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en, LOS ANGELES COUNTY DISTRICT ATTORNEY’S OFFICE
BUREAU OF FRAUD AND CORRUPTION PROSECUTIONS
MAJOR FRAUD DIVISION
y
“or tos STEVE COOLEY « District Attorney JANICE L. MAURIZI « Director
JOHN K. SPILLANE © Chief Deputy District Attorney
CURTIS A. HAZELL « Assistant District Attomey
O7-l- Bse3-97
Fug In Office Sep~26-2007
Barry Laux HY 17:03:85
we . 2667-41336
Cobb County District Attorney’s Office Page £ 18-cy
10 E. Park Square, 5" Floor .
Marietta, GA 30090-9618 C
C. Stephenson
Clerk of 2
September 19, 2007 9 aperior Court Cobb County
People v. Kenneth Green BA311682
Dear Mr. Laux:
Thank you so much for your help over the phone. | am always so grateful when |
receive assistance from DA’s and law enforcement in other jurisdictions.
| have enclosed three conformed copies of the Petitions to Compel that were filed
today in the Los Angeles Superior Court. The last document is merely a proposed
order for your court to follow if it wishes. In my experience, courts prefer to use
their own forms, but it is there just in case.
As | said, our witness coordinators are always available to schedule transportation
and hotel accommodations. As you might imagine, we do it quite often.
Eugene Hafrahan
Deputy District Attorney
{cel) 323.646.0376
ehanrahan@lacounty.gov
201 North Figueroa Street
Sixteenth Floor
Los Angeles, CA 90012
(213) 580-320010
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STEVE COOLEY CONFO
District Attorney OF ORIGIN, \
EUGENE P. HANRAHAN Los Angeles Super tGe
Deputy District Attorne ourt
201 N. Figueroa St., 16 Floor SEP 19 2007
Los Angeles, CA 90012
(213) 580-3227 JOnNA,Clarke, Execuyve OHicer/Clery
Attorneys for Plaintiff oT [ee
SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES
People of the State of Case No.: BA311682
California,
EX PARTE UNDER SEAL
os PETITION FOR ATTENDANCE OF OUT
Plaintiff, OF STATE WITNESS DEBRA B.
CORTNER
vs.
DATE: September 197, 2007
Kenneth Green,
TRIAL DATE: October 10, 2007
TESTIMONY DATE: October 12, 2007
Defendant.
TIME: 8:30 a.m.
COURT: Dept. 100
COMES NOW, the People of the State of California, through
their attorneys, Steve Cooley, District Attorney, and Eugene
Hanrahan, Deputy District Attorney, to file their petition for
the attendance of out-of-state witness DEBRA B. CORTNER, Solvay
Pharmaceuticals, 901 Sawyer Road, Marietta, GA 30062, (Office
Phone 770.578.2004) which is based on the files and records of
this case.
Petition to Compel Out-of-State Witness - 1
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TO: THE HONORABLE JUDGE OF THE SUPERIOR COURT FOR LOS ANGELES
COUNTY, STATE OF CALIFORNIA:
Eugene Hanrahan, Deputy District Attorney of Los Angeles County,
California, certifies as follows under the Uniform Act to Secure
the Attendance of Witnesses from Without the State in Criminal
Cases, Penal Code section 1334 et seq.:
1. There is now pending in this court the above-entitied
prosecution by the State of California against KENNETH GREEN,
who is charged with having committed the following offenses
against the laws of California: 1) counterfeiting Pfizer's
trademark [Penal Code section 302(a)]; 2) counterfeiting Solvay
Pharmaceuticals’ trademark [Penal Code section 302(a], 3)
possession for sale of anabolic steroids [Penal Code section
11378], and 4) manufacturing anabolic steroids [(Penal Code
section 11379.6(a)]. See, Attached Information, Exh. 1.
2. To prove that the defendant counterfeited Solvay
Pharmaceuticals’ trademarks for Anadrol and Unimed, the People
require a representative from Solvay Pharmaceuticals to testify
that Kenneth Green lacked permission to manufacture or possess
Anadrol tablets stamped “UNIMED” and “86 33”, and that the
tablets seized from Mr. Green and his accomplice’s possession
were counterfeit.
Petition to Compel Out-of-State Witness - 2
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3. DEBRA B. CORTNER is a material and necessary witness to this
case without whose testimony the People can not establish the
element that Kenneth Green lacked permission to manufacture or
possess Solvay Pharmaceutical’s trademarks.
4. DEBRA B. CORTNER is listed as the contact person and Quality
Compliance Manager on a memo dated September 21, 2004 that
apparently alerted the United States Food and Drug
Administration to the seizure of counterfeit Anadrol tablets.
See, Attached Memorandum, Exh. 2.
5. DEBRA B. CORTNER informed Dan Hancz of the Los Angeles
County Department of Health that a sample of Anadrol tablets
seized by the Los Angeles County Sheriff's Department and
forwarded to Solvay Pharmaceuticals was counterfeit.
6. On January 6, 2004, DEBRA B. CORTNER informed Dan Hancz by
e-mail that she would be preparing the Field Alert Report for
the Food & Drug Administration for counterfeit Anadrol lot
06785B which corresponds to the Anadrol seized by the Sheriff's
Department .
7. The case is currently set for trial-setting and 995 motions
on October 1, 2007. The last day for the trial is October 10,
2007. The testimony of DEBRA B. CORTNER is therefore
anticipated on October 12, 2007.
Petition to Compel Out-of-State Witness - 3
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8. The State of California shall pay DEBRA B. CORTNER witness
fees, travel expenses, a per diem, and any reasonable and
necessary additional expenses ordered by the court per Penal
Code 1334.2.
9. If DEBRA B. CORTNER as a witness, comes into the State of
California in obedience to a summons directing her to attend and
testify at this proceeding, the laws of the State of California
and of any other state through which she may be required to pass
by the ordinary course of travel to attend the trial shall give
her protection from the arrest of the service of process, civil
or criminal, in connection with matters which arose before her
entrance into that state, pursuant to such summons. PC section
1334.4.
10. DEBRA B. CORTNER has been cooperative towards the People’s
investigation and helpful in explaining the attached memorandum.
11. The People shall make every effort to minimize the
inconvenience of the travel and testimony of DEBRA B. CORTNER in
the arrangement of her transportation and hotel reservations.
12. On September 17, 2007, Matt Owens, Counsel for Solvay
Pharmaceuticals, wrote the attached e-mail to the People
advising that DEBRA B. CORTNER “will not be testifying in the
case” and requesting that the People “cease all contact with her
Petition to Compe] Out-of-State Witness - 4
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and all other Solvay employees” because Anadrol is no longer one
of Solvay Pharmaceuticals’ drugs. See, Attached e-mail, Exh. 3.
13. This advisory and request has made it impossible to obtain
DEBRA B. CORTNER’s testimony by any other means.
14. As part of the investigation,.the Los Angeles County
Sheriff's Department sent seized Anadrol labels, tablets, and
UNIMED die stamps to Solvay Pharmaceuticals. DEBRA B. CORTNER
e-mailed to Dan Hancz that the tablets were stored in Solvay
Pharmaceutical’s DEA-approved vault. The People also request
the return of all evidence to the Los Angeles County Sheriff's
Department, Major Crimes Bureau-HALT, 313 N. Figueroa St., Rm
803, Los Angeles, CA 90012 forthwith.
WHEREFORE, it is requested that this court certify by the
issuance of a certificate under the seal of the Superior Court
of Los Angeles County, State of California, for the purpose of
being presented to a judge of a court of record in the State of
Georgia, in a proceeding to compel the attendance of DEBRA B.
CORTNER as a witness in and for the State of California.
2
7. (E07 Respectfully Submitted,
Date
EUGENE HANRAHAN
Deputy District Attorney
Petition to Compel Out-of-State Witness - 5
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STEVE COOLEY
District Attorney
EUGENE P. HANRAHAN
Deputy District Attorney
California State Bar No. 185826
201 N. Figueroa St., 16" Floor
Los Angeles, CA 90012
(213) 580-3227
Attorneys for Plaintiff
SUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES
People of the State of Case No.: BA311682
California, EX PARTE UNDER SEAL
CERTIFICATE OF JUDGE OF
REQUESTING STATE OF CALIFORNIA
FOR ATTENDANCE OF OUT-OF-STATE
WITNESS DEBRA B. CORTNER
Plaintiff,
vs.
Kenneth Green, DATE: September 19, 2003
COURT DATE: October 10, 2007
TESTIMONY DATE: October 12, 2007
Defendant.
TIME: 8:30 a.m.
COURT: Dept. 100
TO THE HONORABLE JUDGE OF THE COURT OF GEORGIA:
I, a , hh , Judge of the Superior
Court for Los Angeles County, California, a court of record,
certify:
1. That there is now pending in the court the above-entitled
prosecution; that Eugene Hanrahan, Deputy District Attorney, has
made a request for attendance of DEBRA B. CORTNER, an out-of-
Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 1
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state witness, to appear and testify in said cause; that the
court finds that the testimony of the requested witness, DEBRA
B. CORTNER, is material, and that the attendance of said witness
is necessary at this proceeding in the Superior Court for the
State of California, Los Angeles County, Criminal Courts
Building, 210 W. Temple St., Los Angeles, CA 90012 at 8:30 a.m.
on October 12, 2007, for the purpose of giving testimony.
2. That a true copy of said request for attendance of out-of-
state witness is attached and its terms incorporated for all
purposes.
3. That pursuant to California’s adoption of the Uniform Act to
Secure the Attendance of Witnesses from Without the State in
Criminal Cases, Penal Code section 1334 et seq., upon
presentation of this certificate to a judge of a court of record
in Cobb County, Geogia, this court respectfully requests that a
time and place for a hearing shall be fixed by the judge in
GEORGIA who shall make an order directing the witness to appear
at the hearing to determine that the witness is material and
necessary and will not cause undue hardship to the witness to be
compelled to attend and testify in the prosecution in this case
in Los Angeles, California. Id.
6.That if DEBRA B. CORTNER as such witness, comes into the State
of California in obedience to a summons directing her to attend
Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 2
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and testify at said proceeding, the laws of the State of
California and of any other state through which said witness may
be required to pass by the ordinary course of travel to attend
said proceeding, shall give her protection from arrest or the
service of process, civil or criminal, in connection with
matters which arose before her entrance into this state pursuant
to said summons. Id.
7. That DEBRA B. CORTNER shall be provided travel expenses, a
per diem, and any other reasonable additional costs. Id.
8. That the court in Georgia issue a subpoena, with a copy of
this certificate attached ordering DEBRA B. CORTNER to attend
and testify in the Los Angeles County Superior Court, Dept. 100,
Criminal Courts Building, 210 W. Temple St., Los Angeles, CA
90012 at 8:30 am.
9. That in any of these hearing, this certificate shall be
prima facie evidence of all the facts stated therein. Id.
//
//
Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 3
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10. That DEBRA B. CORTNER, or any representative from Solvay
Pharmaceuticals, return any evidence relating to this case that
was provided to them by the Los Angeles County Sheriff's
Department, including UNIMED die stamps, counterfeit Anadrol
labels, and counterfeit Anadrol tablets.
iilt2 thes Tseove
Date Honorable Judge of the
5 Superior Court, Los Angeles
County, California
Certificate of Califoria State Court Requesting Attendance of Out of State Witness~ 4
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IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
IN AND FOR THE COUNTY OF LOS ANGELES
STATE OF CALIFORNIA )
COUNTY OF LOS ANGELES ) SS. CERTIFICATE
I, the undersigned, Judge of the Superior Court of the
State of California in and for the County of Los Angeles, do
hereby certify that the said Superior Court is a Court of Record
having a Clerk and Seal; that said Clerk who has signed the
attached Attestation is the duly appointed, qualified Courtroom
Clerk of a Superior Court Department of the State of California,
in and for the County of Los Angeles, and was so qualified at
the time of the signing of said Attestation; that the Clerk is
the legal custodian of said Seal; that said signature is the
Clerk’s genuine handwriting; and that all of the Clerk’s
official acts as said Clerk are entitled to full faith and
credit; and I further certify that said attestation is in due
form of law.
WITNESS MY HAND this date MG a .
Hevtcce
Honorable Judge of the Superior Court
County of Los Angeles
State of California
Judge's Certificate re: Clerk - 1
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IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA
IN AND FOR THE COUNTY OF LOS ANGELES
I, the undersigned, Clerk of the SUPERIOR COURT FOR THE
STATE OF CALIFORNIA, certify that h phen It Marr 8 ’
by whom the foregoing certificate was made and whose genuine
signature is subscribed, was, at the time of signing the same,
and still is, Judge of the Superior Court of the State of
California, in and for the County of Los Angeles, duly
commissioned, qualified, and sworn, and to whose acts of such
full faith and credit are due.
In witness thereof, I have set my hand and affixed the Seal
of this Court. /
Date CLERK’ OF THE SUPERIOR COURT
COUNTY OF LOS ANGELES
STATE OF CALIFORNIA
Clerk's Cerificate re: Judge - 1
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COURT OF THE STATE OF GEORGIA
COBB COUNTY
IN THE MATTER OF
DEBRA B. CORTNER
Solvay Pharmaceuticals
901 Sawyer Rd.
Marietta, GA 30062
PROPOSED SUMMONS TO TESTIFY
IN OUT-OF-STATE
CRIMINAL PROCEEDING
In the matter of proceedings to compel the attendance of
DEBRA B. CORTNER at a criminal proceeding in the State of
California, to wit, JURY TRIAL, in the case of People vs.
KENNETH GREEN, case number BA311682.
TO ANY SHERIFF, CONSTABLE, OR OTHER LAW ENFORCEMENT
OFFICIAL AUTHORIZED TO SERVE CRIMINAL SUMMONS IN THE STATE OF
GEORGIA, COBB COUNTY:
The matter of the issuance of a summons requiring DEBRA B.
CORTNER to attend as a witness on request of the State of
California before the Los Angeles County Superior Court on
October 12, 2007 having come to be heard on this date
, it is found as follows:
1. That there is now pending in the Los Angeles County Superior
Court the above-entitled prosecution; that Eugene Hanrahan,
Deputy District Attorney, has made a request for attendance of
DEBRA B. CORTNER, an out-of-state witness, to appear and testify
in said cause; that the court finds that the testimony of the
Proposed Summons - 1
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requested witness, DEBRA B. CORTNER, is material, and that the
attendance of said witness is necessary at this proceeding in
the Superior Court for the State of California, Los Angeles
County, Criminal Courts Building, 210 W. Temple St., Los
Angeles, CA 90012 at 8:30 a.m. on October 12, 2007, for the
purpose of giving testimony.
2. That a true copy of said request for attendance of out-of-
state witness is attached and its terms incorporated for all
purposes.
3. That if DEBRA B. CORTNER as such witness, comes into the
State of California in obedience to a summons directing her to
attend and testify at said proceeding, the laws of the State cf
California and of any other state through which said witness may
be required to pass by the ordinary course of travel to attend
said proceeding, shall give her protection from arrest or the
service of process, civil or criminal, in connection with
matters which arose before her entrance into this state pursuant
to said summons.
7. That DEBRA B. CORTNER shall be provided travel expenses, a
TT
per diem, and any other reasonable additional costs.
8. That in any of these hearing, this certificate shall be
prima facie evidence of all the facts stated therein.
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1. DEBRA B. CORTNER be summoned and commanded to appear
IT IS HEREBY ORDERED THAT -
before the Los Angeles Superior Court at the Los Angeles
County courthouse, Criminal Courts Building, 210 W. Temple
St., Court 100, Los Angeles, CA 90012 on October 12, 2007,
at 8:30 a.m.and there to testify and to speak the truth in
the criminal proceedings.
DEBRA B. CORTNER, or any representative of Solvay
Pharmaceuticals, immediately send any evidence in their
possession received from the Los Angeles County Sheriff's
Department relating to the prosecution of Kenneth Green
including counterfeit Anadrol labels, UNIMED die stamps,
and counterfeit Anadrol tablets to the Los Angeles County
Sheriff's Department, Major Crimes Bureau - HALT, 313
Figueroa St., Rm 803, Los Angeles, CA 90012.
Witness, the Honorable Judge of this Court this date
The Honorable Judge of the State of Georgia
Proposed Summons - 3
st a4 age Hat
Aa-@tseetSUPERIOR COURT OF THE STATE OF CALIFORNIA
FOR THE COUNTY OF LOS ANGELES
THE PEOPLE OF THE STATE OF CALIFORNIA, | CASE NO. BA311682
Plaintiff,
v.
01 KENNETH GREEN (12/29/1946) INFORMATION
Defendant, | Arraignment Hearing
Date: 06/15/2007
Department: CEN 132
INFORMATION
SUMMARY
Ct. Charge Special
No. Charge Range Defendant Allegation
1 PC 350(A)(2) 16-2-3 GREEN, KENNETH PC 12022.6(A)(2)
PC 186.11(A)(3)
2 PC 350(A)(2) 16-2-3 GREEN, KENNETH PC 186.11(A)(3)
3 HS 11378 16-2-3 GREEN, KENNETH
4 HS 11379,.6(A) 3-5-7 GREEN, KENNETH PC 1203.073(B)(3)
The District Attorney of the County of Los Angeles, by this Information alleges that:
COUNT |
On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of
COUNTERFEIT OF REGISTERED MARK, in violation of PENAL CODE SECTION 350(a)(2), a Felony, was
committed by KENNETH GREEN, who did willfully and unlawfully manufacture, intentionally sell and knowingly
possess for sale a counterfeit of a mark registered with the Secretary of State and registered on the Principal Register
of the United States Patent and Trademark Office, to wit: PFIZER.
It is further alleged that in the commission of the above offense the said defendant, KENNETH GREEN,
with the intent to do so, took, damaged and destroyed property of a value exceeding $150,000, within the meaning of
Penal Code Section 12022.6(a)(2).
Rev, 940-1/99_DA Case 26301321 Page 1
INFORMATION
Alleg.
Effect
+2 Yrs
+1Yr.
+1 Yr.
PSP
Case No. BA311682
91 ated
AD-@TVIEETAa—-24G2
#arIt is further alleged, pursuant to Penal Code section 186.11(a)(3), that the offenses set forth in
Counts | and 2 are related felonies, a material element of which is fraud and embezzlement, which involve a pattern
of related felony conduct, and the pattern of related felony conduct involves the taking of more than One Hundred
Thousand Dollars ($100,000).
eR
COUNT 2
On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of
COUNTERFEIT OF REGISTERED MARK, in violation of PENAL CODE SECTION 350(a)(2), a Felony, was
committed by KENNETH GREEN, who did willfully and unlawfully manufacture, intentionally sell and knowingly
possess for sale a counterfeit of a mark registered with the Secretary of State and registered on the Principal Register
of the United States Patent and Trademark Office, to wit! SOLVAY PHARMACEUTICALS.
eR RK
COUNT 3
On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of
POSSESSION FOR SALE OF A CONTROLLED SUBSTANCE, in violation of HEALTH & SAFETY CODE
SECTION 11378, a Felony, was committed by KENNETH GREEN, who did unlawfully possess for purpose of sale
a controlled substance, to wit: ANABOLIC STEROIDS.
"NOTICE: Conviction of this offense will require you to register pursuant to Health and Safety Code Section 11590.
Failure to do so is a crime pursuant to Health and Safety Code Section 11594."
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Rev. 940-1/99 DA Case 26301321 Page 2 Case No. BA311682 <
INFORMATIONID# 20@7-@133616-cYU
Page 18
NOTICE: Conviction of this offense will require the defendant to provide DNA samples and print
impressions pursuant to Penal Code sections 296 and 296.1. Willful refusal to provide the samples and - *
impressions is a crime. . .
THIS INFORMATION CONSISTS OF 4 COUNTS.
Filed in Superior Court, . .
County of Los Angeles
DATED: 3: G7 STEVE COOLEY
DISTRICT ATTORNEY
.County of Los“Angeles,
BY: )
DEPUTY DISTRICT ATTORNEY
/HT
Pursuant to Penal Code Section 1054.5(b), the People are hereby informally requesting that defense counsel provide
discovery to the People as required by Penal Code Section 1054.3.
Rev. 940-1/99 DA Case 26301321 Page 4 Case No. BA311682
INFORMATIONDITKA I>
PPTI2 IC. (07°
OCI VOLUNTARY SUSPECT COUNTERFEIT REPORT
Provided by: Solvay Pharmaceuticals Inc. 901 Sawyer Road Marietta, GA 30062
Contact: Debra B. Cortner
Manager, QA Compliance (DEA-GMP)
Phone: 770-578-2004 Fax: 770-578-5785
debra.cortner@solvay.com
http://www.solvaypharmaceuticals-us.com
http://www.unimed.com
To: Ms. Nancy Kennedy
Send hard copy internal reports to: OCI (SAIC IOD)
7500 Standish Place
Rockville, MD 20855
301-294-4030
TYPE OF REPORT () Initial (X) Follow-up ( ) Final
MANUFACTURER CONTROL NUMBER:
ANADROL®-50 (oxymetholone) 50 mg tablets
Lot # 08786B
NDA 16-848
NDC No. 0051-8633-33
OCI CONTROL NUMBER:
DETAILS OF COMPLAINT:
It is suspected that the ( ) drug , ( ) packaging/labeling , ( X ) both are counterfeit
1) Trademark appearing on suspected counterfeit product
Tablets imprinted with “Unimed 8633”
Printed Labels had the Trade Name ANADROL®-50.
2) Generic name appearing on suspected counterfeit product
Labels were printed with the generic name Oxymetholone.
3) Dosage form, strength and package size(s)
50 mg tablets, bottle of 100
4) Lot number(s)
Labels were printed with the Lot Number 08786B.
5) Expiration date(s) of drug
Labels were printed with the Expiration date 04/2005.
6) Date (and details) concerning companies receipt of information about the suspected
counterfeit
On 07 September 2004, the patient’s son called reporting that the Anadrol his
mother received in Mexico had broken or damaged tablets. Product is assumed to
be counterfeit because the lot number and expiration date, city and state on the
bottle’s label match the counterfeit product.
Solvay Pharmaceuticals, Inc. confirmed that the lot number and expiration date
matched the counterfeit product.
car SES
6) ateg
MI-GTVEETTA-Z9G2 Hal7) Date and results of any analysis confirming counterfeit
N/A
8) Source(s) of counterfeit product
Counterfeit product was purchased in Mexico.
9) Basis for determining that product is counterfeit if other than chemical analysis above
See item 6 above.
10) Comments
None
114) Summary of investigation by company to date
NIA
12) Locations of manufacturing sites for this product
The legitimate product was contract manufactured at Oread Pharmaceutical
Manufacturing in Palo Alto, CA for Unimed, a subsidiary of Solvay
Pharmaceuticals, Inc. It was distributed by UPS Logistics, Newark, DE. The last
shipment date by UPS Logistics for this lot was March 19, 2002. The quantity
released for distribution was 7447 bottles on October 20, 2000.
Oread, the firm that had contract manufactured Anadrol, is no longer in business.
_ Solvay Pharmaceuticals is currently establishing the Anadrol manufacturing
process at their Baudette, MN manufacturing facility, with an expected resumption
of manufacturing in late 2004 or early 2005..
13) Other law enforcement agency notifications already made
FDA Atlanta District Office
Compliance Office -Mr. Phil Campbell
Recall Coordinator - Mr. Arnold Best
DEA Atlanta District Office
Special Agent in Charge - Mr. Mike Shortis
LA County Department of Health Services
Mr. Daniel Hancz
21 September 2004
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ND-GIVIJEETEa-2682 HAI~ Dec"12-03 01:54pm From- 7-028 = =P.002/004 = F-08
=| : O58
Attachment 1
ANADROL® -50 (oxymetholone) 50 mg Tablets
NDA-Field Alert Report
NDA 16-848
Lot 08786B
10 December 2003 Page lof 3
Product Information:
Solvay Pharmaceuticals, Inc. is providing this information to FDA's Atlanta District Office
in the form of a follow-up NDA-Field Alert Repart for ANADROL®-50 (oxymetholone) 50
mg Tablets, Lot 08786B. The expiration date of the lot is 04/2005. The initial report was
submitted on November 26, 2003.
The legitimate product was contract manufactured at Oread Pharmaceutical
Manufacturing in Palo Alto, CA for Unimed, a subsidiary of Solvay Pharmaceuticals, Inc.
It was distributed by UPS Logistics, Newark, DE. The last shipment date by UPS
Logistics for this lot was March 19, 2002. The quantity released for distribution was
7447 bottles on October 20, 2000.
Reason for Field Alert Report:
On 28 November 2008 Solvay contacted Danie! Hancz of the Los Angeles County
Department of Health Services in response to a message left with Solvay
Pharmaceuticals concerning confiscated Unimed identified products. A routine search of
The Vitamin Factary in Hayward, CA revealed samples of tablets that had “Unimed
8633” stamped on them. Along with the samples they also found dies jor a tablet press
with the Unimed name, Approximately 5kg of finished product was discovered with Lot#
08786B indicated with an expiration date of 4-05. The L.A. County Department of Health
Services laboratory will analyze the material to see if contains oxymetholone.
Product will also be shipped to Solvay Pharmaceuticals, Inc. for analysis. Mr. Hancz
requested a complete report as to our findings. A punch seized in the inspection will also
be provided to Solvay Pharmaceuticals, Inc.
Solvay Pharmaceuticals, Inc. confirmed that the lot number and expiration date
coincided with an actual lot manufactured by Oread for Unimed.
INVESTIGATION (on-going):
Samples (36 tablets), dies and labels were received from the L.A. County Department of
Health Services on December 3, 2004. A visual inspection revealed the following:
4. The depth of the score mark and the actual imprint on the 36 tablets seems shallow
when compared to Anadro! tablets (lot 08687B) maintained by Solvay
Pharmaceuticals, Inc. which were manufactured during the same period as the lot in
question (08786B)
2. The die with the 8633 has a tablet score mark between the 86 and the 33 that would
facilitate the breaking in half of any tablet produces with this tool as does the actual
Anadrol product.
Te alieg
AID-GTSEETE-2662 #aTDec-2-03
01:84pm Frome
T-028 «= P.003/004 = F-DEB
Attachment 1
ANADROL® -50 (oxymetholone) 50 mg Tablets
NDA-Field Alert Report
NDA 16-848
Lot 08786B
10 December 2003 Page 2 of 3
3. The 8.5 "X11" sheet of labels is the INCORRECT revision (07-2902-42-06) from the
label that is Included with the batch record for lot 08786B (07-2902-42-06).
a. Revision 07-2902-42-06 indicates that the product is “Manufactured for
Unimed Pharmaceuticals, Ins. a Solvay Pharmaceuticals, Inc.
Company...”; whereas revision 07-2902-42-05 indicates that the product
is “Manufactured for Unimed Pharmaceuticals, Inc.”
b. Furthermore, the suspected counterfeit label had what seems tobea
lighter ink and possibly a different font.
Analytical ID testing was completed on Monday, December 8, 2003.
4. Identification testing revealed that there is no active ingredient (oxymethoione)
present in the tablets received trom the L.A. County Department of Health
Services.
a. The IR spectrum from the Anadrol evidence sample does not show
absorbances at the same wavelengths as the spectrum from USP
Oxymetholone RS. Very little residue was chloroform extracted from the
suspect tablets and what was present yielded an IR spectrum that looks
similar to that of a sugar such as sucrose or sorbital. Therefore It is
concluded that little or no oxymetholone is present in the tablets.
b, Solvay Pharmaceuticals, Inc. is investigating what additional testing may
be performed to determine the composition of the tablets supplied by the
L.A. County Department of Health Services.
On December 10, 2003, Solvay Pharmaceuticals, Inc. contacted Ms. Nancy Kennedy of
the Office of Criminal Investigation to communicate the results of the initial testing. Ms.
Kennedy was informed that Solvay had determined that this was 2 counterfeit issue.
Ms. Kennedy informed Solvay that she would pravide the information to the L.A. district
FDA field agent and that she suspected that this was related to an on-going case in
California.
Subsequent to the telephone contact with Ms. Kennedy, Solvay contacted Messrs
Arnold Best and Phil Campbell of the FDA Atlanta District Office. Solvay is seeking
guidance as to what actions are needed to resolve this issue. At this point Solvay
Pharmaceuticals, Inc. has not committed to conducting a recall for the following reasons:
4, The last date of distribution of the legitimate product was March 19, 2002.
a. Itis anticipated that the lot is no longer in the pharmacies as we are
currently shipping other lots of Anadrol 50.
2. No bottled product was seized by the L.A, County Department of Health
Services.
22 alieg
NO-GTIEETE-Z2662 #AII« Dacm12-03
O1:84ea Fro 1-028 P.004/004 F088
Attachment 1
ANADROL® -50 (oxymetholone) 50 mg Tablets
NDA-Field Alert Report
NDA 16-848
Lot 08786B
Q December 2003 Page 3 of 3
a. Solvay is seeking information from the L.A. County Department of Health
Services if any packaging materials were found at the Vitamin Factory.
b. The tablets provided to Solvay for testing were provided in a plastic bag,
not in a bottle. The labels provided to Solvay were on an 8,5” X 11” sheet
of office supply label paper.
Evaluation of the tooling provided by the L.A. County Department of Health Services
revealed the following:
1.
The bag contained two tablet press punches. One is a 5.25” upper punch the other a
3.5” lower punch (TSM B2-type). The upper punch tip face is embossed with “8633”
and the lower punch tip face is embossed with “Unimed”. The punches have no
other descriptive markings.
2. Solvay Pharmaceuticals uses TSM B-type punches (upper and lower both 5.25”).
The embossing on Solvay Pharmaceuticals ANADROL® (oxymetholone) Tablets
punches is opposite from the unknown punches (“8683” on the lower and “Unimed”
on the upper). The embossing style is also obviously different and the Solvay
Pharmaceuticals punch tips are chrome plated where the unknown punches have a
brushed finish (see attached images).
Actions being taken in response to the subject issue by Solvay Pharmaceuticals, Inc,
include:
RON
a
Notification to FDA via filing of this follow-up NDA-Field Alert Report.
Investigation of additional testing to determine the composition of the tablets.
Provide further follow-up reports to FDA.
Request guidance from FDA as to what actions are necessary to address this issue
io the satisfaction of the agency.
Hold an internal meeting to strategize and determine potential actions to be taken.
fa abeg
AI-BT9EETS-20G2 HII‘Owens, Matthew" To
™ jew.Owens@solvay.co cc “Cortner, Debra" , "Young,
David"
09/17/2007 12:02 PM bee a@soWvay
Subject RE: Trial of Kenneth Green
Mr. Hanrahan:
Please be advised that Ms. Cortner will not be testifying in the case you mention below. Please cease all
communication with Ms. Cortner and all other Solvay employees. This includes members of Solvay's legal
department. Anadrol is not a Solvay product, and Solvay cannot provide assistance to you with regard to
your case.
Matt Owens
Senior Counsel
Solvay Pharmaceuticals
From: EHanrahan@da.lacounty.gov [mailto:EHanrahan@da.lacounty.gov]
Sent: Wednesday, September 12, 2007 3:20 PM
To: Cortner, Debra
Subject: Trial of Kenneth Green
Dear Ms. Cortner,
| believe that | have spoken with you previously about this case in which | believe that you wrote a report
to the FDA alerting them to our case here in California involving the counterfeit manufacture of Anadrol.
This case is set for trial in which your testimony will be necessary on October 15, 2007. | am writing just
to check in and confirm your availability on or about that date. Please reply or call me at the number
below. Thank you,
Eugene Hanrahan
Los Angeles Couny District Attorneys Office
201 N. Figueroa St., 16th Fioor
Los Angeles, CA 90012
(213)580-3227
yz abeg
AD-GTISETS-42902 HAT
Preview
ae en, LOS ANGELES COUNTY DISTRICT ATTORNEY’S OFFICE BUREAU OF FRAUD AND CORRUPTION PROSECUTIONS MAJOR FRAUD DIVISION y “or tos STEVE COOLEY « District Attorney JANICE L. MAURIZI « Director JOHN K. SPILLANE © Chief Deputy District Attorney CURTIS A. HAZELL « Assistant District Attomey O7-l- Bse3-97 Fug In Office Sep~26-2007 Barry Laux HY 17:03:85 we . 2667-41336 Cobb County District Attorney’s Office Page £ 18-cy 10 E. Park Square, 5" Floor . Marietta, GA 30090-9618 C C. Stephenson Clerk of 2 September 19, 2007 9 aperior Court Cobb County People v. Kenneth Green BA311682 Dear Mr. Laux: Thank you so much for your help over the phone. | am always so grateful when | receive assistance from DA’s and law enforcement in other jurisdictions. | have enclosed three conformed copies of the Petitions to Compel that were filed today in the Los Angeles Superior Court. The last document is merely a proposed order for your court to follow if it wishes. In my experience, courts prefer to use their own forms, but it is there just in case. As | said, our witness coordinators are always available to schedule transportation and hotel accommodations. As you might imagine, we do it quite often. Eugene Hafrahan Deputy District Attorney {cel) 323.646.0376 ehanrahan@lacounty.gov 201 North Figueroa Street Sixteenth Floor Los Angeles, CA 90012 (213) 580-320010 di 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 STEVE COOLEY CONFO District Attorney OF ORIGIN, \ EUGENE P. HANRAHAN Los Angeles Super tGe Deputy District Attorne ourt 201 N. Figueroa St., 16 Floor SEP 19 2007 Los Angeles, CA 90012 (213) 580-3227 JOnNA,Clarke, Execuyve OHicer/Clery Attorneys for Plaintiff oT [ee SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF LOS ANGELES People of the State of Case No.: BA311682 California, EX PARTE UNDER SEAL os PETITION FOR ATTENDANCE OF OUT Plaintiff, OF STATE WITNESS DEBRA B. CORTNER vs. DATE: September 197, 2007 Kenneth Green, TRIAL DATE: October 10, 2007 TESTIMONY DATE: October 12, 2007 Defendant. TIME: 8:30 a.m. COURT: Dept. 100 COMES NOW, the People of the State of California, through their attorneys, Steve Cooley, District Attorney, and Eugene Hanrahan, Deputy District Attorney, to file their petition for the attendance of out-of-state witness DEBRA B. CORTNER, Solvay Pharmaceuticals, 901 Sawyer Road, Marietta, GA 30062, (Office Phone 770.578.2004) which is based on the files and records of this case. Petition to Compel Out-of-State Witness - 1 2 abeg NI-BTYEETS-Z2H62 #aI10 qd 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 TO: THE HONORABLE JUDGE OF THE SUPERIOR COURT FOR LOS ANGELES COUNTY, STATE OF CALIFORNIA: Eugene Hanrahan, Deputy District Attorney of Los Angeles County, California, certifies as follows under the Uniform Act to Secure the Attendance of Witnesses from Without the State in Criminal Cases, Penal Code section 1334 et seq.: 1. There is now pending in this court the above-entitied prosecution by the State of California against KENNETH GREEN, who is charged with having committed the following offenses against the laws of California: 1) counterfeiting Pfizer's trademark [Penal Code section 302(a)]; 2) counterfeiting Solvay Pharmaceuticals’ trademark [Penal Code section 302(a], 3) possession for sale of anabolic steroids [Penal Code section 11378], and 4) manufacturing anabolic steroids [(Penal Code section 11379.6(a)]. See, Attached Information, Exh. 1. 2. To prove that the defendant counterfeited Solvay Pharmaceuticals’ trademarks for Anadrol and Unimed, the People require a representative from Solvay Pharmaceuticals to testify that Kenneth Green lacked permission to manufacture or possess Anadrol tablets stamped “UNIMED” and “86 33”, and that the tablets seized from Mr. Green and his accomplice’s possession were counterfeit. Petition to Compel Out-of-State Witness - 2 £ afieg NI-GTIELTa-2EG2 HAITI10 il 12 13 14 is 16 17 18 19 20 21 22 23 24 25 26 27 28 29 3. DEBRA B. CORTNER is a material and necessary witness to this case without whose testimony the People can not establish the element that Kenneth Green lacked permission to manufacture or possess Solvay Pharmaceutical’s trademarks. 4. DEBRA B. CORTNER is listed as the contact person and Quality Compliance Manager on a memo dated September 21, 2004 that apparently alerted the United States Food and Drug Administration to the seizure of counterfeit Anadrol tablets. See, Attached Memorandum, Exh. 2. 5. DEBRA B. CORTNER informed Dan Hancz of the Los Angeles County Department of Health that a sample of Anadrol tablets seized by the Los Angeles County Sheriff's Department and forwarded to Solvay Pharmaceuticals was counterfeit. 6. On January 6, 2004, DEBRA B. CORTNER informed Dan Hancz by e-mail that she would be preparing the Field Alert Report for the Food & Drug Administration for counterfeit Anadrol lot 06785B which corresponds to the Anadrol seized by the Sheriff's Department . 7. The case is currently set for trial-setting and 995 motions on October 1, 2007. The last day for the trial is October 10, 2007. The testimony of DEBRA B. CORTNER is therefore anticipated on October 12, 2007. Petition to Compel Out-of-State Witness - 3 abeg AD-BTIJELTE-2662 HII10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 8. The State of California shall pay DEBRA B. CORTNER witness fees, travel expenses, a per diem, and any reasonable and necessary additional expenses ordered by the court per Penal Code 1334.2. 9. If DEBRA B. CORTNER as a witness, comes into the State of California in obedience to a summons directing her to attend and testify at this proceeding, the laws of the State of California and of any other state through which she may be required to pass by the ordinary course of travel to attend the trial shall give her protection from the arrest of the service of process, civil or criminal, in connection with matters which arose before her entrance into that state, pursuant to such summons. PC section 1334.4. 10. DEBRA B. CORTNER has been cooperative towards the People’s investigation and helpful in explaining the attached memorandum. 11. The People shall make every effort to minimize the inconvenience of the travel and testimony of DEBRA B. CORTNER in the arrangement of her transportation and hotel reservations. 12. On September 17, 2007, Matt Owens, Counsel for Solvay Pharmaceuticals, wrote the attached e-mail to the People advising that DEBRA B. CORTNER “will not be testifying in the case” and requesting that the People “cease all contact with her Petition to Compe] Out-of-State Witness - 4 g abeg AD-BTVIEETS-266e #aI10 il 12 13 14 15 16 1? 18 19 20 21 22 23 24 25 26 27 28 29 and all other Solvay employees” because Anadrol is no longer one of Solvay Pharmaceuticals’ drugs. See, Attached e-mail, Exh. 3. 13. This advisory and request has made it impossible to obtain DEBRA B. CORTNER’s testimony by any other means. 14. As part of the investigation,.the Los Angeles County Sheriff's Department sent seized Anadrol labels, tablets, and UNIMED die stamps to Solvay Pharmaceuticals. DEBRA B. CORTNER e-mailed to Dan Hancz that the tablets were stored in Solvay Pharmaceutical’s DEA-approved vault. The People also request the return of all evidence to the Los Angeles County Sheriff's Department, Major Crimes Bureau-HALT, 313 N. Figueroa St., Rm 803, Los Angeles, CA 90012 forthwith. WHEREFORE, it is requested that this court certify by the issuance of a certificate under the seal of the Superior Court of Los Angeles County, State of California, for the purpose of being presented to a judge of a court of record in the State of Georgia, in a proceeding to compel the attendance of DEBRA B. CORTNER as a witness in and for the State of California. 2 7. (E07 Respectfully Submitted, Date EUGENE HANRAHAN Deputy District Attorney Petition to Compel Out-of-State Witness - 5 3 alieg AIO-OBTIEETS-2692 HAI10 1. 12 i3 14 is 16 17 18 19 20 21 22 23 24 25 26 27 28 29 STEVE COOLEY District Attorney EUGENE P. HANRAHAN Deputy District Attorney California State Bar No. 185826 201 N. Figueroa St., 16" Floor Los Angeles, CA 90012 (213) 580-3227 Attorneys for Plaintiff SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF LOS ANGELES People of the State of Case No.: BA311682 California, EX PARTE UNDER SEAL CERTIFICATE OF JUDGE OF REQUESTING STATE OF CALIFORNIA FOR ATTENDANCE OF OUT-OF-STATE WITNESS DEBRA B. CORTNER Plaintiff, vs. Kenneth Green, DATE: September 19, 2003 COURT DATE: October 10, 2007 TESTIMONY DATE: October 12, 2007 Defendant. TIME: 8:30 a.m. COURT: Dept. 100 TO THE HONORABLE JUDGE OF THE COURT OF GEORGIA: I, a , hh , Judge of the Superior Court for Los Angeles County, California, a court of record, certify: 1. That there is now pending in the court the above-entitled prosecution; that Eugene Hanrahan, Deputy District Attorney, has made a request for attendance of DEBRA B. CORTNER, an out-of- Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 1 2 abeg NI-OBTIJEETA—-2eB2 HAI10 4 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 state witness, to appear and testify in said cause; that the court finds that the testimony of the requested witness, DEBRA B. CORTNER, is material, and that the attendance of said witness is necessary at this proceeding in the Superior Court for the State of California, Los Angeles County, Criminal Courts Building, 210 W. Temple St., Los Angeles, CA 90012 at 8:30 a.m. on October 12, 2007, for the purpose of giving testimony. 2. That a true copy of said request for attendance of out-of- state witness is attached and its terms incorporated for all purposes. 3. That pursuant to California’s adoption of the Uniform Act to Secure the Attendance of Witnesses from Without the State in Criminal Cases, Penal Code section 1334 et seq., upon presentation of this certificate to a judge of a court of record in Cobb County, Geogia, this court respectfully requests that a time and place for a hearing shall be fixed by the judge in GEORGIA who shall make an order directing the witness to appear at the hearing to determine that the witness is material and necessary and will not cause undue hardship to the witness to be compelled to attend and testify in the prosecution in this case in Los Angeles, California. Id. 6.That if DEBRA B. CORTNER as such witness, comes into the State of California in obedience to a summons directing her to attend Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 2 Q afieg AI-A@TVILETS-246Ge HAI10 ik 12 13 Aa is 16 7 18 19 20 au 22 23 24 25 26 27 28 29 and testify at said proceeding, the laws of the State of California and of any other state through which said witness may be required to pass by the ordinary course of travel to attend said proceeding, shall give her protection from arrest or the service of process, civil or criminal, in connection with matters which arose before her entrance into this state pursuant to said summons. Id. 7. That DEBRA B. CORTNER shall be provided travel expenses, a per diem, and any other reasonable additional costs. Id. 8. That the court in Georgia issue a subpoena, with a copy of this certificate attached ordering DEBRA B. CORTNER to attend and testify in the Los Angeles County Superior Court, Dept. 100, Criminal Courts Building, 210 W. Temple St., Los Angeles, CA 90012 at 8:30 am. 9. That in any of these hearing, this certificate shall be prima facie evidence of all the facts stated therein. Id. // // Certificate of Califoria State Court Requesting Attendance of Out of State Witness- 3 & abeg AD-GTIVEETS—-24e@2 HAI10 11 12 13 14 15 16 17 18 19 20 22 22 23 24 25 26 27 28 29 10. That DEBRA B. CORTNER, or any representative from Solvay Pharmaceuticals, return any evidence relating to this case that was provided to them by the Los Angeles County Sheriff's Department, including UNIMED die stamps, counterfeit Anadrol labels, and counterfeit Anadrol tablets. iilt2 thes Tseove Date Honorable Judge of the 5 Superior Court, Los Angeles County, California Certificate of Califoria State Court Requesting Attendance of Out of State Witness~ 4 at alieg NI-GTVIEETS-ZeGe HAT10 iL 12 13 14 15 16 7 18 19 20 21 22 23 24 25 26 27 28 29 IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA IN AND FOR THE COUNTY OF LOS ANGELES STATE OF CALIFORNIA ) COUNTY OF LOS ANGELES ) SS. CERTIFICATE I, the undersigned, Judge of the Superior Court of the State of California in and for the County of Los Angeles, do hereby certify that the said Superior Court is a Court of Record having a Clerk and Seal; that said Clerk who has signed the attached Attestation is the duly appointed, qualified Courtroom Clerk of a Superior Court Department of the State of California, in and for the County of Los Angeles, and was so qualified at the time of the signing of said Attestation; that the Clerk is the legal custodian of said Seal; that said signature is the Clerk’s genuine handwriting; and that all of the Clerk’s official acts as said Clerk are entitled to full faith and credit; and I further certify that said attestation is in due form of law. WITNESS MY HAND this date MG a . Hevtcce Honorable Judge of the Superior Court County of Los Angeles State of California Judge's Certificate re: Clerk - 1 IT alieg NIO-BTVEETA—-2o92 HAL10 ll 12 13 14 is 16 17 18 ig 20 21 22 23 24 25 26 27 28 29 IN THE SUPERIOR COURT OF THE STATE OF CALIFORNIA IN AND FOR THE COUNTY OF LOS ANGELES I, the undersigned, Clerk of the SUPERIOR COURT FOR THE STATE OF CALIFORNIA, certify that h phen It Marr 8 ’ by whom the foregoing certificate was made and whose genuine signature is subscribed, was, at the time of signing the same, and still is, Judge of the Superior Court of the State of California, in and for the County of Los Angeles, duly commissioned, qualified, and sworn, and to whose acts of such full faith and credit are due. In witness thereof, I have set my hand and affixed the Seal of this Court. / Date CLERK’ OF THE SUPERIOR COURT COUNTY OF LOS ANGELES STATE OF CALIFORNIA Clerk's Cerificate re: Judge - 1 at alieg N3-O@TSEf Tea-2zea2 HaI10 il 12 13 14 is 16 17 18 19 20 21 22 23 24 25 26 27 28 29 COURT OF THE STATE OF GEORGIA COBB COUNTY IN THE MATTER OF DEBRA B. CORTNER Solvay Pharmaceuticals 901 Sawyer Rd. Marietta, GA 30062 PROPOSED SUMMONS TO TESTIFY IN OUT-OF-STATE CRIMINAL PROCEEDING In the matter of proceedings to compel the attendance of DEBRA B. CORTNER at a criminal proceeding in the State of California, to wit, JURY TRIAL, in the case of People vs. KENNETH GREEN, case number BA311682. TO ANY SHERIFF, CONSTABLE, OR OTHER LAW ENFORCEMENT OFFICIAL AUTHORIZED TO SERVE CRIMINAL SUMMONS IN THE STATE OF GEORGIA, COBB COUNTY: The matter of the issuance of a summons requiring DEBRA B. CORTNER to attend as a witness on request of the State of California before the Los Angeles County Superior Court on October 12, 2007 having come to be heard on this date , it is found as follows: 1. That there is now pending in the Los Angeles County Superior Court the above-entitled prosecution; that Eugene Hanrahan, Deputy District Attorney, has made a request for attendance of DEBRA B. CORTNER, an out-of-state witness, to appear and testify in said cause; that the court finds that the testimony of the Proposed Summons - 1 et abe NI-GTIVYJEETS-26o62 HAT10 il 12 13 14 15 16 17 18 ig 20 21 22 23 24 25 26 27 28 23 requested witness, DEBRA B. CORTNER, is material, and that the attendance of said witness is necessary at this proceeding in the Superior Court for the State of California, Los Angeles County, Criminal Courts Building, 210 W. Temple St., Los Angeles, CA 90012 at 8:30 a.m. on October 12, 2007, for the purpose of giving testimony. 2. That a true copy of said request for attendance of out-of- state witness is attached and its terms incorporated for all purposes. 3. That if DEBRA B. CORTNER as such witness, comes into the State of California in obedience to a summons directing her to attend and testify at said proceeding, the laws of the State cf California and of any other state through which said witness may be required to pass by the ordinary course of travel to attend said proceeding, shall give her protection from arrest or the service of process, civil or criminal, in connection with matters which arose before her entrance into this state pursuant to said summons. 7. That DEBRA B. CORTNER shall be provided travel expenses, a TT per diem, and any other reasonable additional costs. 8. That in any of these hearing, this certificate shall be prima facie evidence of all the facts stated therein. ot abeg Proposed Summons - 2 A2-OT10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 1. DEBRA B. CORTNER be summoned and commanded to appear IT IS HEREBY ORDERED THAT - before the Los Angeles Superior Court at the Los Angeles County courthouse, Criminal Courts Building, 210 W. Temple St., Court 100, Los Angeles, CA 90012 on October 12, 2007, at 8:30 a.m.and there to testify and to speak the truth in the criminal proceedings. DEBRA B. CORTNER, or any representative of Solvay Pharmaceuticals, immediately send any evidence in their possession received from the Los Angeles County Sheriff's Department relating to the prosecution of Kenneth Green including counterfeit Anadrol labels, UNIMED die stamps, and counterfeit Anadrol tablets to the Los Angeles County Sheriff's Department, Major Crimes Bureau - HALT, 313 Figueroa St., Rm 803, Los Angeles, CA 90012. Witness, the Honorable Judge of this Court this date The Honorable Judge of the State of Georgia Proposed Summons - 3 st a4 age Hat Aa-@tseetSUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUNTY OF LOS ANGELES THE PEOPLE OF THE STATE OF CALIFORNIA, | CASE NO. BA311682 Plaintiff, v. 01 KENNETH GREEN (12/29/1946) INFORMATION Defendant, | Arraignment Hearing Date: 06/15/2007 Department: CEN 132 INFORMATION SUMMARY Ct. Charge Special No. Charge Range Defendant Allegation 1 PC 350(A)(2) 16-2-3 GREEN, KENNETH PC 12022.6(A)(2) PC 186.11(A)(3) 2 PC 350(A)(2) 16-2-3 GREEN, KENNETH PC 186.11(A)(3) 3 HS 11378 16-2-3 GREEN, KENNETH 4 HS 11379,.6(A) 3-5-7 GREEN, KENNETH PC 1203.073(B)(3) The District Attorney of the County of Los Angeles, by this Information alleges that: COUNT | On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of COUNTERFEIT OF REGISTERED MARK, in violation of PENAL CODE SECTION 350(a)(2), a Felony, was committed by KENNETH GREEN, who did willfully and unlawfully manufacture, intentionally sell and knowingly possess for sale a counterfeit of a mark registered with the Secretary of State and registered on the Principal Register of the United States Patent and Trademark Office, to wit: PFIZER. It is further alleged that in the commission of the above offense the said defendant, KENNETH GREEN, with the intent to do so, took, damaged and destroyed property of a value exceeding $150,000, within the meaning of Penal Code Section 12022.6(a)(2). Rev, 940-1/99_DA Case 26301321 Page 1 INFORMATION Alleg. Effect +2 Yrs +1Yr. +1 Yr. PSP Case No. BA311682 91 ated AD-@TVIEETAa—-24G2 #arIt is further alleged, pursuant to Penal Code section 186.11(a)(3), that the offenses set forth in Counts | and 2 are related felonies, a material element of which is fraud and embezzlement, which involve a pattern of related felony conduct, and the pattern of related felony conduct involves the taking of more than One Hundred Thousand Dollars ($100,000). eR COUNT 2 On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of COUNTERFEIT OF REGISTERED MARK, in violation of PENAL CODE SECTION 350(a)(2), a Felony, was committed by KENNETH GREEN, who did willfully and unlawfully manufacture, intentionally sell and knowingly possess for sale a counterfeit of a mark registered with the Secretary of State and registered on the Principal Register of the United States Patent and Trademark Office, to wit! SOLVAY PHARMACEUTICALS. eR RK COUNT 3 On or between September 3, 2003 and November 15, 2003, in the County of Los Angeles, the crime of POSSESSION FOR SALE OF A CONTROLLED SUBSTANCE, in violation of HEALTH & SAFETY CODE SECTION 11378, a Felony, was committed by KENNETH GREEN, who did unlawfully possess for purpose of sale a controlled substance, to wit: ANABOLIC STEROIDS. "NOTICE: Conviction of this offense will require you to register pursuant to Health and Safety Code Section 11590. Failure to do so is a crime pursuant to Health and Safety Code Section 11594." Ls! o eK + fo o 9 oN 3 "os os W & o B l 0 Rev. 940-1/99 DA Case 26301321 Page 2 Case No. BA311682 < INFORMATIONID# 20@7-@133616-cYU Page 18 NOTICE: Conviction of this offense will require the defendant to provide DNA samples and print impressions pursuant to Penal Code sections 296 and 296.1. Willful refusal to provide the samples and - * impressions is a crime. . . THIS INFORMATION CONSISTS OF 4 COUNTS. Filed in Superior Court, . . County of Los Angeles DATED: 3: G7 STEVE COOLEY DISTRICT ATTORNEY .County of Los“Angeles, BY: ) DEPUTY DISTRICT ATTORNEY /HT Pursuant to Penal Code Section 1054.5(b), the People are hereby informally requesting that defense counsel provide discovery to the People as required by Penal Code Section 1054.3. Rev. 940-1/99 DA Case 26301321 Page 4 Case No. BA311682 INFORMATIONDITKA I> PPTI2 IC. (07° OCI VOLUNTARY SUSPECT COUNTERFEIT REPORT Provided by: Solvay Pharmaceuticals Inc. 901 Sawyer Road Marietta, GA 30062 Contact: Debra B. Cortner Manager, QA Compliance (DEA-GMP) Phone: 770-578-2004 Fax: 770-578-5785 debra.cortner@solvay.com http://www.solvaypharmaceuticals-us.com http://www.unimed.com To: Ms. Nancy Kennedy Send hard copy internal reports to: OCI (SAIC IOD) 7500 Standish Place Rockville, MD 20855 301-294-4030 TYPE OF REPORT () Initial (X) Follow-up ( ) Final MANUFACTURER CONTROL NUMBER: ANADROL®-50 (oxymetholone) 50 mg tablets Lot # 08786B NDA 16-848 NDC No. 0051-8633-33 OCI CONTROL NUMBER: DETAILS OF COMPLAINT: It is suspected that the ( ) drug , ( ) packaging/labeling , ( X ) both are counterfeit 1) Trademark appearing on suspected counterfeit product Tablets imprinted with “Unimed 8633” Printed Labels had the Trade Name ANADROL®-50. 2) Generic name appearing on suspected counterfeit product Labels were printed with the generic name Oxymetholone. 3) Dosage form, strength and package size(s) 50 mg tablets, bottle of 100 4) Lot number(s) Labels were printed with the Lot Number 08786B. 5) Expiration date(s) of drug Labels were printed with the Expiration date 04/2005. 6) Date (and details) concerning companies receipt of information about the suspected counterfeit On 07 September 2004, the patient’s son called reporting that the Anadrol his mother received in Mexico had broken or damaged tablets. Product is assumed to be counterfeit because the lot number and expiration date, city and state on the bottle’s label match the counterfeit product. Solvay Pharmaceuticals, Inc. confirmed that the lot number and expiration date matched the counterfeit product. car SES 6) ateg MI-GTVEETTA-Z9G2 Hal7) Date and results of any analysis confirming counterfeit N/A 8) Source(s) of counterfeit product Counterfeit product was purchased in Mexico. 9) Basis for determining that product is counterfeit if other than chemical analysis above See item 6 above. 10) Comments None 114) Summary of investigation by company to date NIA 12) Locations of manufacturing sites for this product The legitimate product was contract manufactured at Oread Pharmaceutical Manufacturing in Palo Alto, CA for Unimed, a subsidiary of Solvay Pharmaceuticals, Inc. It was distributed by UPS Logistics, Newark, DE. The last shipment date by UPS Logistics for this lot was March 19, 2002. The quantity released for distribution was 7447 bottles on October 20, 2000. Oread, the firm that had contract manufactured Anadrol, is no longer in business. _ Solvay Pharmaceuticals is currently establishing the Anadrol manufacturing process at their Baudette, MN manufacturing facility, with an expected resumption of manufacturing in late 2004 or early 2005.. 13) Other law enforcement agency notifications already made FDA Atlanta District Office Compliance Office -Mr. Phil Campbell Recall Coordinator - Mr. Arnold Best DEA Atlanta District Office Special Agent in Charge - Mr. Mike Shortis LA County Department of Health Services Mr. Daniel Hancz 21 September 2004 @2 abeg ND-GIVIJEETEa-2682 HAI~ Dec"12-03 01:54pm From- 7-028 = =P.002/004 = F-08 =| : O58 Attachment 1 ANADROL® -50 (oxymetholone) 50 mg Tablets NDA-Field Alert Report NDA 16-848 Lot 08786B 10 December 2003 Page lof 3 Product Information: Solvay Pharmaceuticals, Inc. is providing this information to FDA's Atlanta District Office in the form of a follow-up NDA-Field Alert Repart for ANADROL®-50 (oxymetholone) 50 mg Tablets, Lot 08786B. The expiration date of the lot is 04/2005. The initial report was submitted on November 26, 2003. The legitimate product was contract manufactured at Oread Pharmaceutical Manufacturing in Palo Alto, CA for Unimed, a subsidiary of Solvay Pharmaceuticals, Inc. It was distributed by UPS Logistics, Newark, DE. The last shipment date by UPS Logistics for this lot was March 19, 2002. The quantity released for distribution was 7447 bottles on October 20, 2000. Reason for Field Alert Report: On 28 November 2008 Solvay contacted Danie! Hancz of the Los Angeles County Department of Health Services in response to a message left with Solvay Pharmaceuticals concerning confiscated Unimed identified products. A routine search of The Vitamin Factary in Hayward, CA revealed samples of tablets that had “Unimed 8633” stamped on them. Along with the samples they also found dies jor a tablet press with the Unimed name, Approximately 5kg of finished product was discovered with Lot# 08786B indicated with an expiration date of 4-05. The L.A. County Department of Health Services laboratory will analyze the material to see if contains oxymetholone. Product will also be shipped to Solvay Pharmaceuticals, Inc. for analysis. Mr. Hancz requested a complete report as to our findings. A punch seized in the inspection will also be provided to Solvay Pharmaceuticals, Inc. Solvay Pharmaceuticals, Inc. confirmed that the lot number and expiration date coincided with an actual lot manufactured by Oread for Unimed. INVESTIGATION (on-going): Samples (36 tablets), dies and labels were received from the L.A. County Department of Health Services on December 3, 2004. A visual inspection revealed the following: 4. The depth of the score mark and the actual imprint on the 36 tablets seems shallow when compared to Anadro! tablets (lot 08687B) maintained by Solvay Pharmaceuticals, Inc. which were manufactured during the same period as the lot in question (08786B) 2. The die with the 8633 has a tablet score mark between the 86 and the 33 that would facilitate the breaking in half of any tablet produces with this tool as does the actual Anadrol product. Te alieg AID-GTSEETE-2662 #aTDec-2-03 01:84pm Frome T-028 «= P.003/004 = F-DEB Attachment 1 ANADROL® -50 (oxymetholone) 50 mg Tablets NDA-Field Alert Report NDA 16-848 Lot 08786B 10 December 2003 Page 2 of 3 3. The 8.5 "X11" sheet of labels is the INCORRECT revision (07-2902-42-06) from the label that is Included with the batch record for lot 08786B (07-2902-42-06). a. Revision 07-2902-42-06 indicates that the product is “Manufactured for Unimed Pharmaceuticals, Ins. a Solvay Pharmaceuticals, Inc. Company...”; whereas revision 07-2902-42-05 indicates that the product is “Manufactured for Unimed Pharmaceuticals, Inc.” b. Furthermore, the suspected counterfeit label had what seems tobea lighter ink and possibly a different font. Analytical ID testing was completed on Monday, December 8, 2003. 4. Identification testing revealed that there is no active ingredient (oxymethoione) present in the tablets received trom the L.A. County Department of Health Services. a. The IR spectrum from the Anadrol evidence sample does not show absorbances at the same wavelengths as the spectrum from USP Oxymetholone RS. Very little residue was chloroform extracted from the suspect tablets and what was present yielded an IR spectrum that looks similar to that of a sugar such as sucrose or sorbital. Therefore It is concluded that little or no oxymetholone is present in the tablets. b, Solvay Pharmaceuticals, Inc. is investigating what additional testing may be performed to determine the composition of the tablets supplied by the L.A. County Department of Health Services. On December 10, 2003, Solvay Pharmaceuticals, Inc. contacted Ms. Nancy Kennedy of the Office of Criminal Investigation to communicate the results of the initial testing. Ms. Kennedy was informed that Solvay had determined that this was 2 counterfeit issue. Ms. Kennedy informed Solvay that she would pravide the information to the L.A. district FDA field agent and that she suspected that this was related to an on-going case in California. Subsequent to the telephone contact with Ms. Kennedy, Solvay contacted Messrs Arnold Best and Phil Campbell of the FDA Atlanta District Office. Solvay is seeking guidance as to what actions are needed to resolve this issue. At this point Solvay Pharmaceuticals, Inc. has not committed to conducting a recall for the following reasons: 4, The last date of distribution of the legitimate product was March 19, 2002. a. Itis anticipated that the lot is no longer in the pharmacies as we are currently shipping other lots of Anadrol 50. 2. No bottled product was seized by the L.A, County Department of Health Services. 22 alieg NO-GTIEETE-Z2662 #AII« Dacm12-03 O1:84ea Fro 1-028 P.004/004 F088 Attachment 1 ANADROL® -50 (oxymetholone) 50 mg Tablets NDA-Field Alert Report NDA 16-848 Lot 08786B Q December 2003 Page 3 of 3 a. Solvay is seeking information from the L.A. County Department of Health Services if any packaging materials were found at the Vitamin Factory. b. The tablets provided to Solvay for testing were provided in a plastic bag, not in a bottle. The labels provided to Solvay were on an 8,5” X 11” sheet of office supply label paper. Evaluation of the tooling provided by the L.A. County Department of Health Services revealed the following: 1. The bag contained two tablet press punches. One is a 5.25” upper punch the other a 3.5” lower punch (TSM B2-type). The upper punch tip face is embossed with “8633” and the lower punch tip face is embossed with “Unimed”. The punches have no other descriptive markings. 2. Solvay Pharmaceuticals uses TSM B-type punches (upper and lower both 5.25”). The embossing on Solvay Pharmaceuticals ANADROL® (oxymetholone) Tablets punches is opposite from the unknown punches (“8683” on the lower and “Unimed” on the upper). The embossing style is also obviously different and the Solvay Pharmaceuticals punch tips are chrome plated where the unknown punches have a brushed finish (see attached images). Actions being taken in response to the subject issue by Solvay Pharmaceuticals, Inc, include: RON a Notification to FDA via filing of this follow-up NDA-Field Alert Report. Investigation of additional testing to determine the composition of the tablets. Provide further follow-up reports to FDA. Request guidance from FDA as to what actions are necessary to address this issue io the satisfaction of the agency. Hold an internal meeting to strategize and determine potential actions to be taken. fa abeg AI-BT9EETS-20G2 HII‘Owens, Matthew" To ™ jew.Owens@solvay.co cc “Cortner, Debra" , "Young, David" 09/17/2007 12:02 PM bee a@soWvay Subject RE: Trial of Kenneth Green Mr. Hanrahan: Please be advised that Ms. Cortner will not be testifying in the case you mention below. Please cease all communication with Ms. Cortner and all other Solvay employees. This includes members of Solvay's legal department. Anadrol is not a Solvay product, and Solvay cannot provide assistance to you with regard to your case. Matt Owens Senior Counsel Solvay Pharmaceuticals From: EHanrahan@da.lacounty.gov [mailto:EHanrahan@da.lacounty.gov] Sent: Wednesday, September 12, 2007 3:20 PM To: Cortner, Debra Subject: Trial of Kenneth Green Dear Ms. Cortner, | believe that | have spoken with you previously about this case in which | believe that you wrote a report to the FDA alerting them to our case here in California involving the counterfeit manufacture of Anadrol. This case is set for trial in which your testimony will be necessary on October 15, 2007. | am writing just to check in and confirm your availability on or about that date. Please reply or call me at the number below. Thank you, Eugene Hanrahan Los Angeles Couny District Attorneys Office 201 N. Figueroa St., 16th Fioor Los Angeles, CA 90012 (213)580-3227 yz abeg AD-GTISETS-42902 HAT