CRIMINAL PROSECUTIONS: PATIENT SAFETY Partnership for Safe Medicines Interchange 2014 September 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. Marks Senior Litigation Counsel Consumer Protection Branch U.S. Department of Justice [email protected]Views offered in this presentation are my own views, and not necessarily views of the Department of Justice.
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.
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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.
• Lindsay Kelly, AUSA, Eastern District of Virginia
• Jaime Peña, AUSA, District of Colorado
UPDATE FROM LAST YEAR
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”
FROM TURKEY TO MISSOURI (EDMO)
• Blast Faxes to Target Doctors: lower costs (40-60% typical)
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
FROM TURKEY TO MISSOURI (EDMO)
2014• TURKISH SUPPLIERS TO TAYLOR: OZKAN
SEMIZOGLU/SABAHADDIN AKMAN (OZAY PHARMACEUTICAL)
• BOTH DEFENDANTS PLED GUILTY AND AWAIT SENTENCING
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)
U.S. v. SANDHU (EDMO)
AND KSANDHU INDICTED 10/14 • OPERATED “ONLINEBOTOX.COM”• SOLD BOTOX & JUVEDERM• SISTERS KAMALDEEP AND NAVDEEP SANDHU INDICTED: