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

linda.marks@usdoj.govViews offered in this presentation are my own views, and not necessarily views of the Department of Justice.

PANELISTS

• 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:

CONSPIRACY, SMUGGLING, FDCA ADULTERATED DRUGS, OBSTRUCTION

CHARGES INCLUDE CONSPIRACY, SMUGGLING, INTRODUCING ADULTERATED & MISBRANDED DRUGS, OBSTRUCTION

Botox – 30% Less than US Price

GALLANT PHARMA, EDVA

March 2013

• 10 INDIVIDUALS & 1 CORP. INDICTED FOR CONSPIRACY, SMUGGLING, INTRODUCING MISBRANDED DRUGS, WIRE FRAUD, UNLICENSED WHOLESALING

GALLANT PHARMA, EDVA

• CANCER & INJECTABLE COSMETIC DRUGS• UNLICENSED WHOLESALER• UNAPPROVED DRUGS IMPORTED FROM TURKEY,

INDIA, SWITZERLAND, UAE

REPACKAGERS IN U.K. & CANADA

GALLANT PHARMA, EDVA

• 13 DEFENDANTS: COMPANY OWNERS, SALES REPS, OPERATORS; SUPPLIERS; PHYSICIAN & OFFICE MANAGER

• 11 CONVICTIONS (& 2 FUGITIVES)!• REPACKAGERS IN U.K. & CANADA

GALLANT PHARMA, EDVA

ENNNNNNNNNNNNNEXT:

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

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

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

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

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)

Q & A TIME (then lunch . . . )