Petition for Writ of Certiorari — Lena Lasher, Petitioner v. United States
Supreme Court briefDec 28, 2020
Ask Donna
What actually matters in this document.
Text
\
21-762
NO.
ORIGINAL
IN THE
SUPREME COURT OF THE UNITED STA" ES
FILED
DEC 2 8 2020
^JPREEMEFCOIJRTLmqK
ie*Y\oi Vastah
— PETITIONER
(Your Name)
vs.
^fli W S^oAe’a of ft
meAi qsk_
_ respqndent(S) ..
ON PETITION FOR A WRIT OF CERTIORARI TO
^L)n\‘SfroAes Coun4 o( Appeals
-W %qc.o*\6 Ci'jicxuT
(NAME OF COURT THArLAST RULED ON MERITS OF YOUR CASE)
PETITION FOR WRIT OF CERTIORARI
&
:• •
Wwa. Lastah
(Your Name)
1L ?ccVfcw ^sV
(Address)
U\QjV\
QT
(City, State, Zip Code)
(Phone Number)
RECEIVED
NOV 1 6 2021
OFFICE OF THE CLERK
SUPREME COURT. U.S.
QUESTIONS PRESENTED
1. Where the government prosecutes a licensed pharmacist under “Misbranding”, 18 usc§ 371, 21 USC§§
331(a) and 333(a)(2), for dispensing “invalid” prescription issued by licensed medical practitioners, is the
government required to prove that the pharmacist knew the prescription written by licensed medical
practitioners to be “invalid” and “outside the scope of the medical practitioners scope of professional
practice? See 20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
2. Does a “good faith” defense in the context of a licensed pharmacist prosecuted under “Misbranding”,
18 usc§ 371, 21 USC§§ 331(a) and 333(a)(2), protect pharmacists who have an honest but mistaken belief
that they have dispensed the charged prescription in “the usual course of medical practitioners’
professional practice;” and, if so, must that belief be objectively reasonable? See 20-1410 RUAN, XIULU
V. UNITED STATES, CERTIORARI GRANTED
3. Was the Plaintiff’s constitutional right denied due to prosecutors’ suppression of exculpatory video
recordings evidence in the government's possession, in violation of Brady v. Maryland?
LIST OF PARTIES
[y| All parties appear in the caption of the case on the cover page.
[ ] All parties do not appear in the caption of the case on the cover page. A list of
all parties to the proceeding in the court whose judgment is the subject of this
petition is as follows:
RELATED CASES
./•••
TABLE OF AUTHORITIES
Cases
Boyd v. United States, 271 U.S. 104 (1926)
Cheek v. United States, 498 U.S. 192 (1991)
Colautti v. Franklin, 439 U.S. 379 (1979)
Elonis v. United States, 135 S. Ct. 2001, 2008 (2015)
Grayned v. City of Rockford, 408 U.S. 104
Haines v. Kerner 404 U.S. 519 (1972)
Humphreys v. Drug Enft Admin., 96 F.3d 658 (3d Cir. 1996)
Johnson v. United States, 135 S.Ct. 2551 (2015)
Linder v. United States, 268 U.S. 5 (1925)
Liparota v. United States, 471 U.S. 419 (1985)
McDonnell v. United States, 136 S. Ct. 2355 (2016)
Posters ‘N‘ Things, Ltd. v. United States, 511 U.S. 513 (1994)
Rehaif v. United States, 139 S. Ct. 2191 (2019)
Sessions v. Dimaya, 138 S. Ct. 1204 (2018)
Skilling v. United States, 561 U.S. 358 (2010)
United States v Jobe, 487 F2d 268 (10th Cir. 1973)
United States v. August, 984 F.2d 705 (6th Cir.1992)
United States v. Bek, 493 F.3d 790 (7th Cir. 2007)
United States v. Collier, 478 F.2d 268 (5th Cir. 1973)
United States v. Dorotich, 900 F.2d 192 (9th Cir. 1990)
United States v. Feingold, 454 F.3d 1001 (9th Cir. 2006)
United States v. Gambler, 662 F.2d 834 (D.C. Cir. 1981)
4United States v. Garrison, 888 F.3d 1057 (9th Cir. 2018)
United States v. Godofsky, 943 F.3d 1011 (6th Cir. 2019)
United States v. Gross, 961 F.2d 1097 (3rd Cir. 1992)
United States v. Hayes, 794 F.2d 1348 (9th Cir. 1986)
United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006)
United States v. Jones, 825 F. App'x 335 (6th Cir. 2020)
United States v. Joseph, 709 F.3d 1082 (11th Cir. 2013)
United States v. Kahn, 989 F.3d 806 (10th Cir. 2021)
United States v. Katz, 445 F.3d 1023 (8th Cir. 2006)
United States v. King, 898 F.3d 797 (8th Cir. 2018)
United States v. Kirk, 584 F.2d 773 (6th Cir. 1978)
United States v. Kohli, 847 F.3d 483 (7th Cir. 2017)
United States v. Lawson, 682 F.2d 480 (4th Cir. 1982)
United States v. Lee, 966 F.3d 310 (5th Cir.)
United States v. Li, 819 F. App’x 111 (3d Cir. 2020)
United States v. Limberopoulos, 26 F.3d 245 (1st Cir. 1994)
United States v. Lovern, 590 F.3d 1095 (10th Cir. 2009)
United States v. McElroy, 910 F.2d 1016 (2d Cir. 1990)
United States v. Mclver, 470 F.3d 550 (4th Cir. 2006)
United States v. Merrill, 513 F.3d 1293 (11th Cir. 2008)
United States v. Moore, 423 U.S. 122 (1975)
United States v. Nelson, 383 F.3d 1227 (10th Cir. 2004)
United States v. Nivica, 887 F.2d 1110 (1st Cir. 1989)
United States v. Norris, 780 F.2d 1207 (5th Cir. 1986)
United States v. Plesons, 560 F.2d 890 (8th Cir. 1977)
United States v. Purpera, 844 F. App’x 614 (4th Cir. 2021)
United States v. Rosenberg, 515 F.2d 190 (9th Cir. 1975)
United States v. Ruan, 966 F.3d 1101 (11th Cir. 2020)
United States v. Sabean, 885 F.3d 27 (1st Cir. 2018)
United States v. Singh, 54 F.3d 1182 (4th Cir.1995)
United States v. Smith, 573 F.3d 639 (8th Cir. 2009)
United States v. Stump, 735 F.2d 273 (7th Cir. 1984)
United States v. Tobin, 676 F.3d 1264 (11th Cir. 2012)
United States v. Tran Trong Cuong, 18 F.3d 1132 (4th Cir. 1994)
United States v. U.S. Gypsum Co., 438 U.S. 422 (1978)
United States v. Vamos, 797 F.2d 1146 (2d Cir. 1986)
United States v. Voorhies, 663 F.2d 30 (6th Cir. 1981)
United States v. Wexler, 522 F.3d 194 (2d Cir. 2008)
Statutes
21 U.S.C. SS 331(a) and 333(a)(2)
21U.S.C. §821
21 U.S.C. §841
Treatises
Adam H. Kurland, Prosecuting 01' Man River: The Fifth Amendment, the Good Faith Defense, and the NonTestifying Defendant, 51 U. Pitt L. Rev. 841 (1990)
Amy J. Dilcher, Damned If They Do, Damned If They Don't: The Need for a Comprehensive
Public Policy to Address the Inadequate Management of Pain, 13 ANNALS HEALTH L. 81 (2004)
6 Daniel S. Jonas, The Circuit Split Over Instructing The Jury Specifically On The Good Faith
Defense: A Consequence of Superlegislation By Courts Or The Standards Of Appellate Review, 46 SYRACUSE
L. REV. 61 (1995)
Deborah Heilman, Prosecuting Doctors For Trusting Patients, 16 G EO . MASON L. R EV. 701 (2009)
Kelly K. Dineen, Addressing Prescription Opioid Abuse Concerns in Context: Synchronizing
Policy Solutions to Multiple Complex Public Health Problems, 40 Law & Psychol. Rev. 1 (2016)
Lagisetty, Pooja, et al., “Assessing reasons for decreased primary care access for individuals on prescribed
opioids,” PAIN . 2021 May; Vol 162. Issue 5. p 13
MM. Reidenberg & O. Willis, Prosecution of Physicians for Prescribing Opioids to Patients, 81 CLINICAL
PHARMACOLOGY & THERAPEUTICS 903 (2007)
Powell D, Tamara M, Chou, Roger. CDC guideline for prescribing opioids for chronic pain—
United States, 2016. JAMA 2016;315:1622 Other
Fuqua, Anne, The other opioid crisis: pain patients who can’t access the medicine we need, THE
WASHINGTON POST (March 9, 2018)
Goodnough & Hoffman, Good News: Opioid Prescribing Fell. The Bad? Pain Patients Suffer, Doctors Say, THE
NEW YORK T IMES (March 6, 2019)
McCoy & Mount, Unintended Consequences: Inside the fallout of America’s crackdown on opioids, THE
WASHINGTON P OST (May 31, 2018)
O'Donnell & Alltucker, Pain patients left in anguish by doctors 'terrified' of opioid addiction, despite CDC
change, USAT ODAY (June 24, 2019)
Rider, Travis, What Chronic-Pain Patients Are Deeply Afraid Of, THE NEW YORK TIMES (Oct. 31, 2019)
TABLE of CONTENTS
OPINIONS BELOW
1
JURISDICTION
2
CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED
3
PETITION FOR A WRIT OF CERTIORARI
STATEMENT OF THE CASE
3-8
FACTS
8-13
REASONS FOR GRANTING THE WRIT
13-28
I. Review Is Necessary To Resolve A Number Of Circuit Splits Centering Around The Central
Question Of What Level Of Intent Is Necessary For Conviction Of A Licensed Pharmacist Under
“Misbranding”..................................................................................................................................
13
II. Issuance Of “Objective” Good Faith Instruction Is Inconsistent With The Mens Rea Of
Knowledge Required By The Court’s Case Law.
18
III. Requiring That The Government Prove That A Pharmacist Know A Given prescription written by licensed
medical practitioners Is Outside The Scope Of Professional Practice Is Necessary To Save "Misbranding”
From Being Void For Vagueness As Applied To Pharmacists.
21
IV. The Present Issue Is Of Significant National Importance.......
24
V. The national importance of having the Supreme Court decide the issue to resolve the existence of multiple
conflicts between the decision of which review is sought and a decision of the second appellate court on the
same issue, Arsean Lamone HICKS v. Director, DEPARTMENT OF CORRECTIONS. Record No.
131945. Decided: February 26, 2015
26
CONCLUSION
28
INDEX TO APPENDICES
APPENDIX A - United States Court of Appeals for the Second Circuit August 11, 2020 Order
APPENDIX B - United States Court of Appeals for the Second Circuit October 29, 2020 Order
APPENDIX C - US Supreme Court September 13, 2021 Order
Exhibit A - District Court 12/18/2019 Order - on file with the Court
IN THE
SUPREME COURT OF THE UNITED STATES
PETITION FOR WRIT OF CERTIORARI
Petitioner respectfully prays that a writ of certiorari issue to review the judgment below.
OPINIONS BELOW
[/] For cases from federal courts:
to
The opinion of the United States court of appeals appears at Appendix
the petition and is
; or,
[ ] reported at
[ ] has been designated for publication but is not yet reported; or,
[^3 is unpublished.
to
The opinion of the United States district court appeal’s at Appendix
the petition and is
or,
[ ] reported at
[ ] has been designated for publication but is not yet reported; or,
[ ] is unpublished.
[ ] For cases from state courts:
The opinion of the highest state court to review the merits appears at
Appendix ____ to the petition and is
;or,
[ ] reported at
[ ] has been designated for publication but is not yet reported; or,
[ ] is unpublished.
The opinion of the _
appears at Appendix
court
to the petition and is
[ ] reported at____
; or,
[ ] has been designated for publication but is not yet reported; or,
[ ] is unpublished.
1.
JURISDICTION
bl] For cases from federal courts:
The date^orrwhich the ^Lmitecl States Court of Appeals decided my case
was
[ ] No petition for rehearing was timely filed in my case.
[yj] A timely petition for rehearing was denied by the United States Court of
Appeals on the following date: Qc.-tob-fl-V) A.9 ) QOAU, and a copy of the
order denying rehearing appears at Appendix
B .
1/1 An extension of time to file the petition for a writ of certiorari was granted '
to and including /Datfe/nbcn^
\ (date) onSeptEftbe^RSiO^J.
(date)
in Application No.U9C.AS. Ho. 5-0-%% \
The jurisdiction of this Court is invoked under 28 U. S. C. § 1254(1).
[ ] For cases from state courts:
The date on which the highest state court decided my case was
A copy of that decision appears at Appendix_______
[ ] A timely petition for rehearing was thereafter denied on the following date:
—-------------------------------- , and a copy of the order denying rehearing
appears at Appendix
[ ] An extension of time to file the petition for a writ of certiorari was granted
to and including____
(date) on
(date) in
Application No. __ A
The jurisdiction of this Court is invoked under 28 U. S. C. § 1257(a).
CONSTITUTIONAL AND STATUTORY PROVISIONS INVOLVED
The Fifth Amendment to the United States Constitution prohibits any person from being deprived of
his or her liberty without due process of law:
“No person shall be held to answer for a capital, or otherwise infamous crime,
unless on a presentment or indictment of a Grand Jury, except in cases
arising in the land or naval forces, or in the Militia, when in actual service in time
of War or public danger; nor shall any person be subject for the same offence to be
twice put in jeopardy of life or limb; nor shall be compelled in any criminal case to
be a witness against himself, nor be deprived of life, liberty, or property, without
due process of law; nor shall private property be taken for public use, without just
compensation.”
18 U.S.C.A § 841 (a)(1) states:
“Except as authorized by this subchapter, it shall be unlawful for any person
knowingly or intentionally -to manufacture, distribute, or dispense, or possess with intent
to manufacture, distribute, or dispense, a controlled substance”
21 U.S.C. SS 331(a) and 333(a)(2):
Introducing misbranded drugs into interstate commerce
21 C.F.R § 1306.04(a) provides the requirements for lawful prescription by a physician:
“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose
by an individual practitioner acting in the usual course of his professional practice. The responsibility for
the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to
be a prescription issued not in the usual course of professional treatment or in legitimate and authorized
research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829)
and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be
subject to the penalties provided for violations of the provisions of law relating to controlled
substances.”
STATEMENT OF THE CASE
I.
This case presents a clear and unambiguous vehicle for the Court to address increasingly divergent inter
and intra-circuit splits pertaining to the mens rea the government must establish to secure the conviction of a
licensed pharmacist under Misbranding. Here, the pharmacist dispensed "regular” "non-controlled”
prescriptions written by licensed medical practitioners the Government claimed to be "invalid”.
“Currently, there are at least three different mens rea requirements recognized by the Courts of Appeal. Three
circuits unequivocally impose strict liability on practitioners who prescribe outside the usual course of
professional practice; two (arguably three) impose a knowing or intentional scienter; and the remainder
3
impose varying degrees of negligence. Confusion on this point has led to a number of inter- and intra-circuit
splits regarding what constitutes a “good faith” defense for doctors charged under §841. A valid defense in one
circuit amounts to an admission of guilt in another.
Relying on this court’s holding in United States v. Moore, 423 U.S. 122 (1975), and language from
C.F.R § 1306.04(a), the circuits universally agree that, in order to convict a licensed medical practitioner under
§841, the government must establish that the charged prescriptions were not issued either (1) for “a legitimate
medical purpose” or (2) “by an individual practitioner acting in the usual course of his professional practice.”
The Tenth Circuit (and every other circuit except the Ninth Circuit) interprets this language as allowing for
conviction under two different theories. The government must prove either: (1) that the prescription was not
written for a legitimate medical purpose; or (2) that the prescription was outside the usual course of professional
practice “generally recognized throughout the United States.” United States v. Nelson, 383 F.3d 1227,1233
(10th Cir. 2004).
The Eleventh, Tenth, and Fifth Circuits hold that, while the government must prove that a defendant
knew she was issuing a prescription for no legitimate medical purpose, a doctor charged under the “usual
course” prong is strictly liable for any prescriptions she writes that are, in fact, outside the scope of professional
practice regardless of whether she knew that they were outside said scope. United States v. Tobin, 676 F.3d 1264,
1283 (11th Cir. 2012); United States v. Norris, 780 F.2d 1207,1209 (5th Cir. 1986).
The First, Second, Third, Fourth, Sixth, Seventh, Eighth, and Ninth Circuits have each issued decisions
explicitly or implicitly requiring the government to prove that the defendant knowingly or intentionally acted
outside the scope of professional practice. United States v. Sabean, 885 F.3d 27, 45 (1st Cir. 2018); United States
v. Wexler, 522 F.3d 194, 206 (2d Cir. 2008); United States v. Li, 819 F. App'x 111, 118 (3d Cir. 2020)
(unpublished); United States v. Hurwitz, 459 F.3d 463, 478, 480 (4th Cir. 2006); United States v. Jones, 825 F.
App’x 335, 339 (6th Cir. 2020); United States v. Kohli, 847 F.3d 483, 490 (7th Cir. 2017); United States v. Smith,
573 F.3d 639, 649-50 n.4 (8th Cir. 2009); United States v. Feingold, 454 F.3d 1001,1008 (9th Cir. 2006).
Despite the majority of circuits’ consensus that a doctor must intentionally or knowingly issue a
prescription outside the scope of professional practice, jury instructions in the Second, Fourth, Sixth, and Eighth
Circuits define good faith “objectively.” In those circuits, a defendant acts in good faith only when she acts
4
within what she reasonably should have believed or “reasonably believed” to be the usual course of professional
practice. United States v. Vamos, 797 F.2d 1146,1152 (2d Cir. 1986); Hurwitz, 459 F.3d at 478 (4th); United
States v. Godofsky, 943 F.3d 1011, 1026 (6th Cir. 2019); United States v. King, 898 F.3d 797, 807-08 (8th Cir.
2018). The effect of these instructions is to allow a jury to convict based on a mens rea of negligence rather than
knowledge or intent. In those circuits, a defendant who holds a sincere belief about what prescription practices
are permissible and writes prescriptions based on that belief can still be convicted under the CSA.
The Seventh and Ninth Circuits allow for a good faith instruction directing the jury to consider the
defendant’s subjective good faith. Kohli, 847 F.3d at 489; United States v. Hayes, 794 F.2d 1348,1351 (9th Cir.
1986). In those circuits, a defendant who holds a sincere belief about what prescription practices are permissible
and writes prescriptions based on that belief is not guilty of intentionally writing prescriptions outside the usual
course of professional practice.
The Eleventh Circuit jury instruction on good faith defines good faith as acting within the scope of
professional practice, without any reference to the defendant’s beliefs. United States v. Ruan, 966 F.3d 1101,
1167 (11th Cir. 2020); United States v. Joseph, 709 F.3d 1082,1097 (11th Cir. 2013) (“The law of this Circuit is
not even clear that [the defendant] was entitled to a “good faith” jury instruction at all.”).
This Court last considered any case involving the prosecution of a medical practitioner under §841 in
1975. United States v. Moore, 423 U.S. 122 (1975). The increase of prosecutions against medical practitioners
under the CSA over the last decade has not worked to clarify circuit court law but instead has birthed an
exponential increase in inter- and intra- circuit inconsistency. This case presents a clear opportunity to resolve
these inconsistencies precisely because the holding of the Tenth Circuit unambiguously imposes strict liability on
doctors acting outside the scope of professional practice. United States v. Kahn, 989 F.3d 806, 825 (10th Cir.
2021) (We hold that §841(a)(l) and § 1306.04(a) require the government to prove that a practitioner-defendant...
issued a prescription that was objectively not in the usual course of professional practice.”).
Statutory Framework
The Controlled Substances Act makes it unlawful for any person “knowingly or intentionally to
distribute or dispense a controlled substance.” 21 U.S.C. §841(a). Medical practitioners are exempt from this
prohibition. See 21 U.S.C. §§ 821-23. In Moore, this Court recognized that a doctor’s scope of authority as
5
defined in the CSA is somewhat circular. 423 U.S. at 124. (“Section 822(b) defines the scope of authorization
under the Act in circular terms. ‘Persons registered ... under this subchapter... are authorized (to dispense
controlled substances)... to the extent authorized by their registration and in conformity with the other
provisions of this subchapter.”) Id. The defendant in Moore challenged his conviction arguing that he could not
be prosecuted under §841 because he was duly licensed and registered under the CSA. Id. This Court reasoned
that the CSA could not have intended to exempt all practitioners from liability under §841. Id. Thus, the Court
found that a physician remains criminally liable when he ceases to distribute or dispense controlled substances as
a medical professional and acts instead as a “pusher.” Id. at 138.
Under authorization of the CSA, see 21 U.S.C. § 821, the Attorney General issued CFR §1306.04
indicating the conditions under which registrants are authorized to dispense controlled
substances:
“A prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting in the usual
course of his professional practice.”” 21-5261 KAHN, SHAKEEL V. UNITED
STATES, CERTIORARI GRANTED
In the Plaintiff’s case, the Government never proved that the Plaintiff knew the prescriptions she
dispensed were “invalid”.
II. The District Court denied the Plaintiff’s 3/19/2020 motion for a certificate of appealability based on newlydiscovered-evidence motion for a new trial, challenging the denial of a newly-discovered-evidence motion for a
new trial after the May 15, 2015 verdict, as untimely in that “any motion for a new trial grounded on newly
discovered evidence must be file within 3 years after the verdict or finding of guilty.” However, the suppressed
exculpatory video recordings, a Brady violation, were NOT turned over to the Plaintiff until July 24, 2018,
which was more than 3 years after the Plaintiff’s verdict. Therefore, it was IMPOSSIBLE for “such
motions be made within three years after verdict”.
It must be stressed that the prosecutors referenced these video recordings as if they were in evidence at
trial, while knowing the video evidence was exculpatory. Their suppression of it, and their tampering with the
evidence, also show that they knowingly presented false evidence to the jury.
Judge Buchwald denied the Plaintiff’s request for a new trial based on newly discovered evidence as 6
“untimely”. She chose to ignore the Supreme Court’s recent ruling of Arsean Lamone HICKS v. Director,
DEPARTMENT OF CORRECTIONS. Record No. 131945. Decided: 7 February 26, 2015 in that "the statute
of limitations for habeas claims must be tolled while such evidence is suppressed.” The Appellate Court
should grant the Plaintiff a new trial based on the Supreme Court’s recent ruling of Arsean Lamone HICKS
v. Director, DEPARTMENT OF CORRECTIONS. Record No. 131945. Decided: February 26, 2015, and based
on the fact the newly discovered evidence were not turned over to the Plaintiff until July 24, 2018, more than 3
years after the Plaintiff’s verdict; thus the Plaintiff is not capable nor able to file within the 3 years statute of
limitation. Therefore, the Plaintiff is seeking to toll the statute.
A. The exculpatory video recordings evidence, which were previously suppressed by the prosecution, AUSA DANIEL
RICHENTHAL, show:
(1) The Plaintiff was not present at the alleged crime scene on the dates (6/1/2012,6/12/2012, 7/16/2012,
7/17/2012, 8/13/2012, 8/16/2012, 8/27/2012, and 10/2/2012 the alleged crimes were supposedly
committed, and
(2) The Plaintiff was working in a different pharmacy and not engaged in any of the alleged acts the
prosecution describes, such as remotely monitoring or supervising, nor directing employees in other
locations to commit the alleged crime.
(3) The Plaintiff was working at a different pharmacy on October 2, 2012 when opioids was dispensed to
“unkempt" individuals,
(4) The Plaintiff never dispensed the drug "butalbital" as indicted, charged, and convicted of, and proof
of same was withheld from the jury.
Most importantly, the Plaintiff’s lack of presence is also shown on the work schedule and EZY passes.
The governing pharmacy law (PA 27.12(b)(2) and the criminal statute 21 U.S.C. Sec. 321 (g)(1), 352(a), 352(c),
353(b)(1), 353(b)(4)(A), 21 U.S.C. Sec. 331(a) and 333 (a)(2) REQUIRE the accused to be present at the
pharmacy at the time the specific prescriptions in question were filled and/or "shipped". Also, the governing
pharmacy law protects a pharmacist from being held liable for another's actions. Numerous pharmaceutical law
and protocol support the Plaintiff's testimony while impeaching the testimony of Prosecution witnesses and one
of the main contentions of the prosecution's case. The lack of ability to present that critical video evidence,
7
while the government asserted the knowledge of it's existence further undermined the truth and advanced the
perjured testimony. See Demarco v United States 928 F.2d 1074 (11th cir. 1991). The failure for the prosecution
to correct perjured testimony is ground for the reversal of conviction.
The Government also has a copy of the work schedule from the Hellertown Pharmacy (HP) and Palmer
Pharmacy & Much More (PP) showing Plaintiff was not at work during the dates and times of the shipments
referenced.
The Prosecution and their witnesses also claim the Plaintiff was in New Jersey: remotely monitoring,
supervising, and directing employees in the PA stores to commit the crimes. The Prosecutors specifically stated
that the video evidence showed the Plaintiff remotely monitoring and remotely directing workers in
Pennsylvania pharmacies to commit the alleged acts. But the Prosecution never presented that video evidence.
They instead suppressed it and the Judge withheld it. Unsurprisingly, the video shows the Plaintiff busily
working in a New Jersey Pharmacy on all of the dates in question, not remotely monitoring or supervising
employees in the other stores, as the prosecution claimed. The prosecution and its witnesses claimed the
Plaintiff did not count pills, reused medications, improperly labeled and stored medications. However, the
admittance of vastly superior video evidence will show that the Plaintiff follows rules and regulations of
pharmacy law, properly handling pills and prescriptions, labeling and storing and destroying medications
properly, and dispensing medications with valid prescriptions which were verified by doctors, all
contradicting the prosecutors' witnesses sworn testimony. The video recordings will further prove the drug
“butalbital” NEVER existed in the pharmacies.
The United States Supreme Court stressed that a defendant’s due process rights are violated both when a
prosecutor knowingly presents false testimony and when he knowingly fails to correct such perjury. The Court
also held that the same rule applies even when the false testimony concerns only the witness’s credibility, since
“a lie is a lie, no matter what its subject.” Napue v. Illinois, 360 U.S. 264 (1959). Bivens v. Six Unknown Fed.
Narcotics Agents, 403 U.S. 388 (1971)
FACTS
On September 2, 2016, the Second Court wrongfully affirmed the petitioner's conviction of May 15,
2015 in violation of 18 U.S.C. 371 (Count I); introducing misbranded drugs into interstate commerce in
8
violation of 21 U.S.C. 331(a) and 333(a)(2) (Count II); conspiracy to commit mail and wire fraud in violation of
18 U.S.C. 1349 (Count III); and mail and wire fraud in violation of 18 U.S.C. 1341 and 1343 (Counts IV and
V). She was sentenced to 36 months’ imprisonment, for:
a. dispensing “butalbital” (See Exh D) which NEVER existed in the pharmacies,
b. the dispensing of tramadol which was NOT a controlled substances at the time of dispensing, but became a
federally controlled substance nineteen months after the Petitioner’s indictment/arrest, but the only
misbranding alleged about Tramadol is only applicable to controlled substances (Valid Prescription standard),
c. the dispensing of “highly addictive pain meds” which is a term that does not exist in law nor in the health care
industries and used only to deceive the jury by creating standards that do not exist under the law, which both the
District and Appellate Court failed to mention ONE name of the “highly addictive pain meds” that was
dispensed, because there were NONE.
The principal argument was that Lasher dispensed “regular” “non-controlled” prescriptions written
by licensed medical practitioners the Government deemed to be “invalid”. The government further lied
to the jury that the “regular” “non-controlled” prescriptions Lasher dispensed were “highly addictive pain meds”
and they presented testimony known to be false multiple times during the trial. In fact, the prosecution placed
regular prescription drugs, drugs that are not controlled substances and have no known potential for abuse, into a
"made-up" category that NO drug has ever been placed in, a category they called "highly addictive pain meds"
sometimes calling it "addictive pain meds", without any facts to back up the invention of this phrase nor any
references to scientific, medical, pharmaceutical or pharmacological literature (T.1768). This was done to
prejudice and profile the Plaintiff; in fact, NONE of the drugs the Plaintiff dispensed via the "fulfillment"
pharmacy were classified as "pain meds"(T.1768), or a controlled substance at the time of dispensing.
Multiple DEA agents testified to receiving the drug “butalbital” even though the drug they were
prescribed and received was Fioricet. Early in the pre-trial phase it was established that the pharmacies never
stocked nor dispensed butalbital. It is a very uncommon drug, its use is primarily if not exclusively in
manufacturing. The drug dispensed was Fioricet. To call the drug by a different name is a lie,
misrepresenting the material fact of the matter. It also defies the definitions within the law for both Drug
and Fixed-Combination Drug. These agents committed perjury; the Jury were deceived as to the drug
9
prescribed. If a juror ever had to see a doctor over tension headaches, or had a loved one who did, they would
very likely know that Fioricet is not a controlled substance and there is a chance they would have seen through
the deceptions that were presented to them about the drug.
A jury convicted Lasher on five counts and she was sentenced to three years in prison
“The original good faith instruction proposed by Kahn read:
“The good faith of a defendant, whether or not objectively reasonable, is a complete defense to the
crimes charged, because good faith on the part of a defendant is inconsistent with specific intent, which is an
essential part of the charges. A defendant who acts upon an opinion honestly held by him or her at the
time of the alleged acts, or pursuant to a belief honestly entertained by him or her at the time of the alleged acts,
cannot be found guilty even though his or her opinion is erroneous or his or her belief is mistaken or wrong.
A defendant’s good faith must have existed at the time the alleged unlawful acts were committed. One
cannot assert good faith as a defense if the opinions or beliefs advanced as justifications for the good faith
defense were formulated after the commission of criminal acts. If you find that the defendant lied about some
aspect of the charged conduct, you may consider that, in addition to other evidence presented, in determining
whether the defendant acted in good faith.
While the term “good faith” has no precise definition, it means, among other things, a belief or opinion
honestly held, an absence of malice or ill will, and an intention to avoid taking unfair advantage of another.” 201410 RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
In the practice of pharmacy, good faith means the honest exercise of good professional judgment as to a
patient’s medical needs. “Good faith connotes an honest effort to treat patients in compliance with generally
recognized and accepted standards of medical practice.
The burden of proving good faith does not rest with a defendant because a defendant does not have any
obligation to prove anything in this case. It is the government’s burden to prove to you, beyond a reasonable
doubt, that a defendant acted knowingly and intentionally.
In determining whether or not the government has proven that a defendant acted intentionally, you the
jury should consider all of the evidence in the case bearing on that defendant's state of mind.” R. 694 at 10-11.”
20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
10
The instruction issued by the Petitioner’s district court read:
“ The defendant has advanced the defense of good faith. Good faith means a state of mind consisting of honesty
in belief or purpose and the absence of intent to defraud or mislead.” T. 1924 At 14-17”
“Petitioner argued that the government must prove both that the instant prescriptions were written
outside “usual course of the medical practitioner’s profession” and without a “legitimate medical purpose.”
R.729 at 8-9; 5/21/19 Tr. 7.” 20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
The Petitioner, a licensed pharmacist, is not responsible for a doctor’s actions or state of mind and the
Government can not make up a standard out of thin air accusing the Petitioner of dispensing “invalid”
prescriptions prescribed by licensed medical practitioners; the Government did not prove that the Plaintiff knew
the prescriptions written by licensed medical practitioners which the Plaintiff dispensed were “invalid”.
A. The Court of Appeals’ Decision
Petitioner appealed to the Second Circuit, arguing that:
1. The Petitioner abided by all pharmacy law in dispensing these prescriptions and there was no reason to
suspect that these prescriptions were not valid; to date, the Government never proved that the Plaintiff knew
the prescriptions she dispensed were “invalid”.
2. The statute of limitations for habeas claims must be tolled while exculpatory evidence is suppressed.
The Second Circuit affirmed. Lena Lasher v. United States, 20-221 (2nd Cir. 2019).
On August 11, 2020 United States Court of Appeals for the Second Circuit GRANTED the Plaintiff
leave to file an oversize motion for a certificate of appealability; however, they:
1. Then Denied her Document for panel RECONSIDERATION and a motion for RECONSIDERATION
ENBANC for a certificate of appealability on October 29, 2020 (See Appendix B)
2. Dismissed Lasher's appeal stating they "lacked jurisdiction to hear Lasher's appeal because a district court's
order denying a certificate of appealability is not an appealable final order". However, the Second Circuit Court
was incorrect.
“Kahn’s assertion that “good faith is a defense because it negates the mens rea element of the offense” is
without merit.... Unlike other criminal offenses, good faith does not go to mens rea for §841 offenses involving
practitioners. Rather, as numerous other circuits have recognized, good faith defines the scope of professional 11
practice, and thus the effectiveness of the prescription exception and the lawfulness of the actus reus.” Id. at 826.
The Tenth Circuit, thus, asserted that a doctor’s actual intentions or beliefs are irrelevant. According to the Tenth
Circuit’s decision, a doctor who unintentionally writes a prescription negligently is guilty of a crime under the
CSA. The Tenth Circuit has imposed strict liability on doctors who act outside the usual course of professional
practice even if they do so unintentionally.” See 20-1410 RUAN, XIULU V. UNITED STATES,
CERTIORARI GRANTED
In this Petitioner’s case, “good faith is a defense because it negate the mens rea element of the offense”
in that a pharmacist cannot read the mind of the licensed medical practitioners in regard to his doctor patient
relationship; the law simple does not require this, because the law expects doctors to adhere to their own
professional standards. Pharmacists dispense prescriptions. Here, no specific prescription was cited to be
misbranded by any one. No evidence of such was provided by anyone. Instead, the Government’s allegation
was intentionally vague so as to deceive the jury. Further, the indictment intentionally conflates an allegation
that the Plaintiff did this or that she directed “others” to commit these alleged crimes, but does not name anyone
else. Again, no evidence was ever presented to support these allegations other than testimony that can shown to
be false. There is nothing of intent in the indictment, there is nothing specific in the indictment.
The Defendants also should know that the bonafide relationship standard for normal
NON - controlled prescriptions do not require a pharmacist to assess a doctor-patient relationship. In fact,
there is no formal assessment for a pharmacist to determine whether there is a bonafide relationship between a
doctor and his patient, that relationship is between them; there is no established criteria under federal law for a
pharmacist to know if the doctor consulted their patients. The signatures on the prescriptions are the doctor's
promise to the rest of the health care community and the patients, that the prescriptions are valid and that their
job was done properly. A relationship could in fact exist and be denied at trial, as the doctors testifying at the
criminal trial against the Plaintiff were only testifying to avoid their own jail time for other crimes. On top of
this, the Plaintiff, before filling these fulfillment pharmacy prescriptions, actually required doctors to fill out and
submit forms stating that they did phone consult directly with the patients. Evidence of this requirement that
went above and beyond the requirements under the law was withheld by the District Court because it was
physical evidence that would directly contradict testimony of one of the prosecution’s witnesses.
12
None of this changes the fact that the Prosecution’s and the district court’s applying of the face-toface requirement to non-Controlled Substances is a deception, deceiving the jury that the Controlled
Substances Act’s requirements for valid prescriptions was meant to be applied to NON - Controlled
Substances.
Plaintiff now moves for a certificate of appealability to appeal the District Court’s unconstitutional
denial of her habeas corpus by submitting this writ of certiorari, to affirm her actual innocence.
REASONS FOR GRANTING REVIEW
I. REVIEW IS NECESSARY TO RESOLVE A NUMBER O F CIRCUIT SPLITS CENTERING
AROUND THE CENTRAL QUESTION O F WHAT LEVEL OF INTENT IS NECESSARY FOR
CONVICTION OF A LICENSED PHARMACIST UNDER MISBRANDING - DISPENSING “regular”
“non-controlled” prescriptions written by licensed medical practitioners the Government claimed to be
“invalid”. “The Tenth Circuit, in the case at bar, as well as the Eleventh and Fifth Circuits, have explicitly
held that a defendant is strictly liable for acting outside the scope of professional practice. Tobin, 676 F.3d at
1283; Norris, 780 F.2d at 1209. In those circuits, a doctor acting outside the scope of professional practice is
culpable under §841 even if she intended to comply with what she believed to be the usual course of professional
practice and the charged prescriptions were actually serving a legitimate medical purpose. Having a mistaken
view about what the standards of medical practices are or what most doctors actually do (depending upon one’s
interpretation of “usual course of professional practice”) is not a defense.
The Ninth and Seventh Circuits are the most explicit in holding that the government must prove that a
medical practitioner intentionally acted outside the usual scope of professional practice and/or issued a
prescription knowing it served no legitimate medical purpose. Kohli, 847 F.3d at 490 (“In other words, the
evidence must show that the physician not only intentionally distributed drugs, but that he intentionally ‘act[ed]
as a pusher rather than a medical professional.’”); Feingold, 454 F.3d at 1008 (“[T]he government must prove ...
that the practitioner acted with intent to distribute the drugs and with intent to distribute them outside the course
of professional practice. In other words, the jury must make a finding of intent not merely with respect to
distribution, but also with respect to the doctor's intent to act as a pusher rather than a medical professional.”);
United States v. Garrison, 888 F.3d 1057,1064 (9th Cir. 2018).
13
Other Courts of appeal have issued decisions that either implicitly or explicitly required a finding of
knowledge. See Hurwitz, 459 F.3d 463 (4th) (“attorney's statement [admitting that his client acted outside the
scope of professional practice] therefore cannot be viewed as a clear and unambiguous admission that [the
defendant] knowingly acted outside the bounds of accepted medical practice.”); Jones, 825 F. App'x at 339 (6th)
(“To have convicted [the defendant] under §841(a)(l), the jury must have found that Jones filled prescriptions
for Schedule II substances knowing that the prescriptions were outside the scope of professional practice and
that they were not for a legitimate medical purpose.”) (unpublished); Sabean, 885 F.3d at 45 (1st) (“It stressed
that the government had to prove, at a minimum, that the defendant “was aware to a high probability the
prescription was not given for a legitimate medical purpose in the usual course of professional practice” and that
the defendant “consciously and deliberately avoided learning that fact.”); Li, 819 F. App’x at 118 (3rd) (“It is
settled law that ‘a district court does not abuse its discretion in denying a good faith instruction where the
instructions given already contain a specific statement of the government’s burden to prove the elements of a
‘knowledge’ crime.’ Here the District Court instructed the jury on the requirements to prove knowledge. Thus, it
acted within its discretion.”) (unpublished); Wexler, 522 F.3d at 206 (2nd) (mistake “however gross”
insufficient); Smith, 573 F.3d at 649-50 n.4 (8th) (instruction conflating civil standard of care with usual course
of professional practice was cured, in part, by good faith instruction which noted that “unreasonable belief
sincerely held is good faith.”).
Even among those circuits requiring that a doctor knowingly act outside the scope of professional
practice, a split has developed as to what constitutes “good faith.” See Deborah Heilman, Prosecuting Doctors
For Trusting Patients, 16 G EO . M ASON L. R EV . 701, 715 (2009). The consensus view in the circuits is that
medical practitioners charged with violating §841 are entitled to some form of good faith instruction. However,
the good faith instructions approved of by the courts of appeals are often inconsistent with the circuit’s proffered
view on the level of intent required to prove a practitioner’s guilt.
The Seventh and the Ninth Circuits’ good faith instructions are largely (though not entirely) consistent
with the view that a doctor must knowingly act outside of the scope of professional practice:
The Seventh, and Ninth, and First Circuits allow for instructions that define good faith
14
“subjectively.” That is, instructions that ask the jury to consider the defendant’s “honest efforts” without
requiring that a defendant’s belief regarding the usual course of professional practice be “reasonable.”
“[Tjhe Defendant may not be convicted if he dispenses or causes to be dispensed controlled
substances in good faith to patients in the usual course of professional medical practice. Only the lawful
acts of a physician, however, are exempted from prosecution under the law. The Defendant may not be
convicted if he merely made an honest effort to treat his patients in compliance with an accepted
standard of medical practice.... Good faith in this context means good intentions and the honest exercise
of good professional judgment as to the patient’s medical needs.”
Kohli, 847 F.3d at 489 (7th).
“[Gjood faith means an honest effort to prescribe for a patient’s condition in accordance with the
standard of medical practice generally recognized and accepted in the country. Mistakes, of course, are
not a breach of good faith.... You need not agree with or believe in a standard practice of the profession,
but must only be concerned with a good faith attempt to act according to them. Good faith is not
merely a doctor’s sincere intention towards the people who come to see him, but, rather, it involves his sincerity
in attempting to conduct himself in accordance with a standard of medical practice generally recognized
and accepted in the country.”
Hayes, 794 F.2d at 1351 (9th). In both the Seventh and Ninth Circuits, what actually constitutes the usual course
of professional practice is an objective question. The subjective aspect requires that the doctor know he is acting
outside the scope of what is objectively accepted medical practice. Id.
On the other side of the spectrum, the Eleventh Circuit’s good faith instruction is consistent with its view
that a doctor is strictly liable and takes all consideration of a doctor’s mental state out of consideration. The
Eleventh Circuit instruction defines good faith as a doctor actually acting in accordance with a standard of
medical practice generally recognized in the United States. Ruan, 966 F.3d at 1167 (“A controlled substance is
prescribed by a physician in the usual course of professional practice and, therefore, lawfully if the substance is
prescribed by him in good faith as part of his medical treatment of a patient in accordance with the standard of
medical practice generally recognized and accepted in the United States.”).
15
Even while, at times, implicitly suggesting that knowledge that a prescription is outside the usual course
of professional practice is a requirement, the Second, Sixth, Eighth, and Fourth Circuits authorize varying
degrees of “objective” good faith instructions.
In Wexler, 522 F.3d at 206, the Second Circuit recognized that a mistake “however gross” is not
sufficient find a defendant guilty under §841. Id. Nevertheless, the court, in the same case, approved of a good
faith instruction that defined good faith as what the defendant “should have reasonably believed to be proper
medical practice.” Id. The good faith instruction issued explicitly allowed for conviction based on an
unreasonable mistake. If one can be convicted based on an unreasonable mistake, then one can be convicted for a
“gross mistake” and without knowledge that she acted outside the usual course of professional practice.
In Godofsky, 943 F.3d at 1017, the Sixth Circuit engages in a lengthy discussion of the distinction
between objective and subjective good faith. In relevant part, the Sixth Circuit finds that “Without explicitly
saying it this way, the court appears to have drawn a distinction between subjective good faith (“well, I did what
I thought was best”), which it rejected, and objective good faith (do “what you believe complies with [the rules
and regulations]”), which it accepted.” Id. However, the Sixth Circuit reiterated that any mistake on the
doctor’s part as to the scope of professional practice must be judged from the perspective of a reasonable
physician. Id. at 1026; United States v. Voorhies, 663 F.2d 30, 34 (6th Cir. 1981) (approving of good faith
instruction that reads “It connotes an observance of conduct in accordance with what the physician should
reasonably believe to be proper medical practice.”). If the standard a practitioner is held to is based on what a
reasonable physician should believe, then that practitioner can be convicted for negligence and knowledge is not
actually required.
In King, 898 F.3d at 808, the Eighth Circuit upheld the district court’s refusal to issue the defendant’s
proffered good faith instructions, finding (1) that the defendant’s good faith instruction was erroneous because it
was not “objective” and (2) that the district court properly required the jury to find knowledge. But see Smith,
573 F.3d at 649-50 (noting that instruction conflating civil standard of care with usual course of professional
practice was cured, in part, by good faith instruction which noted that “unreasonable belief sincerely held is good
faith.”). A good faith instruction that is purely objective is inconsistent with a requirement that the juiy find
subjective knowledge or intent.
16
The Fourth Circuit has case law suggesting that knowledge is required to obtain a conviction. Hurwitz,
459 F.3d at 468-69. Nevertheless, in United States v. Purpera, 844 F. App'x 614, 617 (4th Cir. 2021), the Fourth
Circuit indicated that the defendant's proffered good faith instruction was insufficiently “objective.” There, the
defendant’s proffered instruction defined good faith as a doctor acting in conformity with what he “reasonably
believed” to be the scope of professional practice. Id. The Fourth Circuit indicated that the defendant’s
instruction by even referencing what the defendant actually believed, even while qualifying that it must be
reasonable, was too close to a “subjective” instruction. Id. On its face, the Fourth Circuit’s opinion allows for
conviction even in the case of reasonable mistakes. Thus, again, based on an objective good faith instruction, a
defendant can be convicted without knowledge in the Fourth Circuit despite the fact that the Fourth Circuit has
indicated that knowledge is required.
In each of these circuits, it is sufficient for the government to prove that the doctor acted unreasonably,
even if honestly, and still obtain a conviction. As a practical effect, therefore, there are at least three different
versions of the scienter requirements that the government must prove to convict a licensed practitioner under
§841. Three circuits impose strict liability (Fifth, Eleventh, and Tenth), two require actual intent or
knowledge (Seventh and Ninth), and the remainder of circuits require some degree of negligence.” 20-1410
RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
“Clarification from this Court as to the elements the government must prove to secure the
conviction of a medical practitioner under §841 would also provide much needed guidance on other
inconsistencies among the circuits. For example, even in circuits where knowledge is not a
requirement, the issuance of a willful blindness instruction is commonplace. See, e.g., United States v.
Lee, 966 F.3d 310, 323 (5th Cir.) (“The instruction “should rarely be given,” ... but what seems rare is a
health care prosecution without the instruction.”); Sabean, 885 F.3d at 45; United States v. Leonard, 738
F. App’x 7,11 (2d Cir. 2018); Hurwitz, 459 F.3d at 481; United States v. Katz, 445 F.3d 1023,1031 (8th
Cir. 2006). The only logical reason to issue the willful blindness instruction is if knowledge is an
element of the offense. If a defendant’s knowledge of acting outside the scope of professional practice is
not an element of the offense, it seems incongruous to issue a willful blindness instruction. Furthermore,
even in those circuits where medical practitioners are subject to a negligence or strict liability standard,
the conviction of other medical practitioners (such as nurses or technicians) for dispensing medication
outside the scope of professional practice under the same statute requires proof of actual knowledge.
See, e.g., United States v. Lovern, 590 F.3d 1095,1105 (10th Cir. 2009) (finding insufficient evidence
that technician knew prescriptions were outside the scope of professional practice); United States
v. Lawson, 682 F.2d 480, 482 (4th Cir. 1982) (“[t]he question, then, in any case where a pharmacist is
charged with illegal distribution of controlled substances, is whether he knew that the purported
prescription was not issued for a legitimate medical purpose or in the usual course of medical practice.17
But see Sabean at 45 (allowing good faith instruction as to nurse practitioner that referenced the nurse’s
“reasonable belief”).” 20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI GRANTED
The difference is not insignificant. What are very plausible and sometimes successful defenses in one
circuit are admissions of guilt in others. Cf. Hurwitz, 459 F.3d at 480 (reversing despite counsel’s admission that
his client was acting outside the scope of professional practice because said admission did not necessarily
concede that defendant knew he was acting outside the usual scope of professional practice) with Kahn, 989 F.3d
at 825 (“We hold that §841(a)(l) and § 1306.04(a) require the government to prove that a practitionerdefendant ... issued a prescription that was objectively not in the usual course of professional practice.”).
Section 841 is not a minor or technical criminal statute. It imposes significant penalties
on those convicted. It is difficult to find a similar statute with such wide-ranging disagreement as
to the basic mens rea elements of the offense.” 20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI
GRANTED
In the petitioner’s case, mens rea requires the Petitioner to know that the licensed medical prescribers
were acting outside the scope of professional practice. The Petitioner believes all the prescriptions she
dispensed, written and signed by the licensed medical prescribers, were within the licensed medical prescribers’
scope of professional practice in which the prescriptions were prescribed properly for the correct medical
condition, and were with correct strength, dosage, and instruction as documented in, including but not limited to,
the “Drug Facts and Comparisons”, “Lexicomp”, and “Physicians Desk Reference”. The trial judge withheld
evidence that further proved I was acting in good faith. In fact, the government is not citing a legal standard but
is making up one in regard to misbranding as they did with the definition of “drug”. Further, the doctor's
signature on the prescription is their own legal OATH that the prescription is legitimate.
“II. ISSUANCE OF “OBJECTIVE ” GOOD FAITH INSTRUCTION IS INCONSISTENT WITH THE
MENS REA OF KNOWLEDGE REQUIRED BY THE COURTS CASE LAW.
L<As the Tenth Circuit recognized, the “objective” good faith instruction is not a “good faith” instruction as
commonly understood. Generally, good faith is not a “defense” as such. Rather, it is an articulation of a
defendant’s theory of the case. Good faith is inconsistent with conviction precisely because a person acting in
good faith does not have the required mens rea. Daniel S. Jonas, The Circuit Split Over Instructing The Jury 18
Specifically On The Good Faith Defense: A Consequence of Superlegislation By Courts Or The Standards Of
Appellate Review, 46 S YRACUSE L. R EV . 61, (1995) (collecting appellate cases indicating that a good faith
instruction need not be issued if the jury is adequately instructed on the intent element of the offense); Adam H.
Kurland, Prosecuting Ol' Man River: The Fifth Amendment, the Good Faith Defense, and the Non-Testifying
Defendant, 51 U. Pitt L. Rev. 841, 856 (1990). Therefore, good faith instructions are tailored to the mens rea of
the offense. The understanding that good faith is a negation of a knowing or intentional mens rea is so ingrained
that a plurality of appellate courts will not reverse a conviction for failure to give a good faith instruction if the
jury instructions otherwise properly defined the knowledge and intent elements of the offense. United States v.
Nivica, 887 F.2d 1110,1125 (1st Cir. 1989); United States v. McElroy, 910 F.2d 1016,1026 (2d Cir. 1990);
United States v. Gross, 961 F.2d 1097,1103 (3rd Cir. 1992), United States v. Dorotich, 900 F.2d 192,193-94 (9th
Cir. 1990); United States v. Gambler, 662 F.2d 834, 837 (D.C. Cir. 1981).
This Court has held that defining a defendant’s good faith as being dependent upon whether his
(mistaken) belief was “objectively reasonable” effectively reduces the mens rea. Cheek v. United States, 498
U.S. 192,197 (1991).
The inconsistency between the “objective” good faith instructions applied to doctors charged under §841
and the “subjective” good faith instructions given in cases involving other criminal charges is well illustrated
by the Fourth Circuit’s decision in United States v. Hurwitz. In Hurwitz, the defendant was charged both with
distributing outside the scope of professional practice under §841 and healthcare fraud. 459 F.3d at 468-69. The
jury was read a subjective good faith instruction as to the fraud counts. Id. at 477. However, the Fourth Circuit
held that the district court properly rejected the defendant’s proffered “subjective” good faith instruction as to
the §841 counts. Id. Although the Fourth Circuit found that the defendant’s proffered good faith instruction was
not a correct statement of law, it reversed because the district court instructed the jury that good faith was not a
defense to the §841 counts. If conviction under §841 requires that the government prove that a defendant
intentionally issue a prescription outside the scope of professional practice, there does not seem to be any
rational justification for issuing a materially different good faith instruction than would be required for any other
specific intent offense.
19
An objective “Good Faith” instruction is inconsistent with this Court’s decision in Moore and this court’s
pre-CSA case law. Prior to the enactment of the CSA, the distribution of narcotics was governed by the Harrison
Act, 38 Stat. 785. Under the Harrison Act, distribution of controlled substances by registered medical
professionals was permitted “in the course of his professional practice only.” Linder v. United States, 268 U.S. 5*
13 (1925). In Moore, this Court considered the question of whether a registered medical practitioner was
“exempted from prosecution under s 841 by virtue of his status as a registrant” under the CSA. 423 U.S. at 124.
27The Court found that, were the CSA construed to authorize all prescriptions “thereby exempting them from
other constraints, it would constitute a sharp departure from other laws.” Id. 132-33 (“It is unlikely that Congress
would seek, in this oblique way, to carve out a major new exemption, not found in the Harrison Act...”).
However, the standard as articulated in Moore did not allow for a conviction simply because the doctor
happened to step outside of the usual course of professional practice. The jury in Moore was instructed that the
defendant “could not be convicted if he merely made ‘an honest effort’ to prescribe for detoxification in
compliance with an accepted standard of medical practice.” Id. at 143 n. 20. The defendant testified that he knew
he was acting outside the scope of accepted medical standards. Id. at 144. Nothing in Moore suggested that a
medical professional could be convicted as a drug dealer if he held mistaken beliefs about the practices that most
medical professionals employ.
The fact that doctors charged under the Harrison Act were entitled to a good faith defense was well
established in the Court’s Harrison Act Cases. In Linder, the Court reversed because the indictment failed to
articulate facts that the defendant doctor had any “conscious design to violate the law.” 268 U.S at 17. In Boyd
the “disputed question was whether the defendant issued the prescriptions in good faith.” Boyd v. United States,
271 U.S. 104,105 (1926). The instruction in Boyd read in part: “whether or not the defendant in prescribing
morphine to his patients was honestly seeking to cure them of the morphine habit, while applying his curative
remedies, it is not necessary for the jury to believe that defendant’s treatment would cure the morphine habit, but
it is sufficient if defendant honestly believed his remedy was a cure for this disease.” Id. At 107- 08. Hence, the
need to prove more than a practitioner’s failure to comply with objective standards in the medical field finds its
origin in this Court’s pre-CSA case law and in Moore. Moore, Linder, and Boyd all required knowledge and
provided subjective standards for judging good faith. The Tenth Circuit’s opinion in Kahn is, consequently, 20
inconsistent with this Court’s precedent.” 20-1410 RUAN, XIULU V. UNITED STATES, CERTIORARI
GRANTED
In the Petitioner’s case, the government did not prove that the Petitioner knew the prescriptions
written by licensed medical practitioners were outside the scope of the licensed medical providers’
professional practice and there’s still no reason to believe these prescriptions were not valid. Therefore,
Mens Rea of knowledge was not proven in the Petitioner’s case because it does not exist.
III. REQUIRING THAT THE GOVERNMENT PROVE THAT A PHARMACIST KNOW A GIVEN
PRESCRIPTION IS OUTSIDE THE SCOPE OF PROFESSIONAL PRACTICE IS NECESSARY TO
SAVE MISBRANDING FROM BEING VOID FOR VAGUENESS AS APPLIED TO PHARMACISTS.
[T]he Government violates [the due process] guarantee by taking away someone’s life, liberty, or
property under a criminal law so vague that it fails to give ordinary people fair notice of the conduct it punishes,
or so standardless that it invites arbitrary enforcement.” Johnson v. United States, 135 S.Ct. 2551, 2556 (2015).
“As generally stated, the void-for-vagueness doctrine requires that a penal statute define the criminal offense
with sufficient definiteness that ordinary people can understand what conduct is prohibited, and in a manner
that does not encourage arbitrary and discriminatory enforcement.” Kolender v. Lawson, 461 U.S. 352,
357(1983). The “doctrine guards against arbitrary or discriminatory law enforcement by insisting that a statute
provide standards to govern the actions of police officers, prosecutors, juries, and judges.” Sessions v. Dimaya,
138 S. Ct. 1204,1212 (2018); United States v. U.S. Gypsum Co., 438 U.S. 422,442 (1978) (“criminal sanctions
would be used, not to punish conscious and calculated wrongdoing at odds with statutory proscriptions, but
instead simply to regulate business practices regardless of the intent with which they were undertaken.”).
The Courts of Appeal recognize that the phrase “outside the scope of professional practice” is not
susceptible to precise definition. United States v. Singh, 54 F.3d 1182,1187 (4th Cir.1995); United States v.
August, 984 F.2d 705, 713 (6th Cir.1992) (“There are no specific guidelines concerning what is required to
support a conclusion that an accused acted outside the usual course of professional practice.”). Indeed, juries are
instructed that there is no precise definition.
Additionally, the Courts of Appeal appear to agree that acting outside the “usual course of professional
practice” requires something more than failure to abide by the civil duty of care. Sabean, 885 F.3d 27 (1st);
21
Wexler, 522 F.3d at 206 (2nd); Feingold, 454 F.3d at 1007(9th); United States v. Tran Trong Cuong, 18 F.3d
1132,1137 (4th Cir. 1994); United States v. Stump, 735 F.2d 273, 276 (7th Cir. 1984). On the other hand,
whether a given prescription falls within the usual course of professional practice is dependent upon “whether
the physician prescribes medicine in accordance with a standard of medical practice generally recognized and
accepted in the United States.” United States v. Merrill, 513 F.3d 1293,1306 (11th Cir. 2008). See also,
Feingold, 454 F.3d at 1011 n. 3 (“The term ‘professional practice' implies at least that there exists a reputable
group of people in the medical profession who agree that a given approach to prescribing controlled substances
is consistent with legitimate medical treatment.”); Norris, 780 F.2d at 1209 (5th); Hurwitz, 459 F.3d at 480 (4th);
Vamos, 797 F.2d at 1153 (2nd); Smith, 573 F.3d at 647—48 (8th). While the courts of appeal are emphatic that the
“duty of care” and “practice generally recognized and accepted in the United States” are not the same thing,
none provide a meaningful method of distinguishing between the two. There is general agreement that a
“mistake however, gross” is not sufficient to constitute a breach of generally accepted medical practice. Wexler,
522 F.3d at 206. That statement is facially inconsistent with allowing the conviction of doctors who make
unreasonable but honest mistakes.
The phrase “usual course of medical practice” could be read to mean a violation of state medical
regulations. Alternatively, it could mean deviation from the norms adhered to by most physicians in the field
even where those norms do not conform with medical regulations. See, e.g., Humphreys v. Drug Enft Admin.,
96 F.3d 658, 662 (3d Cir. 1996) (reversing administrative decision to revoke doctor's registration where the
administrator failed to “discuss the one and only defense raised ... that prescribing antidepressants and other such
drugs for a famous patient in the name of another individual in order to preserve the privacy of the patient was,
in fact, the ‘usual course’ of medical practice in circumstances such as these.”). One might expect that a doctor
could turn to CDC or AMA guidelines on the prescription of opioids to determine what constitutes the “usual”
course of professional practice. However, the CDC guidelines on the use of opioids are advisory. Powell D,
Tamara M, Chou, Roger. CDC guideline for prescribing opioids for chronic pain—United States, 2016. JAMA
2016;315:1624—45.1622p.
The “usual course of professional practice” suffers from two different forms of indeterminacy. It is
indeterminate as to how it should be measured because there is no clear way to determine the standard by
22
which “usual course of professional practice” is to be determined. It is also indeterminate as to degree, because it
is not clear how “usual” or by what percentage of physicians a practice must be generally accepted before
deviation becomes criminal. See Johnson, 135 S. Ct. at 2558 (“By combining indeterminacy about how to
measure the risk posed by a crime with indeterminacy about how much risk it takes for the crime to qualify as a
violent felony, the residual clause produces more unpredictability and arbitrariness than the Due Process Clause
tolerates.”).
“It is common ground that this Court, where possible, interprets congressional enactments so as to avoid
raising serious constitutional questions.” Cheek, 498 U.S. at 203; Skilling v. United States, 561 U.S. 358, 408-09
(2010).
This Court has “repeatedly held that ‘mere omission from a criminal enactment of any mention of
criminal intent should not be read as dispensing with it.” Elonis v. United States, 135 S. Ct. 2001, 2008 (2015).
Where an intent element is missing from some aspect of an offense, the Court will read the statute “to include
broadly applicable scienter requirements.” Id. “[Wrongdoing must be conscious to be criminal.’... [T]his
principle is ‘as universal and persistent in mature systems of law as belief in freedom of the human will and a
consequent ability and duty of the normal individual to choose between good and evil.’” Id.
“[A] defendant generally must ‘know the facts that make his conduct fit the definition of the offense,”’
Id. at 2009. See Posters ‘N‘ Things, Ltd. v. United States, 511 U.S. 513 (1994) (Finding the government must
also prove that the defendant “knew that the items at issue [were] likely to be used with illegal drugs.”); Rehaif
v. United States, 139 S. Ct. 2191, 2197 (2019) (“Without knowledge of that status, the defendant may well lack
the intent needed to make his behavior wrongful. His behavior may instead be an innocent mistake to which
criminal sanctions normally do not attach.”)
The fact that makes a medical practitioner’s conduct unlawful is not simply distributing a controlled
substance, but rather distributing a controlled substance outside the scope of professional practice. The Court
includes a “broadly applicable scienter requirement[]” even where the fact that renders a defendant’s conduct
illegal is derived from a CFR. See Liparota v. United States, 471 U.S. 419, 425 (1985) (interpreting a statute
criminalizing “knowingly possess” or “use” food stamps in an unauthorized manner as requiring knowledge that
the use is unauthorized.). Issuing prescriptions outside the scope of professional practice “is the ‘crucial
23
element’ separating innocent from wrongful conduct.” Rehaif, 139 S. Ct. at 2197.” RUAN, XIULU V.
UNITED STATES, CERTIORARI GRANTED
Requiring that the government prove a defendant pharmacist knew she was dispensing licensed
medical providers’ prescriptions “outside the scope of professional practice could save the statute from
fatal vagueness problems and eliminate the circuit splits and uncertainties noted above. ““This Court has
long recognized that the constitutionality of a vague statutory standard is closely related to whether that standard
incorporates a requirement of mens rea.” Colautti v. Franklin, 439 U.S. 379, 395 (1979).
The CDC and FDA guidelines on treating chronic pain are explicitly not mandatory. Removing any
requirement that the government prove that a medical professional is knowingly acting outside the scope of
professional practice subjects a wide range of well-intentioned medical practitioners, who issue prescriptions
that in fact serve a legitimate medical purpose, to the threat of incredible penalties. This Court does not “construe
a criminal statute on the basis that the government will use it reasonably.” McDonnell v. United States, 136 S.
Ct. 2355, 2372-73 (2016). “[A]a statute ... that can linguistically be interpreted to be either a meat axe or a
scalpel should reasonably be taken to be the latter.” Id.” RUAN, XIULU V. UNITED STATES, CERTIORARI
GRANTED
In the Petitioner’s case, the pharmacist uses her professional judgment each and every time she dispenses
a prescription. Prior to the instant charges, which is during the time period covered in the indictment, the
Pennsylvania Board of Pharmacy inspected the pharmacies where Lasher was employed at, they inspected the
same prescriptions that the Government alleged as invalid (2012) BUT the Pennsylvania Board of Pharmacy
found nothing wrong with these prescriptions because there was and remains nothing wrong with these
prescriptions. Removing any requirement that the government prove that a medical professional is knowingly
acting outside the scope of professional practice subjects those same medical professionals to unlawful and
capricious prosecution.
IV. THE PRESENT ISSUE IS OF SIGNIFICANT NATIONAL IMPORTANCE .
The absence of any clear mechanism for determining whether a given prescription falls inside or outside
of generally recognized medical practice has led to a fear of prosecution and an increasing number of doctors
AND PHARMACISTS withholding medication from patients suffering from chronic pain or even acute
24
illness. Kelly K. Dineen, Addressing Prescription Opioid Abuse Concerns in Context: Synchronizing Policy
Solutions to Multiple Complex Public Health Problems, 40 Law & Psychol. Rev. 1, 51 33(2016); Amy J.
Dilcher, Damned If They Do, Damned If They Don't: The Need for a Comprehensive Public Policy to Address
the Inadequate Management of Pain, 13 ANNALSHEALTH L. 81, 85 (2004). MM. Reidenberg & O. Willis,
Prosecution of Physicians for Prescribing Opioids to Patients, 81 CLINICAL PHARMACOLOGY &
THERAPEUTICS 903, 903 (2007) (fear of prosecution resulting in reduced opioid prescriptions).
It is the fact that an ordinary pharmacist cannot “understand what conduct is prohibited” by
MISBRANDING that has led to this chilling effect. ““Vague laws threaten to transfer legislative power to police
and prosecutors, leaving to them the job of shaping a vague statute's contours through their enforcement
decisions.” Sessions v. Dimaya, 138 S. Ct. 1204,1227-28 (2018); See also, Grayned v. City of Rockford, 408
U.S. 104,108-109 (1972) (“A vague law impermissibly delegates basic policy matters to policemen, judges, and
juries for resolution on an ad hoc and subjective basis”). One recent study found that of 452 responding
clinics in nine states, 43% indicated that they would not prescribe opioids to new patients. Lagisetty, Pooja, et
al., “Assessing reasons for decreased primary care access for individuals on prescribed opioids,” PAIN . 2021
May; Vol 162. Issue 5. p 1379-1386 (Available at, D01:10.1097/j.pain.0000000000002145 (last visited,
July 22, 2021)). If family practitioners are no longer willing to prescribe opioids to new patients out of fear of
prosecution, than in one sense, doing so is outside what doctors generally do, and perhaps outside the usual
course of professional practice. That does not, however, mean that the prescriptions are being withheld because
of medical decision making or the doctor’s best medical judgment.
Press reports in recent years document numerable instances, if anecdotal, of patients in desperate need of
legitimate pain medication who are unable to find a doctor willing to prescribe to them or who are abruptly cut
off from needed medication. McCoy & Mount, Unintended Consequences: Inside the fallout of America’s
crackdown on opioids, THE WASHINGTON POST (May 31, 2018),
https://www.washingtonpost.com/graphics/2018/local/impact-of-americas-opioid-crackdown/; Rider, Travis,
What Chronic-Pain Patients Are Deeply Afraid Of, THE N EW YORK TIMES (Oct. 31, 2019),
https://www.nytimes.com/2019/10/31/opinion/opioid-crisis-addiction.html: Goodnough & Hoffman, Good 25
News: Opioid Prescribing Fell. The Bad? Pain Patients Suffer, Doctors Say, THE NEW YORK TIMES (March
6, 2019), https://www.nytimes.com/2019/03/06/health/opioids-pain-cdc-guidelines.html?smid=nytcoreios-share; O’Donnell & Alltucker, Pain patients left in anguish by doctors 'terrified' of opioid addiction, despite
CDC change, USAT ODAY (June 24, 2019),
https://www.usatoday.com/story/news/health/2019/06/24/pain-patients-left-anguish-doctorswho-fear-opioid-addiction/1379636001/; Fuqua, Anne, The other opioid crisis: pain patients who can’t access
the medicine we need, T HE W ASHINGTON P OST (March 9, 2018),
https://www.washingtonpost.com/outlook/the-other-opioid-crisis-pain-patients-who-cant-accessthe-medicine-they-need/2018/03/09/5ad83b24-2301-lle8-badd-7c9f29a55815_story.html.” RUAN, XIULU V.
UNITED STATES, CERTIORARI GRANTED
In the Petitioner’s case, the Second Circuit has effectively allowed pharmacists to be convicted of a
criminal offense for dispensing prescriptions that (1) a pharmacist may honestly believe are helping a patient and
(2) are actually helping the patient. Therefore, requiring the government to prove both that a practitioner
intentionally issued a prescription not for a legitimate medical purpose and outside the usual course of medical
practice would help to prevent that result.
V. Not only that the decision of the Appellate Court is erroneous, but the national importance of
having the Supreme Court decide the issue to resolve the existence of multiple conflicts between the
decision of which review is sought and a decision of the second appellate court on the same issue.
In this case, the decision of the court that decided the Petitioner’s case is in conflict with the decisions of
the Supreme Court, Arsean Lamone HICKS v. Director, DEPARTMENT OF CORRECTIONS. Record No.
131945. Decided: February 26, 2015
The Appellate Court denied the Plaintiff’s October 8, 2018 motion for a certificate of appealability based
on newly-discovered-evidence motion for a new trial, challenging the denial of a newly-discovered-evidence
motion for a new trial after the May 15, 2015 verdict. However, the suppressed exculpatory video recordings
were NOT turned over to the Plaintiff until July 24, 2018, which was more than 3 years after the Plaintiff's
verdict. Therefore, it is IMPOSSIBLE for “such motions be made within three years after verdict”.
26
'lirousJ be stressedjfhat the prosecutors referenced diese video recordings as if they were in evidence atl
trial, while knowing the^video evidence was exculpatory. Their suppression of it, and their.tampering with"the!
evidence, also showlhat they knowingly presented false evidence to itiejuryj
Judge Buchwald denied the Plaintiff’s request for a new trial based on newly discovered evidence as
“untimely”. She chose to ignore the Supreme Court’s recent ruling of Arsean Lamone HICKS v. Director,
DEPARTMENT OF CORRECTIONS. Record No. 131945. Decided: February 26, 2015 in that “the statute of
limitations for habeas claims must be tolled while such evidence is suppressed.” The Appellate Court
should grant the Plaintiff a new trial based on the Supreme Court’s recent ruling of Arsean Lamone HICKS
v. Director, DEPARTMENT OF CORRECTIONS. Record No. 131945. Decided: February 26, 2015, and based
on the fact the newly discovered evidence were not turned over to the Plaintiff until July 24, 2018, more than 3
years after the Plaintiff’s verdict; thus the Plaintiff is not capable nor able to file within the 3 years statute of
limitation. Therefore, the Plaintiff is seeking to toll the statute.
The exculpatory video recordings are superior to testimony about the Plaintiffs actions and superior to
the Prosecutions own references to these video recordings that they suppressed from evidence while
simultaneously referred to them at trial. The matter at hand is the actions taken by the Plaintiff on all the dates
the alleged crimes took place and on other dates the Plaintiff was working. The video evidence is superior so
thoroughly and completely that no jury could convict the Plaintiff because it shows exactly what the Plaintiff
was doing both on dates where she is accused of committing crimes and her conduct at work in general, whereas
the testimony about her actions and how she conducted herself in her profession are subject to individual biases.
In this case the video evidence shows none of what Prosecutors or its witnesses claim on the dates cited in the
indictment. It directly refutes testimony and the prosecutors description of the video evidence spoken to, but not
shown to, the jury. The video recordings show she was not present on the alleged days of the criminal
activity (6/1/2012, 6/12/2012, 7/16/2012, 7/17/2012, 8/13/2012, 8/16/2012, 8/27/2012, and 10/2/2012 (See Exh
O), and the lack of her presence on October 2, 2012 when opiods was dispensed to allegedly "unkempt"
individuals. The factors present in Plaintiffs case requires the accused to be present at the pharmacy at the time
the drug was shipped on the dates referenced. The Government has a copy of the work schedule from the
Hellertown Pharmacy (HP) and Palmer Pharmacy & Much More (PP) showing the Plaintiff was not at work 27
during the dates and times of the shipments referenced. First, the governing law (PA 27.12(b)(2) and the criminal
statute 21 U.S.C. Sec. 321 (g)(1), 352(a), 352(c), 353(b)(1), 353(b)(4)(A), 21 U.S.C. Sec. 331(a) and 333 (a)(2)
REQUIRE the accused to be present at the pharmacy at the time the specific prescriptions in question were
filled. Also, the governing pharmacy law protects a pharmacist from being held liable for another's actions.
Numerous pharmaceutical law and protocol support the Plaintiffs testimony while impeaching the testimony of
Prosecution witnesses and one of the main contentions of the prosecution's case. The lack of ability to present
that critical video evidence, while the government asserted the knowledge of it's existence further undermined
the truth and advanced the perjured testimony. See Demarco v United States 928 F.2d 1074 (11th cir. 1991). The
failure for the prosecution to correct perjured testimony is ground for the reversal of conviction.
In its February 2015 opinion, the court held that inmates like Hicks must be able to raise their claims.
Senior Supreme Court Justice Elizabeth B. Lacy, writing for the court, said that that the statute of limitations for
habeas claims must be tolled while such evidence is suppressed. To "toll" suspends existing statutes of
limitation. The court agreed with the clinic's argument that tolling is required by a Virginia law that creates a
remedy against obstructions that prevent legal actions from being filed.
Therefore, the Plaintiff is seeking to toll the statute.
CONCLUSION
The Plaintiff, Lena Lasher, sincerely believes that she can justifiably rely on the US Supreme Court case
Haines v. Kerner 404 U.S. 519 (1972), which clearly states that "all Pro-Se litigants must be afforded the
opportunity to present their evidence and that the Court should look to the substance of the" appeal "rather than
the form."
For the foregoing reasons, Petitioner respectfully prays that the Court will grant her Petition for
Certiorari.
Respectfully Submitted,
November 12, 2021
Is/ Lena Lasher
Lena Lasher, Pro se, 16 Patton Street, High Bridge, NJ 08829
908-447-4484
as
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.