Linda I. Marks, Senior Litigation Counsel, Consumer Protection Branch, U.S. Department of Justice speaks around criminal prosecutions of drug counterfeiters and diverters in the US.

1. CRIMINAL PROSECUTIONS:
PATIENT SAFETY
Partnership for Safe Medicines Interchange 2014
September 18, 2014
Newseum, Washington, D.C.
Moderator: Linda I. Marks
Senior Litigation Counsel
Consumer Protection Branch
U.S. Department of Justice
linda.marks@usdoj.gov
Views offered in this presentation are my own views, and not necessarily views of the
Department of Justice.
Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.

2. PANELISTS
• Lindsay Kelly, AUSA, Eastern District of Virginia
• Jaime Peña, AUSA, District of Colorado

3. UPDATE FROM LAST YEAR

4. FROM TURKEY TO MISSOURI (EDMO)
2012
• MISSOURI ONCOLOGIST: DR. ABID NISAR
• CALIFORNIA WHOLESALERS: JAMES
NEWCOMB/SANDRA BEHE (BDMI)
• PACKAGE TO NISAR INCLUDED COLD CHAIN
“GOOEY MESS”

5. FROM TURKEY TO MISSOURI (EDMO)
• Blast Faxes to Target Doctors: lower costs (40-
60% typical)

6. FROM TURKEY TO MISSOURI (EDMO)
2013
• BRITISH WHOLESALER: RICHARD TAYLOR
(RICHARD’S PHARMA LTD.)
• “UNFORTUNATE EXPERIENCE” & “IMMEDIATE
BAD REACTIONS” WHERE PATIENT “STARTED TO
SHAKE”
• ALTUZAN WAS A “HIGH RISK PLAY” WITH
TURKISH LABELING

7. FROM TURKEY TO MISSOURI (EDMO)
2014
• TURKISH SUPPLIERS TO TAYLOR: OZKAN
SEMIZOGLU/SABAHADDIN AKMAN (OZAY
PHARMACEUTICAL)
• BOTH DEFENDANTS PLED GUILTY AND AWAIT
SENTENCING

8. FROM TURKEY TO MISSOURI (EDMO) . . .
and beyond
Other physicians prosecuted:
-- Isabella Martire (PG; motion to withdraw FDCA
misd guilty plea pending)
-- Joel Bernstein (PG; FDCA misd - unapproved
Mabthera)
-- Joel Bernstein, Inc. (PG; health care fraud;
bought $3.4 million oncology drugs)

10. U.S. v. SANDHU (EDMO)
AND KSANDHU INDICTED 10/14
• OPERATED “ONLINEBOTOX.COM”
• SOLD BOTOX & JUVEDERM
• SISTERS KAMALDEEP AND NAVDEEP SANDHU
INDICTED: CONSPIRACY, SMUGGLING, FDCA
ADULTERATED DRUGS, OBSTRUCTION
CHARGES INCLUDE CONSPIRACY,
SMUGGLING, INTRODUCING

11. Botox – 30% Less than US Price

12. GALLANT PHARMA, EDVA
March 2013
• 10 INDIVIDUALS & 1 CORP. INDICTED FOR
CONSPIRACY, SMUGGLING, INTRODUCING
MISBRANDED DRUGS, WIRE FRAUD,
UNLICENSED WHOLESALING

13. GALLANT PHARMA, EDVA
• CANCER & INJECTABLE COSMETIC DRUGS
• UNLICENSED WHOLESALER
• UNAPPROVED DRUGS IMPORTED FROM
TURKEY, INDIA, SWITZERLAND, UAE
REPACKAGERS IN U.K. & CANADA

14. GALLANT PHARMA, EDVA
• 13 DEFENDANTS: COMPANY OWNERS, SALES
REPS, OPERATORS; SUPPLIERS; PHYSICIAN &
OFFICE MANAGER
• 11 CONVICTIONS (& 2 FUGITIVES)!
• REPACKAGERS IN U.K. & CANADA

15. GALLANT PHARMA, EDVA
ENNNNNNNNNNNNNEXT:
U.S. v. JAMES EDWARD QUINN, WORLD
MEDICAL LTD, & ATLANTIC PHARMACEUTICALS
AG
-- UK REPACKAGERS/SHIPPERS
-- CHEMO & COSMETIC DRUGS, IUDs

16. HOSPITAL DRUG DIVERSION:
D. COLO.
• U.S. v. KRISTEN PARKER – SCRUB TECH;
STOLEN FENTANYL SYRINGES; HEP-C
• U.S. v. ASHTON DAIGLE – RN; FENTANYL
SYRINGES REPLACED WITH TAP WATER OR
SALINE SOLUTION
• UNLICENSED WHOLESALER

17. MEDICAL DEVICES:
SPECTRANETICS, D. COLO.
E WHOLESALER
• U.S. v. GEORGE JOHN SCHULTE (CEO)
• MEDICAL LASERS -- LEAD WIRES APPROVED
FOR SPECIFIC TYPES OF OCCLUSIONS
• UNAPPROVED GUIDEWIRES, CATHETER
BALLOONS, LASERS, & STENTS USED IN
SURGERIES

18. MEDICAL DEVICES:
SPECTRANETICS, D. COLO.
• UCENSED WHOLESALER
• SCHULTE CONVICTED OF MAKING FALSE
STATEMENTS TO FDA
• JANUARY 2014: 10TH CIR. UPHELD
CONVICTION
REPACKAGERS IN U.K. & CANADA

19. U.S. v. VAUGHAN CIPPERLY,
D. COLO.
• PHYSICIAN PURCHASED CHEMO DRUGS
FROM QUALITY SPECIALTY PRODUCTS (QSP),
CANADA
• UNAPPROVED, FOREIGN-MADE
• PLED GUILTY TO CONSPIRACY TO INTRODUCE
UNAPPROVED DRUGS; FORFEITED $500,000
• EPACKAGERS IN U.K. & CANADA)

20. Q & A TIME (then lunch . . . )