AAPS Asks 11th Circuit to Reverse Conviction of Dr. John Gianoli

12-14814-A

In the United States Court of Appeals for the Eleventh Circuit

UNITED STATES OF AMERICA,Plaintiff-Appellee,

v.

JOHN ANTHONY GIANOLI, III,Defendant-Appellant.

ON APPEAL FROM U.S. DISTRICT COURT FOR THE MIDDLE DISTRICT OF FLORIDA, TAMPA DIVISION,

NO. 08:11-CR-501-T-24MAP, HON. SUSAN C. BUCKLEW

BRIEF FOR AMICUS CURIAE ASSOCIATION OF AMERICAN PHYSICIANS & SURGEONS, INC., IN SUPPORT

OF DEFENDANT-APPELLANTIN SUPPORT OF REVERSAL

Andrew L. Schlafly N.J. Bar No. 04066-2003 General Counsel 939 Old Chester Rd. Far Hills, NJ 07931 Tel: (908) 719-8608Fax: (908) 934-9207 Email: [email protected] (11th Cir. Admission Pending)

Lawrence J. Joseph (Counsel of Record) D.C. Bar No. 464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]

Counsel for Amicus Curiae

Case: 12-14814 Date Filed: 02/20/2013 Page: 1 of 29

C-1 of 2

CERTIFICATE OF INTERESTED PERSONS AND CORPORATE DISCLOSURE STATEMENT

United States v. Gianoli, No. 12-14814-A

The undersigned counsel hereby certifies, pursuant to 11th Cir. R. 26.1-1,

that – in addition to those previously identified as having an interest in the outcome

of this case – the following additional persons have such an interest:

Association of American Physicians & Surgeons (“AAPS”), amicus curiae;

Joseph, Lawrence John, Counsel for amicus curiae AAPS; and

Schlafly, Andrew Layton, General Counsel, amicus curiae AAPS.

Pursuant to FED. R. APP. P. 26.1, amicus curiae AAPS makes the following

disclosures:

1) For non-governmental corporate parties please list all parent

corporations: None.

2) For non-governmental corporate parties please list all publicly held

companies that hold 10% or more of the party’s stock: None.



C-2 of 2

Dated: February 20, 2013 Respectfully submitted,

Lawrence J. Joseph D.C. Bar #464777 1250 Connecticut Ave. NW, Ste. 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254 Email: [email protected]

Counsel for Amicus Curiae Association of American Physicians & Surgeons

/s/ Lawrence J. Joseph


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TABLE OF CONTENTS

Certificate of Interested Persons and Corporate Disclosure Statement ..................... 1

Table of Contents ........................................................................................................ i

Table of Citations ..................................................................................................... iii

Identity, Interest and Authority to File ...................................................................... 1

Statement of Issues ..................................................................................................... 2

Statement of the Case ................................................................................................. 3

Summary of Argument............................................................................................... 4

Argument.................................................................................................................... 5

I. It Violates Due Process to Target This “Anti-Pill-Mill” Physician With an Undercover Operation and Convict Him For Disregarding an Absurdly False Statement ..................................................... 6

A. The Sting Operation Should Not Have Targeted This Opponent of Pill Mills Whose Practice Weans Patients Off Pain Medication .............................................................................. 7

B. It Violates Due Process to Omit the Tape Recording of the Comprehensive Initial Exam, Which Included an MRI Report That Established That the Patient Was in Pain ........................................................................................................ 8

C. It Violates Due Process to Base a Prosecution on an Absurdly False Statement By the “Patient” That the Physician Correctly Recognized as False and Properly Disregarded ........................................................................................... 9

II. Dr. Gianoli Lacked A Required Mens Rea Because He Correctly Concluded that the “Patient” Was Lying About Giving Drugs to His Girlfriend for Sex and Discharged the “Patient” As Soon As He Was Clear About an Improper Use ........................ 9


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III. This Court Must Reverse Because the Prosecution Added a New Theory of Liability Outside the Indictment and Did Not Necessarily Prevail With the Jury on Either of Its Two Theories of Liability ..................................................................................................... 12

A. The Prosecution Was Required to Seek to Amend the Indictment Before It Proceeded Under a New Theory of Liability ............................................................................................... 14

B. The Prosecution Needed a Special Verdict to Demonstrate that It Prevailed Under Either Theory of Liability ............................................................................................... 15

C. The Professional-Course-of-Practice Theory Must Proceed – If At All – Under an Objective Standard Based on Florida Law .................................................................................... 15

IV. The Enhanced Sentence for Crimes Involving a Position of Trust Is Inapposite to Sting Operations ......................................................... 18

Conclusion ............................................................................................................... 20

Certificate of Compliance ........................................................................................ 21

Certificate of Service ............................................................................................... 22


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TABLE OF CITATIONS

CASES

Altria Group, Inc. v. Good, 555 U.S. 70 (2008) ................................................ 17, 18Berger v. U.S., 295 U.S. 78, 55 S.Ct. 629 (1935) ...................................................... 8 Blatchford v. Native Village of Noatak,

501 U.S. 775, 111 S.Ct. 2578 (1991) ............................................................... 16 Casey v. U.S., 276 U.S. 413, 48 S.Ct. 373 (1928) ..................................................... 9 Dorris v. Absher, 179 F.3d 420 (6th Cir. 1999)......................................................... 5Gonzales v. Raich, 545 U.S. 1, 125 S.Ct. 2195 (2005) ............................................ 17 Hampton v. U.S., 425 U.S. 484, 96 S.Ct. 1646 (1976) .............................................. 6 Kolender v. Lawson, 461 U.S. 352, 103 S.Ct. 1855 (1983) ...................................... 6 Koon v. U.S., 518 U.S. 81, 116 S.Ct. 2035 (1996) .................................................. 19

* Ladner v. Smith, 941 F.2d 356 (5th Cir. 1991) ........................................................ 15 Mason v. Allen, 605 F.3d 1114 (11th Cir. 2010) ..................................................... 14 McNabb v. U.S., 318 U.S. 332, 63 S.Ct. 608 (1943) ........................................... 6, 14 Medtronic, Inc. v. Lohr, 518 U.S. 470, 116 S.Ct. 2240 (1996) ......................... 17, 18 Morissette v. U.S., 342 U.S. 246, 72 S.Ct. 240 (1952) ............................................ 11 Nat’l Fed’n of Indep. Bus. v. Sebelius, 132 S. Ct. 2566 (2012)............................... 10 Oceanair of Florida, Inc. v. N.T.S.B., 888 F.2d 767 (11th Cir. 1989) .................... 14 Raley v. Ohio, 360 U.S. 423, 79 S.Ct. 1257 (1959) ................................................... 6 Rochin v. California, 342 U.S. 165, 72 S.Ct. 205 (1952) .......................................... 6

* Sherman v. U.S., 356 U.S. 369, 78 S.Ct. 819 (1958) ................................................. 9 Springer v. Henry, 435 F.3d 268 (3d Cir. 2006) ........................................................ 1Stenberg v. Carhart, 530 U.S. 914, 120 S.Ct. 2597 (2000) ....................................... 1Tafflin v. Levitt, 493 U.S. 455, 110 S.Ct. 792 (1990) .............................................. 16 U.S. Nat. Bank of Ore. v. Independent Ins. Agents of America, Inc.,

508 U.S. 439, 113 S.Ct. 2173 (1993) ................................................................. 5U.S. v. Fitapelli, 786 F.2d 1461 (11th Cir. 1986) .................................................... 13

* U.S. v. Ghertler, 605 F.3d 1256 (11th Cir. 2010) .................................................... 20


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* U.S. v. Herrick, 545 F.3d 53 (1st Cir. 2008) ............................................................ 15 U.S. v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) ........................................................... 1U.S. v. Russell, 411 U.S. 423, 93 S.Ct. 1637 (1973) ................................................. 6 U.S. v. Rutgard, 116 F.3d 1270 (9th Cir. 1997) ........................................................ 1U.S. v. Terry, 60 F.3d 1541 (11th Cir. 1995) ..................................................... 18-19 U.S. v. Tobin, 676 F.3d 1264 (11th Cir. 2012) ........................................................ 13

* U.S. v. Twigg, 588 F.2d 373 (3d Cir. 1973) ............................................................... 7 U.S. v. Townsend, 555 F.2d 152 (7th Cir. 1977) ....................................................... 9 Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) ..................................... 16-17

STATUTES

U.S. CONST. art. VI, cl. 2 ......................................................................................... 16 U.S. CONST. amend. V, cl. 4 .................................................................................... 14 U.S. Sentencing Guidelines, §3B1.3 .................................................................. 18-19 U.S. Sentencing Guidelines, §3B1.3, Application Notes, ¶4 .................................. 19 Federal Food, Drug, and Cosmetic Act,

21 U.S.C. §§301-399f ...................................................................................... 3 Controlled Substances Act,

21 U.S.C. §§801-904 ..............................................................................passim21 U.S.C. §802(10) .................................................................................................. 18 21 U.S.C. §830(b)(2)(A)(ii) ..................................................................................... 18 21 U.S.C. §841(a)(1) .......................................................................................... 12, 17 21 U.S.C. §841(g)(2)(B)(i) ...................................................................................... 18

RULES AND REGULATIONS

FED. R. APP. P. 29(c)(5) ............................................................................................. 1


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IDENTITY, INTEREST AND AUTHORITY TO FILE

Amicus curiae Association of American Physicians and Surgeons, Inc.

(“AAPS”), a nonprofit corporation, files this amicus brief with the consent of all

the parties.1 Founded in 1943, Amicus is an organization of physician members

located throughout the Nation, including many within the jurisdiction of this

Circuit. For 70 years, AAPS has been dedicated to defending the practice of

private, ethical medicine. AAPS has filed numerous amicus curiae briefs in

noteworthy cases like this one. See, e.g., Springer v. Henry, 435 F.3d 268, 271 (3d

Cir. 2006) (“the Association of American Physicians and Surgeons, argues that the

issue transcends the relationship between the parties and instead impacts thousands

of patients damaged as a result of hospital errors, incompetence, wrongdoing, and

cover-ups”); U.S. v. Hurwitz, 459 F.3d 463 (4th Cir. 2006) (reversing a conviction

as argued by AAPS in its amicus brief); U.S. v. Rutgard, 116 F.3d 1270 (9th Cir.

1997) (reversing many counts of conviction and vacating the sentence, as urged by

AAPS in its amicus brief). AAPS has been cited in several decisions of the U.S.

Supreme Court. See, e.g., Stenberg v. Carhart, 530 U.S. 914, 120 S.Ct. 2597

(2000) (citing an AAPS amicus brief).

1 Pursuant to FED. R. APP. P. 29(c)(5), the undersigned counsel certifies that: counsel for amicus authored this brief in whole; no counsel for a party authored this brief in any respect; and no person or entity – other than amicus, its members, and its counsel – contributed monetarily to this brief’s preparation or submission.


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The disposition of this appeal will affect the rights of AAPS members,

including many physicians who practice within the jurisdiction of this Circuit. The

precedent below sends this message to physicians: do not trust your patients or

your professional instincts. This has a tremendously harmful effect on the practice

of medicine. AAPS has members within this Circuit are affected by the ruling, and

AAPS thereby has a significant interest in filing this amicus brief.

STATEMENT OF ISSUES

1. Whether it violates due process to target an “anti-pill-mill” physician

with an undercover operation and convict him for disbelieving an absurdly false

statement.

2. Whether mens rea is satisfied when a physician rejects a statement by

a (phony) patient for being false when, in fact, it was false.

3. Whether the prosecution’s failure to seek to amend the indictment to

add an alternate theory of liability with a different standard of mens rea and the

District Court’s failure to require a special verdict to distinguish between voting to

convict under the two alternate theories of liability require reversal.

4. Whether the objective standard for assessing liability for prescriptions

not in the “usual course of professional practice” requires the use of a nationwide

standard or a standard based on the law of the state under which the physician was

practicing medicine.


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5. Whether the sentencing enhancement for violating a position of trust

applies where the underlying criminal charge includes the defendant’s status as a

physician and where an undercover officer posing as a patient did not “trust” the

physician whom the officer was seeking to entrap.

STATEMENT OF THE CASE

After a sting operation in which an undercover officer posed as a patient in

severe pain, the United States charged Dr. Gianoli with dispensing oxycodone, a

Schedule II drug under the Controlled Substances Act, 21 U.S.C. §§801-904

(“CSA”). In addition to its status as a CSA-regulated Schedule II drug, oxycodone

also is a drug regulated by the Food & Drug Administration (“FDA”) under the

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§301-399f.

Dr. Gianoli is a Florida-licensed physician who devoted his practice to

weaning his patients off of their dependency on medication. Tr. June 14, 2012, at

7-8. Dr. Gianoli’s practice was the opposite of a “pill mill,” which consists of a

high volume of patients for whom “[e]verybody in the practice gets the same

medication or medications.” Tr. June 13, 2012, at 28:8-9.

The jury found Dr. Gianoli guilty on only one of five counts of prescribing

medication to an undercover agent posing as a patient. The jury hung or acquitted

Dr. Gianoli on the other four counts.


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SUMMARY OF ARGUMENT

Dr. Gianoli’s medical practice was devoted to reducing dependency by

patients on controlled substances. The practice welcomed patients who were in

pain and then attempted to wean them off of their pain prescriptions. None of the

justifications for conducting an undercover sting operation, in an attempt to catch a

physician in selling pain medication, exists here. Dr. Gianoli’s practice was the

opposite and antithesis of a “pill mill.” A conviction and 5-year-sentence for Dr.

Gianoli, based on an artful undercover “sting” operation that resulted in Dr.

Gianoli discharging the patient, transgresses important due process limits. The

decision below is a manifest injustice that requires reversal.

Context matters in medicine, as in law, and the failure by the prosecution to

provide a tape recording of the all-important initial patient encounter should have

led to a directed verdict for Dr. Gianoli below. Taking quotes out of context can

mislead a listener to an incorrect result. By failing to present a tape recording of

the initial examination to the jury, the prosecution gave the jury no context by

which to assess follow-up visits. Nothing in those subsequent visits was criminal

enough to justify five years in jail. Once Dr. Gianoli determined in the initial

examination that the patient was in substantial pain, Dr. Gianoli had a duty to treat

that pain, and he acted well within his professional judgment in discounting the

isolated statements of “sex for drugs” by the patient. Dr. Gianoli concluded that the


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patient was lying in making those statements, and in fact Dr. Gianoli was correct:

the patient was lying. Communication is largely non-verbal, but the non-verbal

aspects of those statements were not picked up by the tape recorder. What Dr.

Gianoli correctly understood to be a false statement by an undercover agent cannot

prove the mens rea necessary for a five-year imprisonment.

The conviction below should also be reversed because the prosecution added

a new theory of liability outside the indictment, which resulted in a lack of a

complete determination by the jury on either of the two prosecutorial theories.

Furthermore, the sentence should not have been enhanced for crimes involving a

position of trust when the conviction was based entirely on an undercover sting

operation.

ARGUMENT

A reviewing court can and should address “a miscarriage of justice” in a

decision below. Dorris v. Absher, 179 F.3d 420, 426 (6th Cir. 1999). In addition,

this reviewing court may extend beyond arguments raised by the parties in order to

correct an injustice. See, e.g., U.S. Nat. Bank of Ore. v. Independent Ins. Agents of

America, Inc., 508 U.S. 439, 448, 113 S.Ct. 2173, 2179 (1993) (addressing an

argument sua sponte on appeal). As explained below, this Court should reverse the

conviction and sentence of Dr. Gianoli.


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I. IT VIOLATES DUE PROCESS TO TARGET THIS “ANTI-PILL-MILL” PHYSICIAN WITH AN UNDERCOVER OPERATION AND CONVICT HIM FOR DISREGARDING AN ABSURDLY FALSE STATEMENT

Due process imposes limits on undercover sting operations and, when the

facts of this case are taken as a whole, those limits were transgressed in this case.

There are bounds on the use of “[t]he awful instruments of the criminal law.”

McNabb v. U.S., 318 U.S. 332, 343, 63 S.Ct. 608, 614 (1943). Entrapping conduct

can violate due process. Raley v. Ohio, 360 U.S. 423, 437-39, 79 S.Ct. 1257, 1265-

66 (1959). So can standardless governmental prosecutions. Kolender v. Lawson,

461 U.S. 352, 358, 103 S.Ct. 1855, 1858 (1983); see also Rochin v. California, 342

U.S. 165, 172-73, 72 S.Ct. 205, 210 (1952) (brutal conduct by government violates

due process);

While government may lie to entrap a target, there are limits to the degree of

deception that may be used. “[W]e may some day be presented with a situation in

which the conduct of law enforcement agents is so outrageous that due process

principles would absolutely bar the government from invoking judicial processes

to obtain a conviction.” U.S. v. Russell, 411 U.S. 423, 431-32, 93 S.Ct. 1637, 1642-

43 (1973). Where “[p]olice overinvolvement in crime … reach[es] a demonstrable

level of outrageousness,” then due process is implicated. Hampton v. U.S., 425

U.S. 484, 495 n.7, 96 S.Ct. 1646, 1653 n.7 (1976) (Powell, J., concurring)

Taken together, these three aspects of the prosecution go beyond what due


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process requires for a civilized society:

Target an opponent of pill mills, a small medical practice designed to wean

patients off of pain medication, for an undercover sting operation designed

to entrap pill mills;

Omit a tape recording of the comprehensive initial examination, which

included an MRI report that established that the patient was in pain; and

Base a prosecution on a tape-recorded, absurdly false statement by the

patient that the physician correctly recognized to be false and properly

disregarded.

Each of these issues is discussed below; taken together, they go beyond the limits

of due process in securing a conviction.

A. The Sting Operation Should Not Have Targeted This Opponent of Pill Mills Whose Practice Weans Patients Off Pain Medication

Where is a lack of a factual predicate for an undercover sting operation, then

a conviction cannot be properly obtained from it. See U.S. v. Twigg, 588 F.2d 373,

381 n.9 (3d Cir. 1973) (a factor in finding a violation of due process is when there

is no apparent evidence of criminal intent to justify the undercover sting

operation). Dr. Gianoli did not run a pill mill, and no one would even think he was

running a pill mill. He took patients on pain medication to get them off the drugs.

That made him an easy target for an undercover agent posing as a pain patient,

because Dr. Gianoli accepted pain patients. But someone who is an easy target for


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a sting operation is not automatically a legitimate target for a sting operation. Low

IQ people are easy targets for sting operations, but not legitimate ones, for

example, unless there is a factual predicate for the entrapment.

The sum and substance of this case is an undercover agent attempting to

elicit incriminating statements and conduct by a physician who was and is opposed

to pain medication, and tried to wean patients off the controlled substances. Any

physician who knows his patients and disregards obviously absurd statements

could be sentenced to five years in jail as Dr. Gianoli has been, under this

precedent. That is not consistent with due process.

B. It Violates Due Process to Omit the Tape Recording of the Comprehensive Initial Exam, Which Included an MRI Report That Established That the Patient Was in Pain

The most important evidence in any case like this is the initial exam that

establishes whether the patient legitimately had pain. Yet the undercover agent

either mishandled or had an equipment failure concerning that central piece of

evidence. Tr. June 12, 2012, at 101. This essential evidence for this type of case –

the all-important initial examination – was never made available to the defense.

This does not comport with due process, and an earnest responsibility for the

prosecution to seek justice and not merely another “win”. Berger v. U.S., 295 U.S.

78, 88, 55 S.Ct. 629, 633 (1935).


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C. It Violates Due Process to Base a Prosecution on an Absurdly False Statement By the “Patient” That the Physician Correctly Recognized as False and Properly Disregarded

The patently absurd drugs-for-sex-with-his-girlfriend statement used by the

undercover agent rendered the crime “the product of the creative activity of law

enforcement officials,” not of Dr. Gianoli. Sherman v. U.S., 356 U.S. 369, 373, 78

S.Ct. 819, 821 (1958). As Justice Brandeis observed, an investigator “may not

provoke or create a crime and then punish the criminal, its creature.” Casey v. U.S.,

276 U.S. 413, 423, 48 S.Ct. 373, 376 (1928) (Brandies, J., dissenting), overruled in

part on other grounds, Turner v. U.S., 396 U.S. 398, 424, 90 S.Ct. 642, 656

(1970). Yet that is what transpired here.

The background of Dr. Gianoli reinforces the unsustainable conduct in

convicting him. Courts inquire “where he sits on the continuum between naive first

offender and streetwise habitue,” and Dr. Gianoli is on the furthest end of someone

who was no more than a “naïve first offender,” casting further doubt on the entire

prosecution and conviction. U.S. v. Townsend, 555 F.2d 152, 155 n.3 (7th Cir.),

cert. denied, 434 U.S. 897, 98 S.Ct. 277 (1977).

II. DR. GIANOLI LACKED A REQUIRED MENS REA BECAUSE HE CORRECTLY CONCLUDED THAT THE “PATIENT” WAS LYING ABOUT GIVING DRUGS TO HIS GIRLFRIEND FOR SEX AND DISCHARGED THE “PATIENT” AS SOON AS HE WAS CLEAR ABOUT AN IMPROPER USE

The Supreme Court has emphasized that “we traditionally presume a mens


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rea requirement if the statute imposes a ‘severe penalty.’” Nat’l Fed’n of Indep.

Bus. v. Sebelius, 132 S. Ct. 2566, 2654 (2012). A five-year prison certainly

constitutes a “severe penalty.” Yet the basis for mens rea in the conviction below

was Dr. Gianoli’s rejection of the credibility of a statement by an undercover agent

that was, indeed, absurd and false. As a matter of law, this cannot establish mens

rea.

The conviction is based on Dr. Gianoli recognizing as false this statement by

the undercover agent (when the statement actually was false):

It’s like I said before, my girlfriend is taking most of them, she holds out on sex unless I have let her have them.

Tr. June 14, 2012, at 81:13-15. Dr. Gianoli understood this statement to be a farce,

as demonstrated by his laughter at it (which was picked up by the tape recording).

Id. at 81:15-17 (“And after he says that, the transcript indicates you were kind of

chuckling.”) It is not a crime to reject as false what is, indeed, false. And

recognizing a statement as false does not satisfy the requirement of mens rea.

If the undercover agent posing as a patient had stated that he was diverting

his medication to Batman and Robin, and Dr. Gianoli rejected that statement as

unbelievable and then prescribed the medication for the pain proven by the MRI

report and other evidence of pain, then as a matter of law Dr. Gianoli has

committed no crime. Likewise, there is no criminal intent by Dr. Gianoli in


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disbelieving a false statement by the undercover agent that said he was diverting

pain medication to his girlfriend for sex.

The conviction below rests on a thorough demonstration of pain, including

an MRI report confirming it (Tr. June 14, 2012, at 6), by an undercover agent who

pretended to be a patient. The agent does not record the comprehensive initial

exam performed by Dr. Gianoli. Instead, the undercover agent records a farcical

remark about giving his drugs to his girlfriend for sex, at which Dr. Gianoli

laughed and correctly rejected as untrue. It is not a crime – and certainly no

evidence of criminal intent – for a physician to reject a far-fetched statement by a

patient that was indeed false.

The U.S. Supreme Court has emphasized that a finding of criminal intent is

fundamental requirement:

The contention that an injury can amount to a crime only when inflicted by intention is no provincial or transient notion. It is as universal and persistent in mature systems of law as belief in freedom of the human will and a consequent ability and duty of the normal individual to choose between good and evil.

Morissette v. U.S., 342 U.S. 246, 250, 72 S.Ct. 240, 243 (1952) (emphasis added).

Lacking in proof of criminal intent, the conviction below of Dr. Gianoli should be

reversed.


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III. THIS COURT MUST REVERSE BECAUSE THE PROSECUTION ADDED A NEW THEORY OF LIABILITY OUTSIDE THE INDICTMENT AND DID NOT NECESSARILY PREVAIL WITH THE JURY ON EITHER OF ITS TWO THEORIES OF LIABILITY

As Dr. Gianoli explains in his brief, the proceedings below suffered two

inter-related and fatal defects with respect to the alternate theories of liability for

violating 21 U.S.C. §841(a)(1). First, the indictment addressed only one of those

theories of liability, but the jury was charged with both. If it wanted to proceed

under the second, alternate theory of liability, the United States needed to seek to

amend the indictment. See Gianoli Br. at 22-26. Second, given the differences

between the two theories of liability, the District Court needed to use a special

verdict to ensure that the jury unanimously convicted Dr. Gianoli under either

theory of liability. See Gianoli Br. at 26-32. Amicus AAPS fully supports both of

these two arguments against Dr. Gianoli’s conviction and adds two related

arguments here. First, these errors are not harmless errors because they deprive this

Court of the ability to know whether the jury unanimously convicted Dr. Gianoli.

Second, if the United States elects to re-try Dr. Gianoli on remand, the prosecution

should rely on Florida standards – not an imagined nationwide standard – to assess

the manner in which Dr. Gianoli practiced medicine.

By way of background, liability for violating 21 U.S.C. §841(a)(1) can rest

on one of two alternate theories when the government prosecutes a physician for

prescribing an FDA-regulated controlled substance in violation of the CSA:


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The prescription was not for a “legitimate medical purpose,” which asks

subjectively whether the physician believed the prescription was for a

legitimate purpose; or

The prescription was not made in the “usual course of professional practice,”

which the prosecution must show under an objective (and national) standard.

U.S. v. Tobin, 676 F.3d 1264, 1280 (11th Cir. 2012). As explained in the next three

sections, the prosecution was procedurally or substantively flawed in several

respects. Before addressing those flaws, however, amicus AAPS first demonstrates

that the procedural failings are not mere “harmless error.”

In an antitrust case that turned on two alternate theories of liability with only

one in the indictment, this Court pointed out that the deviation from required

procedures was not harmless error:

This is not a case in which the harmless error standard may be applied to a mere variance in the indictment. The court instructed the jury on a theory of jurisdiction which had not been charged by the grand jury. In charging the jury that they could find the defendants guilty under either or both theories the trial court materially amended the indictment and destroyed the defendants’ right to be tried only on the charges against them.

U.S. v. Fitapelli, 786 F.2d 1461, 1463-64 (11th Cir. 1986). To the extent that the

aside about harmless error raises the prospect that failure to amend an indictment

ever could qualify as harmless error, amicus AAPS respectfully submits that the

error here is about as harmful as error can be.


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At the outset, the question “[w]hether an error is harmless is a mixed

question of law and fact that [federal courts] review de novo.” Mason v. Allen, 605

F.3d 1114, 1123 (11th Cir. 2010). In the context of this case – with two alternate

theories of liability evaluated under different standards of mens rea – this Court

simply cannot know whether the jury unanimously convicted Dr. Gianoli under

either legal theory with the required mental state. Under the circumstances, the

failure to amend the indictment to add both theories and to use a special verdict

that separately contemplated both theories renders the result below indefensible.

A. The Prosecution Was Required to Seek to Amend the Indictment Before It Proceeded Under a New Theory of Liability

From a purely procedural standpoint, the Due Process Clause required the

United States to seek to amend the indictment to charge Dr. Gianoli with the

alternate “legitimate medical purpose” form of liability. See Gianoli Br. at 22-26. If

that seems like a merely procedural technicality, “[t]he history of liberty has

largely been the history of observance of procedural safeguards,” Oceanair of

Florida, Inc. v. N.T.S.B., 888 F.2d 767, 770 (11th Cir. 1989) (quoting McNabb v.

U.S., 318 U.S. 332, 347, 63 S.Ct. 608, 616 (1943)), which “protect the [public]

from arbitrary action on the part of the [government], however unintended.” Id. For

the reasons that Dr. Gianoli argues in his brief, this Court should reverse because

the United States failed to amend the indictment to include its alternate theory of

liability.


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B. The Prosecution Needed a Special Verdict to Demonstrate that It Prevailed Under Either Theory of Liability

As Dr. Gianoli explains, the District Court needed to use a special verdict in

order to ensure that the jury was unanimous on either the subjective “legitimate

medical purpose” theory of liability or the objective “usual course of professional

practice” theory of liability. See Gianoli Br. at 26-32. The fact that the jury hung

on the other counts where the jury did not outright find Dr. Gianoli not guilty

simply reinforces the unquestionable fact that no-one – not this Court, not the

District Court, and not the United States – knows whether the jury was unanimous

in finding Dr. Gianoli guilty under either theory of liability. And the two tests are

hardly two sides of the same coin, where voting for one means voting for the other.

One test is subjective, while the other is objective, which are two fundamentally

different things. U.S. v. Herrick, 545 F.3d 53, 59 (1st Cir. 2008); Ladner v. Smith,

941 F.2d 356, 360-61 (5th Cir. 1991), overruled on other grounds, U.S. v. Dixon,

509 U.S. 688, 113 S.Ct. 2849 (1993). Because the two tests simply do not even go

to the same question, the jury’s undifferentiated answer to their two separate

question does not answer whether Dr. Gianoli was guilty under either theory of

liability.

C. The Professional-Course-of-Practice Theory Must Proceed – If At All – Under an Objective Standard Based on Florida Law

As explained in the previous two sections, procedural irregularities leave this


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Court with no basis on which to affirm Dr. Gianoli’s conviction. In the event that

the United States elects to re-try this case on remand, the professional-practice

prong of liability should proceed under an objective standard but – rather than

being based on a nationwide standard – that prosecution should be based on

Florida standards because the CSA does not “clearly and manifestly” preempt the

authority of Florida to regulate the terms on which Florida-licensed physicians may

prescribe this FDA-approved drug in the course of their medical practices.

By way of background, the Supremacy Clause provides that federal law

preempts state law whenever they conflict. U.S. CONST. art. VI, cl. 2. Under the

federalist system of dual sovereignty, however, “the States entered the federal

system with their sovereignty intact,” Blatchford v. Native Village of Noatak, 501

U.S. 775, 779, 111 S.Ct. 2578, 2581 (1991), and “the States possess sovereignty

concurrent with that of the Federal Government, subject only to limitations

imposed by the Supremacy Clause.” Tafflin v. Levitt, 493 U.S. 455, 458, 110 S.Ct.

792, 795 (1990). For that reason, federal Courts interpret the laws enacted by

Congress deferentially to the states “because respect for the States as independent

sovereigns in our federal system leads [federal courts] to assume that Congress

does not cavalierly pre-empt [state law].” Wyeth v. Levine, 555 U.S. 555, 565 n.3,

129 S.Ct. 1187, 1195 n.3 (2009) (internal quotations omitted).

Thus, under the Supreme Court’s preemption analysis, all fields – and


17

especially ones like medicine that have been traditionally occupied by state

government – require courts to apply a presumption against preemption. Wyeth,

555 U.S. at 565, 129 S.Ct. at 1194-95. Moreover, even if Congress had preempted

some state action, the presumption against preemption applies to determining the

scope of preemption. Medtronic, Inc. v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240,

2250 (1996). Thus, “[w]hen the text of an express pre-emption clause is

susceptible of more than one plausible reading, courts ordinarily accept the reading

that disfavors pre-emption.” Altria Group, Inc. v. Good, 555 U.S. 70, 77, 129 S.Ct.

538, 543 (2008) (quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 449, 125

S.Ct. 1788, 1801 (2005)). While the Commerce Power allows Congress to set

national rules under the CSA, see Gonzales v. Raich, 545 U.S. 1, 125 S.Ct. 2195

(2005), it is not manifestly clear that Congress intended the CSA to supplant state

law on how physicians practice medicine.2

The United States has prosecuted Dr. Gianoli for violating the generally

worded prohibitions of 21 U.S.C. §841(a)(1), which applies to his practice of

medicine because the CSA defines “dispense” to include “deliver[ing] a controlled

2 In holding that the CSA preempted state law with respect to medical uses for a Schedule I drug, the Supreme Court did not even consider what standards – national or state – apply to determining the validity of prescriptions for Schedule II drugs. Indeed, the Court expressly did not reach several issues, including the “the medical necessity defense,” and even suggested that the plaintiffs there could obtain relief by working with the Department of Justice to move marijuana to a different CSA schedule. Raich, 545 U.S. at 31, 125 S.Ct. at 2215.


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substance to an ultimate user … by … a practitioner, including the prescribing and

administering of a controlled substance.” 21 U.S.C. §802(10). Although not

expressly applicable here, the CSA elsewhere defines “valid prescription” without

reference to supplanting state standards for the practice of medicine:

The term “valid prescription” means a prescription which is issued for a legitimate medical purpose by an individual practitioner licensed by law to administer and prescribe the drugs concerned and acting in the usual course of the practitioner’s professional practice.

21 U.S.C. §830(b)(2)(A)(ii). Conversely, where the CSA intends federal interests

in prescription writing to take precedence over state law, the CSA expressly

requires registration with the Attorney General. See 21 U.S.C. §841(g)(2)(B)(i).

Here, therefore, nothing in the CSA commends an imagined nationwide standard

over the existing state standards for validly prescribing FDA-regulated drugs.

Under Medtronic and Altria Group, supra, this Court should recognize that the

CSA’s admitted preemption of state authority to allow wholesale distribution of

Schedule II drugs does not prevent interpreting the CSA’s preemptive scope

narrowly to rely on state law to determine the validity of physicians’ prescriptions.

IV. THE ENHANCED SENTENCE FOR CRIMES INVOLVING A POSITION OF TRUST IS INAPPOSITE TO STING OPERATIONS

The District Court held that Dr. Gianoli’s status as a licensed physician

triggered the sentencing enhancement for abusing a position of trust, U.S.

Sentencing Guidelines, §3B1.3, a legal issue that this Court reviews de novo. U.S.


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v. Terry, 60 F.3d 1541, 1545 (11th Cir. 1995) (“whether the defendant’s conduct

justifies the ‘abuse of trust’ enhancement is a question of law reviewed de novo”);

Koon v. U.S., 518 U.S. 81, 96, 116 S.Ct. 2035, 2046 (1996). By way of

background, Section 3B1.3 includes two prongs, one based on “abus[ing] a

position of public or private trust” and the other on “us[ing] a special skill.” U.S.

Sentencing Guidelines, §3B1.3.3 Amicus AAPS agrees with Dr. Gianoli that this

enhancement was inappropriate here, both for the double-counting argument that

he raises and for the second reason that undercover police officers do not, in fact,

“trust” the defendants whom they seek to entrap.

First, Dr. Gianoli correctly argues that the sentence for the underlying

offense already incorporates the idea of a physician acting outside his professional

obligations. See Gianoli Br. at 32-37. As Dr. Gianoli points out (id. at 34), Circuit

precedent and even the Guidelines themselves expressly provide as much: “This

adjustment may not be employed if an abuse of trust or skill is included in the

base offense level or specific offense characteristic.” U.S. Sentencing Guidelines,

§3B1.3 (emphasis added). For that reason, physicians should not fall under the

enhanced sentencing of Section 3B1.3 simply because they are physicians.

3 See id, Application Notes, ¶4 (“‘Special skill’ refers to a skill not possessed by members of the general public and usually requiring substantial education, training or licensing [such as] pilots, lawyers, doctors, accountants, chemists, and demolition experts”).


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Second, the ostensible patient – Detective Pittaluga – was actually an

undercover police officer who did not trust Dr. Gianoli. But “[a] relationship of

trust between the defendant and the victim is the sine qua non of the abuse-of-trust

enhancement.” U.S. v. Ghertler, 605 F.3d 1256, 1264 (11th Cir. 2010). For that

reason, “‘the abuse of trust enhancement applies only where the defendant has

abused discretionary authority entrusted to the defendant by the victim.’” Id.

(quoting U.S. v. Garrison, 133 F.3d 831, 839 (11th Cir. 1998) (emphasis in

Garrison)). No such abuse applied here, and the position-of-trust enhancement is

simply not available in “sting” or entrapment cases like this one.

CONCLUSION

For the foregoing reasons, the conviction below should be reversed.

Dated: February 20, 2013

Andrew L. Schlafly N.J. Bar No. 04066-2003 General Counsel 939 Old Chester Rd. Far Hills, NJ 07931 Tel: (908) 719-8608Fax: (908) 934-9207 Email: [email protected] (11th Cir. Admission Pending)

Respectfully submitted,



/s/ Lawrence J. Joseph/s/ Andrew L. Schlafly


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CERTIFICATE OF COMPLIANCE


1. The foregoing complies with FED. R. APP. P. 32(a)(7)(B)’s type-

volume limitation because the brief contains 4,739 words excluding the parts of the

brief that FED. R. APP. P. 32(a)(7)(B)(iii) exempts.

2. The foregoing complies with FED. R. APP. P. 32(a)(5)’s type-face

requirements and FED. R. APP. P. 32(a)(6)’s type style requirements because the

brief has been prepared in a proportionally spaced type-face using Microsoft Word

2010 in Times New Roman 14-point font.

Dated: February 20, 2013 Respectfully submitted,





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CERTIFICATE OF SERVICE

I hereby certify that on February 20, 2013, I electronically submitted the

foregoing document to the Clerk for filing and transmittal of a Notice of Electronic

Filing to the participants in this appeal who are registered CM/ECF users. I further

certify that I have mailed the foregoing document by Priority U.S. Mail, postage

prepaid, to the following participants in the case who are not registered CM/ECF

users:

James A. Muench Robert E. O’NeillKathy Peluso U.S. Attorney’s Office 400 N Tampa St Ste 3200 Tampa, FL 33602-4798

Donald C. Turner Don Turner Legal Team 1160 Grimes Bridge Rd Bldg B Roswell, GA 30075

Lawrence J. Joseph, D.C. Bar #464777 1250 Connecticut Ave, NW, Suite 200 Washington, DC 20036 Tel: (202) 355-9452 Fax: (202) 318-2254Email: [email protected]



Documents

AAPS Asks 11th Circuit to Reverse Conviction of Dr. John Gianoli