FILED Court ofCalifornja
Sup~tj~t
County of Los Angeles
OCT 222014 1
SheTrjR
Caflcr Exec~ijy
~
8
SUPERIOR COURT OF THE STATE OF CALIFORNIA
9
FOR THE COUNTY OF LOS ANGELES
10 11
COORDINATION PROCEEDiNG SPECIAL TITLE [RULE 3.550]
JUDICIAL COUNCIL COORDINATION PROCEEDING NO. 4775
RISPERDAL AND INVEGA PRODUCT LIABILITY CASES
CASE MANAGEMENT ORDER NO. 5 RE: PLAINTIFF AND DEFENDANT FACT SHEETS
12 13
14 __________________
__________________
15
TI-uS DOCUMENT RELATES TO:
16
ALL CASES
17
—
18
This Case Management Order shall govern all cases that are presently pending in or
19 subsequently filed in or transferred to the RISPERDAL and INVEGA PRODUCT LIABILITY 20 CASES, JCCP 4775, This Order concerns the agreed upon Plaintiff Fact Sheet and Defendant
21 Fact Sheet. 22 A.
PLAINTIFF FACT SHEET
23
1.
In every case currently part of JCCP 4775 and in all other cases that become part of
24 JCCP 4775 by virtue of add-on petition, each Plaintiff shall complete a Plaintiff Fact Sheet 25 (“PFS’t) and serve the PFS to Defendants as set forth in section A(2)(c) below. A copy of the 26 agreed upon form of the PFS is attached hereto as Exhibit “A.” 27
2,
Within the timefrarnes set forth in section A(2)(f) below, Defendants shall serve
28 on Plaintiffs: [PROPOSED] CASE MANAGEMENT ORDER NO, 5 RE: PLAINTJFP AND DEFENDANT FACT SHEETS
1
a.
A Completed PFS. A “Completed PFS” is a signed PFS accompanied by
2 executed authorizations, as set forth in section A(2)(d) below, and a signed declaration in the form 3
attached to the PFS (Exhibit “B”). Each Plaintiff is required to answer each question in the PFS
4 and leaye no blanks, even if Plaintiff can only answer the question in good faith by indicating “not 5 applicable” or “unknown.” The PFS shall be verified in accordance with California Code of Civil 6 Procedure sections 2030.250(a) and 2031.250(a). 7
b.
A Completed PFS shall be treated the same as interrogatory answers and
8 responses to requests for production under the California Code of Civil Procedure, and will be 9 governed by California standards applicable to written discovery except as stated herein, If a 10 Plaintiffasserts that information and/or documents are protected by the attorney-client privilege 11 and/or the work product doctrine, the Plaintiff will produce a log describing the withheld 12 information and/or documents. 13
c.
Service of a PFS shall be via email, addressed to Defendants’ Liaison
14 Counsel at Drinker Biddle & Reath LLP at RisperdalPFS@dbr.com, as well as Plaintiffs’ Co-Lead 15 16
Counsel Sanders Viener Grossman, L.L.P. at RisperdalPFS@thcsandersfirrn.com. d.
Authorizations for the release of records.
The parties have agreed to
17 authorizations in the forms attached hereto collectively as Exhibit “C” and Exhibit “D” for the 18 release ofmedical records, psychotherapy records, and other records. Each Plaintiff shall serve on 19 Defendants authorizations with signatures for all health care providers identified on the PES 20 (except for those where an objection is raised under Paragraph A(2)(b) above), and executed 21 waivers of the consumer notice provisions set forth in California Code of Civil Procedure sections 22 1985 et seq., 2020.410 et seq and 2020.510 et seq., in the form attached as Exhibit “Cl.” 23 Additionally, each plaintiff shall serve on defendants signed authorizations for the release of 24 academic records, employment records, and priol’ litigation records, the forms of which are 25 attached hereto as Exhibits “E,” “F” and “G,” respectively (except for those where an objection is 26 raised under Paragraph A(2)(b) above).
¼
27 28
2 [PROPOSED] CASE MANAGEMENT ORDERNO. 5 RE: PLA~NT1FFAND DEFENDANT FACT SHEETS
1
e.
Records in Plaintiff’s or Plaintiffs counsel’s possession. Plaintiff or
2 Plaintiffs counsel shall provide copies of all responsive non-privileged documents subject to the 3 Requests for Production at section XVII of the PFS. 4 5
f.
Deadlines for Service of Plaintiff Fact Sheets. (i)
For all cases pending in the JCCP as of the date this order is issued
6
by the Court, Plaintiffs shall serve a Completed PVS as soon as practicable, but by
7
no later than si~y(60) day~of this order. If a law firm has a total of 25 or more
8
Plaintiffs in actions pending in this JCCP at the time of the entry of this (for
9
example, 25 individual cases or multiparty complaints containing a total of 25 or
10
more Plaintiffs), the PFS for those Plaintiffs cases shall be the served on a rolling
11
basis as follows: The first 25 Plaintiffs or 25% of the total inventory of that law
12
firm’s pending cases in the JCCP, whichever is greater, shall serve a PFS within 60
13
days of the date this Order is issued by the Court: for the next 25% of the
14
remaining Plaintiffs, a PF’S shall be served within another 30 days (i.e., within 90
15
days of the date this Order is issued by the Court); for the next 25% of the
16
remaining Plaintiffs, a PFS shall be served within another 30 days (i.e., within 120
17
days of the date this Order is issued by the Court); for the last 25% of the remaining
18
Plaintiffs, a PFS shall be served within another 30 days (i.e., within 150 days of the
19
date this Order is issued by the Court). The Plaintiffs shall produce the PFS in
20
groups of.25% based on alphabetical order. Defendants shall provide each law finn
21
with more than 25 plaintiffs a list identi~’ingthe, plaintiffs in alphabetical order.
22
Defendants shall grant any reasonable request by a law firm to substitute cases in
23
the production tiineline.
24
(ii)
For all cases filed or coordinated after the Court issues this Order,
25
the Plaintiff is required to serve a Completed PFS within 60 days of the date the
26
Plaintiff’s action is coordinated via Add-On Petition.
27 28 3 [PROPOSED] CASE MANAGEMENT ORDER NO.5 RE: PLAINTIFF AND DEFENDANT FACT SHEETS
‘
1
(iii)
If, after the entry of this order, a law firm files or has transferred into
2
this JCCP more than 25 Plaintiff actions during a calendar month (for example, 25
3
individual cases or multiparty complaints containing a total of 25 or more
4
Plaintiffs), the serving of the PFS for those 25 or more eases shall be on a rolling
5
basis as set forth in section 2.f.(i) above.
6
(iv)
The deadlines for service of the PFS are subject to change and may
7
be extended by agreement with Defendants or by the Court based on the volume of
8
PFSs to be served.
9
3.
In the event a Plaintiffs Completed PFS fails to provide requested information and
10 documents or Plaintiff fails to provide a Completed PFS within the time limits set forth herein, 11 Defendants may notify the individual Plaintiff’s counsel in writing of such failure, along with a 12 specification of the alleged deficiencies, and advise that if the deficiencies are not cured within 13 thirty (30) days, a motion to compel or other appropriate relief may be filed. All of Plaintiffs 14 supplemental answers correcting the deficiencies shall be accompanied by a signed and dated 15 declaration in the form attached to the PFS. (Exhibit “B.”) 16
4.
In the event that an institution or medical provider to whom any authorization is
17 presented refuses to provide records in response to that authorization, Defendants shall notify the 18 individuals Plaintiffs counsel, and the Plaintiff shall execute and return within tori (10) business 19 days whatever form is required by that institution or provider, such as a form with an original 20 signature, a notarized form, or the institution’s own form in order to secure the release of the 21 relevant records. 22 B.
DEFENDANT FACT SHEET
23
1.
For each Completed PFS served on Defendants, Defendants shall complete and
24 submit a Defendant Fact Sheet (“DFS”) and submit the DFS to Plaintiffs’ Co-Liaison Counsel and 25 Plaintiff’s counsel in that individual Plaintiffs case, as set forth in section B(2)(c) below. A copy 26 of the agreed-upon form of the DFS is atta9hed hereto as Exhibit “H.” 27
28 4 [PROPOSED] CASE MANAGEMENT ORDER NO, 5 RE: PLAINTIFF AND DEFENDANT FACT SI-mETS
1
2.
Within the timeframe set forth in section B(3) below, Defendants shall serve on
2 Plaintiffs:
3
a.
A Completed DFS. In each individual case designated for case specific
4 discovery, Defendants shall provide a “Completed DES,” which shall be verified in accordance 5 with California Code of Civil Procedure sections 2030.250(b) and 2031.250(b). A “Completed 6 PFS” is a signed DFS accompanied by a signed declaration in the form attached to the PFS 7 (Exhibit “I”). Defendants are required to answer each question in the DES and leave no blanks, 8 even if Defendants can only answer the question in good faith by indicating “not applicable” 9
01’
‘unknown.”
10
b.
A Completed DFS shall be treated the same as interrogatory answers and
11 responses to requests for production under the California Code of Civil Procedure, and will be 12 governed by the standards applicable to written discovery under the California Code of Civil 13 Procedure. 14
c.
Service of the 1)FS shall be via email, addressed to Plaintiffs’ Co-Lead
15 Counsel Sanders Viener Grossman, L.L.P. at RisperdalDpS@TheSanderSFirlThCOlTl, as well as to 16 Plaintiff’s counsel named in the individual Plaintiff’s case. 17
d.
Documents in Defendants’ or Defendants’ counsel’s possession. Defendants
18 or Defendants’ counsel shall provide copies of all documents specifically requested in the DFS. 19
3.
The timing of the service ofthe DFS shall be as follows:
20
a.
If a Plaintiffprovides a Completed PFS pursuant to this Order, Defendants
21 are required to serve a DFS within the time deadlines specified herein. A missing phone number, 22 zip code or other insubstantial information in the PFS or the assertion of an objection shall not 23 relieve Defendants of their duty to timely serve a DFS. Defendants shall serve a DFS within sixty 24 (60) days of Plaintiff’s service of a Substantially Complete PFS. 25
b.
The deadlines for service of the DFS are subject to change and may be
26 extended by agreement with Plaintiffs’ Co-Lead Counsel or by the Court based on the volume of~ 27 PFSs received. 28 —
5 [PROPOSED] CASE MANAGEMENT ORDER NO.5 RE: PLAINTIFF AND DEFENDANT FACT SHEETS
1
4.
In the event Defendants’ Completed DFS fails to provide requested information
2 and documents or Defendant fails to provide a Completed I)FS within the time limits set forth 3 herein, Plaintiff’s individual counsel may notify Defendant’s counsel in writing of such failure, 4 along with a specification of the alleged deficiencies, and advise that if the deficiencies are not 5 6
cured within thirty (30) days, a motion to compel and other appropriate relief may be filed. 5. The parties reserve their respective rights to seek relief from the Court regarding the
7 timing and scope of their obligation to provide fact sheets. 8 APPROVED: 9
12
ATTORNEYS FOR PLAINTIFFS
ATTORNEYS FOR DEFENDANTS
By:_______
II’ IS SO ORDERE
B%r//~A~
18
-
I-Ion. W~/tmF’. Hig berger
19 20
21 22 23 24 25
26
_______________
6
[PROPOSEDI CASE MANAGEMENT ORDER NO.5 RE: PLAINTtFF AND DEFENDANT FACT SHEETS
EXHIB1TA
SUPERIOR COURT OF THE STATE OF CALIFORNIA FOR THE COUN’I’Y OF LOS ANGELES COORDiNATION PROCEEDING SPECIAL TITLE [RULE 3.550~
JUDICIAL COUNCIL COORDINATION PROCEEDING NO. 4775
IUSPERDAL® AN]) INVEGA®
PLAINTIFF’S FACT SHEET
PRODUCT LJABJLITY CASES
______________________________________
Assigned for All Purposes to:
I-Ion. William F. Highberger
THIS DOCUMENT RELATES TO: All Cases
PLAINTIFF’S FACT SHEET Please provide the following information for each individual on whose behalf a claim is being made. If you are completing this questionnaire in a representative capacity, please respond to all questions with respect to the person who used Risperdal® andlor risperidone.’ Those questions using the term “You” refer to the person who used Risperdal® and/or risperidone. In filling out this form, please use the following definitions: (1) “healthcare provider” means any hospital, clinic, center> physician’s office, infirmary, medical or diagnostic laboratory, or other facility that provides medical, dietary, ophthalmology, psychiatric or psychological care or advice, and any pharmacy, weight loss center, dentist, x-ray department, laboratory, physical therapist 01’ physical therapy department, rehabilitation specialist physician, psychiatrist, osteopath, homeopath, chiropractor, psychologist, therapist, nurse, herbalist, nutritionist, dietician, or other persons or entities involved in the evaluation, diagnosis, care and/or treatment of you; (2) “document” means any writing or record of every type that is in your possession or the possession of your counsel, including but not limited to written documents, e-mail, cassettes, videotapes, DVDs, photographs, charts, computer discs or tapes, x-rays, drawings, graphs, phono-records, non-identical copies and other data compilations from which information can be obtained and translated, if necessary, by the respondent through electronic devices into reasonably usable forms. You may attach as many sheets of paper as necessary to fully answer these questions. If you have any documents (as defined above), including, hut not limited to, packaging, instructions, Risperdal® and/or risperidone product, or other materials or items that you are requested to produce as part of answering this fact sheet or that relate to Risperdal® and/or risperidone or any other antipsychotic medication you allegedly took, or the incident, injuries, claims, or damages that are the subject of your complaint, you must NOT dispose of, alter or modify these documents or materials in any way. You are also required to give all of these In cases where Plaintiff claims to have used Invega (paliperidone), Plaintiff will respond and produce documents accordingly.
I
documents and materials to your attorney as soon as possible. If you are unclear about these obligations please contact your attorney. This Plaintiff Fact Sheet constitutes discovery responses subject to California Code of Civil Procedure §~2030-2031 et seq. Notwithstanding Plaintiff’s election to incorporate California Code of Civil Procedure section 2030.230 in these responses and to specify the writings from which the answer may be derived or ascertained, Plaintiff shall provide this information based upon his/her current personal knowledge and shall not limit his response to referring Defendants to infonnation in medical andlor pharmacy records.. In responding to the PFS, Plaintiffis not required to review the medical records that were collected for case investigation or ligation purposes. Plaintiff shall provide the names, addresses, and telephone numbers of health care providers from information reasonably available where requested. Plaintiff is not required to render a medical opinion or to speculate regarding conditions or diagnoses he does not understand or that ate beyond his/her expertise. In completing this Fact Sheet you are under oath and must provide information that is true and correct to the best of your knowledge. I.
PRELIMINARY INFORMATION
A.
Full name of person who used Risperdal®:_~.
B.
Case caption and civil action no.:
C.
Your attorney’s name:~~
—
Firm:____________ _____________________________________________________ Address:____________________________________ Fax number:_____________________________
Telephone number:
E-mail address:______________________________ If you are completing this Fact Sheet on behalf of a minor, a mentally incapacitated person or the estate of a deceased person, state: 1.
Your name and address:
2.
Representative conservator):..
3.
Your relationship to deceased or represented person:
4,
Court which appointed you and date of appoinftnent:
capacity
(i.e.:, administrator,
2
executor,
guardian,
parent or
H.
PERSONAL INFORMATION FOR rr~ RISPERDAL® USER
A.
Address:
_______________________________________________________
Address and dates for every residence since you first ingested Risperdal® or Invega®: Address:_________________ Address:
___________________________Dates:_ _______________________________Dates:
_______
B.
Maiden, or any other names used by you, and dates of use:
C.
Social Security Number:
D.
Date and city/state of birth:.._._
B.
Sex:
F.
Ethnicity:
Male_____
Female:
Date of Death:
__________
_____
African-American Caucasian Asian Other (please specify)
-—
Hispanic
—~
Native American
——
—
G.
Marital Status:________
II.
Have you ever sei~edin any branch of the military? Yes
-
No
1.
If yes, branch and dates ofservice:
2.
Were you ever rejected or discharged from military service for any reason related to youi’ medical, physical, psychiatric or emotional condition? Yes No If yes, state the condition and the date of occurrence:._______________
I.
Schools you have attended:
1.
Elementary School: Name:__________________________________________________________ Address: Grade, completed:~ Dates of attendance: -
2.
Middle School: Narne:_, Address:________________ Grade, completed: 3
Dates of attendance: 3.
High School: Name:_____________________________ Address:________________________________ Grade, completed: Dates of attendance:
4.
If you attended school beyond high school, as to each school state: Name: Address _____________________________________________________________ Dates of attendance:__________________________________________ Degree awarded and major:~ —
*
J,
Please attach additional pages as needed.
EMPLOYMENT INFORMATION 1.
For each employer for the past ten (10) years, state:
N~ineofEmployei
*
2.
Addiess and Phone Numbet
~b Title/Duties
—
Dates t.nh~Moyect
Please attach additional pages as needed Since the age of 21, have you ever been unemployed? Yes _No If yes, state date(s) of and reasons for any unemployment:,
3.
Have you ever missed work for more thanthirty (30) days for reasons related to you!’ health (medical, physical, psychiatric or emotional condition)? Yes No —
If yes, please state the dates; employer and health condition:
4
—
III.
RISPERDAL®
Pose ___________
-~
A.
_____
~
-R~asónfqr..~e~ 1aandAd~Ve.~Qf~’
P~’esoi’ibhi~ysjoián :
~-Y
~-
c~.e’
~
I
--~
Do you continue to take Risperdal®? Yes
_
No
If no, state when you stopped and why:
—
B.
Has any healthcare provider recommended that you not use Risperdal®? Yes No * If yes, state the name and address of that healthcare provider and the date of that recommendationwas made: ___________________________________________________— * If any such advice or recommendationwas in writing, please attach a copy.
C.
Have you had any direct communication, oral or’ written, with Johnson & Johnson Co., Janssen Phannaceutica Products, L.P., Janssen L.P., Janssen Pharmaceutica, L.P., Janssen Pharmaceutics, Inc., or any of theii’ representatives? Yes No —
D.
Identify the specific materials produced by Elsevier or Excerpta Medica suggesting that Risperdal and/or Invega were safe and effective for use~in treating children and adolescents or in treating Plaintiffs condition that the prescribing physician relied on in prescribing the medication: —
IV.
INVEGA®
Date(s) ofUse ________
_____
_
Dose Name an~Addies~of ~
______
_
~
__
Reason Lot Us~ ..~.
:‘..
_
5
-..
Name and Addi~ssof .~
_
¼
E~_~I
_1_I______
A.
Do you continue to take Invega®? Yes If no, state when you stopped and why:
B.
Has any healthcare provider recommended that you not use Invega®? Yes No * If yes, state the name and address of that healthcare provider and the date of that recommendation was made: ___________________________________________________ * If any such advice or recommendationwas in writing, please attach a copy.
V.
SEROQUEL®
—
No
—
—
ife(&~~
~
~
,
.pr!jb~Physic!an~..~.
___________
a4i~t~f
‘~1~T~C~
~i~gP~4~y.
____________
A.
Do you continue to take Seroquel®? Yes If no, state when you stopped and why:
No
B.
I-las any healthcare provider recommended that you not use Seroquel®? Yes No * If yes, state the name and address of that healthcare provider and the date of that recommendation was made: * If any such advice or recommendationwas in writing, please attach a copy.
VT.
ZYPREXA®
—
Date(s) o~Use ___________
Dose
N4m6 and Addiess of ~i’e~cri~iig’Physi6i~n
Reasctn fox Use ;‘~.,
6
:..
N~iueand Adchess of ______
—
11
_
A.
Do you continue to take Zyprexa®? Yes If no, state when you stopped and why:
No
B.
Has any healthcare providci’ recommended that you not use Zyprexa®? Yes No * If yes, state the name and address of that healthcare provider and the date of that
—
—
recommendation was made: *
If any such advice or recommendation was in writing, please attach a copy.
7
—
VII.
INJTJRIES, SYMPTOMS, DIAGNOSES & DAMAGES
A.
Have you suffered any physical, mental or emotional condition as a result of using: 1.
B.
Risperdal®?
—
No
—
If you answered yes, for each condition separately state or provide: I.
Detailed description of condition:
2. 3. 4. 5.
The date you first became aware of the condition: How you first became aware of it:________________________________ Which drug(s) you believe caused your condition:, Whether you have consulted with any healthcare provider(s) regarding the condition? Yes No If yes, please identify healthcare provider’s name and address:.____.—
-
____________-—
*
C.
Yes
Please attach additional pages if necessary.
Are you claiming that you have paid, or will have to pay, any monetary damages as a result of having used Risperdal®? Yes No Ifyes, please describe:.~
VIII. HEALTHCARE PROVIDERS AND PHAI(MACIES A.
Identify, the following for each healthcare provider, including psychiatrists, psychologists, social workers, or mental health professionals, you have consulted since ten (10) years prior to your first ingestion of Risperdal® to present (or if you are a minor, please list all healtheare providers) and check the appropriate box for the healthcare providers for whom you are not seeking information called for in Section 1V of the Defense Pact Sheet:
Nai ~p~oia1ty __
Addiess and Phone Number
I Dates of
Ticatinent
______~~•ikd
8
~Reasou fom Tieatment
1N0D1~S I tespon~e iequned, rf
*
B.
Please attach additional pages if necessary.
Identify the following for each time you were hospitalized and/or received treatment in an emergency room or procedures in an out-patient setting since ten (10) years prior to your first ingestion of Risperdal® to present (or if you are a minor, please list all hospitalizations):
Tii~pmta~ Name
Ad4ress ai~YhoxteNu~l~7 Dat~sofTteatqi~ ~
Please attach additional pages if necessary.
*
C.
~jj
Identify the following for each pharmacy, drugstore and/or other supplier (including mail order and internet pharmacies) where you have ‘filled prescriptions since ten (10) years prior to your first ingestion of Risperdal® to present (or if you are a minor, please list all phannacies, etc.):
[i~aimao~ Narhe ___________________
___
L
Addiess and Phone Numbei
Dates/DateRanges Piecciiptions Weme ___________________________ ~ ~
I
-.
*
Please attach additional pages if necessary.
9
-_
~ecifyWhethem Prescu~t1onWas foi sperdal® ~‘ “.-~
__
IX.
MEDICAL BACKGROUND
A.
Current Height:
Weight:
_______
At the time of first Risperdal ingestion: Height: B
Weight:
Have you ever t~cenmedications ~rescription or over-the-counter) to control your weight? Yes _No_ If yes, please list the medication(s), the date(s) you took the medication(s), and the healthcare provider(s) that prescribed the Medication(s) (if applicable):
I)i’inking I-Iistoi’y
C. 1.
Do you currently drink alcohol (beer, wine, whiskey, etc.)? Yes If yes, how many drinks per day?
No
—
______
2.
Have you ever drunk alcohol (beer, wine, whiskey; etc.)? Yes _No If yes, what was your greatest alcohol consumption over an extended (six (6) month or greater) period within the last ten (10) years: drinks per (day/week) When was this period? to ——
_______—
D.
Smoking History 1. I.
E.
—
______—
Do you currently smoke cigarettes? Yes
No
—
If yes, how many cigarettes per day? Have you ever smoked cigarettes? Yes No If yes, when did you start smoking cigarettes? If you have smoked cigarettes in the past, hut you do not currently smoke cigarettes, when did you stop? —
—
Medical History: Have you everbeen diagnosed or treated or any of the following?
~e~ttoI’ ~ i Schizophrenia Bipolar Disorder Depression Any other mental illness or disease
__
~
~~‘:“,:~:
~
.‘~
~
:.ent ______________________________
______ .
j~ypeI diabetes inellitus Typelldiab~tes llitu~orNIDD Diabetes mellitus Gestational Diabetes Diabetic coma Diabetic ketoacidosis (DKA) Diabetic ketosis
—‘
-
______ —
,
-
.
-_____
——
10
——
~—.
_____
________——
____________________________________________ Oalactorrhea Glycosuriaiglucosuria (sugar in your urine)__—— ~y~,eoomastia Hyperglycemia (high blood sugar) Any othei’ problems related to blood sugar, glucose, ketones, or insulin High Cholesterol/hyperlipidemia j~ghtriglycerides Obesity (overweight) Pancreatitis Pituitary Tumor Neuroleptic Mali~antSyndm’omne Tardive Dyskinesia ox other movement disorder ~ExtrapyrarnidalSymptoms (BPS) I Hyperprolactinemia ~
~
~‘
~ ______________
-~
——
______
______
_________—
________________
______
______
______
______
______
—
-_______
-_____________
________________
___________________
-____
_____
______
______
_____
_____
I
_____________________________
_____________________________
F.
Do you currently suffer from any physical injuries, illnesses or disabilities that are not causedby Risperdal? Yes No If yes, please Identify: Injury, illness or disability: Date(s) of onset: _______________________________________________ Date(s) of diagnosis: Physician by whom first treated: Physician’s address (if not otherwise provided):
X.
MEDICATIONS
A.
Do you currently take, or have you taken, any ofthe following medications:
~.~iQatJon No’ Ifyes, dose and.. dates of usage Abilify (Aripiprazole) Clozaril (Clozapine) Gcodon (Zipmsidone) Haldol (Haloperidol) Navane (Thiothixine) SoIian(Atnisulpride) ~zi,,(~1ifluoperazi11e) Tborazine(Chlol’pi’ornaZinO) TrilafonlTriaVil ~Perphenazine) Any other psychiatric medication (Ifyes, please specify ~~_~.~___J_ ~
_____________
—~
______
_______________________
——
-
-—________
--_____
B.
—
-
‘
______
____________________
Have you ever taken or used any illegal/illicit drugs or methadone? Yes __No If yes, please list drug(s) and period(s).of use: ..
11
— ——
XI.
FAMILY MEDICAL HISTORY
A.
To the best of your knowledge, please indicate whether your parents, siblings1 children or grandparents have ever suffered from or are/were treated for any of the following:
[Coiid~tion Obesity Diabetes ~yp~glycemia ~~ertension or high blood pressure Vascular problems or poor circulation Glucose Intolerance Glandular disease High cholesterol or triglycerides Alcoholism Gynecomastia Any diagnosed psychiatric disease fy~p~case specify ) -~ ~.
Y~s
I
_______‘
~ _____‘
________________-
______
____________________________________
______
______________--
______
______
________________
______ ——
______—
—~
________ ‘
__________________
-~
‘
XII.
FACT WITNESSES
A.
Other than your healthcare providers, please identify all persons whom you believe possess information concerning your injury and/or other facts related to your claim:
l~’~”~’:~’;.:~-; :‘.
B.
‘~2I~~ ~
~
,:~‘~
Have you obtained a statement, oral or written, from any persons not a party to this action? Yes No (Ifyes, please attach a copy.) —
—
‘
12
XIII. INSURANCE AND BENEFITS A,
Has any insurance or other company (including Medicare/Medicaid) provided you with medical coverage or paid your medical bills at any time beginning ten (10) years prior to your prescription of Risperdal® through the present? Yes No If yes, then identify the following as to each such company: —
—
_---~
B.
Have you ever applied for worker’s compensation, Social Security, state or federal disability benefits or any other form of disability claim? Yes No If yes, then identify the following as to each application submitted: ___________________
td.,of ~
~
~
13
~
~
XIV. PRIOR LEGAL ACTIONS A.
Have you ever filed a lawsuit of made a claim, other than in the present suit, seeking civil/monetary damages? Yes No If yes, then identify the following as to each: —
Cai~tionw.~dCa~bNoI~ Date riled
I
Nat’~iieofAoio~i’~5t~com~ ~i
LaWyesN,a~meancf Addi6ss
B.
-
Have you ever been convicted of, or pled guilty to, a crime within the past ten (10) years, or a felony or crime of moral turpitude ever? Yes __No If yes, describe the crime or offense, the state and county in which convicted/pled guilty, and the outcome of the charge: —
C.
Are you a participant in any settlement relating to your use of: Seroquel®: Yes No Zyprexa®: Yes No Any other antipsyohotic: Yes _No If yes, provide the name of the other antipsychotic: —
—
—.
—
14
‘
XV.
DOCUMENTS
A.
Please sign and attach to this Fact Sheet the authorizations for the release of records.
B.
If completing this Fact Sheet on behalf of a deceased person, please attach the legal documentation establishing that you are the legal representative and the Decedent’s death certificate and autopsy report (If applicable).
C.
Please indicate whether You or your counsel in this ease have any of the following materials in your possession by placing a check mark next to the word “yes” or “no.” If yes, attach a copy of any such documents. In responding, note that Risperdal® is risperidone, Seroquel® is quetiapine, and Zyprexa® is olanzapine. 1. Medical records from any physician, hospital or healthcare provider for the ten (10) years prior to Your first ingestion of Risperdal®, Seroquel®, or Zyprexa® (whichever is earlier~to present. Yes _No —
2. Pharmacy records for the ten (10) years prior to Your first ingestion of Risperdal® Seroquel®, or Zyprexa® (whichever is earlier) to present, including receipts, prescriptions or records ofpurchase. Yes No —
—
3. Advertisements for Risperdal® or articles discussing Risperdal® that You reviewed before and dui’ing the time you took Risperdal®. Yes No —
4. The packaging, including the box and label, for Risperdal® and any remaining medication prescribed for or taken by You (plaintiffs must retain the originals of the items requested). Yes No 5. Product use instructions, product warnings, package inserts, pharmacy handouts or other materials distributed with or provided to You in connection with Your use of Risperdal®. Yes No —
6. Documents that mnention Risperdal® or any alleged health risks or hazards related to Risperdal® in Your possession at or before the time of the injury alleged in Your complaint. Yes_No —
7. Statements obtained from oi. given by any person having knowledge of facts relevant to the subject of Your specific case. Yes _No —
8. Documents that were provided to You by any of the defendants. Yes
No
—
9. Documents constituting any communications or correspondence between You and any representative of the defendants. Yes
—
No
—
10, Documents concerning any antipsychotic medications you have used or ingested, other than Risperdal®. Yes No If,yes, identify the antipsychoticmedication:_______________________________ —
—
15
11. Photographs, drawings, journals, slides, videos, DVDs ci’ any other media relating t~ Your alleged injury or Your life after the incident. Yes No 12. If You claim you have suffered a loss of earnings or earnings capacity, Yomf earnings statements or Form 1099 for each ofthe last five (5) years. Yes No —
13. If You claim you have suffered a loss of earnings or earnings capacity, all employment records in Your possession, including employment applications, performance evaluations, paychecks and pay stubs. Yes No —
—
14. If You claim any loss from medical expenses, copies of all bills from any physician, hospital, pharmacy or other healthcare provider. Yes _~No —
15. If You have been the claimant or subject of any worker’s compensation, Social Security or other disability proceeding, all documents relating to such pm’oceeding. Yes No 16. Copies of all pleadings, including but not limited to complaints, answers to complaints, answers to interrogatories, deposition notices, transcripts of depositions, settlement papers, releases, stipulations of dismissal and covenants not to sue in any action for personal injuries by or on behalf of You at any time during your life, except as protected by various legal privileges and/or confidentiality orders or agreements in place. Yes No If You arc claiming legal privileges and/or protection afforded by confidentiality orders or agreements, identify the documents that You are not producing: —
—
17. Journals, diaries, notes, letters, c-mails or other documents written by You or received by You which refer to Your injuries allegedly caused by Risperdal®, or the risks and/or benefits of Risperdal®, or which m’efei to this litigation, except as protected by various legal privileges and/or confidentiality orders or agreements in place. Yes No If You are claiming legal privileges andlor protection afforded by confidentiality orders or agreements, identify the documents that You are not producing: 18. Print-outs of all websites, social networking sites or blogs, including but not limited to Facebook, Twitter, MySpace, and Skype, which are maintained or created by You and which refer to Your injuries allegedly cai.ised by Risperdal®, or the risks and/or benefits of Risperdal®, or which refer to this litigation. Yes No 19. Print-outs of internet postings or communications, including but not limited to public forums, message boards, Facebook, Twitter, MySpace, and Skype, made by You and which refer to Your injuries allegedly caused by Risperdal®, or the risks and/or benefits of Risperdal®, or whichrefer to this litigation. Yes No —
16
*
~ v
EXHIBIT
B
DECLARATION I,
—
—-
______
—
,
declare under penalty of perjury under the laws of the
State of California that all of the information provided in this PlaintiffFact Sheet is true, complete and correct to the best of my knowledge, information and belief and that I have supplied all the documents requested in Part
of this Plaintiff’s Fact Sheet to the extent that
such documents are in my possession or in the possession of my lawyers, and that I have supplied the authorizations attached to this declaration.
Date:________________ Signature
17
EXHIBIT “C” ACTIVE/ 77552222. I
AUTHORIZATION FOR RELEASE OF ALL RECORDS
Patient Name: Other name(s) used by Patient:
_____________________________________________
DOB: Social Security Number: Case Name:
__________________________________
PRO VIDER NAME: PROVIDER ADDRESS:
___________________________________ ____________________________________
_______________________________________________ ________________________________________________________
___________________________________________________
I hereby authorize all health care providers, physicians, hospitals, clinics, and institutions; medical facilities; mental health clinics, mental health hospitals, pharmacies, educational facilities, former and present employers, insurance providers, including Medicare and Medicaid, Social Security Administration Disability Determination Services, and Department of Workers’ Claims to release all existing medical records and information, relating to the medical care, treatment, physical/mental conditiomi; and documentation of medical expenses revealed by your observation or treatment past, present and future, including records generated by third parties, as well as all educational and employment records regarding Patient to: RccordTrack 651 Allendale Road King of Prussia, PA 19406 I understand that this authorization includes but not limited to information regarding the diagnosis and treatment of drug, alcohol, Acquired Immune Deficiency Syndrome (AIDS) and psychiatric and psychological disorders, excluding Psychotherapy Notes as defined by the Health Insurance Portability and Accountability Act, 45 CFR 164.50. It also includes x-ray reports, laboratory reports, CT scans reports, MRI scans, EEGs, EKOs, sonograms, arteriograms, fetal monitor strips, discharge summaries, photographs, surgery consent form; informed consent forms regarding family planning, admission and discharge records, operation records, doctor and nurses notes, prescriptions, mnedical bill, invoices, histories, diagnoses, home health records, diabetic flow sheets, electronic and digital records, psychiatric treatment and counseling records, psychological treatment and counseling records, narratives, and any correspondence/memoranda and billing information. It also includes, to the extent such records currently exist and are in your possession, insurance records, including Medicare/Medicaid and other public assistance claims, applications, statements, eligibility material, claims or claim disputes, resolutions amid payments, medical records provided as evidence of services provided, and any other document or things pertaining to services furnished under Title XVII of the Social Security Act or other forms of public assistance (federal, state, local, etc.). It also includes my complete employment personnel file, including attendance reports, performance reports, W-4 forms, W-2 forms, medical reports and/or any and all other records relating to my employment, past and present, and all educational records, including courses taken, degrees obtained, and attendance records. This listing is not meant to be exclusive.
ACTIVF./77552222.I
1
This authorization permits you to release copies of records you trade in connection with examinations, diagnosis and treatment of me; it does not permit you, nor does it authorize you to speak to anyone concerning your care and treatment of me. It does not permit you to be interviewed or to give any statements concerning your care and treatment of me. I, the undersigned individual am on notice that: •
This request for disclosure of protected health information and any disclosure of the same pursuant hereto are at the request of the individual.
•
Any health care provider disclosing the above requested information may not condition treatment, payment, enrollment or eligibility for benefits on whether the individual signs this authorization.
•
This authorization can be revoked through written notice to the individual above listed entities, except to the extent that action has been taken in reliance on this authorization. The undersigned is aware of the potential that protected health information disclosed pursuant to this authorization is subject to re-disclosure in a manner that will not be protected by HIPAA regulations.
•
A photocopy of this authorization shall be considered as effective and valid as the original, and this authorization will remain in effect until settlement or final disposition of the above-referenced case or five (5) years from the date of this authorization, whichever comes later.
I have carefully read and understand the above, and do herein expressly and voluntarily authorize the disclosure of the above-information about, or medical records of my condition to those persons or agencies listed above. Date: _______________________________ (Signature) Patient or Patient Representative
• •
Printed Name of Patient’s Representative (if applicable)
Description of Representatives authority to act for patient / relationship to patient (if applicable) Address: [Plaintiff’s name and addressj
ACT1VE/ 77552222.1
2
EXHIBIT “C4” ACTIVE/ 77552247,1
.
AUTHORIZATION TO RELEASE PERSONAL RECORDS OF CONSUMER (Pursuant to Cal. Code of Civil Procedure §~ 1985 ci seq., 2020.410 ci. seq., and 2020.510 ci seq.) To: Name: DOB: SSN: Attorney’s Name and State Bar Number: Office Address: Telephone Number: Attorney for (Name):
I, ________, hereby authorize you to immediately release and furnish to: Drinker Biddle & Reath LLP. and/or their duly assigned agents. including Record Trak the following information: ___________________________
* Copies
of any and all records maintained by you that pertain to mc.
1.
I understand that 1 have the right to revoke this authorization at any time. 1 understand that if I revoke this authorization I must do so in writing and present my written revocation to the Provider at the Provider’s above address. I understand the revocation will not apply to information that has already been released in response to this authorization. I understand the revocation will not apply to my insurance company when the law provides my insurer with the right to contest a claim under my policy. Unless otherwise revoked, this authorization will expire in two years.
2.
1 understand that authorizing the disclosure of my records is voluntary. I can refuse to sign this authorization. I umiderstand 1 may inspect or copy the information to be used or disclosed. I understand that any disclosure of information carries with it the potential for an unauthorized re-disclosure and the information may not be protected by federal confidentiality rules.
3.
Pursuant to Cal. Code Civ. Proc. §~l985.3(c)(2), 1985.6(c)(2), 2020.410(d), and 2020.510(d), if an attorney signs this authorization on my behalf, the attorney has acted with my consent.
4.
A notarized signature is not required. A copy of this authorization may be used in place of an original.
•
Print Name:_____________________ Signature:
AciIVI~f77552247.1
______________
—•___________
_______________________ (consumer/representative) _________
Date•___________________
EXHIBIT “D” ACTJVE/ 77552298. I
AUTHORiZATION FOR USE OR DISCLOSURE OF PROTECTEI) HEALTH II’4FORMATION (PSYCHOTHERAPY NOTES) Patient Name: ___________________________________________________
1.
_______________
1 hereby authorize _________________________ __________________________(the “Practitioner”), to release a copy of my protected health information in my medical record to: Name and Address of Authorized Recipients: RecordTrack 651 Allendale Road King of Prussia, Pennsylvania 19406
2.
Description of protected health, information to be released or disclosed pursuant to this authorization: Psychotherapy notes, which include notes (in any medium) of the Practitioner or any mental health practitioner documenting, analyzing and/or describing the comutents of a conversation during any private counseling sessions and/or group, joint or family counseling sessions. I understand that the psychotherapy notes may contain information regarding my diagnosis and/or treatment for HIV and/or AIDS.
3.
The Protected Health lnformation indicated above is to be used and/or disclosed for the following purpose(s):
4.
This authorization expires on the following date/event:
Two j’ears after the date ofits authorization 5.
I understand that, when my Protected Health Information is used and disclosed pursuant to this authorization, my protected health information may be subject to re-disclosure by the authorized recipient and may no longer be protected under the federal privacy regulations issued by the U.S. Department of Health and Human Services.
6.
1 understand that I may revoke this authorization at any time by notifying the Practitioner, in writing, at: ______________________________________________________________________________________________ •Attn: Privacy Officer, but that any such revocation will not be effective with respect to any actions that the Practitioner took in reliance upon this authorization and before receiving my written revocation,
7.
I understand that I may refuse to sign this authorization and that doing so will not affect my treatment by the Practitioner or payment for that treatment.
AC1’IVE/ 77552298.1
1
•
8.
The Practitioner will not receive payment or any other remuneration in exchange for using, and/or disclosing my protected health information as descm’ibed above.
I have read the above and authorize the use and/or disclosure of the Protected Health Information as stated.
(Signature) Patient or Patient Representative
Date
If signed by Patient’s Representative, indicate relationship to the Patient:
ACTIVW 77552298.1
2
•
EXHIBIT “E”
ACTIVB/ 77552423.1
•
I
•
AUTHORIZATION FOR RELEASE OF ACADEMIC RECORDS
____ _______ _______•
Plaintiff/Patient’s Name: Date of Birth:
____
_______
Social Security No.:
______
Current Address:
TO:
-
________________________________
You are hereby authorized to disclose, make available and furnish to Drinker Biddle & Reath LLP, 50 Fremont St., 20th Floor, San Francisco, CA 94 105-2235, copies of any and all documents relating to enrollment atthe school, including but not limited to, the complete academic file including documents reflecting courses taken, teachers, grades and standardized test results,
Dated this
_____
day of_______
,
20
.
Signature of Plaintiff Print or Type Name
Sworn to and subscribed before me this _dayof_
ACTIVE/ 77552423.1 1
________________,20_
EXHIBIT “F”
ACT1V~/77552530.1
•
•
AUTHORIZATION FOR RELEASE OF INFORMATION
TO:
___________________
___________
____
In conjunction with pending litigation, you are hereby authorized to release to my attorneys, _________________________________ and/or their authorized representatives or affiliated counsel, and to DRINKER, BIDDLE & REATH LLP, attorneys for Janssen Pharmaceuticals, Inc. (f/k/a Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen Pharmaceutica Products, LP ,OrthoMcNeil Pharmaceutical Products, inc.) and/or their authorized representatives, including but not limited to, RecordTrack, the following: Any and all records in your possession or under your control pertaining to the employment of , including but not limited to, applications for employment, employee health files, descriptions of job functions, evaluations, reviews, and job performance summaries, payroll and earnings statements, and correspondence and memorandums regarding the undersigned. This Authorization is an informed consent for the release of records, and I understand that I have a right to receive a copy of this Authorization upon request. A copy of this signed Authorization shall be deemed as valid as the original. I understand that the information requested cannot be released without my specific consent. These records shall be used or disclosed solely in connection with the current litigation and which involves the person named above. This authorization shall cease to be effective as of the date on which the litigation concludes. This consent is subject to revocation by the undersigned at any time except to the extent that action has been taken in reliance thereon. 1 understand that once the information I have authorized to be disclosed reaches the noted recipient, that person or organization may redisclose it, at which time it may no longer be protected under Privacy laws.
Dated:
____________________—
_________________________________ [Plaintiff~sName] Date ofBirth
ACTIVE/ 77552530.1
1
•
EXHIBIT “G”
ACTIVE/ 77552599.1
•.
..
AUTHORIZATION FOR RELEASE OF LITIGATION RECORDS Plaintiff/Patient’s Name: J)ate of Birth:
__________
___________
__________________
__________________________________
Social Security No.: Current Address: TO:
_________________________________
______ __________________ ________________________________
__________________________________ by parent/guardian ad litem, hereby authorize ________-~_______ to disclose, make available and furnish to Drinker Biddle & Reath LLP, 50 Fremont St., 20th Floor, San Francisco, CA 94105-2235, copies of the following litigation documents (not including documents covered by the Attorney-Client and Work Product Privileges) pertaining to the civil actionfmled on behalf of by parent/guardian ad litemn, ________________-~by the (law firm and/or attorney) in connection with the following lawsuit(s):
____________
________
________________________ .
_____
1. 2. 3. 4. 5. 6. 7.
8.
______,
—. -_________
_____—~
.
-______
—.
All pleadings and court filings, including any certifications by all parties. All medical andlor psychiatric evaluations pertaining to All court orders. All deposition transcripts. All discovery requests directed to __________________, and/or his/her legal representative, if any. All discovery responses answered by ___________________, and/or his/her legal representative, if any. All medical, personnel, or educational records pertaining to All records pertaining to produced by any party to the litigation. _________
_________
—.
_________________
__________________
I understand that this authorization includes information regarding the diagnosis and treatment of drug, alcohol, Acquired Immune Deficiency Syndrome (AIDS), and psychiatric and psychological disorders as well as psychotherapy notes. It also includes x-ray reports, laboratory reports, CT scans repbrts, MRI scans, BEGs, EKGs, sonograms, arteriograms, fetal monitor strips, discharge summaries, photographs, surgery consent forms, inform consent forms regarding family planning, admission and discharge records, operation records, doctor and nurses notes, prescriptions, medical bills, invoices, histories, diagnoses, psychiatric treatment and counseling records, psychological treatment and counseling records, narratives, and any correspondence/memoranda and billing information. It also includes, to the extent such records currently exist and are in your possession, insurance records, including Medicare/Medicaid and ACTIVE/77552599.l
I
other public assistance claims, applications, statements, eligibility material, claims or claim disputes, resolutions and payments, medical records provided as evidence of services provided, and any othex document or things pertaining to services furnished under Title XVII of the Social Security Act or other forms of public assistance (federal, state, local, etc.) One set of these materials is to be provided to Drinker Biddle & Reath LLP at the expense ofDrin.ker Biddle & Reath LLP. Copies of all documents furnished pursuant to this authorization will be provided to my attorneys, at ______________—
_______
—
‘s expense.
I have carefully read and understand the above, and do herein expressly and voluntarily authorize the disclosure of the above information about the litigation, including any medical records, to those persons or agencies listed above. A facsimile, copy or photocopy of this authorization shall authorize you to release the records herein. This authorization shall be in force and effect until one year from date of execution, at which time this authorization expires.
Dated this
—_____
day of
___________,20_
Signature
Print or Type Name
AcTJvw 77552599.1 2
EXHIBIT H
•1
•
SUPERIOR COURT OF THE STATE OF CALIFORNTA FOR THE COUNTY OF LOS ANGELES COORDINATION PROCEEDING SPECIAL TITLE [RULE 3.550]
JUDICIAL COUNCIL COORDiNATION PROCEEDiNG NO. 4775
IUSPERDAL® AND INVEGA® PRODUCT LIABILITY CASES •
Assigned for All Purposes to: Hon. William F, I-Iighberger
THIS DOCUMENT RELATES TO:
All Cases
•
DEFENDANT FACT SHEET
For each case, Defendants Janssen Phannaceuticals, Inc., Johnson & Johnson Company and Johnson & Johnson Pharmaceutical Research and Development, L.LC. (collectively, “Defendants”) must complete this Defendant Fact Sheet (“DFS”). The DFS must be completed and served on all counsel in the action identified in Section 1 below. Defendants will produce documents from reasonably accessible data sources. In answering the following questions, the term “Plaintiff’ refers to the party who alleges that he ot’ she was injured, a decedent who is iepreseiited by an administrator, or a minor who is represented by a parent or guardian. The term “RISPERDAL” means the antipsychotic drug risperidone, also known by the brand name RISPERDAL~and/or RISPERDAL CONSTA°. If Plaintiff has claimed used of INVEGA in Section IV of the Plaintiffs Fact Sheet, then all requests ‘for information regarding RISPERDAL® shall include 1NVEGA® and/or IN’VEGA SUSTENNA ®, an extended release formulation of paliperidone, the primary active inetaholite of the older atypical antipsychotic risperidone. The relevant period for’ the DFS is February 1, 1994 to January 1, 2010. You should attach additional sheets of paper if necessary to completely answer the following questions. I.
CASE INFORMATION This DFS pertains to the following case: Case caption:
-
-‘
DocketNo.:
‘
TI.
-
CONTACTS AND COMMTJNICATIONS WITH PLAINTIFF’S PRESCRIBING IIEALTEICARE PROVIDER
In Section III [and IV, if applicable] of Plaintiffs Fact Sheet, Plaintiff identified person(s) who prescribed and/or dispensed RISPERDAL to the Plaintiff (hereinafter, “Prescribing Healthcare Provider”). For each Prescribing Healthcare Provider identified, state the following: A.
DEAR DOCTOR OR HEALTHCARE PROVIDER LETTERS:
1. Were any of the following letters addressed to “Dear Doctor” or “Dear Healthcare Provider” or other mailings regarding RISPERDAL sent to the Prescribing Healthcare Provider(s) identified by the Plaintiff? a.
April 16, 2003:
Yes LI
No LI
b.
September 9, 2003:
Yes LI
No LI
c.
November 10, 2003: Yes 0
No 0
d.
July 21, 2004:
Yes 0
No LI
e.
May 2005:
Yes LI
No LI
2.
If Yes, produce any documents reflecting dissemination of the letter or other communication to the Prescribing Healthcare Provider(s). 3. If your answer is “yes,” but you are unable to produce the documents requested in question II.A.2., please provide an explanation for your inability to produce the documents. B.
OThER CONTACTS WITH PLAINTIFF’S PRESCRIBING HLEALTHCARE PROVIDER:
• I. Produce all call notes from all call note databases, including the “AS400”, “Viewpoint”, “Siebel” and “Dendrite” databases, reflecting each known meeting or consultation between Defendants or anyone on behalf of Defendants with any Prescribing Healthçare Provider concerning RISPERDAL. a.
The call notes will be limited to the relevant time period, but will not be
redacted as to other products to the extent they are mentioned in the comments section.
b. 2. PLAINTIFF’S
The call notes will be producedin an Access database format.
Produce all ernails sent to the Prescribing Healthcare Provider(s) from LAST NAME
2
Defendants’ sales representatives who are identified in the call notes as having called upon the Prescribing Healthcare Provider(s) during the relevant period concerning RISPERDAL. This information shall be produced in PDF format. To the extent this data is searchable as it is ordinarily maintained, the PDF will embed searchable text. •
3. Produce Medical Information Requests (“MIRs”) made by the Prescribing Healthcare Provider and the corresponding company response(s), to the extent they exist, within the relevant time period limited to RISPERDAL. To the dxtent this data is searchable as it is ordinarily maintained, the PDF will embed searchable text. 4. Produce sampling information tied to Prescribing Healthcare Provider(s), limited to RISPBRDAL, whether it be contained in the call notes or in a sampling database. To the extent possible and/or where available, include information concerning (a) the number of sample packets provided and the dosages provided; (b) the dates they were provided; (c) the lot numbers for the samples provided; (d) the identity of the person(s) who provided the sample; and (e) any posters, literature or information either provided for display in the Prescribing Healthcare Provider’s office or waiting room or intended to be given to patients along with such samples, including Bates number, 5. To the extent available, state whether any Prescribing Healthcare Provider attended any Continuing Medical Education (“CME”) course or event sponsored by Defendant(s) where RISPERDAL was discussed. a, If Yes, identif~’the date of the CME, any third-party vendor who arranged or prepared materials for the CME, the speakers, whether Prescribing Healthcare Provider was an attendee or speaker, the location ofthe CME, the title of the CME, the cost of the CME to the Prescribing Healthcare Provider, and attach the speaker materials, any comments or reviewby the Prescribing Healthcare Provider, any documents provided to attendees, and any document or record evidencing the Prescribing Healthcare Provider’s attendance, If no such documents are available, identify the third-party vendor(s) that possess such documents.
•
6. Other than the contacts identified above, state whether there are any documents indicating that a sales representative for Defendants ever met 01’ consulted with each Prescribing Healthcare Provider identified concerning RISPERDAL, its indications (approved or otherwise), its effects, its benefits and/or its risks. YesO 7.
NoD
If Yes, identify each document.
PLAINTIFF’S LAST NAME
‘
3
C.
CONSULTINGWITH PLAINTIFF’S PRESCRIBING HEALTHCAB~ PRO VThEJ(
1, To your knowledge, state whether the Prescribing Healthcare Provider(s) has ever been consulted and/or retained by Defendants as a “key opinion leader,” member of a “speaker’s bureau,” a clinical investigator, or a member of an advisory board regarding Risperdal. YesD
NoD
2. If the Prescribing Healthcare Provider(s) has been ~onsulted and/or retained by Defendants as a Key Opinion Leader regarding RISPERDAL, produce documents that provide the followinginformation: whether the Prescribing Healthcare Provider everspoke at or attended any event, conference or other meeting regarding Risperdal; presentation or speaker materials provided by Defendants or used by Prescribing Healthcare Provider, to the extent any exist; speaker training provided by Defendants, to the extent any exist; the amount paid by Defendants to the Prescribing Healthcare Provider, if any; all agreements or contracts between the Defendants and the Prescribing Healthcare Provider; and, to the extent it exists, any written communications between Defendants and the Prescribing Healthcare Provider relating to his or her role as a Key Opinion Leader. 3. If the Prescribing Healthcare Provider(s) has been consulted and/or retained by Defendants as a member of a “speaker’s bureau” regarding RISPERDAL, produce documents that provide the following information: date of the program; name of the program; whether the Prescribing Flealthcare Provider was an attendee or a speaker; the amount of payment, ifpaid;, to the extent it exists, the colTesponding speaker program materials; and, to the extent it exists, any consulting agreements and contracts between the Prescribing Healthcare Provider(s) and Defendants, 4. If the Prescribing Healthcare Provider(s) has been consulted and/or retained by Defendants as a clinical investigator regarding RJISPERDAL, produce documents that provide the following information: the protocol number, study title, doctor location when available, the amount paid by Defendants to the Prescribing Healthcare Provider, if any, and the identity of the clinical research organization, if available.
5.
If ~hePrescribing Flealthcare Provider(s) has been consulted and/or retained by Defendants as a member of an advisory board regarding RISPERDAL, produce documents th~t provide the following information: the name of the advisory board, the date(s) the advisory board met, the amount of payment, if paid, and, to the extent it exists, any consulting agreements and contracts between the Prescribing Hea!thcare Provider(s) and Defendants. 6. Ifthe Prescribing Healthcare Provider(s) ever contacted~either orally or in writing, Defendants to request information concerning RISPERDAL, its indications, its effects and/or its risks, attach any document pertaining to any such request and Defendant(s) response, if any. -
PLAINTIFF’S LAST
-
NAME
4
III.
PLAINTIFF’S PRESCRIBING HEALTHCARE PROVIDER’S PRESCRIBING PRACTICES •
Foi’ each Prescribing Healthcare Provider identified in Section III rand IV, if applicable] of Plaintiff’s Fact Sheet, state or produce the following. 1. Do you have access to any database or information which purports to track any of Plaintiff’s Prescribing Healthc.axe Provider(s)’s prescribing practices with respect to RISPERDAL (including, but not limited to, the number of prescriptions and the time frame when these products were prescribed)? YesO
NoD
2. If Yes, please produce or identify the database(s) oi’ document(s) which capture(s) that information and attach the report(s) from the database(s). IV.
PLAINTIFF’S TREATING HEALTHCA~REPROVIDERS
In Sections VII.B.5. and VillA. of Plaintiff’s Fact Sheet, Plaintiff identified who heated the Plaintiff for his or her RISPERDAL-related injuries (hereinafter, “Treating Healthcare Provider”). For each Treating Healthcare Provider identified, state the following: A.
DEAR DOCTOR ORHEALTHCARE PROVIDER LETTERS:
1. Were any of the following letters addressed to “Dear Doctor” or “Dear Healthcare Provider” or other mailings regarding RISPERDAL sent to the Treating Healthcare Provider(s) identified by the Plaintiff? a.
April 16, 2003:
Yes LI
No 0
b.
September 9, 2003:
Yes 0
No 0
c.
November 10, 2003: Yes LI
No 0
d.
July2l,2004:
YesO
NoD
e.
May2005:
Yes 0
NoD
2. If Yes, produce any documents reflecting dissemination, of the letter or other communication to the Treating Healthcare Provider(s). 3.
If your answer is “yes,” but you are unable to produce the documents requested in
PLAINTIFFS LAST NAME
5
question IV.A.2., please provide an explanation for your inability to produce the documents. B.
OTHER CONTACTS WITH PLAINTIFF’S TREATING BEALTHCA~ PROVLD~R~
1.
To your knowledge, state whether the Treating Healthcare Provider(s) has ever been consulted and/or retained by Defendants as a “key opinion leader,” member of a “speaker’s bureau,” a clinical investigator, or a member of an advisory board regarding RISPERDAL. YesD
NoD
2. Ifthe Treating Healthcare Provider(s) has been consulted and/or retained by Defendants as a Key Opinion Leader regarding RISPERDAL, produce documents that provide the followinginformation: whether the Treating Healthc~reProvider ever spoke at or attended any event, conference or other meeting regarding Risperdal; presentation or speaker materials provided by Defendants or used by ‘l’reating Healthcare Provider, to the extent any exist; speaker training provided by Defendants, to the extent any exist; the amount paid by Defendants to the Treating Healthcare Provider, if any; all agreements or contracts between the Defendants and the Treating Healtheare Providei’; and, to the extent it exists, any written communications between Defendants and the Treating Healthcare Provider’ relating to his or her role as a Key Opinion Leader. 3. If the Treating Healthcare Provider(s) has been consulted and/or retained by Defendants as a member of a “speaker’s bureau” regarding RISPERDAL, produce documents that provide the following information: date of the program; name of the program; whether the Treating I-Iealthcarc Provider was an attendee or a speaker; the amount of payment, if paid; and, to the extent it exists, the corresponding speaker program materials. 4. if the Treating Healthcare Provider(s) has been consulted and/or retained by Defendants as a clinical investigator regarding RTSPERDAL, produce documents that provide the ‘following information: the protocol number, study title, doctor location when available, the amount paid by Defendants to the Treating Healthcare Provider, if any, and the identity of the clinical research organization, if available. 5, If the Treating Healthcare Provider(s) has been consulted and/or retained by Defendants as a member of an advisory board regarding RISPERDAL, produce doci~mentsthat provide the following information: the name of the advisory board, the date(s) the advisory board met, and the amount ofpayment, if paid. 6. Produce all call notes from all call note databases, including the “AS400”, “Viewpoint”, “Siebel” and “Dendrite” databases, reflecting each known meeting or consultation between Defendants or anyone on behalf of Defendants with any Treating I—Iealthcare Provider concerning RISPERDAL. PLAINTIFFS LASTNAME
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a. The call notes will be limited to the relevant time period, but will not be redacted as to other products to the extent they are mentioned in the comments section. b.
The call notes will be produced in an Access database format.
7. Produce Medical Information Requests (“MIRs”) made by the Treating Healthcare Provider and the corresponding company response(s), to the extent they exist, within the relevant time period limited to RISPERDAL. To the extent this data is searchable as it is ordinarily maintained, the PDF will embed searchable text. V.
I
I
PLAINTIFF’S MEDICAL CONDITION A.
1-lave you contacted or been contacted by Plaintiff, any of his/her physicians, or anyone on behalf of Plaintiff concerning Plaintiff (other than attorneys)? YesU
NoD
B.
Produce any and all documents, which reflect any communication between any person and you concerning Plaintiff and identify same by date and Bates range.
C.
Produce a copy of any MedWatch form, other than documents initiated in the course of litigation, which refers or relates to Plaintiff.
Dated:___________
PLAINTIFF’S LAST NAME
I
_______________
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_____
____
I
I
VERIFICATION I am employed by ____________________, one of the Defendants in this litigation. I am authorized, in my capacity as certification on behalf of
________,
________________
by _____________.
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—,
to execute this
The foregoing answers were
prepared with the assistance of ________________________________________________________
I declare under penalty of perjury under the laws of the State of California that all of the information provided in this Defendant Fact Sheet is true and correct to the best ofmy knowledge upon information and belief formed after a reasonable inquiry and process. Date:
________________—
__________________________——
EXHIBIT “I”
ACTWE/ 77552746.1
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-
VERIFICATION I am employed by
——_____________________________
this litigation. I am authorized, in my capacity as this certification on behalf of
,
one of the Defendants
______________________________—
in
to execute
____________________________________. The foregoing
answers were prepared with the assistance of
.
I declare under penalty ofperjury under the laws of the State of California that all of the information provided in this Defendant Fact Sheet is true and correct to the best of my knowledge upon information and beliefformed after a reasonable inquiry and process.
Date:
___________________________
ACTIVI3/ 77552746.1
1
PROOF OF SERVICE 2
STATE OF CALIFORNIA, COUNTY OF ORANGE
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I am employed in the County of Orange~State of California. I am over the age of 18 and not a party to the within action. My business address is: Robinson Calcagnie Robinson Shapiro Davis, Inc., 19 Corporate Plaza Drive, Newport Beach, California 92660. 6
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On October 21, 2014,1 served the foregoing document described as:
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CASE MANAGEMENT ORI)ER NO. 5 RE: PLAINTIFFS AND
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DEFENDANT FACT SHEETS
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on the interested parties in this action through the use of the California Risperdal® and Invega® Product Liability Cases Website maintained by Case Anywhere. I caused the foregoing document to be transmitted to Case Anywhere for electronic service in the following manner (check one box):
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I provided the document(s) listed above electronically to Case Anywhere through the
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Case Anywhere website pursuant to the instructions on that website. [The document will be deemed served on the date that it was uploaded to the website as indicated by the Case Anywhere system.]
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I declare under penalty of perjury tinder the laws ofthe State of California that the foregoing is true and correct.
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Executed on this 21st day of October, 2014, at Newport Beach, California.
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~4i~~I)
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LISA CLARK.
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.