PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
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Transcript of PSM Interchange 2014 Panel 2: Linda Marks, Criminal Prosecutions: Patient Safety
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CRIMINAL PROSECUTIONS:PATIENT SAFETY
Partnership for Safe Medicines Interchange 2014September 18, 2014
Newseum, Washington, D.C.
Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.
Moderator: Linda I. MarksSenior Litigation Counsel
Consumer Protection BranchU.S. Department of Justice
[email protected] offered in this presentation are my own views, and not necessarily views of the Department of Justice.
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PANELISTS
• Lindsay Kelly, AUSA, Eastern District of Virginia
• Jaime Peña, AUSA, District of Colorado
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UPDATE FROM LAST YEAR
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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”
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FROM TURKEY TO MISSOURI (EDMO)
• Blast Faxes to Target Doctors: lower costs (40-60% typical)
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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
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FROM TURKEY TO MISSOURI (EDMO)
2014• TURKISH SUPPLIERS TO TAYLOR: OZKAN
SEMIZOGLU/SABAHADDIN AKMAN (OZAY PHARMACEUTICAL)
• BOTH DEFENDANTS PLED GUILTY AND AWAIT SENTENCING
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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)
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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 ADULTERATED & MISBRANDED DRUGS, OBSTRUCTION
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Botox – 30% Less than US Price
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GALLANT PHARMA, EDVA
March 2013
• 10 INDIVIDUALS & 1 CORP. INDICTED FOR CONSPIRACY, SMUGGLING, INTRODUCING MISBRANDED DRUGS, WIRE FRAUD, UNLICENSED WHOLESALING
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GALLANT PHARMA, EDVA
• CANCER & INJECTABLE COSMETIC DRUGS• UNLICENSED WHOLESALER• UNAPPROVED DRUGS IMPORTED FROM TURKEY,
INDIA, SWITZERLAND, UAE
REPACKAGERS IN U.K. & CANADA
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GALLANT PHARMA, EDVA
• 13 DEFENDANTS: COMPANY OWNERS, SALES REPS, OPERATORS; SUPPLIERS; PHYSICIAN & OFFICE MANAGER
• 11 CONVICTIONS (& 2 FUGITIVES)!• REPACKAGERS IN U.K. & CANADA
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GALLANT PHARMA, EDVA
ENNNNNNNNNNNNNEXT:
U.S. v. JAMES EDWARD QUINN, WORLD MEDICAL LTD, & ATLANTIC PHARMACEUTICALS AG-- UK REPACKAGERS/SHIPPERS-- CHEMO & COSMETIC DRUGS, IUDs
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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
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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
REPACKAGERS IN U.K. & CANADA
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MEDICAL DEVICES: SPECTRANETICS, D. COLO.
• UCENSED WHOLESALER• SCHULTE CONVICTED OF MAKING FALSE
STATEMENTS TO FDA• JANUARY 2014: 10TH CIR. UPHELD
CONVICTIONREPACKAGERS IN U.K. & CANADA
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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)
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Q & A TIME (then lunch . . . )