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					                                    No. 05-4884


                  UNITED STATES COURT OF APPEALS
                      FOR THE FOURTH CIRCUIT


                      UNITED STATES OF AMERICA,

                                 Plaintiff-Appellee,

                                         vs.

                         RONALD A. McIVER, D.O.,

                                Defendant-Appellant.


                   Appeal from the United States District Court
        for the District of South Carolina, Anderson/Greenwood Division
                     District Court Criminal Case No. 8:04-745



                        APPELLANT'S BRIEF


For Appellant Ronald McIver, D.O.:

ELI D. STUTSMAN
621 S.W. Morrison, 13th Floor
Portland, Oregon 97205
  Telephone: (503) 274-4048

C. RAUCH WISE
305 Main Street
Greenwood, South Carolina 29646
  Telephone: (864) 229-50 10
                      I. STATEMENT OF JURISDICTION

A.    District court jurisdiction

      This is a criminal case. Dr. Ronald McIver was prosecuted under the

Controlled Substances Act, 21 V.S.C. § 801 et seq ("CSA"). The United States

District Court for the District of South Carolina had jurisdiction pursuant to 18

V.S.C. § 3231. Dr. McIver was convicted of one count of conspiracy, 21 D.S.C. §

846, and eight counts of unlawful distribution, 21 D.S.C. § 84l(a)(l);   he was

acquitted of six distribution counts.

B.    Appellate court jurisdiction

      The appeal is from the final judgment. The district court imposed sentence

on August 26,2005, and filed the judgment on September 19,2005.          Dr. McIver

timely filed his notice of appeal on August 31, 2005. This court has jurisdiction

pursuant to 28 D.S.C. § 1291.

                       II. STATEMENT OF THE ISSUES

      Dr. McIver challenges the district court's jury instructions that, in the

context of trial, equated a deviation from "professional norms" with criminal guilt.

      Dr. McIver raises two challenges to expert testimony. First, Dr. McIver

raises a plain error argument that the district court erred when it allowed the

government's expert witness to state a legal conclusion on the ultimate issue that


                                           1
told the jury nothing more than what verdict to return, and second, he challenges

the district court's converse ruling that prohibited Dr. McIver's expert witness from

testifying that physicians who practice in a minority group are still within the

bounds of medical practice.

      Dr. McIver challenges the sufficiency of the evidence to sustain his

convictions for unlawfully distributing controlled substances to Larry Shealy, and

further challenges the sufficiency of the evidence to sustain the findings that

Shealy's death resulted from the OxyContin and Roxicodone that Dr. McIver

prescribed.

      Dr. McIver also challenges the sufficiency of the evidence to sustain each of

his other convictions.

                         III. STATEMENT OF THE CASE

      Dr. McIver was indicted on one count of conspiracy to unlawfully distribute

controlled substances and fourteen counts of unlawful distribution of controlled

substances, based on prescriptions for controlled substances that he issued to ten

patients of his pain management clinic. The jury trial lasted seven days, with five

days of evidence (April 11-15, 2005), closing argument and jury instructions on

April 18, 2005, and a verdict received on April 19, 2005.

      The jury found Dr. McIver guilty of the conspiracy count and eight

                                          2
distribution counts. The jury acquitted on six distribution counts. The jury made

findings regarding the weights of the controlled substances distributed, and found

that death resulted from Larry Shealy's use of the controlled substances distributed

to him in two counts.

      Dr. McIver's motion for a new trial was denied after a hearing on April 26,

2005. Sentencing occurred August 26,2005.         The district court imposed

concurrent sentences of 360 months' imprisonment on counts 11 and 12 and 240

months' imprisonment on each other count.

                          IV. STATEMENT OF FACTS

A.    The practice of pain management

      The practice of pain management is varied and controversial.      J.A. 1077-79,

1083. There is no standardization in the treatment of pain. l.A. 1083. There is a

question among physicians over how aggressively to treat chronic pain patients.

J.A. 1077-78. Most physicians agree on the use of high doses of opioids for

terminal cancer patients. l.A. 1077. While the majority of physicians do not use

opioids aggressively with non-terminal patients, there is a minority group of

physicians who treat chronic pain more aggressively and with more opioids than

the majority group. J.A. 1078. A physician's prescribing practices should be

dictated by his clinical experience. J.A. 1074.


                                          3
      The use of opioids (narcotics) is a legitimate treatment option. J.A.501-02.

The opioids oxycodone (trade names OxyContin, OxyFast, OxyIR, and

Roxicodone), hydromorphone (trade name Dilaudid), morphine (trade names

Avinza and MSIR), and methadone are Schedule II controlled substances. J.A.48.

      There is no legal or pham1acological maximum dosage of the controlled

substances listed above. J.A. 51, 575. The dosage and increases in dosage

("titration") are left to the physician's medical judgment. J.A. 50, 509-10.

      Because opioids are subject to abuse, physicians look for certain warning

signs (or "flags") that a patient may be disingenuous.   J.A. 502-04.

B.    Dr. McIver's patients

      The indictment charged Dr. McIver with conspiracy and unlawful

distribution of controlled substances to ten patients. J.A. 13-24 (Indictment), 39

(identifying individuals in indictment). Dr. McIver was acquitted of the charges

related to his treatment of Hannah, Riegel, Davis, and Hawfield, and of the

charges related to the July 2002 treatment of Shealy (count 10). The remaining

counts are discussed below.

      Dr. McIver established a physician-patient relationship with each patient.

He treated each using a multimodal approach that employed numerous therapies,

such as ultrasound, trigger point injections, chiropractic work, and TENS electric


                                          4
stimulation, in addition to prescribing medications. J.A. 180-84, 193 (Smith); 212,

217-18 (Brown); 253 (Boyer); 417, 963-65 (Shealy); 350, 367-68 (Barnes); 392,

403, 409 (Knight).

      Dr. McIver treated Brown for Reflex Sympathetic Dystrophy Syndrome

("RSD"), a very painful condition. J.A. 206, 215. He treated Shealy for severe

pain in his back, neck, shoulders, and knees. J.A. 422, 962-63. He treated Barnes

for fibromyalgia. J.A. 347-48. He treated Knight for chronic back pain following

a car accident. J.A. 388.

      Smith falsely complained of wrist pain, corroborated by a scar on one wrist

and arthritis in the other wrist. J.A. 179, 188, 195. Boyer falsely complained of

severe pain in his foot stemming from a childhood accident, and had suture marks

to corroborate his claim. J.A. 249,254-56.    Both Smith and Boyer were using

their medications recreationally by injecting them intravenously.   J.A. 176, 250.

      Boyer had track marks in April, 2002, during his time in Dr. McIver's care.

I.A. 250-51. He did not think Dr. McIver saw them. J.A. 254.

      Dr. McIver found a syringe in Smith's pocket during one visit. I.A. 185.

Dr. McIver considered Smith's explanation that he used the syringe for "juicing

up" bait plausible but suspect. J.A. 185, 980.

      Smith and Boyer were friends, but would sometimes pretend not to know


                                          5
each other. J.A. 251. Dr. McIver was suspicious of Smith and Boyer and

contacted the Department of Health and Environmental Control ("DHEC") to relay

his suspicions and request an investigation.!   J.A. 83-84, 981. DHEC employee

Larry McElrath thought the letter was unusual, did not investigate the people

named in the letter, and told Dr. McIver to resolve the issues within the physician-

patient relationship.   J.A. 85-86.

         For three months in 2001, Brown had been addicted to crack cocaine. lA.

207-08. She reported that fact to Dr. McIver. J.A.207-08.      Brown's father

accused her of abusing her medications and wrote Dr. McIver to request

information on Brown's treatment plan. J.A. 226,233.       Brown's father was

dissatisfied with the general response Brown permitted Dr. McIver to send. l.A.

233-38.

         Shealy died in his sleep on May 28,2003.   l.A.4l9.   His death is discussed

below.

         Barnes told Dr. McIver on several occasions that she could not take the

methadone he prescribed because it made her sleepy. J.A.356.       Dr. McIver

thought that Barnes's complaints about methadone were "not insurmountable" and




       IDrs. Storick and Duc testified that they also would contact DHEC or law
enforcement with suspicions about patients. l.A. 613, 615, 1102, 1105.

                                           6
continued to prescribe methadone, along with "something     * * * to help   [her] stay

awake while [she] was taking" the methadone. l.A. 356,942.

      Barnes sold some of her medications.    Tr. l.A. 353. Dr. McIver received

anonymous telephone calls that said Barnes was selling her medications, after

which Dr. McIver ordered a quantitative drug screen, which would tell him how

much of the drug was present. l.A.954. Dr. McIver also contacted the Lancaster

County Sheriffs Office to request information on whether Barnes was involved in

illegal drug trade, but he received no response. l.A. 126-30, 955. When Barnes

did not take the drug test, Dr. McIver ordered a second quantitative test and told

Barnes he would discharge her as a patient if she did not take it. l.A. 954, 957.

Barnes did not return after that visit. l.A. 957. Barnes said she stopped seeing Dr.

McIver after experiencing withdrawal when she ran out of medications. l.A. 357-

58.

      Knight took her medications as directed and did not abuse them. l.A.407.

Knight had two negative drug screens, but assured Dr. McIver on each occasion

that she was taking her medications as directed. l.A. 407, 993. Dr. McIver called

the laboratory and learned that the test used by the laboratory would not detect

OxyContin. l.A. 994. Dr. McIver's file notes indicate that subsequent drug

screens performed in the office tested positive. l.A. 540, 994.


                                          7
       Dr. McIver occasionally contacted Greenwood County Sheriffs Deputy

Grogan with the names of people of whom he was suspicious. l.A. 113. In May,

2002, Deputy Grogan arrested Tammy Plyler, a patient of Dr. McIver's, for selling

her medication, and informed Dr. McIver of the arrest. l.A. 113.2

       After her arrest, Plyler visited Dr. McIver and told Dr. McIver that it was

her brother's wife, also named Tammy Plyler, that was arrested. l.A. 114. Dr.

McIver verified that there was another "Tammy Plyler." l.A. 1005. Dr. McIver

called the Detention Center and obtained the social security number, driver's

license number, date of birth, and address for the Tammy Plyler arrested. lA.

1005. None of the information matched that of Dr. McIver's patient. l.A. 1005.

Dr. McIver believed that his patient was not the person arrested. l.A. 1005. On

July 22, 2002, Dr. McIver wrote two prescriptions for Plyler. l.A. 114.

       Dr. McIver contacted Deputy Grogan afterward and gave him copies of the

prescriptions.   J.A. 114-15, 1006. Deputy Grogan retrieved the booking

photograph of the "Tammy Plyler" he arrested and took it to Dr. McIver. l.A. 115.

The photograph identified Dr. McIver's patient as the person arrested. l.A. 115.

Dr. McIver discharged Plyler as a patient. l.A. 1006.




      2Dr. McIver was not charged with unlawfully distributing controlled
substances to Plyler.

                                          8
C.    The government's expert witness, Dr. Steven Storick

      Dr. Storick is board-certified in pain management, and is in private practice

in pain management.   J.A.498-99.   Dr. Storick reviewed two prescriptions that Dr.

McIver wrote for Brown, and patient files for Brown, Shealy, Barnes, Knight, and

a patient named John Davis who was not included in the indictment. J.A.515,

518-558. Dr. Storick did not review the me<iical files for patients Hannah, Smith,

Boyer, Riegel, Robbie Davis, or Hawfield.

      1. Brown

      Dr. Storick opined that Brown's prescriptions were "inappropriate" and

potentially lethal because the instructions permitted Brown to vary the dosage as

needed for her pain. J.A.516.   Dr. Storick stated that that is "just not the way you

practice medicine." J.A.516.    He conceded, however, that "[a]bout five years ago

or so we were doing exactly what you see Dr. McIver doing, giving large doses of

pain medicines and giving breakthrough medicines every four hours as needed."

J.A. 589. Physicians would double and triple doses "just as [the defense was]

advocating." l.A. 589-90.

      Dr. Storick confirmed that Brown "obviously has a chronic pain problem,"

but contended that the use of opioids for RSD "is a very controversial issue." .LA.

522. Regarding Brown's past crack cocaine addiction, Dr. Storick stated that it is


                                          9
not per se outside the bounds of medical practice to prescribe opioids to a former

addict. l.A. 629. Dr. Storick did not think it was "appropriate" to prescribe

OxyContin to Brown, in light of her past addiction, but allowed that it was an

honest disagreement in judgment. l.A.630.

      Dr. Storick opined that, because Dr. McIver "prescribed liberally and

without specific guidelines on pm [as needed] basis," his actions were "outside the

course of legitimate medical practice" and "wrong." l.A. 523,632.      Had Dr.

McIver prescribed a dose of five pills, instead of one to five pills as needed, "it

would sit better." l.A.643.

      2. Shealy

      Regarding Shealy, Dr. Storick was provided with Dr. Mitchell's file for

Shealy but not Dr. McIver's. J.A. 523-25. Dr. Storick reviewed only the

prescriptions Dr. McIver wrote for Shealy in reaching his conclusion. J.A.525.

Dr. Storick conceded that prescribing opioids to Shealy was not per se

inappropriate, but stated that because of Shealy's noncompliance with Dr.

Mitchell's dosing instructions, he would have prescribed opioids "on a strict basis

and close monitoring" without escalating the dose as Dr. McIver did. l.A. 606.

Due to "[t]he combinations of the high dose opioids," Dr. Storick opined that

"there's no legitimate reason to be prescribing all these drugs" for a patient not


                                          10
suffering from cancer. J.A.527.

      3. Barnes

      Dr. Storick stated that the "whole scenario" of Dr. McIver's treatment of

Barnes was a "red flag," because Dr. McIver was treating her for fibromyalgia, "a

pain syndrome," that is "hard to diagnose" and "very controversial" to treat. lA.

533. Dr. Storick opined that, when opioids are used to treat fibromyalgia, it

should be in "low dosages." J.A.533.     Dr. Storick acknowledged that there is a

difference of opinion in the medical profession, and some physicians do treat

fibromyalgia with opioids, but stated that it is not "standard" treatment. J.A.662-

63.

      The prosecutor questioned whether Dr. McIver should have continued

prescribing methadone if Barnes told him that she was not taking it.3 J.A.531-32.

Dr. Storick answered no, that it would be illegal. J.A. 532.

      The diagnosis, the "excessive doses," and the cost of the medication which

created the potential for drug diversion, led Dr. Storick to the conclusion that "this

is probably one of the worst cases I've seen" and that "it was way outside the

course of legitimate medical practice." J.A.534.




       3As noted above, Barnes's testimony was that she told Dr. McIver she had
difficulty taking the methadone, not that she was not taking it at all.

                                          11
      4. Knight

      Dr. Storick acknowledged that Knight had legitimate complaints of pain.

I.A.647.    He questioned the distance Knight traveled to see Dr. McIver, but

acknowledged that patients sometimes follow physicians when their offices move.

J.A. 542,646.     Dr. Storick conceded that the use ofOxyContin or similar

medications "may be appropriate" in treating Knight's pain. J.A. 652.

      Dr. Storick noted the negative drug screens from the laboratory, an order for

a blood drug screen with no results in the file, and the file notations of positive

drug screens in Dr. McIver's office. I.A. 539-40. Dr. Storick would have sent

Knight to the hospital for a blood draw to determine whether she was taking the

medication, and would have stopped treating her with opioids after one negative

retest. J.A. 542, 656-57. Dr. Storick opined that it was not an acceptable medical

practice to continue to prescribe opioids to Knight after two negative drug tests.

I.A. 657.

      Dr. Storick opined that "treating [Knight] for pain is not an unreasonable

treatment option," but that the distance she drove to the clinic, the "escalating

doses of pain medications," and the negative drug screens raised "red flags." lA.

542. Dr. Storick concluded that "legitimate prescribing of medication was

inappropriate [sic]." I.A.543.


                                           12
D.    Shealy's death

      Dr. Janice Ross is a board certified pathologist. l.A.425.     She performed

the autopsy on Shealy. I.A.427.

      Shealy had an enlarged heart, which takes years to develop. I.A. 427, 431.

Shealy had an enlarged spleen and liver, caused "probably entirely" by congestive

heart failure, which also developed over years. I.A.431.       Shealy had

atherosclerosis--hardening   of the arteries-in two of the three main arteries. lA.

427, 431. One main artery was ninety percent blocked, which is severe, and

another was fifty percent blocked. l.A.430.     Artery blockage prevents the heart

from getting blood and can cause a heart attack     l.A.431.    Shealy had pulmonary

congestion, which means that his heart wasn't pumping blood forward, so the

blood backed up into other organs. I.A.435.      Shealy had congested organs. lA.

427. He had had a previous heart attack     l.A.427.

      There were twelve pills in Shealy's stomach (eleven OxyContin and one

Roxicodone) and powdery material in the stomach contents. I.A. 427, 476. Dr.

Ross referred the case to a toxicology lab to analyze the stomach contents, and to a

forensic toxicologist, Dr. Demi Garvin, to analyze the findings. I.A.427.

      The level of oxycodone in Shealy's system was 404 nanograms per

milliliter. J.A. 432. Dr. Ross referred to Baselt's textbook, which stated that that


                                           13
level of oxycodone could be toxic in conjunction with some other central nervous

system depressing drugs. I.A. 433. After receiving Dr. Garvin's toxicology report,

Dr. Ross rendered the opinion that Shealy died from an overdose of oxycodone.

J.A.429.   Dr. Ross relied entirely on Dr. Garvin in determining that the oxycodone

level was toxic. I.A. 432, 434-35.

      Dr. Garvin reviewed Dr. Ross's preliminary findings, the morgue's notated

history, the pharmacy inventory, and the toxicology report and analysis of the

stomach contents. I.A. 437, 439-40. However, neither Dr. Ross nor the coroner

were able to provide Dr. Garvin with Shealy's medical history, so she did not

review it. I.A. 441.

      Drs. Ross, Garvin and Duc all agreed that if a person developed a tolerance

to oxycodone, it would be less likely that that person would overdose or die from

use of oxycodone. I.A. 434, 441, 462, 1133. Shealy had been prescribed the same

dose of OxyContin for at least two and as many as six months prior to his death.

J.A. 462, 967-68, 1133. The gastric contents denlOnstrated that Shealy was taking

his pills as directed. I.A. 481. As a result, Shealy would have developed a

tolerance for oxycodone. I.A. 462, 1133. "[T]oxicology results can be misleading

if [the toxicologist is] not aware of what the individual's medical history was."

J.A.441.   However, at the time they concluded that 404 nanograms per milliliter


                                          14
of oxycodone was toxic to Shealy, neither Dr. Garvin or Dr. Ross had reviewed

Shealy's medical history, and neither was aware of Shealy's tolerance to

oxycodone. J .A. 434, 441.

      Dr. Garvin concluded that Shealy died as a result of ingesting a lethal level

of oxycodone. J.A.442.4      In determining what is a toxic level of oxycodone, Dr.

Garvin referred to Baselt's textbook Disposition of Toxic Drugs and Chemicals in

    which stated that deaths had been reported from a combination of oxycodone
_M_a_n,

and another central nervous system depressant where the oxycodone level ranged

from 400 nanograms per milliliter to 2700 nanograms per milliliter. J.A. 457,483-

84.

      Dr. Garvin conceded that deaths in those cases involved oxycodone in

combination with another depressant drug. J.A.457.      Dr. Garvin twice pointed to

the fact that Shealy was on Alprazolam as well. J.A. 458, 483. Alprazolam (trade

name Xanax) is a benzodiazepine used for anxiety. J.A.464.      The level of

Alprazolam in Shealy's system was 16 nanograms per milliliter. J.A.458.        Dr.

Garvin did not know the amount of Alprazolam required before it became toxic in

combination with oxycodone. l.A.489.




     40xyContin is a controlled release form of oxycodone. Roxicodone is an
immediate release form of oxycodone.

                                           15
      Shealy had oxycodone, Alprazolam, and hydrocodone in his system at the

time of his death; hydrocodone was not on the list of medications that had been

prescribed to him.s I.A. 458, 466, 476-77.

      Dr. Garvin maintained that there was "enough OxyContin on board in Mr.

Shealy's blood to have resulted in his death alone, much less in combination with

another central nervous system depressant," but only cited studies in which

another drug combined with oxycodone to cause death to support that conclusion.

lA. 458.

E.    Dr. Ronald McIver

      Dr. Ronald McIver is a Doctor of Osteopathy registered with the Drug

Enforcement Administration ("DEA") and authorized to prescribe controlled

substances. J.A. 46, 50, 881.

      Dr. McIver operated his own pain management clinic, seeing six to twelve

patients a day. J.A. 897, 905. In his clinic, Dr. McIver used: three ultrasound

units, which stin1ulate blood flow and decrease inflammation; HakoMed and

Matrix units, which provide electrical stimulation; a traction table, which spreads

the vertebrae and relaxes the muscles; two iontophoresis units, which use


       5Hydrocodone is a Schedule II controlled substance. 21 C.F.R. § 1308.12.
Hydrocodone is a narcotic and may cause respiratory depression in sensitive
patients or at high doses. Physician's Desk Reference at 901 (54th ed. 2000).

                                         16
electrodes to drive medication deep into the tissues; and a gravity inversion unit,

which helps relax muscles, stretch joints, and stretch vertebrae. J.A.900-04.

      Dr. McIver subscribed to the belief that a physician should titrate (increase

dosage) "for as much pain relief as possible with manageable side effects." lA.

995. Dr. McIver would increase the dose until the patient reached an acceptable

level of pain relief or until the side effects became unmanageable.   J.A.996.   That

is an acceptable medical practice. J.A. 996.

      Dr. McIver looked for "yellow flags" to tell him that a patient's complaints

of pain were not genuine, and used pain contracts and pill counts to discourage

and control abuse of medications.   J.A. 907-10, 923.

      Dr. McIver discussed his treatment of each patient referred to in the

indictment. He never treated a patient for other than a legitimate medical purpose,

and never prescribed a medication outside the bounds of professional practice.

J.A. 1003.

F.    The defense's expert witness, Dr. Thomas Due, Jr.6

      Dr. McIver called Dr. Duc as an expert witness. J.A. 1063. Dr. Duc is

board certified in anesthesiology and pain management, and is in private practice

in pain management.   J.A. 1062.


      6Dr. Duc's surname is mis-transcribed as "Duke" in the transcript.

                                          17
      Dr. Duc reviewed Dr. McIver's files, provided by defense counsel, on

Hannah, Smith, Brown, Riegel, Davis, Hawfield, Shealy, Barnes, and Knight. J.A.

1088-89. He testified to the "positives and negatives" he saw. J.A. 1089. The

negatives were a lack of the patients' previous medical records, very little

intervention by behaviorists, psychologists, or psychiatrists, and the "biggie," high

doses. J .A. 1090-91. However, there are medical articles and speakers that

advocate the belief in using high dosages for chronic pain management. J.A.

1091. Dr. Duc also noted that Dr. McIver, as is common for osteopathic doctors,

used more physical therapies than he or other M.D.s do. J.A. 1091-92.

      Based on his review, Dr. Duc believed Dr. McIver was prescribing opioids,

including OxyContin, for legitimate medical purposes. J.A. 1092. Dr. McIver was

examining the patients and treating them for pain. J.A. 1092.

                     V. SUMMARY OF THE ARGUMENTS

      The district court erred when it instructed the jury to consider the expert

testimony on Dr. McIver's deviation from professional norms to determine

whether Dr. McIver issued the prescriptions outside the bounds of professional

practice (the third element of the crime of unlawful distribution).   In the context of

trial, that was reversible error. The government's expert witness equated a

deviation from professional norms with prescribing medication outside the bounds


                                          18
of professional practice. The district court refused to add to the challenged

instruction a sentence stating that a deviation from professional norms did not, in

and of itself, prove a crime. In that context, the court's instruction informed the

jury that it could convict Dr. McIver of unlawful drug distribution if it found that

his medical practices fell below "professional norms," which is not sufficient proof

of the crime. The errors allowed the jury to convict on lesser proof than was

required. The convictions must be reversed.

       The government's expert also improperly testified in regard to four of the

patients in the indictment that Dr. McIver's prescriptions and practices were

"outside the course of professional practice and for other than a legitimate medical

purpose." That legal conclusion, which told the jury no fact other than what

verdict the expert would reach, was not admissible evidence, and it was plain error

to allow it.

       The trial court conversely excluded, as a legal conclusion, Dr. McIver's

proferred expert testimony that would have informed the jury that physicians who

subscribe to a minority treatment group are still practicing medicine. That fact

was not merely a statement of what verdict to reach, but rather would have given

the jury a fact from a medical expert that it could use to evaluate the evidence.

That type of expert opinion is permissible; the type elicited from the government is


                                          19
not The court erred when it excluded the defense expert's testimony.

      The evidence used to convict Dr. McIver of unlawfully distributing drugs to

Shealy (counts 11 and 12) may have amounted to evidence of a violation of the

civil standard of care, but it did not amount to evidence that Dr. McIver ceased to

act as a physician and instead was engaged in unlawful drug dealing. The

evidence was insufficient to support the distribution charges.

      The evidence also was insufficient to support the jury's findings that the use

of OxyContin resulted in Shealy's death (count 11) or that the use of Roxicodone

resulted in Shealy's death (count 12). Because those findings were used to elevate

Dr. McIver's sentence to life with a twenty year minimum on counts eleven and

twelve, and to establish Dr. McIver's base level on the sentencing guidelines on

each count, each count must be remanded for resentencing if this Court sustains

the convictions.

      The government failed to prove that the prescriptions in the other counts

were issued outside the bounds of professional practice or with the requisite

mental state, which the government sought to prove by evidence of willful

blindness. Because the evidence was insufficient, those convictions cannot be

sustained. Likewise, the conspiracy conviction cannot rest on insufficient

evidence of mens rea, and also cannot be sustained on the insufficient evidence of


                                         20
an agreement produced in this case.

                                  VI. ARGUMENTS

A.    Introduction

      This case concerns the weight of civil "standard of care" evidence in a

criminal prosecution of a physician under the CSA. The distinction between a

civil malpractice lawsuit and a criminal drug prosecution provides a useful starting

point for the Court's analysis.

       1. The burden of proof in a civil malpractice case

      In order to prove medical malpractice, South Carolina law requires:

            "(1) evidence of the generally recognized practice and
      procedures that would be exercised by competent practitioners in a
      defendant doctor's field of medicine under the same or similar
      circumstances and
             "(2) evidence that the defendant doctor departed from the
      recognized and generally accepted standards, practices, and
      procedures in the manner alleged by the plaintiff."

Gooding v. St. Francis Xavier Hosp., 326 S.C. 248, 254 (1997) (emphasis and

paragraphing added).

      2. The burden of proof in a criminal prosecution for unlawful drug
      distribution

      In sharp contrast, in a criminal prosecution against a DEA-registered

physician for unlawful drug distribution, the government must prove beyond a

reasonable doubt that the physician:

                                         21
      (1) knowingly or intentionally

      (2) distributed or dispensed a controlled substance

      (3) outside the course of professional practice.

Those three elements derive from the CSA. 21 U.S.C. § 802(21), 841 (a); see also,

United States v. Moore, 423 U.S. 122, 140 (1975). The crime of unlawful

distribution is a specific intent crime 7 --the physician must have specifically

intended ("knowingly or intentionally") to distribute drugs outside the practice of

medicine.

      3. What did Congress mean by "outside the course of professional
      practice"?

      In Moore, the Court addressed whether a physician is per se exempted from

prosecution under section 841 because of his status as a DEA registrant. 423 U.S.

at 131. The Court answered no; "only the lawful acts of registrants are exempted."

Id. The Court held that a physician who acts as a '''pusher'--not as a physician,"

violates the CSA. Id. at 143. However, a physician's exemption from criminal

liability when he acts in the course of professional practice must be broad enough

to allow a physician "reasonable discretion in treating patients and testing new




      7See, e.g., 21 U.S.C. § 841(a); United States v. Tran Trang Cuong, 18 F.3d
1132, 1144 (4th Cif. 1994) (violation ofCSA requires proof that physician acted
with specific intent).

                                           22
theories," as Congress intended. Id.

      The Court explained that the legislative history of the CSA revealed that a

violation of the CSA "was intended to turn on whether the 'transaction' falls

within or without legitimate channels." Id. at 135 (emphasis added). That is, a

physician's registration "authorizes transactions within 'the legitimate distribution

chain' and makes all others illegaL" ld. at 141 (citation omitted). A physician may

prescribe drugs "only to act 'as a physician.'" Id.

      The Fourth Circuit reached the same conclusion in United States v. Tran

Trong Cuong, 18 F3d 1132 (4th Cif. 1994). The court relied on the criminal

standard enunciated in Moore to determine whether the physician was acting

"beyond the bounds of professional practice." The court stated that civil standard

of care evidence is not sufficient proof of the crime of unlawful drug distribution.

Id. at 1137.

      Thus, under Supreme Court and Fourth Circuit case law, a physician acts

"outside the course of professional practice" when he abandons the practice of

medicine (ceases to act "as a physician") and acts, instead, as a drug dealer ("large

scale 'pusher"') who diverts controlled substances into illicit channels with the




                                          23
specific intent of committing a drug crime.s

      4. How is the crime proved?

      This court has not delineated specific guidelines for determining when a

physician has ceased to act as a physician and converted to a mere drug seller.

United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995). The court has

established one limitation, however. Evidence of negligent medical practices

(such as malpractice, or civil "standard of care" evidence) is not sufficient to prove

a drug crime. Tran Trong Cuong, 18 F.3d at 1137. More is required. Id.

      Therefore, while this court has held that evidence of malpractice may be

relevant (that is, it passes the low threshold for admissibility) to establishing that a

physician's conduct was outside the bounds of professional practice, that evidence

is not sufficient to prove beyond a reasonable doubt that a physician's conduct was

outside the bounds of professional practice.

B.    The district court's instructions regarding professional norms misstated the
      law and violated due process.




       8This court recently used the following phrases to describe actions outside
the bounds of professional practice: "the physician was not practicing medicine,
but was instead cloaking drug deals under the guise of a professional medical
practice," and "in prescribing drugs [the physician] was not acting as a healer but
as a seller of wares. " United States v. Alerre, _ F.3d _ (4th Cir. 2005)
(December 1,2005, slip opinion at 13-14,15), citing Tran Trong Cuong, 18 F.3d
at 1138-40.

                                           24
      1. Standard of Review

      This court reviews the accuracy and adequacy of jury instructions de novo.

United States v. Scott, 424 F.3d 431,434 (4th Cir. 2005). The court reviews to

detennine "whether the instructions construed as a whole, and in light of the whole

record, adequately informed the jury of the controlling legal principles without

misleading or confusing the jury to the prejudice of the objecting party." Spell v.

McDaniel, 824 F.2d 1380, 1395 (4th Cif. 1987). The district court's decisions on

jury instructions are reviewed for an abuse of discretion. United States v. Wilson,

198 F.3d 467,469 (4th Cif. 1999), cert. den, 529 U.S. 1076 (2000). "A district

court by definition abuses its discretion when it makes an error of law." United

States v. Stitt, 250 F.3d 878,896 (4th Cif. 2001), cert. den, 535 U.S. 1074 (2002),

quoting Koon v. United States, 518 U.S. 81,100 (1996).

      In examining a jury instruction that may be "ambiguous and therefore

subject to an erroneous interpretation" for a due process violation, the court

reviews to detennine whether there is a reasonable likelihood that the jury applied

the instruction in an unconstitutional manner to allow conviction based on

insufficient proof. Victor v. Nebraska, 511 U.S. 1, 6 (1994); Boyde v. California,

494 U.S. 370, 380 (1990).




                                          25
      2. Discussion

      Dr. McIver objected to the district court's jury instructions regarding the

"norms of professional practice." J.A. 1302. The district court erred when it

overruled those objections.

      Viewed in the context of trial, the court's instructions misstated the law and

denied Dr. McIver due process of law. The jury was told that it could convict on a

lesser burden of proof than was required, because the instruction told the jury that

it could accept Dr. Storick's erroneous conclusion that a deviation from majority

practices, or professional norms, proved a crime.

             a.       The trial context in which the instruction was given

      The government's expert witness, Dr. Storick, testified that Dr. McIver's

practices fell below the civil standard of care and thus were criminal.   9



      The bulk of Dr. Storick's direct examination involved pat testimony that

covered three areas: the treatments Dr. McIver performed and the prescriptions

issued for each of five patients (Brown, Shealy, Barnes, Knight, and John Davis),

what Dr. Storick would or would not have done or otherwise thought was




       9The commingling of the civil and criminal standards, as was done in Dr.
Storick's testimony, is a recurring problem in prosecutions of DEA-registered
physicians under 21 V.S.C. § 841, and is challenged in several other cases
currently pending before this and other Circuit Courts of Appeal.

                                          26
"inappropriate," and a conclusion that Dr. McIver acted outside the bounds of

medical practice.   10   Dr. Storick based his conclusions that Dr. McIver acted

"outside the course of professional practice" and "for other than a legitimate

medical purpose" on civil standard of care criteria, such as: poor record keeping,

incomplete medical exan1S, what another physician would have done, failure to

pursue alternative remedies, and, most frequently, the dosage of the pills

prescribed.

      Dr. Storick's testimony reveals his dependence on the civil standard of care.

He frequently referred to what he would have done. He stated that prescribing

opioids for certain patients (including Brown as a past drug addict, and Barnes

with a fibromyalgia diagnosis) was "inappropriate" and "outside the course of

professional practice,"even while admitting that other physicians would use

opioids in those situations and conceding that it was a difference in judgment. He

discussed "better" drugs and "better" courses of treatment. As to the large doses

and the "as needed" instructions, with which Dr. Storick disagreed, he conceded

that Dr. McIver's practices were in line with what a majority of physicians did

"five years ago or so." J.A. 589-90. And, he made explicit reference to what a


      lOSeeJ.A. 515-17 (review of Brown's prescriptions), 518-23 (review of
Brown's file), 523-27 (review of Shealy's file), 527-34 (review of Barnes's file),
534-43 (review of Knight's file), 543-58 (review of John Davis's file).

                                             27
typical physician would "tend to do," to what a "reasonable physician" would do,

to "good medicine," and, on one occasion, to the" standard of care of medicine."

l.A. 537, 556, 557.

      Likewise, Dr. Storick's testimony reveals that his definition of what fell

"beyond the bounds of professional practice" did not comport with controlling

case law. For example, Dr. Storick was familiar with a study published by the

University of Wisconsin (a national leader in palliative and hospice care, see lA.

1081) that stated that, in cases of moderate to severe pain, a physician should

titrate (increase dosage) by fifty to one hundred percent. l.A.582-85.    Dr. Storick

dismissed that study with the assertions that "this is a controversial argument" and

"[aJcademic doctors are in [aJ different environment" whereas he "work[ s] for a

living." l.A.585.     Dr. Storick opined that a physician who titrated in accordance

with the University's published study would not be practicing within the bounds of

professional practice. l.A.586.     The suggestion that a physician who follows the

guidance of peer-reviewed medical literature is practicing outside the bounds of

medical practice alone illustrates the problem.

      Dr. Storick equated a deviation from professional norms with action beyond

the bounds of professional practice. The law does not. The law recognizes that

the practice ofmedicine--even     minority practices--is beyond the reach of the CSA.


                                           28
              b.     The jury instructions in this trial incorrectly equated
              deviations from the civil standard of care with criminal
              guilt.

       The jury instructions misled the jury as to the government's burden of proof.

The jury instructions--which       directly referenced the expert testimony--

erroneously ratified Dr. Storick's testimony that deviations from the civil standard

of care proved that Dr. McIver's conduct was outside the bounds of professional

practice.

       The district court began correctly. It instructed the jury on the three

elements of unlawful distribution.       l.A. 1239-41. The district court gave a good

faith instruction.   II   l.A. 1242.

       On the third element (outside the bounds of medical practice), the district

court correctly instructed the jury that a physician's DEA registration allows the

physician to distribute controlled substances "only to act as a physician," and that

"there are no specific guidelines" for determining whether a physician acts outside

the bounds of professional practiceY        l.A. 1241-42.

       The district court erred, however, when it nevertheless attempted to instruct




       llThat instruction applies to the mens rea element and ensures that the jury
finds specific intent.

       12UnitedStates v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995).

                                              29
the jury on guidelines for determining whether a physician acts outside the bounds

of professional practice. The court instructed the jury as follows:

              "In determining the defendant's - whether the defendant's
      conduct was within the bounds of professional practice you should,
      subject to the instructions I give you concerning the credibility of
      experts and other witnesses, consider the testimony you have heard
      relating to what has been characterized during the trial as the norms
      of professional practice.

              "You should also consider the extent to which, if at an, any
      violation of professional norms you find to have been committed by
      the defendant interfered with his treatment of his patients and
      contributed to an over prescription and/or excessive dispensation of
      controlled substances. You should consider the defendant's actions as
      a whole and the circumstances surrounding them.

              "A physician's conduct may constitute a violation of an
      applicable professional regulation as well as applicable criminal
      statute. However, a violation of a professional regulation does not in
      and of itself establish a violation of criminal law. As I have just
      indicated, in determining whether or not the defendant is guilty of the
      crimes for which he is charged you should consider the totality of his
      actions and the circumstances surrounding them and the extent and
      severity of any violations of professional norms you find he
      commi tted. "

l.A. 1243-44.

      In the context of trial, those instructions misled the jury as to the

government's burden of proof. As discussed above, a violation of professional

norms does not equate with a violation of the criminal standard. Tran Trang

Cuang, 18 F.3d at 1137. "A criminal prosecution requires more." Id. The words


                                          30
alone illustrate the problem: the "norms" of professional practice are "a standard

of conduct" or an "average"; the "bounds" of professional practice are "the

external or limiting line[s]." Webster's Third New International Dictionary 260

(bound and bounds), 1540 (norm and norms) (1993).

      Yet the district court instructed the jury that it should consider a violation of

professional norms for just that purpose: to determine the existence of the third

element of the crime and establish crhninal guilt.!3 Viewed in the context of trial,

in which the government's evidence equated the two, the court's instruction was

"misleading or confusing" to Dr. McIver's prejudice.

      The trial context further establishes that the defense asked the district court

to add a sentence to the challenged instruction that would have specified that a

deviation from professional norms did not, in and of itself, prove that the

prescription was issued outside the bounds of professional practice, but the district

court refused.!4 Although the defense's proffered instruction was a correct




       13Notonly did the court's instruction permit the jury to consider the evidence
of deviations from professional norms, the district court's use of the word "should"
mandated the jury's consideration of that evidence in deciding guilt.

       14Theproffered instruction was: "If you find the defendant did not comply
with the professional norms, you are still required to find the defendant not guilty
unless you find his actions were outside the bounds of medical practice." l.A.
1302.

                                          31
statement of the law, the district court refused to clarify that issue for the jury.

      In the context of trial, the instructions on professional norms did more than

tell the jury that the evidence may be relevant. The instructions permitted the jury

to find guilt on the basis of deviations from norms alone, thus permitting

conviction on insufficient proof. Tran Trong Cuong, 18 F.3d at 1137. A new trial

is warranted.

                c.   The error is reversible error

      The charge as a whole did not cure the error. In addition to the passages

quoted above, the court instructed the jury that "mention * * * of a standard of

care" and "the words 'medical malpractice'" refer to civil actions, which "is not

what we're talking about here. * * *. We're talking about whether or not this

physician prescribed a controlled substance outside the bounds of his professional

medical practice." l.A. 1246.

      Read as a whole, the jury was instructed: that a violation of professional

regulations, a violation of a "standard of care," or "medical malpractice" did not

prove that Dr. McIver departed the bounds of professional practice; but that a

violation of professional norms did constitute proof that Dr. McIver departed the

bounds of professional practice and thus was guilty of the crime.

      However, there was no evidence that Dr. McIver violated any professional


                                           32
regulations,15 nor any direct reference to the "standard of care"16 or "medical

malpractice"   I?   on the counts charged.   IS   Thus, while those instruction may have

advised the jury that two discrete pieces of evidence--Brown's father's complaint

and Dr. Storick's opinion of Dr. McIver's treatment of John Davis--did not prove

guilt on the crimes charged, it did nothing to dilute or cure the court's instruction

to the jury that it should rely on the more pervasive testimony from Dr. Storick

regarding deviations from professional norms in determining criminal guilt.

      Likewise, the instructions correctly defining the "bounds of professional


      15A violation of professional regulations (incurring possible sanctions from
the Board of Medicine) is something different than a violation of professional
norms (incurring possible civil liability for malpractice). The only evidence
related to professional regulations was Brown's father's complaint to the Board of
Medical Examiners, which did not result in a hearing. J.A. 238-41,246.

       16Theonly testimony from Dr. Storick that involved explicit reference to the
"standard of care" related to Dr. McIver's treatment of John Davis. While that
evidence was irrelevant and indeed would fail to prove criminal guilt, Dr. McIver
was not indicted for any charges related to his treatment of John Davis.

      17Therewas no mention of "medical malpractice."
      18
         It bears mention that the court's instructions were contradictory at best At
best, a deviation from a professional norm is a deviation from the civil standard of
care--the recognized and generally accepted standards, practices, and procedures
that would be exercised by competent practitioners under the same or similar
circumstances with the same patient--and thus malpractice. At worst, a deviation
from a professional norm would fail even to prove malpractice, because the
deviation may be justified by the circumstances or the patient, which is why civil
malpractice law requires those factors to be considered in evaluating a deviation
from generally accepted practices.

                                                  33
practice" as acting "as a physician" with "good faith" did nothing to cure the

court's incorrect instruction that the jury may find that a physician exceeds those

bounds when he violates professional norms.

       In summary, the correctness of the court's instructions on what does not

prove guilt did not cure the error in the instructions on what does prove guilt. The

jury instruction error requires reversal.

             d.      Dr. McIver was denied due process

       The instructional error also requires reversal under the due process clause of

the United States Constitution.   For the reasons argued above, the instructions

created a reasonable likelihood that the jury understood that it could find guilt

based on proof of a violation of the civil standards (or "professional norms ")

underlying Dr. Storick's testimony. By allowing conviction on a lesser burden of

proof than required, the instructions violated the Fourteenth Amendment's due

process guarantee.   Victor, 511 U.S. at 6; Boyde, 494 U.S. at 380.

C.    It was plain error to allow the government's expert to testifY to his belief
      that defendant violated the law--the ultimate legal question for the jury.

       1. Standard of Review

       This court reviews a district court's evidentiary rulings for abuse of

discretion. Stitt, 250 F.3d at 896. "A district court by definition abuses its

discretion when it makes an error of law.   II   Id., quoting Koon, 518 U.S. at 100.

                                            34
      This court may reverse plain error. Fed.R.Crim.P.52(b).        To demonstrate

plain error, the defendant must establish that error occurred, that it was plain, and

that it affected his substantial rights. United States v. Olano, 507 U.S. 725, 732

(1993); Stitt, 250 F.3d at 883. This court has discretion whether to reverse in the

face of plain error, and should exercise that discretion when the error "seriously

affect[s] the fairness, integrity or public reputation of judicial proceedings."

Olano, 507 U.S. at 736, quoting United States v. Atkinson, 297 U.S. 157, 160

(1936) (modification by Olano Court).

      2. Discussion

       In each chart review the prosecutor asked for Dr. Storick's opinion whether

Dr. McIver's treatment of the patient "was outside the usual course of medical

practice or for other than a legitimate medical purpose?" See l.A. 523 (Brown),

527 (Shealy), 534 (Barnes), 542-43 (Knight), 557-58 (John Davis). Dr. Storick

answered each time that Dr. McIver was acting outside the course of professional

practice. See Id. The questions called for and elicited an improper and

inadmissible legal conclusion.

      Federal Rule of Evidence 704, Opinion on Ultimate Issue, provides in

relevant part:

            "(a) Except as provided in subdivision (b), testimony in the
      form of an opinion or inference otherwise admissible is not

                                           35
       objectionable because it embraces an ultimate issue to be decided by
       the trier of fact."

       Thus, Rule 704 permits an expert witness to "embrace" an ultimate issue if

his or her opinion is otherwise admissible. Federal Rule of Evidence 702 renders

expert testimony admissible when "scientific, technical, or other specialized

knowledge will assist the trier of fact to understand the evidence or to determine a

fact in issue. n

       In United States v. Barile, 286 F.3d 749 (4th Cif. 2002), this court examined

the interplay of those two rules. The court began by noting that, while Rule 704

was "designed specifically to abolish the 'ultimate issue' rule," it did not "lower the

bars so as to admit all opinions." Id. (citations omitted). Rather, it "shift[ ed] the

focus to whether the testimony is 'otherwise admissible.'" Id., quoting Torres v.

County of Oakland, 758 F.2d 147, 150 (6th Cif. 1985). Rules 701,702, and 403

require that the opinion testimony be helpful to the jury and not waste time, and

"afford ample assurances against the admission of opinions which would merely

tell the jury what result to reach." Id. at 759-60, citing Fed.R.Evid. 704 advisory

committee's notes (emphasis added).

       The court provided the following general rule:

       "Expert testimony that merely states a legal conclusion is less likely
       to assist the jury in its determination. See Woods v. Lecureux, 110
       F.3d 1215, 1220 (6th Cif. 1997) ('It is, therefore, apparent that

                                           36
      testimony offering nothing more than a legal conclusion--i.e.,
      testimony that does little more than tell the jury what result to reach--
      is properly excluded under the Rules.')."

Id. at 760 (footnote and additional citation omitted). "To determine when a

question posed to an expert witness calls for an improper legal conclusion, the

district court should consider first whether the question tracks the language of the

legal principle at issue or of the applicable statute, and second, whether any terms

employed have specialized legal meaning." Id., citing Torres.

      The prosecutor's questions, and Dr. Storick's answers, violated that

principle. The questions and answers were worded, usually verbatim, in the words

of the statute. They tracked the language of the legal principle and had specialized

legal meaning. In short, the question led Dr. Storick to respond by "supply[ing]

the jury with no information other than the expert's view of how its verdict should

read." That question, asked at the conclusion of each file review, and Dr. Storick's

answer is the one prohibited by Rules 702 and 704. Id. at 760.

      The error is plain under the Rules and Barile. The improper introduction of

expert testimony that told the jury that the expert considered Dr. McIver guilty

denied Dr. McIver a fair trial. Dr. McIver was acquitted of several counts, but was

convicted of crimes involving each patient about whom Dr. Storick offered his

legal conclusion. Accordingly, Dr. McIver respectfully requests that this court


                                          37
exercise its discretion to correct the error and remand his case for a new trial.

D.    The district court improperly excluded proffered testimony from defendant's
      expert witness.

      1. Standard of Review

      This court reviews the district court's exclusion of expert testimony for

abuse of discretion. Barile, 286 F.3d at 753. A "district court by definition abuses

its discretion when it makes an error of law." Id., quoting Stitt, 250 F .3d at 896.

      2. Discussion

      Dr. McIver also called an expert witness, Dr. Duc. Dr. Duc explained that

there is no standardization in the treatment of pain. J.A. 1083. There is a majority

treatment group which "treat[s] with far lesser opioids" and is "less likely to use

opioids." l.A. 1084. There is also a minority treatment group that treats pain more

aggressively and has expanded beyond the treatment limitations of the majority

group. J.A. 1084.

      The defense asked: "Would the minority group be within the bounds of

medical practice?" J.A. 1085. The government objected, arguing that the question

called for a legal conclusion. J.A. 1085. The district court sustained the objection,

and stated: "It's for the jury to make that determination in this case." J.A. 1085.

      The district court by definition abused its discretion when it excluded the

proffered testimony, because it made an error of law. The solicited testimony was

                                          38
not an improper legal conclusion. As discussed above, Rule 704 does not prohibit

expert opinions on legal conclusions that are otherwise admissible. Rule 702

renders "otherwise admissible" an expert opinion that gives the jury facts it can

use to reach its verdict, without telling the jury what verdict the expert would

reach.

         The defense question solicited proper testimony regarding facts. It sought

testimony that physicians practicing in a minority group are still practicing

medicine. It did not tell the jury whether Dr. Duc thought Dr. McIver was

practicing medicine, as did Dr. Storick's testimony. That question was reserved

for the jury. In short, it was not excludable under Rule 702 or Rule 704. The trial

court incorrectly excluded the testimony.

         The exclusion harmed Dr. McIver's case. The jury had heard evidence of

majority medical practices and Dr. Storick's opinion that Dr. McIver's practices,

which did not follow the majority, fell outside the bounds of medical practice.

The defense's proffered evidence would have aided Dr. McIver's defense. It would

have told the jury that, even if it found that Dr. McIver's practices fell outside of

the majority, that is not the end of the inquiry; a physician may deviate from the

majority practice and still be practicing medicine. The district court's exclusion of

that evidence over Dr. McIver's objection prejudiced the defense and is reversible


                                            39
error.

E.       The evidence was insufficient to prove beyond a reasonable doubt that Dr.
         McIver issued prescriptions to Larry Shealy for OxyContin (count 11) and
         Roxicodone (count 12) unlawfully.

         1. Standard of Review

         A reviewing court shall sustain a conviction if there is substantial evidence,

in the light most favorable to the government, to uphold it. United States v.

Burgos, 94 F.3d 849,862-63 (4th Cir. 1996), cert. den, 519 U.S. 1151 (1997). In a

criminal case, "substantial evidence is evidence that a reasonable finder of fact

could accept as adequate and sufficient to support a conclusion of a defendant's

guilt beyond a reasonable doubt." Id. at 862 (citation omitted). It is more than

the "any evidence" standard rejected in Jackson v. Virginia, 443 U.S. 307 (1979).

         2. Discussion

         It is undisputed that Dr. McIver wrote the prescriptions at issue in counts 11

and 12. The government's proof failed, however, on the other elements required to

prove a crime. The government's burden required it to prove beyond a reasonable

doubt that Dr. McIver acted outside the bounds of professional practice (that is, he

ceased acting as a physician) with specific intent to commit a drug crime when he

issued the prescriptions.   Moore, 423 U.S. at 141; Tran Trong Cuong, 18 F.3d at

1144. The evidence does not support such a finding.


                                            40
      Shealy suffered back pain for several years, and his family physician, Dr.

Mitchell, prescribed OxyContin to treat Shealy's pain. Shealy took more

medication than prescribed by Dr. Mitchell, and therefore needed refills early. Dr.

Mitchell advised Shealy against taking his medication in higher doses than

prescribed, and ultimately referred Shealy to Dr. McIver.

      There is more than one possible explanation for a patient who takes more

medication than directed. The patient may be abusing his medications. Or, the

patient may have "pseudoaddiction," which means the patient is being "under

dosed" and needs more medication. J.A. 1095.

      Dr. McIver reviewed Shealy's medical history and determined that, in fact,

Shealy had been under-treated for his condition. Dr. McIver increased Shealy's

dosage to 80 milligrams of OxyContin in February 2002. Count 10 alleged that

the prescription Dr. McIver issued to Shealy in July 2002 for 150 80-mg units of

OxyContin was issued outside the course of professional practice. The jury

acquitted Dr. McIver of unlawfully issuing that prescription, finding that Dr.

McIver was acting as a physician at that time.

      Dr. McIver continued to treat Shealy, and continued to prescribe

OxyContin. Dr. McIver also prescribed Roxicodone, short-acting oxycodone, for

breakthrough pain. There is no evidence of any drug diversion or abuse


                                         41
concerning Shealy from the time that the jury determined that Dr. McIver was

acting as Shealy's physician to the time of the May 2003 prescriptions at issue in

counts 11 and 12. Furthermore, it was undisputed that Shealy had a legitimate

complaint of pain that required treatment, and that opioid treatment was a valid

treatment option. l.A. 603, 606. Dr. Storick's criticism of Dr. McIver's treatment

of Shealy was with the high doses of opioids prescribed. Similarly, Dr. Garvin's

criticism of Dr. McIver's treatment of Shealy was that the high doses and

directions to take as needed were not "appropriate." l.A.453.

      Thus, Dr. McIver's convictions in counts 11 and 12 rest on medical

evidence, and disagreements about Dr. McIver's medical practices, and not on any

evidence of drug diversion. That evidence is insufficient in a drug crime

prosecution as a matter of law. The congressional intent behind the CSA--

preventing diversion of drugs to illicit channels to satisfy the cravings of

addicts-does not reach as far as founding a criminal conviction on complaints

about dosage in an established patient-physician relationship.   The DEA itself

recognizes that dosage and increases in dosage are left to the physician's medical

judgment under the CSA. l.A.50. See also, l.A. 509-10 (Dr. Storick), 1074 (Dr.




                                          42
DUC).19


      Moreover, Dr. Storick conceded that Dr. McIver's prescribing practices

were in accord with the generally accepted practices of the year 2000:

      "About five years ago or so we were doing exactly what you see Dr.
      McIver doing, giving large doses of pain medicines and giving
      breakthrough medicines every four hours as needed. And those
      patients you doubled their dose, you tripled their dose of long-acting
      medicine, just as [the defense is] advocating."

l.A.589.   Evidence that Dr. McIver followed that practice in the year 2003 is

insufficient to prove that, in doing so, Dr. McIver had ceased to act as a physician

and converted to mere drug dealer.

      Because there is no evidence of a drug crime in counts 11 and 12, only

evidence that amounts at most to medical malpractice, the evidence is insufficient

as a matter of law. Tran Trong Cuong, 18 F.3d at 1137.

F.    The evidence was insufficient to prove beyond a reasonable doubt that use
      of the prescription for OxyContin (count 11) or use of the prescription for
      Roxicodone (count 12) resulted in Shealy's death.




       19DEAAgent Rene Crowley testified that dosage is left to the physician's
medical judgment. l.A. 50-51. That testimony is consistent with the previous
DEA statement: "The CSA does not address medical treatment issues such as
selection or quantity of the drug prescribed. Such medical decisions arise from the
prescribing physician's medical judgement." The Drug Enforcement Agency and
Proposed Model Guidelines for the Use of Controlled Substances in Pain
Management at 2 (1998) (http://www.medsch.wisc.edu/painpolicy/domestic/
dea98.htm) (accessed December 13, 2005).

                                         43
      1. Standard of Review

      The jury's finding will be sustained if there is substantial evidence, in the

light most favorable to the government, to uphold it. Burgos, 94 F.3d at 862-63.

      A fact used to increase a sentence must be proved beyond a reasonable

doubt. Blakely v. Washington, 542 U.S. 296, 301 (2004).

      2. Discussion

      The jury found that Shealy's death resulted from his use of OxyContin

(count 11) and from his use of Roxicodone (count 12). That finding elevated the

penalty for the charge of unlawful distribution of a controlled substance to life

with a minimum sentence of twenty years. Any fact that increases the sentence for

a crime must be proved to the jury beyond a reasonable doubt. Blakely, 542 U.S.

at 301, citing Apprendi v. New Jersey, 530 U.S. 466 (2000).

      There was insufficient evidence to prove beyond a reasonable doubt that Dr.

McIver distributed a lethal amount of OxyContin (count 11) or Roxicodone (count

12) to Shealy. Dr. McIver challenged the sufficiency of the evidence in the district

court, and renews that challenge on appeal.

      Dr. Garvin concluded that Shealy died from an overdose of oxycodone. Dr.

Ross reached the same conclusion in the autopsy report, but relied "entirely" on

Dr. Garvin's conclusion in doing so. l.A. 434-35. No other evidence was offered


                                         44
to prove that Shealy died as a result of the use of the OxyContin or Roxicodone

distributed by Dr. McIver. For the reasons explained below, Dr. Garvin's

conclusion is insufficient to support the findings in counts 11 and 12.

        First, though Dr. Garvin maintained that Shealy could have died from

OxyContin20 alone, she conceded that reported deaths from the level of oxycodone

in Shealy's system occurred only when the oxycodone was taken in combination

with another central nervous system depressant. Thus, there was no authority for

the proposition that either OxyContin or oxycodone would cause death at that

level. 2]

        Second, Dr. Garvin conceded that authorities stated, and she agreed, that




        Dr. Garvin testified that there was no way to discern what amount of the
        20

oxycodone in Shealy's system was OxyContin and what was Roxicodone. She
further testified that if Shealy took the OxyContin as prescribed, and it appeared
he did, it would not equal the level of oxycodone in his system. Thus, she could
not have meant that he could have died from OxyContin alone, but must have
meant that he could have died from oxycodone alone.
        21
        See, General Electric Co. v. Joiner, 522 U.S. 136,146 (1997) (expert
testimony is not helpful and thus not admissible under Rule 702 where "there is
simply too great an analytical gap between the data and the opinion proffered").
Here, Dr. Garvin extrapolated from an accepted premise (that level of oxycodone,
in combination with another central nervous system depressant, can cause death)
to an unfounded conclusion (that level of oxycodone, alone, can and did cause
death). If such a leap renders the evidence inadmissible as not helpful, it also
renders the evidence insufficiently" substantial" to prove the fact beyond a
reasonable doubt.

                                          45
death cannot be attributed to anyone single drug when a person dies after using

multiple drugs. l.A. 466. Shealy was using OxyContin, Roxicodone, Alprazolam,

and hydrocodone22 (which was not prescribed by Dr. McIver) at the time of his

death. The evidence is insufficient to prove beyond a reasonable doubt that

Shealy died rrom his use of oxycodone.

      Third, Dr. Garvin did not account for Shealy's tolerance to oxycodone,

while admitting that tolerance would affect the conclusions that could be drawn

from the toxicology evidence. Dr. Garvin conceded that Shealy had been

prescribed the same dosage of OxyContin and Roxicodone for the two months

prior to his death, and that he would have developed a tolerance to oxycodone if

he was taking his medications as prescribed, as it appeared he was. Dr. Garvin

had not reviewed Shealy's medical records before concluding that he died rrom an

oxycodone overdose, and admitted that if Shealy had developed a tolerance to the

drug (as she later admitted Shealy had), the toxicology results could be

misleading. l.A.441. Because she admitted Shealy had a tolerance to oxycodone,

(as Dr. Duc and Dr. McIver also confirmed in their testimony), her conclusion




     22Dr.Garvin failed to account for the effect of the hydrocodone, which Dr.
McIver did not prescribe, in her conclusion.

                                         46
was--by her own admission--unreliable.23

      Fourth, Dr. Garvin failed to adequately account for the significant

alternative explanations for Shealy's death. Shealy had already had one heart

attack. Over the years, congestive heart failure had caused Shealy to develop an

enlarged heart, spleen, and liver. Shealy had ninety percent blockage in one of

three major coronary arteries and fifty percent blockage in another. Those

blockages prevent the heart from getting blood, which can cause a heart attack.

Shealy had pulmonary congestion, which meant his heart was not pumping blood

forward and blood was backing up and congesting other organs. J.A. 427, 430-31,

435. The failure to adequately account for obvious alternate explanations justifies

outright exclusion of an expert opinion under Rule 702. See, Claar v. Burlington

N.R.R., 29 F.3d 499,502-03    (9th Cif. 1994). Just as such evidence did not pass

the bar for admissibility in Claar, here it is not "substantial"enough to suffice to

prove a fact beyond a reasonable doubt

      Each of these considerations independently renders the toxicology evidence

insufficient to support the jury's findings that Shealy's death resulted from his use

of OxyContin or Roxicodone.      Taken together, there is no question the


      23Similarly, Shealy's medical records showed that he had been on
Alprazolam for many months and would have been tolerant to it Defense Exhibit
12.

                                           47
prosecution failed to make its case.

      The aggravated crime carried a minimum sentence of 20 years; the

unaggravated crime carried a maximum sentence of 20 years. Dr. McIver must be

resentenced on counts 11 and 12. Moreover, the district court imposed sentence

on each count by using the challenged findings to establish the base level under

the sentencing guidelines. Therefore, each count must be remanded for

resentencing.

G.    The evidence was insufficient to prove beyond a reasonable doubt that Dr.
      McIver unlawfully issued any of the prescriptions in this case.

       1. Standard of Review

      A reviewing court shall sustain a conviction if there is substantial evidence,

in the light most favorable to the government, to uphold it. Burgos, 94 F.3d at

862-63.

      2. Discussion

      Dr. McIver issued the prescriptions to Brown, Smith, Boyer, Barnes and

Knight, but the government failed to produce sufficient evidence that those

prescriptions were issued outside the bounds of professional practice, or were

issued with the specific intent to commit a drug crime.




                                         48
              a. The government produced insufficient evidence that the
              prescriptions were issued outside the bounds of professional
              practice.

      A DEA-registered physician violates the CSA only when he ceases to act as

a physician. Many of the reported cases of physicians convicted under the CSA

involved physicians who issued prescriptions to persons with whom they did not

have a physician-patient relationship.24 In cases that involved true patients, the

facts clearly established the diversion of drugs outside of medical channels.25 No

reported case, in any federal circuit, has held that evidence of medical practices

alone--no matter how "inappropriate" a witness may characterize them--proved a

drug crime.




      24
        See, e.g., United States v. Daniel, 3 F.3d 775 (4th Cir. 1993) (physician
issued prescriptions on request, with no exam); United States v. Norris, 780 F.2d
1207 (5th Cir. 1986) (same); United States v. Kaplan, 895 F.2d 618 (9th Cir.
1990) (physician issued prescriptions to people he never examined); United States
v. Nelson, 383 F.3d 1227 (10th Cir. 2004) (physician approved prescriptions for
patients who applied online without examining them).
      25
        See. e.g., Singh, 54 F.3d 1182 (4th Cir. 1995) (prescriptions issued in
exchange for sexual intercourse, and in other people's names); Tran Trong Cuong,
18 F.3d at 1134 (physician coached the patients in their complaints of pain and
advised them how to avoid criminal investigation); United States v. Albert, 675
F2d 712 (5th Cir. 1982) (physician exchanged prescriptions for stolen goods);
United States v. Jackson, 576 F.2d 46 (5th Cir. 1978) (prescription issued for
patients to "get high" or "escape from reality"); United States v. Green, 511 F.2d
1062 (7th Cir. 1975) (physician issued prescriptions in obviously fictitious names
such as Lana Turner and Mark Twain).

                                          49
                   l.     Barbee Brown (count 4)

      It was undisputed that Dr. McIver was treating Brown as a physician for

RSD. l.A.522.    The criticism of Dr. McIver's treatment of Brown was with the

dosage and direction to take one to five pills for breakthrough pain as needed, and

the fact that Brown previously had been addicted to crack cocaine.

      On the first point, as argued above, Dr. Storick's testimony that Dr. McIver's

prescribing practices were standard practice in the year 2000 defeats his

conclusion that those practices in April 2002 establish the abandonment of the

practice of medicine. At worst, the evidence shows that Dr. McIver's practices

were outdated and possibly constituted malpractice. That evidence fails to show

that Dr. McIver became a drug dealer.

      On the second point, Dr. Storick conceded that there is a debate among

physicians whether to treat former drug addicts with opioids, that some physicians

do so, and that it is a difference in medical judgment. l.A.629-30.   That evidence

likewise fails to prove that Dr. McIver's exercise of medical judgment was,

instead, an abandonment of the practice of medicine.

                   ll.   Angela Knight (counts 14 and 15)

       It was undisputed that Dr. McIver was treating Knight for legitimate

complaints of pain. l.A.647.   Although Knight traveled to see Dr. McIver in


                                         50
Greenwood, she started with Dr. McIver in his York office, and it is not unheard

of for a patient to follow a physician when the physician's office moves. J.A.646.

Dr. Storick also conceded that the use of OxyContin was a valid treatment option

for Knight. J.A.652.

      Dr. Storick based his opinion that Dr. McIver's treatment of Knight was

outside the bounds of professional practice in part on the "escalating doses of pain

medications" prescribed.   l.A. 542. As argued above, dosage is not evidence of

drug dealing within a patient-physician relationship in which the patient's

condition justifies the use of opioids. Rather, dosage is committed to the

physician's medical judgment.

      The other factor was Knight's two negative drug screens. J.A.539-40.

Although subsequent drug screens tested positive, Dr. Storick claimed it was

unreasonable to continue testing until the test was positive, and that any

prescriptions issued after the negative screens were issued outside the bounds of

medical practice.26 However, the existence of the positive test results, whether




       26Dr.McIver testified that the subsequent tests were conducted because he
learned from the laboratory that it did not use a test that would detect OxyContin.
lA. 994. At least one state court has recognized the truth of that fact. State ex rei
DHS v. Simmons, _ Or App _ (December 14,2005 slip opinion) ("The kind of
urinalysis that will detect the presence of Oxycontin is not done by all screening
laboratories. ").

                                          51
considered by Dr. Storick or not, confirm that Knight was taking the medication

and qualify Dr. Storick's conclusion. The evidence was insufficient to prove that

the prescriptions in counts 14 and 15 were issued outside the bounds of

professional practice.

      In effect, the government's case on these counts depended on the

government establishing that Knight was diverting her medications and Dr.

McIver was willfully blind to that fact in continuing to prescribe to her. The

deficiency of the government's claim of willful blindness is discussed below.

                    m.     Kyle Barnes (count 13)

      Dr. McIver treated Barnes for fibromyalgia. While Dr. Storick initially

suggested that it was per se outside the bounds of medical practice to treat

fibromyalgia with opioids, he conceded that some physicians treat fibromyalgia

with opioids and that he simply holds a difference in judgment. J.A.662-63.      The

exercise of medical judgment does not constitute the abandonment of medicine.

      The government also pointed to Barnes's complaints to Dr. McIver that she

could not take the methadone pills because they made her sleepy, she did not like

the taste, and she could barely tolerate the dose. J.A. 356, 1059. The government

elicited evidence that it is illegal to prescribe opioids to a patient who the

physician knows is not taking them. J.A.532.      While that may be, the evidence


                                           52
did not establish that Dr. McIver knew Barnes was not taking her pills. Rather,

the evidence established that Barnes told Dr. McIver she did not like taking her

pills. Dr. McIver prescribed a medication to alleviate the side effect of sleepiness,

and continued prescribing methadone. That action was not outside the bounds of

medical practice.

       Finally, the evidence established that Dr. McIver received anonYmous

telephone calls stating that Barnes was selling her medications, and contacted the

Lancaster County Sheriffs Department in December 2003, for information

regarding whether Barnes was involved in the drug trade. The anonYmous calls

and contact with the Sheriffs Department are discussed below, as related to mens

rea element. For purposes of detern1ining whether that evidence proves that the

prescription was issued outside the bounds of professional practice, suffice to say

that the prescription at issue was written seven months earlier, in May 2003.

Indictment, l.A. 22. There is no evidence that Dr. McIver was aware of even an

allegation of illicit activities by Barnes in May, 2003.

                     IV.    Seth Boyer (count 5) and Les Smith (count 3)

       Boyer and Smith both testified that they used their medications

recreationally.   However, the evidence failed to establish that Dr. McIver

prescribed the medications to them for recreational use.


                                           53
      Both men saw Dr. McIver within a physician-patient relationship.    Both

complained of pain, and had objective signs (scars and marks) that corroborated

their claims. The evidence of illicit drug use with Boyer was the fact that he had

track marks on his arm in April 2002 when the prescription at issue was written.

lA. 250-51. However, the government presented no evidence that Dr. McIver

was aware of the track marks. The government established only that Dr. McIver

examined Boyer's arm in January 2002, and did not see track marks then. J.A.

1020. There was no evidence that Dr. McIver later saw Boyer's tTack marks, and

the evidence showed that Boyer himself did not think that Dr. McIver ever saw his

track marks. The government's evidence failed to prove that Dr. McIver issued the

April 2002 prescription to Boyer outside the bounds of professional practice.

      Similarly, the government failed to establish when Dr. McIver found Smith

in possession of a syringe. Without evidence that Dr. McIver found the syringe

before issuing the March 2002 prescriptions for which he was charged, the

knowledge that Smith possessed a syringe does not prove that the prescriptions

were issued outside the bounds of professional practice.

            b. The government produced insufficient evidence of a criminal
            mental state

      The government failed to prove that Dr. McIver knew that Brown, Knight,

Smith, Boyer or Barnes were diverting drugs yet continued to prescribe to them.

                                         54
Regarding Brown and Knight, the government failed to prove that either woman

was engaged in drug diversion at all, much less that Dr. McIver knew of it,27 Both

women told Dr. McIver, and testified at trial, that they were taking their

medications as directed to treat painful conditions.

         Smith and Boyer gave Dr. McIver false or exaggerated complaints of pain,

buttressed by physical evidence that corroborated the complaints, because they did

not believe he would give them prescriptions otherwise. Barnes truly suffered

from fibromyalgia, but took only some of her medication and sold the rest. On

those counts, the government did not prove that Dr. McIver knew of the drug

diversion. The evidence established at most that Dr. McIver suspected drug

diversion. Suspicion is not knowledge.

         Thus, the government relied on the principle of willful blindness to prove

mens rea. Willful blindness is also called deliberate ignorance, and it means just

that: that the defendant is ignorant of the fact because he deliberately avoided

learning it. The doctrine allows the jury to infer knowledge or intent when a

defendant is willfully blind to a criminal act.




         27Theissue of Knight's negative drug screens is discussed in more detail
below.

                                           55
                     1.     The doctrine of willful blindness

        A defendant's willful blindness to, or deliberate ignorance of, an operative

fact will suffice for actual knowledge of that fact if:

        (l) the defendant was aware of a high probability of the existence of the

fact;

        (2) yet deliberately avoided learning whether the fact existed;

        (3) with the conscious purpose of evading criminalliability;28

        (4) unless the defendant genuinely believed that that the fact did not exist.

See, Robin Charlow, Wilful Ignorance and Criminal Culpabili~y, 70 Tex.L.Rev.

1351,1413-18 (1992); cf, e.g., United States v. Baron, 94 F.3d 1312,1318 n. 3

(9th Cir. 1996) (a willful blindness instruction is rarely appropriate, and should be

given only when the government presents specific evidence that the defendant

actually suspected criminal activity, deliberately avoided taking steps to confirm

or deny those suspicions, and did so in order to provide himself with a defense in

the event of prosecution); United States v. Whittington, 26 F.3d 456,462-63 (4th

Cir. 1994) (instruction was appropriate where evidence established that the




        28
       The Fourth Circuit has not adopted the third requirement (that the
defendant's ignorance was for the purpose of providing a defense to a
prosecution). United States v. Ruhe, 191 F.3d 376,385 (4th Cir. 1999).

                                           56
defendants "went to great lengths" to insulate themselves from liability).29

      The government does not prove a case of willful blindness where a

defendant should have known of the existence of a fact (see, United States v.

Campbell, 977 F.3d 854, 859 (4th Cir. 1992)) or acted with reckless disregard to

the possibility of the fact's existence (see, Whittington, 26 F .3d at 462).

                    ll.    Application to Smith (count 3), Boyer (count 5), and
                           Barnes (count 13)

      Both Smith and Boyer testified that there was no understanding between

them and Dr. McIver that their complaints of pain were false and served only to

shroud a drug deal. The government's evidence of willful blindness to illicit drug

use consisted of: the long distances Smith and Boyer traveled to see Dr. McIver,

the men's behavior in sometimes pretending not to know each other in the office

waiting room, Smith's possession of a syringe, and Boyer's track marks.

      Barnes actually suffered from fibromyalgia. However, Barnes only took

some of her methadone pills and sold the rest, and sold morphine on one occasion

(the date was not established on the record). Dr. McIver received anonymous




       29Thisparagraph and the citations therein are taken from an unpublished
disposition of this court in United States v. Ebert, 178 F.3d 1287 (4th Cir. 1999).
Because much of the argument borrows from Ebert, Dr. McIver has included a
copy of Ebert in an addendum to this brief in accordance with Local Rules 28(b)
and 36(c).

                                           57
telephone calls that said Barnes was selling her medication.

      The question is whether those pieces of evidence add up to willful

blindness. The answer is no.

      First, even if Dr. McIver knew of these facts at the time he issued the

prescriptions at issue (an assumption challenged above), it is questionable whether

Smith's possession of a syringe and Boyer's track marks create a "high probability"

that either man was abusing the medications that Dr. McIver prescribed. It is

possible to abuse other substances and still have a valid complaint of pain that

requires medical attention. Regarding Barnes, it is axiomatic in criminal law that

an anonymous phone call does not establish probable cause (a mere probability:

more likely than not); it follows that the anonymous phone calls about Barnes

failed to establish a high probability that Barnes was, in fact, selling her

medications. In any event, there is no evidence that Dr. McIver received those

calls, or any other indication that Barnes was selling her medication, before he

issued the May 2003 prescription at issue in count 13.

      Second, assuming arguendo the government produced evidence that Dr.

McIver was aware of a high probability that Smith, Boyer, or Barnes were abusing

their prescription medications, the government's proof failed on the other

requirements of the doctrine. The government did not produce evidence that Dr.


                                           58
McIver deliberately avoided learning whether the fact existed--the crux of

deliberate ignorance. To the contrary, the record establishes that Dr. McIver

contacted DHEC and the Lancaster County Sheriffs Department with information

about Smith, Boyer, and Barnes, and requested information about whether those

clients were (or even had been) involved in drug offenses.

      Even in the light most favorable to the government, that evidence is not

sufficient to prove beyond a reasonable doubt Dr. McIver deliberately avoided

learning whether thefact existed. Cf United States v. Barnhart, 979 F.2d 647,

652 (8th Cir. 1992) (instruction was appropriate where defendant failed to act on

an obvious opportunity to learn of the fact's existence). The evidence was

insufficient to prove mens rea with Smith, Boyer, or Barnes.

                   lll.   Application to Knight (counts 14 and 15)

      Dr. McIver was not willfully blind to any drug diversion by Knight. First,

the government failed to prove that Knight was diverting drugs. Although two of

Knight's drug screens were negative, both Knight and her companion insisted

Knight was taking her medications as directed. J.A. 407, 993. Subsequent drug

screens confirmed that Knight was taking her medications. J.A. 540, 994. There

was no other evidence to suggest drug diversion by Knight.

      Second, here again Dr. McIver did not fail to take action. He telephoned the


                                        59
laboratory and learned that its drug screens would not detect OxyContin. He

ordered additional drug screens to determine whether Knight was taking her

medications. Because the record did not establish substantial evidence from

which the jury could find willful blindness, the convictions must be reversed.

                c.   Conclu.sion

       For each count of unlawful distribution, the government was required to

prove that Dr. McIver issued the prescription outside the bounds of professional

practice, with the specific intent of committing a drug crime. For each count, the

government failed to prove one or both of those elements. The convictions must

be reversed.

       Finally, in addition to the challenge below, it bears noting that the reasons

why the evidence is insufficient to prove that Dr. McIver was issuing prescriptions

outside the bounds of professional practice also illustrate that the evidence was

insufficient that he was in a conspiracy to do so. Therefore, Dr. McIver's

conviction on count one must be reversed, along with his convictions for unlawful

distribution.

H.     The evidence was insufficient to prove a conspiracy beyond a reasonable
       doubt.

       1. Standard of Review

       A reviewing court shall sustain a conviction if there is substantial evidence,

                                          60
in the light most favorable to the government, to uphold it. Burgos, 94 F.3d at

862-63 "

      2. Discussion

      The elements of a conspiracy in violation of21 U.S.C. § 841 are:

      n(l) an agreement to * * * distribute existed between two or more
      persons; (2) the defendant knew of the conspiracy; and (3) the
      defendant knowingly and voluntarily became a part of this
      conspiracy. "

Burgos, 94 F.3d at 857 (citations omitted). The gravamen of the crime is the

agreement to effectuate a criminal act. Id., quoting United States v. Laughman,

618 F.2d 1067, 1074 (4th Cir.), cert. den, 447 U.S. 925 (1980).

             a.       Insufficient evidence of the actus reus

      The evidence of the actus reus is lacking. There was no evidence that Dr.

McIver entered into any agreement, tacit or otherwise, with any of his patients to

deal drugs. Several patients, including Brown and Knight, testified that they were

not abusing their medications.    Each patient who sold abused his or her medication

(Smith and Boyer who were drug abusers; Boyer and Barnes who sold some of

their medication) testified that he or she did not conspire with Dr. McIver to get

the medication. To the contrary, Smith and Boyer testified that they lied, and

thought they had to lie, to Dr. McIver to get the medication, not that he was in a



                                           61
tacit understanding with them.30 And, Barnes truthfully complained of pain and

was taking her medications to treat her conditions while selling some pills; she too

did not offer any evidence that Dr. McIver conspired with her to unlawfully

distribute drugs.

      Because the evidence of an agreement to unlawfully divert drugs was

insufficient, the conspiracy conviction cannot stand.

             b.     Insufficient evidence of mens rea

      The court denied Dr. McIver's motion for directed verdict after finding that

"the government has established a case of willful indifference or ignorance at least

for the jury to evaluate." J.A.726.   That ruling was error; the evidence was

insufficient to establish willful blindness to a conspiracy.

      The jury rejected the notion that Dr. McIver was in a conspiracy with

Shealy.31 And, for the reasons eXplained in Issue G above, the evidence was not

sufficient to establish a case of willful blindness to a conspiracy involving the

other patients to whom Dr. McIver was convicted of unlawfully prescribing drugs.



     3°When a physician is "conned," he has not violated the CSA. Tran Trong
Cuong, 18 F .3d at 1144.
       31Thejury found that the conspiracy did not result in death, which excludes
Shealy's involvement in it, as the only counts related to Shealy on which the jury
found Dr. McIver guilty were counts in which the jury also found that death
resulted from Shealy's use of the drug prescribed.

                                           62
      The district court admitted the evidence concerning Tammy Plyler as

relevant to the conspiracy count. There again, however, the evidence shows only

that Dr. McIver was aware of a high probability that his patient was involved in

illegitimate drug channels; it does not show that he deliberately avoided learning

the truth. To the contrary, Deputy Grogan's testimony showed that Dr. McIver

actively participated in determining the truth about whether Plyler was involved in

the illegal drug trade. The evidence of willful blindness was insufficient to go to

the jury on the conspiracy charge.

      Because the evidence failed to establish the act (the agreement) or the

mental state (deliberate ignorance), the conspiracy conviction must be reversed.



                                VII. CONCLUSION

      Dr. McIver raises seven issues in this brief. Three issues involve challenges

to the sufficiency of the evidence. Dr. McIver seeks reversal of each conviction,

on the grounds that it was based on insufficient evidence of a crime.

      Dr. McIver also argues three independent grounds that warrant a new trial:

      •.     the erroneous jury instruction that ratified the idea that a violation of
             the civil standard of care equated to proof of criminal guilt;

             the error in allowing the government's expert witness to offer a legal
             conclusion as to the verdict the jury should reach; and


                                          63
            the erroneous exclusion of the defense's expert witness's testimony on
            whether minority medical practices are within the bounds of
            professional practice.

      In the alternative, Dr. McIver seeks resentencing, on the grounds that the

government failed to prove that Shealy's death resulted from his use of the

controlled substances at issue in counts 11 and 12.

      RESPECTFULL Y SUBMITTED,




dA--··
Eli D. Stutsman
Of Attorneys for Appellant
                                           ~-C. Rauch Wise
                                             Of Attorneys for Appellant




                                      64
                             REQUEST FOR ORAL ARGUMENT

              Oral argument is respectfully requested due to the complexity of the case
        and the number of interrelated issues.



    ~D.
        R-------
            Stutsman
      Of Attorneys for Appellant

                             STATEMENT OF RELATED CASES

              United States v. Alerre, et aI., _ F.3d _ (4th Cir. 2005) (opinion issued
        December 1, 2005). Physicians prosecuted under CSA challenged the
        commingling of the civil and criminal standards as ineffective assistance of
        counsel and as prosecutOIial misconduct).

               United States v. Hurwitz, No. 05-4474. Physician prosecuted under CSA
        challenged jury instructions on mens rea, "beyond the bounds of medical
        practice," and "not for a legitimate medical purpose."


    ~                              ..


     Of Attorneys for Appellant

                             CERTIFICATE OF COMPLIANCE
                                Pursuant to Rule 32(a)(7)(C)
                                 for Case Number 05-4884

              I certifY that pursuant to Federal Rule of Appellate Procedure 32(a)(7)(B)
    and Local Rule 32(b) the attached opening brief is proportionally spaced, has a 14-
    point typeface, and contains 14,000 words (14,000 limit), exclusive of tables and
    certificates, and any statutory appendix that may be attached.


~
    Of Attorneys for Appellant
           CERTIFICATE OF FILING AND SERVICE OF BRIEF

      I certify that I filed the foregoing APPELLANT'S BRIEF on December 20,
2005, pursuant to Local Rule 31 (c) and (d) by sending the original brief and eight
copies thereof via first class mail postage prepaid to:

      Clerk, United States Court of Appeals
       for the Fourth Circuit
      1100 East Main Street, Suite 501
      Richmond, Virginia 23219-3517

       I further certify that I served the foregoing APPELLANT'S BRIEF on
December 20, 2005, pursuant to Local Rule 31 (c) and (d) by sending two copies
of the original brief via first class mail postage prepaid to:

      William C. Lucius, Esquire
      105 N. Spring Street, Suite 200
      Post Office Box 10067
      Greenville, South Carolina 29603



  .. Stutsman
Of Attorneys for Appellant
    CERTIFICATE OF FILING AND SERVICE OF JOINT APPENDIX

      I certify that Counsel Press filed the JOINT APPENDIX on December 20,
2005, by hand delivering six copies thereof to:

      Clerk, United States Court of Appeals
        for the Fourth Circuit
      1100 East Main Street, Suite 501
      Richmond, Virginia 23219-3517

      I further certify that Counsel Press served the JOINT APPENDIX on
December 20,2005, by sending a copy thereof via third party commercial carrier
(FedEx) to:

      William C. Lucius
      Office of the US Attorney
      105 North Spring Street, Suite 200
      Greenville, South Carolina 29603


~?-----=~
Eli D. Stutsman
Of Attorneys for Appellant

				
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