able to do that
myself."). I thus reject Respondent's contention that he did not
authorize the nine stamped prescriptions.\16\
---------------------------------------------------------------------------
\16\ Even if he did not authorize the prescriptions, the
evidence supports a finding that Respondent authorized the
pharmacist to issue prescriptions under the authority of his
registration. Under DEA case law, a registrant who authorizes others
to use his registration is responsible for any misuse of his
registration by these individuals. See Paul H. Volkman, 73 FR 30630,
30644 n.42 (2008); Rose Mary Jacinta Lewis, 72 FR 4035, 4040 (2007);
Robert G. Hallermeier, 62 FR 26818, 26820 (1997); Summer Grove
Pharmacy, 54 FR 28522, 28523 (1989).
---------------------------------------------------------------------------
Moreover, Respondent did not claim that these were oral
prescriptions. Thus, Respondent also violated DEA regulations because
he did not manually sign the prescriptions. See 21 CFR 1306.05(a)
("Where an oral order is not permitted, prescriptions shall be written
with ink or indelible pencil or typewriter and shall be manually signed
by the practitioner.") \17\
---------------------------------------------------------------------------
\17\ An oral prescription must be "reduced to writing by the
pharmacist" and "contain[ ] all information required by 21 CFR
1306.05, except for the signature of the practitioner." 21 CFR
1306.21(a).
---------------------------------------------------------------------------
As the foregoing demonstrates, Respondent's experience in
dispensing controlled substances and his record of compliance with laws
related to controlled substances is characterized by his repeated
prescribing in violation of state laws prohibiting the unauthorized
practice of medicine as well as those requiring that a physician
personally perform a physical examination of a patient he prescribes
to. These prescriptions also violated Federal law because in issuing
them, Respondent lacked "a legitimate medical purpose" and acted
outside of "the usual course of [his] professional practice." 21 CFR
1306.04(a). I thus hold that the Government has satisfied its prima
facie burden of showing that Respondent has committed acts which
"render his registration * * * inconsistent with the public
interest." 21 U.S.C. 824(a)(4).
Sanction
Under Agency precedent, where, as here, "the Government has proved
that a registrant has committed acts inconsistent with the public
interest, a registrant must 'present sufficient mitigating evidence to
assure the Administrator that [he] can be entrusted with the
responsibility carried by such a registration.'" Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008) (quoting 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), [DEA] has repeatedly held that where a registrant has
committed acts inconsistent with the public interest, [he] must accept
responsibility for [his] actions and demonstrate that [he] will not
engage in future misconduct." Medicine Shoppe, 73 FR at 387; see also
Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006);
Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v.
DEA, 419 F.3d at 483 ("admitting fault" is "properly consider[ed]"
by DEA to be an "important factor[ ]" in the public interest
determination).
It is acknowledged that Respondent ceased his internet prescribing
activities shortly after the execution of the search warrant. It is
also acknowledged that Respondent took a course of the American Academy
of Pain Management, which included subjects pertaining to the
prescribing of controlled substances.
The ALJ found, however, that Respondent has not accepted
responsibility for his misconduct. ALJ at 43-45. As support for this
finding, the ALJ cited: (1) Respondent's statement to the investigators
that he believed the Ken Drugs' scheme was lawful because the Kennedee
Group was well known, had a large business, and that Shobola had
researched its legality, (2) his testimony that he relied on Ken Drugs'
employees to screen for drug abusers, which she characterized as
"disingenuous at best," and (3) his "evasive and unresponsive"
testimony in "describing his interactions with Ken Drugs patients."
ALJ at 43-44.
The ALJ's finding is well supported by the record. With respect to
Respondent's contention that he believed that what he was doing was
lawful, I have previously held that "a licensed physician * * * is * *
* properly charged with the obligation to determine what the law
require[s] with respect to his prescribing activities." Patrick W.
Stodola, M.D., 74 FR 20727, 20735 (2009). In short, Respondent's
various contentions as to why he believed Shobola's internet
prescribing scheme was lawful are absurd on their faces.
Indeed, further evidence of Respondent's failure to accept
responsibility is his testimony that "[t]here was not one letter, not
one comment from any medical quality boards or anyone, regarding
safety, regarding guidance in any way" as to "the practice of
telemedicine." Tr. 209.\18\ As noted above, this is utter nonsense, as
prior to his prescribing, each of the three States whose residents he
prescribed to (California, Ohio, and Tennessee) had enacted statutes
and/or promulgated regulations which clearly prohibited his prescribing
without obtaining a state license and without physically examining his
patients.
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\18\ Notably, at an earlier point in his testimony, Respondent
stated: "We were all constantly reviewing legalities and making
certain that we were responding to the best practice possible." Tr.
202. See also Tr. 222 ("there were very, very few guidelines").
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As the California Court of Appeal has noted, "the proscription of
the unlicensed practice of medicine is neither an obscure nor an
unusual state prohibition of which ignorance can reasonably be claimed,
and certainly not by persons * * * who are licensed health care
providers. Nor can such persons reasonably claim ignorance of the fact
that authorization of a prescription pharmaceutical constitutes the
practice of medicine." Hageseth v. Superior Court, 59 Cal. Rptr. 3d
385, 403 (Ct. App. 2007). The same is true of the state law standards
for establishing a valid doctor-patient relationship.
Respondent's testimony regarding how Ken Drugs screened for drug
abusers likewise manifests a degree of irresponsibility that is
incompatible
[[Page 78754]]
with what DEA expects of a registrant. While Respondent testified that
other employees were responsible for screening the patients, he
acknowledged that if the patients "were liars * * * they could break
through" and that "a lot of fraud can happen." He then justified his
prescribing notwithstanding the obvious diversion risk, claiming that
he is not a lawyer or police agent and that as "a physician * * * I
take people at their word" and "as a family physician, I have
patients that come to me face-to-face and can be dishonest with me."
Id. at 206-09.
Later, Respondent claimed that he could identify drug abusers and
drug seekers by their voice or diction, but then acknowledged that this
was "by no means, any criteria to determine who is being evasive" and
that it was "very, very less than perfect." Id. at 230-31. Putting
aside the obvious risk of diversion by prescribing to people one never
meets, if Respondent, as a trained physician, could not identify drug
abusers and drug seeking patients, it should have been apparent that
Ken Drugs' employees could not either. Yet he proceeded to prescribe
controlled substances to numerous persons even though he had no idea as
to whether they were legitimate patients or drug seekers and
abusers.\19\
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\19\ The National Center on Addiction and Substance Abuse (CASA)
has reported that "[t]he number of people who admit abusing
controlled prescription drugs increased from 7.8 million in 1992 to
15.1 million in 2003." National Center on Addiction and Substance
Abuse, Under the Counter: The Diversion and Abuse of Controlled
Prescription Drugs in the U.S. 3 (2005) (cited in Stodola, 74 FR at
10089 n.24). Moreover, "[a]pproximately six percent of the U.S.
population (15.1 million people) admitted abusing controlled
prescription drugs in 2003, 23 percent more than the combined number
abusing cocaine (5.9 million), hallucinogens (4.0 million),
inhalants (2.1 million) and heroin (328,000)." Id. Relatedly,
"[b]etween 1992 and 2003, there has been a * * * 140.5 percent
increase in the self-reported abuse of prescription opioids"; in
the same period, the "abuse of controlled prescription drugs has
been growing at a rate twice that of marijuana abuse, five times
greater than cocaine abuse and 60 times greater than heroin abuse."
Id.
CASA has further reported that teenagers "represent an
especially vulnerable group," because "[t]eens may view
prescription drugs as relatively safe either when abused alone or in
combination with alcohol or other drugs." Id. According to CASA,
"[i]n 2003, 2.3 million teens ages 12 to 17 (9.3 percent) reported
abusing a controlled prescription drug in the past year; 83 percent
of them reported abusing opioids." Id. Moreover, "[b]etween 1992
and 2002, the number of [first time] teenage prescription opioid
abusers increased by 542 percent." Id.
Finally, CASA noted that "[i]nternet sites not adhering to
state licensing requirements, medical board standards or Federal law
have enabled consumers to obtain controlled prescription drugs
without a valid prescription or physician supervision and without
regard to age." Id. at 63. CASA also noted that "illegal
[i]nternet pharmacies have introduced a new avenue through which
unscrupulous buyers and users can purchase controlled substances for
unlawful purposes." Id. Moreover, "[t]he age of the customers
appears not to be an issue for Internet pharmacies," and that there
are "no mechanisms in place to block children from purchasing
controlled drugs over the Internet." Id. at 66.
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The ALJ was also unimpressed by Respondent's testimony regarding
his interactions with Ken Drugs' patients. For example, Respondent
testified that Ken Drugs' customers would not be able to get him "on
the phone until they had gone through some of these hurdles" such as
sending in their medical records. Id. at 206. He also claimed that
there were times when the customers got through to him without having
provided their medical records, and that he "would have to say, 'No,
we can't help you.'" Id. at 214. Yet he prescribed to both the DEA
and DOH Investigators who had not sent in any records. He also
testified that he discussed "the risk of habituation" with the
persons he prescribed to. Id. at 217. Once again, he did not do so when
he prescribed to either the DEA or DOH Investigators.
As the ALJ found, much of Respondent's testimony was self-serving
and disingenuous. Moreover, Respondent repeatedly attempted to minimize
his misconduct, which is egregious. In short, Respondent has failed to
acknowledge any wrongdoing on his part. Accordingly, I agree with the
ALJ's finding that Respondent has failed to accept responsibility for
his misconduct and that this "warrants the finding * * * that his
continued registration poses a threat to the public health and
safety." ALJ at 46.\20\ Having concluded that Respondent has failed to
rebut the Government's prima facie case, his registration will be
revoked and any pending application will be denied.
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\20\ See also Stodola, 74 FR at 20730-31 (practitioner's
continued registration deemed inconsistent with the public interest
where, inter alia, "he has not accepted responsibility for his
misconduct but blames others"); Leslie, 68 FR at 15231 (revoking
registration where, inter alia, "Respondent refuse[d] to take
responsibility for his past misconduct" and "remain[ed] steadfast
in his insistence upon denying any previous wrongdoing"); Prince
George Daniels, 60 FR 62881, 62887 (1995) (registrant's "lack of
candor * * * as to the full extent of his involvement in the cocaine
incident creates concern about his future conduct"); John Stanford
Noell, 59 FR 47359, 47361 (1994) (denying Respondent's application
for registration where, as to factor five, "Respondent has
exhibited no remorse for his illegal activities").
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a)(4), as well as by 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, BL6686541, issued to Ronald Lynch, M.D.,
be, and it hereby is, revoked. I further order that any application for
renewal or modification of such registration be, and it hereby is,
denied. This Order is effective January 18, 2011.
Dated: December 3, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31650 Filed 12-15-10; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO). |
